Methodological quality evaluation of randomized controlled trials in rheumatoid arthritist related with preparations of Tripterygium wilfordii / 中华风湿病学杂志

ABSTRACT

Objective To assess the methodological quality of randomized controlled trials (RCTs) of rheumatoid arthritis (RA) treated with preparations of Tripterygium wilfordii to provide a scientific basis for the improvement of clinical trials and systematic review. Methods CBMdisc (1978-2000) and TCMLRS (1984-2000) were searched for RCTs on rheumatoid arthritis treated with preparations of Tripterygium Wilfordii. Jadad scale and the evaluating scale designed by the EBM methodological research group of Guangzhou University of TCM were used to evaluate the methodological quality of the trials. Results Of the 27 randomized trials included in this study, seven described the methods for randomization and only one had randomized concealment. Blindness was used in six of the trials. Twenty-four of the trials were found to be of low methodological quality with Jadad scores below three. Although all of the trials had their diagnostic standards for subject selection, only 37% described the inclusion and (or) exclusion criteria. Information about drug safety was not reported in 21% of the trials. Conclusions In general, the methodological quality of the studies is disappointing. Many shortcomings exist in the methodology of the included literatures, which calls for future attention to the correct use of the principles of randomization, control and blindness in randomized control trials.