Herbal traditional Chinese medicine and its evidence base in gastrointestinal disorders

Table 1 Consolidated standards of reporting trial criteria and level of adherence in herbal traditional Chinese medicine treatment clinical trials

Item	Criterion	Adherence
Group allocation	Randomization	Often claimed; specifics are rarely reported
Hypothesis	Prospective formulation	Rarely reported
Parameter	Primary, secondary outcome	Rarely reported; often inclusion of parameters irrelevant to the initial question
Patients, Treatment time	Selection, rationale for duration	Mostly given
Intervention, control	Herbal composition, placebo	Often lacking, even for drugs under consideration
Blinding	Physician, patient blinding	Often lacking
Data evaluation	Statistical methods	Often lacking. In a lot of publications the reanalysis is impossible or gives different results
	Data selection	Often only report of criteria which are statistically significant. Rarely report of data being comparable
	Data presentation	Often no data for range, standard deviation, confidence interval or relative risk presented
		Often no distinction between “in group“ effects and “between group“ effects
Interpretation	Conclusions	Often overoptimistic. Lack of consideration for results not fitting the initial assumption

Data compilation and modification from a previous report[30]. CONSORT: Consolidated standards of reporting trials; TCM: Traditional Chinese medicine.

Table 2 Clinical trials with herbal traditional Chinese medicine preparations for gastroesophageal reflux disease and esophagitis

Ref.	Patients	Intervention	Control	Outcome	Remarks
Zhang et al[52], 2012	186 pat.; GERD, no diagnostic criteria	64 pat.; 3 × 6 g Dalitong + 20 mg rabeprazole; 4 wk	61 pat.; 20 mg rabeprazole (control 1)	Intervention significantly better; unclear whether a comparison is within or between groups	No randomi-zation criteria → cohort study
			61 pat.; 3 × 10 mg domperidon + 20 mg rabeprazole (control 2); 4 wk
Li et al[53], 2011	120 pat.; non- erosive reflux disease, no diagnostic criteria	60 pat.; 3 × 10 g Tongjiang capsules; 4 wk	60 pat.; 3 × 5 mg mosapride citrate; 4 wk	For scores: in-tervention significantly better - only in PPP cal-culation; unclear whether a comparison is within or between groups	Relevant data were not available; ill defined scoring system. OR including 1 is significant
Xu et al[55], 2007	116 pat.; GERD	Integrated Chinese + Western medicine; no further data	Western medicine, no further data	Better long term significant effects, no significant short term effects	Inconsistent data presentation
Xu et al[56], 2006	78 pat.; laryngopharyn- gitis by GERD, ENT diag- nostic criteria	1 dose/d Banxia Xiexing Tang; 4 wk	2 × 6 g/d Linsang Liyan Wan, 4 wk	Variety of cumulative scores; treatment is more effective	No comparative treatment
Zhong et al[54], 2005	75 pat.; reflux esophagitis	45 pat; 1 dose/d Jiangni Hewei decoction; 8 wk	30 pat; omeprazole 20 mg/d, 8 wk	No difference in cure rate, total efficiency, symptoms, gastroscopy score. Significantly lower recurrence rate in verum group	Low patient number
Ghen et al[51], 2004	63 pat.; GERD, no diagnostic criteria	30 pat.; 2 × 100 mL ZhiZhu pills; 8 wk	33 pat.; 2 × 150 mg ranitidine + 2 × 10 mg cisapride; 8 wk	Unclear whether a comparison is within or between groups; “significant improvement in all criteria”	Conclusions cannot be reproduced
Hao et al[57], 1998	42 pat.; GERD, diagnosis by TCM criteria	42 pat.; Yunqitang I, II, III; 4 wk	No control therapy given	“Yunqitang is effective” by TCM scoring system

GERD: Gastroesophageal reflux disease; TCM: Traditional Chinese medicine.

Table 3 Clinical trials with herbal traditional Chinese medicine preparations for gastritis

