Efficacy and safety of traditional Chinese medicine decoctions as an adjuvant treatment for rheumatoid arthritis: A systematic review and meta-analysis

Clinical Snapshot

Key Findings

• P Value: P < .00001 for primary outcome

• Effect Size: Risk Ratio (RR) = 1.25 for overall clinical efficacy; statistically significant improvements also reported for ESR, CRP, RF, SJC, DAS, morning stiffness duration, VAS, TCM Symptom Score, and IL-1

• Primary Outcome: Overall clinical efficacy of TCM decoctions as adjuvant therapy versus control in rheumatoid arthritis

• Nnt Or Sensitivity: NNT not calculable from abstract data alone; the RR of 1.25 implies a 25% relative increase in achieving 'overall efficacy' compared to control, but absolute risk difference and baseline event rate are not reported in the abstract, precluding NNT calculation

• Confidence Interval: 95% CI: 1.21–1.29 for primary outcome (overall efficacy)

Clinical Application

TCM decoctions require access to trained TCM practitioners for individualised prescription, specialised herbal pharmacies, and patient willingness to prepare and consume decoctions regularly. Standardisation of formulations for clinical trials or routine practice is a major practical barrier. Cost, time burden, and palatability may affect adherence. Herb-drug interactions with DMARDs (particularly methotrexate hepatotoxicity potentiation) require careful monitoring. TCM is a registered health profession in Australia under the Chinese Medicine Board of Australia (CMBA) within AHPRA, and TCM practitioners are legally required to be registered. However, TCM decoctions are not listed on the PBS and are not TGA-approved therapeutic goods in the same regulatory framework as conventional medicines. The RACGP does not currently endorse TCM decoctions as adjuvant RA therapy in its clinical guidelines. Australian rheumatologists should be aware that patients may be self-administering TCM decoctions alongside prescribed DMARDs or biologics, with potential for herb-drug interactions. Clinicians should enquire about TCM use and consider referral to an AHPRA-registered TCM practitioner for co-management if patients wish to pursue this approach. The TGA regulates listed herbal medicines but not individualised decoctions prepared by practitioners. Adults with established rheumatoid arthritis receiving conventional pharmacotherapy (likely DMARDs including methotrexate, leflunomide, or biologics) who are seeking or already using adjunctive TCM therapy. The evidence base is derived exclusively from Chinese populations, limiting direct applicability to ethnically diverse Western populations.

Abstract

BACKGROUND: To assess the effectiveness and safety of traditional Chinese medicine (TCM) decoctions as an additional therapy for rheumatoid arthritis (RA) via a systematic review and meta-analysis. METHODS: Databases including PubMed, Web of Science, Cochrane Library, Embase, China National Knowledge Infrastructure, and Wanfang were searched up to June 2024. Randomized controlled trials (RCTs) on TCM decoctions as adjunctive RA treatment were included. Primary outcomes were efficacy and safety. Effect sizes were measured using standardized mean difference, risk ratio, and 95% confidence intervals. Sensitivity and subgroup analyses were conducted to test result robustness and identify heterogeneity sources. Data were analyzed using RevMan 5.4 and Stata 15. In addition, the quality of evidence was assessed using grading of recommendations assessment, development and evaluation grading. RESULTS: Thirty-six RCTs with 6934 participants showed that TCM decoctions significantly improved overall efficacy versus control (risk ratio = 1.25, 95% confidence interval [1.21-1.29], P < .00001). They also reduced erythrocyte sedimentation rate, C-reactive protein, rheumatoid factor, swollen joint count, Disease Activity Score, and morning stiffness duration compared to placebo. Subgroup analysis suggested treatment duration, disease duration, and age may affect efficacy. Among them, the quality of evidence was high for Visual Analog Scale, and moderate for overall efficacy, C-reactive protein, Disease Activity Score, Traditional Chinese Medicine Symptom Score, and interleukin-1. CONCLUSION: TCM decoctions as adjunctive RA treatment significantly enhance efficacy. However, due to study limitations, further large-scale, multicenter RCTs are needed to confirm these findings.

References

1. 1.Xu, Y., Luo, L., Chen, Y., & Liu, X. (2026). Efficacy and safety of traditional Chinese medicine decoctions as an adjuvant treatment for rheumatoid arthritis: A systematic review and meta-analysis. Medicine. https://doi.org/10.1097/MD.0000000000049452