Ⅰ. Structured Abstracts describing RCTs and the References Reporting Them
- 1. Infections (including Viral Hepatitis) (23 abstracts, 29 references)
- 2. Cancer (Condition after Cancer Surgery and Unspecified Adverse Drug Reactions of Anti-cancer Drugs) (90 abstracts, 109 references)
- 3. Blood Diseases including Anaemia (8abstracts, 9 references)
- 4. Metabolism and Endocrine Diseases (13 abstracts, 17 references)
- 5.Psychiatric/Behavioral Disorders (21 abstracts, 25 references)
- 6. Nervous System Diseases (including Alzheimer's Disease) (18 abstracts, 21 references)
- 7. Eye Diseases (4 abstracts, 5 references)
- 8. Ear Diseases (9 abstracts, 10 references)
- 9. Cardiovascular Diseases (19 abstracts, 22 references)
- 10. Respiratory Diseases (including Influenza and Rhinitis) (58 abstracts, 74 references)
- 11. Gastrointestinal, Hepato-Biliary-Pancreatic Diseases (71 abstracts, 90 references)
- 12. Skin Diseases (19 abstracts, 22 references)
- 13. Diseases of the Musculoskeletal System and Connective Tissue (21 abstracts, 20 references)
- 14. Genitourinary Tract Disorders (including Climacteric Disorders) (43 abstracts, 50 references)
- 15. Ante/Post-partum Diseases (11 abstracts, 13 references)
- 18. Symptoms and Signs (27 abstracts, 36 references)
- 19. Injury, Poisoning, and Postoperative Pain (11 abstracts, 11 references)
- 21. Others (44 abstracts, 51 references)
Ⅱ. Structured Abstracts describing Meta-analysis and the References Reporting Them
- 2. Cancer (Condition after Cancer Surgery and Unspecified Adverse Drug Reactions of Anti-cancer Drugs) (5 abstracts, 5 references)
- 5. Psychiatric/Behavioral Disorders (3 abstracts, 3 references)
- 6. Nervous System Diseases (incl uding Alzheimer's Disease) (2 abstract, 2 reference)
- 11. Gastrointestinal, Hepato-Biliary-Pancreatic Diseases (3 abstracts, 3 references)
- 15. Ante/Post-partum Diseases (1 abstract, 1 reference)
- Note:
- Original English titles assigned by authors were used in this list and the structured abstracts. When references had no English titles, the Task Force translated the original Japanese titles into English ones (*).
- Abbreviations:
- C: The Cochrane Library (CENTRAL), I: Igaku Chuo Zasshi (Japana Centra Revuo Medicana, Ichushi), N: Database Offered by Nikkankyo (the Japan Kampo Medicines Manufacturers Association)
1. Infections (including Viral Hepatitis) (23 abstracts, 29 references)
| ICD-10 | Research Question |
Kampo Formula |
References | Study Design |
Source |
|---|---|---|---|---|---|
| A08.0 |  To evaluate the efficacy of saireito (柴苓湯) for rotavirus infection. |
saireito (柴苓湯) |
Yoshiya K, Nakazawa S. A controlled study of TSUMURA Saireito (柴苓湯) for rotavirus infection*. Nihon Shonika Rinsho (Japanese Journal of Pediatrics). 1992; 45: 1889-91 (in Japanese). | quasi-RCT | N |
| Yoshiya K, Nakazawa S. A controlled study of TSUMURA Saireito (柴苓湯) for rotavirus infection*. Dai 9-kai Nihon Shoni Toyo Igaku Kenkyukai Koen Kiroku Nihon Shoni Toyo Igakkaishi (Proceedings of the 9th meeting of the Japan Pediatric Society for Oriental Medicine) 1993; 9: 20-3 (in Japanese). | N | ||||
| A09 | Efficacy of keihito for diarrhea in children. |
keihito (啓脾湯) |
Miyazaki R, Tomita H. A study of the efficacy of keihito for diarrhea in children*. Kampo no Rinsho (Journal of Kampo Medicine) 1996; 43: 217-23 (in Japanese). | quasi- RCT |
N |
| A09.0 | To evaluate the effectiveness of Kampo therapy for infectious diarrhea. |
goreisan (五苓散), goreisan (五苓散) ＋shakuyakukanzoto (芍薬甘草湯) |
Miura Y, Yamagishi Y, Mikamo H, et al. Investigation into the effects of Kampo therapy for infectious diarrhea.* Sanfujinka Kampo Kenkyu no Ayumi (Recent Progress of Kampo Medicine in Obstetrics and Gynecology) 2011; 28: 102–4 (in Japanese). | RCT-envelope | I |
| A09.0 | To compare the efficacy and safety of goreisan (五苓散) with that of probiotics in Japanese adults with acute infectious gastroenteritis. |
goreisan (五苓散) |
Morita F, Yokokawa H, Matsuda N, Fujibayashi K, et al. Comparative efficacy of goreisan and probiotics in Japanese adults with acute infectious gastroenteritis：Randomized controlled trial. Traditional & Kampo Medicine 2017; 4:89-93. | RCT | I |
| A16.2 | Improvement effects on appetite and host defense in patients undergoing chemotherapy for pulmonary tuberculosis. |
hochuekkito (補中益気湯) ＋ shosaikoto (小柴胡湯) |
Watanabe A, Hasegawa S. Effect of combined Kampo medicines as adjuvant therapy for pulmonary tuberculosis*. Nippon Iji Shinpo (Japan Medical Journal) 1992; (3553): 76-7 (in Japanese). | RCT | N |
| hochuekkito (補中益気湯) |
Watanabe A, Takahashi N, Uchida Y, et al. Efficacy of hochuekkito as adjuvant therapy for pulmonary tuberculosis*. JAMA (Japanese version) 1992; 13 (6) suppl: 20-1 (in Japanese). | N | |||
| A16.2 | To determine the efficacy of hochuekkito (補中益気湯) for reducing hepatic dysfunction and improving digestion and malabsorption in tuberculosis patients undergoing chemotherapy |
hochuekkito (補中益気湯) |
Shijubo N, Nakanishi F. Experience with hochuekkito in the short-course intensified chemotherapy for pulmonary tuberculosis – the reducing effect on hepatic dysfunction occurring as an adverse drug reaction–*. Kampo Igaku (Kampo Medicine) 1993; 17: 241-3 (in Japanese). | RCT | N |
| Nakanishi F. Experience with hochuekkito in the short-course intensified chemotherapy for pulmonary tuberculosis*. Nikkei Medical 1994; 23 (12): 24-5 (in Japanese). | N | ||||
| A31.0 | To evaluate the effectiveness of hochuekkito (補中益気湯) as an adjunct to conventional treatment for progressed refractory pulmonary Mycobacterium avium complex (MAC) disease. |
hochuekkito (補中益気湯) |
Enomoto Y, Hagiwara E, Komatsu S, et al. Pilot quasi-randomized controlled study of herbal medicine hochuekkito as an adjunct to conventional treatment for progressed pulmonary mycobacterium avium complex disease. PLOS ONE 2014; 9: 1-8. | quasi- RCT |
C&N |
| A49.0 | To evaluate whether hochuekkito has efficacy in preventing colonization and infection with methicillin-resistant Staphylococcus aureus (MRSA). |
hochuekkito (補中益気湯) |
Seki T, Matsumoto T, Deguchi H, et al. Evaluation of the efficacy of hochuekkito in preventing MRSA colonization and infection*. Kampo Igaku (Kampo Medicine) 1999; 23: 196-7 (in Japanese). | RCT- envelope |
I |
| A49.0 | To evaluate whether hochuekkito can improve immune and nutritional status in immuno-compromised hosts. |
hochuekkito (補中益気湯) |
Suzuki J, Arata S, Sugiyama M. Improvement of immunity and nutrition by hochuekkito in immuno-compromised hosts — for the control of MRSA —*. Progress in Medicine 2002; 22: 1362-3 (in Japanese). | RCT | I |
| A49.3 J20.0 |
To evaluate the efficacy of bakumondoto (麦門冬湯) for coughing associated with mycoplasma bronchitis. |
bakumondoto (麦門冬湯) |
Watanabe N, Makino S, Nakagawa T, et al. A study on the efficacy of bakumondoto for coughing associated with mycoplasma infections. Science of Kampo Medicine 2017; 41:116-8 (in Japanese). | RCT- envelope |
I |
| A49.8 | To evaluate the efficacy and safety of triple therapy with proton pump inhibitor, antibiotic, and goshuyuto for Helicobacter pylori (H. pylori) infection. |
goshuyuto (呉茱萸湯) |
Higuchi K, Arakawa T, Ando K, et al. Eradication of Helicobacter pylori with a Chinese Herbal medicine without emergence of resistant colonies. American Journal of Gastroenterology 1999; 94: 1419-20. | RCT | C |
| B02.2 | To evaluate whether hochuekkito has a preventive effect on postherpetic neuralgia (PHN). |
hochuekkito (補中益気湯) |
Taniguchi S, Terai T, Kono T, et al. The effect of hochuekkito on postherpetic neuralgia*. Hifu no Rinsho (Clinical Practice of Dermatology) 1999; 41: 601-3 (in Japanese). | RCT | I |
| hochuekkito (補中益気湯) |
Taniguchi S, Kono T, Terai T. Preventive effect of hochuekkito on postherpetic neuralgia*. Progress in Medicine 2002; 22: 863-5 (in Japanese). | RCT | N | ||
| B18.1 | Therapeutic effect of shosaikoto combined with interferon (IFN) -beta therapy on chronic active hepatitis B. |
shosaikoto (小柴胡湯) |
Sata M, Amagase H, Koga S, et al. Therapeutic effect of IFN-b (Feron) plus shosaikoto combination therapy on chronic active hepatitis B*. Rinsho to Kenkyu (Japanese Journal of Clinical and Experimental Medicine) 1994; 71: 814-20 (in Japanese). | RCT- envelope |
I |
| B18.1 | Efficacy of shosaikoto on chronic hepatitis B. |
shosaikoto (小柴胡湯) |
Sato S, Ishikawa K, Chiba T. Efficacy of Sho-saiko-to on chronic type B hepatitis. Shokakika (Gastroenterology) 1991; 15: 39-49 (in Japanese). | RCT- envelope |
N |
| B18.1 | Efficacy and safety in children with HBe antigen-positive chronic hepatitis B. |
shosaikoto (小柴胡湯) |
Shiraki K, Tanimoto K, Togashi T, et al. A study of the efficacy of shosaikoto in children with HBe antigen-positive chronic hepatitis B*. Shonika Rinsho (Japanese Journal of Pediatrics) 1991; 44: 2146-51 (in Japanese). | RCT | N |
| Shiraki K, Tanimoto K. Clinical Evaluation of the efficacy of TSUMURA Shosaikoto in children with chronic hepatitis B*. Dai 7-kai Nihon Shoni Toyo Igaku Kenkyukai Koen Kiroku (Proceedings of the 7th meeting of the Japan Pediatric Society for Oriental Medicine) 1991; 7: 18-22 (in Japanese). | N | ||||
| B18.2 | Determination of efficacy and safety of shosaikoto for type C chronic liver diseases. |
shosaikoto (小柴胡湯) |
Hatakeyama S, Ueki J, Ishizuka M, et al. Comparative study of ursodeoxycholic acid and Shosaikoto as treatment for chronic liver diseases type C. Yakuri to Chiryo (Japanese Pharmacology & Therapeutics) 1994; 22: 3295-305 (in Japanese). | RCT- envelope |
I |
| B18.2 | Efficacy of shosaikoto combined with interferon for reducing adverse effects in patients with chronic hepatitis C. |
shosaikoto (小柴胡湯) |
Nakajima O, Sone M. Interferon plus shosaikoto combination therapy for chronic hepatitis C (the first report) - effectiveness in reducing adverse effects of interferon-*. Rinsho to Kenkyu (Japanese Journal of Clinical and Experimental Medicine). 1993; 70: 2994-3002 (in Japanese with English abstract). | RCT- envelope |
I |
| B18.2 | Efficacy and safety of shosaikoto in chronic hepatitis C after interferon therapy |
shosaikoto (小柴胡湯) |
Sone M, Nakajima O. Evaluation of the usefulness of shosaikoto in the treatment of chronic hepatitis C after interferon therapy*. Rinsho to Kenkyu (Japanese Journal of Clinical and Experimental Medicine) 1995; 72: 3193-7 (in Japanese). | RCT | I |
| Nakajima O, Sone M. Evaluation of the usefulness of shosaikoto in the treatment of chronic hepatitis C after interferon therapy - the second report-*. Rinsho to Kenkyu (Japanese Journal of Clinical and Experimental Medicine) 1998; 75: 1883-8 (in Japanese). | I | ||||
| B18.2 | To confirm the efficacy of shosaikoto for interferon-resistant chronic hepatitis C. |
shosaikoto (小柴胡湯) |
Nakajima O, Sone M, Kurokawa K, et al. The Complemental treatment for chronic hepatitis C. Kagaku Ryoho Kenkyusyo Kiyo (Bulletin of the Institute of Chemotherapy) 2003; 34: 40-51 (in Japanese with English abstract). | RCT- envelope |
I |
| B18.2 | To confirm the efficacy of shosaikoto for chronic hepatitis C. |
shosaikoto (小柴胡湯) |
Nakajima O, Sone M, Onishi H, et al. Preventive effect of shosaikoto on the progression of chronic hepatitis C to cirrhosis*. Rinsho to Kenkyu (Japanese Journal of Clinical and Experimental Medicine) 1999; 76: 1008-16 (in Japanese). | RCT | I |
| B18.2 | Efficacy of interferon plus shosaikoto combination therapy for chronic hepatitis C. |
shosaikoto (小柴胡湯) |
Tanaka N, Matsuzaki Y, Osuga T, et al. A comparative study of IFN monotherapy versus IFN plus TJ-9 shosaikoto combination therapy in patients with chronic hepatitis C (interim report)*. Progress in Medicine 1993; 13: 2868-72 (in Japanese). | RCT- envelope |
N |
| B18.2 | Efficacy for reducing adverse effects of interferon therapy in patients with chronic hepatitis C |
maoto (麻黄湯) + keishito (桂枝湯) + kojinmatsu (紅参末) |
Isai H. Efficacy of Kampo formulations for reducing adverse effects of interferon therapy in patients with chronic hepatitis C*. Shindan to Chiryo (Diagnosis and Treatment) 1996; 84: 1505-9 (in Japanese). | RCT | N |
| B24.0 | Efficacy and safety in the treatment of HIV infection |
shosaikoto (小柴胡湯) |
Fukue H, Hagiwara T, Yoshida S, et al. Efficacy of high-dose shosaikoto for HIV infection*. HIV Kansensha Hassho Yobo, Chiryo ni kansuru Kenkyuhan Heisei 7 Nendo Kenkyu Hokokusho (Research Report by the Study Group on Prevention and Treatment of HIV Infection) 1996: 203-10 (in Japanese). | DB-RCT | N |
- Note:
- Original English titles assigned by authors were used in this list and the structured abstracts. When references had no English titles, the Task Force translated the original Japanese titles into English ones (*).
- Abbreviations:
- C: The Cochrane Library (CENTRAL), I: Igaku Chuo Zasshi (Japana Centra Revuo Medicana, Ichushi), N: Database Offered by Nikkankyo (the Japan Kampo Medicines Manufacturers Association)
2. Cancer (Condition after Cancer Surgery and Unspecified Adverse Drug Reactions of Anti-cancer Drugs) (90 abstracts, 109 references)
| ICD-10 | Research Question |
Kampo Formula |
References | Study Design |
Source |
|---|---|---|---|---|---|
| C15.9 | To evaluate the efficacy of rikkunshito (六君子湯) for anorexia and nausea/vomiting occurring after cancer chemotherapy for advanced esophageal cancer |
rikkunshito (六君子湯) |
Seike J. Efficacy of rikkunshito for anorexia and nausea/vomiting caused by cancer chemotherapy*. Kampo Igaku (Science of Kampo Medicine) 2010; 34: 12–3 (in Japanese). | RCT | N |
| Seike J, Sawada T, Kawakita N, et al. A new candidate supporting drug, rikkunshito, for the QOL in advanced esophageal cancer patients with chemotherapy using docetaxel/5-Fu/CDDP. International Journal of Surgical Oncology 2011; 2011: 1-7. DOI: 10.1155/2011/715623. | N | ||||
| C15.9 | To evaluate the efficacy of daikenchuto (大建中湯) for postoperative recovery in patients with esophageal carcinoma. |
daikenchuto (大建中湯) |
Nishino T, Yoshida T, Goto M, et al. The effects of the herbal medicine Daikenchuto (TJ-100) after esophageal cancer resection, open-label, randomized controlled trial. Esophagus 2018; 15: 75-82. | RCT | C |
| C15.9 K13.7 |
To investigate the impact of daiokanzoto (大黄甘草湯) and hangeshashinto (半夏瀉心湯) on oral mucositis, tongue coating bacteria, and gingiva condition in patients with esophageal cancer undergoing chemotherapy. |
daiokanzoto (大黄甘草湯), hangeshashinto (半夏瀉心湯) |
Moriyama S, Hinode D, Yoshioka M, et al. Impact of the use of Kampo medicine in patients with esophageal cancer during chemotherapy：a clinical trial for oral hygiene and oral condition. Journal of medical investigation 2018; 65,:184‐90. | RCT- envelope |
C |
| C16.9 | To evaluate the preventive effect of rikkunshito (六君子湯) on postoperative reflux esophagitis. |
rikkunshito (六君子湯) |
Mizuno S, Yamagiwa K, Iwata M, et al. Effect of early treatment with TSUMURA Rikkunshito on gastrointestinal symptoms after resection of gastric cancer — focusing on reflux esophagitis -*. Progress in Medicine 2001; 21: 1366-7 (in Japanese). | RCT | I |
| C16.9 | To verify the effects of rikkunshito (六君子湯) on cisplatin-induced anorexia in gastric cancer patients. |
rikkunshito (六君子湯) |
Ohno T, Yanai M, Ando H, et al. Rikkunshito, a traditional Japanese medicine, suppresses cisplatin-induced anorexia in humans. Clinical and Experimental Gastroenterology 2011; 4: 291-6. | RCT- cross over |
N |
| C16.9 | To evaluate the efficacy of rikkunshito (六君子湯) for gastrointestinal symptoms following endoscopic submucosal dissection (ESD) of early gastric cancer. |
rikkunshito (六君子湯) |
Uehara R, Isomoto H, Minami H, et al. Characteristics of gastrointestinal symptoms and function following endoscopic submucosal dissection and treatment of the gastrointestinal symptoms using Rikkunshito. Experimental and Therapeutic Medicine 2013; 6: 1083-88. | RCT | N |
| C16.9 | Improvement effect on host-immunity in patients undergoing postoperative adjuvant chemotherapy (UFT 300 mg/day) for gastric cancer. |
juzentaihoto (十全大補湯) |
Konno H, Maruo Y, Baba S, et al. Improvement of host-immunity by Juzen-taiho-to in the postoperative adjuvant chemotherapy for patients with gastric cancer. Biotherapy 1997; 11: 193-9 (in Japanese with English abstract). | RCT- envelope |
N |
| C16.9 | Efficacy for reducing adverse effects and improving performance status (PS) in patients undergoing postoperative adjuvant chemotherapy (fluoropyrimidine anticancer drug) for gastric cancer. |
ninjin’yoeito (人参養栄湯) |
Sugimachi K. A study of the usefulness of ninjin'yoeito in the postoperative adjuvant chemotherapy for gastric cancer*. Rinsho to Kenkyu (Japanese Journal of Clinical and Experimental Medicine) 1995; 72: 454-8 (in Japanese). | RCT- envelope |
I |
| C16.9 | To evaluate the efficacy of juzentaihoto combined with oral 5-FU as postoperative adjuvant chemotherapy in patients with surgically treated gastric cancer. |
juzentaihoto (十全大補湯) |
Yamada T. Randomized controlled trial of the efficacy of juzentaihoto (TJ-48) combined with oral 5-FU for gastric cancer*. Progress in Medicine 2004; 24: 2746-7 (in Japanese) | RCT- envelope |
N |
| C16.9 | To evaluate the efficacy of hangeshashinto (半夏瀉心湯) for gastric cancer chemotherapy-induced oral mucositis. |
hangeshashinto (半夏瀉心湯) |
Aoyama T, Nishikawa K, Takiguchi N, et al. Double-blind, placebo-controlled, randomized phase II study of TJ-14 (hangeshashinto) for gastric cancer chemotherapy-induced oral mucositis. Cancer chemotherapy and pharmacology 2014; 73: 1047-54. | DB-RCT | C&N |
| C16.9 | To evaluate the effectiveness and safety of daikenchuto (大建中湯) for postoperative bowel dysmotility after gastric cancer and total gastrectomy. |
daikenchuto (大建中湯) |
Omori K. Prospective randomized controlled study of daikenchuto for postoperative dysmotility after total gastrectomy*. Progress in Medicine 2012; 32: 614-5 (in Japanese). | RCT | N |
| C16.9 | To evaluate the effects of daikenchuto (大建中湯) on gastrointestinal emptying and motility in patients after total gastrectomy with jejunal pouch interposition reconstruction. |
daikenchuto (大建中湯) |
Endo S, Nishida T, Nishikawa K, et al. Dai-kenchu-to, a Chinese herbal medicine, improves stasis of patients with total gastrectomy and jejunal pouch interposition. American Journal of Surgery 2006; 192: 9-13. | RCT- cross over |
C |
| C16.9 | To evaluate the efficacy and safety of daikenchuto (大建中湯) for promoting peristalsis in patients with reduced intestinal peristalsis after total gastrectomy. |
daikenchuto (大建中湯) |
Akamaru Y, Takahashi T, Nishida T, et al. Effects of daikenchuto, a Japanese herb, on intestinal motility after total gastrectomy: a prospective randomized trial. Journal of Gastrointestinal Surgery 2015; 19: 467-72. | RCT | N |
| C16.9 | To verify the effects of daikenchuto (大建中湯) for intestinal tract motility after total gastrectomy for gastric cancer patients. |
daikenchuto (大建中湯) |
Yoshikawa K, Shimada M, Wakabayashi G, et al. Effect of daikenchuto, a traditional Japanese herbal medicine, after total gastrectomy for gastric cancer: a multicenter, randomized, double-blind, placebo-controlled, phase II trial. Journal of American College of Surgeons 2015; 221: 571-8. | DB-RCT | C&N |
| C18.9 | To elucidate the mechanism by which juzentaihoto reduces the adverse reaction to treatment with 5-fluorouracil (5-FU) (hepatopathy) by determining the distribution of 5-FU in tissues of patients with colorectal cancer receiving slow-release tegafur preoperatively. |
juzentaihoto (十全大補湯) |
Toda T, Matsuzaki K, Kawano T, et al. Preoperative and postoperative combination therapy with slow-release tegafur capsules and Juzen-taiho-to in patients with colorectal cancer - Tissue concentrations and thymidine phosphorylase activity -. Gan no Rinsho (Japanese Journal of Cancer Clinics) 1998; 44:317-23 (in Japanese with English abstract). | RCT- envelope |
N |
| C18.9 | Immunostimulation and suppression of liver metastasis in postoperative patients with colorectal cancer |
shosaikoto (小柴胡湯) |
Sasaki K, Takashima K, Kitagawa K, et al. Immunostimulation and suppression of liver metastasis by Kampo medicines in postoperative patients with colorectal cancer*. Progress in Medicine 1992; 12: 1652-5 (in Japanese). | RCT | N |
| C18.9 | Immunostimulation and improvement of nutritional status in postoperative patients with colorectal cancer |
ninjin’yoeito (人参養栄湯) |
Araki Y, Tanaka T, Ogata Y, et al. Immunological evaluation of the efficacy of Kampo prescription for postoperative patients with colorectal cancer*. Shinyaku to Rinsho (Journal of New Remedies and Clinic) 1992; 41: 1670-6 (in Japanese). | RCT- envelope |
N |
| C18.9 | To evaluate the clinical efficacy of juzentaihoto for the prevention of postoperative recurrence of colorectal cancer. |
juzentaihoto (十全大補湯) |
Sasaki K, Ezoe E, Araya J, et al. Effects of Kampo medicine on the immune Functions in gastroenteric cancer patients. Kampo to Saishin-chiryo (Kampo & the Newest Therapy) 2006; 15: 9-14 (in Japanese). | RCT | N |
| Sasaki K, Takasaka H, Furuhata T, et al. Effect of Kampo medicine on cancer chemotherapy. Geka Chiryo (Surgical Therapy) 2007; 97: 504-10 (in Japanese). | N | ||||
| C18.9 | To evaluate the efficacy of 1-week preoperative treatment with hochuekkito for improving pre- and postoperative nutritional status and immune function in patients scheduled to undergo laparotomy for large intestine carcinoma. |
hochuekkito (補中益気湯) |
Nishimura G. Evaluation of clinical efficacy of hochuekkito in improving nutritional/immune status in patients with surgery for large intestine carcinoma*. Progress in Medicine 2009; 29: 84-5. | RCT-envelope | N |
| C18.9 | To clarify the efficacy and adverse effects of goshajinkigan (牛車腎気丸) for peripheral neuropathy induced by oxaliplatin therapy for advanced or recurrent colorectal cancer. |
goshajinkigan (牛車腎気丸) |
Nishioka M, Shimada M, Kurita N, et al. The Kampo medicine, Goshajinkigan, prevents neuropathy in patients treated by FOLFOX regimen. International Clinical Journal of Oncology 2011; 16: 322-7. | RCT | N |
| Nishioka M, Shimada M, Kurita N, et al. The significance of Kampo as needed for cancer therapy – How to put it to use in clinical settings – Goshajinkigan alleviates FOLFOX-related peripheral neuropathy*. Sanfujinka Kanpo Kenkyu no Ayumi (Recent Progress of Kampo Medicine in Obstetrics and Gynecology) 2012; (29): 22–7 (in Japanese). | I | ||||
| C18.9 | To investigate the inhibitory effect of TSUMURA Goshajinkigan (牛車腎気丸) Extract Granules(TJ-107) on oxaliplatin-induced peripheral neuropathy (OPN). |
goshajinkigan (牛車腎気丸) |
Kono T, Hata T, Morita S, et al. Goshajinkigan oxaliplatin neurotoxicity evaluation (GONE) : a phase 2, multicenter, randomized, double-blind, placebo-controlled trial of goshajinkigan to prevent oxaliplatin-induced neuropathy. Cancer Chemotherapy and Pharmacology 2013; 72: 1283-90. | DB-RCT | N |
| C18.9 | To evaluate the preventive effect of goshajinkigan (牛車腎気丸) for FOLFOX-induced peripheral neurotoxicity. |
goshajinkigan (牛車腎気丸) |
Oki E, Emi Y, Kojima H,et al. Preventive effect of goshajinkigan on peripheral neurotoxicity of FOLFOX therapy (GENIUS trial): a placebo-controlled, double-blind, randomized phase III study. International Journal of Clinical Oncology 2015; 20: 767-75. | DB-RCT | C&N |
| C18.9 | To compare the preventive effects of hangeshashinto (半夏瀉心湯) for delayed diarrhea following administration of CPT-11 for colorectal cancer. |
hangeshashinto (半夏瀉心湯) |
Miyauchi H. A comparative study of the preventive effects of hangeshashinto and oral alkalizer for delayed diarrhea in chemotherapy for colorectal cancer (FOLFILI)*. Progress in Medicine 2012; 32: 628-9 (in Japanese). | RCT | N |
| C18.9 | To verify the clinical effects of hangeshashinto (半夏瀉心湯) for chemotherapy-induced oral mucositis. |
hangeshashinto (半夏瀉心湯) |
Matsuda C, Munemoto Y, Mishima H, et al. Double-blind, placebo-controlled, randomized phase II study of TJ-14 (hangeshashinto) for infusional fluorinated-pyrimidine-based colorectal cancer chemotherapy-induced oral mucositis. Cancer Chemotherapy Pharmacology 2015 ;76: 97-103. | DB-RCT | C&N |
| C18.9 | To evaluate the anti-inflammatory effects of daikenchuto (大建中湯) on patients with colorectal cancer following laparoscopic resection. |
daikenchuto (大建中湯) |
Yoshikawa K, Shimada M, Nishioka M, et al. The effects of the Kampo medicine (Japanese herbal medicine) ’’Daikenchuto’’ on the surgical inflammatory response following laparoscopic colorectal resection. Surgery Today 2012; 42: 646-51. | RCT | I |
| C18.9 | To evaluate the effects of daikenchuto (大建中湯) on intestinal paralysis after surgery for colorectal cancer. |
daikenchuto (大建中湯) |
Nagashima Y, Tanaka N, Furukawa K, et al. Effects of daikenchuto (TJ-100) on intestinal paralysis after surgery for colorectal cancer*. Progress in Medicine 1998; 18: 903-5 (in Japanese). | RCT | N |
| C18.9 | To verify inhibition of inflammatory cytokine production and post-operative enhanced reactivation of intestinal function by daikenchuto (大建中湯) in colorectal cancer patients. |
daikenchuto (大建中湯) |
Ota M. A Randomized controlled trial of perioperative daikenchuto for colorectal cancer surgery*. Progress in Medicine 2012; 32: 618–9 (in Japanese). | RCT | N |
| C18.9 | To evaluate the effectiveness of daikenchuto (大建中湯) for perioperative intestinal paralysis following laparoscopic colon cancer surgery. |
daikenchuto (大建中湯) |
Yaegashi M, Otsuka K, Itabashi T, et al. Applying a Kampo medication to lower gastrointestinal tract surgery*. Shokaki Geka (Gastroenterological Surgery) 2013; 36: 1315-24. | RCT | C&N |
| Yaegashi M, Otsuka K, Itabashi T, et al. Daikenchuto stimulates colonic motility after laparoscopic -associated colectomy. Hepato-Gastroenterology 2014; 61: 85-9. | N | ||||
| C18.9 | To evaluate the effectiveness and safety of daikenchuto (大建中湯) soon after colorectal cancer surgery. |
daikenchuto (大建中湯) |
Watanabe K. Effects of Daikenchuto on early bowel movement after colorectal cancer surgery.* Kampo Igaku (Science of Kampo Medicine) 2010; 34: 346–7 (in Japanese). | quasi- RCT |
N |
| Fujii S. Effects of Daikenchuto on early bowel movement after colorectal cancer surgery.* Progress in Medicine 2011; 31: 468–9 (in Japanese). | N | ||||
| C18.9 | To evaluate the efficacy of daikenchuto (大建中湯) for gastrointestinal dysfunction following colon surgery. |
daikenchuto (大建中湯) |
Katsuno H, Maeda K, Kaiho T, et al. Clinical efficacy of daikenchuto for gastrointestinal dysfunction following colon surgery: a randomized, double-blind, multicenter, placebo-controlled study (JFMC39-0902). Japanese Journal of Clinical Oncology 2015; 45: 650-6. | DB-RCT | N |
| C18.9 | To verify the effects of daikenchuto (大建中湯) for gastrointestinal function recovery after laparotomy in patients with sigmoid colon cancer or rectosigmoid cancer. |
daikenchuto (大建中湯) |
Katsuno H, Maeda K, Ohya M, et al. Clinical pharmacology of daikenchuto assessed by transit analysis using radiopaque markers in patients with colon cancer undergoing open surgery: a multicenter double-blind randomized placebo-controlled study (JFMC39-0902 additional study). Journal of Gastroenterology 2016; 51: 222-9. | DB-RCT | N |
| C20.0 | To evaluate the effects of daikenchuto on intestinal obstruction following colorectal cancer surgery. |
daikenchuto (大建中湯) |
Takagi K, Nagata H, Horie T, et al. Effect of the preventive herbal therapy using Dai-kenchu-to on intestinal obstruction following curative resection for colorectal cancer: prospective, randomized study. Kampo Kenkyu (Kampo Research) 2007; (429): 270-1 (in Japanese). | RCT | I |
| C22.0 | To evaluate the effect of juzentaihoto for reducing adverse effects of Spongel + Lipiodol + phosphatidyl choline + cisplatin treatment in transarterial embolization (TAE) for hepatocellular carcinoma. |
juzentaihoto (十全大補湯) |
Nagatomo H, Shigehira M. Efficacy of TSUMURA Juzentaihoto for reducing the adverse effects of the anticancer drug cisplatin*. Kampo Igaku (Kampo Medicine) 1992; 16: 116-9 (in Japanese). | RCT | N |
| C22.0 | Preventive effect on the progression of cirrhosis to liver cancer |
shosaikoto (小柴胡湯) |
Ayukawa K, Sato T, Nagase S, et al. Preventive effect of shosaikoto on liver carcinogenesis*. Rinsho to Kenkyu (Japanese Journal of Clinical and Experimental Medicine) 1994; 71: 1874-6 (in Japanese). | quasi- RCT |
I |
| C22.0 | To evaluate the efficacy of liver protectors for preventing carcinogenesis in patients with chronic hepatitis C. |
shosaikoto (小柴胡湯), juzentaihoto (十全大補湯) |
Tarao K, Shibuya A, Ohkawa S, et al. Prevention of hepatocarcinogenesis by anti-inflammatory therapy: is combination anti-inflammatory therapy targeting an ALT level of under 80 units effective for hepatitis C virus-related cirrhosis (Child A)?: comparison with monotherapy*. Kanagawa Cancer Center – Nenpo (Annual Report) 2003; 19: 92 (in Japanese). | RCT | N |
| Tarao K. Persistent inflammation and hepatocarcinogenesis in chronic hepatitis C and hepatitis C virus-related cirrhosis*. Kanagawa Igakkai Zasshi (The Journal of the Kanagawa Medical Association) 2006; 33: 115-8 (in Japanese). | N | ||||
| Tarao K. Prevention of HCC by anti-inflammatory agents in patients with chronic hepatitis C. Rinsho Shokaki Naika (Clinical Gastroenterology)2007; 22: 961-9 (in Japanese). | N | ||||
| C22.0 | To evaluate the hepatocellular carcinoma-preventive effect of juzentaihoto (十全大補湯) administered for liver cirrhosis. |
juzentaihoto (十全大補湯) |
Higuchi K, Watanabe A. Study on liver cancer-preventive effect of juzentaihoto in patients with liver cirrhosis*. Methods in Kampo Pharmacology 2000; 5: 29-33 (in Japanese). | RCT- envelope |
N |
| C22.0 | To evaluate the hepatocellular carcinoma-preventive effect of juzentaihoto (十全大補湯) administered for liver cirrhosis. |
juzentaihoto (十全大補湯) |
Higuchi K, Shimizu Y, Yasumura S, et al. Preventive effect of liver carcinogenesis by Juzen-Taiho-To in the patients with liver cirrhosis. Kan-Tan-Sui 2002; 44: 341-6 (in Japanese) | RCT- envelope |
