Herbal traditional Chinese medicine and its evidence base in gastrointestinal disorders

Table 11 Clinical trials with herbal traditional Chinese medicine preparations for irritable bowel syndrome

Ref.	Patients	Treatment	Control	Outcome	Remarks
Su et al[200], 2013	240 pat.; IBS-D, Rome III criteria	120 pat.; modified Sishen Wan, dose not given, 4 wk	120 pat.; Chao Maiya, dose not given, 4 wk	Significant better in treatment group for effective rate, cure rate, recurrence	Randomized; 4 dropouts in therapy, 12 dropouts in placebo; cure rate defined as lack of symptoms
Bian et al[202], 2013	120 pat.; IBS-C, Rome III	60 pat.; 7.5 g bid Ma Zi Ren Wan,18 wk	60 pat.; placebo, 18 wk	After 10 wk good effect, declining afterwards	Randomized, blinded; well conducted study
Huang et al[210], 2011	90 pat.; lBS-C, long term care	45 pat.; 1.5 (mild), 3 (moderate) or 4.5 g/d (severe) CCH1 powder, 8 wk. 27 remaining at 12 wk	45 pat.; placebo (no details), 8 w. 31 remaining after 12 wk	After 4 and 8 wk: increased bowel movement, reduced enema use, rescue laxative. After 12 wk: only reduced rescue laxative	Randomized, double blind, placebo controlled. 12 dropout CCH1, 11 dropouts placebo; 9 withdrawals
Cheng et al[203], 2011	120 pat.; IBS-C, excessive constipation by Rome III and TCM	60 pat.; Hemp Seed pill 7.5 g/bid, 8 wk, follow-up 8 wk	60 pat.; placebo (Dextrin, tea essence, gardenin, caramel)	During treatment sign improvement, after follow-up n.s.	Randomized, double blind. 7-10 dropouts.
Gao et al[207], 2010	80 pat.; IBS-D	40 pat.; Jianpi Tiaogan Wen Shen recipe, dose not given, 4 wk	40 pat.; pinaverium bromide, dose not given, 4 wk	No difference in effective rate, cure rate; less mucus, better long term of verum (P < 0.01)	3 dropouts in verum, 4 dropouts in control
Zhang et al[197], 2010	360 pat.; IBS-D	180 pat.(?); Chinese medicine-syndrome differentiation therapy, dose not given, 4 wk	180 pat. (?); pinaverium bromide, dose not given, 4 wk	TCM significantly superior	No information on dropout, dose, symptom scores
Jia et al[204], 2010	132 pat.; constipation with conventional and TCM criteria	44 pat.; 70 mg tid Yun Chang capsule, 2 wk	44 pat.; placebo tid 2 wk	Symptom score improvement in both YCC groups, no dose difference	11 dropouts; well designed study
Zhang[212], 2009	80 pat.; functional constipation	43 pat.; 105 mg tid YCC 40 pat.; 5 g/d compound plantain-senna	40 pat.; 5 g/d starch placebo, 2 wk	Stool frequency and property, clinical symptom scores, transit time sign. improved
Pan et al[195], 2009	120 pat.; IBS-D Rome III	Granule, 2 wk 80 pat.; 2 pkg/d Tongxie Yaofang granules, 4 wk	40 pat.; 3 × 2 tbl/d Miyarisam, 4 wk	No difference in symptoms; sign. increase in mast cell activation (6 pat. per group)	Miyarisam is described as placebo; 3 dropouts in intervention group
Gao et al[205], 2009	104 pat.; IBS-D	78 pat.; 4 caps. tid Changjishu	26 pat.; 3 caps. tid glutamine compound enteric capsule, 3 wk	All clinical scores sign. improved
Wu and Zhang[198], 2008	125 pat.; IBS-D	Soft elastic capsule, 3 wk 2 groups:	pinaverium 50 mg, oryzanol 10 mg, and bifid triple viable 420 mg, 3/d, 4 wk	SF 36: in 6 of 8 scores TCM superior
Lv and Wang[201], 2008	58 pat.; IBS-C	TCM therapy not specified, TCM selected patented herbs, dose and number not given; 4 wk 30 pat.; Tongyouqing, no dose given, 4 wk	28 pat.; 6 mg qid tegaserod maleate; 4 wk	Symptom score better in treatment group	Scant data
Wang et al[214], 2007	216 children; with constipation	105 pat.; 20 g/d Forlax, 2 wk	111 pat.; 15 mL/d lactulose, 2 wk	Significant: bowel movement, stool consistency, complete clinical remission, abdominal pain
Zhang et al[206], 2007	198 pat.; IBS	66 pat.; 1.2 g tid Dinggui oil, 2 wk;	66 pat.; 5 g tid placebo, 2 wk	High dose is effective (54% effective), low dose 28.8%, placebo 21.9%	Randomized double blind, placebo controlled
Wang et al[209], 2006	60 pat.; IBS-D, Rome II	66 pat. 0.8 g tid Dinggui oil, 2 wk 30 pat.; 3 × 5 g/d Tong Xiening granule, 3 wk	30 pat.; 3 × 5 g/d placebo, 3 wk	NPIS scale: improvement in some pain parameters	Randomized, double blind, well controlled study
Leung et al[196], 2006	119 pat.; IBS-D, Rome II, + TCM criteria	60 pat.; Tong Xie Yao Fang, no dose; 8 wk; 8 wk follow-up	59 pat.; placebo, no dose; 8 wk, 8 wk follow-up	Significant improvement in bowel frequency, initial pain relief; other parameters (BSS, SF36) n.s.	14 (verum) 10 dropouts; randomized, blinded, well conducted
Yu et al[216], 2005	47 pat.; IBS-C, Rome criteria 45 pat.; IBS-D	24 pat.; 2 × 100 mL/d modified Sinisan, 8 wk No number; compound Changjitai; no dose, no duration	23 pat.; 3 × 10 mg cisapride tabl., 8 wk No number; pinaverium bromide, no dose, no duration	Symptom score, rectal tolerance vol. sign. improved Defecation episodes, stool quality, tenesms, distension sign. better (83% > 73%)	Cisapride as control improves gastric emptying Statistics not reproducible
Shen et al[208], 2003
Bensoussan[193,194], 2001	116 pat.; IBS, Rome criteria	38 pat.; individualized herbs, 43 pat. standard formula; 16 wk	35 pat.; placebo; 16 wk	Both treatment groups better than placebo on key outcome parameters; no difference between treatment groups	Proof of principle study

BSS: Bowel symptom score; FD: Functional dyspepsia; IBS-D: Irritable bowel syndrome, diarrhoeic type; IBS-C: Irritable bowel syndrome, constipation type; NPIS: Numeric pain intensity scale; SF-36: Short Form 36 life style questionnaire; TCM: Traditional Chinese medicine; YCC: Yun Chang capsule.