Ref.	Patients	Intervention	Control	Outcome	Remarks
Hu et al[61], 2012	565 pat.; gastritis or duodenal ulcer, gastroscopy	LAC (see con- trol), + 3 caps. 2/d Jinghua Weikang, 7 d, then Jinghua Weikang for 14 more days	30 mg lansopra- zole, 1000 mg amoxicilline, 500 mg clarithromycine (LAC) 2/d, 7 d, then lansoprazole 30 mg 1/d for 14 more days; or LAC + 220 mg bismuth citrate 2/d, 7 d, then bismuth citrate for 14 more days	14C-urea test - no difference (abstract unclear). Similar efficiency, better symptomatic improvement (bloating, belching)	11 hospitals; data presentation in abstract unclear. All gastritis patients were included in the intervention group
Li et al[64], 2011	150 pat.; chronic atrophic gastritis	120 pat.; Wei Yan serial recipe (WYSR) I - IV; no dose given, 2 × 3 mo	30 pat.; Weifuchun pills; no dose given, 2 × 3 mo	WYSR is superior to control in total effective rate, symptoms, pathology. No difference in HIF, vEGF	Improved precancerous lesions
Li et al[65], 2011	229 pat.; chronic atrophic gastritis	119 pat.; Hua Zhuo Jiedu recipe, no dose given; 2 × 3 mo	110 pat.; Weifuchun tablets; no dose given; 2 × 3 mo	Significantly better: pathological results, tumor markers. No difference in acid secretion	No rationale or parameter selection
Hu et al[62], 2010	642 pat.; chronic gastritis or gastric ulcer + H. pylori	196 pat.; PCM + Wenweishu 224 pat.; PCM + Yangweishu; 7 d	222 pat.; 40 mg bid pantoprazole, 500 mg bid clarithromycine, 400 mg bid metronidazole (PCM); 7 d	Better symptom relief, no difference in H. pylori eradication	No parameter for symptoms given
Hu et al[63], 2008	67 pat.; chronic gastritis + TCM symptoms; gastroscopy	42 pat.; 4 × 0.5 g, tid Yiweikang capsules; 2 mo	25 pat.; 4 caps. tid; Wenweishu; 2 mo	Improved symptoms in verum; no difference in H. pylori eradication	Diagnostically not homogenous; control in this group is verum in 2010 publication[62]
Zeng et al[74], 2006	90 pat.; chronic gastritis	80 mg or 160 mg Jinghua Weikang	3 × 10 mg/d domperidone; 14_d. No group size given	Unclear whether in group or be-tween group differences	Data presentation insufficient
Wu et al[66], 2005	68 pat.; chronic atrophic gastritis + TCM symptoms	36 pat.; Kangwei granules, 2 × 12 wk. No dose given	32 pat.; Weifuchun, 2 × 12 wk. No dose given	Gastroscopy, pathology significantly improved, symptoms n.s.	Parameters not specified
Xia[67], 2004	98 pat.; chronic gastritis	Herbal pairs; patient number, dose and treatment duration not given	Banxia Xiexin Tang decoction, pat. number, dose and treatment duration not given	Treatment is superior	No explanation given
Chen et al[73], 2003	362 pat.; gastropathy with H. pylori infection	288 pat.; Kang Wei granules. No further data given	74 pat.; triple therapy plus bismuth (De Nol)	Improves symptoms of TCM classification	No data given for diagnosis, intervention type and results
Ji et al[68], 1999	226 pat.; gastritis with H. pylori infection	136 pat.; Xialian Yiyou capsule, 4 wk. Dose not given	90 pat.; Lizhu Dele capsules, 4 wk. Dose not given	Significant improvement in clinical symptoms
Lu et al[69], 1998	75 pat.; chronic atrophic gastritis	45 pat.; Wei Shu capsules; 6 mo. Dose not given	30 pat.; Wei Ning granules; 6 mo. Dose not given	Atrophy, metaplasia, dysplasia significantly improved	No data specification
Zhong et al[70], 1997	202 pat.; chronic gastritis, intestinal metaplasia	117 pat.; modified Shijinzu decoction, 3 mo; dose not given	85 pat.; Weimeisu, 3 mo; dose not given	Treatment group significantly better	No data specification
Yin et al[71], 1996	143 pat.; chronic gastritis by EGD, + TCM symptoms	75 pat.; Piweiping caps. I, II, III, IV; 3-6 mo. Dose not given	68 pat.; Sanjiu Weitai; 3-6 mo; dose not given	Significantly better cure rate, symptom score, biochemical parameter	Some parameters do not make sense (lymphocyte transformation test, cAMP, DNA)
Li et al[75], 1995	200 pat.; chronic atrophic gastritis	Gastrosia con-valescens; no data of pat. number, dose and duration	Domperidon; no data on patient number, dose and duration of treatment	Significantly superior to control	No parameter specified
Long et al[72], 1994	Verru-cous gas-tritis, no further informa-tion	Combined TCM + Western medicine; no further information	Western medicine (furazolidone, cimetidine); no further information	Combination is significantly better than WM alone	Insufficient data presentation
Liu et al[76], 1992	138 pat.; intestinal metaplasia; 104 pat.; atypical metaplasia	Xiao Wei Yan powder, 5-7 g/tid; 2-4 mo; no pat. number	No information; not treated?	Verum is effective	No description of control group

H. pylori: Helicobacter pylori; PCM: Pantoprazole, clarithromycine and metronidazole triple therapy; TCM: Traditional Chinese medicine.

Table 4 Clinical trials with herbal traditional Chinese medicine preparations for gastric or duodenal ulcers

