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Treatment of Rheumatic Diseases with Tripterygium wilfordii

Tripterygium wilfordii glycosides (often abbreviated as TWG or TG) are pharmaceutical preparations derived from the plant Tripterygium wilfordii. The production of these preparations involves extraction and purification of specific glycosidic compounds, primarily by means of column chromatography. The aim of these procedures is to enrich defined active constituents such as triptolide and celastrol while simultaneously reducing the concentration of toxic acidic compounds. However, Tripterygium wilfordii glycosides still contain a mixture of pharmacologically active and toxic components [1] [2] [3] [4]. Consequently, all studies in which Tripterygium glycosides were administered were excluded from the present analysis. In this work, only studies were considered in which Tripterygium wilfordii was applied as an extract of the whole thunder god vine plant and not as a mixture of different herbal substances.

In addition, all duplicate publications identified on the basis of the above-mentioned keywords were excluded. Ultimately, 13 studies were included in the analysis.

1. Potential mechanism of action, active constituents, and available preparations

Tripterygium wilfordii, a medicinal plant used in traditional Chinese medicine, has attracted attention as a potential therapeutic option in rheumatoid arthritis (RA). The MMI Pharmindex lists, under the keyword “Tripterygium”, a single full-extract preparation that is marketed as a non-prescription dietary supplement.

2. Overview of the scientific evidence for clinical efficacy in the literature

Several systematic reviews and meta-analyses have documented its efficacy in the treatment of RA, particularly in comparison with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) such as methotrexate or sulfasalazine [5] [6] [7]. Across these analyses, Tripterygium wilfordii—both as monotherapy and in combination therapy—consistently led to significant improvements in clinical parameters such as the number of swollen and tender joints, erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP) [8] [9]. With regard to the ACR20 response rate, the documented superiority over sulfasalazine is particularly noteworthy [6]. In another study, an improvement in forced vital capacity was reported in patients with systemic sclerosis-associated interstitial lung disease treated with Tripterygium wilfordii [10]. No clinical trials, randomized controlled trials, or meta-analyses could be identified for other inflammatory rheumatic diseases.

3. Potential applications in rheumatology and expected beneficial effects 

Pharmacologically active constituents of Tripterygium wilfordii could potentially be used as an adjunct to csDMARD therapy in RA. It should be noted that preparations containing Tripterygium wilfordii glycosides have been successfully evaluated in the treatment of RA in some studies; however, these preparations are neither approved nor available in Germany.

4. Potential adverse effects and limitations

Publications by Lv et al. and Zhou et al. report that adverse events occurred in 46.4–48% of treated RA patients [11] [8]. Reported adverse events include hepatic dysfunction with elevated liver enzymes (9.6–11.5%), abdominal complaints (29.0%) with nausea (13–22%), vomiting (15%), diarrhea (25%), dyspepsia (22%), abdominal pain (18%), upper respiratory tract infections (1.9–18%), menstrual disturbances (5.0–12.5%), and skin rash (12%) [12] [13] [11] [8].

A critical appraisal of the clinical findings of the aforementioned studies is warranted. The majority of trials were based on relatively soft endpoints, most notably the ACR20 response [7] [5, 8], which reflects only a 20% improvement in clinical parameters and inflammatory markers and must therefore be considered a weak endpoint. More robust endpoints such as ACR50, ACR70, or complete remission (e.g. defined by DAS28 < 2.6) were reported only in isolated cases or were not used as primary endpoints [9]. Imaging-based assessment of radiographic progression was performed in only a single long-term study, which further limits the generalizability to routine clinical practice.

Another major limitation is the absence of head-to-head comparison studies with modern therapies, in particular biological DMARDs (bDMARDs) and targeted synthetic DMARDs (tsDMARDs). It therefore remains unclear whether Tripterygium wilfordii is equivalent or superior to these agents in terms of efficacy.