I |
| C22.0 | To evaluate the anti-inflammatory efficacy of daikenchuto in postoperative patients with liver carcinoma. |
daikenchuto (大建中湯) |
Yoshikawa K. Evaluation of anti-inflammatory efficacy of daikenchuto —A study in a fasted rat model and a randomized controlled trial in postoperative patients with colorectal cancer—*. Dai 5 Kai Nippon Shokakan Gakkai Sokai Gakujutsu Syukai (5th Annual Meeting of the Japanese Gastroenterological Association)(Workshop 5) 2009:9-10. | RCT | N |
| C22.0 | To evaluate the usefulness of daikenchuto (大建中湯) in postoperative patients who underwent hepatectomy. |
daikenchuto (大建中湯) |
Nishi M, Shimada M, Uchiyama H, et al. The beneficial effects of Kampo medicine dai-ken-chu-to after hepatic resection：a prospective randomized control study. Hepato-Gastroenterology 2012; 59: 2290-4. | RCT | N |
| C22.0 | To evaluate the effect of daikenchuto (大建中湯) on abdominal bloating in patients who underwent hepatectomy for liver malignancies. |
daikenchuto (大建中湯) |
Hanazaki K, Ichikawa K, Munekage M, et al. Effect of Daikenchuto (TJ-100) on abdominal bloating in hepatectomized patients. World Journal of Gastrointestinal Surgery 2013; 5: 115-22. | RCT | N |
| C22.0 | To evaluate the safety and effectiveness of daikenchuto (大建中湯) for gastrointestinal motility after surgery for liver cancer. |
daikenchuto (大建中湯) |
Shimada M, Morine Y, Nagano H, et al. Effect of TU-100, a traditional Japanese medicine, administered after hepatic resection in patients with liver cancer: a multi-center, phase III trial (JFMC40-1001). International Journal of Clinical Oncology 2015; 20(1): 95-104. | DB-RCT | C |
| C22.0 | To evaluate the hepatoprotection effect of inchinkoto (茵チン蒿湯) after hepatectomy with preoperative administration of inchinkoto. |
inchinkoto (茵チン蒿湯) |
Mizutani T, Yokoyama Y, Kokuryo T, et al. Does inchinkoto, a herbal medicine, have hepatoprotective effects in major hepatectomy? a prospective randomized study. HPB：The Official Journal of The International Hepato Pancreato Biliary Association 2015; 17: 461-9. | RCT | N |
| C24.0 | To evaluate the drug efficacy of inchinkoto (茵チン蒿湯) as a choleretic drug on livers of patients with biliary obstruction due to bile duct carcinoma. |
inchinkoto (茵チン蒿湯) |
Watanabe S, Yokoyama Y, Oda K, et al. Choleretic effect of inchinkoto, a herbal medicine, on livers of patients with biliary obstruction due to bile duct carcinoma. Hepatology Research 2009; 39: 247-55. | RCT | C&I |
| C25.9 | To evaluate the effect of juzentaihoto (十全大補湯) for antigen-specific immunity and performance status of advanced pancreatic cancer patients receiving peptide vaccine therapy. |
juzentaihoto (十全大補湯) |
Yutani S, Komatsu N, Matsueda S, et al. Juzentaihoto failed to augment antigen-specific immunity but prevented deterioration of patients’ conditions in advanced pancreatic cancer under personalized peptide vaccine. Evidence-Based Complementary and Alternative Medicine 2013: 1-10. doi：10.1155/2013/981717 | RCT | N |
| C25.9 | To evaluate the preventive efficacy of daikenchuto (大建中湯) as treatment for paralytic ileus after pancreatoduodenectomy. |
daikenchuto (大建中湯) |
Okada K, Kawai M, Hirono S, et al. Evaluation of the efficacy of daikenchuto (TJ-100) for the prevention of paralytic ileus after pancreaticoduodenectomy: a multicenter, double-blind, randomized, placebo-controlled trial. Surgery 2016; 159: 1333-41. | DB-RCT | C |
| Maeda H, Okada K, Fujii T, et al. Transition of serum cytokines following pancreaticoduodenectomy：A subsidiary study of JAPAN-PD. Oncology Letters 2018;16: 6847-53. | C | ||||
| C34.9 | Preventive effect on myelosuppression in patients undergoing chemotherapy for primary lung cancer. |
juzentaihoto (十全大補湯) |
Yamagata T, Ajimura K, Yukawa S. Effect of juzentaihoto on myelosuppression during lung cancer chemotherapy*. Therapeutic Research 1998; 19: 705-8 (in Japanese). | RCT- envelope |
N |
| C34.9 | Preventive effect of hochuekkito on general malaise in patients undergoing chemotherapy for advanced primary lung cancer. |
hochuekkito (補中益気湯) |
Inui H, Yamagata T, Minakata Y, et al. Prevention of side effects during lung cancer chemotherapy by Hochuekki-to. Kampo to Saishin-chiryo (Kampo & the Newest Therapy) 1993; 2: 56-60 (in Japanese). | RCT- cross over |
N |
| C34.9 | To evaluate the efficacy of hochuekkito combined with clarithromycin (CAM) for improvement in the prognosis of lung cancer. |
hochuekkito (補中益気湯) |
Kato S, Kishiro I, Machida S, et al. Combined effects of hochu-ekki-to (Bu-Zhong-Yi-Qi-Tang) and clarithromycin on Lung Carcinoma. Kampo to Meneki-Arerugi (Kampo and Immuno-Allergy) 1999; 13: 83-8 (in Japanese with English abstract). | RCT | N |
| C34.9 | To evaluate the efficacy of hochuekkito for the prevention and relief of general malaise related to chemotherapy for primary lung cancer (squamous cell carcinoma, adenocarcinoma, and small cell carcinoma). |
hochuekkito (補中益気湯) |
Mori K, Saito Y, Tominaga K. Utility of hochu-ekki-to in general malaise accompanying lung cancer chemotherapy. Biotherapy 1992; 6: 624-7 (in Japanese with English abstract). | RCT | I |
| C34.9 | To evaluate the safety and efficacy of hangeshashinto (半夏瀉心湯) (TJ-14) for CPT-11-induced diarrhea during combination chemotherapy with cisplatin (CDDP) plus irinotecan hydrochloride (CPT-11) for advanced non-small-cell lung cancer (NSCLC). |
hangeshashinto (半夏瀉心湯) |
Mori K, Machida S, Yoshida T, et al. Usefulness of Kampo medicine (hangeshashin-to) in the prevention of irinotecan-induced diarrhea in advanced non-small cell lung cancer. Proceedings of the American Society of Clinical Oncology 1999; 18: 518a, Abstract 1996 | RCT- envelope |
C |
| Mori K, Hirose T, Machida S, et al. Kampo medicines for the prevention of irinotecan-induced diarrhea in advanced non-small cell lung cancer. Gan to Kagaku Ryoho (Japanese Journal of Cancer and Chemotherapy) 1998; 25: 1159-63 (in Japanese with English abstract). | C | ||||
| Mori K. Hangeshashin-to (Kampo medicined) in the prevention of irinotecan-induced diarrhea in advanced non-small cell lung cancer. Progress in Medicine 1999; 19: 886-90 (in Japanese with English abstract). | N | ||||
| Mori K, Kondo T, Kamiyama Y, et al. Preventive effect of Kampo medicine (hangeshashin-to) against irinotecan-induced diarrhea in advanced non-small-cell lung cancer. Cancer Chemotherapy and Pharmacology 2003; 51: 403-6. | C | ||||
| C34.9 | To evaluate the efficacy of bakumondoto (麦門冬湯) on improvement in cough after lung cancer surgery. |
bakumondoto (麦門冬湯) |
Tsunezuka Y. The efficacy of bakumondoto on prolonged cough after lung cancer surgery. Kampo to Meneki Arerugi (Kampo and immuno-allergy) 2008; 22: 43-55 (in Japanese with English abstract). | RCT- envelope |
I |
| Tsunezuka Y. The efficacy of bakumondoto on prolonged cough after lung cancer surgery — QOL analysis with 36-Item Short Form (SF-36) v2*. Progress in Medicine 2010; 30: 100-1 (in Japanese). | N | ||||
| C34.9 | To evaluate the efficacy of rikkunshito (六君子湯) for chemotherapy-induced appetite loss. |
rikkunshito (六君子湯) |
Oteki T, Ishikawa A, Sasaki Y, et al. Effect of rikkunshi-to treatment on chemotherapy-induced appetite loss in patients with lung cancer: a prospective study. Experimental and Therapeutic Medicine 2016; 11: 243-6. | RCT | N |
| C34.9 | To evaluate the preventive effect of shakuyakukanzoto (芍薬甘草湯) for arthralgia and myalgia following carboplatin and paclitaxel combination chemotherapy for non-small cell lung cancer |
shakuyakukanzoto (芍薬甘草湯) |
Yoshida T, Sawa T, Ishiguro T, et al. The efficacy of prophylaetic shakuyaku-kanzo-to for myalgia and arthralgia following carboplatin and paclitaxel combination chemotherapy for non-small cell lung cancer. Support Care Cancer 2009; 17: 315-20. | RCT | N |
| C50.9 | To verify the effects of goshajinkigan (牛車腎気丸) for peripheral neuropathy during chemotherapy for breast cancer. |
goshajinkigan (牛車腎気丸) |
Abe H, Kawai Y, Mori T, et al. The kampo medicine Goshajinkigan prevents neuropathy in breast cancer patients treated with Docetaxel. Asian Pacific Journal of Cancer Prevention. 2014; 14: 6351-6. | RCT | N |
| C50.9 | To evaluate the efficacy of the carbonate spring foot bath and goshajinkigan (牛車腎気丸) for lower-extremity peripheral neuropathy due to cancer chemotherapy. |
goshajinkigan (牛車腎気丸) |
Kawabata K, Nakano T, Tsutsumi J, et al. Evaluation of alleviation for lower-extremity peripheral neuropathy due to cancer chemotherapy. Effectiveness of the carbonate spring foot bath and goshajinkigan*. Journal of the Japanese Society of Footcare. 2014; 12: 145-50 (in Japanese). | RCT- envelope |
I |
| C50.9 | To evaluate the efficacy of hochuekkito or ninjin’yoeito for reducing adverse drug reactions and improving quality of life (QOL) in breast cancer patients undergoing postoperative (after curative resection or initial treatment) Sunfral S (800 mg/day). |
ninjin’yoeito (人参養栄湯) or hochuekkito (補中益気湯) |
Nagao K, Nishimura R, Matsuda M, et al. Clinical evaluation of the combined effect of tegafur and hozai (traditional Chinese medicine)*. Toho Igaku (Eastern Medicine) 1998; 14: 63-71 (in Japanese with English abstract). | RCT- envelope |
N |
| C50.9 | To evaluate effects of ninjin′yoeito (人参養栄湯) prophylaxis dosing on the postoperative immune status in breast cancer patients. |
ninjin’yoeito (人参養栄湯) |
Takanami I, Ohnishi H. Clinical effects of ninzin-yoei-to as the immunopotentiator. Kiso to Rinsho (The Clinical Report) 1988;22: 1835-46 (in Japanese). | RCT | N |
| C50.9 | Efficacy of supportive therapy for advanced breast cancer patients. |
juzentaihoto (十全大補湯) |
Adachi I. Supporting therapy with shi quan da bu tang in advanced breast cancer patients. Biomedical Research 1990; 11 suppl: 25-31. | RCT- envelope |
N |
| Adachi I, Watanabe T, Chen JY, et al. Supportive therapy of oriental medicine for patients with advanced breast cancer. Gan to Kagaku Ryoho (Japanese Journal of Cancer and Chemotherapy) 1989; 16: 1538-43 (in Japanese with English abstract). | C＆I | ||||
| Adachi I. Juzen-taiho-to as a supporting therapy in advanced breast cancer. Biotherapy 1989; 3: 782-8 (in Japanese with English abstract). | I | ||||
| C57.7 | To evaluate the efficacy of using juzentaihoto (十全大補湯) to augment preoperative autologous blood donation in cancer patients. |
juzentaihoto (十全大補湯) |
Aoe H, Matsuo T, Ebisutani M, et al. Effects of juzentaihoto (ten strong tonic herbs decoction) on presurgical autologous blood pooling in cancer patients*. Sanfujinka Kampo Kenkyu no Ayumi (Recent Progress of Kampo Medicine in Obstetrics and Gynecology) 2000; 17: 67-71 (in Japanese). | RCT | N |
| Aoe H, Ota M, Kawahara N, et al. Effects of juzentaihoto in preoperative autologous blood pooling*. Rinsho Kensa (Journal of Medical Technology) 2003; 47: 395-9 (in Japanese). | I | ||||
| Aoe H. Effect of Juzen-taiho-to on haematological recovery from predeposit autologous blood donation*. Pharma Medica 2007; 25: 11-4 (in Japanese). | I | ||||
| C57.7 | To evaluate the effects of preoperative administration of shosaikoto (小柴胡湯) on thrombocytopenia in gynecologic cancer patients receiving anti-cancer drugs. |
shosaikoto (小柴胡湯) |
Mori T, Tauchi K, Yokoyama S, et al. Effects of Sho-saiko-to (Xiao-Chai-Hu-Tang) on thrombocytopenia bei therapy with anti-cancer drugs. Sanfujinka Chiryo (Obstetrical and Gynecological Therapy) 1992; 65: 102-5 (in Japanese). | RCT | N |
| C57.7 | To evaluate the effect of kamikihito (加味帰脾湯) on thrombocytopenia and leukopenia in patients receiving anti-cancer drugs. |
kamikihito (加味帰脾湯) |
Inoue S, Kuwahara H, Kato Y, et al. Thrombopoietic and leukopoietic effects of a traditional Chinese herbal medicine, formula reverti lienalis compositae (Japanese name: Kami-kihi-to TJ-137) in cancer patients. Biotherapy 1998; 12: 1071-6 (in Japanese with English abstract). | RCT- cross over |
N |
| C57.7 | To evaluate the effect of combined juzentaihoto (十全大補湯) on myelosuppression during chemotherapy in patients with gynecologic cancers. |
juzentaihoto (十全大補湯) |
Fujiwara M, Koumoto Y. Effect of juzentaihoto on myelosuppression due to chemotherapy for gynecologic malignant tumor*. Sanfujinka Kampo Kenkyu no Ayumi (Recent Progress of Kampo Medicine in Obstetrics and Gynecology) 1998; 15: 86-9 (in Japanese). | RCT- cross over |
N |
| C57.7 | To evaluate the potential use of sokeikakketsuto (疎経活血湯) and shakuyakukanzoto (芍薬甘草湯) in preventing peripheral nerve disorder in patients receiving taxol. |
sokeikakketsuto (疎経活血湯) |
Miyabe Y, Taniguchi C, Kawashima M, et al. Effect of Kampo medicines (sokeikakketsuto, shakuyakukanzoto) for taxol-caused peripheral nerve disorder – evaluation by current perception threshold measured by Neurometer®*. Sanfujinka Kampo Kenkyu no Ayumi (Recent Progress of Kampo Medicine in Obstetrics and Gynecology) 2006; 23: 65-8 (in Japanese). | RCT- cross over |
N |
| C57.7 | To evaluate the efficacy of goshajinkigan (牛車腎気丸) for peripheral neuropathy induced by chemotherapy (paclitaxel and carboplatin) for uterine and ovarian cancer. |
goshajinkigan (牛車腎気丸) |
Kaku H, Kumagai S, Onoue H, et al. Objective evaluation of the alleviating effects of goshajinkigan on peripheral neuropathy induced by paclitaxel/carboplatin therapy: A multicenter collaborative study. Experimental and Therapeutic Medicine 2012; 3: 60-5. | RCT | N |
| C57.7 | To evaluate the efficacy and safety of shakuyakukanzoto (芍薬甘草湯) and L-glutamine for paclitaxel-induced myalgia and arthralgia. |
shakuyakukanzoto (芍薬甘草湯) |
Hasegawa K, Mizutani Y, Kuramoto H, et al. The Effect of L-glutamine and shakuyaku-kanzo-to for paclitaxel-induced myalgia/arthralgia. Gan to Kagaku Ryoho (Japanese Journal of Cancer and Chemotherapy) 2002; 29: 569-74 (in Japanese with English abstract). | RCT- cross over |
I |
| C57.7 R11.0 |
To evaluate the efficacy and safety of rikkunshito (六君子湯) added to antiemetics for nausea, vomiting, and anorexia in patients treated with cisplatin and paclitaxel for cervical and endometrial cancers. |
rikkunshito (六君子湯) |
Ohnishi S, Watari H, Sakuragi N, et al. Additive effect of rikkunshito, an herbal medicine, on chemotherapy-induced nausea, vomiting, and anorexia in uterine cervical or corpus cancer patients treated with cisplatin and paclitaxel: results of a randomized phase II study (JORTC KMP-02). Journal of Gynecologic Oncology 2017; 28: 1-10. doi: 10.3802/jgo.2017.28.e44 | RCT | C |
| C57.7 N95.1 |
To evaluate the effect of Kampo medicines kamikihito (加味帰脾湯) and kamishoyosan (加味逍遙散) on menopausal symptoms in gynecological cancer patients. |
kamishoyosan (加味逍遙散), kamikihito (加味帰脾湯) |
Yoshimura A, Sawada K, Sasano T, et al. Effect of Japanese Kampo medicine therapy for menopausal symptoms after treatment of gynecological malignancy. Obstetrics and Gynecology International 2018: 1-6. | RCT- envelope |
N |
| C57.9 | Efficacy for relieving subjective symptoms and improving activities of daily living in patients following gynecologic cancer surgery. |
ninjin’yoeito (人参養栄湯) |
Mizuno M, Yoshikawa H, Taketani Y, et al. Clinical effects of ninjin'yoeito on performance status (PS) and recovery of physical strength in patients following gynecologic cancer treatment — comparison with no-treatment controls—*. Sanka to Fujinka (Obstetrics and Gynecology）1993; 60: 1533-45 (in Japanese). | RCT | I |
| C57.9 | To evaluate the efficacy of combination of ninjin’yoeito and juzentaihoto for reducing adverse effects of cyclophosphamide, adriamycin, cisplatin (CAP) chemotherapy including myelosuppression, renal impairment, and gastrointestinal symptoms. |
ninjin’yoeito (人参養栄湯) ＋juzentaihoto (十全大補湯) |
Hasegawa K, Fukunishi H, Kiyoshige K, et al. Clinical usefulness of Kampo medicines (Ninjin-yoei-to, Juzen-taiho-to) for side effects in gynecologic cancer chemotherapy — Effects on reducing side effects by CDDP in CAP therapy—. Wakan Iyakugaku Gakkaishi (Journal of Traditional Medicines) 1994; 11: 181-7 (in Japanese with English abstract). | RCT | N |
| C57.9 | Efficacy of ninjin'yoeito on subjective and objective symptoms and bone-marrow function during postoperative chemotherapy or radiotherapy in female patients with genital cancer. |
ninjin’yoeito (人参養栄湯) |
Yamamoto T, Fujita H, Okada H, et al. Clinical evaluation of the effects of ninjin'yoeito on subjective and objective symptoms and bone-marrow function during chemotherapy or radiotherapy in female patients with genital cancer*. Oncology & Chemotherapy 1994; 10: 126-34 (in Japanese). | RCT- envelope |
N |
| C57.9 | To evaluate the efficacy of ninjin’yoeito for reducing myelosuppression due to chemotherapy for gynecologic cancer. |
ninjin’yoeito (人参養栄湯) |
Oda T. My prescription — clinical application of ninjin’yoeito in gynecologic cancer — a preventive effect on bone marrow suppression—*. WE 2004; 9: 5-6. | quasi- RCT |
I |
| Oda T, Ohnuki T, Kihara K, et al. A clinical study of a traditional Chinese herbal medicine, NINJIN-YOUEI TO in bone marrow suppression due to chemotherapy in gynecologic cancer. Yamagata Kenritsu Byoin Igaku Zasshi (The Yamagata Journal of Medicine) 2004; 38; 6-9 (in Japanese). | I | ||||
| C57.9 | To evaluate the efficacy of juzentaihoto (十全大補湯) and ninjin’yoeito (人参養栄湯) combined with an erythropoietin (EPO) preparation in preoperative autologous blood donation in cancer patients. |
juzentaihoto (十全大補湯), ninjin’yoeito (人参養栄湯) |
Aoe H, Sumida Y, Kawahara N, et al. Efficacy of an erythropoietin preparation and Kampo medicines in preoperative autologous blood donation in cancer patients*. Jikoketsu Yuketsu (Journal of Japanese Society of Autologous Blood Transfusion) 1999; 12: 100-4 (in Japansese). | RCT | N |
| C57.9 | To evaluate the efficacy of goshajinkigan (牛車腎気丸) and keishikajutsubuto (桂枝加朮附湯) as treatment for chemotherapy-induced myalgia, arthralgia, and numbness in ovarian cancer. |
goshajinkigan (牛車腎気丸), keishikajutsubuto (桂枝加朮附湯) |
Sato Y, Yamamoto S, Tanoue K, et al. Evaluation of the effects of herbal medicines on the side effects of TC therapy (muscle pain, arthralgia, numbness). A cross-over study between goshajinkigan and keishikajutsubuto. Sanfujinka Kampo Kenkyu no Ayumi 2015; 32:68-71 (in Japanese). | RCT- cross over |
N |
| C61 N42.8 |
To evaluate the efficacy and safety of Kampo medicines (hochuekkito [補中益気湯] and keishibukuryogan [桂枝茯苓丸]) for enhancing the immune response to tailor-made cancer peptide vaccine therapy (PPV) in men with castration-resistant prostate cancer (CRPC). |
hochuekkito (補中益気湯) + keishibukuryogan (桂枝茯苓丸) |
Koga N, Moriya F, Waki K, et al. Immunological efficacy of herbal medicines in prostate cancer patients treated by personalized peptide vaccine. Cancer Science 2017; 108: 2326-32. | RCT | N |
| C64 K12.3 |
To evaluate the clinical usefulness of gargling with hangeshashinto (半夏瀉心湯) for treatment of oral mucositis caused by sunitinib in patients with metastatic renal cancer. |
hangeshashinto (半夏瀉心湯) |
Oh-oka H. The clinical usefulness of gargling with hangeshashinto for treatment of oral mucositis caused by sunitinib in patients with metastatic renal cancer. Kampo Medicine 2018;69: 1-6 (in Japanese with English abstract). | RCT | I |
| C67.9 | To evaluate the effect of postoperative adjuvant chemotherapy for bladder cancer on survival (the efficacy of the combination with juzentaihoto was assessed in patients stratified into 3 groups). |
juzentaihoto (十全大補湯) |
Fukui I, Gotoh S, Kihara K, et al. Adjuvant chemotherapy for invasive bladder cancer: multicenter study. Nippon Hinyokika Gakkai Zasshi (Japanese Journal of Urology) 1992; 83: 1633-9 (in Japanese with English abstract). | RCT | N |
| C68.9 | Efficacy and safety of saireito for relieving the adverse urological effects of anticancer drugs. |
saireito (柴苓湯) |
Ohkawa T, Ebisuno S, Watanabe T, et al. Clinical evaluations of Saireito, a herbal drug, for the side-effects of cancer chemotherapy in urological field. Biotherapy 1990; 4: 1445-60 (in Japanese with English abstract). | RCT- envelope |
I |
| C80.0 | To evaluate the efficacy of juzentaihoto for reducing adverse effects and improving quality of life (QOL) in postoperative patients undergoing chemotherapy (tegafur-uracil [UFT] 4 capsules/day) for gastric, colorectal, or breast cancer (curative resection/non-curative resection). |
juzentaihoto (十全大補湯) |
Kosaka A, Hojyo M, Osaku M, et al. The value of TSUMURA Juzentaihoto (TJ-48) in reducing adverse effects of anticancer drugs from the perspective of QOL improvement*. Progress in Medicine 1993; 13: 1072-9 (in Japanese). | RCT- envelope |
N |
| Kosaka A, Kamiya T, Sumiyama M, et al. Usefulness of TSUMURA Juzentaihoto (TJ-48) for reducing adverse effects of anticancer drugs and improving QOL*. Progress in Medicine 1994; 14: 2259-64 (in Japanese). | N | ||||
| C80.0 | Efficacy and safety for reducing adverse reactions during cancer radiotherapy. |
juzentaihoto (十全大補湯) |
Tanaka Y, Hashimoto S. Effects of TSUMURA Juzentaihoto on various complaints occurring as adverse reactions during radiotherapy*. JAMA (Japanese version) 1988; (6) suppl: 70-1 (in Japanese). | RCT- envelope |
N |
| Hashimoto S, Tanaka Y. Adverse reactions to cancer radiotherapy*. Sanfujinka no Sekai (World of Obstetrics and Gynecology) 1990; 42 suppl: 176-84 (in Japanese). | N | ||||
| C80.0 | Effect on the cell-mediated immunity of postoperative patients with esophageal, gastric, or colorectal cancer. |
juzentaihoto (十全大補湯) |
Yamada T. Clinical study of Juzen-taiho-to administration for postoperative esophageal carcinoma, gastric carcinoma, and colorectal carcinoma — Influence of surgical intervention and postoperative chemotherapy on cell mediated immunity—. Wakan Iyaku Gakkaishi (Journal of Medical and Pharmaceutical Society for WAKAN-YAKU) 1992; 9: 157-64 (in Japanese with English abstract). | RCT- envelope |
N |
| C80.0 | To evaluate the effects of juzentaihoto (十全大補湯) on leukopenia in patients receiving cancer chemotherapy. |
juzentaihoto (十全大補湯) |
Suzuki S, Abe R, Nomizu T, et al. Effect of juzentaihoto (TJ-48) on leukopenia in patients receiving cancer chemotherapy*. Progress in Medicine 1995; 15: 1968-71 (in Japanese). | RCT- envelope |
I |
| C80.0 | Clinical effects in patients undergoing chemotherapy (tegafur). |
hochuekkito (補中益気湯), ninjin’yoeito (人参養栄湯) |
Ohara T, Onda M, Futagawa S, et al. Clinical evaluation of the combined effect of Bu-Zhong-Yi-Qi-Tang (Japanese name, Hochu-ekki-to) or Ren-Shen-Yang-Rong-Tang (Japanese name, Ninjin-youei-to) and the anticancer drug tegafur. Yakuri to Chiryo (Japanese Phamacology & Therapeutics) 1993; 21: 4423-34 (in Japanese). | RCT- envelope |
C&I |
| C80.0 | To evaluate whether preoperative administration of hochuekkito relieves surgical stress in patients with gastric or colorectal cancer. |
hochuekkito (補中益気湯) |
Saito S, Iwagaki H, Kobayashi N, et al. Effects of a Japanese herbal medicine (TJ-41) on surgical stress of patients with gastric and colorectal cancer*. Nihon Rinsho Geka Gakkai Zasshi (Journal of Japan Surgical Association) 2006; 67: 568-74 (in Japanese). | RCT | I |
| C80.0 | To evaluate the effectiveness of hochuekkito (補中益気湯) for cancer-related fatigue. |
hochuekkito (補中益気湯) |
Jeong JS, Ryu BH, Kim JS, et al. Bojungikki-tang for cancer-related fatigue: A pilot randomized clinical trial. Integrative Cancer therapies 2010; 9: 331-8. | RCT | N |
| C80.0 | To evaluate the efficacy of preoperative administration of hochuekkito (補中益気湯) for postoperative systemic inflammatory response syndrome (SIRS) in gastric/colon cancer. |
hochuekkito (補中益気湯) |
Iwagaki H, Saito S. Regulation of post-operative systemic inflammatory response syndrome (SIRS) by preoperative administration of hochuekkito (a Japanese herbal medicine). Nihon Toyo Igaku Zasshi (Kampo Medicine) 2010; 61: 78–83 (in Japanese with English abstract). | RCT | I |
| C80.0 | To evaluate the improvement in subjective symptoms and leukopenia after ninjin'yoeito (人参養栄湯) administration in patients undergoing radiotherapy for thoracoabdominal tumors. |
ninjin’yoeito (人参養栄湯) |
Okawa T, Hashimoto S, Sakamoto S, et al. Ninjin-Yoei-To in the treatment of leukopenia and symptoms associated with radiotherapy of malignant tumors. Gan no Rinsho (Japanese Journal of Cancer Clinics) 1995; 41: 41-51 (in Japanese with English abstract). | RCT | I |
| C80.0 | To evaluate the healing effect of TSUMURA Saibokuto (柴朴湯) on mucositis induced by head-and-neck and mediastinal irradiation. |
saibokuto (柴朴湯) |
Saito Y, Mitsuhashi N, Takahashi I, et al. Effect of TSUMURA Saiboku-to as an agent for healing damage in treatment of radiomucositis due to irradiation of the head and neck area and mediastinum. Biotherapy 1992; 6: 1899-906 (in Japanese with English abstract). | RCT | N |
| C80.0 | To evaluate the efficacy of hangeshashinto (半夏瀉心湯) for delayed diarrhea induced by irinotecan (CPT-11) in patients with metastatic gastric and colorectal cancer. |
hangeshashinto (半夏瀉心湯) |
Hibi S, Ina K, Furuta R, et al. Clinical effects of hange-shashin-to on combination therapy of S-1/irinotecan for patients with metastatic gastric and colorectal cancer*. Gan to Kagaku Ryoho (Japanese Journal of Cancer Chemotherapy) 2009; 36: 1485–8 (in Japanese with English abstract). | RCT- envelope |
C&I |
| C80.0 F05.9 |
To evaluate the efficacy and safety of yokukansan (抑肝散) for postoperative delirium in patients with gastrointestinal and lung cancers. |
yokukansan (抑肝散) |
Sugano N, Aoyama T, Sato T, et al. Randomized phase II study of TJ-54 (Yokukansan) for postoperative delirium in gastrointestinal and lung malignancy patients. Molecular and Clinical Oncology 2017; 7: 569-73. | RCT | C&N |
| D25.9 | To evaluate the anti-tumor effect of keishibukuryogan in patients with hysteromyoma/uterine adenomyosis. |
keishibukuryogan (桂枝茯苓丸) |
Yamamoto K, Hirano F, Ikoma N, et al. Efficacy of keishibukuryogan for hysteromyoma/uterine adenomyosis. Sanfujinka Kampo Kenkyu no Ayumi (Recent Progress of Kampo Medicine in Obstetrics and Gynecology) 2003; 20: 135-7 (in Japanese). | RCT | I |
- Note:
- Original English titles assigned by authors were used in this list and the structured abstracts. When references had no English titles, the Task Force translated the original Japanese titles into English ones (*).
- Abbreviations:
- C: The Cochrane Library (CENTRAL), I: Igaku Chuo Zasshi (Japana Centra Revuo Medicana, Ichushi), N: Database Offered by Nikkankyo (the Japan Kampo Medicines Manufacturers Association)
3. Blood Diseases including Anaemia (8abstracts, 9 references)
| ICD-10 | Research Question |
Kampo Formula |
References | Study Design |
Source |
|---|---|---|---|---|---|
| D50.0 | To evaluate the efficacy and safety of tokishakuyakusan for hypochromic anemia in patients with uterine myoma. |
tokishakuyakusan (当帰芍薬散) |
Akase T, Akase T, Onodera S, et al. A comparative study of the usefulness of toki-shakuyaku-san and an oral iron preparation in the treatment of hypochromic anemia in cases of uterine myoma. Yakugaku Zasshi (Journal of the Pharmaceutical Society of Japan) 2003; 123: 817-24. | RCT | C&I |
| D50.8 | Efficacy of ninjin'yoeito for iron deficiency anemia due to menorrhagia. |
ninjin’yoeito (人参養栄湯) |
Yanagihori A, Miyagi M, Hori M, et al. Efficacy of ninjin'yoeito for iron deficiency anemia*. Rinsho to Kenkyu (Japanese Journal of Clinical and Experimental Medicine) 1995; 72: 2605-8 (in Japanese). | RCT- envelope |
I |
| D50.8 | Combined effect of erythropoietin and ninjin'yoeito on anemia after autologous blood donation. |
ninjin’yoeito (人参養栄湯) |
Aoe H, Takada K, Kawahara N, et al. Effectiveness of erythropoietin and ninjin'yoeito in preoperative autologous blood donation*. Jikoketsu Yuketsu (Journal of Japanese Society of Autologous Blood Transfusion) 1997; 10: 145-51 (in Japanese). | RCT | N |
| D64.8 | To evaluate the efficacy and safety of ninjin’yoeito for ribavirin-induced anemia. |
ninjin’yoeito (人参養栄湯) |
Motoo Y, Mouri H, Ohtsubo K, et al. Herbal medicine ninjinyoeito ameliorates ribavirin-induced anemia in chronic hepatitis C: A randomized controlled trial. World Journal of Gastroenterology 2005; 11: 4013-7. | RCT | C |
| D64.8 | To evaluate the efficacy and safety of juzentaihoto (十全大補湯) for erythropoietin-resistant anemia in patients on hemodialysis. |
juzentaihoto (十全大補湯) |
Nakamoto H, Mimura T, Honda N. Orally administrated Juzen-taiho-to/TJ-48 ameliorates erythropoietin (rHuEPO)-resistant anemia in patients on hemodialysis. Hemodialysis International 2008; 12: S9-14. | RCT | C |
| D69.6 | Efficacy of goreisan for thrombocytopenia after cholecystectomy. |
goreisan (五苓散), shosaikoto (小柴胡湯) |
Seki M. Efficacy of goreisan for preventing thrombocytopenia and activating vascular endothelial cells after cholecystectomy*. Wakan Iyaku Gakkaishi (Journal of Medical and Pharmaceutical Society for WAKAN-YAKU) 1990; 7: 510-1 (in Japanese). | RCT | N |
| D72.8 | Preventive effect of preoperative administration of shosaikoto on postoperative lymphopenia in female patients. |
shosaikoto (小柴胡湯) |
Hatano T. Mitigation of postoperative lymphopenia and protection of T cells by preoperative administration of Xial-Chai-Hu-Tang. Saitama Ika Daigaku Zasshi (Journal of Saitama Medical School) 1990; 17: 357-63 (in Japanese with English abstract). | RCT | N |
| D86.0 | Effects of keishikajutsubuto on the levels of angiotensin-converting enzyme and lysozyme in sarcoidosis patients. |
keishikajutsubuto (桂枝加朮附湯) |
Inagaki M, Nakazawa T, Michimata H, et al. Treatment experience with TSUMURA Keishikajutsubuto for pulmonary sarcoidosis*. Wakan Iyaku Gakkaishi (Journal of Medical and Pharmaceutical Society for WAKAN-YAKU) 1990; 7: 316-7 (in Japanese). | RCT | N |
| Inagaki M. Effectiveness of Kampo medicine in relieving complaints associated with chronic intractable diseases*. Kampo Shinryo 1993; 12: 1-3 (in Japanese). | N |
- Note:
- Original English titles assigned by authors were used in this list and the structured abstracts. When references had no English titles, the Task Force translated the original Japanese titles into English ones (*).
