Article type
Year
Abstract
Objective: To identify the RCT of traditional Chinese medicine in the eleven non-key Chinese medical journals so as to submit the results to the CENTRAL and the Chinese Clinical Trial Database; if possible, to have a preliminary investigation of the quality of these trials ( RCT ) so as to provide a recommendation for reviewers.
Method: The eleven non-key medical journals of TCM from 1995 to 2000 were handsearched to identify the RCT based on the criteria for RCT developed by the Cochrane handbook. Page by page of each identified RCT was checked by handseachers according to a self-made quality checklist to see whether it is a substantial RCT. The main elements of this checklist included the method of RCT, inclusion and exclusion, sample size, statistical method, the description between two groups etc.
Results: From 1995 to 2000, a total of 66 volumes, 390 issues were checked among which the articles were 22739. The total number of RCT increased from 95 to 1416 during 1995 to 2000. The majority of the identified RCTs were positive results and their effectiveness reached 90%. No detail randomized method description, only 38 RCTs had a detail description (2.68%). Only 24 RCT (1.69% ) were double blind. Besides, among the total of 1416 RCTs, 1220 described outcome index, 1203 described statistical method, 934 had baseline comparison, 828 diagnostic criteria, 197 had inclusion and exclusion criteria, 136 described follow up, finally only 89 had a description of side effect. The majority of the identified RCTs were positive results and their effectiveness reached 90%.
Conclusion: The preliminary study on the 6 years of 11 non-key medical journals have showed that there exists a publication bias. Though RCTs have shown that TCM may provide promising opportunities for some diseases, we should carefully evaluate and consider the quality of the included RCT while doing systematic reviews.
Method: The eleven non-key medical journals of TCM from 1995 to 2000 were handsearched to identify the RCT based on the criteria for RCT developed by the Cochrane handbook. Page by page of each identified RCT was checked by handseachers according to a self-made quality checklist to see whether it is a substantial RCT. The main elements of this checklist included the method of RCT, inclusion and exclusion, sample size, statistical method, the description between two groups etc.
Results: From 1995 to 2000, a total of 66 volumes, 390 issues were checked among which the articles were 22739. The total number of RCT increased from 95 to 1416 during 1995 to 2000. The majority of the identified RCTs were positive results and their effectiveness reached 90%. No detail randomized method description, only 38 RCTs had a detail description (2.68%). Only 24 RCT (1.69% ) were double blind. Besides, among the total of 1416 RCTs, 1220 described outcome index, 1203 described statistical method, 934 had baseline comparison, 828 diagnostic criteria, 197 had inclusion and exclusion criteria, 136 described follow up, finally only 89 had a description of side effect. The majority of the identified RCTs were positive results and their effectiveness reached 90%.
Conclusion: The preliminary study on the 6 years of 11 non-key medical journals have showed that there exists a publication bias. Though RCTs have shown that TCM may provide promising opportunities for some diseases, we should carefully evaluate and consider the quality of the included RCT while doing systematic reviews.