 5. Final recommendation of the commission

Tripterygium wilfordii may possess therapeutic potential in RA; however, the available evidence is limited by substantial methodological shortcomings, including the predominant use of weak endpoints and the lack of comparisons with modern treatment options. No approved preparation with a defined content of active ingredients is currently available in Germany. Use of Tripterygium wilfordii may be associated with adverse drug reactions, particularly hepatic dysfunction and gastrointestinal complaints. Its use as a dietary supplement with the intention of alleviating musculoskeletal symptoms is not recommended.

References

1. Fang W, Peng F, Yi T, Zhang C, Wan C, Xu H, Lam CW, Yang X: Biological activity and safety of Tripterygium extract prepared by sodium carbonate extraction. Molecules 2012, 17(9):11113-11123.

2. Du X, Nyagblordzro M, An L, Gao X, Du L, Wang Y, Ondieki G, Kikete S, He X: Pharmacokinetic and Toxicological Characteristics of Tripterigium Glycosides and Their Derivatives. Curr Drug Metab 2018, 19(7):605-627.

3. Wu W, Cheng R, Boucetta H, Xu L, Pan JR, Song M, Lu YT, Hang TJ: Differences in Multicomponent Pharmacokinetics, Tissue Distribution, and Excretion of Tripterygium Glycosides Tablets in Normal and Adriamycin-Induced Nephrotic Syndrome Rat Models and Correlations With Efficacy and Hepatotoxicity. Front Pharmacol 2022, 13:910923.

4. Qian Q, Gao Y, Xun G, Wang X, Ge J, Zhang H, Mou F, Su S, Wang Q: Synchronous Investigation of the Mechanism and Substance Basis of Tripterygium Glycosides Tablets on Anti-rheumatoid Arthritis and Hepatotoxicity. Appl Biochem Biotechnol 2022, 194(11):5333-5352.

5. Wang HL, Jiang Q, Feng XH, Zhang HD, Ge L, Luo CG, Gong X, Li B: Tripterygium wilfordii Hook F versus conventional synthetic disease-modifying anti-rheumatic drugs as monotherapy for rheumatoid arthritis: a systematic review and network meta-analysis. BMC Complement Altern Med 2016, 16:215.

6. Luo Y, Hou X, Xi A, Luo M, Wang K, Xu Z: Tripterygium wilfordii Hook F combination therapy with methotrexate for rheumatoid arthritis: An updated meta-analysis. J Ethnopharmacol 2023, 307:116211.

7. Cameron M, Gagnier JJ, Chrubasik S: Herbal therapy for treating rheumatoid arthritis. Cochrane Database Syst Rev 2011(2):Cd002948.

8. Zhou YZ, Zhao LD, Chen H, Zhang Y, Wang DF, Huang LF, Lv QW, Liu B, Li Z, Wei W et al: Comparison of the impact of Tripterygium wilfordii Hook F and Methotrexate treatment on radiological progression in active rheumatoid arthritis: 2-year follow up of a randomized, non-blinded, controlled study. Arthritis Res Ther 2018, 20(1):70.

9. Tao X, Younger J, Fan FZ, Wang B, Lipsky PE: Benefit of an extract of Tripterygium Wilfordii Hook F in patients with rheumatoid arthritis: a double-blind, placebo-controlled study. Arthritis Rheum 2002, 46(7):1735-1743.

10. Yang L, Wang Q, Hou Y, Zhao J, Li M, Xu D, Zeng X: The Chinese herb Tripterygium wilfordii Hook F for the treatment of systemic sclerosis-associated interstitial lung disease: data from a Chinese EUSTAR Center. Clin Rheumatol 2020, 39(3):813-821.

11. Goldbach-Mansky R, Wilson M, Fleischmann R, Olsen N, Silverfield J, Kempf P, Kivitz A, Sherrer Y, Pucino F, Csako G et al: Comparison of Tripterygium wilfordii Hook F versus sulfasalazine in the treatment of rheumatoid arthritis: a randomized trial. Ann Intern Med 2009, 151(4):229-240, w249-251.