- Abbreviations:
- C: The Cochrane Library (CENTRAL), I: Igaku Chuo Zasshi (Japana Centra Revuo Medicana, Ichushi), N: Database Offered by Nikkankyo (the Japan Kampo Medicines Manufacturers Association)
4. Metabolism and Endocrine Diseases (13 abstracts, 17 references)
| ICD-10 | Research Question |
Kampo Formula |
References | Study Design |
Source |
|---|---|---|---|---|---|
| E11.9 | Efficacy and safety of seishinrenshiin on improvement in glucose tolerance. |
seishinrenshiin (清心蓮子飲) |
Azuma M, Motomiya M, Toyota T. Effects of Seishin-Renshi-In (TJ-111) on blood sugar levels of patients with non-insulin-dependent diabetes mellitus. Nihon Toyo Igaku Zasshi (Japanese Journal of Oriental Medicine) 1994; 45: 339-44 (in Japanese with English abstract). | RCT- envelope |
N |
| E14 | To evaluate the efficacy and safety of goshajinkigan (牛車腎気丸) for treatment of diabetic complications. |
goshajinkigan (牛車腎気丸) |
Watanabe K, Shimada A, Miyaki K, et al. Long-term effects of goshajinkigan in prevention of diabetic complications: A randomized open-labeled clinical trial. Evidence-Based Complementary and Alternative Medicine 2014 :1-8. doi：10.1155/2014/128726 | RCT | C&N |
| E22.9 | To evaluate the efficacy of unkeito for reducing high luteinizing hormone (LH) levels and improving ovulation disorder. |
unkeito (温経湯) |
Ushiroyama T, Ikeda A, Sakai M, et al. Effects of unkei-to, an herbal medicine, on endocrine function and ovulation in women with high basal level of luteinizing hormone secretion. The Journal of Reproductive Medicine 2001; 46: 451-6. | RCT- envelope |
C |
| E28.2 | To evaluate the efficacy of switching to unkeito from treatment based on the traditional diagnostic criterion “eight-principle pattern identification” in women with polycystic ovary syndrome (PCOS). |
unkeito (温経湯), tokisyakuyakusan (当帰芍薬散), keishibukuryogan (桂枝茯苓丸) |
Ushiroyama T, Hosotani T, Mori K, et al. Effects of switching to wen-jing-tang (unkei-to) from preceding herbal preparations selected by eight-principle pattern identification on endocrinological status and ovulatory induction in women with polycystic ovary syndrome. The American Journal of Chinese Medicine 2006; 34: 177-87. | RCT- envelope |
C |
| E28.3 | To evaluate the efficacy of unkeito for luteal phase deficiency. |
unkeito (温経湯) |
Ushiroyama T, Ikeda A, Higashio S, et al. Unkei-to for correcting luteal phase defects. The Journal of Reproductive Medicine 2003; 48: 729-34. | RCT- envelope |
C |
| E66.9 | To evaluate the anti-obesity effect of bofutsushosan extract granules in obese patients and the course of high-sensitivity C-reactive protein (HS-CRP) as an arteriosclerosis-promoting factor. |
bofutsushosan (防風通聖散) |
Namiki T. Basic and clinical investigation of the effect of Kampo medicines on arteriosclerosis*. Uehara Kinen Seimei Kagaku Zaidan Kenkyu Hokokushu (Research Reports of Uehara Memorial Foundation) 2007; 21: 60-3 (in Japanese). | RCT- envelope |
I |
| E78.5 | Efficacy and safety of daisaikoto combined with probucol in patients with hyperlipidemia. |
daisaikoto (大柴胡湯) |
Takashima T, Ohmori K, Higuchi N, et al. Combination therapy with probucol and daisaikoto (a Kampo medicine) - Effects of daisaikoto on HDL metabolism -. Domyaku Koka (The Journal of Japan Atherosclerosis Society) 1993; 21: 47-52 (in Japanese with English abstract). | RCT- envelope |
N |
| daisaikoto (大柴胡湯) |
Yamamoto K. A study of the hepatic triglyceride (TG)-lowering effects and antioxidant capacity of various Kampo preparations*. Proceedings of the 4th Kampo Treatment Seminar at Kyoto University 1995: 48-56 (in Japanese). | N | |||
| E78.5 | Efficacy and safety of daisaikoto in patients with hyperlipidemia. |
daisaikoto (大柴胡湯) |
Sasaki J, Matsunaga A, Handa K, et al. Effect of daisaikoto on hyperlipidemia - comparison with clinofibrate -*. Rinsho to Kenkyu (Japanese Journal of Clinical and Experimental Medicine) 1991; 68: 3861-71 (in Japanese). | RCT | I |
| E78.5 | Efficacy and safety of daisaikoto combined with bezafibrate in patients with hyperlipidemia. |
daisaikoto (大柴胡湯) |
Muramatsu N, Okayasu M. Clinical study on hyperlipidemia at bezafibrate and Da-chai-hu-tang (Dai-saiko-to) for the combination therapy. Shigaku (Odontology) 1993; 81: 94-9 (in Japanese with English abstract). | RCT | N |
| E78.5 | Effects of daisaikoto on serum lipid level and cerebral circulation. |
daisaikoto (大柴胡湯) |
Yamano S, Sawai F, Hashimoto T, et al. Comparative effects between Dai-Saiko-to and elastase on lipid metabolism and cerebral circulation in patients with hyperlipidemia. Kampo to Saishin-chiryo (Kampo & the Newest Therapy) 1995; 4: 309-13 (in Japanese). | RCT- envelope |
N |
| E87.8 | Efficacy and safety of goreisan in the treatment of hyponatremia after surgery for cholelithiasis or gallbladder polyps. |
goreisan (五苓散), shosaikoto (小柴胡湯) |
Takagi S. Mitigation of hyponatremia after operation for cholelithiasis or gallbladder polyp by preoperative administration of Wu-Ling-San. Journal of Saitama Medical School 1990; 17: 145-50 (in Japanese with English abstract). | RCT | N |
| Seki M, Fujioka M, Hatano T, et al. Analysis of regulatory effects of Gorei-san on circulatory, metabolic and diuretic function - especially in relation to endothelial activation and increase of urinary 6-keto-prostaglandin F1a level-. Nihon Toyo Igaku Zasshi (Japanese Journal of Oriental Medicine) 1992; 42: 313-22 (in Japanese with English abstract). | N | ||||
| E88.9 | To evaluate whether bofutsushosan (防風通聖散) reduces obesity. |
bofutsushosan (防風通聖散) |
Uebaba K, Xu F. Association between the SNP in sympathetic b3-adrenergic receptor gene and the efficacy of bofutsushosan*. Nihon Toyo Igaku Zasshi (Kampo medicine) 2003; 54: S225. | DB-RCT | N |
| Kamohara S, Kawakami T, Uebaba K, et al. A study on the development of individualized medicine for the prevention, diagnosis, and treatment of metabolic syndrome using an integrative approach*. Ikagaku Oyo Kenkyu Zaidan Kenkyu Hokoku (Research Papers of the Suzuken Memorial Foundation) 2009; 26: 399-403. | N | ||||
| Xu FH, Uebaba K, Ogawa H, et al. Personalized effects of a Kampo herbal formulation on metabolism — A randomized, double-blind, placebo controlled study of bohutusei-san — — Toho Igaku (Eastern Medicine) 2012; 28: 37-59 (in Japanese). | I | ||||
| E88.9 | To evaluate the effects of co-administration of probiotics with bofutsushosan (防風通聖散) on obesity. |
bofutsushosan (防風通聖散) |
Lee S J，Bose S，Seo J-G, et al. The effects of co-administration of probiotics with herbal medicine on obesity，metabolic endotoxemia and dysbiosis：A randomized double-blind controlled clinical trial. Clinical Nutrition 2014; 33: 973-81. | DB-RCT | N |
- Note:
- Original English titles assigned by authors were used in this list and the structured abstracts. When references had no English titles, the Task Force translated the original Japanese titles into English ones (*).
- Abbreviations:
- C: The Cochrane Library (CENTRAL), I: Igaku Chuo Zasshi (Japana Centra Revuo Medicana, Ichushi), N: Database Offered by Nikkankyo (the Japan Kampo Medicines Manufacturers Association)
5.Psychiatric/Behavioral Disorders (21 abstracts, 25 references)
| ICD-10 | Research Question |
Kampo Formula |
References | Study Design |
Source |
|---|---|---|---|---|---|
| F01.9 | Efficacy of chotosan in the treatment of vascular dementia. |
chotosan (釣藤散) |
Shimada Y, Terasawa K, Yamamoto T, et al. A well-controlled study of choto-san and placebo in the treatment of vascular dementia. Wakan Iyakugaku Zasshi (Journal of Traditional Medicines) 1994; 11: 246-55. | RCT-envelope | I |
| Shimada Y, Terasawa K, Yamamoto T, et al. Efficacy of Choto-san on vascular dementia: A well, placebo-controlled study. Wakan Iyakugaku Zasshi (Journal of Traditional Medicines) 1994; 11: 370-1 (in Japanese). | I | ||||
| F01.9 | Efficacy of chotosan in the treatment of vascular dementia. |
chotosan (釣藤散) |
Terasawa K, Shimada Y, Kita T, et al. Choto-san in the treatment of vascular dementia: A double blind, placebo-controlled study. Phytomedicine 1997; 4: 15-22. | DB-RCT | N |
| Terasawa K. Chotosan in the treatment of vascular dementia. Pharma Medica 2007; 25: 57-9 (in Japanese). | I | ||||
| F03 | To evaluate the efficacy of hachimijiogan for dementia. |
hachimijiogan (八味地黄丸) |
Iwasaki K, Kanbayashi S, Chimura Y, et al. A randomized, double-blind, placebo-controlled clinical trial of the Chinese herbal medicine “ba wei di huang wan” in the treatment of dementia. Journal of the American Geriatrics Society 2004; 52: 1518-21. | DB-RCT | C |
| F03 | To evaluate the efficacy of chotosan for improvement of cognitive function and activities of daily living in dementia patients. |
chotosan (釣藤散), goshajinkigan (牛車腎気丸) |
Suzuki T, Futami S, Igari Y, et al. A Chinese herbal medicine, choto-san, improves cognititive function and activities of daily living of patients with dementia: A double-blind, randomized, placebo-controlled study. Journal of the American Geriatrics Society 2005; 53: 2238-40. | DB-RCT | C |
| F03 | To evaluate the efficacy and safety of yokukansan for treating behavioral disorders and improving activities of daily living in dementia patients. |
yokukansan (抑肝散) |
Iwasaki K, Satoh-Nakagawa T, Maruyama M, et al. A randomized, observer-blind, controlled trial of the traditional Chinese medicine yi-gan san for improvement of behavioral and psychological symptoms and activities of daily living in dementia patients. Journal of Clinical Psychiatry 2005; 66: 248-52. | RCT | C |
| F03 | To evaluate the efficacy and safety of yokukansan in the treatment of behavioural and psychological symptoms of dementia. |
yokukansan (抑肝散) |
Mizukami K, Asada T, Kinoshita T, et al. A randomized cross-over study of a traditional Japanese medicine (kampo), yokukansan, in the treatment of the behavioural and psychological symptoms of dementia. The International Journal of Neuropsychopharmacology 2009; 12: 191-9. | RCT- cross over |
C |
| F03 | To evaluate the efficacy and safety of yokukansankachimpihange (抑肝散加陳皮半夏) on cognitive function. |
yokukansankachimpihange (抑肝散加陳皮半夏) |
Fujita H, Yoshida M, Yomoda S. Effects of Yokukansankachimpihange on cognitive ability, an open randomized controlled trial. Psychiatry 2013; 23: 130-8 (in Japanese with English abstract). | quasi- RCT |
N |
| F03 | To evaluate the effectiveness of yokukansan (抑肝散) for cognitive dysfunction after surgery for fracture of the proximal femur/ in the elderly. |
yokukansan (抑肝散) |
Egawa H, Hamaguchi S. Clinical applications of Kampo medications – Clinical applications of Kampo medications for Postoperative Cognitive Dysfunction (POCD) – Yokukansan and perioperative management of fracture of the proximal femur in the elderly.* Nou 21 (Brain 21) 2015; 18: 271-4. | RCT | I&N |
| F05.9 | To evaluate the efficacy of yokukansan (抑肝散) for postoperative delirium after cardiovascular surgery in the elderly. |
yokukansan (抑肝散) |
Takase S. The efficacy of Yokukansan (抑肝散) on postoperative delirium after cardiovascular surgery in the elderly*. Kampo Igaku (Science of Kampo Medicine)2010; 34: 132–4 (in Japanese). | RCT- envelope |
N |
| Takase S, Yokoyama H. Using a Kampo medication in the perioperative period – The preventative effects of yokukansan (抑肝散) on postoperative delirium after cardiovascular surgery in the elderly*. Kampo to Saishin-chiryo (Kampo & the Newest Therapy) 2013; 22: 113–19 (in Japanese). | N | ||||
| C80.0 F05.9 |
To evaluate the efficacy and safety of yokukansan (抑肝散) for postoperative delirium in patients with gastrointestinal and lung cancers. |
yokukansan (抑肝散) |
Sugano N, Aoyama T, Sato T, et al. Randomized phase II study of TJ-54 (Yokukansan) for postoperative delirium in gastrointestinal and lung malignancy patients. Molecular and Clinical Oncology 2017; 7: 569-73. | RCT | C&N |
| F20.9 | To evaluate the efficacy and safety of yokukansan (抑肝散) for treatment-resistant schizophrenia. |
yokukansan (抑肝散) |
Miyaoka T, Furuya M, Yasuda H, et al. Yi-gan san as adjunctive therapy for treatment-resistant schizophrenia: an open-label study. Clinical Neuropharmacology 2009; 32: 6-9. | RCT | N |
| F20.9 | To evaluate the efficacy and safety of yokukansan (抑肝散) for treatment-resistant schizophrenia. |
yokukansan (抑肝散) |
Miyaoka T, Furuya M, Horiguchi J, et al. Efficacy and safety of yokukansan in treatment-resistant schizophrenia: a randomized, multicenter, double-blind, placebo-controlled trial. 2015 Evidence-Based Complementary and Alternative Medicine 2015; 1-11. doi: 10.1155/2015/201592. | DB-RCT | C&N |
| Miyaoka T, Furuya M, Horiguchi J, et al. Efficacy and safety of yokukansan in treatment-resistant schizophrenia: a randomized, double-blind, placebo-controlled trial (a positive and negative syndrome scale, five-factor analysis). Psychopharmacology 2015; 232: 155-64. | N | ||||
| F41.9 | To evaluate the effectiveness and safety of yokukansan (抑肝散) in preoperative sedation. |
yokukansan (抑肝散) |
Arai YC, Kawanishi J，Sakakima Y, et al. The effect of the kampo medicine Yokukansan on preoperative anxiety and sedation levels. Evidence-Based Complementary and Alternative Medicine. 2014: 1-4. doi：10.1155/2014/965045 | RCT | N |
| F41.9 | To evaluate the efficacy of saibokuto as a potentiator of the anxiolytic and antidepressant effects of diazepam. |
saibokuto (柴朴湯) |
Ishida H, Otake T, Kurihara H, et al. Clinical study on augmentative effect of Saiboku-to for anxiolytic and antidepressive action of diazepam. Pain Clinic, 1999; 20: 395-9 (in Japanese). | RCT | N |
| F43.1 | To evaluate the efficacy and safety of saikokeishikankyoto (柴胡桂枝乾姜湯) for posttraumatic stress disorder (PTSD). |
saikokeishikankyoto (柴胡桂枝乾姜湯) |
Numata T, Gunfan S, Takayama S, et al. Treatment of posttraumatic stress disorder using the traditional Japanese Herbal Medicine saikokeishikankyoto: A randomized observer-blinded controlled trial in survivors of the Great East Japan earthquake and tsunami. Evidence-Based Complementary and Alternative Medicine 2014: 1-6. doi:10.1155/2014/683293 | RCT | C&N |
| F45.3 | Efficacy for relieving discomfort in the throat. |
saibokuto (柴朴湯) |
Yamagiwa M, Sakakura Y, Harada T, et al. Therapeutic response to various drugs in patients with continuous or periodic discomfort in the throat. Jibiinkoka Rinsyo (Practica otologica) 1990; 83: 1687-92 (in Japanese with English abstract). | RCT | N |
| F45.3 | To evaluate the efficacy of lansoprazole in patients with pharyngolaryngeal paresthesia and acid reflux symptoms (compared with rikkunshito as a control). |
rikkunshito (六君子湯) |
Yamagiwa M, Fujita K. Effect of treatment using lansoprazole on patients with an abnormal sensation in the throat and concomitant heart burn. Jibi to Rinsho (Otologia Fukuoka) 2007; 53: 109-15 (in Japanese with English abstract). | quasi- RCT |
I |
| F45.9 | Symptom-relieving effects in elderly patients with underlying chronic disease. |
hachimijiogan (八味地黄丸) ＋ kojinmatsu (紅参末) |
Kaneko H, Nakanishi K, Murakami A, et al. Clinical evaluation of combination treatment of Hatimi-zio-gan and Red Ginseng Powder on unidentified clinical complaints - estimation of double blind comparative study in many hospitals -. Therapeutic Research 1989; 10: 4951-65 (in Japanese). | DB-RCT- envelope |
I |
| F45.9 | To evaluate the efficacy and safety of kamikihito (加味帰脾湯) and kamishoyosan (加味逍遙散) for otorhinolaryngological symptoms with a strong psychosomatic element. |
kamikihito (加味帰脾湯) |
Tanaka H. Problems and approaches to treatment of psychosomatic disease by an otorhinolaryngologist, and Kampo treatment for psychosomatic cases with depressive tendency – Focusing on kamikihito (加味帰脾湯) –. Phil Kampo 2014; 47: 20-2. | RCT- cross over |
I |
| F52.2 | Efficacy and safety of oral prostaglandin E1 in the treatment of erectile dysfunction. |
goshajinkigan (牛車腎気丸) |
Sato Y, Horita H, Adachi N, et al. Effect of oral administration of prostaglandin E1 on erectile dysfunction. British Journal of Urology 1997; 80: 772-5. | quasi- RCT |
N |
| F52.2 | To compare the efficacy of LEOPIN ROYAL with that of Kampo medicines for aging in males. |
kamishoyosan (加味逍遙散), hangekobokuto (半夏厚朴湯), saikokaryukotsuboreito (柴胡加竜骨牡蛎湯), hochuekkito (補中益気湯), goshajinkigan (牛車腎気丸), hachimijiogan (八味地黄丸) |
Nishimatsu H, Kitamura T, Yamada D, et al. Improvement of symptoms of aging in males by a preparation LEOPIN ROYAL containing aged garlic extract and other five of natural medicines-comparison with traditional herbal medicines (Kampo). Aging male 2014; 17: 112-6. | RCT | C&N |
- Note:
- Original English titles assigned by authors were used in this list and the structured abstracts. When references had no English titles, the Task Force translated the original Japanese titles into English ones (*).
- Abbreviations:
- C: The Cochrane Library (CENTRAL), I: Igaku Chuo Zasshi (Japana Centra Revuo Medicana, Ichushi), N: Database Offered by Nikkankyo (the Japan Kampo Medicines Manufacturers Association)
6. Nervous System Diseases (including Alzheimer's Disease) (18 abstracts, 21 references)
| ICD-10 | Research Question |
Kampo Formula |
References | Study Design |
Source |
|---|---|---|---|---|---|
| G10 | Efficacy and safety of yokukansan in patients with Huntington’s disease. |
yokukansan (抑肝散) saikokaryukotsu-boreito (柴胡加竜骨牡蛎湯) |
Satoh T, Takahashi T, Iwasaki K, et al. Traditional Chinese Medicine on four patients with Huntington's disease. Movement Disorders 2009; 24: 453-5. | RCT- cross over |
N |
| G20.0 | To evaluate the efficacy and safety of rikkunshito (六君子湯) for anorexia and indigestion in patients with Parkinson's disease. |
rikkunshito (六君子湯) |
Yakabi K, Yamaguchi N, Ono S, et al. Open label trial of the efficacy and safety profile of rikkunshito used for the treatment of gastrointestinal symptoms in patients with Parkinson's disease: a pilot study. Current Therapeutic Research 2017; 87: 1-8. | RCT- cross over |
N |
| G25.9 | To evaluate the effectiveness and safety of shakuyakukanzoto (芍薬甘草湯) on extrapyramidal symptoms during antipsychotic treatment. |
shakuyakukanzoto (芍薬甘草湯) |
Ota T, Miura I, Kanno-Nozaki K, et al. Effects of shakuyaku-kanzo-to on extrapyramidal symptoms during antipsychotic treatment: a randomized, open-label study. Journal of Clinical Psychopharmacology 2015; 35: 304-7. | RCT | C&N |
| G30.1 | Efficacy and safety of yokukansan in the treatment of behavioral and psychological symptoms of dementia (BPSD) in elderly patients with Alzheimer's disease. |
yokukansan (抑肝散) |
Monji A, Takita M, Samejima T, et al. Effect of yokukansan on the behavioral and psychological symptoms of dementia in elderly patients with Aizheimer's disease. Progress in Neuro-Psychopharmacology & Bioiogical Psychiatry 2009; 33: 308-11. | RCT | N |
| Monji A, Kanba S. Effectiveness of yokukansan (抑肝散) on BPSD in Alzheimer’s disease — Results of a long-term antipsychotic combination trial at a department of neuropsychiatry in Kyushu*. No 21 (Brain 21) 2009; 12: 446-51 (in Japanese). | I | ||||
| G30.1 | To investigate the efficacy and safety of yokukansan (抑肝散) as a common treatment for behavioral and psychological symptoms of dementia (BPSD) in patients with Alzheimer’s disease (AD). |
yokukansan (抑肝散) |
Okahara K, Ishida Y, Hayashi Y, et al. Effects of yokukansan on behavioral and psychological symptoms of dementia in regular treatment for Alzheimer's disease. Progress in Neuro Psychopharmacology & Biological Psychiatry 2010; 34: 532-6. | RCT | C |
| G30.1 | To evaluate the efficacy of yokukansan (抑肝散) and risperidone in the treatment of behavioral and psychological symptoms of dementia (BPSD) |
yokukansan (抑肝散) |
Furuhashi Y. Comparative efficacy of risperidone versus Yokukansan (抑肝散) on behavioral and psychological symptoms of dementia in patients with Alzheimer’s disease*. Kampo Igaku (Science of Kampo Medicine) 2010; 34: 120–1 (in Japanese). | RCT | N |
| G30.1 | To evaluate the efficacy and safety of yokukansan (抑肝散) for behavioral and psychological symptoms of dementia (BPSD). |
yokukansan (抑肝散) |
Teranishi M, Kurita M, Nisiho S, et al. Efficacy and tolerability of risperidone, yokukansan, and fluvoxamine for the treatment of behavioral and psychological symptoms of dementia: A blinded, randomized trial. Journal of Clinical Psychopharmacology 2014; 33: 600-7. | RCT | N |
| Kurita M, Efficacy and tolerability of yakukansan for behavioral and psychological symptoms of dementia (BPSD) – A 3-way comparative trial of risperidone and fluvoxamine. Brain 21 2015; 18: 249-52. | RCT | I&N | |||
| G30.1 | To evaluate the efficacy and safety of yokukansan (抑肝散) for behavioral and psychological symptoms of dementia due to Alzheimer's disease. |
yokukansan (抑肝散) |
Furukawa, K, Tomita N, Une K, et al. Randomized double-blind placebo-controlled multicenter trial of Yokukansan for neuropsychiatric symptoms in Alzheimer's disease. Geriatrics and Gerontology International 2017; 17: 211-8. | DB-RCT | C |
| G30.9 | To evaluate the efficacy and safety of kihito for Alzheimer-type dementia. |
kihito (帰脾湯), goshajinkigan (牛車腎気丸) |
Higashi K, Rakugi H, Yu H, et al. Effect of kihito extract granules on cognitive function in patients with Alzheimer's-type dementia. Geriatrics & Gerontology International 2007; 7: 245-51. | RCT | I |
| G43.9 | To evaluate the efficacy and safety of goshuyuto for treatment of migraine. |
goshuyuto (呉茱萸湯) |
Maruyama T. Goshuyu-to versus lomerizine hydrochloride in the prophylactic treatment of migraine headaches: an open crossover trial. Itami to Kampo (Pain and Kampo Medicine) 2006; 16: 30-9 (in Japanese with English abstract). | RCT- cross over |
I |
| G47.0 | To evaluate the efficacy and safety of DS-4773 for sedation versus sansoninto used as control. |
sansoninto (酸棗仁湯) |
Matsushita M, Saito M, Katayama S, et al. Clinical evaluation of DS-4773 on sedative effect: a cross-over trial. Yakuri to Chiryo (Japanese Pharmacology & Therapeutics) 1994; 22: 2371-82 (in Japanese). | RCT- cross over |
I |
| G47.1 | Effect of kakkonto on sleepiness after sleep deprivation. |
kakkonto (葛根湯) |
Zhuang H.Y., Kim Y, Kurachi M, et al. Effect of kakkon-to on sleepiness after sleep deprivation of normal young adults. Shinkei Seishin Yakuri (Japanese journal of neuropsychopharmacology) 1992; 14: 319-25 (in Japanese with English abstract). | DB-RCT cross over |
I |
| Hagino H, Kim Y, Kurachi M, et al. Effect of Kakkon-to on sleepiness after sleep deprivation with quantitative EEG method. Noha to Kindenzu (Japanese Journal of Electroencephalography and Electromyography) 1995; 23: 361-7 (in Japanese with English abstract). | N | ||||
| G47.3 | To evaluate the lipid lowering and antihypertensive effects of bofutsushosan (防風通聖散) and daisaikoto (大柴胡湯) for patients with obstructive sleep apnea as a complication of obesity and hypertension. |
bofutsushosan (防風通聖散), daisaikoto (大柴胡湯) |
Murase K, Toyama Y, Harada Y, et al. Evaluation and comparison of the effect of two Chinese herbal medicines (Bofu-tsusho-san and Dai-saiko-to) on metabolic disorders in obstructive sleep apnea patients. American journal of respiratory and critical care medicine 2013; 187: A5694. | RCT | C |
| G47.9 | Effectiveness of orengedokuto on sleep disorder in patients in the acute phase of psychotic disorders. |
orengedokuto (黄連解毒湯) |
Yamada K, Kanba S, Ohnishi K, et al. Clinical effectiveness of oren-gedoku-to for sleep disorder associated with acute schizophrenia and other psychotic disorders. Nihon Toyo Igaku Zasshi (Japanese Journal of Oriental Medicine) 1997; 47: 827-31 (in Japanese with English abstract). | RCT- envelope |
N |
| G47.9 | To evaluate the efficacy of yokukansanka-chimpihange for sleep disorders. |
yokukansanka-chimpihange (抑肝散加陳皮半夏), anchusan (安中散) |
Aizawa R, Kanbayashi T, Saito Y, et al. Effects of yoku-kan-san ka chimpi-hange on the sleep of normal healthy adult subjects. Psychiatry and Clinical Neurosciences 2002; 56: 303-4. | RCT- cross over |
C&I |
| G51.3 | Efficacy of shakuyakukanzoto for relieving facial spasm. |
shakuyakukanzoto (芍薬甘草湯) |
Kimura H, Otake T, Ishikura H. Efficacy of shakuyakukanzoto for relieving facial spasm*. Shindan to Chiryo (Diagnosis and Treatment) 1991; 79: 2505-8 (in Japanese). | RCT | N |
| G54.4 | To evaluate the efficacy of goshajinkigan for treatment of lumbar (low back) and leg pain. |
goshajinkigan (牛車腎気丸) |
Sekine R, Watanabe H, Mimura M, et al. The effects of Gosha-jinki-gan on the low back pain and lower limb pain caused by the lumbar spine: A comparison of Gosha-jinki-gan with Benfotiamine. Itami to Kampo (Pain and Kampo Medicine) 2003; 13: 84-7 (in Japanese) | RCT- cross over |
I |
| G81.9 | To evaluate the efficacy and safety of hochuekkito (補中益気湯) for decreased ADL, nutrition, and immune state in patients with hemiplegia due to sequelae of cerebrovascular disorders who are undergoing rehabilitation. |
hochuekkito (補中益気湯) |
Fukumura N, Yamamoto H, Kitahara M, et al. Hochuekkito suppresses the incidence of inflammatory complications in patients with sequelae of cerebrovascular disorders in the convalescent rehabilitation ward – Study in a multicenter randomized controlled trial. Japanese Journal of Rehabilitation Medicine 2017; 54: 303-14 (in Japanese with English abstract). | RCT | I |
- Note:
- Original English titles assigned by authors were used in this list and the structured abstracts. When references had no English titles, the Task Force translated the original Japanese titles into English ones (*).
- Abbreviations:
- C: The Cochrane Library (CENTRAL), I: Igaku Chuo Zasshi (Japana Centra Revuo Medicana, Ichushi), N: Database Offered by Nikkankyo (the Japan Kampo Medicines Manufacturers Association)
7. Eye Diseases (4 abstracts, 5 references)
| ICD-10 | Research Question |
Kampo Formula |
References | Study Design |
Source |
|---|---|---|---|---|---|
| H00.0 | To evaluate the efficacy of hainosankyuto for internal hordeolum in the acute phase. |
hainosankyuto (排膿散及湯) |
Takama N, Fujiwara T. The Efficacy of hainou-san-kyu-to for internal hordeolum. Ganka Rinsho Iho (Japanese Review of Clinical Ophthalmology) 2006; 100: 9-11 (in Japanese). | RCT | I |
| H18.9 | To evaluate the efficacy of goshajinkigan for corneal sensitivity, superficial keratitis, and tear secretion in patients with insulin-dependent (type 1) diabetes mellitus. |
goshajinkigan (牛車腎気丸) |
Nagaki Y, Hayasaka S, Hayasaka Y, et al. Effects of goshajinkigan on corneal sensitivity, superficial punctate keratopathy and tear secretion in patients with insulin-dependent diabetes mellitus. American Journal of Chinese Medicine 2003; 31: 103-9. | DB-RCT | C |
| Nagaki Y. Effects of goshajinkigan on diabetic keratopathy*. Kampo Igaku (Kampo Medicine) 2004; 28: 63-5 (in Japanese). | N | ||||
| H25.9 | To evaluate the efficacy of Kampo medicines for aqueous flare elevation after small-incision cataract surgery. |
orengedokuto (黄連解毒湯), kakkonto (葛根湯), saireito (柴苓湯) |
Ikeda N, Hayasaka S, Nagaki Y, et al. Effects of traditional Sino-Japanese herbal medicines on aqueous flare elevation after small-incision cataract surgery. Journal of Ocular Pharmacology and Therapeutics 2001; 17: 59-65. | RCT | C |
| H25.9 | To evaluate the efficacy of Kampo medicines for aqueous flare elevation after complicated cataract surgery. |
kakkonto (葛根湯), saireito (柴苓湯) |
Ikeda N, Hayasaka S, Nagaki Y, et al. Effects of kakkon-to and Sairei-to on aqueous flare elevation after complicated cataract surgery. American Journal of Chinese Medicine 2002; 30: 347-53. | RCT | C |
- Note:
- Original English titles assigned by authors were used in this list and the structured abstracts. When references had no English titles, the Task Force translated the original Japanese titles into English ones (*).
- Abbreviations:
- C: The Cochrane Library (CENTRAL), I: Igaku Chuo Zasshi (Japana Centra Revuo Medicana, Ichushi), N: Database Offered by Nikkankyo (the Japan Kampo Medicines Manufacturers Association)
8. Ear Diseases (9 abstracts, 10 references)
| ICD-10 | Research Question |
Kampo Formula |
References | Study Design |
Source |
|---|---|---|---|---|---|
| H65.0 | To evaluate the efficacy of shoseiryuto combined with eppikajutsuto for otitis media with effusion (OME) in adults. |
shoseiryuto (小青竜湯) +eppikajutsuto (越婢加朮湯) |
Inoue H. Rapid effect of combination therapy with shoseiryuto and eppikajutsuto for acute otitis media with effusion in adults. Jibi to Rinsho (Otologia Fukuoka) 2001; 47: 361-6 (in Japanese). | quasi- RCT |
I |
| H65.9 | Efficacy of saireito for otitis media with effusion. |
saireito (柴苓湯) |
Machii K, Ikezono T, Utasato S, et al. Comparative study of the efficacy of saireito monotherapy versus antiallergic agent plus carbocysteine combination therapy for otitis media with effusion*. Kampo Igaku (Kampo Medicine) 1992; 16: 200-3 (in Japanese). | RCT | N |
| H65.9 | Efficacy of saireito for otitis media with effusion. |
saireito (柴苓湯) |
Sato H, Nakamura H, Honjo I, et al. Clinical evaluation of Tsumura-Saireito in children with otitis media with effusion - A comparative randomized controlled study of cepharanthine -. Jibiinkoka Rinsho (Practica otologica) 1988; 81: 1383-7 (in Japanese with English abstract). | RCT | N |
| H66.9 | To evaluate the efficacy and safety of juzentaihoto (十全大補湯) in children with recurrent otitis media. |
juzentaihoto (十全大補湯) |
Yoshizaki T. A multicenter, double-blind, randomized controlled trial on the usefulness of juzentaihoto in children with recurrent otitis media* (2009—clinical study—general—007) Chozai to Joho (Dispensing and Information) Health Labour Sciences Research Grant, General Research Program for Practical Application of Medical Technology, 2009, General Research Report in 2011. 2012: 1-23 (in Japanese). | DB-RCT | N |
| Ito M, Maruyama Y, Kitamura K, et al. Randomized controlled trial of juzen-taiho-to in children with recurrent acute otitis media Auris Nasus Larynx 2017; 44: 390-7. | I | ||||
| H90.5 | To compare the effectiveness of saireito (柴苓湯) and isosorbide for low-frequency sensorineural hearing loss. |
saireito (柴苓湯) |
Kaneko T. Comparison of saireito and isosorbide in efficacy against low-frequency sensorineural hearing loss. Kampo to Saishin Chiryo (Kampo and the Newest Therapy) 2010; 19: 233–9 (in Japanese with English abstract). | quasi- RCT |
I |
| H93.1 | Efficacy of saireito for tinnitus. |
saireito (柴苓湯) |
Tanaka H. Efficacy of a Kampo preparation combined with tranquilizers in patients with tinnitus. Jibiinkoka Rinsho (Practica otologica) 1996; suppl 89: 8 (in Japanese). | RCT- cross over |
N |
| H93.1 | To evaluate the efficacy of chotosan for tinnitus. |
chotosan (釣藤散) |
Suzuki T. Clinical efficacy of chotosan for tinnitus. Pathology and treatment of tinnitus and dizziness. The 28th Chiba Symposium of Japanese Traditional Medicine Tokyo: Kudansha; 2001:8-20 (in Japanese). | RCT- cross over |
I |
| H93.1 | To evaluate the efficacy and safety of goshajinkigan (牛車腎気丸) for tinnitus. |
goshajinkigan (牛車腎気丸), chotosan (釣藤散) |
Onishi S. Kampo treatment for tinnitus and hearing impairment*. JOHNS 1990; 6: 535-9 (in Japanese). | quasi- RCT |
N |
| H93.1 | To evaluate the effects of hangekobokuto (半夏厚朴湯) on chronic tinnitus. |
hangekobokuto (半夏厚朴湯) |
Ino T, Odaguchi H, Wakasugi A, et al. A randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy of hangekobokuto in adult patients with chronic tinnitus. Journal of Traditional Medicines 2013; 30: 72-81. | DB-RCT | I |
- Note:
- Original English titles assigned by authors were used in this list and the structured abstracts. When references had no English titles, the Task Force translated the original Japanese titles into English ones (*).