Ref.	Patients	Intervention	Control	Outcome	Remarks
Hu et al[61], 2012	565 pat.; duodenal ulcer or gastritis, gastroscopy	LAC (see control), + 3 caps. 2/d Jinghua Weikang, 7 d, then Jinghua Weikang for 14 more days	30 mg lansoprazole, 1000 mg amoxicilline, 500 mg clarithromycine (LAC) 2/d, 7 d, then lansoprazole 30 mg 1/d for 14 more days; or LAC + 220 mg bismuth citrate 2/d, 7 d, then bismuth citrate for 14 more days	14C-urea test - no difference (abstract unclear). Similar efficiency, better symptomatic improvement (bloating, belching)	11 hospitals; data presentation in abstract unclear. All gastritis patients were included in the intervention group. Study also included under “gastritis”
Hu et al[62], 2010	642 pat.; chronic gastritis or gastric ulcer + H. pylori	196 pat.; PCM + Wenweishu 224 pat.; PCM + Yangweishu; 7 d	222 pat.; 40 mg bid pantoprazole, 500 mg bid clarithromycine, 400 mg bid metronidazole (PCM); 7 d	Better symptom relief, no difference in eradication	No parameter for symptoms given
Zhang et al[78], 2009	46 pat.; active peptic ulcer, no H. pylori infections	Yiqi Huoxue formula + omeprazole, 5_wk. No information on patient number, dosage	Omeprazole, 5 wk. No information on patient number, dosage	bFGF, vEGF in-creased in treatment, histological improvement. No difference in recurrence	Scant data description
Deng et al[79], 2007	60 pat.; gastric ulcer, after 1 wk triple therapy	Qifang Weitong powder + omeprazole, 5 wk. No further details	Omeprazole, 5 wk. No further details	Mucosa thickness, glandular morphology improved (significant)	Scant data description
Lin et al[84], 2007	56 pat.; gastric ulcer + TCM symptom	26 pat.; Jianwei Yuyang granule, 4 wk. No further data	30 pat.; famotidine + sucralfat, 4 wk. No further data	Compliance, symptom integral sign. better; ulcer healing, clinical effects n.s.	Incomplete results description
Zhou et al[77], 2007	50 pat.; acute gastric ulcer + TCM symptoms	30 pat.; 1 dose/d in 2 × 100 mL solution; Jianpi Qingre Huayu recipe; 8 wk	20 pat.; 2 × 300 mg ranitidine; 8 wk	Effective rate n.s.; cure rate significant better. Sign. differences in T lymphocyte subsets	Randomized, statistics implausible, irrelevant parameters
Zhou et al[81], 2005	120 pat.; peptic ulcer, 10 controls no ulcer	6 groups, no clear description of treatment (ranitidine, Jianweiyuyang granules)	No description of control group	Combination improves symptoms and syndrome. No effect on ulcer healing, H. pylori eradication	No description of groups and intervention
Ji et al[82], 2006	200 pat.; duodenal ulcer	100 pat.; 160 mg Jinghua Weikang capsule 3/d; 4 wk	100 pat.; 20 mg famotidine 2/d; 4 wk	H. pylori eradication, anorexia, eructation, incidence of UAW sig. better, remission, healing n.s.	Only P values are given
Zhang et al[80], 2005	438 pat.; duodenal ulcer	330 pat.; Haigui Yuyang capsule, 6 wk. No dose given	108 pat.; ranitidine, 6 wk. No dose given	No difference between groups; only distension better in verum	“Double blind, double dummy, randomized”
He et al[85], 2001	120 pat.; gastric ulcer	60 pat.; Qingwei Zhitong pill. No dose or duration	60 pat.; Sifangwei tablet. No dose or duration	Better ulcer healing, no difference in TCM symptoms	Unclear description
Wan et al[86], 1996	200 pat.; peptic ulcer	Yuyang powder, no further data	Cimetidine, no further data	Cure rate n.s., recurrence significantly better	Scant data presented
Yang et al[87], 1995	150 pat.; peptic ulcer	Bushen Kangkui decoction; no further details	Cimetidine; no further details	Cure rate n.s., recurrence significantly better	Scant data presented
Li et al[88], 1995	80 children; peptic ulcer	Unspecified treatment for 8 wk	No control	Effective after 8 wk (92% cure rate)	(empirical recipe)
Yang et al[83], 1994	80 pat.; duodenal ulcer	Kuiyangqing pills; duration, dose not given	32 pat.; bismuth aluminate. No dose, duration	Effective treatment	Unclear group description, no parameter for efficiency, outdated control therapy
Ma and Guo[89], 1992	508 pat.; intractable peptic ulcer	260 pat.; 50 g/d Chuanjia Weidan; 4 wk	248 pat.; 800 mg/d cimetidine; 4 wk	Cure rates similar, H. pylori eradication, relapse superior
Li and Yin[90], 1991	494 pat. (?); peptic ulcer	354 pat.; Jian Wei Yu Yang tablets. No further data	140 pat.; ranitidine, no further data	Treatment superior in cure rate	Scant data presented
Zhou et al[91], 1991	Not defined, peptic ulcer	Wei Yang An	Cimetidine, no further data	Short term effects similar, in long term Wei Yang An superior	No data presented

bFGF: Basic fibroblast growth factor; H. Pylori: Helicobacter pylori; PCM: Pantoprazole, clarithromycine, metronidazole; vEGF: Vascular endothelial growth factor.

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.

