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Original Research Article | OPEN ACCESS

Protective effect of Salvia miltiorrhiza in rheumatoid arthritis patients: A randomized, single-blind, placebo-controlled trial

Zheng Yuan, Changsong Zhao, Qiang Zhang , Zhengrong Gao

Department of Orthopedics, Beijing Ditan Hospital, Capital Medical University, No.8, Jingshun East Street, Chaoyang District 100015, Beijing, China;

For correspondence:-  Qiang Zhang   Email: zhangqwte@sina.com   Tel:+861084322527

Accepted: 23 September 2020        Published: 30 October 2020

Citation: Yuan Z, Zhao C, Zhang Q, Gao Z. Protective effect of Salvia miltiorrhiza in rheumatoid arthritis patients: A randomized, single-blind, placebo-controlled trial. Trop J Pharm Res 2020; 19(10):2235-2241 doi: 10.4314/tjpr.v19i10.30

© 2020 The authors.
This is an Open Access article that uses a funding model which does not charge readers or their institutions for access and distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0) and the Budapest Open Access Initiative (http://www.budapestopenaccessinitiative.org/read), which permit unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited..

Abstract

Purpose: To study the protective effect of Salvia miltiorrhiza (SM) against rheumatoid arthritis (RA) in RA patients.
Methods: Sixty RA patients were divided into two groups: SM (n = 30) and placebo (n =30) groups given SM at a dose of 250 mg/kg (3 capsules/day), and placebo (3 capsule/day), respectively, for 12 weeks. Patient responses based on American College of Rheumatology (ACR), health assessment questionnaire (HAQ) score, and global assessment of disease (GAD) were recorded. Moreover, Disease Activity Score (DAS) 28, pain score (visual analogue score, VAS), rheumatoid factor (Rh factor), and inflammatory cytokines (markers) were determined.
Results: After 12 weeks of intervention with SM, ACR20 (30 %)/ACR50 patient response (13.3%, i.e., score for swelling and tenderness of joints), was significantly improved. There were considerable reductions in GAD, HAQ, DAS 28, pain score (VAS), and levels of erythrocyte sedimentation rate (ESR), acute phase reaction protein (CRP), Rh factor (IgM) and inflammatory cytokines (IL-1β, IL-6 and TNF-α), when compared to placebo (p < 0.01). Treatment with SM produced milder adverse effects than treatment with placebo (p < 0.01).
Conclusion: Overall, SM produces better anti-RA effect than placebo by significantly altering ACR patient response, reducing GAD, HAQ, DAS 28 scores, Rh factor, ESR, CRP and inflammatory cytokines in RA patients. However, a large-scale clinical trial is needed before SM can be recommended for combating RA and its related symptoms.

Keywords: Salvia miltiorrhiza, Rheumatoid arthritis, DAS 28, Adverse effect

Impact Factor
Thompson Reuters (ISI): 0.523 (2021)
H-5 index (Google Scholar): 39 (2021)

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