- Abbreviations:
- C: The Cochrane Library (CENTRAL), I: Igaku Chuo Zasshi (Japana Centra Revuo Medicana, Ichushi), N: Database Offered by Nikkankyo (the Japan Kampo Medicines Manufacturers Association)
9. Cardiovascular Diseases (19 abstracts, 22 references)
| ICD-10 | Research Question |
Kampo Formula |
References | Study Design |
Source |
|---|---|---|---|---|---|
| I10 | To evaluate the efficacy of chotosan and orengedokuto for hypertension using ambulatory blood pressure monitoring. |
chotosan (釣藤散), orengedokuto (黄連解毒湯) |
Narumi J, Kohsaka S, Miyazawa S, et al. Evaluation of the Kampo monotreatment for hypertensive patients using ambulatory blood pressure monitor. Wakan Iyakugaku Zasshi (Journal of Traditional Medicines) 1994; 11: 282-3 (in Japanese). | RCT | N |
| Narumi J, Kohsaka S, Miyazawa S, et al. Evaluation of the Kampo monotreatment for hypertensive patients using ambulatory blood pressure monitoring*. Kampo Shinryo 1996; 15: 34-5 (in Japanese). | N | ||||
| I10 | Efficacy and safety of daisaikoto and chotosan in patients with essential hypertension. |
daisaikoto (大柴胡湯), chotosan (釣藤散) |
Sasaki J, Matsunaga A, Kusuda M, et al. Efficacy of daisaikoto and chotosan in patients with essential hypertension*. Rinsho to Kenkyu (Japanese Journal of Clinical and Experimental Medicine) 1993; 70: 1965-75 (in Japanese). | RCT- envelope |
I |
| I10 | Effects of daisaikoto and saikokaryukotsu-boreito on serum lipid levels in patients with mild to moderate hypertension. |
daisaikoto (大柴胡湯), saikokaryukotsu-boreito (柴胡加竜骨牡蠣湯) |
Saku K, Hirata K, Zhang B, et al. Effects of Chinese herbal drugs on serum lipids, lipoproteins and apolipoproteins in mild to moderate essential hypertensive patients. Journal of Human Hypertension 1992; 6: 393-5. | RCT | C |
| I10 | To evaluate the efficacy and safety of orengedokuto in patients with hypertension symptoms. |
orengedokuto (黄連解毒湯) |
Arakawa K, Saruta T, Abe K, et al. Double-blind placebo-controlled trial of TSUMURA Orengedokuto (TJ-15) for the treatment of accessory symptoms of hypertension*. Rinsho to Kenkyu (Japanese Journal of Clinical and Experimental Study) 2003; 80: 354-72 (in Japanese) | DB-RCT | I |
| Arakawa K, Saruta T, Abe K, et al. Improvement of accessory symptoms of hypertension by TSUMURA Orengedokuto Extract, a four herbal drugs containing Kampo-Medicine Granules for ethical use: a double-blind, placebo-controlled study. Phytomedicine 2006; 13: 1-10. | C | ||||
| I10 | To verify the effectiveness of the combined use of bofutsushosan (防風通聖散) with Western medical treatments for obesity hypertension patients using Ambulatory Blood Pressure Monitoring (ABPM). |
bofutsushosan (防風通聖散) |
Azushima K, Tamura K, Haku S, et al. Effects of the oriental herbal medicine Bofu-tsusho-san in obesity hypertension: a multicenter, randomized, parallel-group controlled trial (ATH-D-14-01021.R2). Atherosclerosis 2015; 240(1): 297-304. | RCT | C |
| I50.9 | To investigate combined effect of goreisan (五苓散) in elderly tolvaptan-responder patients with heart failure. |
goreisan (五苓散) |
Tamano M, Toyoda S, Kato S, et al. Clinical investigation of the combined effect of goreisan and tolvaptan in tolvaptan-responder elderly patients with heart failure. Progress in Medicine 2018; 38: 751-6 (in Japanese). | RCT | I |
| I51.9 | Efficacy and safety of orengedokuto plus red ginseng combination therapy for relieving symptoms associated with hypertension. |
orengedokuto (黄連解毒湯), orengedokuto (黄連解毒湯) ＋ kojinmatsu (紅参末) |
Kaneko H, Nakanishi K, Murakami A, et al. Clinical evaluation of the effect of Ohrengedoku-Toh and Ohrengedoku-Toh - Red Ginseng mixture on chronic cardiovascular disorders in middle and aged patients. The Ginseng Review 1991; 12: 89-93 (in Japanese with English abstract). | DB-RCT | N |
| I62.0 | To evaluate the effectiveness and safety of goreisan (五苓散) after chronic subdural hematoma surgery in elderly people. |
goreisan (五苓散) |
Yoshikawa T, Munakata S, Okuma H. Effectiveness of Goreisan for recurrence prevention in elderly cases of chronic subdural hematoma surgery— Interim report on a comparative trial.* Noshinkei Geka to Kampo (Neurosurgery and Kampo) 2010: 16 (in Japanese). | RCT | N |
| I62.0 | To investigate the preventative effect of goreisan (五苓散) on post-operative recurrence of chronic subdural hematoma. |
goreisan (五苓散) |
Katayama K, Matsuda N, Kakuta K, et al. The effect of goreisan on the prevention of chronic subdural hematoma recurrence: multi-center randomized controlled study. Journal of Neurotrauma 2018; 35: 1537-42. | RCT | C |
| I63.9 | Efficacy and safety of orengedokuto (黄連解毒湯) in the treatment of cerebral infarction. |
orengedokuto (黄連解毒湯) |
Ito E, Takahashi A, Kuzuya F. Clinical effectiveness of TSUMURA Orengedokuto in the treatment of cerebral infarction*. Geriatric Medicine 1991; 29: 303-13 (in Japanese). | RCT- envelope |
I |
| I63.9 | To evaluate the effectiveness of saireito (柴苓湯) for acute ischemic stroke. |
saireito (柴苓湯) |
Nakae Y. Effectiveness of saireito in acute ischemic stroke. Kampo to Saishin Chiryo (Kampo & the Newest Therapy) 2013; 22: 329-32. | RCT | I&N |
| I67.9 | Efficacy and safety of orengedokuto for relieving psychiatric symptoms in patients with late effects of cerebrovascular disease. |
orengedokuto (黄連解毒湯) |
Otomo E, Togi H, Kogure K, et al. Clinical usefulness of TSUMURA Orengedokuto for the treatment of cerebrovascular disease: a well-controlled study comparing TSUMURA Orengedokuto versus Ca hopantenate, using sealed envelopes for allocation*. Geriatric Medicine 1991; 29: 121-51 (in Japanese). | RCT- envelope |
I |
| I69.4 | To evaluate the efficacy and safety of tokishakuyakusan for treatment of hypofunction and decreased independence in patients with sequelae of cerebrovascular disorder. |
tokishakuyakusan (当帰芍薬散) |
Shimada Y. Efficacy of tokishakuyakusan for hypofunction and decreased independence in patients with sequelae of cerebrovascular disorder*. Kosei Rodo Kagaku Kenkyuhi Hojokin Choju Kagaku Kenkyu Jigyo: Koreisha no Nokekkan Shogai no Shinten Yobo wo Mokuteki to Shita Kampoyaku niyoru Tailor-made Iryo no Kaihatsu, Heisei 18 Nendo Buntan Kenkyu Hokokusho (Ministry of Health, Labour and Welfare, Science Research Grant, Comprehensive Studies on Science of Aging, Development of Personalized Medicine using Kampo Medicines to Prevent Progression of Cerebrovascular Disorders in the Elderly, Working-group Research Report Fiscal Year 2006) 2007: 22-30 (in Japanese) | RCT | N |
| I69.4 | To evaluate the effectiveness of tokishakuyakusan in reducing impairment and increasing independence in post-stroke patients. |
tokishakuyakusan (当帰芍薬散) |
Goto H, Satoh N, Hayashi Y, et al. A Chinese herbal medicine, tokishakuyakusan, reduces the worsening of impairmenis and independence after stroke: A 1-year randomized, controlled trial. Evidence-based complementary and Ａlternative Ｍedicine 2009: 1-6. (2011: 1-6. doi: 10.1093/ecam/nep026) | RCT | N |
| I73.0 | To evaluate the effectiveness of orengedokuto in improving peripheral circulation in Raynaud’s phenomenon. |
tokishakuyakusan (当帰芍薬散), orengedokuto (黄連解毒湯) |
Akiyama Y, Ohno S, Asaoka T, et al. The combination therapy with sarpogrelate hydrochloride and Kampo medicine (oren-gedoku-to or toki-shakuyaku-san) for Raynaud's phenomenon. Japanese Journal of Oriental Medicine 2001; 51: 1101-8 (in Japanese with English abstract). | quasi- RCT |
N |
| I80.3 | To evaluate the effect of keishibukuryogan on swelling in patients with deep vein thrombosis (DVT) of the lower limb. |
keishibukuryogan (桂枝茯苓丸) |
Uchida N. A Randomized controlled trial of the Chinese herbal medicine Keisi-bukuryo-gan (Gui-Zhi-Fu-Ling-Wan) in the treatment of deep vein thrombosis. Jomyakugaku (Jomyakugaku) 2009; 20:1-6 (in Japanese with English abstract). | RCT | I |
| I84.9 | To evaluate the clinical efficacy of otsujito combined with aluminum potassium sulfate/tannic acid (ALTA) sclerotherapy, the latest treatment for hemorrhoids. |
otsujito (乙字湯) |
Kato N, Kato K, Hosoi Y. Effects of Otsuji-to in patients with hemorrhoid using ALTA and LE combined therapy*. Kato N, Kato K, Hosoi Y. Effects of Otsuji-to in patients with hemorrhoid using ALTA and LE combined therapy*. (Journal of Medicine and Pharmaceutical Science) 2008; 60:747-53 (in Japanese). | RCT | I |
| I89.0 | To evaluate the efficacy and safety of goshajinkigan in the treatment of lymphedema. |
goshajinkigan (牛車腎気丸) |
Abe Y. The efficacy of goshajinkigan against lymphedema*. Kampo Igaku (Kampo Medicine) 2002; 25: 284-7 (in Japanese). | RCT | I |
| Abe Y, Kosugi I, Kasashima F, et al. Lymphedema and Kampo*. Progress in Medicine 2003; 23: 1538-9 (in Japanese). | N | ||||
| I95.1 | To evaluate the safety and efficacy of goreisan in the treatment of orthostatic hypotension in patients with diabetes mellitus. |
goreisan (五苓散) |
Nakamura H, Nakamura T, Nakagawa S et al. Efficacy of goreisan in treatment of orthostatic hypotension in patients with diabetes mellitus*. Diabetes Frontier 2000; 11: 561-3 (in Japanese). | RCT- cross over |
I |
- Note:
- Original English titles assigned by authors were used in this list and the structured abstracts. When references had no English titles, the Task Force translated the original Japanese titles into English ones (*).
- Abbreviations:
- C: The Cochrane Library (CENTRAL), I: Igaku Chuo Zasshi (Japana Centra Revuo Medicana, Ichushi), N: Database Offered by Nikkankyo (the Japan Kampo Medicines Manufacturers Association)
10. Respiratory Diseases (including Influenza and Rhinitis) (58 abstracts, 74 references)
| ICD-10 | Research Question |
Kampo Formula |
References | Study Design |
Source |
|---|---|---|---|---|---|
| J00 | To compare the efficacy of Kampo treatment and fenoprofen as antipyretics in patients with common cold syndrome associated with fever. |
kakkonto (葛根湯), maoto (麻黄湯), keimakakuhanto (桂麻各半湯), chikujountanto (竹ジョ温胆湯), shoseiryuto (小青竜湯), keishikashakuyakuto (桂枝加芍薬湯), kososan (香蘇散) |
Homma Y. Kampo treatment of patients with common cold syndrome associated with fever. Nihon Toyo Igaku Zasshi (Japanese Journal of Oriental Medicine) 1995; 46: 285-91 (in Japanese with English abstract). | RCT- envelope |
N |
| J00 | Effect on the duration and resolution of symptoms and treatment efficacy in patients with common cold syndrome. |
maobushisaishinto (麻黄附子細辛湯) |
Homma Y, Takaoka K, Yozawa H, et al. Effectiveness of Mao-bushi-saishin-to in treating common cold syndrome - controlled comparative study using the sealed envelope method -. Nihon Toyo Igaku Zasshi (Japanese Journal of Oriental Medicine) 1996; 47: 245-52 (in Japanese with English abstract). | RCT- envelope |
I |
| Homma Y. Treatment of common cold by a Kampo medicine - Maobushisaishin-tou-. Pharma Medica 2007; 25: 19-21 (in Japanese). | |||||
| J00 | To evaluate the efficacy and safety of shosaikoto in patients with common cold. |
shosaikoto (小柴胡湯) |
Kaji M, Kashiwagi S, Yamakido M, et al. A double-blind, placebo-controlled study of TSUMURA Shosaikoto (TJ-9) for common cold*. Rinsho to Kenkyu (Japanese Journal of Clinical and Experimental Study) 2001; 78: 2252-68 (in Japanese). | DB-RCT | I |
| J00 | To evaluate the efficacy and safety of bakumondoto for postinfectious cough. |
bakumondoto (麦門冬湯) |
Fujimori K, Suzuki E, Simojo F. Comparison between bakumondoto (mai men dong tang) and dextromethorphan hydrobromide in terms of effect on postinfectious cough: a pilot study. Nihon Toyo Igaku Zasshi (Japanese Journal of Oriental Medicine) 2000; 51: 725-32 | RCT | I |
| J00 | To compare the cough-improvement effect of maobushisaishinto and western drugs in patients with the common cold. |
maobushisaishinto (麻黄附子細辛湯) |
Nishizawa Y, Nagano F, Yamada M, et al. A randomized comparison of cough-improvement effects between mao-bushi-saishin-to and western drugs for cold in common patients with allergic cold syndrome. Kampo to Meneki Arerugi (Kampo and Immuno-Allergy) 2005; 18: 56-67 (in Japanese with English abstract). | RCT | N |
| J00 | To compare the effects of treatment (Kampo medicine vs. Western medicine) for upper airway inflammation in children. |
Kampo medicine (maoto [麻黄湯], keimakakuhanto [桂麻各半湯], etc.) |
Abe K. Outcomes of treatment for upper airway inflammation in children with Kampo medicine and Western medicine*. Dai 10-kai Nihon Shoni Toyo Igaku Kenkyukai Koen Kiroku (Proceedings of the 10th meeting of the Japan Pediatric Society for Oriental Medicine) 1993; 10: 19–23 (in Japanese). | quasi- RCT |
N |
| Abe K, Takagi K, Comparison of treatment results between Kampo medicine-treated group and Western medicine-treated group for upper respiratory tract inflammation in children, Kampo medicine 1993; 43: 509-15. | |||||
| J00 | To compare the effects of two different treatments, Western medicine and byakkokaninjinto (白虎加人参湯), on summertime cold. |
byakkokaninjinto (白虎加人参湯) |
Abe K. Effects of treatment with Kampo medicine compared to Western medicine for cold symptoms (summer-time cold, influenza) — byakkokaninjinto and maoto*. Nihon Shoni Toyo Igakkaishi (Journal of the Japan Pediatric Society for Oriental Medicine) 2003; 19: 46–52 (in Japanese). | quasi- RCT |
N |
| J00 | To evaluate the efficacy of Kakkonto (葛根湯) for alleviating early cold symptoms. |
Kakkonto (葛根湯) |
Okabayashi S, Goto M, Kawamura T, et al. Non-superiority of Kakkonto, a japanese herbal medicine, to a representative multiple cold medicine with respect to anti-aggravation effects on the common cold: a randomized controlled trial. 2014 Internal Medicine 2014; 53: 949-56. | RCT | N |
| J00 | To evaluate the efficacy and safety of shimpito (神秘湯) for treatment of cough associated with cold syndrome. |
shimpito (神秘湯) |
Itagaki K, Efficacy of shimpito for treatment of cough associated with cold syndrome.* Igaku to Yakugaku (Japanese Journal of Medicine and Pharmaceutical Science) 2013; 70: 813-6 (in Japanese). | quasi- RCT |
I&N |
| J00 | To verify the effectiveness of Kampo medications for the prevention of common cold syndrome in the elderly. |
rikkunshito (六君子湯), hochuekkito (補中益気湯), juzentaihoto (十全大補湯), ninjin’yoeito (人参養栄湯), rokumigan (六味丸), hachimijiogan (八味地黄丸), goshajinkigan (牛車腎気丸) |
Kato S, Tamano M, Okamura A, et al. Clinical Research The preventive effects of Kampo medications for common cold syndrome in the elderly*.Kampo Igaku (Science of Kampo Medicine) 2015; 39: 183-6. | RCT | I&N |
| J02.9 | To evaluate the efficacy of kikyoto (桔梗湯) for treatment of postoperative sore throat. |
kikyoto (桔梗湯) |
Kuwamura A, Komasawa N, Takahashi R, et al. Preoperative oral administration of kikyo-to, a Kampo medicine, alleviates postoperative score throat: a prospective, double-blind, randomized study. Journal of Alternative and Complementary Medicine 2016; 22: 294-7. | DB-RCT | C |
| J10.1 | To evaluate the effect of maoto in combination with oseltamivir on the duration of fever. |
maoto (麻黄湯) | Kubo T. Effect of maoto for treatment of influenza in children (from The 56th General Meeting of The Japan Society for Oriental Medicine, presentation C-41)*. Medicament News 2005 Sep 5; 1846: 15. | RCT | N |
| Kubo T, Nishimura H. Antipyretic effect of mao-to, a Japanese herbal medicine, for treatment of type A influenza infection in children. Phytomedicine 2007; 14: 96-101. | C | ||||
| J10.1 | To evaluate the efficacy of maoto (麻黄湯) in combination with oseltamivir phosphate in treating pediatric influenza. |
maoto (麻黄湯) | Kimoto H, Kuroki H. Efficacy of combined administration of oseltamivir phosphate and maoto in treating influenza. Kampo Igaku (Kampo Medicine) 2005; 29: 166-9 (in Japanese). | quasi- RCT |
I |
| J10.1 | To evaluate the efficacy of combined oseltamivir phosphate and maoto (麻黄湯) for the treatment of pediatric influenza. |
maoto (麻黄湯) | Kuroki H, Kimoto H. Successful treatment of combination therapy with oseltamivir and mao-to for influenza — 3rd report-. Kampo to Meneki-Arerugi (Kampo and Immuno-allergy) 2006; 19: 17-25 (in Japanese with English abstract). | quasi- RCT |
N |
| J10.1 | To evaluate the efficacy and safety of maobushisaishinto as an adjuvant for influenza vaccination in the elderly. |
maobushisaishinto (麻黄附子細辛湯) |
Iwasaki K, Taguchi M, Cyong JC, et al. Effects of mao-bushi-saishin-to on influenza vaccination in elderly subjects; a randomized control study. Kampo to Meneki-Arerugi (Kampo and Immuno-Allergy) 2004; 17: 97-103 (in Japanese with English abstract) | RCT- envelope |
N |
| Iwasaki K. Influenza and Kampo in the elderly*. TSUMURA Mail Magazine 2008; Suppl: 22-3 (in Japanese) | N | ||||
| J10.1 | To evaluate the efficacy of coadministration of maoto (麻黄湯) and Shosaikoto (小柴胡湯) for the treatment of influenza A infection, in comparison to oseltamivir. |
maoto (麻黄湯) + shosaikoto (小柴胡湯) |
Yaegashi H. Efficacy of coadministration of maoto and shosaikoto, a Japanese traditional herbal medicine (Kampo medicine), for the treatment of influenza A infection, in comparison to oseltamivir. Nihon Hokan Daitai Iryo Gakkaishi (Japanese Journal of Complementary and Alternative Medicine). 2010; 7: 59–62 (in English with Japanese summary). |
RCT | N |
| J10.1 | To evaluate the efficacy of maoto (麻黄湯) against influenza A in adults. |
maoto (麻黄湯) | Saita M, Naito T, Boku S, et al. The efficacy of ma-huang-tang (maoto) against influenza. Kampo to Meneki Arerugi (Kampo and Immuno-allergy). 2010; 23: 17–26 (in Japanese with English abstract). | RCT | N |
| Saita M, Naito T, Boku S, et al. The efficacy of ma-huang-tang (maoto) against influenza. Health 2011; 3: 300-3. | N | ||||
| J10.1 | To compare the effectiveness of oseltamivir, zanamivir, and maoto (麻黄湯) in adult influenza patients. |
maoto (麻黄湯) | Nabeshima S, Kashiwagi K, Ajisaka K, et al. A randomized, controlled trial comparing traditional herbal medicine and neuraminidase inhibitors in the treatment of seasonal influenza. Journal of Infection and Chemotherapy 2012; 18: 534-43. | RCT | N |
| J10.1 | To compare the effects of two different treatments (a Kampo medicine treatment and a Western medicine treatment) on influenza. |
Kampo medicine (maoto [麻黄湯], keimakakuhanto [桂麻各半湯], etc.) |
Abe K. Outcomes of treatment for upper airway inflammation in children with Kampo medicine and Western medicine*. Dai 10-kai Nihon Shoni Toyo Igaku Kenkyukai Koen Kiroku (Proceedings of the 10th meeting of the Japan Pediatric Society for Oriental Medicine) 1993; 10: 19–23 (in Japanese). | quasi- RCT |
N |
| J10.1 | To compare the effects on influenza of treatment with byakkokaninjinto (白虎加人参湯), maoto (麻黄湯), antibiotics, and amantadine. |
byakkokaninjinto (白虎加人参湯), maoto (麻黄湯) |
Abe K. Effects of treatment with Kampo medicine compared to Western medicine for cold symptoms (summer-time cold, influenza) — byakkokaninjinto and maoto*. Nihon Shoni Toyo Igakkaishi (Journal of the Japan Pediatric Society for Oriental Medicine) 2003; 19: 46–52 (in Japanese). | quasi- RCT |
N |
| J10.1 | To evaluate the effectiveness of two brands of maoto (麻黄湯) and oseltamivir in the time required to clear influenza virus from the pharynx in type A influenza patients. |
maoto (麻黄湯) | Kawamura K. No difference between two brands of maoto and oseltamivir in the time required to clear influenza virus from the pharynx in type A influenza patients*. Nihon Shonika Rinsho (Japanese Journal of Pediatrics) 2009; 62: 1855-61 (in Japanese). | quasi- RCT |
N |
| J10.1 | To compare the effect the combination of oseltamivir phosphate and Western medications with that of oseltamivir phosphate and maoto (麻黄湯) for pediatric influenza. |
maoto (麻黄湯) | Kuroki H, Kimoto H. An investigation of Western and Kampo integrated medicine for influenza*. Kampo to Meneki-Allergy (Kampo and Immunoallergy) 2005; 18: 47-55 (in Japanese). | quasi- RCT |
N |
| J10.1 | To evaluate the long-term effects of juzentaihoto (十全大補湯) on maintenance of the anti-influenza antibody titer in elderly people after influenza vaccination. |
juzentaihoto (十全大補湯) |
Saiki I, Koizumi K，Goto H, et al. The long-term effects of a kampo medicine, Juzentaihoto, on maintenance of antibody titer in elderly people after influenza vaccination. Evidence-Based Complementary and Alternative Medicine 2013: 1-8. doi: 10.1155/2013/568074 | RCT | N |
| J20.0 | To compare the efficacy of bakumondoto and tipepidine hibenzate as antitussive agents in patients with mycoplasmal bronchitis. |
bakumondoto (麦門冬湯) |
Watanabe N, Miyazawa T. Comparative study of the effect of bakumondoto and tipepidine hebinzate on cough in patients with mycoplasmal bronchitis. Kampo to Meneki-Arerugi (Kampo and Immuno-Allergy) 2007; 21: 31-6 (in Japanese). | RCT- envelope |
N |
| Watanabe N, Nakagawa T, Miyazawa T. Examination of effective antitussive against cough caused by mycoplasma bronchitis. Kampo to Meneki-Arerugi (Kampo and Immuno-Allergy) 2008; 22: 63-8 (in Japanese with English abstract). | I | ||||
| A49.3 J20.0 |
To evaluate the efficacy of bakumondoto (麦門冬湯) for coughing associated with mycoplasma bronchitis. |
bakumondoto (麦門冬湯) |
Watanabe N, Makino S, Nakagawa T, et al. A study on the efficacy of bakumondoto for coughing associated with mycoplasma infections. Science of Kampo Medicine 2017; 41:116-8 (in Japanese). | RCT- envelope |
I |
| J30.1 | Preventive effect and safety of preseasonal administration of shoseiryuto in patients with cedar pollen allergy (hay fever). |
shoseiryuto (小青竜湯) |
Ohya Y. Kampo treatment for allergic diseases: from the perspective of a general hospital*. Progress in Medicine 1988; 8: 604-12 (in Japanese). | RCT | N |
| Ohya Y. Efficacy of preseasonal administration of shoseiryuto for cedar pollen alergy*. Kampo Shinryo 1991; 10: 42-8 (in Japanese). | N | ||||
| J30.1 | Effects of shoseiryuto and ryokankyomi-shingeninto on springtime nasal allergy. |
shoseiryuto (小青竜湯), ryokankyomi-shingeninto (苓甘姜味辛夏仁湯) |
Mori H. Comparative study of Kampo preparations Sho-Seiryu-To and Ryokankyomishingenin-To for nasal allergy. Therapeutic Research 1996; 17: 3691-6 (in Japanese with English abstract). | quasi- RCT |
N |
| J30.1 | Effects of shoseiryuto and eppikajutsuto on springtime nasal allergy. |
shoseiryuto (小青竜湯), eppikajutsuto (越婢加朮湯) |
Mori H, Shimazaki Y, Kurata H, et al. Comparative study of Kampo preparations Sho-Seiryu-To and Eppika-Jutsu-To for nasal allergy and allergic conjunctivitis. Therapeutic Research 1997; 18: 3093-9 (in Japanese with English abstract). | quasi- RCT |
N |
| J30.1 | Effects of shoseiryuto and daiseiryuto on springtime nasal allergy. |
shoseiryuto (小青竜湯), daiseiryuto (大青竜湯) [keishitogo- makyokansekito (桂枝湯合麻杏甘石湯)] |
Mori H. Comparative study of Kampo preparations Sho-Seiryu-To and Dai-Seiryu-To for nasal allergy and allergic conjunctivitis. Therapeutic Research 1998; 19: 3299-307 (in Japanese with English abstract). | quasi- RCT |
N |
| J30.1 | To compare the efficacy of shoseiryuto and keimakakuhanto in treating springtime nasal allergy and allergic conjunctivitis. |
shoseiryuto (小青竜湯), keimakakuhanto (桂麻各半湯) [keisito+maoto (桂枝湯+麻黄湯)] |
Mori H, Kurata H, Shimazaki Y, et al. Comparative study of Kampo preparations sho-sei-ryu-to and kei-ma-kakuhan-to for nasal allergy and allergic conjunctivitis in spring. Therapeutic Research 1999; 20: 2941-7 (in Japanese with English abstract). | quasi- RCT |
N |
| J30.1 | To compare the effects of shoseiryuto and maobushisaishinto in treating springtime nasal allergy and allergic conjunctivitis. |
shoseiryuto (小青竜湯), maobushisaishinto (麻黄附子細辛湯) |
Yoshimoto T, Mori H, Kurata H, et al. Comparative study of Kampo preparations sho-sei-ryu-to and maoh-bushi-saisin-to for nasal allergy and allergic conjunctivitis in spring. Therapeutic Research 2002; 23: 2253-9 (in Japanese with English abstract). | quasi- RCT |
I |
| J30.1 | To compare the effects of shoseiryuto and gokoto in subjects with nasal allergy and allergic conjunctivitis in spring. |
shoseiryuto (小青竜湯), gokoto (五虎湯) |
Shimazaki Y, Mori H, Kurata H, et al. Comparative study of Kampo preparations Sho-Sei-Ryu-To and Go-Ko-To for nasal allergy and allergic conjunctivitis in spring. Therapeutic Research 2001; 22: 2385-91 (in Japanese with English abstract). | quasi- RCT |
I |
| J30.3 | Efficacy and safety of shoseiryuto in the treatment of perennial nasal allergy. |
shoseiryuto (小青竜湯) |
Baba S, Takasaka T, Inamura N, et al. Double-blind clinical trial of Sho-seiryu-to (TJ-19) for perennial nasal allergy. Jibiinkoka Rinsho (Practica otologica) 1995; 88: 389-405 (in Japanese with English abstract). | DB-RCT | C&I |
| J30.3 | To evaluate the efficacy and safety of maobushisaishinto extract granules prepared based on Shanghanlun (傷寒論, Treatise on Cold Damage Diseases) and conventionally-prepared maobushisaishinto extract powder in the treatment of perennial nasal allergy. |
maobushisaishinto (麻黄附子細辛湯) |
Nakai Y, Ohashi Y, Esaki Y, et al. Clinical evaluation of maobushisaishinto for nasal allergy*. Jibi-inkouka Tenbou (Oto-Rhino-Laryngology, Tokyo) 1990; 33: 655-73 (in Japanese). | quasi- RCT |
N |
| J32.9 | Effectiveness of shin'iseihaito and shigyakusan for chronic rhinitis and sinusitis. |
shin’iseihaito (辛夷清肺湯), shigyakusan (四逆散) |
Sakurada T, Ikeda K, Takasaka T, et al. Clinical effectiveness of Kampo medicine for chronic rhinitis and sinusitis. Jibiinkoka Rinsho (Practica otologica) 1992; 85: 1341-6 (in Japanese with English abstract). | RCT- envelope |
N |
| J39.2 | Efficacy of saibokuto for relieving complaints after thyroid or parathyroid surgery. |
saibokuto (柴朴湯) |
Suzuki S, Furukawa H, Ami H, et al. Experience with TSUMURA Saibokuto (TJ-96) in patients who underwent thyroid or parathyroid surgery*. Progress in Medicine 1994; 14: 2254-8 (in Japanese). | RCT- envelope |
I |
| J40 | To evaluate the efficacy and safety of shoseiryuto in the treatment of bronchitis. |
shoseiryuto (小青竜湯) |
Miyamoto T, Inoue H, Kitamura S, et al. Effect of TSUMURA Sho-seiryu-to (TJ-19) on bronchitis in a double-blind placebo-controlled study. Rinsho Iyaku (Journal of Clinical Therapeutics & Medicine) 2001; 17: 1189-214 (in Japanese with English abstract). | DB-RCT | I |
| Miyamoto T. Clinical effectiveness of Shosei-ryuto in bronchitis. Pharma Medica 2007; 25: 23-5 (in Japanese). | I | ||||
| J44.9 | Effectiveness of bakumondoto as an expectorant. |
bakumondoto (麦門冬湯) |
Sasaki H, Satou K, Sasaki M, et al. Usefulness of Bakumondo-to in senile chronic respiratory disease patients having difficulty in expectoration: comparison with bromhexine hydrochloride preparations. Kampo to Meneki-Arerugi (Kampo and Immuno-allergy) 1993; 7: 139-45 (in Japanese with English abstract). | RCT- envelope |
N |
| J44.9 | To determine the efficacy of smoking cessation combined with administration of seihaito for chronic obstructive pulmonary disease (COPD). |
seihaito (清肺湯) |
Kato S, Matsuda T, Nakajima T, et al. Clinical significance of the combination therapy of smoking cessation and seihaito for chronic obstructive pulmonary disease. Kampo to Saishin-chiryo (Kampo & the Newest Therapy) 2005; 14: 260-5 (in Japanese). | RCT- envelope |
I |
| Kato S, Oda K, Hasumi H, et al. The combined effect of smoking cessation and Seihai-to on airway clearance on COPD patients. Kampo to Meneki-Arerugi (Kampo and Immuno-Allergy) 2006; 19: 26-35 (in Japanese with English abstract). | N | ||||
| J44.9 | To investigate the effect of hochuekkito on systemic inflammation in subjects with chronic obstructive pulmonary disease (COPD). |
hochuekkito (補中益気湯) |
Shinozuka N, Tatsumi K, Nakamura A, et al. Evaluation of systemic inflammation and utility of hochuekkito administration in subjects with COPD*. Kosei Rodosho Kagaku Kenkyu Kenkyuhi Hojokin Nanchisei Shikkan Kokufuku Kenkyu Jigyo Kokyufuzen ni Kansuru Chosa Kenkyu Heisei 18 Nendo Buntan Kenkyu Hokokusho (Ministry of Health, Labour and Welfare, Science Research Grant: The Intractable Disease Treatment Research Project, Research on Respiratory Failure, Working-group Research Report Fiscal Year 2006)2007:94-9 (in Japanese). | RCT- envelope |
N |
| Shinozuka N, Tatsumi K, Nakamura A, et al. A traditional herbal medicine hochuekkito improves systemic inflammation in patients with COPD. American Journal of Respiratory and Critical Care Medicine 2007; 175: A638. | C | ||||
| Shinozuka N, Tatsumi K, Nakamura A, et al. The traditional herbal medicine Hochuekkito improves systemic inflammation in patients with chronic obstructive pulmonary disease. Journal of the American Geriatrics Society 2007; 55: 313-4. | C | ||||
Fukuchi Y, Tatsumi K. Utility evaluation of Kampo in the treatment of chronic obstructive pulmonary disease*. Kosei Rodosho Kagaku Kenkyuhi Hojokin Choju Kagaku Sogo Kenkyu Jigyo: Mansei Heisokusei Shikkan ni Taisuru Kampochiryo no Yuyosei Hyoka ni Kansuru Kenkyu, Heisei 18 Nendo Sokatsu Kenkyusyo Hokokusho (Ministry of Health, Labour and Welfare, Science Research Grant: Comprehensive Studies on Science of Aging, Study on Evaluation of Usefulness of Kampo Treatment for Chronic Obstructive Pulmonary Disease, Summary Report Fiscal Year 2006), 2007:1-31 (in Japanese). |
N | ||||
| Tatsumi K, Shinozuka N, Nakayama K, et al. Hochuekkito improves systemic inflammation and nutritional status in elderly patients with chronic obstructive pulmonary disease. The American Geriatrics Society 2009; 57: 169-70. | N | ||||
| J44.9 | To evaluate the effect of bakumondoto (麦門冬湯) on cough in patients with chronic obstructive pulmonary disease (COPD). |
bakumondoto (麦門冬湯) |
Mukaida K, Hattori N, Kondo K, et al. A pilot study of the multiherb Kampo medicine bakumondoto for cough in patients with chronic obstructive pulmonary disease. Phytomedicine 2011; 18: 625-9. | RCT- cross over |
N |
| Hattori N, Mukaida K, Haruta Y, et al. A pilot study of the effects of Bakumondoto (TJ-29) on cough in chronic obstructive pulmonary disease (COPD)*. Kampo to Meneki – Arerugi (Kampo and Immuno-Allergy) 2011; 24: 38–45 (in Japanese with English abstract). | N | ||||
| J44.9 | To investigate the efficacy and safety of adding hochuekkito (補中益気湯) to pulmonary rehabilitation for patients with chronic obstructive pulmonary disease (COPD). |
hochuekkito (補中益気湯) |
Hamada H, Sekikawa K, Murakami I, et al. Effects of Hochuekkito combined with pulmonary rehabilitation in patients with COPD. Experimental and Therapeutic Medicine 2018; 16 :5236-42. | RCT | C |
| J45.0 | Development of saibokuto inhalation therapy, and to evaluate its efficacy in preventing attacks of aspirin-induced asthma. |
saibokuto (柴朴湯) |
Nishizawa Y, Nishizawa Y, Yoshioka F, et al. Suppressive Effect of Japanese Herbal Medicine, Saiboku-to (Cai-Pu-Tang) on Brochospasms in Aspirin-induced Bronchial Asthmatic Patients. A Randomized, Double-blind Test. Jibi-inkoka Tenbo (Oto-Rhino-Laryngology Tokyo) 2001; 44: 5-13 (in Japanese with English abstract). | DB-RCT | I |
| J45.0 | To evaluate the efficacy of short-term inhaled saibokuto in suppressing airway constriction, and long-term inhaled saibokuto in alleviating psychological suffering. |
saibokuto (柴朴湯) |
Nishizawa Y, Nishizawa Y, Yoshioka F, et al. Suppressive effect of Kampo medicine, Cai-pu-tang (Japanese name: Saiboku-to, TJ-96) on brochospasms in aspirin-induced bronchial asthmatic patients and decrease of chronic pain. Especially psychological pain. Itami to Kampo (Pain and Kampo Medicine) 2001; 11: 14-21 (in Japanese with English abstract). | RCT- cross over |
I |
| J45.0 | To investigate the clinical effect of saibokuto for the treatment of atopic asthma. |
saibokuto (柴朴湯) |
Urata Y, Yoshida S, Irie Y, et al. Treatment of asthma patients with herbal medicine TJ-96: a randamized controlled trial. Respiratory Medicine 2002; 96: 469-74. | RCT- cross over |
C |
| J45.0 | To evaluate the efficacy and safety of inhaled shimpito for the control of aspirin-induced asthma. |
shinpito (神秘湯) |
Nishizawa Y, Nishizawa Y, Yoshioka F, et al. Suppressive effect of Chinese tracitional medicine, she-bi-tang (shinpi to) on bronchospasm in aspirin-indolerant bronchial asthmatic patients — a randomized, group-paralleled comparative trial —. Jibi-inkoka Tenbo (Oto-rhino-laryngology Tokyo) 2003; 46: 3-14 (in Japanese with English abstract). | RCT | C&I |
| J45.0 | To evaluate the efficacy and safety of inhaled shimpito therapy for improving asthma symptoms in patients with aspirin-induced asthma. |
shinpito (神秘湯) |
Nishizawa Y, Nishizawa Y, Goto GH, et al.A randomized, group-parallel comparative trial of the suppressiveeffect of Chinese traditional medicine, shen-mi-tang (shin-pi-to), compared to sodium oramolycate inhalation in improving subjective and objective symptoms in bronchial asthmatics. Jibi-inkoka Tenbo (Oto-rhino-laryngology Tokyo) 2004; 47: 20-7 (in Japanese with English abstract). | RCT | C&I |
| J45.0 | To investigate the effect of saibokuto inhalation therapy in improving quality of life (QOL) in patients with aspirin-intolerant asthma. |
saibokuto (柴朴湯) |
Nishizawa Y, Nishizawa Y, Goto HG. Chronic pain in intractable and chronic medical conditions -*. Mansei Totsu (The Journal of the Japanese Society for the Study of Chronic Pain) 2002; 21: 67-77 (in Japanese with English abstract). | RCT | I |
| J45.9 | Efficacy and safety of saibokuto in patients with steroid-dependent bronchial asthma. |
saibokuto (柴朴湯) |
Egashira Y, Nagano H, et al. Results of a comparative clinical study of the effect of "TSUMURA Saiboku-to" (TJ-96) against steroid dependent bronchial asthma in 2 groups, a Saiboku-to administration group and a non-administration group, divided by the envelope method. Kampo to Meneki-Arerugi (Kampo and Immuno-allergy) 1990; 4: 128-44 (in Japanese with English abstract). | RCT- envelope |
N |
| Egashira Y, Nagano H. A multicenter clinical trial of TJ-96 in patients with steroid-dependent bronchial asthema. A comparison of groups allocated by the envelope method. Annals of the New York Academy of Science 1993; 685: 580-3. | C | ||||
| J45.9 | Efficacy and safety of saibokuto in the treatment of bronchial asthma in children. |
saibokuto (柴朴湯) |
Ito S, Mikawa H. Effect of "TSUMURA Saiboku-to" (TJ-96) on bronchial asthma in children. Kampo to Meneki-Arerugi (Kampo and Immuno-allergy) 1990; 4: 115-25 (in Japanese with English abstract). | RCT- envelope |
N |
| Ito S, Mikawa H. Clinical evaluation of Saibokutou in the treatment of children with bronchial asthma. Kiso to Rinsho (The Clinical Report) 1992; 26: 3993-8 (in Japanese). | I | ||||
| J45.9 | Efficacy of shinpito for inhibiting exercise-induced asthma and relieving clinical symptoms in patients with moderate or worse bronchial asthma. |
shinpito (神秘湯) |
Tubaki T, Ebisawa M, Akimoto K, et al. Effects of Shinpi-to (Shenbi-tang) on bronchial asthma. Kampo to Meneki-Arerugi (Kampo and Immuno-allergy) 1994; 8: 65-71 (in Japanese with English abstract). | RCT | N |
| J45.9 | To assess the efficacy and safety of inhaled saibokuto while reducing the amount of inhaled beclomethasone during the course of treatment for bronchial asthma. |
saibokuto (柴朴湯) |
Nishizawa Y, Nishizawa Y, Nagano F, et al. Sparing effect of saibokuto inhalation on inhaled beclomethasone dipropionate to halved of reduction of inhaled beclomethasone dipropinate-dose: well-controlled comparative study of saiboku-to-inhalation and sodium cromoglycate-inhalation. Jibi-inkoka Tenbo (Oto-rhino-laryngology Tokyo) 2002; 45: 8-15 (in Japanese with English abstract). | RCT | C&I |
| J45.9 | To compare the efficacy of the anxiolytic-like agent saibokuto with that of shoseiryuto in patients with bronchial asthma. |
saibokuto (柴朴湯), shoseiryuto (小青竜湯) |
Nishizawa Y, Nishizawa Y, Yoshioka F, et al. Clinical effect of a Kampo medicine, chai-po-tang (Japanese name: saiboku-to) compared with xiao-quing-long tang (Japanese name: shoseiryu-to) in asthmatics with anxiety and depression due to asthmatic attacks. Nihon Toyo Shinshin Igaku Kenkyu (Journal of Japanese Association of Oriental Psychosomatic Medicine) 2003; 18: 11-7 (in Japanese with English abstract). | RCT | I |
| J45.9 | To assess the efficacy of the anxiolytic-like agent, saibokuto, in treating bronchial asthma. |
saibokuto (柴朴湯) |
Nishizawa Y, Nishizawa Y, Yoshioka F, et al. Clinical effect of a Chinese tracitional herbal medicine, chai-po-tang (Japanese name: saiboku-to) compared with clotiazepam in patients with bronchial asthmatics and anxiety disorder in multicenter randomized, comparative trial. Nihon Toyo Shinshin Igaku Kenkyu (Journal of Japanese Association of Oriental Psychosomatic Medicine) 2002; 17: 20-7 (in Japanese with English abstract). | RCT | I |
| J45.9 | To evaluate the efficacy and safety of saibokuto in patients with asthma exacerbations based on anticipatory anxiety. |
saibokuto (柴朴湯) |
Nishizawa Y, Nishizawa Y, Yoshioka F, et al. Clinical effect of chai-po-tang (Japanese name: saiboku-to), a Chinese tracitional herbal medicine, in patients with bronchial asthma and autonomic nerve dysfunction: a multicenter, randomized, double-blined, placebo-controlled study. Nihon Toyo Shinshin Igaku Kenkyu (Journal of Japanese Association of Oriental and Psychosomatic Medicine) 2004; 19:37-41 (in Japanese with English abstract). | RCT | I |
| J69.0 | To investigate whether hangekobokuto (banxia houp tang) improves cough reflex in elderly patients likely to have aspiration pneumonia. |
hangekobokuto (半夏厚朴湯) |
Iwasaki K, Cyong JC, Kitada S, et al. A traditional Chinese herbal medicine, banxia houp tang, improves cough reflex of patients with aspiration pneumonia. Journal of the American Geriatrics Society 2002; 50: 1751-2. | RCT | C |
| J69.0 | To evaluate whether hangekobokuto prevents aspiration pneumonia and pneumonia-related mortality in elderly people with dementia. |
hangekobokuto (半夏厚朴湯) |
Iwasaki K, Kato S, Monma Y, et al. A pilot study of banxia houpu tang, a traditional Chinese medicine, for reducing pneumonia risk in older adults with dementia. Journal of the American Geriatrics Society 2007; 55: 2035-40. | RCT | C |
| Iwasaki K, Kato S, Monma Y, et.al. A pilot study of banxia houpu tang, a traditional Chinese medicine, for reducing pneumonia risk in brain-damaged elderly. International Journal of Stroke 2010; 5 suppl 2: 38-9. | C | ||||
| J98.8 | To evaluate the efficacy, impact on recurrence rate, and medical cost efficiency of antibiotics plus Kampo combination therapy for bacterial respiratory infections. |
juzentaihoto (十全大補湯), hochuekkito (補中益気湯), kakkonto (葛根湯), keishito (桂枝湯), kososan (香蘇散), shosaikoto (小柴胡湯) |
Mikamo H, Tamaya T. Usefulness of Kampo medicine for the treatment of infections from the perspective of medical economics*. Sanfujinka Kampo Kenkyu no Ayumi (Recent Progress of Kampo Medicine in Obstetrics and Gynecology) 2007; 24: 105-8 (in Japanese). | RCT | I |
- Note:
- Original English titles assigned by authors were used in this list and the structured abstracts. When references had no English titles, the Task Force translated the original Japanese titles into English ones (*).
