Comparison of Tripterygium wilfordii Hook F versus sulfasalazine in the treatment of rheumatoid arthritis: a randomized trial.
Abstract | BACKGROUND: Extracts of the medicinal plant Tripterygium wilfordii Hook F (TwHF) have been used in China for centuries to treat a spectrum of inflammatory diseases. OBJECTIVE: DESIGN: Randomized, controlled trial. A computer-generated code with random, permuted blocks was used to assign treatment. SETTING: 2 U.S. academic centers (National Institutes of Health, Bethesda, Maryland, and University of Texas, Dallas, Texas) and 9 rheumatology subspecialty clinics (in Dallas and Austin, Texas; Tampa and Fort Lauderdale, Florida; Arlington, Virginia; Duncanville, Pennsylvania; Wheaton and Greenbelt, Maryland; and Lansing, Michigan). PATIENTS: INTERVENTION: MEASUREMENTS: The primary outcome was the rate of achievement of 20% improvement in the American College of Rheumatology criteria (ACR 20) at 24 weeks. Secondary end points were safety; radiographic scores of joint damage; and serum levels of interleukin-6, cholesterol, cortisol, and adrenocorticotropic hormone. RESULTS: Outcome data were available for only 62 patients at 24 weeks. In a mixed-model analysis that imputed data for patients who dropped out, 65.0% (95% CI, 51.6% to 76.9%) of the TwHF group and 32.8% (CI, 21.3% to 46.0%) of the sulfasalazine group met the ACR 20 response criteria (P=0.001). Patients receiving TwHF also had significantly higher response rates for ACR 50 and ACR 70 in mixed-model analyses. Analyses of only completers showed similar significant differences between the treatment groups. Significant improvement was demonstrated in all individual components of the ACR response, including the Health Assessment Questionnaire disability score. Interleukin-6 levels rapidly and significantly decreased in the TwHF group. Although not statistically significant, radiographic progression was lower in the TwHF group. The frequency of adverse events was similar in both groups. LIMITATIONS: Only 62% and 41% of patients continued receiving TwHF extract and sulfasalazine, respectively, during the 24 weeks of the study. Long-term outcome data were not collected on participants who discontinued treatment. CONCLUSION: In patients who continued treatment for 24 weeks and could also use stable oral prednisone and nonsteroidal anti-inflammatory drugs, attainment of the ACR 20 response criteria was significantly greater with TwHF extract than with sulfasalazine.
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Authors | Raphaela Goldbach-Mansky, Mildred Wilson, Roy Fleischmann, Nancy Olsen, Joel Silverfield, Phillip Kempf, Alan Kivitz, Yvonne Sherrer, Frank Pucino, Gyorgy Csako, Rene Costello, Tuyet Hang Pham, Christopher Snyder, Désirée van der Heijde, Xuelian Tao, Robert Wesley, Peter E Lipsky |
Journal | Annals of internal medicine
(Ann Intern Med)
Vol. 151
Issue 4
Pg. 229-40, W49-51
(Aug 18 2009)
ISSN: 1539-3704 [Electronic] United States |
PMID | 19687490
(Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Intramural)
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Chemical References |
- Anti-Inflammatory Agents, Non-Steroidal
- Antirheumatic Agents
- Plant Extracts
- Sulfasalazine
- Prednisone
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Topics |
- Adult
- Aged
- Anti-Inflammatory Agents, Non-Steroidal
(therapeutic use)
- Antirheumatic Agents
(adverse effects, therapeutic use)
- Arthritis, Rheumatoid
(drug therapy)
- Drug Therapy, Combination
- Female
- Gastrointestinal Diseases
(chemically induced)
- Humans
- Male
- Middle Aged
- Patient Compliance
- Phytotherapy
(adverse effects)
- Plant Extracts
(adverse effects, therapeutic use)
- Prednisone
(therapeutic use)
- Sulfasalazine
(adverse effects, therapeutic use)
- Tripterygium
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