Table 6 Clinical trials with herbal traditional Chinese medicine preparations for hepatitis

Ref.	Patients	Treatment	Control	Outcome	Remarks
Deng et al[108], 2012	180 pat.; liver cirrhosis with HBV infection	90 pat.; Fuzheng Huayu tablet, 6 mo	90 pat.; placebo, 6 mo	Anxiety, depression, social deficit improved; levels of cirrhosis, coagulation, splenomegaly improved
Wang et al[132], 2012	60 pat.; chronic HBV infection	40 pat.;8 capsules 3 ×/d Xinganbao capsule, 6 mo	20 pat.; 5 tablets 3×/d Heluo Shugan tablet, 6 mo	Lowered laboratory values, histological parameters in 21/40 treatment patients
Mao et al[120], 2012	288 pat.; HBeAg positive	125 pat.; 5_MU IFNα1b + Yixuesheng capsules, 3 mo	163 pat.; 5 MU IFNα1b	Significant better treatment at 3 and 12 mo, not at 24 mo	22 patients lost in control group
Zhang et al[121], 2012	164 pat.; HBeAg-positive chronic HBV	Entecavir + Shenxian Yiganling, dose and duration missing	Entecavir, dose and duration not given	Unchanged: ALT, undetectable virus load; Conversion rate better in treatment group	Insufficient data presentation
Qiu et al[122], 2012	240 pat.; HBeAg-positive chronic hepatitis	10 mg/d adefovir dipivoxil, duration and patient number not given	10 mg/d adefovir dipivoxil + Baihua Xianglian Detoxification recipe 2 ×/d, duration and patient number not given	In nearly all comparisons treatment group is better	Strange definition of treatment and control group, unclear whether differences within a group or between groups were compared
Tang et al[123], 2012	80 pat.; chronic HBV hepatitis	37 pat.; lamivudine + Fu Zheng Huayu capsules, 6 mo; later lamivudine monotherapy indefinitely	43 pat.; lamivudine, indefinitely	No differences between groups for ALT, AST, virus load; better TGF-β1/BMP-7 ratio; pathology: treatment group better
Hu et al[124], 2012	98 pat.; acute on chronic liver failure	66 pat.; “classic Western treatment” + high dose herbs, 12 wk	32 pat.; “classic Western treatment”, 12 wk	Treatment improves survival, laboratory values improved	Herbs selected by personal preference, no randomization
Zhou et al[133], 2011	84 pat.; chronic HBV hepatitis with cirrhosis	1 dose 2 ×/d Xiaozhang recipe; 12 mo	Fuzheng Huayu capsule, 5 pills, 3 ×/d, 12 mo	No difference between groups	Indirect comparison, unclear presentation of results
Deng et al[130], 2011	24 pat.; chronic HCV infection	24 pat.; 2.5 g 3 ×/d Sho-Sai So To; 12 mo	No control group	Mixed effects on liver enzymes, histology, virus load	Cohort study
Tang et al[125], 2010	57 pat.; chronic HBV, HBeAg positive	Entecavir + Yidu recipe, 6 mo. Dose and patient number not given	Entecavir, 6 mo; dose and patient number not given	No difference in HBeAg conversion, HBV-DNA values; improved ALT, AST, HBV-DNA, symptoms	7 dropouts, no distribution given; different data for HBV-DNA; no percentages given
Li et al[126], 2010	60 pat.; severe chronic HBV infection	30 pat.; “conventional integrative medicine” + Huchang Jiedu decoction enema 1/d; 3 wk	30 pat.; “conventional integrative medicine”, 3 wk	Better values than control group for ALT, AST, bilirubin, globulines, endotoxin, prothrombin, cholesterol, calcium
Liang et al[127], 2010	104 pat.; chronic HBV hepatitis	54 pat.; routine therapy + Danqi Huogan capsule; 3 mo; dose not given	50 pat.; “routine therapy”, 3 mo, dose not given	Improved symptoms and signs, decreased HK, blood viscosity, plasma viscosity, RBC aggregation	Unfamiliar parameters, no specific data given
Tang et al[109], 2009	208 pat.; chronic viral hepatitis	116 pat.; Astragali compound, 2 mo	92 pat.; “other drugs in regular clinical use”, 2 mo	Clinical efficiency, seroconversion better in treatment group	Unspecified controls, no percentages and SD
Chi et al[128], 2009	405 pat.; chronic HBV infection	220 pat.; lamivudine + Chai Shao Liu Jun Tang, 18 mo	185 pat.; lamivudine, 18 mo	ALT, HBeAg, HBV-DNA suppression, mutation in treatment group better	Numbers don't add up
Xiao et al[110], 2007	57 pat.; chronic HBV infection + cirrhosis	45 pat.; routine medication + Kang Gang Qian granule, dose and duration not given	12 pat.; “routine medication”, dose and duration not given	Treatment group better in liver function, laboratory and pathology parameters	Small control group