- Abbreviations:
- C: The Cochrane Library (CENTRAL), I: Igaku Chuo Zasshi (Japana Centra Revuo Medicana, Ichushi), N: Database Offered by Nikkankyo (the Japan Kampo Medicines Manufacturers Association)
11. Gastrointestinal, Hepato-Biliary-Pancreatic Diseases (71 abstracts, 90 references)
| ICD-10 | Research Question |
Kampo Formula |
References | Study Design |
Source |
|---|---|---|---|---|---|
| K11.7 | Efficacy of ninjin'yoeito for improvement of xerostomia induced by oxybutynin hydrochloride. |
ninjin’yoeito (人参養栄湯) |
Miyazaki Y, Yamada A, Saitou M. Effect of Ninjin-Youei-tou on xerostomia induced by oxybutynin hydrochloride. Shinyaku to Rinsho (Journal of New Remedies and Clinics) 1994; 43: 2613-7 (in Japanese). | RCT | N |
| K11.7 | To compare the efficacy of bakumondoto versus cevimeline hydrochloride hydrate (Evoxac) or nizatidine (Acinon) for treating dry mouth. |
bakumondoto (麦門冬湯) |
Umemoto M, Nin T, Miuchi S, et al. Treatment of human dry mouth using various medicines. Jibiinkoka Rinsho (Practica otologica) 2007; 100: 145-52 (in Japanese with English abstract). | RCT | I |
| K11.7 | To evaluate the effects of bakumondoto (麦門冬湯) on neuropeptide levels in human plasma and saliva |
bakumondoto (麦門冬湯) |
Satoh Y, Itoh H, Takeyama M. Effects of bakumondoto on neuropeptide levels in human saliva and plasma. Journal of Traditional Medicines 2009; 26: 122-30. | RCT- cross over |
I |
| K11.7 | To evaluate the effects of daikenchuto (大建中湯) on salivary secretion and salivary neuropeptide levels in humans after a single oral dose. |
daikenchuto (大建中湯) |
Suzuki Y, Itoh H, Yamamura R, et al. Significant increase in salivary substance P level after a single oral dose of Japanese herbal medicine Dai-kenchu-to in humans. Biomedicine & Aging Pathology 2012; 2: 81-4. | RCT- cross over |
N |
| K12.1 | Efficacy and safety of orento for treating stomatitis. |
orento (黄連湯) | Oka S. The effects of Oren-to on stomatitis. Nihon Toyo Igaku Zasshi (Japanese Journal of Oriental Medicine) 1995; 46: 439-45 (in Japanese with English abstract). | RCT | N |
| C64 K12.3 |
To evaluate the clinical usefulness of gargling with hangeshashinto (半夏瀉心湯) for treatment of oral mucositis caused by sunitinib in patients with metastatic renal cancer. |
hangeshashinto (半夏瀉心湯) |
Oh-oka H. The clinical usefulness of gargling with hangeshashinto for treatment of oral mucositis caused by sunitinib in patients with metastatic renal cancer. Kampo Medicine 2018;69: 1-6 (in Japanese with English abstract). | RCT | I |
| C15.9 K13.7 |
To investigate the impact of daiokanzoto (大黄甘草湯) and hangeshashinto (半夏瀉心湯) on oral mucositis, tongue coating bacteria, and gingiva condition in patients with esophageal cancer undergoing chemotherapy. |
daiokanzoto (大黄甘草湯), hangeshashinto (半夏瀉心湯) |
Moriyama S, Hinode D, Yoshioka M, et al. Impact of the use of Kampo medicine in patients with esophageal cancer during chemotherapy：a clinical trial for oral hygiene and oral condition. Journal of medical investigation 2018; 65,:184‐90. | RCT- envelope |
C |
| K14.6 | To evaluate the efficacy of saibokuto compared with tranquilizer plus vitamin B complex combination therapy for patients with glossodynia. |
saibokuto (柴朴湯) |
Bessho K, Okubo Y, Hori S, et al. Effectiveness of Kampo medicine (Sai-Boku-To) in treatment of patients with glossdynia. Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology, and Endodontology 1998; 86: 682-6. | RCT | C |
| Yamada T, Bessho K, Murakami K, et al. Clinical evaluation of sai-boku-to (Kampo medicine) for glossodynia. Shika Yakubutsu Ryoho (Oral Therapeutics and Pharmacology) 1998; 17: 18-22 (in Japanese with English abstract). | N | ||||
| Yamada T, Bessho K. Clinical evaluation of sai-boku-to (Kampo medicine) for glossodynia. Kampo to Saishin-chiryo (Kampo & the Newest Therapy) 1999; 8: 261-5 (in Japanese). | I | ||||
| K21.0 | To evaluate the efficacy of rikkunshito combined with a proton pump inhibitor (PPI) for treating gastroesophageal reflux disease (GERD). |
rikkunshito (六君子湯) |
Koide A. Effect and role of TJ-43: rikkun-shi-to from the aspects of endoscopic findings and QOL improvement in GERD patients. Medical Tribune Online (Digestive Disease Week: DDW) 2005: 6-7 (in Japanese). | RCT | N |
| K21.0 | To evaluate the efficacy of hangekobokuto-combined treatment in patients with respiratory symptoms associated with refractory gastroesophageal reflux disease (GERD). |
hangekobokuto (半夏厚朴湯) |
Kato S, Nakajima T, Matsuda T, et al. The effectiveness of the traditional Kampo medicine, “banxia houpu tang (hangekobokuto)” to respiratory disturbance by esophageal reflux disease. Kampo to Saishin-chiryo (Kampo & the Newest Therapy) 2005; 14: 333-8 (in Japanese). | RCT- envelope |
I |
| K21.9 | To evaluate the efficacy of TSUMURA Rikkunshito Extract Granules for treatment of non-erosive reflux disease (NERD) unresponsive to proton pump inhibitors (PPIs). |
rikkunshito (六君子湯) |
Koide A. Establishment of new treatment strategy for non-erosive reflux disease (endoscopy-negative gastroesophageal reflux disease) — potential of rikkunshito*. MedicalQ 2006; 187 (in Japanese). | RCT | N |
| K21.9 | To evaluate the effectiveness of rikkunshito (六君子湯) for patients with proton pump inhibitor (PPI)–resistant gastroesophageal reflux disease (GERD, and especially non-erosive reflux disease [NERD]). |
rikkunshito (六君子湯) |
Tominaga K, Fujiwara Y, Shimoyama Y, et al.Rikkunshito improves PPI-refractory NERD: a prospective randomized multi-center trial in Japan. Gastroenterology 2010; 138: S655-6. | RCT | N |
| Tominaga K, Fujiwara Y, Arakawa T, et al. GERD — Rikkunshito*. Shindan to Chiryo (Diagnosis and Treatment) 2011; 99: 771–6 (in Japanese). | N | ||||
| Tominaga K, Iwakiri R, Fujimoto K, et al. Rikkunshito improves symptoms in PPI-refractory GERD patients: a prospective, randomized, multicenter trial in Japan. Journal of Gastroenterology 2012; 47: 284-92. | N | ||||
| K21.9 | To evaluate the effects of rikkunshito (六君子湯) on esophageal motor function and gastroesophageal reflux. |
rikkunshito (六君子湯) |
Morita T. Effects of rikkunshito (TJ-43) on gastroesophageal reflux, esophageal motor functions and salivary secretion: placebo-controlled double-blind study. Nikkei Medical (Supplement) 2010; 8: 27 (in Japanese). | DB-RCT- cross over |
N |
| Morita T, Furuta K, Adachi K, et al. Effects of Rikkunshito (TJ-43) on esophageal motor function and gastroesophageal reflux. Journal of Neurogastroenterology and Motility 2012; 18: 181-6. | N | ||||
| K21.9 | To evaluate the effects of rikkunshito (六君子湯) on esophageal motor function and gastroesophageal reflux. |
rikkunshito (六君子湯) |
Morita T. Effects of rikkunshito (TJ-43) on gastroesophageal reflux, esophageal motor functions and salivary secretion: placebo-controlled double-blind study. Nikkei Medical (Supplement) 2010; 8: 27 (in Japanese). | DB-RCT- cross over |
N |
| K21.9 | To evaluate the efficacy and safety of rikkunshito (六君子湯) for proton-pump inhibitor (PPI)-refractory laryngopharyngeal reflux (LPR). |
rikkunshito (六君子湯) |
Tokashiki R,Okamoto I,Funato N, et al. Rikkunshito improves globus sensation in patients with proton-pump inhibitor-refractory laryngopharyngeal reflux. World Journal of Gastroenterology. 2013; 19: 5118-24. | RCT | N |
| K21.9 | To evaluate the efficacy and safety of rikkunshito (六君子湯) for proton pump inhibitor-refractory non-erosive reflux disease. |
rikkunshito (六君子湯) |
Tominaga K, Kato M, Takeda H, et al. A randomized，placebo-controlled，double-blind clinical trial of Rikkunshito for patients with non-erosive reflux disease refractory to proton-pump inhibitor：The G-Pride study. Journal of Gastroenterology 2014; 49: 1392-1405. | DB-RCT | N |
| Sakata Y, Tominaga K，Kato M, et al. Clinical characteristics of elderly patients with proton pump inhibitor-refractory non-erosive reflux disease from theG-PRIDE study who responded to Rikkunshito. BMC Gastroenterology 2014; 14: 1-10. | RCT | N | |||
| K21.9 | To determine the efficacy and safety of hangeshashinto (半夏瀉心湯) in treating patients with proton pump inhibitor (PPI)-refractory gastroesophageal reflux disease (GERD). |
hangeshashinto (半夏瀉心湯) |
Takeuchi T, Hongo H, Kimura T, et al. Efficacy and safety of hangeshashinto for treatment of GERD refractory to proton pump inhibitors : Usual dose proton pump inhibitors plus hangeshashinto versus double-dose proton pump inhibitors: randomized. Journal of Gastroenterology 2019; 1-12. | RCT | N |
| K25.9 | To compare the efficacy of saikokeishito, H2 receptor antagonist, or their combination for preventing recurrence of gastric ulcer. |
saikokeishito (柴胡桂枝湯) |
Nakahara A, Kashimura H, Fukutomi H. Gastric ulcer - saikokeishito or shigyakusan monotherapy -*. Nikkei Medical (separate-volume supplement) 1988; 17: 20-1 (in Japanese). | RCT- envelope |
N |
| Fukutomi H, Nakahara A. Traditional oriental therapy of the gastric ulcer. Shokakika (Gastroenterology) 1990; 12: 159-65 (in Japanese). | N | ||||
| K27.9 | To evaluate the usefulness of H2-blocker (cimetidine) combined with Kampo medicine (shigyakusan, saikokeishito) as a maintenance therapy for peptic ulcer. |
shigyakusan (四逆散), saikokeishito (柴胡桂枝湯) |
Watanabe H. A study of peptic ulcer maintenance therapy combined with Kampo medicines*. Kampo Igaku (Kampo Medicine) 1995; 19: 18-21 (in Japanese). | RCT | N |
| K29.7 | Efficacy and safety of rikkunshito and hangeshashinto for treating acute gastritis and acute exacerbation of chronic gastritis. |
rikkunshito (六君子湯), hangeshashinto (半夏瀉心湯) |
Ohta Y, Nishioka M, Yamamoto Y, et al. Multicenter clinical evaluation of Kampo preparations for medical use in the treatment of gastritis (acute gastritis and acute exacerbation of chronic gastritis) - comparison with gefarnate as a control -*. Shindan to Chiryo (Diagnosis and Treatment) 1990; 78: 2935-46 (in Japanese). | RCT- envelope |
N |
| K29.7 | Efficacy and safety of rikkunshito for treating gastritis (acute gastritis and acute exacerbation of chronic gastritis). |
rikkunshito (六君子湯) |
Miyoshi A, Kaneko E, Nakazawa S, et al. Clinical evaluation of TJ-43 TSUMURA Rikkunshito in the treatment of gastritis (acute gastritis and acute exacerbation of chronic gastritis) - multicenter comparative study using sodium azulene sulfonate as a control -*. Shindan to Chiryo (Diagnosis and Treatment) 1991; 79: 789-810 (in Japanese). | RCT- envelope |
N |
| K29.7 | To evaluate the efficacy and safety of TSUMURA Rikkunshito for treating gastritis in a comparison with cetraxate as a control. |
rikkunshito (六君子湯) |
Takemoto T, Matsuda K, Tada M, et al. Clinical evaluation of the efficacy of TJ-43 Tsumura Rikkunshi-To on gastritis with abdominal symptom - multicenter group study in comparison with cetraxate -. Shokakika (Gastroenterology) 1990; 12: 223-34 (in Japanese with English abstract). | RCT- envelope |
N |
| K30 | Efficacy and safety of rikkunshito for treating epigastric indefinite complaints complicated by depression. |
rikkunshito (六君子湯) |
Kawamura S, Okita K, Tada M, et al. Clinical comparison of TSUMURA Rikkunshito and sulpiride in the treatment of indefinite complaints of epigastric distress - mainly the antidepressive effect and the improvement of gastric emptying -*. Progress in Medicine 1992; 12: 1156-62 (in Japanese). | RCT- envelope |
N |
| K30 | Efficacy of rikkunshito for treating indefinite complaints of epigastric distress. |
rikkunshito (六君子湯) |
Komatsuzaki O. Clinical effect of TSUMURA Rikkunshito on indefinite epigastric distress - comparison with a control agent, and assessment mainly based on the endoscopic findings and the histology of gastric mucosal biopsy specimens before and after the treatment -*. Kampo Igaku (Kampo Medicine) 1993; 17: 120-31 (in Japanese). | RCT- envelope |
N |
| K30 | Efficacy of saireito for post-infectious dyspepsia in infants. |
saireito (柴苓湯) |
Ito J, Ito Y, Asai M, et al. Efficacy of saireito (TSUMURA) for post-infectious dyspepsia in infants: comparison with intestinal regulators*. Shonika Shinryo (Journal of Pediatric Practice) 1992; 55: 2089-92 (in Japanese). | RCT | I |
| K30 | Efficacy of rikkunshito in dyspeptic patients. |
rikkunshito (六君子湯) |
Tatsuta M, Iishi H. Effect of treatment with Liu-jun-zi-tang (TJ-43) on gastric emptying and gastrointestinal symptoms in dyspeptic patients. Alimentary Pharmacology and Therapeutics 1993; 7: 459-62. | RCT | C |
| K30 | Efficacy and safety of rikkunshito for treating complaints of gastrointestinal disorders including chronic gastritis. |
rikkunshito (六君子湯) |
Miyoshi A, Yachi A, Masamune O, et al. Clinical evaluation of TJ-43 TSUMURA Rikkunshito in the treatment of indefinite complaints of gastrointestinal disorders including chronic gastritis - a multicenter comparative study using cisapride as a control -*. Progress in Medicine 1991; 11: 1605-31 (in Japanese). | RCT- envelope |
N |
| K30 | To evaluate the efficacy of rikkunshito as an agent to improve symptoms before endoscopy in patients with upper abdominal symptoms and need for endoscopy of the upper gastrointestinal tract. |
rikkunshito (六君子湯) |
Koide A. Adoption of rikkunshito before endoscopy in patients with upper abdominal symptoms*. Nikkei Medical 2002; 31: 22-3 (in Japanese). | RCT- envelope |
N |
| Koide A. The improvement of QOL by rikkunshito in patients with need for endoscopy*. Medical Tribune 2004: 45 (in Japanese) | N | ||||
| Yamaguchi T, Koide A. Usefulness of Rikkun-shi-to (TJ-43), a Chinese herbal medicine, for the treatment of gastro-esophageal reflux disease (GERD). Medical Science Digest 2007; 33: 748-52 (in Japanese). | N | ||||
| K30 | To evaluate the efficacy and safety of TJ-43 TSUMURA Rikkunshi-to in patients with dyspepsia caused by dysfunction of the upper gastrointestinal tract. |
rikkunshito (六君子湯) |
Harasawa S, Miyoshi A, Miwa T, et al. Double-blind multicenter post-marketing clinical trial of TJ-43 TSUMURA Rikkunshi-to for the treatment of dysmotility-like dyspepsia. Igaku no Ayumi (Journal of Clinical and Experimental Medicine) 1998; 187: 207-29 (in Japanese). | DB-RCT | I |
| Harasawa S. The role of rikkunshito against NUD (non-ulcer dyspepsia) — especially its efficacy in dysmotility-like NUD*. Progress in Medicine 1999; 19: 843-8 (in Japanese). | N | ||||
| Harasawa S. Evidence from an RCT of rikkunshito (六君子湯) for epigastric complaints*. Kampo Igaku (Science of Kampo Medicine) 2011; 35: 113-7 (in Japanese). | N | ||||
| K30 | To clarify the effect of rikkunshito (六君子湯) on increasing ghrelin secretion and improving symptoms and its mechanism of action in patients with functional dyspepsia (FD). |
rikkunshito (六君子湯) |
Arai M. Rikkunshito significantly enhances the secretion of ghrelin in patients with functional dyspepsia*. Kampo Igaku (Kampo Medicine) 2009; 33: 405-6. | RCT | N |
| Matsumura T, Arai M, Suzuki T, et al. The traditional japanese medicine rikkunshito improves upper gastrointestinal symptoms in patients with functional dyspepsia. Gastroenterology 2010; 138: S471. | C | ||||
| Arai M, Matsumura T, Yoshikawa M, et al. Analysis of the Rikkunshito efficacy on patients with functional dyspepsia*. Nihon Yakurigaku Zasshi (Folia Pharmacologica Japonica) 2011; 137: 18–21. (in Japanese). | N | ||||
| Arai M, Matsumura T, Tsuchiya N, et al. Rikkunshito improves the symptoms in patients with functional dyspepsia, accompanied by an increase in the level of plasma ghrelin. Hepato-Gastroenterology 2012; 59: 62-6. | N | ||||
| K30 | To evaluate the efficacy and safety of rikkunshito (六君子湯) in patients with functional dyspepsia. |
rikkunshito (六君子湯) |
Tominaga K, Sakata Y, Kusunoki H, et al. Rikkunshito simultaneously improves dyspepsia correlated with anxiety in patients with functional dyspepsia: A randomized clinical trial (the DREAM study). Neurogastroenterology and Motility 2018; 1-12. doi: 10.1111/nmo.13319 | DB-RCT | N |
| K30.0 | To evaluate the efficacy of TSUMURA Rikkunshito Extract Granules for stimulating gastrointestinal emptying in patients after pylorus-preserving gastrectomy (PPG). |
rikkunshito (六君子湯) |
Nishida T. Effect of rikkunshito on gastrointestinal function in patients after gastrectomy*. Progress in Medicine 2006; 26: 3224-5 (in Japanese). | RCT- cross over |
N |
| Takahashi T, Endo S, Nakajima K, et al. Effect of rikkunshito, a Chinese herbal medicine, on stasis in patients after pylorus-preserving gastrectomy. World Journal of Surgery 2009; 33: 296-302. | C | ||||
| K30.0 | To evaluate the effects of rikkunshito (六君子湯) on gastric contraction and expansion. |
rikkunshito (六君子湯) |
Shiratori M, Shoji T, Kanazawa M, et al.Effect of rikkunshito on gastric sensorimotor function under distention. Neurogastroenterology & Motility 2011; 23: 323-9, e155-6. | RCT- cross over |
N |
| K30.0 | To evaluate the treatment effects of rikkunshito (六君子湯) on functional dyspepsia. |
rikkunshito (六君子湯) |
Suzuki H, Matsuzaki J, Fukushima Y, et al. Randomized clinical trial: rikkunshito in the treatment of functional dyspepsia-a multicenter, double-blind, randomized, placebo-controlled study. Neurogastroenterology and Motility 2014; 26: 950-61. | DB-RCT | C&N |
| K31.9 | To evaluate the effects of daikenchuto (大建中湯) and orengedokuto (黄連解毒湯) on cardiac output (CO) and superior mesenteric artery (SMA) blood flow. |
daikenchuto (大建中湯), orengedokuto (黄連解毒湯) |
Takayama S, Seki T, Watanabe M, et al. The herbal medicine Daikenchuto increases blood flow in the superior mesenteric artery. The Tohoku Journal of Experimental Medicine 2009; 219: 319-30. | RCT- cross over |
C&I |
| K31.9 | Comparative evaluation of the regulatory effects of thermal stimulation to the abdomen and Daikenchuto (大建中湯) on superior mesenteric artery (SMA) blood flow in healthy people. |
daikenchuto (大建中湯) |
Takayama S, Seki M, Watanabe M, et al. The effect of warming of the abdomen and of herbal medicine on superior mesenteric artery blood flow - a pilot study. Forschende Komplementär medizin 2010; 17: 195-201. | RCT | N |
| K31.9 | To verify the effectiveness of rikkunshito (六君子湯) on gastrointestinal motility function in critically ill patients. |
rikkunshito (六君子湯) |
Hayakawa M, Ono Y, Wada T, et al. Effects of rikkunshito (traditional Japanese medicine) on enteral feeding and the plasma ghrelin level in critically ill patients: a pilot study. Journal of Intensive Care 2014; 2: 53. | DB-RCT | C&I |
| K56.0 | To evaluate the efficacy and safety of daikenchuto for improving intestinal peristalsis in patients with intestinal paralysis after surgery for abdominal aortic aneurysm (AAA). |
daikenchuto (大建中湯) |
Takagaki Y, Kawasaki S, Komai H, et al. The effect of Chinese hearb medicine (dai-kenchu-to) on paralytic ileus after repair of abdominal aortic aneurysm. Nihon Rinsho Geka Gakkai Zasshi (Journal of Japan Surgical Association) 2000; 61: 325-8 (in Japanese with English abstract). | RCT | N |
| K56.5 | Efficacy of daikenchuto in patients with adhesive ileus. |
daikenchuto (大建中湯) |
Ohyabu H, Matsuda S, Kurisu S, et al. Evaluation of daikenchuto in patients with adhesive ileus in a randomized trial*. Progress in Medicine 1995; 15: 1954-8 (in Japanese). | RCT- envelope |
I |
| K58.9 | Efficacy of saikokeishito and keishikashakuyakuto for irritable bowel syndrome (IBS). |
saikokeishito (柴胡桂枝湯), keishikashakuyakuto (桂枝加芍薬湯) |
Ishii F, Iizuka B, Nagasako K, et al. Evaluations of the therapeutic efficacy of saikokeishito (TJ-10) versus keishikashakuyakuto (TJ-60) for irritable bowel syndrome and saireito (TJ-114) for ulcerative colitis*. Progress in Medicine 1993; 13: 2893-900 (in Japanese). | RCT | N |
| K58.9 | Efficacy and safety of keishikashakuyakuto for irritable bowel syndrome. |
keishikashakuyakuto (桂枝加芍薬湯) |
Sasaki D, Uehara A, Hiwatashi N, et al. Clinical efficacy of keishikashakuyakuto for irritable bowel syndrome - a multicenter, randomized, parallel-group clinical trial -*. Rinsho to Kenkyu (Japanese Journal of Clinical and Experimental Medicine) 1998; 75: 1136-52 (in Japanese). | DB-RCT | I |
| K58.9 | To evaluate the efficacy and safety of keihito (啓脾湯) in patients with irritable bowel syndrome. |
keihito (啓脾湯) |
Mori H, Iwamoto M. Comparison study of keihito and trimebutine maleate for irritable bowel syndrome. Therapeutic Research 1999; 20: 2179-85 (in Japanese). | quasi-RCT | I |
| K58.9 | To evaluate the effect of daikenchuto (大建中湯) on rectal sensation in patients with irritable bowel syndrome. |
daikenchuto (大建中湯) |
Acosta A, Camilleri M, Linker-Nord S, et al. A pilot study of the effect of daikenchuto on rectal sensation in patients with irritable bowel syndrome. Journal of Neurogastroenterological Motility 2016; 22: 69-77. | DB-RCT | N |
| K59.0 | Efficacy of junchoto and mashiningan for atonic constipation in the elderly. |
junchoto (潤腸湯), mashiningan (麻子仁丸) |
Ishioka T. Comparison of the efficacy of junchoto and mashiningan for atonic constipation in the elderly stratified by physical strength*. Kampo no Rinsho (Journal of Kampo Medicine) 1996; 43: 1431-7 (in Japanese). | RCT- cross over |
N |
| K59.0 | A preceding double-blinded controlled trial of daiokanzoto, compared with placebo, in the treatment of constipation found it was effective against constipation, but not useful (no details available). The objective of this study was to reexamine the effects of daiokanzoto on constipation using a newly-defined assessment standard and the same results mentioned above. |
daiokanzoto (大黄甘草湯) |
Miyoshi A, Masamune O, Fukutomi H, et al. The clinical effect of TSUMURA Daio-Kanzo-To Extract Granules for ethical use (TJ-84) on constipation using double blind test. Shokakika (Gastroenterology) 1994; 18: 299-312 (in Japanese with English abstract). | DB-RCT | I |
| Miyoshi A, Masamune O, Fukutomi H, et al. The clinical effect of TSUMURA Daio-Kanzo-to Extract Granules for ethical use (TJ-84) against the constipation based on the new standard. Shokakika (Gastroenterology) 1996; 22: 314-28 (in Japanese with English abstract). | I | ||||
| Harasawa S, Miyoshi A. Reevaluation of Kampo medicine in patients with constipation - efficacy of Daio-kanzo-to -. Shokakigan (Japanese Journal of Cancer of the Digestive Organs) 1996; 6: 271-7 (in Japanese with English abstract). | I | ||||
| K59.0 | To evaluate the efficacy and safety of kumibinroto for chronic constipation in elderly dialysis patients. |
kumibinroto (九味檳榔湯) |
Nishizawa Y, Nishizawa Y, Goto HG, et al. Prospective multicenter randomized group-parallelled study: effect of Chinese traditional herb medicine, jiu-wei-bing-lang-tang (Japanese name: kumi-binro-to) on constipation in elderly patients with renol dialysis. Kampo Kenkyu (Kampo Research) 2004; 388: 132-8 (in Japanese). | RCT | I |
| K59.0 | To evaluate the effects of daikenchuto (大建中湯) in combination for chronic constipation patients taking sennoside. |
daikenchuto (大建中湯) |
Horiuchi A, Nakayama Y, Tanaka N. Effect of traditional Japanese medicine, Daikenchuto (TJ-100) in patients with chronic constipation. Gastroenterology Research 2010; 3: 151-5. | RCT | N |
| K59.0 | To evaluate the efficacy and safety of daikenchuto (大建中湯) in the treatment of functional constipation. |
daikenchuto (大建中湯) |
Iturrino J, Camilleri M, Wong BS, et al. Randomised clinical trial： the effects of daikenchuto, TU-100，on gastrointestinal and colonic transit, anorectal and bowel function in female patients with functional constipation. Alimentary Pharmacology and Therapeutics 2013; 37: 776-85. | DB-RCT | C |
| K59.0 | To evaluate the efficacy and safety of daikenchuto (大建中湯) as treatment for functional constipation in poststroke patients. |
daikenchuto (大建中湯) |
Numata T, Takayama S, Tobita M, et al. Traditional Japanese medicine Daikenchuto improves functional constipation in poststroke patients. Evidence-Based Complementary and Alternative Medicine 2014: 1-8. doi：10.1155/2014/231258 | RCT | C&N |
| Numata T, Takayama S, Iwasaki K, et al. A prospective comparative trial using the Kampo medicine, daikenchuto (大建中湯) for constipation in poststroke patients. Kampo & the Newest Therapy 2015; 24:145-152 | RCT- envelope |
I&N | |||
| K59.8 | To verify the anti-inflammatory effects of daikenchuto (大建中湯) on intestinal distress in the aftermath of gastrointestinal surgery. |
daikenchuto (大建中湯) |
Ikemoto T. The role of Kampo in gastrointestinal surgery and the effectiveness of daikenchuto (大建中湯) for intestinal stress - From bacterial translocation to microbiome*. Progress in Medicine 2011; 31: 466-7 (in Japanese). | RCT | N |
| K70.9 | Efficacy of Kampo medicines for alcoholic liver disease. |
shosaikoto (小柴胡湯), shosaikoto (小柴胡湯) ＋inchingoreisan (茵チン五苓散) |
Takahashi H, Maruyama K. Clinical aspects of Kampo treatment for alcoholic liver disease. Igaku no Ayumi (Journal of Clinical and Experimental Medicine) 1993; 167: 811-4 (in Japanese). | RCT | N |
| K73.2 | Effiacy and safety of shosaikoto for chronic active hepatitis. |
shosaikoto (小柴胡湯) |
Hirayama C, Okumura M, Tanikawa K, et al. A multicenter randomized controlled clinical trial of Sho-Saiko-To in chronic active hepatitis. Gastroenterologia Japonica 1989; 24: 715-9. | DB-RCT | C＆I |
| Hirayama C, Okumura M, Tanikawa K, et al. A multicenter randomized controlled clinical trial of shosaiko-to in chronic active hepatitis. Kan-Tan-Sui 1990; 20: 751-9 (in Japanese). | I | ||||
| Hirayama C, Okumura M, Tanikawa K, et al. A multicenter randomized controlled clinical trial of shosaiko-to in chronic active hepatitis – Variation in serum enzyme activity*. Kan-Tan-Sui 1992; 25: 551–8 (in Japanese). | I | ||||
| K73.9 | Efficacy and safety of saireito for chronic hepatitis. |
saireito (柴苓湯) |
Sasaki D, Sudoh T, Kunikane M, et al. Usefulness of Kanebo Saireito Extract Fine Granules for chronic hepatitis - a comparative study (with randomization carried out using the sealed-envelope method) -*. Progress in Medicine 1989; 9: 2923-37 (in Japanese). | RCT- envelope |
I |
| K73.9 | To evaluate whether use of Kampo medicines (Shimbuto [真武湯] and Ninjinto [人参湯]) in combination with pegylated interferon a plus ribavirin promotes therapeutic responses in patients with chronic hepatitis C. |
Shimbuto (真武湯), Ninjinto (人参湯) |
Kainuma M, Furusyo N, Murata M, et al. The effectiveness of traditional Japanese medicine(Kampo), in combination with pegylated interferon α plus ribavirin for patients with chronic hepatitis C: A pilot study. Journal of Traditional Medicines 2013; 30: 132-9. | RCT | I |
| K75.9 | Efficacy of shosaikoto for chronic non-A, non-B hepatitis in children. |
shosaikoto (小柴胡湯) |
Tajiri H, Kozaiwa K, Sawada A, et al. Efficacy of shosaikoto for chronic non-A, non-B hepatitis in children (non-A, non-B hepatitis in children and shosaikoto)*. Nihon Shoni Toyo Igaku Kenkyukai Kaishi（Journal of the Japan pediatric society for oriental medicine） 1996; 12: 12-7 (in Japanese). | RCT- envelope |
N |
| K76.9 | Efficacy of saikokeishito for liver dysfunction induced by chemotherapy for pulmonary tuberculosis. |
saikokeishito (柴胡桂枝湯) |
Mizutani Y, Imai S, Watanabe H, et al. Saiko-Keishi-To on patients with pulmonary tuberculosis: effect on liver disfunction. Donan Igakkaishi (Journal of the Medical Association of South Hokkaido) 1994; 29: 247-9 (in Japanese). | RCT- envelope |
N |
| K76.9 Z94.4 |
To evaluate the efficacy and safety of daikenchuto (大建中湯) on the reinforcing effect of oral/tubal caloric intake in patients undergoing liver transplantation. |
daikenchuto (大建中湯) |
Kaido T, Shinoda M, Inomata Y,et al. Effect of herbal medicine daikenchuto on oral and enteral caloric intake after liver transplantation: a multicenter, randomized controlled trial. Nutrition 2018; 54: 68-75. | DB-RCT | N |
| K80.2 | Effects of shosaikoto, goreisan, and tokishakuyakusan on the sphincter of Oddi. |
goreisan (五苓散), tokishakuyakusan (当帰芍薬散), shosaikoto (小柴胡湯) |
Seki M, Fujioka M, Hatano T, et al. Differences between the effects of Sho-saiko-to, Gorei-san, and Toki-shakuyaku-san on the sphincter of Oddi - An intraoperative cholangiomanometric study -. Nihon Toyo Igaku Zasshi (Japanese Journal of Oriental Medicine) 1993; 43: 395-402 (in Japanese with English abstract). | RCT | N |
| K82.8 | Efficacy of goreisan and tokishakuyakusan on urinary 6-keto-prostaglandin F1a level in patients with gallbladder stones or polyps. |
goreisan (五苓散), tokishakuyakusan (当帰芍薬散), shosaikoto (小柴胡湯) |
Takagi S. Increase of urinary 6-keto-prostaglandin F1a level by preoperative administration of Gorei-san or Toki-shakuyaku-san to the patients of gallbladder stones or polyps. Wakan Iyaku Gakkaishi (Journal of Medical and Pharmaceutical Society for WAKAN-YAKU) 1992; 9: 32-9 (in Japanese with English abstract). | RCT | N |
| K83.1 | Efficacy of inchinkoto for improving the bilirubin reduction rate after biliary drainage in patients with obstructive jaundice. |
inchinkoto (茵チン蒿湯) |
Okabayashi T, Tanaka N, Orita K. The effect of a Kanpo medicine, Inchinko-to for the bilirubin reduction rate after biliary drainage on the patients with obstructive jaundice. Nihon Rinsho Geka Gakkaishi (Journal of Japan Surgical Association) 1998; 59: 2495-500 (in Japanese with English abstract). | RCT- envelope |
I |
| K91.0 | To evaluate the effect of rikkunshito (六君子湯) on postoperative nausea and vomiting. |
rikkunshito (六君子湯) |
Okuno S, Hirayama K, Inoue J, et al. Effects of rikkunshito on the postoperative nausea and vomiting (PONV) after laparoscopic gynecological surgery. Masui (Japanese Journal of Anesthesiology) 2008; 57: 1502-9 (in Japanese with English abstract). | RCT | C |
| K91.0 | To verify the inhibitory effect of goreisan (五苓散) on nausea and vomiting after surgery under general anesthesia. |
goreisan (五苓散) |
Kori K, Oikawa T, Odaguchi H, et al. Go-rei-San，a Kampo medicine，reduces postoperative nausea and vomiting：a prospective，single-blind，randomized trial. The Journal of Alternative and Complementary Medicine. 2013; 19: 946-50 | RCT | N |
| K91.0 | To evaluate the efficacy and safety of goreisan (五苓散) for nausea and vomiting after gynecological surgery under general anesthesia. |
goreisan (五苓散) |
Kume K, Kasuya Y, Ozaki M. Effect of Goreisan，a traditional Japanese Kampo medicine，on postoperative nausea and vomiting in gynecological patients. JA Clinical Reports 2017; 3: 552: 1-6. doi: 10.1186/s40981-017-0122-5 | DB-RCT | N |
| K91.3 | Efficacy and safety of daikenchuto for ileus. |
daikenchuto (大建中湯) |
Kubo N, Uchida Y, Akiyoshi T, et al. Efficacy of daikenchuto for ileus - a multicenter study -*. Progress in Medicine 1995; 15: 1962-7 (in Japanese). | RCT- envelope |
I |
| K91.3 | To evaluate the efficacy of daikenchuto for the treatment of postoperative ileus and the improvement of postoperative conditions. |
daikenchuto (大建中湯) |
Itoh T, Yamakawa J, Mai M, et al. The effect of the herbal medicine dai-kenchu-to on post-operative ileus. The Journal of International Medical Research 2002; 30: 428-32. | RCT | C |
| K91.8 | Efficacy and safety of shosaikoto for postoperative liver dysfunction. |
shosaikoto (小柴胡湯) |
Okabayashi T, Mimura H, Orita K. Usefulness of Shosaikoto (TJ-9) in the treatment of postoperative liver dysfunction*. Progress in Medicine 1989; 9: 851-5 (in Japanese). | RCT- envelope |
N |
| K91.8 | Effect of shosaikoto on postoperative liver dysfunction. |
shosaikoto (小柴胡湯) |
Usuba A, Gao L. S., Motoki R. Effect of sho-saiko-to (xao-chai-hu-tang) on liver dysfunctions after surgery - the benefits of preoperative administration and the importance of diagnosis according to traditional Chinese logic -. Nihon Toyo Igaku Zasshi (Japanese Journal of Oriental Medicine) 1992; 43: 1-12 (in Japanese). | RCT | N |
| K91.9 | To evaluate the effects of daikenchuto (大建中湯) on gastrointestinal and colonic transit and bowel function in healthy humans. |
daikenchuto (大建中湯) |
Manabe N., Camilleri M, Rao A, et. al. Effect of Daikenchuto (TU-100) on gastrointestinal and colonic transit in humans. American Journal of Physiology. Gastrointestinal and Liver Physiology 2010; 298: G970-5. | DB-RCT | C |
| K92.9 | Efficacy and safety of keishikashakuyakuto combined with acarbose. |
keishikashakuyakuto (桂枝加芍薬湯) |
Hasebe K, Machida M, Yada M, et al. Clinical application of Keishi-ka-syakuyaku-to for abdominal symptoms caused by a-glucosidase inhibitor acarbose. Kiso to Rinsho (The Clinical Report) 1997; 31: 3179-86 (in Japanese with English abstract). | quasi- RCT |
I |
| K92.9 | To evaluate the clinical effect of rikkunshito on gastrointestinal adverse reactions induced by fluvoxamine, an antidepressant. |
rikkunshito (六君子湯) |
Oka T, Tamagawa Y, Hayashida S, et al. Rikkunshi-to atenuates adverse gastrointestinal symptoms induced by fluvoxamine. Biopsychosocial Medicine 2007; 1: 21. | RCT | I |
| K92.9 | To evaluate the effect of rikkunshito (六君子湯) on gastrointestinal adverse reactions induced by milnacipran, an antidepressant. |
rikkunshito (六君子湯) |
Oka T. Rikkunshito attenuates milnacipran–induced adverse gastrointestinal symptoms and potentiates its antidepressant effect. Medical Tribune 2008;41:82 (in Japanese). | RCT | N |
- Note:
- Original English titles assigned by authors were used in this list and the structured abstracts. When references had no English titles, the Task Force translated the original Japanese titles into English ones (*).