12. Jiang M, Zha Q, Zhang C, Lu C, Yan X, Zhu W, Liu W, Tu S, Hou L, Wang C et al: Predicting and verifying outcome of Tripterygium wilfordii Hook F. based therapy in rheumatoid arthritis: from open to double-blinded randomized trial. Sci Rep 2015, 5:9700.

13. Lv QW, Zhang W, Shi Q, Zheng WJ, Li X, Chen H, Wu QJ, Jiang WL, Li HB, Gong L et al: Comparison of Tripterygium wilfordii Hook F with methotrexate in the treatment of active rheumatoid arthritis (TRIFRA): a randomised, controlled clinical trial. Ann Rheum Dis 2015, 74(6):1078-1086.

14. Wang X, Zu Y, Huang L, Yu J, Zhao H, Wen C, Chen Z, Xu Z: Treatment of rheumatoid arthritis with combination of methotrexate and Tripterygium wilfordii: A meta-analysis. Life Sci 2017, 171:45-50.

15. Cameron M, Gagnier JJ, Little CV, Parsons TJ, Blümle A, Chrubasik S: Evidence of effectiveness of herbal medicinal products in the treatment of arthritis. Part 2: Rheumatoid arthritis. Phytother Res 2009, 23(12):1647-1662.

16. Cibere J, Deng Z, Lin Y, Ou R, He Y, Wang Z, Thorne A, Lehman AJ, Tsang IK, Esdaile JM: A randomized double blind, placebo controlled trial of topical Tripterygium wilfordii in rheumatoid arthritis: reanalysis using logistic regression analysis. J Rheumatol 2003, 30(3):465-467.

Appendix

Appendix 1
Assessment of the evidence base: design of the PubMed search.

A PubMed search was conducted using the keywords listed in the table below. For the search terms “tripterygium wilfordii rheumatic or tripterygium wilfordii arthritis” and “tripterygium wilfordii and connective tissue disease,” 521 search results were initially identified. The search was restricted to the terms “Clinical Trial,” “Meta-Analysis,” “Randomized Controlled Trial,” and “English language.”

KeywordsReferences identified in PubMed
tripterygium wilfordii rheumatic or tripterygium wilfordii arthritisn = 30
tripterygium wilfordii and vasculitis rheumaticn = 0
tripterygium wilfordii and connective tissue disseasen = 28
tripterygium wilfordii rheumatioid arthritisn = 30
tripterygium wilfordii and psoriatic arthritisn = 0
tripterygium wilfordii and spondyloarthritisn = 0
tripterygium wilfordii and systemic sclerosisn = 1
tripterygium wilfordii and sharp syndromen = 0
tripterygium wilfordii and lupusn = 0
tripterygium wilfordii and giant cell arteriitisn = 0
tripterygium wilfordii and temporalis arteriitisn = 0
tripterygium wilfordii and panarteriitis nodosan = 0
tripterygium wilfordii and granulomatosis with polyangiitisn = 0
tripterygium wilfordii and microscopic polyangiitisn = 0
tripterygium wilfordii and eosinophlic granulomatosis with polyangiitisn = 0


Appendix 2
Overview of the evaluated publications.
 

