TABLE 3.

General characteristics of multi-center clinical trials on TCHM performed overseas (in regions other than mainland China and Taiwan, China) in the recent 15 years.

Trial	Country	Sample size		Disease of treatment	Intervention measurement		Treatment cycles	Primary outcome
		Treatment group	Control group		Treatment group	Control group
Takao et al. (2021)	Japan	3,000	3,000	COVID-19	Oral intake of Hochu-ekki-to (Buzhong Yiqi decoction)	Placebo	8w	Positive results of PCR analysis of SARS-CoV-2RNA; number of patients with at least one of the following symptoms: fever, cough, expectoration, discomfort, and shortness of breath
Takayama S et al. (2020)	Japan	75	75	COVID-19	Routine treatment + Gegen decoction (kakkon-to:KT) 2.5 g and shosaikotokakikyosekko (ka-kikyo-sekko:SSKKS) 2.5 g	Routine treatment, using antipyretics, analgesics, or antitussives	2w	Days of alleviation of at least one of the following symptoms: fever, expectoration, cough, discomfort, and shortness of breath
Ayuse et al. (2020)	Japan	45	45	Glossalgia	Routine treatment + Wulingsan (Goreisan)	Routine treatment	12w	1) Assessment of VAS pain degree scale 2) Activity of salivary amylase (10 -200 kIU/L)
								3) Tongue examination (engorgement of dorsal lingual veins)
Ogawa-Ochiai et al. (2020)	Japan	85	85	Acute diverticulitis	Intravenous injection of antibiotics + oral intake of Dahuang Mudan decoction	Simple intravenous injection of antibiotics + placebo	10d	1) Success rate of diverticulitis treatment
								2) Hospital stay
								3) Improvement of inflammatory responses (c –reactive protein (CRP), white blood cells (WBC), and neutrophil count)
								4) Type of fever
								5) Days to initiation of food intake
								6) Recurrence rate (assessment at 1 year after registration)
								7) Incidence of adverse events
Jeong et al. (2020)	Korea	40	40	Mild neurocognitive disorder (mNCD)	Traditional herbal medicine Jujadokseo-hwan (consisted of 7 herbal components: aloe, angelica sinensis, pericarpium citri reticulatae, ginseng, liquorice, tuckahoe, and grifola)	Placebo	12w	1) Score of Seoul verbal learning test-elderly’s version (SVLT-E)
								2. SVLT-E, Rey complex figure test, Digit span test, Korean-Boston naming test, calculation ability, controlled oral word association test
Sung WS et al. (2019)	Korea	42	42	Chronic waist pain	Acupuncture + palm pill	Acupuncture	6w	1) Assessment of VAS pain degree scale
Ko et al. (2018)	Korea	30	30	Cold hypersensitivity in the hands and feet (CHHF)	Intake of herbal medicine Ojeok-sa​​n (Wujisan)	Placebo	8w	1) Assessment of visual analogue scale (VAS) score
								2) Mean changes in body skin temperature at particular acupoints, and total score of the Korean version of the WHO Quality of Life-BREF
Katayama et al. (2018)	Japan	92	88	Postoperative treatment of chronic subdural hematoma	Surgical treatment + oral intake of Wulingsan (goreisan)	Surgical treatment	12w	1) Recurrence rate of chronic subdural hematoma (CSDH)
								2) Hmatoma volume reduction rate shown by CT scanning
Ohnishi et al. (2017)	Japan	20	19	Cervical carcinoma or endometrial carcinoma	Standard treatment + oral intake of rikkunshito (Liujunzi decoction, consisted of atractylodes, ginseng, pinellia ternate, hoelen, violet, fructus aurantii, liquorice, and ginger)	Standard nursing	13d	Visual analogue scale (VAS) assessment, severity of nausea, and appetite
Ko et al. (2017)	Korea	33	33	Cold hypersensitivity in the hands (CHH)	Intake of Danggui Sini decoction	Placebo	6w	1) Visual analogue scale (VAS)
								2) Change of skin temperature of hands, Clinical global impression (CGI) scale, restoration rate of skin temperature of hands after cold stimulation, and total score of the Korean version of the WHO Quality of Life
Kaido et al. (2015)	Japan	55	55	Intestinal dysfunction after liver transplantation	Daikenchuto	Oral intake of placebo before meal	14d	1) Total oral or enteral caloric intake
								2) Abdominal distension determined using numeric rating scales (NRS)
								3) Abdominal pain determined using NRS.
Katsuno et al. (2016)	Japan	38	33	Colorectal carcinoma	Daikenchuto	Placebo	8d	X-ray evaluated gastrointestinal tract transit time or radiopaque markers, and the time to first flatus
Wang et al. (2015)	USA	46	22	Food allergy	Food Allergy Herbal Formula (FAHF-2; A preparation of 5 herbal medicines based on the TCHM Wuweiwan)	Placebo	24w	Incidence of adverse events and immunological parameters
Matsuda et al. (2015)	Japan	46	47	Colorectal carcinoma	Banxia Xiexin decoction	Placebo	2w	Safety, incidence of chemotherapy induced oral mucositis
Azushima et al. (2015)	Japan	54	52	Obesity hypertension	Fangfeng Tongsheng granule	Routine drug therapy	24w	Body weight, clinical blood pressure, dynamic blood pressure, brachial-ankle pulse wave velocity (baPWV), and incidence of adverse events
Oki et al. (2015)	Japan	89	93	Chemotherapy induced peripheral neuropathy (neurotoxicity)	Niuche Shenqi pill	Placebo	24w	Time of neuropathy treatment, incidence of adverse events
Kono et al. (2013)	Japan	44	45	Chemotherapy induced peripheral neuropathy (neurotoxicity)	Niuche Shenqi pill	Placebo	26w	Incidence of adverse events
Okada et al. (2013)	Japan	110	110	Paralytic ileus after resection of pancreatic carcinoma	Daikenchuto	Placebo	17d	Incidence of postoperative paralytic ileus lasting >72 h after surgery, time to first flatus after surgery, and gastrointestinal symptom rating scale score
Odaguchi et al. (2006)	Japan	28	25	Headache	Goshuyuto	Placebo	16w	Surface temperature of the thumb and toe, cutaneous blood flow, deep body temperature, the tissue oxygen saturation in the brain and the crural muscles, the hardness of the trapezius muscle, and the blood serotonin (5-HT) level