- Abbreviations:
- C: The Cochrane Library (CENTRAL), I: Igaku Chuo Zasshi (Japana Centra Revuo Medicana, Ichushi), N: Database Offered by Nikkankyo (the Japan Kampo Medicines Manufacturers Association)
12. Skin Diseases (19 abstracts, 22 references)
| ICD-10 | Research Question |
Kampo Formula |
References | Study Design |
Source |
|---|---|---|---|---|---|
| L20.8 | Efficacy and safety of shosaikoto for treating atopic dermatitis and for withdrawing or tapering topical corticosteroids. |
shosaikoto (小柴胡湯) |
Shimoda S, Hashizume S, Morita M, et al. Efficacy of TSUMURA Shosaikoto for atopic dermatitis*. Hifuka ni okeru Kampo Chiryo no Genkyo 1991; 2: 15-24 (in Japanese). | RCT | N |
| L20.9 | To evaluate the efficacy and safety of hochuekkito (補中益気湯) in patients with kikyo (気虚, delicate constitution) associated with atopic dermatitis (AD). |
hochuekkito (補中益気湯) |
Furue M, Tanaka Y, Kobayashi H, et al. Efficacy of Kanebo Hochuekkito in patients with atopic dermatitis with “qi-kyo” – a multicenter, double-blind trial*. Arerugi (Japanese Journal of Allergology). 2005; 54: 1020 (in Japanese). | DB-RCT | N |
| Kobayashi H, Ishii M, Takeuchi S, et al. Efficacy and safety of a traditional herbal medicine, hochu-ekki-to in the long-term management of kikyo (delicate constitution) patients with atopic dermatitis: A 6-month, multicenter, double-blind, randomized, placebo-controlled study. Evidence-based Complementary and Alternative Medicine 2008: 1-7. (2010; 7: 367-73. ) | N | ||||
| Kobayashi H, Ishii M, Furue M. Efficacy of hochuekkito for skin symptoms in patients with atopic dermatitis associated with qikyo – An investigation by rash element –*. Nishinihon Hifuka (the Nishinihon Journal of Dermatology) 2012; 74: 642-7 (in Japanese). | I | ||||
| L20.9 | To evaluate the efficacy and safety of byakkokaninjinto (白虎加人参湯) used concomitantly in the treatment of atopic dermatitis. |
byakkokaninjinto (白虎加人参湯) |
Wadabayashi M. Kampo Clinical Report: Study on benefits of byakkokaninjinto in treating atopic dermatitis. Phil Kampo 2017; 73: 14-5 (in Japanese). | quasi-RCT | I |
| L20.9 | To evaluate the efficacy and safety of orengedokuto (黄連解毒湯) and goreisan (五苓散) for dampness-heat pattern in atopic dermatitis (AD) patients. |
orengedokuto (黄連解毒湯) + goreisan (五苓散), goreisan (五苓散) |
Choi I, Kim S, Kim Y, et al. The effect of TJ-15 plus TJ-17 on atopic dermatitis: a pilot study based on the principle of pattern identification. The Jornal of Alternative and Complementary Medicine 2012; 18: 576-82. | DB-RCT | N |
| L20.9 | To evaluate the efficacy of unseiin (温清飲) or shimotsuto (四物湯) for the subjective and objective symptoms of atopic dermatitis. |
unseiin (温清飲), shimotsuto (四物湯) |
Kobayashi H, Yanagihara S, Tamiya H, et al. Combined effects of herbal medicines on the subjective and objective symptoms of patients with atopic dermatitis - a comparison study of unseiin or shimotsuto -. The Nishinihon Journal of Dermatology 2016; 78:171-6 (in Japanese). | RCT- envelope |
I |
| L29.8 | Efficacy and safety of orengedokuto and goshajinkigan for the treatment of senile pruritus. |
orengedokuto (黄連解毒湯), goshajinkigan (牛車腎気丸) |
Ohkawara A, Furuya K, Kurisu Y, et al. Experience with Orengedokuto (TJ-15) and goshajinkigan (TJ-107) for the treatment of senile pruritus*. Nishinihon Hifuka (The Nishinihon Journal of Dermatology) 1991; 53: 1234-41 (in Japanese). | RCT- envelope |
I |
| L29.8 | Efficacy of tokiinshi combined with a bath preparation containing licorice extract in patients with senile xerosis. |
tokiinshi (当帰飲子) |
Iida T, Nishiyama C, Suzuki H. The effects of Toki-Inshi and a bath preparation containing licorice extract on patients with senile pruritus. Nihon Toyo Igaku Zasshi (Japanese Journal of Oriental Medicine) 1996; 47: 35-41 (in Japanese with English abstract). | RCT | N |
| L29.8 | Efficacy of hachimijiogan for the treatment of senile pruritus. |
hachimijiogan (八味地黄丸) |
Ishioka T, Aoi R. Comparative evaluation of hachimijiogan and ketotifen fumarate on senile pruritus*. Shinyaku to Rinsho (Journal of New Remedies and Clinics) 1992; 41: 2603-8 (in Japanese). | RCT- cross over |
N |
| L29.8 | Efficacy of rokumigan and hachimijiogan for the treatment of senile pruritus. |
hachimijiogan (八味地黄丸), rokumigan (六味丸) |
Ishioka T. Comparative evaluation of Rokumigan and Hachimi-jiogan on senile pruritus. Therapeutic Research 1995; 16: 1497-504 (in Japanese with English abstract). | RCT- cross over |
N |
| L29.9 | Effect on itching due to eczema and other skin disorders. |
unseiin (温清飲) | Kusumoto M, Fujimura Y, Yamada H, et al. Evaluation of the effectiveness of various drugs for relieving itching due to eczema carried out by personnel in inpatient pharmacy practice: assessment based on "itching" score -*. Iyaku Journal (Medicine and Drug Journal) 1993; 29: 973-6 (in Japanese). | RCT | N |
| L29.9 | Efficacy of orengedokuto and tokiinshi for the treatment of pruritus. |
orengedokuto |
Ohkuma M. Treatment of pruritus by Chinese drugs. Wakan Iyaku Gakkaishi (Journal of Medical and Pharmaceutical Society for WAKAN-YAKU) 1993; 10: 126-30 (in Japanese with English abstract). | RCT | N |
| L29.9 | Efficacy of orengedokuto, tokiinshi, external application, and oral antihistamine monotherapy or combination therapy for the treatment of pruritus. |
orengedokuto (黄連解毒湯) ＋ tokiinshi (当帰飲子) |
Ohkuma M. Treatment of pruritus by Chinese drugs with external application and oral antihistamine. Wakan Iyakugaku Zasshi (Journal of Traditional Medicines) 1994; 11: 302-3 (in Japanese). | RCT | N |
| L30.9 | Efficacy and safety of jumihaidokuto for the treatment of chronic eczema and atopic dermatitis. |
jumihaidokuto (十味敗毒湯) |
Kobayashi K, Ohkawara A. Therapeutic effect of jumihaidokuto on chronic eczema and atopic dermatitis*. Hifuka ni okeru Kampo Chiryo no Genkyo (Current Situation of Kampo Therapy in Dermatology) 1994; 5: 25-34 (in Japanese). | RCT- envelope |
N |
| L40.9 | Efficacy of saireito combined with topical steroid therapy for psoriasis. |
saireito (柴苓湯) |
Kukita A, Harada S, Fujisawa R, et al. The clinical efficacy of the herb medicine, TJ-114 (Sairei-to), on the topical steroid therapy of psoriasis vulgaris. Rinsho Iyaku (Journal of Clinical Therapeutics & Medicines) 1991; 7: 927-36 (in Japanese with English abstract). | RCT- envelope |
C&I |
| L50.8 | To evaluate the efficacy of jumihaidokuto (十味敗毒湯) in urticaria. |
jumihaidokuto (十味敗毒湯) |
Murota H, Azukizawa H, Katayama I. Impact of Jumihaidokuto (Shi-Wei-Bai-Du-Tang) on treatment of chronic spontaneous urticaria: a randomized controlled study. Chinese Journal of Integrative Medicine 2017; 1-5. doi: 10.1007/s11655-017-2950-6. (2019; 25: 820-4.) | RCT | C |
| L50.9 | Efficacy of kakkonto as an adjuvant for reducing adverse reactions to oxatomide. |
kakkonto (葛根湯) |
Tanaka M. Effects of oxatomide on urticaria. Yakuri to Chiryo (Japanese Pharmacology and Therapeutics) 1991; 19:5029-31 (in Japanese). | RCT | N |
| L70.0 | Efficacy of jumihaidokuto and orengedokuto for the treatment of acne vulgaris. |
jumihaidokuto (十味敗毒湯), orengedokuto (黄連解毒湯) |
Ohkuma M. Treatment of acne by Chinese drugs and external application. Wakan Iyaku Gakkaishi (Journal of Medical and Pharmaceutical Society for WAKAN-YAKU) 1993; 10: 131-4 (in Japanese with English abstract). | RCT | N |
| Ohkuma M. Treatment of acne by Chinese drugs and external application - comparison with oral antibiotics -. Nihon Toyo Igaku Zasshi (Japanese Journal of Oriental Medicine) 1993; 44: 173-7 (in Japanese). | N | ||||
| L70.0 | To examine the effectiveness and safety of keigairengyoto (荊芥連翹湯) in treating acne vulgaris. |
keigairengyoto (荊芥連翹湯) |
Ito K, Masaki S, Hamada M, et al.Efficacy and safety of the traditional Japanese medicine keigairengyoto in the treatment of acne vulgaris. Dermatology Research and Practice 2018: 1-7. | RCT | C |
| L89 | Effects of juzentaihoto (十全大補湯) on pressure ulcers. |
juzentaihoto (十全大補湯) |
Nagai Y, Hasegawa M, Tago O, et al. Assessment of the therapeutic effect of Juzentaihoto on pressure ulcer. Kampo to Saishin-chiryo (Kampo & The Newest Therapy) 2009; 18: 143-9. | RCT- envelope |
I |
- Note:
- Original English titles assigned by authors were used in this list and the structured abstracts. When references had no English titles, the Task Force translated the original Japanese titles into English ones (*).
- Abbreviations:
- C: The Cochrane Library (CENTRAL), I: Igaku Chuo Zasshi (Japana Centra Revuo Medicana, Ichushi), N: Database Offered by Nikkankyo (the Japan Kampo Medicines Manufacturers Association)
13. Diseases of the Musculoskeletal System and Connective Tissue (21 abstracts, 20 references)
| ICD-10 | Research Question |
Kampo Formula |
References | Study Design |
Source |
|---|---|---|---|---|---|
| M06.90 | To evaluate the efficacy of saireito in the management of chronic rheumatoid arthritis in a controlled trial using lobenzarit, a western medicine with the established efficacy, as control. |
saireito (柴苓湯) |
Matsuura M. Efficacy of saireito in the management of chronic rheumatoid arthritis (RA)*. Modern Physician 1994; 14: 403-8 (in Japanese). | RCT- envelope |
I |
| M06.90 | Efficacy for reducing adverse effects of steroids in patients with chronic rheumatoid arthritis. |
jiinkokato (滋陰降火湯) |
Matsuta K, Gu XP, Ito K, et al. Evaluation of jiinkokato and steroid combination therapy for chronic rheumatoid arthritis*. Kampo Igaku (Kampo Medicine) 1995; 19: 50-2 (in Japanese). | RCT | N |
| M17.9 | To compare the efficacy of Kampo medicines (boiogito and shuchibushimatsu with NSAIDs for improving analgesia, quality of life (QOL), and exercise capacity in patients with knee osteoarthritis. |
boiogito (防已黄耆湯) + shuchibushimatsu (修治附子末) |
Nishizawa Y, Nishizawa Y, Amenomori Y, et al. A comparison of the analgesic effect of non-steroid anti-inflammatory drugs (NSAIDs alminoprofen) and those of a Chinese traditional herbal medicine, Boi-ogi-to and Shuchi-Bushi-Powder on osteoarthropathy of the knee joint in middle-aged and elderly patients with knee-joint osteoarthropathy. Itami to Kampo (Pain and Kampo Medicine) 1998; 8: 17-32 (in Japanese with English abstract). | RCT | I |
| M17.9 | To evaluate the efficacy of boiogitoka-shuchibushimatsu for gonarthrosis. |
boiogitoka-shuchibushimatsu (防已黄耆湯加修治附子末) |
Nishizawa Y, Nishizawa Y, Yoshioka F, et al. Therapeutic effect of boiogitoka-shuchibushimatsu on gonarthrosis: a 10-year prospective randomized controlled trial with loxoprofen sodium*. Pharma Medica 2007; 25: 15-21 (in Japanese). | RCT | I |
| M17.9 | To evaluate the efficacy and safety of boiogito (防已黄耆湯), a Kampo medicine for gonarthrosis with joint effusion. |
boiogito (防已黄耆湯) |
Majima T, Inoue M, Kasahara Y, et al. Effect of the Japanese herbal medicine, boiogito, on the osteoarthritis of the knee with joint effusion. Sports Medicine Arthroscopy Rehabilitation Therapy & Technology 2012; 4: 1-6. | RCT | N |
| M35.0 | To evaluate the efficacy and safety of bakumondoto therapy for dryness associated with primary Sjogren’s syndrome. |
bakumondoto (麦門冬湯) |
Nishizawa Y, Nishizawa Y, Yoshioka F, et al. Long-term effects of traditional Chinese herbal medicine, mai-men-dong-tang (Japanese name: bakumondo-to) compared with bromhexine, hydrochloride on sicca syndrome, especially, salivary secretion in patients with primary Sjogren’s syndrome: a multicenter, randomized well controlled group parallel comparative trial study with bromhexine. Nihon Daekisen Gakkaishi (Journal of the Japan Salivary Gland Society) 2002; 43: 62-6. | RCT | I |
| M35.0 | To evaluate the efficacy and safety of bakumondoto therapy for salivary hyposecretion associated with primary Sjogren’s syndrome. |
bakumondoto (麦門冬湯) |
Nishizawa Y, Nishizawa Y, Yoshioka F, et al. Long-term effect of traditional Chinese herbal medicine, mai-men-don-tang on sicca syndrome, especially, salicary secretion in patients with primary Sjogren’s syndrome: a multicenter, randomized well controlled group-pararell double-blined study. Nihon Daekisen Gakkaishi (Journal of the Japan Salivary Gland Society) 2004; 45: 66-74. | DB-RCT | N |
| M35.0 | To evaluate the efficacy and safety of bakumondoto for treatment of secondary Sjogren’s syndrome. |
bakumondoto (麦門冬湯) |
Nishizawa Y, Nishizawa Y, Goto GH, et al. The Multicenter randomized comparative study of kampo herbal medicine, mai-men-dong-tang (Japanese name Bakumondo-to) compared with bromhexine on salivary secretion in secondary Sjogren’s syndrome. Itami to Kampo (Pain and Kampo Medicine) 2004; 14: 10-7 (in Japanese with English abstract). | RCT | I |
| M35.0 | To evaluate the efficacy and safety of bakumondoto for treatment of dryness associated with secondary Sjogren’s syndrome. |
bakumondoto (麦門冬湯) |
Nishizawa Y, Nishizawa Y, Yoshioka F, et al. Improving effect of Chinese herb medicine mai-men-dong- tang (Japanese name: bakumondo-to) comparative with sicca syndrome in especial salivary patients with secondary Sjogren’s syndrome in multicenter, well controlled, long-term comparative study. Nihon Daekisen Gakkaishi (Journal of the Japan Salivary Gland Society) 2003; 44: 65-70. | RCT | N |
| M35.0 | To evaluate the efficacy for Sjogren’s syndrome. |
bakumondoto (麦門冬湯), rokumigan (六味丸), hachimijiogan (八味地黄丸), hochuekkito (補中益気湯) |
Ohno S. The effect of Kampo medicine on salivary secretion in Sjogren’s syndrome. Kampo to Saishin-chiryo (Kampo & the Newest Therapy) 2006; 15: 134-40 (in Japanese). | quasi- RCT |
I |
| M48.02 | To evaluate the efficacy of hachimijiogan, goshajinkigan, and shuchibushi powder for relief of residual symptoms after surgical treatment of cervical spinal stenosis. |
hachimijiogan (八味地黄丸), goshajinkigan (牛車腎気丸), goshajinkigan (牛車腎気丸) + shuchibushimatsu (修治附子末) |
Maeshima S, Katayama Y. Spine and spinal cord diseases 1. Traditional Chinese medicines for the spinal disorders. Kampo to Saishin-chiryo (Kampo & the Newest Therapy) 2004; 13: 232-6 (in Japanese). | RCT | I |
| M48.06 | Efficacy and safety of hachimijiogan for lumbar spinal stenosis. |
hachimijiogan (八味地黄丸) |
Hayashi Y, Saito E, Takahashi O. Usefulness of hachimijiogan for lumbar spinal stenosis*. Geriatric Medicine 1994; 32: 585-91 (in Japanese). | quasi- RCT |
N |
| M48.06 | To evaluate the efficacy of goshajinkigan and shuchibushi powder for relief of chronic low back pain associated with lumbar spinal stenosis. |
goshajinkigan (牛車腎気丸), goshajinkigan (牛車腎気丸) + shuchibushimatsu (修治附子末) |
Maeshima S, Katayama Y. Spine and spinal cord diseases 1. Traditional Chinese medicines for the spinal disorders. Kampo to Saishin-chiryo (Kampo & the Newest Therapy) 2004; 13: 232-6. | RCT | I |
| M54.56 | To evaluate the clinical effect of shakuyakukanzoto on acute lumbago (so-called strained back). |
shakuyakukanzoto (芍薬甘草湯) |
Tamakawa S, Ogawa H. The effect of Shakuyaku-kanzo-to and Goshakusan on lumbago. Itami to Kampo (Pain and Kampo Medicine) 1997; 7: 83-5 (in Japanese with English abstract). | RCT | N |
| M54.56 | To clinically evaluate the effects of keishibukuryogan and its combination with bushi on nonspecific lumbago in women during menopause. |
keishibukuryogan (桂枝茯苓丸), keishibukuryogan (桂枝茯苓丸) ＋ shuchibushimatsu (修治附子末) |
Ohta H, Makita K. Lumbago - with emphasis on nonspecific lumbago, which obstetricians and gynecologists think is the most common form in women -*. Chiryo (The Journal of Therapy) 1995; 77: 1646-57 (in Japanese). | RCT | N |
| M54.56 | To evaluate the efficacy and safety of goshajinkigan in comparison with that of tiaramide hydrochloride for lumbago in the elderly. |
goshajinkigan (牛車腎気丸) |
Nakamura T, Souza ACA, Ouchi Y, et al. Effects of goshajinkigan on lumbago*. Dai 4 Kai Tokyo Naika Kampo Kenkyukai Koen Naiyo Shu 1989; 4: 24-9 (in Japanese). | RCT- envelope |
N |
| M62.59 | To evaluate the efficacy of juzentaihoto combined with hachimijiogan in patients with disuse syndrome. |
juzentaihoto (十全大補湯), hachimijiogan (八味地黄丸) |
Wang XD, Yoshida K, Honda K, et al. Study of the immunoregulatory activity of the combination therapy with juzentaihoto and hachimijiogan in patients with disuse syndrome*. Kampo Igaku (Kampo Medicine) 2006; 30: 65-7 (in Japanese). | RCT- envelope |
I |
| M79.2 | To evaluate the efficacy of maobushisaishinto (麻黄附子細辛湯) for treatment of occipital neuralgia. |
maobushisaishinto (麻黄附子細辛湯) |
Nakajima K, Sato H, Ooyama K, Is maobushisaishinto effective for neuropathic pain? Effect of maobushisaishinto on occipital neuralgia* Itami to Kampo (Pain and Kampo Medicine) 2014: 24: 31-7 (in Japanese with English abstract). | RCT- envelope |
I&N |
| M81.1 | Combined effect of keishibukuryogan and vitamin D3 on osteopenia in women during menopause. |
keishibukuryogan (桂枝茯苓丸) |
Ohta H, Nemoto K. Effect of concurrent administration of active vitamin D3 and TSUMURA Keishibukuryogan on osteopenia following oophorectomy*. Kampo Igaku (Kampo Medicine) 1989; 13: 173-9 (in Japanese). | RCT | N |
| M81.1 | Combined effect of keishibukuryogan or tokishakuyakusan and vitamin D3 on osteopenia in women during menopause. |
keishibukuryogan (桂枝茯苓丸), tokishakuyakusan (当帰芍薬散) |
Ohta H, Nemoto K. Preventive effect of 1a-hydroxyvitamin D3 plus Kampo medicine combination therapy on osteopenia following oophorectomy - comparison between keishibukuryogan and tokishakuyakusan -*. Sanfujinka Kampo Kenkyu no Ayumi (Recent Progress of Kampo Medicine in Obstetrics and Gynecology) 1990; 7: 65-70 (in Japanese). | RCT | N |
| M81.9 | Positive effects on menopause index, bone mass, and anemia in postmenopausal women with osteoporosis. |
kamikihito (加味帰脾湯) |
Kanai S. The effect of Kami-kihi-to on the maintenance of bone mass in patients with osteoporosis. Nihon Toyo Igaku Zasshi (Japanese Journal of Oriental Medicine) 1998; 49: 59-66 (in Japanese with English abstract). | quasi- RCT |
N |
- Note:
- Original English titles assigned by authors were used in this list and the structured abstracts. When references had no English titles, the Task Force translated the original Japanese titles into English ones (*).
