ICD-10	Research Question	Kampo Formula	References	Study Design	Source
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
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
A16.2		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).	RCT	N
A16.2	Efficacy for reducing hepatic dysfunction and improving hiiqikyo (脾胃気虚, spleen-stomach qi deficiency） in tuberculosis patients undergoing chemotherapy	hochuekkito (補中益気湯)	Nakanishi F. Experience with hochuekkito in the short-course intensified chemotherapy for pulmonary tuberculosis. Nikkei Medical* 1994; 23 (12): 24-5 (in Japanese).	RCT	N
A16.2		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
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
A49.8	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, Kono T, Terai T. Preventive effect of hochuekkito on postherpetic neuralgia. Progress in Medicine* 2002; 22: 863-5 (in Japanese).	RCT	I
B02.2		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	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
B18.1		shosaikoto (小柴胡湯)	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).	RCT	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)	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).	RCT	I
B18.2		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
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: 176-84 (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

ICD-10	Research Question	Kampo Formula	References	Study Design	Source
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
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
C18.9		juzentaihoto (十全大補湯)	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).	RCT	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 evaluate the reduction in the number of days to postoperative flatulence and the anti-inflammatory efficacy of daikenchuto in patients who underwent laparotomy for large intestine 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
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 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.	quasi- RCT	N
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- envelope	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
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	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
C57.9	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) ＋ hochuekkito (補中益気湯)	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
C57.9		ninjin’yoeito (人参養栄湯)	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).	quasi- 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, 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).	RCT- envelope	N
C80.0		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
C80.0	Efficacy and safety for reducing adverse reactions during cancer radiotherapy.	juzentaihoto (十全大補湯)	Hashimoto S, Tanaka Y. Adverse reactions to cancer radiotherapy. Sanfujinka no Sekai* (World of Obstetrics and Gynecology) 1990; 42 suppl: 176-84 (in Japanese).	RCT- envelope	N
C80.0		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
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	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
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

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 tokishakuyakusan 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
D50.8	To evaluate the efficacy of juzentaihoto and ninjin’yoeito 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
D50.8	To evaluate the efficacy of using juzentaihoto to augment preoperative autologous blood donation in cancer patients.	juzentaihoto (十全大補湯)	Aoe H. Effect of Juzen-taiho-to on haematological recovery from predeposit autologous blood donation. Pharma Medica* 2007; 25: 11-4 (in Japanese).	RCT	I
			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).		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
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
D69.6	Effects of preoperative administration of shosaikoto 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
D70	Improvement in thrombocytopenia and leukopenia by kamikihito administration 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
D70	Effects of juzentaihoto 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
D70	Improvement in subjective symptoms and leukopenia by ninjin'yoeito 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
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
D75.8	Effect of combined juzentaihoto 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
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
D86.0		keishikajutsubuto (桂枝加朮附湯)	Inagaki M. Effectiveness of Kampo medicine in relieving complaints associated with chronic intractable diseases. Kampo Shinryo* 1993; 12: 1-3 (in Japanese).	RCT	N

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
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
E78.5		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).	RCT- envelope	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)	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).	RCT	N
E87.8		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
E88.9	To evaluate whether bofutsushosan (防風通聖散) reduces obesity.	bofutsushosan (防風通聖散)	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.	DB-RCT	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*) 2009; 54: S225.	DB-RCT	N

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
F01.9	Efficacy of chotosan in the treatment of vascular dementia.	chotosan (釣藤散)	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).	RCT-envelope	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
F01.9	Efficacy of chotosan in the treatment of vascular dementia.	chotosan (釣藤散)	Terasawa K. Chotosan in the treatment of vascular dementia. Pharma Medica 2007; 25: 57-9 (in Japanese).	DB-RCT	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
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
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
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

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) saikokaryukostu-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
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
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	I
G47.1	Effect of kakkonto on sleepiness after sleep deprivation.	kakkonto (葛根湯)	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).	DB-RCT	N
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
G62.9	To evaluate the potential use of sokeikakketsuto and shakuyakukanzoto by current perception threshold measurement in preventing peripheral nerve disorder in patients receiving taxol.	sokeikakketsuto (疎経活血湯), shakuyakukanzoto (芍薬甘草湯)	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

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. The American Journal of Chinese Medicine 2003; 31: 103-9.	DB-RCT	C
H18.9		goshajinkigan (牛車腎気丸)	Nagaki Y. Effects of goshajinkigan on diabetic keratopathy. Kampo Igaku* (Kampo Medicine) 2004; 28: 63-5 (in Japanese).	DB-RCT	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. The American Journal of Chinese Medicine 2002; 30: 347-53.	RCT	C

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
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

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
I10		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 monitoring. Kampo Shinryo* 1996; 15: 34-5 (in Japanese).	RCT	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
I10		orengedokuto (黄連解毒湯)	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.	DB-RCT	C
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
I63.9	Efficacy and safety of orengedokuto 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
I67.9	Efficacy and safety of hachimijiogan in patients with hypertension or cerebrovascular disease and their concomitant symptoms.	hachimijiogan (八味地黄丸)	Ito K, Yamamoto H, Saibara T, et al. The usefulness of Kanebo Hachimijiogan in patients with hypertension or cerebrovascular disease (excluding acute phase symptoms) and their concomitant symptoms: a multicenter, double-blind, crossover study. Shindan to Chiryo* (Diagnosis and Treatment) 1988; 76: 1096-114 (in Japanese).	DB-RCT (cross over)	I
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: eCAM2009: 1-6.	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
I89.0		goshajinkigan (牛車腎気丸)	Abe Y, Kosugi I, Kasashima F, et al. Lymphedema and Kampo. Progress in Medicine* 2003; 23: 1538-9 (in Japanese).	RCT	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

