Cholelithiasis (gallstone disease) causes significant morbidity, severe complications, and economic burden worldwide. Though current surgical therapies are effective for gallstones, some types of gallstones (e.g., calcium bilirubinate calculi) cannot easily be eradicated by surgery and they often recur in the bile duct system, putting people at high risk of severe complications. The objective of this review was to evaluate the benefits and harms of Chinese medicinal herbs for people with cholelithiasis. Though some Chinese medicinal herbs appear to be safe for people with asymptomatic, mild, or moderate disease, they have not been conclusively shown to have curative effects on gallstones due to the low methodological quality (high risk of bias) of the included trials. Thus, randomised clinical trials with low risk of bias should be conducted to assess the effects of Chinese medicinal herbs before they can be used widely in the clinic.
This review reveals no strong evidence that the analysed Chinese medicinal herbs have any beneficial effects on asymptomatic or mild-to-moderate cholelithiasis. Definitive conclusions will require much better designed randomised trials to reduce risk of bias and allow detailed assessment of clinical outcomes.
Cholelithiasis is a common disease of the biliary tract. Chinese medicinal herbs are being used widely as an alternative treatment in people with cholelithiasis, but their beneficial or harmful effects have not been assessed systematically.
To assess the beneficial and harmful effects of Chinese medicinal herbs in people with cholelithiasis.
We conducted searches in the Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, EMBASE, Science Citation Index Expanded, Chinese Medicine Conference Disc, and Chinese Bio-Medicine Disc to January 2013. We handsearched four Chinese journals. No language or year of publication restrictions were applied.
Randomised clinical trials studying Chinese medicinal herbs for treatment of cholelithiasis.
Two review authors (SJ, TG) independently extracted data. For dichotomous data, we estimated the risk ratio (RR), and for continuous data, we calculated the mean difference. We also calculated 95% confidence intervals (CI).
Eleven randomised trials with 1205 participants with asymptomatic or mild-to-moderate cholelithiasis were included. None of the randomised clinical trials compared a single Chinese medicinal herb with a Western medicine or with surgery. No placebo-controlled trials were identified. In the trials comparing one Chinese herbal medicine (Gandanxiaoshi tablet) versus another (Aihuodantong tablet), there was no significant difference in the improvement of upper abdominal pain after the end of treatment (RR 1.21; 95% CI 0.71 to 2.05), and the heterogeneity among trials was not substantial. No other outcomes could be assessed. The remaining trials of Chinese medicinal herbs (Qingdan capsule, Danshu capsule, Paishi capsule, Rongdanpaishi capsule), did not offer specific data on symptoms, signs, or change in gallstones that would permit assessment of significant differences in curative effects between the treatment and control groups. No serious adverse events were reported.