The efficacy of the traditional Chinese medicine Juanbi pill combined with methotrexate in active rheumatoid arthritis: study protocol for a randomized controlled trial

Qiong Wang, Yi-Ru Wang, Qing-Yun Jia, Li Liu, Chong-Qing Xu, Xiao-Yun Wang, Min Yao, Xue-Jun Cui, Qi Shi, Yong-Jun Wang, Qian-Qian Liang, Qiong Wang, Yi-Ru Wang, Qing-Yun Jia, Li Liu, Chong-Qing Xu, Xiao-Yun Wang, Min Yao, Xue-Jun Cui, Qi Shi, Yong-Jun Wang, Qian-Qian Liang

Abstract

Background: Rheumatoid arthritis (RA) is a chronic autoimmune disease characterized by swelling and painful joints, eventually leading to joint destruction. There is still a lack of effective therapy to treat RA. The Juanbi pill is a Chinese medicine that has been widely used to treat active RA in China for hundreds of years, relieving pain and protecting the affected joints from malformation. However, there is no solid evidence to show the effect of the Juanbi pill on the management of active RA.

Methods/design: We will conduct a multicenter, randomized, double-blind, placebo-controlled clinical trial to determine whether the traditional Chinese medicine Juanbi pill could relieve joint pain in RA and protect the joints. A total of 120 patients with active RA will be enrolled and treated with the Juanbi pill or a placebo for 3 months. The primary outcome measures are as follows: rate of in the American College of Rheumatology (ACR)50, change in the 28-joint Disease Activity Score (DAS28) from baseline at beginning of therapy to 3 months, and a change in the van der Heijde modified Sharp score measured from baseline to 12 months. The secondary outcome measures are as follows: rate of change in ACR20, ACR70, Health Assessment Questionnaire-Disability Index (HAQ-DI), and change in score in the Patient Assessment of Arthritis Pain, Patient Global Assessment of Arthritis, and the Athens Insomnia Scale (AIS) from baseline to 2-week, 1-month, 2-month, 3-month, 6-month, and 12-month follow up. In addition, the rate of change (score) in the ACR50 and DAS28 from the baseline to 2-week, 1-month, 2-month, 6-month, and 12-month follow up are also the secondary outcome measures.

Discussion: Although the Juanbi pill has been used in China for many years to treat RA, there is a lack of consensus about its effectiveness. This trial will provide convincing evidence about the effect of Juanbi pill on active RA.

Trial registration: ClinicalTrials.gov, NCT02885597 . Registered on 30 August 2016.

Keywords: Active rheumatoid arthritis; Juanbi pill; Methotrexate; Randomized controlled trial; Traditional Chinese medicine.

Conflict of interest statement

Ethics approval and consent to participate

The trial will be conducted in accordance with the Declaration of Helsinki and Ethical Guidelines for Clinical Research, and the trial protocol has been approved by the Research Ethical Committee of Longhua hospital, affiliated with Shanghai University of Traditional Chinese Medicine, Shanghai, China (approval number 2016LCSY033), Yueyang Integrated Medicine Hospital affiliated with Shanghai university of Traditional Chinese Medicine (number 2017–001), and Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine. Ethics approval is not required, as the central ethics committee has provided approval for all three centers (number 2016-K-35). All adult participants will provide written informed consent before participating.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Project overview. RA, rheumatoid arthritis; MTX, methotrexate
Fig. 2
Fig. 2
Schedule of enrollment and assessments. ACR, American College of Rheumatology; DAS28, 28-joint Disease Activity Score; HAQ-DI, Health Assessment Questionnaire-Disability Index; AIS, Athens Insomnia Scale; SF-36, 36-item Short-Form Health Survey; MTX, methotrexate

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