- Abbreviations:
- C: The Cochrane Library (CENTRAL), I: Igaku Chuo Zasshi (Japana Centra Revuo Medicana, Ichushi), N: Database Offered by Nikkankyo (the Japan Kampo Medicines Manufacturers Association)
14. Genitourinary Tract Disorders (including Climacteric Disorders) (43 abstracts, 50 references)
| ICD-10 | Research Question |
Kampo Formula |
References | Study Design |
Source |
|---|---|---|---|---|---|
| N02.8 | Efficacy and safety of saireito in childhood IgA nephropathy with focal/minimal mesangial proliferation. |
saireito (柴苓湯) |
Yoshikawa N, Ito H, Sakai T, et al. A prospective controlled study of Sairei-to in childhood IgA nephropathy with focal/minimal mesangial proliferation.Nihon Jinzo Gakkaishi (The Japanese Journal of Nephrology) 1997; 39: 503-6 (in Japanese with English abstract). | RCT- envelope |
C |
| N02.8 | Efficacy and safety of Kampo medicines for IgA nephropathy in adults. |
saireito (柴苓湯) |
Saruta T, Konishi K. Efficacy of Kampo medicines for renal diseases - with emphasis on saireito -*. 21 Seiki no Iryo to Kampo (Medical Care and Kampo in the 21st Century) 1994: 157-65 (in Japanese). | RCT- envelope |
N |
| N04.9 | Efficacy of initial steroid therapy with saireito for preventing relapse in childhood steroid-responsive nephrotic syndrome. |
saireito (柴苓湯) |
Yoshikawa N, Ito H, Takekoshi Y, et al. Standard versus long-term prednisolone with Sairei-to for initial therapy in childhood steroid-responsive nephrotic syndrome: A prospective controlled study. Nihon Jinzo Gakkaishi (The Japanese Journal of Nephrology) 1998; 40: 587-90 (in Japanese with English abstract). | RCT- envelope |
C＆I |
| N20.9 | Efficacy for promoting the spontaneous discharge of upper urinary tract stones after extracorporeal shock wave lithotripsy. |
choreito-goshimotsuto (猪苓湯合四物湯) ＋ shakuyakukanzoto (芍薬甘草湯) |
Kinoshita H, Kanaya H, Yamamoto S, et al. Effects of Chinese herbal medicine in promoting the spontaneous discharge of upper urinary tract stones after ESWL. Nishinihon Hinyokika (The Nishinihon Journal of Urology) 1993; 55: 61-6 (in Japanese with English abstract). | RCT | N |
| N20.9 | To evaluate the efficacy of low-dose tamsulosin and choreito for stone expulsion after extracorporeal shock wave lithotripsy (ESWL) in patients with ureteral stones. |
choreito (猪苓湯) |
Kobayashi M, Naya Y, Kino M, et al. Low dose tamsulosin for stone expulsion after extracorporeal shock wave lithotripsy: Efficacy in Japanese male patients with ureteral stone. International Journal of Urology 2008; 15: 495-8. | RCT | I |
| N32.8 | To evaluate the efficacy and safety of goshajinkigan and propiverine hydrochloride for overactive bladder. |
goshajinkigan (牛車腎気丸) |
Nishizawa Y., Nishizawa Y, Yoshioka H., et al. Efficacy and safety of Chinese traditional medicine, niu-che-shwn-qi-wan (Japanese name: goshajinki-gan) versus propiverine hydrochloride on health-related quality of life in patients with overactive bladder in prospective randomized comparative study. Kampo to Saishin-chiryo (Kampo & the Newest Therapy) 2007; 16: 131-42 (in Japanese). | RCT | I |
| N35.9 | To evaluate the protective effect of saireito (柴苓湯) on postoperative urethral stricture. |
saireito (柴苓湯) |
Oh-oka H. Effect of Saireito for Prevention and Improvement of Urethral Stricture after Transurethral Resection of the Prostate. Kampo Medicine 2016; 67: 244-50. (in Japanese with English abstract). | RCT | I |
| N39.0 | Efficacy of shosaikoto for improving immunity in the elderly. |
shosaikoto (小柴胡湯) |
Toba K. Role in host defense mechanisms and effect on prognosis of urinary tract infections in elderly subjects: A trial of a Chinese drug formulation. Taisha (Metabolism and Disease) 1992; 29 suppl: 350-4 (in Japanese). | RCT- envelope |
N |
| Toba K. Role in host defense mechanisms and effect on the prognosis of urinary tract infections in elderly subjects: A trial of a Chinese drug formulation*. Dai 8 Kai Tokyo Naika Kampo Kenkyukai Koen Naiyo Shu (Proceedings of the 8th Meeting of the Tokyo Society for Internal Kampo Medicine) 1993; 8: 31-42 (in Japanese). | N | ||||
| N39.9 | Efficacy of choreito and choreito-goshimotsuto for relieving nonspecific lower urinary tract complaints. |
choreito (猪苓湯), choreito-goshimotsuto (猪苓湯合四物湯) |
Ohkawa T, Ebisuno S, Watanabe T. Urological diseases and Kampo medicine*. Dai 23 Kai Nihon Igakkai Sokai Sateraito Shinpojiumu Nihon Toyo Igakkai Rinsho Kampo Kenkyukai Koen Naiyo Shu (Proceedings of the Meeting for Clinical Kampo Medicine of the Japan Society for Oriental Medicine, the Satellite Symposium of the 23rd General Assembly of the Japan Medical Congress) 1992: 22-39 (in Japanese). | RCT- envelope |
N |
| N39.9 | Efficacy of choreito and hachimijiogan for relieving urinary frequency, voiding pain, and incomplete emptying in patients without organic urinary tract disease. |
hachimijiogan (八味地黄丸), choreito (猪苓湯) |
Fuse H, Sakamoto M, Iwasaki M, et al. Effect of chorei-to and hachimi-jio-gan on unidentified complatints on urinary tract. Hinyoki Geka (Japanese Journal of Urological Surgery) 1995; 8: 603-9 (in Japanese). | RCT- envelope |
N |
| N39.9 | To evaluate the effect of single-dose administration of maobushisaishinto on urine flow. |
maobushisaishinto (麻黄附子細辛湯) |
Aoki Y, Ueda K, Tsutani K, et al. The influence of formula ma-huang-fu-zi-xi-xin-tang (mao-bushi-saishin-to; Mbst) on the results of urodynamic studies. Journal of Traditional Medicine 2001; 18: 203-9. | RCT- cross over |
I |
| N40 | Efficacy and safety for treating atopic dermatitis and for withdrawing or tapering topical corticosteroids. |
hachimijiogan (八味地黄丸), choreito (猪苓湯) |
Sakamoto Y, Iwasaki M, Kazama T, et al. Study of effects Hachimi-jio-gan and Chorei-to on prostatic hypertrophy. Dai 13 Kai Hinyokika Kampo Kenkyukai Koen Shu (Proceedings of the 13th Meeting of the Urological Society for Kampo Medicine) 1996: 7-14 (in Japanese with English abstract). | RCT- envelope |
N |
| N41.1 | Efficacy and safety of goshajinkigan in the treatment of chronic prostatitis. |
goshajinkigan (牛車腎気丸) |
Horiba M, Kato S, Tanaka T, et al. Clinical validity of gosha-jinki-gan in the treatment of chronic prostatitis - open comparative study with gosha-jinki-gan vs ciprofloxacin -. Gendai Toyo Igaku (The Journal of Traditional Sino-Japanese Medicine) 1994; 15: 37-44 (in Japanese). | RCT- envelope |
N |
| N41.1 | To evaluate the efficacy and safety of goshajinkigan for relieving lower urinary tract symptoms (LUTS) in patients with benign prostatic hyperplasia (BPH) and concomitant overactive bladder (OAB). |
goshajinkigan (牛車腎気丸) |
Ishizuka O, Yamanishi T, Gotoh M, et al. LUTS: new evidence – clinical efficacy of Kampo formulations focusing on goshajinkigan -*. Urology View 2009; 7: 81-4. | RCT- cross over |
I |
| C61 N42.8 |
To evaluate the efficacy and safety of Kampo medicines (hochuekkito [補中益気湯] and keishibukuryogan [桂枝茯苓丸]) for enhancing the immune response to tailor-made cancer peptide vaccine therapy (PPV) in men with castration-resistant prostate cancer (CRPC). |
hochuekkito (補中益気湯) + keishibukuryogan (桂枝茯苓丸) |
Koga N, Moriya F, Waki K, et al. Immunological efficacy of herbal medicines in prostate cancer patients treated by personalized peptide vaccine. Cancer Science 2017; 108: 2326-32. | RCT | N |
| N46 | Positive effect on sperm profiles of male infertility patients. |
saikokaryukotsu-boreito (柴胡加竜骨牡蛎湯), hochuekkito (補中益気湯) |
Hiramatsu M, Maehara I, Takahashi M, et al. Treatment experience with saikokaryukotsu-boreito and hochuekkito in male infertility patients*. Kampo Igaku (Kampo Medicine) 1993; 17: 246-8 (in Japanese). | RCT | N |
| N46 | Efficacy and safety of hochuekkito in the treatment of male infertility. |
hochuekkito (補中益気湯) |
Kazama T. Male infertility*. Current Therapy 1988; 6: 1683-6 (in Japanese). | RCT- envelope |
N |
| N50.8 | To evaluate the efficacy of androgen replacement therapy (ART) combined with saikokaryukotsuboreito (柴胡加竜骨牡蛎湯) for late-onset hypogonadism (LOH) syndrome. |
saikokaryukotsuboreito (柴胡加竜骨牡蛎湯) |
Sugimoto K, Shigehara K, Izumi K, et al. Effect of combination of Saiko-ka-ryukotsu-borei-to with androgen replacement therapy for LOH syndrome. Nihon Sei Kino Gakkai Zasshi (Japanese Journal of Sexual Medicine) 2009; 24: 349–53 (in Japanese). | RCT | I |
| N64.9 | Efficacy of kamishoyosan in the treatment of mastitis. |
kamishoyosan (加味逍遙散), keishibukuryogan (桂枝茯苓丸) |
Inoue M. Kampo treatment for mastitis - kamishoyosan -*. Kampo Igaku (Kampo Medicine) 1994; 18: 238-41 (in Japanese). | RCT- envelope |
N |
| N64.9 | Efficacy of shigyakusan in the treatment of mastitis. |
shigyakusan (四逆散), keishibukuryogan (桂枝茯苓丸) |
Inoue M. Kampo therapy for mastitis - shigyakusan -*. Kampo Igaku (Kampo Medicine) 1990; 14: 132-6 (in Japanese). | RCT- envelope |
N |
| N64.9 | Efficacy of tsudosan in the treatment of mastitis. |
tsudosan (通導散), keishibukuryogan (桂枝茯苓丸) |
Inoue M. Clinical study of effects of Tsu-do-san on mastitis. Nihon Toyo Igaku Zasshi (Japanese Journal of Oriental Medicine) 1993; 43: 517-21 (in Japanese). | RCT- envelope |
N |
| N64.9 | Efficacy of tokakujokito in the treatment of mastitis. |
tokakujokito (桃核承気湯), keishibukuryogan (桂枝茯苓丸) |
Inoue M. Clinical studies on effects of Tokakujoki-to for fibro-cystic disease of the breast. Nihon Toyo Igaku Zasshi (Japanese Journal of Oriental Medicine) 1992; 42: 415-8 (in Japanese). | RCT- envelope |
N |
| N81.4 | To evaluate the hachimijiogan-induced improvement in postoperative discomfort associated with surgery for uterine prolapse and quality of life (QOL). |
hachimijiogan (八味地黄丸) |
Oribe K, Nishida Y. Efficacy of hachimijiogan for discomfort after surgery for uterine prolapse. Gekkan Kampo Ryoho (Monthly Journal of Kampo Medicine and Herbs) 2006; 10: 282-8 (in Japanese). | RCT | N |
| N93.9 | To evaluate the efficacy and safety of kyukikyogaito for menometrorrhagia. |
kyukikyogaito (キュウ帰膠艾湯) |
Iwabuchi S. Effect of kyuki-kyogai-to on stopping dysfunctional uterine bleeding — comparison with occidental hemostatic drugs -. Nihon Toyo Igaku Zasshi (Japanese Journal of Oriental Medicine) 2000; 50: 883-903 (in Japanese with English abstract). | quasi- RCT |
I |
| N94.6 | Double-blind study on pain-relieving effect of tokishakuyakusan on dysmenorrheal. |
tokishakuyakusan (当帰芍薬散) |
Kotani N, Oyama T, Sakai I, et al. Analgesic effect of a herbal medicine for treatment of primary dysmenorrhea - a double-blind study. The American Journal of Chinese Medicine 1997; 25: 205-12. | DB-RCT | C |
| N95.1 | To compare the clinical effects of keishibukuryogan monotherapy with combined therapy (keishibukuryogan plus autonomic modulator). |
keishibukuryogan (桂枝茯苓丸) |
Tanaka E, Saito H, Hiroi M. Kampo treatment for nonspecific complaints in climacteric women - comparison of clinical efficacy of Kampo medicine alone versus Kampo medicine combined with tofisopam -*. Kampo Shinryo 1997; 16: 22-4 (in Japanese). | RCT | N |
| N95.1 | Clinical effect on climacteric disorders. |
tokishakuyakusan (当帰芍薬散), kojinmatsu (紅参末) |
Samukawa K, Ogita S. Climacteric disorders and medicinal ginseng*. Chiryogaku (Biomedicine & Therapeutics) 1994; 28: 57-62 (in Japanese). | RCT- envelope |
N |
| N95.1 | To compare hormone replacement therapy (HRT) and Kampo therapy as treatment of climacteric disorders. |
Kampo therapy （keishibukuryogan (桂枝茯苓丸), kamishoyosan (加味逍遙散), goshajinkigan (牛車腎気丸), etc.） |
Ota H. Positioning of Kampo therapy and hormone replacement therapy in treatment of climacteric disorders*. Sanfujinka Kampo Kenkyu no Ayumi (Recent Progress of Kampo Medicine in Obstetrics and Gynecology) 2001; 18: 21-9 (in Japanese). | RCT | I |
| N95.1 | To compare the efficacy of Kampo therapy with that of hormone replacement therapy (HRT) for climacteric disorders and to compare the efficacy of three non-sho-based (非随証) Kampo medicines for gynecological disease. |
kamishoyosan (加味逍遙散), tokishakuyakusan (当帰芍薬散), keishibukuryogan (桂枝茯苓丸), juzentaihoto (十全大補湯) |
Takamatsu K, Musha C, Okano H, et al. Study of usefulness of Kampo therapy for climacteric disorders*. Sanfujinka Kampo Kenkyu no Ayumi (Recent Progress of Kampo Medicine in Obstetrics and Gynecology) 2002; 19: 111-6 (in Japanese). | quasi- RCT |
I |
| tokishakuyakusan (当帰芍薬散), kamishoyosan (加味逍遙散), keishibukuryogan (桂枝茯苓丸) |
Takamatsu K. HRT and Kampo medicine*. Nippon Konenki Igakkai Zasshi (The Journal of the Japan Menopause Society) 2004; 12:155-7 (in Japanese). | N | |||
| Takamatsu K, Makita K, Tanabe K, et al. HRT and Kampo medicine*. Rinsho Kensa (Journal of Medical Technology) 2004; 48: 877-84 (in Japanese). | N | ||||
| Takamatsu K, Tanabe K. Efficacy of Kampo medicine against climacteric disorders*. Sanfujinka Chiryo (Obstetrical and Gynecological Therapy) 2004; 89: 408-15 (in Japanese). | N | ||||
| Takamatsu K. Study of the usefulness of Kampo therapy for climacteric disorders – a randomized trial of three major Kampo medicines for treatment of gynecological disease–*. Sanfujinka Kampo Kenkyu no Ayumi (Recent Progress of Kampo Medicine in Obstetrics and Gynecology) 2006; 23: 35-42 (in Japanese). | I | ||||
| N95.1 | To investigate the equivalence between non-extracted keishibukuryogan and keishibukuryogan extract. |
keishibukuryogan (桂枝茯苓丸) |
Ogita Y, Fujimoto S, Ushiroyama T, et al. Efficacy of formulation TK-061 for various climacteric symptoms — comparison with Teikoku Keishibukuryogan Extract Granules*. Rinsho Fujinka Sanka (Clinical Gynecology and Obstetrics) 2002; 56: 799-810 (in Japanese). | RCT | I |
| Ogita Y, Fujimoto S, Ushiroyama T, et al. Keishibukuryogan formulation TK-061 prepared with crude drug — verification of efficacy for various climacteric symptoms*. Sanka to Fujinka (Obstetrics and Gynecology) 2002; 69: 953-62 (in Japanese). | I | ||||
| N95.1 | To evaluate the efficacy of unkeito for climacteric disorders with depressive symptoms. |
unkeito (温経湯), tokishakuyakusan (当帰芍薬散) |
Koike K, Ohno S, Takahashi N, et al. Efficacy of the herbal medicine unkei-to as an adjunctive treatment to hormone replacement therapy for postmenopausal women with depressive symptoms. Clinical Neuropharmacology 2004; 27: 157-62. | RCT- cross over |
C |
| N95.1 | To evaluate effects of hormone replacement therapy (HRT) alone and in combination with kamishoyosan on climacteric disorders. |
kamishoyosan (加味逍遙散) |
Higuchi T, Tarakida A, Abe K, et al. Comparing the effects of hormone replacement therapy and kamishoyosan treatment on climacteric disorders*. Sanfujinka Kampo Kenkyu no Ayumi (Recent Progress of Kampo Medicine in Obstetrics and Gynecology) 2009; 26: 18-23. | RCT- envelope |
I |
| Higuchi T, Iino K, Tarakida A, et al. A comparing the effects of kamishoyosan or HRT on climactericdisorders in postmenopausal women: results from a randomized controlled trial. Nihon Josei Igaku Gakkai Zasshi (The Journal of Japan Society for Menopause and Women's Health) 2012; 20: 305-12 (in Japanese). | N | ||||
| N95.1 | To evaluate the clinical effects of keishibukuryogan (桂枝茯苓丸) for hot flashes in menopausal American women. |
keishibukuryogan (桂枝茯苓丸) |
Plotnikoff GA, Watanabe K, Torkelson C, et al. The TU-025 Keishibukuryogan clinical trial for hot flash management in postmenopausal women: result and lessons for future research. Menopause 2011; 18: 886-92. | RCT | N |
| C57.7 N95.1 |
To evaluate the effect of Kampo medicines kamikihito (加味帰脾湯) and kamishoyosan (加味逍遙散) on menopausal symptoms in gynecological cancer patients. |
kamishoyosan (加味逍遙散), kamikihito (加味帰脾湯) |
Yoshimura A, Sawada K, Sasano T, et al. Effect of Japanese Kampo medicine therapy for menopausal symptoms after treatment of gynecological malignancy. Obstetrics and Gynecology International 2018: 1-6. | RCT- envelope |
N |
| N95.1 | To evaluate the effects of keishibukuryogan (桂枝茯苓丸) and kamishoyosan (加味逍遙散) on levels of circulating cytokines in patients with hot flashes. |
keishibukuryogan (桂枝茯苓丸), kamishoyosan (加味逍遙散) |
Yasui T, Matsui S, Yamamoto S, et al. Effects of Japanese traditional medicines on circulating cytokine levels in women with hot flashes. Menopause 2011; 18: 85-92 | quasi- RCT |
N |
| N95.1 | To verify the efficacy of nyoshinsan (女神散) for female climacteric disorder. |
nyoshinsan (女神散), tokishakuyakusan (当帰芍薬散), kamishoyosan (加味逍遙散), keishibukuryogan (桂枝茯苓丸) |
Takamatsu K, Fujii E, Mizuno H, et al. An investigation of the usefulness of nyoshinsan for climacteric disorder*. Sanfujinka Kampo Kenkyu no Ayumi (Recent Progress of Kampo Medicine in Obstetrics and Gynecology) 2003; 20: 95-100 (in Japanese). | quasi- RCT |
N |
| N95.1 | To verify the clinical efficacy of porcine placental extract on shoulder stiffness in climacteric women. |
tokishakuyakusan (当帰芍薬散) |
Koike K, Yamamoto Y, Suzuki N, et al. Efficacy of porcine placental extract on shoulder stiffness in climacteric women. Climacteric2013; 16: 447-52. | RCT | N |
| N95.1 | To verify the clinical efficacy of porcine placental extract on shoulder stiffness in postmenopausal women taking hormone replacement therapy. |
tokishakuyakusan (当帰芍薬散) |
Koike K, Yamamoto Y, Suzuki N, et al. Efficacy of porcine placental extract on shoulder stiffness in climacteric women. Climacteric2013; 16: 447-52. | RCT | N |
| N95.1 | To evaluate clinical effects of porcine placental extract on climacteric symptoms in peri-postmenopausal women. |
tokishakuyakusan (当帰芍薬散) |
Koike K, Yamamoto Y, Suzuki N, et al. Efficacy of porcine placental extract on climacteric symptoms in peri-and postmenopausal women. Climacteric 2013; 16: 28-35. | RCT | N |
| N95.8 | To compare the efficacy of keishibukuryogan and hormone replacement therapy (HRT) for relief of hot flashes and chills. |
keishibukuryogan (桂枝茯苓丸) |
Ushiroyama T, Ikeda A, Sakuma K, et al. Comparing the effects of estrogen and an herbal medicine on peripheral blood flow in post-menopausal women with hot flashes: hormone replacement therapy and gui-zhi-fu-ling-wan, a Kampo medicine. American Journal of Chinese Medicine 2005; 33: 259-67. | RCT | C |
| N95.8 | To evaluate the usefulness of Kampo medicine for treatment of depressive patients refractory to hormone replacement therapy (HRT). |
unkeito (温経湯), tokishakuyakusan (当帰芍薬散) |
Matsuo A, Koike K, Hoshina Y, et al. Study of the efficacy of unkeito for depressive and anxiety symptoms during menopause that are refractory to hormone replacement therapy.* Sanfujinka Kampo Kenkyu no Ayumi (Recent Progress of Kampo Medicine in Obstetrics and Gynecology) 2005; 22: 70-4 (in Japanese). | RCT- cross over |
I |
| Koike K. A slight advantage of Kampo treatment for gynecological disease 4: Menopausal depressed mood and the herbal medicine unkei-to. Sanfujinka Chiryo (Obstetrical and Gynecological Therapy) 2006; 92: 784-6 (in Japanese). | N | ||||
| N95.8 | To compare the effects of unkeito and vitamin E on peripheral blood flow. |
unkeito (温経湯) |
Ushiroyama T, Sakuma K, Nosaka S. Comparison of effects of vitamin E and wen-jing-tang (unkei-to), an herbal medicine, on peripheral blood flow in post-menopausal women with chilly sensation in the lower extremities: a randomized prospective study. The American Journal of Chinese Medicine 2006; 34: 969-79. | RCT | C |
| N97.0 | To compare the effects of clomiphene monotherapy with tokishakuyakusan and clomiphene combination therapy infrequent menses, anovular menstrual cycle, and amenorrhea. |
tokishakuyakusan (当帰芍薬散) |
Yasui T, Irahara M, Aono T. Studies on treatment with the combination clomiphene citrate and Toki-shakuyaku-san. Nippon Funin Gakkai Zasshi (Japanese Journal of Fertility and Sterility) 1995; 40: 83-91 (in Japanese). | RCT- envelope |
N |
- Note:
- Original English titles assigned by authors were used in this list and the structured abstracts. When references had no English titles, the Task Force translated the original Japanese titles into English ones (*).
- Abbreviations:
- C: The Cochrane Library (CENTRAL), I: Igaku Chuo Zasshi (Japana Centra Revuo Medicana, Ichushi), N: Database Offered by Nikkankyo (the Japan Kampo Medicines Manufacturers Association)
15. Ante/Post-partum Diseases (11 abstracts, 13 references)
| ICD-10 | Research Question |
Kampo Formula |
References | Study Design |
Source |
|---|---|---|---|---|---|
| O12.0 | To evaluate the effectiveness of saireito (柴苓湯) combined with either sojutsu (蒼朮, Atractylodes Lancea Rhizome) or byakujutsu (白朮, Atractylodes Rhizome) as constituent crude drugs for lower limb edema and functional dyspepsia-like gastrointestinal symptoms. |
saireito (柴苓湯) | Takushima Y, Michigami F. Clinical study of Saireito on gestational edema and upper gastrointestinal symptoms. Igaku to Yakugaku (Japanese Journal of Medicine and Pharmaceutical Science) 2010; 64: 709–15 (in Japanese). | quasi- RCT |
I |
| O20.0 | To evaluate the efficacy of kyukikyogaito as a therapeutic drug for imminent abortion in patients with uterine hemorrhage. |
kyukikyogaito (キュウ帰膠艾湯) |
Ushiroyama T, Araki R, Sakuma K, et al. Efficacy of the kampo medicine xiong-gui-jiao-ai-tang, a traditional herbal medicine, in the treatment of threatened abortion in early pregnancy. American Journal of Chinese Medicine 2006; 34: 731-40. | RCT | C |
| Ushiroyama T, Sakuma K, Nosaka S, et al. Clinical efficacy of kyukikyogaito for imminent abortion with uterine hemorrhage*. Sanfujinka Kampo Kenkyu no Ayumi (Recent Progress of Kampo Medicine in Obstetrics and Gynecology) 2006; 23: 100-3 (in Japanese). | I | ||||
| O47.0 | Usefulness of tokishakuyakusan combined with ritodrine hydrochloride in the management of threatened premature delivery. |
tokishakuyakusan (当帰芍薬散) |
Mizuno M, Sato K, Mori T, et al. Clinical evaluation of TSUMURA Tokishakuyakusan and ritodrine hydrochloride combination therapy in the management of threatened premature delivery*. Sanka to Fujinka (Obstetrics and Gynecology) 1992; 59: 469-80 (in Japanese). | RCT- envelope |
N |
| O90.9 | To evaluate the usefulness of kyukichoketsuin for control of puerperium. |
kyukichoketsuin (キュウ帰調血飲) |
Takushima Y, Inoguchi H, Study on usefulness of kyukichoketsuin for control of puerperium — comparison with methylergometrine maleate (1st report) -*. Progress in Medicine 2001; 21: 1535-42 (in Japanese). | quasi- RCT |
I |
| O90.9 | To evaluate the efficacy and safety of kyukichoketsuin for puerperal psychosomatic disorder. |
kyukichoketsuin (キュウ帰調血飲) |
Sakuma K, Ushiroyama T, Akise D, et al. Clinical efficacy of kyukichoketsuin for regulation of puerperal psychosomatic functions. Sanfujinka no Shinpo (Advances in Obstetrics and Gynecology) 2002; 54: 80-6 (in Japanese with English abstract). | RCT- envelope |
I |
| Ushiroyama T, Sakuma K, Souen H, et al. Therapeutic effects of kyuki-chouketsu-in in restoring postpartum physical condition. American Journal of Chinese Medicine 2003; 31: 437-44. | C | ||||
| O90.9 | To evaluate the clinical usefulness of kyukichoketsuin for “postpartum restoration”. |
kyukichoketsuin (キュウ帰調血飲) |
Wada H, Wada K, Motoyama K. Usefulness in postpartum control by kyukichoketsuin. Sanfujinka no Sekai (World of Obstetrics and Gynecology) 2003; 55: 1057-61. | RCT | I |
| O90.9 | To evaluate the clinical usefulness of kyukichoketsuin during puerperium. |
kyukichoketsuin (キュウ帰調血飲) |
Narimatsu A., Ito A., Usefulness of kyukichoketsuin during puerperium. Rinsho Iyaku (Journal of Clinical Therapeutics & Medicine) 2001; 17: 1329-35 (in Japanese with English abstract). | RCT | I |
| O92.3 | To evaluate the postpartum lactation-promoting effect and safety of kyukichoketsuin. |
kyukichoketsuin (キュウ帰調血飲) |
Ushiroyama T, Sakuma K, Souen H, et al. Xiong-gui-tiao-xue-yin (Kyuki-chouketsu-in), a traditional herbal medicine, stimulates lactation with increase in secretion of prolactin but not oxytocin in the postpartum period. The American Journal of Chinese Medicine 2007; 35: 195-202. | RCT- envelope |
C |
| O92.5 | To evaluate a Kampo medicine effective for relieving the feeling of lactation deficiency. |
kakkonto (葛根湯), Juzentaihoto (十全大補湯), kyukichoketsuin (キュウ帰調血飲), and combination of these Kampo formulations |
Kawakami S, Nishimura J, Umeki M, et al. Kampo therapy for feeling of lactation deficiency*. Sanfujinka Kampo Kenkyu no Ayumi (Recent Progress of Kampo Medicine in Obstetrics and Gynecology) 2003; 20: 140-3. | RCT | I |
| O99.0 | To evaluate whether rikkunshito combined with oral iron can improve hemoglobin level and reduce adverse reactions associated with the administration of iron for anemia in pregnant women. |
rikkunshito (六君子湯) |
Fushiki H, Saeki A, Shiozaki A. Attempt to reduce adverse reactions associated with oral iron preparation for anemia in pregnancy by combination with Rikkunshito (TJ-43)*. Sanfujinka Kampo Kenkyu no Ayumi (Recent Progress of Kampo Medicine in Obstetrics and Gynecology) 2003; 20: 138-9 (in Japanese). | RCT | I |
| O99.3 | To confirm the efficacy of kyukichoketsuin for the “maternity blues.” |
kyukichoketsuin (キュウ帰調血飲) |
Ushiroyama T, Sakuma K, Ueki M. Efficacy of the Kampo medicine xiong-gui-tiao-xue-yin (kyuki-chouketsu-in), a traditional herbal medicine, in the treatment of maternity blues syndrome in the postpartum period. The American Journal of Chinese Medicine 2005; 33: 117-26. | RCT- envelope |
C |
- Note:
- Original English titles assigned by authors were used in this list and the structured abstracts. When references had no English titles, the Task Force translated the original Japanese titles into English ones (*).
- Abbreviations:
- C: The Cochrane Library (CENTRAL), I: Igaku Chuo Zasshi (Japana Centra Revuo Medicana, Ichushi), N: Database Offered by Nikkankyo (the Japan Kampo Medicines Manufacturers Association)
18. Symptoms and Signs (27 abstracts, 36 references)
| ICD-10 | Research Question |
Kampo Formula |
References | Study Design |
Source |
|---|---|---|---|---|---|
| R05 | To evaluate the efficacy of bakumondoto for persistent cough after infection in the elderly. |
bakumondoto (麦門冬湯) |
Nishizawa Y, Nishizawa Y, Yoshioka F, et al. Beneficial effect of Chinese tracitional herbal medicine, Mai-Men-Don-Tang (Japanese name: bakumondo-to) on acute pain in patients with acute internalmedical disease: antitussive effect on elderly patients with post infectious persistent coughs, prospective, multicenter, randomized comparative trial between mai-men-dong-tang and forminoben hydrochloride. Itami to Kampo (Pain and Kampo Medicine) 2003; 13: 12-21 (in Japanese with English abstract). | RCT | I |
| R05.0 | To evaluate the combined effects of bakumondoto (麦門冬湯) and a bronchodilator for prolonged cough following common cold. |
bakumondoto (麦門冬湯) |
Irifune K, Hamada H, Ito R, et al. Antitussive effect of bakumondoto a fixed kampo medicine (six herbal components) for treatment of post-infectious prolonged cough: controlled clinical pilot study with 19 patients. Phytomedicine 2011; 18: 630-3. | RCT- envelope |
C |
| R11 | Effects of a Kampo suppository preparation on vomiting in children |
goreisan (五苓散) |
Nishi K, Takata K, Asano S, et al. Effects of goreisan suppository on vomiting in children - comparison with domperidone suppository -*. Nihon Byoin Yakuzaishikai Zasshi (Journal of Japanese Society of Hospital Pharmacists) 1998; 34: 1173-6 (in Japanese). | quasi- RCT |
N |
| R11 | To evaluate the efficacy and safety of goreisan for vomiting in young children. |
goreisan (五苓散), hochuekkito (補中益気湯) |
Yoshida M, Mizuno T, Mizoguchi F, et al. Efficacy of goreisan suppositories for vomiting in young children (2nd report) – a double-blind study of the hochuekkito suppository–*. Wakan Iyaku Gakkaishi (Journal of Medical and Pharmaceutical Society for WAKAN-YAKU) 1991; 7: 506-7 (in Japanese). | DB-RCT | I |
| Yoshida M. Efficacy of goreisan suppository for vomiting in young children*. Toyoigaku (Japanese Journal of Oriental Medicine) 2000; 28: 36-8 (in Japanese). | N | ||||
| Yoshida M. Efficacy of goreisan suppository*. Nihon Syoni Toyo Igakkaishi (The Japan Pediatric Society for Oriental Medicine)2003; 19: 13-7 (in Japanese). | I | ||||
| C57.7 R11.0 |
To evaluate the efficacy and safety of rikkunshito (六君子湯) added to antiemetics for nausea, vomiting, and anorexia in patients treated with cisplatin and paclitaxel for cervical and endometrial cancers. |
rikkunshito (六君子湯) |
Ohnishi S, Watari H, Sakuragi N, et al. Additive effect of rikkunshito, an herbal medicine, on chemotherapy-induced nausea, vomiting, and anorexia in uterine cervical or corpus cancer patients treated with cisplatin and paclitaxel: results of a randomized phase II study (JORTC KMP-02). Journal of Gynecologic Oncology 2017; 28: 1-10. doi: 10.3802/jgo.2017.28.e44 | RCT | C |
| R11.0 | To evaluate the effectiveness and safety of goreisan (五苓散) suppository on vomiting in pediatric infectious diseases. |
goreisan (五苓散) |
Sakiyama T, Wada E, Inoue M, et al. Study of effectiveness of goreisan suppository. Journal of Japan Pediatric Oriental Medicine Society . 2017; 30: 33-42 (in Japanese). | DB-RCT | I |
| R13.0 | To evaluate the nutrition improvement effects of hochuekkito (補中益気湯) in patients with tube feeding. |
hochuekkito (補中益気湯) |
Sasaki S, Oumi A, Kumeda M, et al. Evaluation of nutrition improvement effects of hochuekkito (補中益気湯) in patients with tube feeding. Science of Kampo Medicine 2014 (in Japanese), 38: 263-6. | RCT | I |
| R22.4 | Efficacy and safety of saireito for posttraumatic or postoperative swelling in the lower extremities. |
saireito (柴苓湯) |
Igarashi I. Clinical study of traditional Chinese medicine therapy for post-operative or post-traumatic swelling in lower extremities. Seikeigeka (Orthopedic Surgery) 1993; 44: 127-31 (in Japanese). | RCT | N |
| R25.2 | Efficacy and safety of shakuyakukanzoto for preventing muscle cramps in diabetic patients. |
shakuyakukanzoto (芍薬甘草湯) |
Yoshida M, Kitaoka H, Masui Y, et al. Effects of Shakuyaku-Kanzo-to on muscle cramp in diabetics. Shinkei Chiryogaku (Neurological Therapeutics) 1995; 12: 529-34 (in Japanese). | RCT- envelope |
N |
| R25.2 | To evaluate the efficacy and safety of shakuyakukanzoto for relief of muscle cramp. |
shakuyakukanzoto (芍薬甘草湯) |
Kumada T, Kumada H, Yoshiba M, et al. Effects of shakuyaku-kanzo-to (Tsumura TJ-68) on muscle cramps accompanying cirrhosis in a placebo-controlled double-blined parallel study. Rinsho Iyaku (Journal of Clinical Therapeutics and Medicine) 1999; 15: 499-523 (in Japanese with English abstract). | DB-RCT | I |
| Kumada T, Kiriyama I, Sone Y, et al. EBM-based Kampo therapy for gastrointestinal diseases 3. Efficacy of shakuyakukanzoto for “muscle cramps in the calves” associated with hepatic cirrhosis*. Nihon Toyo Igaku Zasshi (Kampo Medicine) 2003; 54: 536-8 (in Japanese). | N | ||||
| R25.2 | To evaluate the efficacy and safety of shakuyakukanzoto for muscle cramps in the calves. |
goshajinkigan (牛車腎気丸), shakuyakukanzoto (芍薬甘草湯) |
Nishizawa Y, Nishizawa Y, Amemori Y, et al. A randomized paralleled group comparison in multicenter cooperation: analgesic effect and safety with gosha-jinki-gan and shakuyaku-kanzo-to in the treatment of painful muscle cramps in patients with cirrhosis. Itami to Kampo (Pain and Kampo Medicine) 2000; 10: 13-8 (in Japanese with English abstract). | RCT | I |
| R25.2 | To evaluate the preventive effect and safety of shakuyakukanzoto (芍薬甘草湯) for gastrocnemius muscle hardness in knee osteoarthritis patients doing exercises at home. |
shakuyakukanzoto (芍薬甘草湯) |
Toda Y, Effect of peony and licorice decoction on muscle hardness of gastrocnemius in patients with osteoarthritis of the knee* Seikei Igaku (Orthopedic Surgery) 2015; 66: 521-4. | quasi- RCT |
I&N |
| R25.2 | To evaluate the efficacy of shakuyakukanzoto (芍薬甘草湯) for muscle spasms in lumbar spinal stenosis. |
shakuyakukanzoto (芍薬甘草湯) |
Takao Y, Takaoka Y, Sugano A,et al. Shakuyaku-kanzo-to (Shao-Yao-Gan-Cao-Tang) as Treatment of Painful Muscle Cramps in Patients with Lumbar Spinal Stenosis and Its Minimum Effective Dose. Kobe Journal of Medical Sciences 2015; 61: E132-7. | RCT | C |
| R31 | Efficacy and safety of kyukikyogaito and saireito for essential microscopic hematuria. |
kyukikyogaito (キュウ帰膠艾湯), saireito (柴苓湯) |
Yoshikawa H, Ikeuchi T, Kai Y. Clinical effects of Kyuki-kyogai-to and Sairei-to for essential microscopic hematuria. Kampo to Saishin-chiryo (Kampo & the Newest Therapy) 1997; 6: 55-8 (in Japanese). | RCT | N |
| R31 | Clinical efficacy of saireito for essential hematuria. |
saireito (柴苓湯) |
Suzuki Y, Machida T, Onodera S, et al. Clinical effects of Sairei-to for essential hematuria. Hinyoki Geka (Japanese Journal of Urological Surgery) 1994; 7: 325-7 (in Japanese). | RCT | I |
| R35.0 | To evaluate the effectiveness of goshajinkigan (牛車腎気丸) for nocturnal polyuria with elevated B-type natriuretic peptide. |
goshajinkigan (牛車腎気丸) |
Shimizu Y, Yoshimura K, Soda T, et al. The effects of Gosha-Jinki-Gan, a blended herbal medicine, and furosemide for nocturnal polyuria with elevated B-type natriuretic peptide: a crossover trial. Neurourology and Urodynamics 2010; 29: 833-4. | RCT- cross over |
C |
| Yoshimura K, Shimizu Y, Masui K, et al. Furosemide versus gosha-jinki-gan, a blended herbal medicine, for nocturnal polyuria: a randomized crossover trial. Lower Urinary Tract Symptoms 2012; 4: 77-81. | N | ||||
| R39.8 | Effects of hachimijiogan and seishinrenshiin on anti-heat shock protein (HSP) 60 antibodies. |
hachimijiogan (八味地黄丸), seishinrenshiin (清心レン子飲) |
Sekiguchi Y, Miyai K, Noguchi K, et al. Study of effects of anti-heat shock protein 60 antibody by Ba wei di huang wan and Qing xin lian zi yin (II). Wakan Iyakugaku Zasshi (Journal of Traditional Medicines) 1998; 15: 326-7 (in Japanese). | RCT- cross over |
N |
| R51 | Efficacy and safety of chotosan for relieving the accompanying symptoms and sequelae of cerebrovascular disease, chronic cerebrovascular insufficiency, or hypertension. |
chotosan (釣藤散) |
Matsushita S, Ueda S, Ouchi Y, et al. Usefulness of chotosan (TJ-47) for relieving the accompanying symptoms and sequelae of cerebrovascular disease, chronic cerebrovascular insufficiency, or hypertension*. Geriatric Medicine 1995; 33: 1333-41 (in Japanese). | RCT- envelope |
I |
| R51 | Efficacy and safety of chotosan for relieving headache in patients with spinal cord injury. |
chotosan (釣藤散) |
Nishizawa Y, Nishizawa Y, Fushiki S. Analgesic effects on headache in patients with spinal cord injury. Nippon Zutsu Gakkaishi (Japanese Journal of Headache) 1997; 25: 23-6. | DB-RCT | I |
| R51 | To evaluate the efficacy and safety of goshuyuto for relieving chronic headache using keishininjinto as a control. |
goshuyuto (呉茱萸湯), keishininjinto (桂枝人参湯) |
Seki H, Tateyama M, Sahara M, et al. Pain-relieving effect of goshuyuto on chronic headache: comparison with keishininjinto (with randomization using the sealed-envelope method)*. Shinryo to Shinyaku (Medical Consultation & New Remedies) 1991; 28: 573-6 (in Japanese). | RCT- envelope |
I |
| Seki H, Okita N, Takase S, et al. Pain-relieving effect of goshuyuto on chronic headache: comparison with keishininjinto (with randomization carried out using the sealed-envelope method)*. Pharma Medica 1993; 11: 288-91 (in Japanese). | I | ||||
| R51 | To evaluate the efficacy of goshuyuto for relief of chronic headache and to evaluate the associated adverse drug reactions. |
goshuyuto (呉茱萸湯) |
Odaguchi H, Hanawa Y. Complementary alternative medicine in headache treatment*. Igaku no Ayumi (Journal of Clinical and Experimental Medicine)2005; 215: 1137-40 (in Japanese). | DB-RCT | C |
| Odaguchi H, Wakasugi A, Ito H, et al. The efficacy of goshuyuto, a typical Kampo (Japanese herbal medicine) formula, in preventing episodes of headache. Current Medical Research and Opinion 2006; 22: 1587-97. | N | ||||
| R53 | To evaluate the efficacy of hochuekkito for the elderly with weakness. |
hochuekkito (補中益気湯) |
Satoh N, Sakai S, Kogure T, et al. A randomized double blind placebo-controlled clinical trial of hochuekkito, a traditional herbal medicine, in the treatment of elderly patients with weakness N of one and responder restricted design. Phytomedicine 2005; 12: 549-54. | DB-RCT | C |
| R53.0 | To evaluate the effect of hochuekkito (補中益気湯) on lymphocytes. |
hochuekkito (補中益気湯), hachimijiogan (八味地黄丸) |
Ohno S, Suzuki T, Asaoka T, et al. Effects of Oriental medicine on lymphoid cells. Kampo to Meneki-Allergy (Kampo and Immunoallergy) 1995; 9: 78-86 (in Japanese with English abstract). | quasi- RCT |
C |
| R60.0 | Efficacy of goreisan and saireito for mild edema of the dorsum of the foot in the elderly. |
saireito (柴苓湯) |
Ishioka T. Comparison of the efficacy of goreisan and saireito for mild edema of the dorsum of the foot in elderly subjects stratified by physical strength*. Kampo no Rinsho (Journal of Kampo Medicine) 1997; 44: 1091-5 (in Japanese). | RCT- cross over |
N |
| R60.9 | To investigate the efficacy and safety of saireito on postoperative edema and inflammation after total hip arthroplasty (THA). |
saireito (柴苓湯) |
Kishida Y, Miki H, Nishii T, et al. Therapeutic effects of Saireito (TJ-114), a traditional Japanese herbal medicine, on postoperative edema and inflammation after total hip arthroplasty. Phytomedicine 2007; 14: 581-6. | RCT | C |
| R68.8 | To evaluate the clinical effects of tokishigyakukagoshuyushokyoto (当帰四逆加呉茱萸生姜湯) for peripheral coldness in women. |
tokishigyakukagoshuyu-shokyoto (当帰四逆加呉茱萸生姜湯) |
Nishida S, Eguchi E, Ohira T, et al. Effects of a traditional herbal medicine on peripheral blood flow in women experiencing peripheral coldness: a randomized controlled trial. BMC Complementary Alternative Medicine 2015; 15: 105. | RCT | C&N |
| R73.0 | To evaluate the efficacy and safety of bofutsushosan in obese Japanese women with impaired glucose tolerance. |
bofutsushosan (防風通聖散) |
Hioki C, Yoshimoto K, Yoshida T. Efficacy of bofu-tsusho-san, an oriental herbal medicine, in obese Japanese women with impaired glucose tolerance. Clinical and Experimental Pharmacology and Physiology 2004; 31: 614-9. | DB-RCT | C |
| Hioki C, Yoshimoto K, Yoshida T. Efficacy of bofu-tsusho-san in obese Japanese women with IGT. Rinsho Kampo Yakuri Kenkyukai Kaishi (Journal of the Society for Clinical Kampo Pharmacology), 2004; 100th Memorial Issue: 19-22. | I | ||||
| Hioki C. Efficacy of bofutsushosan in obese women with IGT*. Pharma Medica 2007; 25: 43-8. | I | ||||
| Hioki C, Arai M. Bofutsushosan use for obesity with IGT: search for scientific basis and development of effective therapy with Kampo medicine. Journal of Traditional Medicines 2007; 24: 115-27. | N |
- Note:
- Original English titles assigned by authors were used in this list and the structured abstracts. When references had no English titles, the Task Force translated the original Japanese titles into English ones (*).
