Objective To evaluate the methodological and reporting quality of randomized controlled trials involving traditional Chinese medicine in the treatment of cholelithiasis. Methods We searched CNKI (1994 to 2007), CMCC (1994 to 2007), VIP (1989 to 2007), MEDLINE (1966 to April 2007) and The Cochrane Library (Issue 4, 2006). Data from randomized controlled trials (RCTs) and quasi-RCTs were extracted by two reviewers independently. The methodological quality of included trials was assessed by using the quality assessment criteria recommended by The Cochrane Collaboration, and the reporting quality was assessed by using the CONSORT for TCM checklist. Results Seventeen studies including 16 RCTs and one quasi-RCT were included. The methodological and reporting qualities of included studies were generally low. All studies were graded C. The highest score evaluated by the CONSORT for TCM checklist was 18. Conclusion The quality of RCTs and quasi-RCTs involving traditional Chinese medicine for cholelithiasis is generally low, with a high risk of biases. The reporting of these trials is also incomplete, which would affect a reader’s understanding and evaluation of the validity, importance and applicability of the study results. Therefore, new randomized controlled trials of high quality are required to provide reliable evidence.
Objective To evaluate the effectiveness and safety of Chinese medicine treatment of cholelithiasis. Methods We searched electronic databases including MEDLINE (1966 to Feb. 2009), EMbase (1974 to Feb. 2009), The Cochrane Library (Issue 4, 2008), Chinese Biomedical Literature Database (CBM, 1978 to Feb. 2009), CJFD (CNKI, 1994 to Feb. 2009), the Chinese Scientific and Technical Journals database (VIP, 1989 to Feb. 2009), and a database of Chinese biomedical journals (CMCC, 1994 to Feb. 2009). At the same time, we searched references of the included studies. Metaanalysis was performed using RevMan 5 if there was no significant heterogeneity. We described the date which could not be combined. Results A total of 18 randomized controlled trials involving 2 276 patients were included. According to measurement indicators and interventions, subgroup analysis was performed. Efficacy was reported in 10 studies, which showed that part of proprietary Chinese medicines had a higher efficiency for cholelithiasis. Gallbladder emptying index and the trend of bile into the stone were compared in 5 studies, suggesting that the bile of proprietary Chinese medicines reduced the stone index, which eased the bile tendency to rock. Three studies reported the rate of cholecystokinin. Metaanalysis results suggested that the difference was significant. Two studies reported adverse drug reactions (ADRs), such as epigastric discomfort and diarrhea. Most ADRs were slight, and could be self relieved. Conclusion Results suggest that Chinese medicines produce effects on clinical symptoms of cholelithiasis, gallbladder function and reduce the trend of bile into stones. However, the therapeutic effects for long-term are rarely reported. The conclusion needs further verification due to low methodological quality and apparent heterogeneity.