Quality Evaluation of Randomized Controlled Trials Involving Chinese Herbal Therapy for Cancer Pain

Objective:To evaluate the quality of the published randomized controlled trials(RCTs) involving Chinese herbal therapy for cancer pain.Methods:We searched the literatures in CBM,CMCC,Chongqing VIP database,PubMed and EMBASE from 1986 to 2010 by computer retrieval and natural retrieva1.The quality of the RCTs were evaluated on the basis of Levels of Evidence of Human Studies of Cancer in Complementary and Alternative Medicine by the National Cancer Institute(NCI) and Quality of Reporting of Randomized Controlled Trials of Herbal Medicine Interventions.Results:All the seventy-six literatures of RCTs had clear purpose,and 69.7% of RCTs had complete abstracts including objective,methods,results and conclusion.90.8% of RCTs mentioned randomization,but only 18.4% of RCTs reported the randomized methods and procedures.84.2% of RCTs described the diagnostic criteria,52.6% of RCTs mentioned the included criteria,and 34.2% RCTs mentioned the excluded criteria.6.6% of RCTs applied placebo control.67.1% of RCTs reported the adverse effects,and 31.6% of RCTs analyzed the adverse effects by statistical method.3.9% of RCTs followed up for more than six months.None of included RCTs reported the method of calculating sample quantity and the clinical study registration.Conclusion:The quality of RCTs involving Chinese herbal therapy for cancer pain needs to be increased,and at present the main existing problems include the following aspects:the design of RCTs was not precise enough,the sample quantity was small and had not estimation methods,criteria of pain assessment was variable,the analysis on compliance,case off and follow-up was ignored,the safety evaluation of drugs was lacked.