Herbal traditional Chinese medicine and its evidence base in gastrointestinal disorders

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.