Will Chinese external therapy with compound Tripterygium wilfordii hook F gel safely control disease activity in patients with rheumatoid arthritis: design of a double-blinded randomized controlled trial

Quan Jiang, Xiao-Po Tang, Xian-Chun Chen, Hong Xiao, Ping Liu, Juan Jiao, Quan Jiang, Xiao-Po Tang, Xian-Chun Chen, Hong Xiao, Ping Liu, Juan Jiao

Abstract

Background: Chinese external therapy (CET) is a topical application with mainly Chinese herb medicine therapy with thousands of years of historical implications and is a clinical routine that is commonly used for relieving joint-related symptoms in patients with arthritis in Chinese hospitals. However, there is a paucity of modern medical evidence to support its effectiveness and safety. Thus, we propose to implement a randomized, double-blinded, placebo-controlled clinical trial in patients with rheumatoid arthritis (RA) using, as the experimental intervention, topical application of a hospital-compounded gel preparation of Tripterygium wilfordii Hook F (TwHF).

Methods: This study will be an 8-week double-blinded, randomized, placebo-controlled clinical trial conducted at Guang'anmen Hospital in Beijing, China, and 168 patients with moderately active RA will be randomly assigned with a 1:1 ratio to apply a topical gel preparation containing TwHF or placebo. The primary outcome variable will be the proportion of subjects, by study group, to achieve a 20% improvement in the American College of Rheumatology criteria (ACR20) by week 8. Secondary outcome measures to be assessed at weeks 4 or 8 will include: measurement of ACR20 response rate at week 4, ACR50 response rate, the changes in DAS28 score, and joint synovitis classification assessment monitored by musculoskeletal ultrasound. Safety evaluations conducted at weeks 4, 8 and 12 will be based on spontaneous complaints by the study subjects, but special emphasis will be focused on cutaneous allergy and alterations of menstruation in premenopausal female participants. Statistical analyses will be performed using the intention to treat analysis data set.

Discussion: This proposed clinical trail is designed to evaluate the efficacy and safety of CET based on a single topically-applied agent in a relatively large patient population with RA. This study protocol gives a detailed description of the usage and dosage of the topical compound TwHF gel and the methodology of this study. In addition, it is hoped that the outcomes of this study will be viewed as supporting the generalizability of CET in the setting of inflammatory rheumatic diseases. The results of this study are expected to have important public health implications for Asian RA patients that currently utilize CET as a complimentary treatment.

Trial registration: Clinical trial gov Identifier: NCT02818361 . Registrated on Jun. 15, 2016.

Keywords: Chinese external therapy; Rheumatoid arthritis; Topical application; Tripterygium.

Conflict of interest statement

Ethics approval and consent to participate

We confirm that any aspect of the work covered in this manuscript that has involved RA patients has been conducted with the ethical approval approved by the ethic committee of Guang’anmen Hospital and that it follows the guideline of the Declaration of Helsinki for humans (approval number: 2016–062-KY). Written signed consent to confirm their participations and our legal rights to deal with the data out of them will be obtained from each participant before any study-related procedures are initiated.

Consent for publication

The consent authorized by the Ethic Committee also provides clinical investigators the right to publish study subjects’ data no matter where and when.

Competing interests

We have not received any financial support or other benefits from commercial sources for the study. None of the authors have any financial interests that could create a potential conflict of interest.

Publisher’s Note

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

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