- Abbreviations:
- C: The Cochrane Library (CENTRAL), I: Igaku Chuo Zasshi (Japana Centra Revuo Medicana, Ichushi), N: Database Offered by Nikkankyo (the Japan Kampo Medicines Manufacturers Association)
19. Injury, Poisoning, and Postoperative Pain (11 abstracts, 11 references)
| ICD-10 | Research Question |
Kampo Formula |
References | Study Design |
Source |
|---|---|---|---|---|---|
| S22.3 | Comparison of the efficacy of jidabokuippo (治打撲一方) and non-steroidal anti-inflammatory drugs for fracture of ribs |
Jidabokuippo (治打撲一方) |
Nakae H, Yokoi A, Kodama H, et al. Comparison of the Effects on Rib Fracture between the Traditional Japanese Medicine Jidabokuippo and Nonsteroidal Anti-Inflammatory Drugs: A Randomized Controlled Trial. Evidence Based-Complementary and Alternative Medicine 2012: 1-7. doi: 10.1155/2012/837958. | RCT- envelope |
N |
| S93.4 | To evaluate the efficacy of a Western medicine and a Kampo medicine (jidabokuippo [治打撲一方]) for pain and swelling after a fresh and isolated anterior talofibular ligament (ATFL) grade III injury. |
Jidabokuippo (治打撲一方) |
Takeda N. Conservative therapy for fresh lateral ligament injury of the ankle joint – Comparison of a Western medicine and a Kampo medicine for pain and swelling*. Kampo to Rinsho (Journal of Kampo Medicine) 2010; 1: 128–32 (in Japanese). | RCT | I |
| T67.8 | To evaluate the efficacy of Kampo therapy in patients with heat illness requiring hospitalization. |
hochuekkito (補中益気湯), rikkunshito (六君子湯), daikenchuto (大建中湯), yokukansan (抑肝散) |
Nimura T, Yamada S, Ohwaki T, et al. Evaluation of the efficacy of Kampo therapy in patients with heat illness requiring hospitalization*. Kampo Igaku (Kampo Medicine) 2014: 38; 178-81 (in Japanese). | quasi- RCT |
I&N |
| T67.8 | To evaluate the effect of Kampo extract preparations as an adjunct to the standard therapy to shorten the symptom resolution time in patients with heat illness. |
shakuyakukanzoto (芍薬甘草湯) |
Takamura M, Effectiveness of Kampo extract preparations for the treatment of heat illness.* Kampo to Saishinchiryo (Kampo & the Newest Therapy) 2014; 23: 121-4 (in Japanese). | RCT | N |
| T88.5 | Efficacy of goshuyuto and goreisan for post-spinal headache. |
goshuyuto (呉茱萸湯), goreisan (五苓散) |
Otake T, Kato I, Saito S, et al. The prophylactic effect of "Gosyuyu-to" and "Gorei-san" for post-spinal headache. Pain Clinic 1991; 12: 648-52 (in Japanese). | RCT | N |
| T88.8 | Effects on pain and hyperhidrosis after thoracotomy. |
keishikajutsubuto (桂枝加朮附湯), keishikajutsubuto (桂枝加朮附湯) ＋ shakuyakukanzoto (芍薬甘草湯) |
Isai H. Successful control of postoperative pain and hyperidrosis by Kampo medicine after thoracotomy for pulmonary disease. Itami to Kampo (Pain and Kampo Medicine) 1997; 7: 29-32 (in Japanese with English abstract). | RCT | N |
| T88.8 | To evaluate the effectiveness of shakuyakukanzoto (芍薬甘草湯) for pain after hemorrhoidectomy |
shakuyakukanzoto (芍薬甘草湯) |
Miyazaki M, Yasui M, Ikenaga M, et al. The effect of shakuyaku-kanzo-to (Tsumura TJ-68) on pain after hemorrhoidectomy – a prospective randomized study –. Journal of the Japan Society of Coloproctology 2012; 65: 313–7 (in Japanese with English abstract). | RCT | I |
| T88.8 | To evaluate pre-and post-operative analgesic effects of shakuyakukanzoto (芍薬甘草湯) for treatment of pain after hemorrhoidectomy. |
shakuyakukanzoto (芍薬甘草湯) |
Fukuda Y, Azuma M, Novel pain reliever shakuyaku-kanzo-to after hemorrhoidectomy, Journal of the Japan Society of Coloproctology, 2014; 67: 324-9. | RCT | I&N |
| T88.8 | To evaluate the efficacy and safety of hangeshashinto (半夏瀉心湯) on postoperative sore throat and nausea. |
hangeshashinto (半夏瀉心湯) |
Kuwamura A, Komasawa N, Kori K,et al. Preventive effect of preoperative administration of hange-shashin-to on postoperative sore throat: a prospective, double-blind, randomized trial. Journal of Alternative Complementary Medicine 2015; 21: 485-8. | DB-RCT | C&N |
| T88.8 | To determine the efficacy and safety of preoperative administration of jidabokuippo (冶打撲一方) in treating postoperative pain after tooth extraction with mandible bone removal under general anesthesia. |
jidabokuippo (治打撲一方) |
Komasawa N, Yamamoto K, Ito Y, et al.Preoperative administration of jidabokuippo，a Kampo medicine，alleviates postoperative pain after tooth extraction with mandible bone removal under general anesthesia：a prospective, single-blind, randomized controlled Trial. Journal of Alternative and Complementary Medicine 2018 ;24:1214-8. | RCT- envelope |
C |
| T94.1 | To evaluate the effectiveness and safety of saireito (柴苓湯) for keloid and hypertrophic scars following surgery, burn injury, and wound injury. |
saireito (柴苓湯) | Watanabe Y, Asai S, Hida A, et al. Regarding the utility of saireito against keloid and hypertrophic scars following surgery and injury. Igaku to Yakugaku (Japanese Journal of Medicine and Pharmaceutical Science) 2012; 67: 245–9 (in Japanese). | quasi- RCT |
I |
- Note:
- Original English titles assigned by authors were used in this list and the structured abstracts. When references had no English titles, the Task Force translated the original Japanese titles into English ones (*).
- Abbreviations:
- C: The Cochrane Library (CENTRAL), I: Igaku Chuo Zasshi (Japana Centra Revuo Medicana, Ichushi), N: Database Offered by Nikkankyo (the Japan Kampo Medicines Manufacturers Association)
21. Others (44 abstracts, 51 references)
| ICD-10 | Research Question |
Kampo Formula |
References | Study Design |
Source |
|---|---|---|---|---|---|
| Z01.0 | To evaluate the ability of tokishakuyakusan (当帰芍薬散) to increase ocular blood flow. |
tokishakuyakusan (当帰芍薬散) |
Takayama S, Shiga Y, Kokubun T, et al. The traditional kampo medicine Tokishakuyakusan increases ocular blood flow in healthy subjects. Evidence-Based Complementary and Alternative Medicine 2014: 1-8. doi: 10.1155/2014/586857 | RCT- cross over |
C&N |
| Z01.8 | To evaluate the effect of bakumondoto on cytochrome p450 1A2, xanthine oxidase, and N-acetyltransferase 2 activities. |
bakumondoto (麦門冬湯) |
Saruwatari J, Hisaeda S, Higa Y, et al. The in-vivo effect of Bakumondo-to (TJ-29), a traditional Japanese medicine used for treatment of chronic airway disease, on cytochrome P450 1A2, xanthine oxidase and N-acetyltransferase 2 activity in man. Journal of Pharmacy and Pharmacology 2004; 56: 1171-7. | RCT- cross over |
C |
| Z01.8 | To evaluate the effect of shoseiryuto on blood carbamazepine concentration. |
shoseiryuto (小青竜湯) |
Ohnishi N, Yonekawa Y, Fumihara T. et al. Studies on interactions between traditional herbal and Western medicines, II. Lack of pharmacokinetic interaction between shoseiryu-to and carbamazepine in healthy volunteers. TDM Kenkyu (Japanese Journal of Therapeutic Drug Monitoring) 1999; 16: 399-404. | RCT- cross over |
I |
| Yonekawa Y, Ohnishi N, Kitano N, et al. Drug interaction with Kampo medicines (2): kinetic characteristics of carbamazepine combined with shoseiryuto in healthy volunteers. TDM Kenkyu (Japanese Journal of Therapeutic Drug Monitoring) 1999; 16: 191-2. | N | ||||
| Z01.8 | To evaluate the effect of hachimijiogan on human central retinal artery. |
hachimijiogan (八味地黄丸) |
Isobe H, Yamamoto K, Cyong JC. Effects of hachimi-jio-gan (ba-wei-di-huang-wan) on blood flow in the human central retinal artery. The American Journal of Chinese Medicine 2003; 31: 425-35. | RCT- cross over |
C |
| Z01.8 | To assess the efficacy and safety of hochuekkito on antibody production after influenza vaccination. |
hochuekkito (補中益気湯) |
Hamazaki K, Sawazaki S, Itomura M, et al. No effect of a traditional Chinese medicine, hochu-ekki-to, on antibody titer after influenza vaccination in man: a randomized, placebo-controlled, double-blind trial. Phytomedicine 2007; 14: 11-4. | DB-RCT | C |
| Z01.8 | To evaluate the effect of maobushisaishinto on antibody titer after influenza vaccination. |
maobushisaishinto (麻黄附子細辛湯) |
Terashima Y, Hamazaki K, Itomura M, et al. Effect of a traditional Chinese medicine, maobushisaishinto, on the antibody titer after influenza vaccination: A randomized, placebo-controlled, double-blind trial. Journal of Traditional Medicines 2007; 24: 59-66. | DB-RCT | I |
| Z01.8 | To elucidate the mechanism of bushirichuto activity in raising gut-regulated peptide levels. |
bushirichuto (附子理中湯) |
Sato Y, Katagiri F, Itoh H, et al. Bushi-richu-to raises calcitonin gene-related peptide, substance P, somatostatin, and vasoactive intestinal polypeptides levels in human plasma. Journal of Health Science 2007; 53: 615-21. | RCT- cross over |
I |
| Z01.8 | To evaluate effects of rokumigan on serum amino acid concentrations. |
rokumigan (六味丸) |
Takahashi H, Nakao R, Hirasaka K, et al. Effects of single administration of Rokumi-gan (TJ-87) on serum amino acid concentration of 6 healthy Japanese male volunteers. Journal of Medical Investigation 2007; 54: 91-8. | RCT- cross over |
I |
| Z01.8 | Interaction with the pharmacokinetics of acetaminophen. |
kakkonto (葛根湯) |
Qi J, Toyoshima A, Honda Y, et al. Pharmacokinetic study on acetaminophen: interaction with a Chinese medicine. Journal of Medical and Dental Sciences 1997; 44: 31-5. | RCT- cross over |
C |
| Z01.8 | Effects of kakkonto on the pharmacokinetics of phenacetin. |
kakkonto (葛根湯) |
Shimakura K, Mineshita S, Sanaka M, et al. Effects of kakkonto on the pharmacokinetics of phenacetin in human serum and saliva*. Rinsho Yakuri (Japanese Joournal of Clinical Phamacology and Therapeutics) 1994; 25: 229-30 (in Japanese). | RCT- cross over |
N |
| Z01.8 | Effects of saibokuto and saikokaryukotsu-boreito on central nervous systems in humans. |
saibokuto (柴朴湯), saikokaryukotsu-boreito (柴胡加竜骨牡蛎湯) |
Fukushima M. Profiles of effects of traditional oriental herbal medicines on central nervous system in humans - assessment of Saiboku-to and Saiko-ka-ryukotsu-borei-to using EEG and pharmacokinetics of herbal medicine-derived ingredients as indices -. Seishin Shinkeigaku Zasshi (Psychiatria et Neurologia Japonica) 1997; 99: 355-69 (in Japanese with English abstract). | RCT | N |
| Z01.8 | Effects on bioavailability of ofloxacin (OFLX) in healthy volunteers. |
shosaikoto (小柴胡湯), rikkunshito (六君子湯), saireito (柴苓湯) |
Hasegawa T, Yamaki K, Nadai M, et al. Lack of effect of Chinese medicines on bioavailability of ofloxacin in healthy volunteers. International Journal of Clinical Pharmacology and Therapeutics 1994; 31: 57-61. | RCT- cross over |
C |
| Z01.8 | To evaluate the effects of shosaikoto, saibokuto, and saireito on prednisolone metabolism. |
shosaikoto (小柴胡湯), saibokuto (柴朴湯), saireito (柴苓湯) |
Niitsuma T, Fukuda T, Yamamoto S, et al. Effects of saibokuto and other Saiko-zai (Saiko-drugs) on prednisolone metabolism*. Kampo to Meneki-Arerugi (Kampo and Immuno-allergy) 1993; 7: 43-52 (in Japanese). | RCT- cross over |
N |
| Homma M, Oka K, Ikeshima K, et al. Different effects of traditional Chinese medicines containing similar herbal constituents on prednisolone pharmacokinetics. Journal of Pharmacy and Pharmacology 1995; 47: 687-92. | C | ||||
| Z01.8 | Effect of coadministered Kampo medicine on the pharmacokinetics of levofloxacin (Cravit) |
hochuekkito (補中益気湯), rikkunshito (六君子湯), juzentaihoto (十全大補湯) |
Hasegawa T, Yamaki K, Muraoka I, et al. Effects of traditional Chinese medicines on pharmacokinetics of levofloxacin. Antimicrobial Agents and Chemotherapy 1995; 39: 2135-37. | RCT- cross over |
C |
| Z01.8 | To evaluate the effects of co-administered byakkokaninjinto on pharmacokinetics and renal excretion of antibiotics (tetracycline or ciprofloxacin). |
byakkokaninjinto (白虎加人参湯) |
Ohnishi M, Hitoshi K, Katoh M, et al. Effect of a Kampo preparation, byakkokaninjinto, on pharmacokinetics of ciprofloxacin and tetracycline. Biological & Pharmaceutical Bulletin 2009; 32: 1080-4. | RCT- cross over |
C&I |
| Z01.8 | To evaluate the antioxidative effect of bofutsushosan in healthy adults using the lag time of low-density lipoprotein (LDL) oxidation as the main yardstick. |
bofutsushosan (防風通聖散) |
Ogawa H, Xu F, Uebaba K, et al. Antioxidative potentiality of a Kampo formulation measured by an ex vivo study. The Journal of Alternative and Complementary Medicine 2009; 15: 267-74. |
DB-RCT | N |
| Z01.8 | To compare the effects of kamishoyosan and paroxetine in improving anxiety and depression as menopausal symptoms. |
kamishoyosan (加味逍遙散) |
Yasui T, Yamada M, Uemura H, et al. Changes in circulating cytokine levels in midlife women with psychological symptoms with selective serotonin reuptake inhibitor and Japanese traditional medicine. Maturitas 2009; 62: 146-52. | RCT | N |
| Z01.8 | To evaluate the pharmacokinetic profiles of serum ephedrine and pseudoephedrine after oral administration of kakkonto (葛根湯), and changes in biokinetics after different administered doses. |
kakkonto (葛根湯) |
Inotsume N, Fukushima S, Hayakawa T, et al. Pharmacokinetics of ephedrine and pseudoephedrine after oral administration of kakkonto to healthy male volunteers. Rinsho Yakuri (Japanese Journal of Clinical Pharmacology and Therapeutics)2009; 40: 79-83. | RCT- cross over |
I |
| Z01.8 | To analyze the blood kinetics of indicator components in daikenchuto (大建中湯). |
Daikenchuto (大建中湯) |
Munekage M, Kitagawa H, Ichikawa K, et al. Pharmacokinetics of daikenchuto, a traditional Japanese medicine (Kampo) after single oral administration to healthy Japanese volunteers. Drug Metabolism and Disposition 2011; 39: 1784-8. | RCT | N |
| Z01.8 | To analyze the blood kinetics of indicator ingredients in daikenchuto (大建中湯). |
Daikenchuto (大建中湯) |
Munekage M, Ichikawa K, Kitagawa H, et al. Population pharmacokinetic analysis of daikenchuto，a traditional Japanese medicine (Kampo) in Japanese and US health volunteers. Drug Metabolism and Disposition 2013; 41: 1256-63. | RCT- cross over |
N |
| Z01.8 | To evaluate the effect of daikenchuto (大建中湯) and abdominal thermotherapy on blood flow through the superior mesenteric artery. |
Daikenchuto (大建中湯) |
Takayama S, Okitsu R, Iwasaki K, et al. The effect of warming the abdomen with herbal medicine or thermal therapy on superior mesenteric artery blood flow Kampo to Saishin Chiryo (Kampo & the Newest Therapy) 2011; 20: 253-8 (in Japanese with English abstract). | RCT | I |
| Z01.8 | Pharmacokinetics of the blood concentration of active ingredients of yokukansan (抑肝散) in healthy subjects. |
yokukansan (抑肝散) |
Kitagawa H, Munekage M, Ichikawa K. et al. Pharmacokinetics of active components of yokukansan, a traditional Japanese herbal medicine after a single oral administration to healthy Japanese volunteers: a cross-over, randomized study. PloS One 2015 7; 1-14. | RCT- cross over |
C&N |
| Z01.8 | To analyze the pharmacokinetics of the active ingredients of rikkunshito (六君子湯) in healthy volunteers. |
rikkunshito (六君子湯) |
Kitagawa H, Munekage M, Matsumoto T, et al. Pharmacokinetic profiles of active ingredients and its metabolites derived from rikkunshito, a ghrelin enhancer, in healthy Japanese volunteers: a cross-over, randomized study. PloS One 2015 10; 1-19. | RCT- cross over |
C&N |
| Z01.8 | Comparative analysis of the plasma concentrations of components of shakuyakukanzoto (芍薬甘草湯) after administration of different doses. |
shakuyakukanzoto (芍薬甘草湯) |
Sadakane C, Watanabe J, Fukutake M, et al. Pharmacokinetic profiles of active components after oral administration of a Kampo medicine, shakuyakukanzoto, to healthy adult Japanese volunteers. Journal of Pharmaceutical Sciences 2015; 104(11): 3952-9. | RCT- cross over |
C&N |
| Z01.8 | To evaluate the interaction of daijyokito (大承気湯) on the pharmacokinetics of ranitidine. |
daijyokito (大承気湯) |
Endo Y, Ishihara Y, Tsuno S , et al. Pharmacokinetic interaction study of ranitidine and daijokito in healthy volunteers. Yonago Acta Medica 2016; 59: 111-7. | RCT- cross over |
C |
| Z03.8 | Efficacy of shakuyakukanzoto for relieving pain during colonoscopy. |
shakuyakukanzoto (芍薬甘草湯) |
Arai M, Sato H, Shirota F. An investigation into the relief of colonscopy pain provided by Shakuyaku-kanzo-to. Nihon Toyo Igaku Zasshi (Japanese Journal of Oriental Medicine) 1994; 44: 385-90 (in Japanese with English abstract). | RCT | N |
| Z03.8 | Efficacy of shakuyakukanzoto for relieving pain and complaints during preparation for barium enema. |
shakuyakukanzoto (芍薬甘草湯) |
Imazato S, Kai S, Koizumi K, et al. A clinical study of Shakuyaku-Kanzo-to (Kampo) as a preparation for double contrast barium enema. Therapeutic Research 1997; 18: 5505-10 (in Japanese with English abstract). | RCT | N |
| Imazato S, Kai S, Koizumi K, et al. A Clinical Study of Shakuyaku-Kanzo-to (Kampo) as a Preparation for Double Contrast Barium Enema. Science of Kampo Medicine 1998; 22: 87–92 (in Japanese). | N | ||||
| Z03.8 | Efficacy of a new colon preparation using daiokanzoto (大黄甘草湯). |
daiokanzoto (大黄甘草湯) |
Yokota H, Kanazawa H, Kondo T, et al. New colon preparation using the Kampo herb method (Daio-kanzo-to). Therapeutic Research 1989; 10: 1637-43 (in Japanese with English abstract). | RCT | N |
| Yokota H, Kanazawa H, Kondo T, et al. New colon preparation using the Kampo herb method (daio-kanzo-to). Current Therapy 1989; 7: 749-54 (in Japanese). | |||||
| Yokota H, Kanazawa H, Kondo T, et al. New colon preparation using the Kampo herb method (daio-kanzo-to). Current Therapy 1990; 8: 805-10 (in Japanese). | |||||
| Z03.8 | To evaluate the efficacy of shakuyakukanzoto combined with polyethylene glycol solution (PEG) in pretreatment for large bowel endoscopy. |
shakuyakukanzoto (芍薬甘草湯) |
Saida Y, Takase M, Okumura C, et al. Efficacy of combined use of shakuyakukanzoto in pretreatment for large bowel endoscopy — prospective randomized trial*. Nihon Daicho Kensa Gakkai Zasshi (Journal of the Japan Society of Colon Examination) 2003; 20: 34-7 (in Japanese). | RCT- envelope |
I |
| Z03.8 | To evaluate the efficacy of directly sprayed shakuyakukanzoto on large bowel spasm. |
shakuyakukanzoto (芍薬甘草湯) |
Ai M. Assessment of the antipasmodic effect of peppermint oil and shakuyaku-kanzon-to (TJ-68); a Chinese herbal medicine on the clonic wall. Medical Tribune Online (Digestive Disease Week: DDW) 2005: 10-1 (in Japanese). | RCT | N |
| Z03.8 | To evaluate the efficacy of pretreatment with shakuyakukanzoto for upper gastrointestinal tract endoscopy. |
shakuyakukanzoto (芍薬甘草湯) |
Sugihara N. Effectiveness of shakuyaku-kanzo-to as a pretreatment for upper digestive tract endoscopic examination*. Kampo Shinryo 1999; 18: 17-9 (in Japanese). | quasi- RCT |
N |
| Z03.8 | To evaluate the efficacy of daikenchuto combined with polyethylene glycol solution (PG solution) in pretreatment for large bowel endoscopy. |
daikenchuto (大建中湯) |
Saida Y, Sumiyama Y, Nagao J, et al. Dai-kenchu-to, a herbal medicine, improves precolonoscopy bowel preparation with polyethylene glycol electrolyte lavage: results of a prospective randomized controlled trial. Digestive Endoscopy 2005; 17: 50-3. | RCT- envelope |
C&I |
| Z03.8 | To evaluate the efficacy and safety of direct spraying of shakuyakukanzoto on the colonic mucosa for suppression of bowel movement during colonoscopy. |
shakuyakukanzoto (芍薬甘草湯) |
Ai M, Yamaguchi T, Odaka T, et al. Objective assessment of the antispasmodic effect of shakuyaku-kanzo-to (TJ-68), a Chinese herbal medicine, on the colonic wall by direct spraying during colonoscopy. World Journal of Gastroenterology 2006; 12: 760-4. | RCT | C |
| Z03.8 | To evaluate the efficacy of shakuyakukanzoto solution in preparation for colonoscopy used with the water method of distension. |
shakuyakukanzoto (芍薬甘草湯) |
Mizukami T, Maruyama K, Yamauchi H, et al. Assessment of antispasmodic effect of herbal medicine, shyakuyakukanzoto (TJ-68) on colonoscopy – Using colonoscopy insertion technique “collapsing method” –. Kampo to Saishin-chiryo (Kampo & the Newest Therapy) 2006; 15: 69-76 (in Japanese). | quasi- RCT |
I |
| Z03.8 | To evaluate the bowel cleansing effect of precolonoscopy bowel preparation with polyethylene glycol electrolyte lavage solution (PG solution) combined with daikenchuto and mosapride. |
daikenchuto (大建中湯) |
Saida Y, Nagao J, Nakamura Y, et al. Dai-kenchu-to and mosapride in combination with precolonoscopy bowel preparation with polyethylene glycol electrolyte lavage: results of a prospective randomized controlled trial. Nihon Daicho Kensa Gakkai Zasshi (Journal of the Japan Society of Colon Examination) 2005; 22: 145-8 (in Japanese). | RCT | I |
| Z03.8 | To evaluate the effectiveness of daikenchuto in bowel preparation for barium enema X-ray study. |
daikenchuto (大建中湯) |
Arai J, Nakajima S, Fujinuma S, et al. A Comparative study of bowel preparation for barium enema using divided administrations of powdered magnesium citrate with mosapride or DAIKEN CHUTOU. Nihon Daicho Kensa Gakkai Zasshi (Journal of the Japan Society of Colon Examination) 2002; 19: 170-3 (in Japanese). | RCT | I |
| Z03.8 | To evaluate the effectiveness of shakuyakukanzoto (芍薬甘草湯) as premedication for ERCP in suppressing duodenal peristalsis. |
shakuyakukanzoto (芍薬甘草湯) |
Fujinami H. Assessment of diminished persistalsis using Shakuyakukanzoto (TJ-68) as premedication for endoscopic retrograde cholangiopancreatography (ERCP): randomized placebo-controlled trial. Nikkei Medical (Supplement) 2010; 8: 34 (in Japanese). | RCT | N |
| Fujinami H, Kudo T, Nakayama Y, et al. Assessment of diminished peristalsis using shakuyakukanzoto (TJ-68) as premedication for endoscopic retrograde cholangiopancreatography (ERCP): a randomized, placebo-controlled trial. Gastrointestinal Endoscopy 2010; 71: AB227. | N | ||||
| Z03.8 | To evaluate the efficacy of intraduodenal administration of shakuyakukanzoto (芍薬甘草湯) on duodenal peristalsis during endoscopic retrograde cholangiopancreatography (ERCP). |
shakuyakukanzoto (芍薬甘草湯) |
Fujinami H, Kajiura S, Nishikawa J, et al. The influence of duodenally-delivered Shakuyakukanzoto (Shao Yao Gan Cao Tang) on duodenal peristalsis during endoscopic retrograde cholangiopancreatography：a randomised controlled trial. Chinese Medicine 2017; 12: 3 : 1-6. doi: 10.1186/s13020-016-0125-6 | RCT | N |
| Z04.8 | To assess whether differences in ethical Kampo extract formulation dosage and dosing frequency have an effect on compliance and patient satisfaction. |
Not described | Kita T, Sumino M. The effect of dosage frequency of ethical Kampo extract formulations on drug compliance – a comparison of twice a day and three times a day prescriptions. Igaku to Yakugaku (Japanese Journal of Medicine and Pharmaceutical Science) 2011; 66: 117–22 (in Japanese). | RCT- cross over |
I |
| Z04.8 | To select the Pharmacopeia indicator components for evaluation of the equivalence of kakkonto (葛根湯) extract formulation and decoction. |
kakkonto (葛根湯) |
Horii C, Okonogi A, Okubo T, et al. Studies on bioequivalence of kakkonto decoction and its extract preparation (I)*. Shoyakugaku zasshi 2014; 68: 9-12. | RCT- cross over |
N |
| Horii C, Okonogi A, Okubo T, et al. Study of the equivalence of kakkonto (葛根湯) extract formulation and decoction (II). Natural Medicines 2015; 69: 59-65. | RCT- cross over |
I&N | |||
| Z04.8 | To evaluate the bioequivalence of shoseiryuto (小青竜湯) extract and its decoction. |
shoseiryuto (小青竜湯) |
Horii C, Okonogi A, Studies on bioequivalence of shoseiryuto decoction and its extract preparation (I), Shoyakugaku zasshi (Journal of Natural Medicines) 2014; 68: 65-9. | RCT- cross over |
I&N |
| Z22.8 | To evaluate the effects of hochuekkito on prevention of MRSA carriage, prevention of Pseudomonas aeruginosa carriage, prevention of infection development, neutrophil count, and C-reactive protein (CRP) value. |
hochuekkito (補中益気湯) |
Ueda T, Yamashita K, Nakamori Y, et al. Study of the MRSA carriage-preventing effect of hochuekkito (TJ-41): 1st report*. Progress in Medicine 1999; 19: 1000-3 (in Japanese). | RCT | N |
| Z31.1 | Effect of ovarian stimulation by tokishakuyakusan (used during in vitro fertilization and embryo transfer (IVF-ET) cycles) on follicular growth, luteal function, pregnancy rate, and abortion rate. |
tokishakuyakusan (当帰芍薬散) |
Fujii S, Fukushi Y, Yamaguchi E, et al. A study of the addition of tokishakuyakusan during in-vitro fertilization cycles*. Sanfujinka Kampo Kenkyu no Ayumi (Recent Progress of Kampo Medicine in Obstetrics and Gynecology) 1997; 14: 121-5 (in Japanese). | RCT | N |
| K76.9 Z94.4 |
To evaluate the efficacy and safety of daikenchuto (大建中湯) on the reinforcing effect of oral/tubal caloric intake in patients undergoing liver transplantation. |
daikenchuto (大建中湯) |
Kaido T, Shinoda M, Inomata Y,et al. Effect of herbal medicine daikenchuto on oral and enteral caloric intake after liver transplantation: a multicenter, randomized controlled trial. Nutrition 2018; 54: 68-75. | DB-RCT | N |
- Note:
- Original English titles assigned by authors were used in this list and the structured abstracts. When references had no English titles, the Task Force translated the original Japanese titles into English ones (*).
- Abbreviations:
- C: The Cochrane Library (CENTRAL), I: Igaku Chuo Zasshi (Japana Centra Revuo Medicana, Ichushi), N: Database Offered by Nikkankyo (the Japan Kampo Medicines Manufacturers Association)
Ⅱ. Structured Abstracts describing Meta-analysis and the References Reporting Them
2. Cancer (Condition after Cancer Surgery and Unspecified Adverse Drug Reactions of Anti-cancer Drugs) (5 abstracts, 5 references)
| ICD-10 | Research Question |
Kampo Formula |
Reference | Study Design |
Source |
|---|---|---|---|---|---|
| C26.9 K91.9 |
To assess the efficacy of daikenchuto (大建中湯) in improving intestinal dysfunction after abdominal surgery. |
daikenchuto (大建中湯) |
Zhang L, Cheng Y, Li H, et al. Meta-analysis of randomized controlled trials on the efficacy of daikenchuto on improving intestinal dysfunction after abdominal surgery. Annual of Surgical and Treatment Reseach 2018; 95: 7–15. | meta- analysis | N |
| C26.9 K91.3 |
To analyze whether daikenchuto (大建中湯) accelerates the recovery from prolonged postoperative ileus after open abdominal surgery. |
daikenchuto (大建中湯) |
Kono T, Shimada M, Nishi M, et al. Daikenchuto accelerates the recovery from prolonged postoperative ileus after open abdominal surgery: a subgroup analysis of three randomized controlled trials. Surgery Today 2019: 1-8. | meta- analysis | N |
| C78.8 K91.3 |
A meta-analysis of to evaluate the efficacy of perioperative daikenchuto (DKT)(大建中湯) treatment for postoperative bowel obstruction (postoperative ileus) in gastrointestinal cancer. |
daikenchuto (大建中湯) |
Ishizuka M, Shibuya N, Nagata H, et al. Perioperative administration of traditional Japanese medicine daikenchuto relieves postoperative ileus in patients undergoing surgery for gastrointestinal cancer: a systemic review and meta-analysis. Anticancer Research 2017; 37: 5967-74. | meta- analysis | N |
| C80.0 | To evaluate the efficacy and safety of goshajinkigan (牛車腎気丸) in peripheral neuropathy during chemotherapy. |
goshajinkigan (牛車腎気丸) |
Hoshino N, Ganeko R, Hida K, et al. Goshajinkigan for reducing chemotherapy-induced peripheral neuropathy: a systematic review and meta-analysis. International Journal of Clinical Oncology 2018; 23: 434–42. | meta- analysis | N |
| C97.0 G62.0 |
To examine whether goshajinkigan (牛車腎気丸) prevents chemotherapy-induced peripheral neuropathy (CIPN) in patients receiving neurotoxic chemotherapy. |
goshajinkigan (牛車腎気丸) |
Kuriyama A, Endo K. Goshajinkigan for reducing chemotherapy-induced peripheral neuropathy：a systematic review and meta-analysis. Supportive Care in Cancer 2018 ;26: 1051-9. | meta- analysis | N |
5. Psychiatric/Behavioral Disorders (3 abstracts, 3 references)
| ICD-10 | Research Question |
Kampo Formula |
Reference | Study Design |
Source |
|---|---|---|---|---|---|
| F03 | A systematic review of yokukansan (抑肝散) for behavioral psychological symptoms of dementia (BPSD). |
yokukansan (抑肝散) |
Matsunaga S, Kishi T, Iwata N. Yokukansan in the treatment of behavioral and psychological symptoms of dementia: an updated meta-analysis of randomized controlled trials. Journal of Alzheimer's Disease 2016; 54: 635-43. | meta- analysis | N |
| F03 | To assess the effectiveness and acceptability of choto-san (釣藤散) in the treatment of adults with cognitive impairment. |
chotosan (釣藤散) |
Imai H, Takeshima N, Oda H,et al. Choto-san versus placebo for patients with dementia: systematic review and meta-analysis. Psychogeriatrics 2017; 17: 466-78. | meta- analysis | I |
| F03 | To determine the most efficacious and acceptable treatments of agitation (including yokukansan (抑肝散) in dementia. |
yokukansan (抑肝散) |
Kongpakwattana K, Sawangjit R, Tawankanjanachot ,et al. Pharmacological treatments for alleviating agitation in dementia：a systematic review and network meta-analysis. British Journal of Clinical Pharmacology 2018; 84: 1445-56. | meta- analysis | N |
6. Nervous System Diseases (incl uding Alzheimer's Disease) (2 abstract, 2 reference)
| ICD-10 | Research Question |
Kampo Formula |
Reference | Study Design |
Source |
|---|---|---|---|---|---|
| G30.1 | To perform a systematic review of the efficacy and tolerability of yokukansan (抑肝散) in the treatment of behavioral and psychological symptoms of dementia (BPSD). |
yokukansan (抑肝散) |
Matsuda Y, Kishi T, Shibayama H, et al. Yokukansan in the treatment of behavioral and psychological symptoms of dementia：a systematic review and meta－analysis of randomized controlled trials. Human Psychopharmacology 2013; 28: 80-6. | meta- analysis | N |
| C97.0 G62.0 |
To examine whether goshajinkigan (牛車腎気丸) prevents chemotherapy-induced peripheral neuropathy (CIPN) in patients receiving neurotoxic chemotherapy. |
goshajinkigan (牛車腎気丸) |
Kuriyama A, Endo K. Goshajinkigan for reducing chemotherapy-induced peripheral neuropathy：a systematic review and meta-analysis. Supportive Care in Cancer 2018 ;26: 1051-9. | meta- analysis | N |
11. Gastrointestinal, Hepato-Biliary-Pancreatic Diseases (3 abstracts, 3 references)
| ICD-10 | Research Question |
Kampo Formula |
Reference | Study Design |
Source |
|---|---|---|---|---|---|
| C78.8 K91.3 |
A meta-analysis of to evaluate the efficacy of perioperative daikenchuto (DKT)(大建中湯) treatment for postoperative bowel obstruction (postoperative ileus) in gastrointestinal cancer. |
daikenchuto (大建中湯) |
Ishizuka M, Shibuya N, Nagata H, et al. Perioperative administration of traditional Japanese medicine daikenchuto relieves postoperative ileus in patients undergoing surgery for gastrointestinal cancer: a systemic review and meta-analysis. Anticancer Research 2017; 37: 5967-74. | meta- analysis | N |
| C26.9 K91.3 |
To analyze whether daikenchuto (大建中湯) accelerates the recovery from prolonged postoperative ileus after open abdominal surgery. |
daikenchuto (大建中湯) |
Kono T, Shimada M, Nishi M, et al. Daikenchuto accelerates the recovery from prolonged postoperative ileus after open abdominal surgery: a subgroup analysis of three randomized controlled trials. Surgery Today 2019: 1-8. | meta- analysis | N |
| C26.9 K91.9 |
To assess the efficacy of daikenchuto (大建中湯) in improving intestinal dysfunction after abdominal surgery. |
daikenchuto (大建中湯) |
Zhang L, Cheng Y, Li H, et al. Meta-analysis of randomized controlled trials on the efficacy of daikenchuto on improving intestinal dysfunction after abdominal surgery. Annual of Surgical and Treatment Reseach 2018; 95: 7–15. | meta- analysis | N |
15. Ante/Post-partum Diseases (1 abstract, 1 reference)
| ICD-10 | Research Question |
Kampo Formula |
Reference | Study Design |
Source |
|---|---|---|---|---|---|
| O90.8 | To evaluate the efficacy of kyukichoketsuin in puerperal care in comparison with methylergometrine maleate by conducting a meta-analysis. |
kyukichoketsuin (キュウ帰調血飲) |
Koinuma M, Narikawa H, Kamei M, et al. Meta-analysis on the usefulness in postpartum control by kyukichoketsuin with methylergometrine maleate as control. Nihon Toyo Igaku Zasshi (Kampo Medicine) 2006; 57: 45-55 (in English with Japanese abstract). | meta- analysis | I |
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