Wang[129], 2007	80 pat.; NASH	50 pat.; Yiqi Huoxue reci pe + polyene phosphatidylcholine capsules, 3 mo	30 pat.; polyene phosphatidylcholine capsules, 3 mo	Superior in syndrome, function, blood lipids, ultrasound	Randomized according to their visit; no values given
Yang et al[111], 2006	115 pat.; HBeAg or HBV-DNA positive hepatitis	Fufang Huangqi granule + lamivudine, 24 wk	Fufang Huangqi granule, 24 wk	TCM is superior to second (control) group	In results the group assignment is unclear
Mollison et al[112], 2006	97 pat.; chronic HCV hepatitis	61 pat.; CH100 herbal remedy, 24 wk; 24 wk follow-up	30 pat.; placebo for 24 wk, 24 wk follow-up	No difference on viral titer, liver enzymes	Reduced pain in CH100 group, quality of life parameters similar
Chen et al[113], 2006	90 pat.; HBV-DNA, HBsAg, HBeAg positive	49 pat.; Bu Shen Granule (BSG) + Marine Injection, 1 yr	41 pat.; lamivudine, 1 yr	Clinical parameters are significantly better; reverse ratios are n.s.	The calculations appear to be skewed (42.6 to 61 - n.s.; 42.6%-36.2% sign)
Liu et al[106], 2005	216 pat.; chronic HBV infection with liver cirrhosis	110 pat.; 5 × 1.6 g 3 ×/d Fuzhenghuayu capsule, 24 wk, 12 wk follow-up	106 pat.; 5 × 0.93 g 3×/d Heluoshugan capsule, 24 wk, 12 wk follow-up	No difference in fibrotic scores, suppresses inflammation, improves fibrosis “reverse rate”	Randomized, comparison of 2 herbal TCM preparations
Ye et al[131], 2005	120 pat.; HBV plus cirrhosis, 60 pat. compensated, 60 decomp	60 pat.; decompensated: 8, 16 or 24 mL Salvia injection, 60 d	60 pat.; compensated: 8, 16, 24 mL Salvia injection, 60 d	Dose dependent improvement in all signs, symptoms and lab values Compensated cirrhosis > decompensated	No exact data given
Yang et al[138], 2003	60 pat.; hepatic fibrosis and jaundice	30 pat.; 654-2	30 pat.; routine treatment, 3 mo	Significant improvement in treatment group in clinical and lab values	No specific data provided
		injection, “Gan Xian Tui Huang recipe”, no dose, 3 mo
Long et al[134], 2004	120 pat.; chronic HBV	60 pat.; 100 mg/d matrine i.m., + conventional liver protection; 90 d	60 pat.; conventional liver protection: glucurone, inosine, Vit B compound, caryophyllene	Significant: symptoms and signs, liver function, serum conversion HBeAg, HBV-DNA	Unclear, whether within or in between group differences are reported
Jakkula et al[114], 2004	45 pat.; chronic HCV infection, fatigue	10 g/d fixed comb of 10 herbs; 12 wk	10 g/d placebo, 12 wk	No difference for symptoms, laboratory values, virus load
Zhang et al[115], 2004	50 pat.; chronic HBV infection with cirrhosis	36 pat.; 2 ×/d Zhaoyangwan oral, 3 mo	14 pat.; 3 mU IFN i.m., 3/wk, 3 mo	No effect on serum enzymes, virus reduction, significant changes in lymphocyte subtypes, complement	Not blinded; IFN dose given incorrectly (3 MU)
Li et al[135], 2003	56 pat.; HBV infection, liver fibrosis	30 pat.; Da Ding Feng Zhu decoction, 3 mo; dose not given	26 pat.; colchicine, 3 mo; dose not given	Effective for hyaluronic acid, procollagen III, collagen IV-C, laminin	Inappropriate control, no percentages given
Liu et al[116], 2002	77 pat.; chronic HBV with fibrosis	30 pat.; 2 × 3 tabl./d, each 30 mg salvianolic acid B + 1 MU IFNa 1/d for 1 mo, then 3/wk; 6 mo	30 pat.; placebo, 6 mo	Lower US score, claim of better reduction in fibrosis	17 pat. excluded; unclear application, calculations cannot be reproduced
Chen et al[117], 2000	94 pat.; HBsAg pos.	45 pat.; 400 mg kurorinone i.m./d, 3 mo	49 pat.; 3 MU IFNα, 1 mo 1/d, then 3/wk for 2 mo	No significant difference (CR 31% treatment, 45% IFN)
Akbar et al[118], 1998	20 pat.; Child A chronic hepatitis	9 pat.; 3 × 7.5 mg HpPro oral, 1 wk	11 pat.; mix of known drugs, 1 wk	Significant lower AST and ALT only at some time points	Crossover design, no control specified
Batey et al[119], 1998	44 pat.; chronic HCV	20 pat.; 5 tbl. 3 ×/d CH-100, 6 mo	20 pat.; 5 tbl. 3 ×/d placebo, 6 mo	ALT improvement significant	4 dropouts; scant data presentation
Hu et al[136], 1996	116 pat.; CAH with bilirubinemia	60 pat.; Ganyan IV	56 pat.; Western medicine	Decreased jaundice, ALT	No data given, only percentages

