Observation of the bone destruction of Qingre Huoxue Decoction in the treatment of active rheumatoid arthritis based on MRI evaluation: study protocol for a multicenter, randomized, double-blinded, controlled clinical trial

Abstract

Background: Bone destruction is the key and difficult point in the treatment of RA. Studies have found that the use of traditional Chinese medicine Qingre Huoxue Decoction (QRHXD) can effectively reduce disease activity and delay bone destruction. Magnetic resonance imaging (MRI) is one of the effective ways to evaluate bone destruction in RA in real time, which is helpful to the early evaluation and discovery of synovitis and bone destruction. Therefore, we designed a multicenter, randomized, double-blinded, controlled clinical trial to assess the improvement of the bone destruction of QRHXD in treating RA using MRI. Methods: This study aimed to assess the definitive evidence that the traditional Chinese medicine QRHXD slows bone destruction in RA using MRI. A total of 204 adult participants with RA will be enrolled, with balanced treatment allocation (1:1). The experimental intervention will be QRHXD plus MTX and the control intervention will be QRHXD placebo plus MTX for 24 weeks. The primary outcome measure will be RA MRI score at screening period and 24 weeks. Secondary outcome measures will include the ACR20, ACR50 and ACR70, DAS28, patient report outcome(PRO), health assessment questionnaire(HAQ) and X-ray sharp score of both hands. In addition, the vital signs and adverse reactions of the subjects will be recorded. Discussion: The purpose of this study is to use MRI to confirm that QRHXD can effectively slow the imaging progress of active RA. To provide evidence for the efficacy of Chinese medicine in delaying bone destruction in RA, and help to carry out more clinical research on Chinese medicine prescriptions. Trial registration number Clinical Trials.gov ID: NCT04170504.