Quality assessment on literatures for Domestic randomized controlled clinical studies of anal fissure / 中华中医药杂志

ABSTRACT

Objective: To analyze the published domestic documents of the clinical trial for treatment of anal fissure in past 10 years, to evaluate the quality of literatures about anal fissure randomized controlled clinical trials, and to provide references of clinical studies for the treatments of anal fissure in Traditional Chinese Medicine (TCM). Methods: In term of principles of evidence-based medicine, we evaluate the published domestic literatures of the randomized controlled clinical trial for treatments of anal f issure in past 10 years. Results: We analyze 52 literatures which are in the method of randomized controlled clinical studies. 28 literatures (accounting for 53.85%) record diagnostic criteria, 38 literatures (accounting for 73.08%) make sure standards of evaluating the effect and 18 literatures (accounting for 34.62%) mention comparability between groups without describing the baseline statistics. Only 5 are marked as a funded research projects. Conclusion: in current published literatures of randomized controlled study for treatments of anal fi ssure, the problems are focused on ① Experimental idea is unclear and design is unreasonable, ② The description of implemented process in randomized control is unspecif ic, ③ Signifi cant parameters in statistical data are missed and with less credibility, ④ Criteria of diagnosis and effi cacy are different, ⑤ Evaluation indicators are fuzzy. All above clue to the quality of clinical research needs to be improved rapidly, and standardized evaluation of eff icacy also needs to be created urgently.