ALT: Alanine aminotransferase; AST: Aspartate aminotransferase; CAH: Chronic active hepatitis; HBV: Hepatitis B virus; HCV: Hepatitis C virus; NASH: Nonalcoholic steatohepatitis; TCM: Traditional Chinese medicine; US: Ultrasound.

Table 7 Clinical trials with herbal traditional Chinese medicine preparations for biliary diseases

Ref.	Patients	Treatment	Control	Outcome	Remarks
Wu et al[142], 2012	80 pat.; PBC	40 pat.; UDCA, Fuzheng Huayu capsule; no dose; 48 wk	40 pat.; UDCA, no dose; 48 wk	Significant: itching, fatigue, liver enzymes, IgG, IgM, antibodies, blood flow	Most parameters significant only at one of four time points
Tong et al[143], 2012	60 pat.; PBC, histology	30 pat.; UDCA, Tongdan decoction; no dose; 24 wk	30 pat.; UDCA, no dose; 24 wk	IgM, IgG decreased after 2 yr, less inflammation after 3 yr	No percentages, no scoring system
Qi et al[144], 2009	160 pat.; chronic cholecystitis	80 pat.; Dan An Tang, no dose, no duration	80 pat.; Xiao Yan Li Dan Pian, no dose, no duration	Tr.: total effective rate 95%, control 80% significant	Dan An Tang: cholecystitis relieving; Xiao Yan bile draining
Jiang and He[145], 2003	16 pat.; PBC	No pat. number; UDCA + “some Chinese herbs”, no duration, no dose	No pat. number; UDCA, no dose, no duration	No results that can be interpreted	Conclusions not based on results. Clinical observation
Hu et al[136], 1996	116 pat., CAH with bilirubinemia	60 pat.; Ganyan IV	56 pat.; Western medicine	Decreased jaundice, ALT	No actual data given, only percentages
Cui et al[141], 1989	89 pat.; extrahepatic jaundice	No pat. number; Li Dan Ling; no dose, or duration	No pat. number; “control group”; no dose, or duration	Herbal TCM better for incomplete obstruction, worse for complete	No data presented

PBC: Primary biliary cholangitis; TCM: Traditional Chinese medicine; UDCA: Ursodeoxycholic acid.

Table 8 Clinical trials with herbal traditional Chinese medicine preparations for colon carcinoma

Ref.	Patients	Treatment	Control	Outcome	Remarks
Zhou et al[146], 2009	163 pat.; colon carcinoma, no information on stage	105 pat.; 40 mL/d Zhao's Weitiao No. 3, 30 d = 1 cycle, 4-6 cycles	58 pat.; 40 mL/d Zhao's Weitiao No. 3 + OLF protocol, cycles as treatment	For tumor mass, CEA control is better, for symptom and QoL treatment is better	Assignment according to patients wish; OLF: oxaliplatin, 5-FU + leucovorin. Conclusions incorrect
Liu et al[147], 2005	64 pat.; colon carcinoma postoperatively	43 pat.; chemotherapy + Jianpi Huoxue herbs, 3 mo, no dose given	21 pat.; chemotherapy, 3 mo	Remission 39.5% treatment, 33.3 control; Pi deficiency treatment P < 0.01	Randomized study; effects only in Chinese symptoms
Guo[149], 1999	68 pat.; large intestinal cancer	38 pat.; chemotherapy + Fu Zheng Yiai decoction, no dose, duration	30 pat.; chemotherapy, no dose, duration	Physical strength, survival time, rate, recurrence sign better	No specific data given
Cao et al[148], 1994	79 pat.; diverse advanced carcinoma incl. colon carcinoma	LAK/IL-2 + Lycium Barbarum polysaccharides; no dose, duration	LKA/IL-2	Response rate, remission, NK, LAK cell activity sign. better	4 dropouts. No specific data
Li[150], 1992	176 pat.; malignant tumor of digestive tract	Chemotherapy + Shen Qi injection, no further details given	Chemotherapy, no further details given	No leukocyte decrease, improved cellular immunological function	No specific data given

LKA: Lymphokine activated killer cells; OLF: Oxaliplatin, leucovorin, 5-fluorouracil; QoL: Quality of life.

Table 9 Clinical trials with herbal traditional Chinese medicine preparations for primary hepatocellular carcinoma

