Background/Purpose: Chinese herbal medicine (CHM) is a mainstay in the treatment of rheumatoid arthritis (RA) in China. We conducted a systematic review to appraise the methodological quality of controlled clinical trials evaluating the efficacy and safety of CHM in patients with RA.

Methods:  We searched electronic databases (Medline, EMBASE, The Cochrane Library, and Web of Science) from inception until May 2014 for controlled trials (randomized or not) evaluating the use of CHM including herbals and decoctions (i.e., “tang”), in patients with RA.  The search was not limited by language, year of publication or type of publication. Study selection was performed by 2 independent reviewers. Data extraction and the methodological quality of the trials was assessed using the Cochrane risk of bias tool for randomized trials and Newcastle Ottawa Scale for controlled non-randomized studies.  Descriptive statistics were used to report on risk of selection, performance, detection, attrition, reporting biases and others (i.e., conflict of interests) for randomized trials and selection, comparability and outcome biases for cohort studies.

Results:  Out of 2,125 unique citations only 54 studies were included (51 randomized trials and 3 non-randomized studies) including 7,792 patients.  Only one study was conducted in the US, the remaining in China. There were 3,446 patients receiving CHM. In the control groups 2,283 patients received a disease modifying anti-rheumatic drug (DMARD) (i.e., methotrexate, leflunomide, sulfasalazine, and etanercept), 182 non-steroidal anti-inflammatory drugs (NSAIDs), and 164 inert placebo. Additionally, 1,717 received combined CHM + either DMARD or NSAIDs. In 23 studies patients were described as having active disease, 13 included patients with more than 1 year disease duration, 1 included patients with RA and anemia, and 17 included patients with one or two traditional Chinese medicine (TCM) ‘pathological factors’ (i.e., feng, shi, and/or han). Discontinuations were not reported in 31 studies, but ranged from 0 to 55% in the remaining studies. For the randomized studies, when evaluating selection bias 54% of the studies were judged to have an adequate random sequence generation, but 77% had inadequate allocation concealment.  79% had a high risk of performance bias (not blinding participants and/or personnel) and detection bias was unclear in 56% of the studies; 62% of the studies reported how missing data was handled, therefore attrition bias was judged to be low. In 87% no disclosure of interest or source of founding was reported. For non-randomized studies, all the studies were representative of RA patients, had an adequate ascertainment of intervention with comparable groups, but only one demonstrated that the outcome of interest was not present at start of study or provided the rate of lost to follow-up.

Conclusion:  Studies evaluating CHM often fail to meet expected methodological criteria, and high quality evidence is lacking. Future studies of CHM should be methodologically robust and adhere to reporting guidelines such as the CONSORT statement for TCM.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/quality-assessment-of-controlled-trials-evaluating-chinese-herbal-medicine-in-patients-with-rheumatoid-arthritis-a-systematic-review/