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 assess the efficacy of hochuekkito for the treatment of atopic dermatitis.	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
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)	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: eCAM 2008: 1-7.	DB-RCT	N
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 (温清飲), tokiinshi (当帰飲子)	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
L50.9	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
L70.0		jumihaidokuto (十味敗毒湯), orengedokuto (黄連解毒湯)	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).	RCT	N
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

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
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	C
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).	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
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

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
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 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).	RCT- envelope	N
N39.0		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
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 T, 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
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
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.	tokishakuyakusan (当帰芍薬散), kamishoyosan (加味逍遙散), keishibukuryogan (桂枝茯苓丸)	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).	quasi- RCT	I
		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).		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
		tokishakuyakusan (当帰芍薬散), kamishoyosan (加味逍遙散), keishibukuryogan (桂枝茯苓丸)	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
		tokishakuyakusan (当帰芍薬散), kamishoyosan (加味逍遙散), keishibukuryogan (桂枝茯苓丸)	Takamatsu K, Tanabe K. Efficacy of Kampo medicine against climacteric disorders. Sanfujinka Chiryo* (Obstetrical and Gynecological Therapy) 2004; 89: 408-15 (in Japanese).		N
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
N95.1		keishibukuryogan (桂枝茯苓丸)	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).	RCT	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
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. The 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
N95.8		unkeito (温経湯), tokishakuyakusan (当帰芍薬散)	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).	RCT- cross over	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

ICD-10	Research Question	Kampo Formula	References	Study Design	Source
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
O20.0		kyukikyogaito (キュウ帰膠艾湯)	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).	RCT	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
O90.9		kyukichoketsuin (キュウ帰調血飲)	Ushiroyama T, Sakuma K, Souen H, et al. Therapeutic effects of Kyuki-chouketsu-in in restoring postpartum physical condition. The American Journal of Chinese Medicine 2003; 31: 437-44.	RCT- envelope	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

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; 12: 13-21 (in Japanese with English abstract).	RCT	I
R05	To evaluate the efficacy of bakumondoto for relieving persistent 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	I
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. Efficacy of goreisan suppository for vomiting in young children. Toyoigaku* (Japanese Journal of Oriental Medicine) 2000; 28: 36-8 (in Japanese).	DB-RCT	N
			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).		I
			Yoshida M. Efficacy of goreisan suppository. Nihon Syoni Toyo Igakkaishi* (The Japan Pediatric Society for Oriental Medicine) 2003; 19: 13-7 (in Japanese).		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
R25.2		shakuyakukanzoto (芍薬甘草湯)	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).	DB-RCT	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
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
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, 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).	RCT- envelope	I
R51		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
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, 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.	DB-RCT	C
R51		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	N
R52.9	To evaluate the efficacy and safety of shakuyakukanzoto 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
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
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
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

ICD-10	Research Question	Kampo Formula	References	Study Design	Source
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

ICD-10	Research Question	Kampo Formula	References	Study Design	Source
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
Z01.8		shoseiryuto (小青竜湯)	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.	RCT- cross over	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)	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.	RCT- cross over	C
Z01.8		saireito (柴苓湯), shosaikoto (小柴胡湯)	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
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
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.	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	N
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
Z03.8	Efficacy of a new colon preparation using daiokanzoto.	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
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
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

Ⅰ. Structured Abstracts describing RCTs and the References Reporting Them

Ⅱ. A Structured Abstract describing Meta-analysis and the Reference Reporting It

1. Infections (including Viral Hepatitis) (18 abstracts, 23 references)

2. Cancer (Condition after Cancer Surgery and Unspecified Adverse Drug Reactions of Anti-cancer Drugs) (31 abstracts, 36 references)

3. Blood Diseases including Anaemia (15 abstracts, 18references)

4. Metabolism and Endocrine Diseases (11 abstracts, 14 references)

5. Psychiatric/Behavioral Disorders (11 abstracts, 13 references)

6. Nervous System Diseases (including Alzheimer's Disease) (11 abstracts, 12 references)

7. Eye Diseases (4 abstracts, 5 references)

8. Ear Diseases (5 abstracts, 5 references)

9. Cardiovascular Diseases (15 abstracts, 18 references)

10. Respiratory Diseases (including Influenza and Rhinitis) (42 abstracts, 55 references)

11. Gastrointestinal, Hepato-Biliary-Pancreatic Diseases (53 abstracts, 68 references)

12. Skin Diseases (15 abstracts, 16 references)

13. Diseases of the musculoskeletal system and connective tissue (19 abstracts, 18 references)

14. Genitourinary Tract Disorders (including Climacteric Disorders) (33 abstracts, 40 references)

15. Ante/Post-partum Diseases (10 abstracts, 12 references)

16. Symptoms and Signs (20 abstracts, 28 references)

17. Post-anesthesia and Postoperative Pain (2 abstracts, 2 references)

18. Others (30 abstracts, 32 references)

1. Ante/Post-partum Diseases (1 abstract, 1 reference)