Ref.	Patients	Treatment	Control	Outcome	Remarks
Huang et al[154], 2013	68 pat.; HCC, stage IIIA, IIIB, palliative treatment	32 pat.; BST + Xiaoaiping inj., dose not given, 30 d	36 pat., BST	RECIST, immune function, QoL Karnofsky scale: significant for immune function, immediate therapeutic effect	China classification system. Kaplan-Meyer: First 20 wk no difference (-40%)
Zhai et al[159], 2013	379 pat.; HCC after hepatectomy	185 pat.; 50 mL/d Cinobufacini injection 10 d/mo, 12 mo + 4.5 g bid Jie Du granule, 6 mo	190 pat.; TACE pirarubicin, mitomycin C, once	Herbal TCM prolongs time to recurrence (P = 0.048)	5 dropouts for ITT in verum, 6 dropouts in control. After 14 mo, no further difference
Zhao et al[160], 2012	60 pat.; HCC, after microwave ablation therapy	30 pat.; Fuzheng Yiliu recipe, 6 mo, dose not given	30 pat.; additional treatment	Liver function, fibrosis, immune function improved	Data given only for lymphocytes
Tian et al[164], 2010	97 pat.; primary HCC or CCC	49 pat.; TACE + Ganji Decoction; dose not given, 4 wk; multiple cycles	48 pat.; TACE with mitomycin C, THP, 5-FU	Tumor regression in control better; survival better in test group	Intervention: no cytostatic agents in TACE. No Kaplan Meier shown
Yen et al[155], 2009	42 pat.; unresectable HCC	42 pat.; 750 mg capecitabine + PHY906	Dose escalation study	Improved survival to historical control (?)	No histology
Saif et al[158], 2010
Wang et al[165], 2009	77 pat.; advanced HCC	40 pat.; TACE + Ganji recipe, dose not given, 4 wk (1 course)	37 pat.; TACE	Survival not different at 3 mo, thereafter different; QoL improved
Hou and Lu[166], 2009	67 pat.; mid advanced HCC	35 pat.; TACE (gemcitabin, cisplatin) + TCM according to symptoms; 4 wk	32 pat.; TACE (gemcitabin, cisplatin)	QoL, CT/MRT, immune system. No differences described	Ambiguous data presentation
Chen et al[170], 2007	82 pat.; HCC, after TACE	45 pat.; complex prescription of Chinese crude drugs, 4 wk	37 pat.; routine liver protection, 4 wk	Symptoms improved in therapy group	No differentiation of drugs
Wu et al[171], 2005	61 pat.; HCC	33 pat.; local DDP application (TACE?) + Xiaoshui decoction, 2 mo	28 pat.; DDP application (TACE?)	Ascites, QoL, survival, symptoms: all significant, except QoL	Unclear basic treatment (DDP)
Lao[174], 2005	122 pat.; HCC, after TACE	62 pat.; 150 mg/d matrine injection, 2 wk	60 pat.; “some other hepatinica”, 2 wk	Enzyme levels are increased, no clear group allocation	TACE not speci-fied; effects between groups not clearly described
Lin et al[172], 2005	72 pat.; HCC II or III; with histology and microwave coagulation	36 pat.; 20 mL Shenqi mixture, 3 ×/wk, 1 mo	36 pat.; no additional treatment	Significant: cure rate, Karnofsky score, lymphocytes, AFP, Chinese symptom score	Microwave treatment: 2 times 60 W, 800 s 1/wk
Feng et al[161], 2005	80 pat.; HCC after TACE	20 pat.; dexamethasone + ginsenosides, dose, duration not given	20 pat.; each dexamethasone, ginsenosides or placebo; no dose, no duration	Treatment lowered nausea, vomiting, fever, pain, bone marrow inhibition	TACE not specified; no numbers given
Lin et al[167], 2005	85 pat.; middle advanced HCC	52 pat.; TACE with HCPT, + Shentao Ruangan pill	33 pat.; TACE with HCPT	No difference: tumor size; significant: survival, Chinese symptom score	HCPT: hydroxy- camptothecine
Zhang et al[175], 2004	65 pat.; ad vanced HCC	32 pat.; regular protective therapy + Jia Wei Si Jun Zi Tang; no dose or duration	33 pat.; regular protective therapy; no dose or duration	Sigificant improvement in treatment group; “superior in curative effect”	ICGR15: indocyanine green retention 15 min; intervention treatment mentioned, but not described
Chen et al[156], 2003	100 pat.; moderate and advanced HCC	50 pat.; Cino bufacini injection, no further information	50 pat.; no further information	Every parameter improved in Cinobufacini injection group	No individual parameter reported
Shao et al[176], 2001	60 pat.; middle advanced liver cancer; after TACE	30 pat.; Gan'ai No. I and No. II, no dose or duration given	30 pat.; no further details	Improved survival, recurrence rate, tumor shrinking, AFP, leukocytes	No treatment details
Xu et al[173], 2001	120 pat.; HCC, after resection	61 pat.; herbal TCM for Chinese symptoms, no type, dose, duration	59 pat.; no further treatment	ALT, AST, albumin, γ-GT, bilirubin improved	Unclear whether within or between group differences were reported
Wang[162], 1998	108 pat.; HCC embolism chemotherapy	40 pat.; each herbal TCM preparations, no type duration, dose	40 pat.; no further treatment	Survival rate, short term effects significant	No specific data, no treatment details
Zheng et al[163], 1998	106 pat.; HCC	56 pat.; embolization with Bletilla striata angioembolus, follow-up 4 yr	50 pat.; embolization with Gelfoam, follow-up 4 yr	All clinical parameters better than in control
Han et al[169], 1997	HCC with radiotherapy, no further data available	Xuefu Zhuyu decoction, no details on pat. number, dose, duration	No treatment	Survival significantly improved, metastasis not improved	“showed coordinate effect with radiotherapy”
Peng et al[157], 1993	Late stage HCC	4–8 mL Salvia miltiorrhizae composita; no pat. number given	No treatment description given	Sign. difference between groups	No description of treatment and results
Oka et al[152], 1995	260 pat.; HCC in cirrhosis	130 pat.; conventional drugs + 7.5 g/d Sho Saiko To (TJ-9), 5 yr	130 pat.; no treatment	Survival prolonged (n.s., P = 0.053), for HBs-negative pat. significant	Randomized, prospective, not blinded
Yamamoto et al[153], 1989	260 pat.; HCC in cirrhosis, matched pairs	130 pat.; 7.5 g/d of Sho Saiko To, 34 mo	130 pat.; conventional medicine, 34 mo	Sign. lower incidence of HCC (9 vs 17)

BST: Best supportive treatment; CCC: Cholangiolarcellular carcinoma; HCPT: Hydroxycamptothecine; HCC: Hepatocellular carcinoma; QoL: Quality of life; RECIST: Response Evaluation Criteria In Solid Tumors; TACE: Transarterial chemoembolization; THP: Tetrahydropyranyladriamycine.

