Evaluation of the efficacy of Tongdu Shujin Decoction combined with Adalimumab in the treatment of ankylosing spondylitis: A study protocol for a randomized controlled trial

Abstract

Abstract Introduction Ankylosing spondylitis (AS) is a chronic inflammatory disease that typically affects the axial skeleton and entheses, and can lead to severe physical and psychological damage to patients. However, the current therapies have limitations.Methods and analysis Eighty-patients with AS will be recruited from the Rheumatology Department of the First Affiliated Hospital of the Henan University of Chinese Medicine. The participants will be randomly divided into the treatment and control groups at a 1:1 ratio. Subsequently, all subjects in the treatment group will receive 40 mg adalimumab administered subcutaneously every two weeks for 12 weeks, while patients in the control group will receive an extra dose of Tongdu Shujin Decoction (TDSJ) each day. The primary outcome will be determined by the change in the Ankylosing Spondylitis Disease Activity Score (ASDAS) from baseline to 12 weeks. The secondary outcomes include changes of serum inflammatory cytokines, interleukin-6 (IL-6), interleukin-17 (IL-17), Tumor necrosis factor alpha (TNF-α), changes of anxious depression-related scales, Hospital Anxiety and Depression Scale (HADS) and Patient Health Questionnaire-9 (PHQ-9) as well as changes of McGill Pain Questionnaire (MPQ) and Fatigue Severity Scale (FSS) in patients from baseline to 12 weeks.Ethics and dissemination The ethics committee of the First Affiliated Hospital of Henan University of Chinese Medicine has approved the study on April 27, 2023 (2023HL-116-02). The Chinese national authorities issued approval on 15 May 2023. The outcome of the study will be disseminated via peer-reviewed publications and at congresses.Trial registration number Chinese Clinical Trial Registry. ChiCTR2300071418. Registered on 15th May 2023. https://www.chictr.org.cn/showproj.html?proj=196506