Quality of reporting of two-group parallel randomized controlled clinical trials of multi-herb formulae: A survey of reports indexed in the Science Citation Index Expanded

IntroductionAn increasing number of trials of multi-herb formula interventions are being published in relatively high-ranked medical journals indexed in the Science Citation Index Expanded (SCIE). The aim of the study was to evaluate the quality of reporting of two-group parallel randomized controlled clinical trials (indexed in SCIE) of multi-herb formulae.MethodsComputerized literature searches were performed in SCIE from 1996 to November 2010. Two reviewers independently assessed the included trials using the modified Consolidated Standard of Reporting Trials (CONSORT) 2010 checklist and additional items reflecting the basic characteristics of traditional Chinese medicine (TCM). The number and proportion of reports describing each of the 38 modified CONSORT items and 6 additional TCM items were calculated. We also performed stratified analyses according to whether reports had or had not adopted the CONSORT statement, or according to Chinese reports (conducted in Mainland China, Hong Kong and Taiwan) or non-Chinese reports.ResultsThe reporting of the items recommended by the CONSORT 2010 statement was suboptimal as only 5 items were described in more than 80% of the 153 included reports. For the recommended CONSORT items, adherence was higher in CONSORT-adopters, and more items were reported in non-Chinese reports. The reporting of the TCM items was considered inadequate in the included studies, particularly in non-Chinese reports.ConclusionsThe present study shows that the quality of reporting of these trials is suboptimal. We recommend all journals endorse the CONSORT statement, which would help researchers to improve the reporting of future randomized controlled trials. In addition, the reporting of the TCM items was considered inadequate in the included studies. All TCM practitioners should pay attention to the unique characteristics of TCM and improve the reporting of the recommended TCM items.