Table 10 Clinical trials with herbal traditional Chinese medicine preparations for dyspepsia

Ref.	Patients	Treatment	Control	Outcome	Remarks
Liu et al[177], 2013	180 pat.; functional dyspepsia (FD), as postprandial distress syndrome	90 pat.; Xiao Pi-II, 100 mL, 3×/d, 2 wk	90 pat.; 5 mg mosapride 3 ×/d, 2 wk	3D-ultrasound, questionnaire: bloating, eructation, gastric liquid emptying rate fullness P < 0.05	Not blinded, gastric emptying by 3D-ultrasound, randomized
Zhang et al[178], 2013	162 pat; FD with spleen deficiency and qi stagnation	108 pat.; gastrosis No.1 compound, no dose; 4 wk, 4 wk follow-up	54 pat.; placebo, no dose, 4 wk	Symptomatic improvement (P < 0.01)	No scores given; randomized
Xiao and Li[179], 2013	89 pat.; FD + anxiety or depression	23 pat.; modified Banxia Houpo decoction (MBHD); no dose given; 4 wk	22 pat.; domperidone, no dose; 22 pat., St. John’s Wort, no dose; 4 wk each	Domperidon + St. John’s Wort most effective, domperidone ineffective. Few significant differences (MBHD vs domperidone)	HAMA, HAMD, FD symptom scoring system, randomized
Zhang et al[181], 2013	160 pat.; FD + spleen deficiency and qi stagnation	106 pat.; Liu Jun Zi decoction in 2 × 150 mL water; 4 wk, 4 wk follow-up	54 pat.; placebo in 2 × 150 mL water; 4 wk, 4 wk follow-up	Dyspepsia symptom score, barium emptying markers; TCM group P < 0.01	7 dropouts (5 verum, 2 placebo). Careful conclusions, appropriate, randomized
Li et al[187], 2013	134 pat.; FD	66 pat.; Xiaopi-I, no dose given, 4 wk	68 pat.; 10 mg 3 ×/d domperidone; 4 wk	Not visible whether there were differences between groups	6 dropout verum, 8 dropout domperidone, randomized
Fan et al[180], 2012	170 pat.; FD	Unknown number; individual therapy by Chinese medical syndrome ty- ping; no dose, 4 wk	34 pat.; domperidone or esomeprazole, no dose, 4 wk?	Symptom score, healing rate, effectivity, SF-36 score, physical and mental component summary: n.s.	16 drop outs in verum, 4 drop outs in control. Conclusions are not supported
Wu et al[182], 2011	163 pat.; FD + spleen deficiency and qi stagnation, Rome II	83 pat.; IFC-A pills, 6 g/tid, 4 wk	80 pat.; IFC-S, 6 g/tid, 4 wk	IFC-A better than IFC-S on symptom scale (authors scale)	Randomized, double blind. 3 drop outs. Drug difference Citrus aurantis vs Camellia sinensis
Xia et al[183], 2008	63 pat.; FD	33 pat.; Hewei Xiaopi capsule, dose not given, for 4 wk	30 pat.; domperidone, dose not given, 4 wk	Clinical symptoms-n.s.; EGG: less waves in treated group, 41.9 ± 18.2 vs 50.9 ± 16.0	Clinical symp-toms, electrogastrogram randomized
Gao et al[186], 2007	32 pat.; FD, dyskinesia	Qingre Liqi granule; no dose given, 6 d	No control group	All parameters improved, correlation between gastric emptying time and symptoms	Cohort study
Zhao and Gan[188], 2005	73 pat.; FD + depression, anxiety	Unknown number, Xinwei decoction,unknown dose, 8 wk	Unknown number, domperidone or placebo, unknown dose, 8 wk	Symptom score, total effectivity in TCM sign. better than domperidone, this better than placebo	Curing rate in TCM 70%
Ge et al[189], 2002	100 pat.; functional dyspepsia, TCM symptom	50 pat.; Jian Weishu capsules, decocted separately	50 pat.; Jian Weishu capsules, decocted together	No difference in effects	Claims effectiveness of the herbal TCM preparation
Gu et al[185], 1998	64 pat.; FD	20 pat.; 3 × 100 mL/d Weihuigui decoction; 14 d	44 pat.; no treatment	Improves clinical symptoms, gastric emptying time, no data
Tatsuta and Ishii[184], 1993	42 pat.; chronic idiopathic dyspepsia	22 pat.; Liu Jun Zi Tang (TJ-43) 2.5 g 3 ×/d; 7 d	20 pat.; placebo, no dose given, 7 d	No change in pain, sign for fullness, heartburn, belching and nausea	Gastric emptying by acetaminophen serum conc. No changes in pain at all. Randomized

EGG: Electrogastrogram; FD: Functional dyspepsia; HAMA: Hamilton anxiety scale; HAMD: Hamilton depression scale; MBHD: Modified Banxia Houpo decoction; SF36: Short Form 36 life scale questionnaire.

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.