A multicenter, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of Huangqi Guizhi Wuwutang granule in patients with rheumatoid arthritis

Abstract

Background:Rheumatoid arthritis (RA) is a chronic autoimmune disease characterized by swelling, pain, and synovial damage. Effective methods lack in the treatment of RA. A traditional prescription in use for thousands of years in China, Huangqi Guizhi Wuwutang granule (HGWG) is still chosen to relieve pain and prevent joint malformation in RA patients. However, no evidence-based medical research has been organized to assess the effectiveness and safety of HGWG for RA.Methods/design:We will conduct a multicenter, randomized, double-blind, placebo-controlled clinical trial to determine whether HGWG can relieve pain and protect joints. We will randomly divide 120 patients with active RA into 2 groups, treated for 12 weeks. Main measurement is the rate of ACR50 score (American College of Rheumatology) from the baseline to 12 weeks. Secondary measurements include rate of ACR20/70, change of Disease Activity Score (DAS) 28, Health Assessment Questionnaire-Disability Index (HAQ-DI), Patient Assessment of Arthritis Pain, Patient Global Assessment of Arthritis, and AIS score. The time points are set as baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks, and 48 weeks. In addition, the rate of ACR50 from the baseline to 2 weeks, 4 weeks, 8 weeks, 24 weeks, and 48 weeks’ follow-up are also the secondary outcome measures.Discussion:The findings of this research will elucidate the efficacy and safety of HGWG and provide an alternative treatment for RA. In addition, our data will benefit the clinical decision-making on active RA and possibly be incorporated into future guidelines.Trial registration:ClinicalTrials.gov ID: NCT03593837.

The combination of Chinese and Western Medicine in the management of rheumatoid arthritis: A real-world cohort study across China

“…Biologically, the involvement of Chinese herbal medicine induces multiple treatment pathways and mechanisms especially single herb can contain various kinds of active ingredients targeting RA-related receptors and biomarkers ( Chen et al, 2004 ; van der Greef et al, 2010 ; Seca and Franconi, 2018 ). With human clinical trials and animal studies suggested the efficacy and safety of IM with Chinese herbal medicine and their extractions ( Liu et al, 2018 ; Wang et al, 2019 ), IM approaches are expected to motivate improvements in RA treatments strategies and outcomes. Moreover, as biological agents for rheumatoid arthritis are gradually under consideration for national health insurance coverage, we look forward to investigating the role of biological agents in IM treatment strategies in future studies.…”

Measures of Sleep in Rheumatologic Diseases: Sleep Quality Patient‐Reported Outcomes in Rheumatologic Diseases

“…One trial has studied the change in AIS scores in patients with RA after acupuncture therapy, and several upcoming intervention trials in RA will assess AIS scores at baseline and follow‐up visits (171,177–179).…”

Astragalosides inhibit proliferation of fibroblast‐like synoviocytes in experimental arthritis by modulating LncRNA S56464.1/miR‐152‐3p/Wnt1 signaling axis

“…Bunge. is a frequently used traditional Chinese medicine with antiviral and antioxidant activities and a variety of biological functions, 11 and its compound preparations, such as Huangqi Guizhi Wuwutang and Xinfeng capsule granules, are often used for the treatment of RA clinically 12,13 . In addition, with the development of technology and research methods, increasing numbers of traditional Chinese medicine components, including alkaloids, coumarins, flavonoids, saponins and so on, have been identified and purified 14 .…”