Study Of Common Deficiencies In Clinical Trial Design Of Traditional Chinese Medicine To Treat Sequelae Of Pelvic Inflammatory Disease

Objective: This study was conducted to analyze common deficiencies in clinical trialdesign of traditional Chinese medicine to treat sequelae of pelvic inflammatory disease（PID）.Methods: Firstly，published randomized controlled clinical trials on treatment of PID bytraditional Chinese medicine (TCM) was retrieved, and common deficiencies of trial design wereanalyzed. Next, trial design of a phase Ⅱ clinical trial of XX Capsule to treat sequelae of PID(damp silt stasis) was thoroughly introduced, then deficiencies on the trial design were discussed.Next, advices were given to optimize the trial design.Results: A total of468randomized controlled clinical trials of TCM to treat PID wereincluded for analysis. Common deficiencies in trial design include: improper choice of control,non-scientific diagnostic criteria, imprecise efficacy indicators, improper safety indicators.Strategies to improve trail design were proposed: placebo-controlled design, combineddiagnostic criteria taking into consideration of both traditional Chinese medicine and westernmedicine, normalization of efficacy evaluation criteria, appropriate safety indicator.Conclusions: There are still many deficiencies in clinical trial design of traditionalChinese medicine to treat PID sequelae. More attention should be paid to selection of controldrug, rational use of diagnostic criteria, and normalization of efficacy and security indicators.