Herbal traditional Chinese medicine and its evidence base in gastrointestinal disorders

Table 5 Clinical trials with herbal traditional Chinese medicine preparations for inflammatory bowel disease

Ref.	Patients	Treatment	Control	Outcome	Remarks
Liao et al[94], 2009	39 pat.; Crohn’s disease, postoperative	21 pat.; poly- glycoside of Tripterygium wilfordii, 2 wk	18 pat.; sal azosulfapyridine, 2 wk	Endoscopic recurrence significant better in treatment group	No dose given; 3 dropouts, 2 noncompliance (treatment group)
Han et al[95], 2014	120 pat.; mild to moderate UC	60 pat.; Jianpi suppository, dose not given, 2 × 15 d	60 pat.; mesalazine orally, dose not given	Hemorheology, P-selectin better improved	Randomized; unclear whether group differences exist
He et al[96], 2012	60 pat.; mild to moderate UC, with inner DHAS	30 pat.; 1 dose Qingchang Huashi recipe in 2 × 150 mL, 8 wk	30 pat.; 1 g/qid mesalazine, 8_wk	Symptoms sign, coloscopic, pathological results n.s.
Fukunaga et al[97], 2012	30 pat.; intractable UC	15 pat.; 0.1 g/d Xilei San supp., 2 wk	15 pat.; pla- cebo supp., 2 wk	Verum group with remission P = 0.04 at day 14 and 180. Significant histology, endoscopy
Zhou et al[98], 2012	53 pat.; mild to moderate UC, large intestine DHAS	27 pat.; Qing-chang Huashi recipe oral + Guanchang recipe dermal;Fuzheng Qing-chang recipe oral in remission, 3 mo	26 pat.; 4 × 1 g/d mesalazine, 4 × 0.5 g/d in remission, 3 mo	Diarrhea, blood, pus in stool sign. better	No data given for control group, only P values
Gong et al[92], 2012; Yang et al[93], 2014	320 pat.; active UC, with DHAS	240 pat.; Fu- fangkushen colon-coated capsule, 8 wk	80 pat.; mesalazine enteric coated tablets, 8 wk	Clinical response, remission, mucosal healing, Mayo scores n.s.	Double blind, double dummy
Tong et al[99], 2011	160 pat.; UC with internal DHAS	120 pat.; composite sophora	40 pat.; mesalazine slow release granules, 8 wk	Sign. in Chinese symptom score, mucus + pus stool; others n.s.	Double blind, double dummy
Tong et al[100], 2010	126 pat.; UC, DHAS	colon-soluble capsules, 8 wk composite sophora colon soluble capsule: 42 pat. 6 caps, 3 ×/d; 42 pat. 4 caps., 3 ×/d; 8 w	42 pat.; 4 tbl., mesalazine 3 ×/d (3 g/d), 8 wk	No significant differences, with tendency for herbal TCM
Ling et al[102], 2010	78 pat.; inflammatory bowel disease	A: 26 pat.; herbal TCM oral and as enema; B: 27 pat.; enema only, 1 mo	25 pat.; Western medicine; 1 mo	A > B = C: main symptoms, coloscopic score, pathology; B > C: tenesms	Randomized controlled trial; scant data presentation
Chen et al[101], 1994	153 pat.; intractable UC	Jian Pi Ling tablets; retention ene- ma Radix Sophorae Flavescentis,	A: Salicylazosulfapyridine (SASP), retention enema dexamethasone; 3 mo	Curative rates, effective rates significant better. Immunology normalized in verum group	Doses not given, claimed double blind
		Flos Sophora (RSF-FS) decoction; 3 mo	B: placebo + RSF-FS, 3 mo

DHAS: Damp heat accumulation syndrome; TCM: Traditional Chinese medicine; UC: Ulcerative colitis.