PublicationCohortResults
Wang HL et al. [5]
  • Systematic review and meta-analysis 
  • Identification of 22 relevant studies
  • Tripterygium wilfordii showed superiority over sulfasalazine regarding ACR20, ACR50, and ACR70 response
  • Superiority was also reported tripterygium wilfordii versus methotrexate, leflunomide, sulfasalazine, tacrolimus, minocycline, and placebo with respect to ACR20 response
Luo et al. [6]
  • Meta-analysis 
  • Studies: n = 14
  • The combination of Tripterygium wilfordii and methotrexate shows a higher response rate (RR = 1.15, 95% CI: 1.10, 1.21), partial remission rate (RR = 1.27, 95% CI: 1.15, 1.40), and remission rate (RR = 1.31, 95% CI: 1.11, 1.55) compared to methotrexate monotherapy
  • Tripterygium wilfordii has been shown to improve both clinical symptoms (reduction in the number of painful joints) and laboratory parameters (C-reactive protein, interleukin-6, interleukin-1, erythrocyte sedimentation rate)
  • No increase in adverse events associated with Tripterygium wilfordii
  • Tripterygium wilfordii: Reduces the risk of infections and helps minimize unwanted side effects affecting the liver
  • Tripterygium wilfordii: Reduces the risk of infections and helps minimize unwanted side effects affecting the liver
Wang X et al. [14]
  • Meta-analysis
  • Combination therapy with methotrexate plus Tripterygium wilfordii
  • Number of studies: n = 6
  • Combination therapy with methotrexate and Tripterygium wilfordii results in an increase in treatment response rates (50%) for the reduction of swollen and painful joints, duration of morning stiffness, and decreases in erythrocyte sedimentation rate, C-reactive protein, and rheumatoid factor
Cameron M et al. [7]
  • Systematic Cochrane review
  • Tripterygium wilfordii demonstrates a significant improvement in swollen and painful joints, as measured by ACR20 response, compared to placebo
  • Tripterygium wilfordii demonstrates a significantly better ACR20 response and a significant improvement in HAQ compared to sulfasalazine
Zhou YZ et al. [8]
  • Randomized clinical trial
  • Methotrexat group: n = 69
  • Tripterygium wilfordii group: n = 69
  • Methotrexat plus Tripterygium wilfordii group: n = 69
  • Primary endpoint: radiographic progression (modified total Sharp score 
  • Study duration: 2 years
  • Mean change in the modified total Sharp Score: methotrexate 3.24 ± 6.95; Tripterygium wilfordii 2.70 ± 3.70; and methotrexate plus Tripterygium wilfordii 3.22 ± 5.66
  • Mean change in erosion score: methotrexate 1.59 ± 4.43; Tripterygium wilfordii 1.33 ± 2.03; and methotrexate plus Tripterygium wilfordii 1.44 ± 3.22
  • Mean change in joint space width score: methotrexate 1.67 ± 3.32; Tripterygium wilfordii 1.31 ± 2.41; and methotrexate plus Tripterygium wilfordii 1.78 ± 3.24
  • ACR20 response: methotrexate 55.0%; Tripterygium wilfordii 73.9%; and methotrexate plus Tripterygium wilfordii 72.9%
  • DAS28 remission: methotrexate 17.4%; Tripterygium wilfordii 43.5%; and methotrexate plus Tripterygium wilfordii 34.8%
  • Comparable adverse events
Goldbach-Mansky R et al. [11]
  • Randomized clinical trial
  • Tripterygium wilfordii versus Sulfasalazin
  • Sulfasalazin group: n = 61
  • Tripterygium wilfordii group: n = 60
  • Tripterygium wilfordii 60 mg 3 x daily
  • Sulfasalazin 1000 mg 2 x daily
  • Primary endpoint: ACR20 response
  • Study duration: 24 weeks
  • ACR20 response: Tripterygium wilfordii 65.0% versus 32.8% sulfasalazine
  • Treatment adherence: Tripterygium wilfordii 62% and sulfasalazine 41%
Lv QW et al. [13]
  • Multicenter, open-label, randomized clinical study 
  • Methotrexat group: n = 69
  • Tripterygium wilfordii group: n = 69
  • Methotrexat plus Tripterygium wilfordii group: n = 69
  • Methotrexat 12,5 mg 1 x Woche
  • Tripterygium wilfordii 20 mg 3x daily
  • Primary endpoint: ACR50 response
  • Study duration: 24 weeks
  • ACR50 response rate: methotrexate 46.4%; Tripterygium wilfordii 55.1%; and methotrexate plus Tripterygium wilfordii 76.8%
  • Mean DAS28: methotrexate 4.03 ± 1.70; Tripterygium wilfordii 3.57 ± 1.74; and methotrexate plus Tripterygium wilfordii 3.19 ± 1.39
  • Mean HAQ: methotrexate 0.76 ± 0.80; Tripterygium wilfordii 0.58 ± 0.74; and methotrexate plus Tripterygium wilfordii 0.45 ± 0.55
Jiang M et al. [12]
  • Double-blind randomized study
  • Group with a potentially positive correlation to response to Tripterygium wilfordii
  • Methotrexat plus Sulfasalazin group: n = 52
  • Tripterygium wilfordii group: n = 52
  • Group with a potentially negative correlation to response to Tripterygium wilfordii
  • Methotrexat plus Sulfasalazin group: n = 52
  • Tripterygium wilfordii group: n = 62
  • Primary endpoint: ACR20 response
  • Study duration: 24 weeks

