Comment on Literatures of Clinical Randomized Controlled Trials of Traditional Chinese Medicine for Acute Myocardial Infarction / 广州中医药大学学报

ABSTRACT

[ Objective ] To assess the quality of clinical randomised controlled trials (RCT) of traditional Chinese medicine (TCM) for acute myocardial infarction (AMI). [Methods] Eighty - three journals of TCM from the first issues of 1977 to the latest issues of 2002 were manually searched and reviewed under the following inclusion criteria clinical trials of TCM for AMI with 'randomized controlled or randomised being mentioned. And a questionnaire was designed according to the criteria of RCT with the items of diagnostic standard, consistent of baseline, method of randomization, concealment in allocation, blind method, intention - to - treat analysis, statistic methods and conclusion. Percentages of each item were figured out to assess the quality. [Results] Two thousand five hundred and one trials were associated with heart diseases, among which 102 were associated with AMI and 42 accorded with the inclusion criteria. Calculation method of sample size, concealment in allocation and intention - to - treat analysis after drop - out were mentioned in none of the 42 articles, single - blind method adopted in 4 (9.52%) , diagnostic standard described in 40 (95.24%), baseline consistent illuminated in 27 (64.29%), method of randomization presented in 8 (19.05%) , statistic methods used mistakenly in 6 (14.28%) and statistic methods not described in 18 (42.86%). [Conclusion] There still exist some problems in the design of RCT of TCM for AMI (1) mistaken use of randomization method; (2) less adoption of calculation method of sample size, concealment in allocation and intention - to - treat analysis after drop - out; (3) improper application of statistic methods; (4) lower rate of utilization for blind study.