Analyzing the quality of clinical randomized control trial of Traditional Chinese Medicine for coronary heart disease (CHD)

Article type
Authors
Duan X, Zhou L, Wu T
Abstract
Objective: To assess the quality of clinical randomized control trials (RCT) of Traditional Chinese medicine for CHD.

Method: Handsearched 83 Journals of Traditional Chinese Medicine (1977-2002.6). Include criteria: clinical randomized controlled trial of Traditional Chinese medicine for CHD.

Results: (1) 675 trials were included; (2) 58 (8.59%) trials mentioned the method of randomization; (3) 637 (94.37%) trials mentioned diagnosis criteria and include criteria; (4) None mentioned allocation concealment; (4) There were 64 (9.48%) blind trials; (5) There were 563 (83.41%) trials had similar baseline; (6) None mentioned the calculation basement of sample size. (7) None of the trials performed intention-to-treat in 6 trials in which appeared withdrawn of participants; (8) There were 24 (3.56%) trials used incorrect statistics method, and 394 (58.37%) trials did not described their statistic method for their statistic result.

Conclusion: Up to now, RCT did not been widely used in Chinese traditional medicine clinical research, and we hardly to see the calculation base of sample size, allocation concealment, blinding and intention-to-treat been used in RCTs of this field. The problems also are that the concept of randomized allocation and randomized sampling been confused in some of articles; the using rate of right methods of statistic was low; taking one with another, the quality of RCTs of Chinese Traditional medicine in the treatment of CHD should be improved.