ACR20 response

  • Group with a potentially positive correlation to response to Tripterygium wilfordii
  • Methotrexat plus Sulfasalazin: 64,6 %
  • Tripterygium wilfordii: 82,6 %
  • Group with a potentially negative correlation to response to Tripterygium wilfordii
  • Methotrexat plus Sulfasalazin: 85,1 %
  • Tripterygium wilfordii: 52,9 %
  • No significant difference between the groups in terms of adverse events
Tao X et al. [9]
  • Double-blind randomized study
  • Placebo group: n = 12
  • Tripterygium wilfordii group (low dose 180 mg/day): n = 12
  • Tripterygium wilfordii group (high dose 360 mg/Tag): n =12
  • Primary endpoint: ACR20 response
  • Study duration: 20 weeks

ACR20 response 

  • Plazebo group: 0 %
  • Tripterygium wilfordii group (low dose): 40 %
  • Tripterygium wilfordii group (high dose): 80 %
Cameron et al. [15] 
  • Meta-analysis (Cochrane review)
  • In three studies, products made from Tripterygium wilfordii (Thunder God Vine) were compared with placebos and yielded positive results; however, the data could not be pooled because the interventions and measures differed.
Cibere J et al. [16]
  • Randomized, double-blind, placebo-controlled study 
  • Topical application of Tripterygium wilfordii
  • Tripterygium wilfordii group: n = 30
  • Plazebo group: n = 30
  • Primary endpoint: ACR20 response
  • Study duration: 6 weeks

ACR20 response 

  • Tripterygium wilfordii 58 %
  • Plazebo 20 %
Tao X et al. [9]
  • Open-label, phase I dose-finding study 
  • n = 13
  • stepwise increase of Tripterygium wilfordii dose from day 0 to day 48 from 30 mg to 570 mg/day 
  • stable Tripterygium wilfordii dose between day 48 and day 76 of 570 mg/day
  • A dose of up to 570 mg/day of Tripterygium wilfordii can be considered a clinically stable dose
  • Clinical benefit with Tripterygium wilfordii at doses up to 360 mg per day
Yang L et al. [10]
  • n = 76
  • Study duration: 1 year
  • Tripterygium wilfordii 40 – 60 mg per day
  • Cyclophosphamid oral 100 mg per day
  • Tripterygium wilfordii group: n = 28
  • Cyclophosphamid group: n = 48
  • Significant improvement in forced vital capacity (Tripterygium wilfordii group: +0.11 ± 0.25 liters versus cyclophosphamide group: +0.07 ± 0.23 liters) and predicted forced vital capacity (Tripterygium wilfordii group: +3.83 ± 8.58% versus cyclophosphamide group: +3.47 ± 7.87%)
  • No significant change in DLCO and TLC

 

Last updated: March 11, 2026

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