Comparison of Tripterygium wilfordii Hook F versus sulfasalazine in the treatment of rheumatoid arthritis: a randomized trial.
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
To compare the benefits and side effects of TwHF extract with those of sulfasalazine for the treatment of active rheumatoid arthritis.


METHODS
Randomized, controlled trial. A computer-generated code with random, permuted blocks was used to assign treatment.


METHODS
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).


METHODS
121 patients with active rheumatoid arthritis and 6 or more painful and swollen joints.


METHODS
TwHF extract, 60 mg 3 times daily, or sulfasalazine, 1 g twice daily. Patients could continue stable doses of oral prednisone or nonsteroidal anti-inflammatory drugs but had to stop taking disease-modifying antirheumatic drugs at least 28 days before randomization.


METHODS
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.


CONCLUSIONS
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.


CONCLUSIONS
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.
Goldbach-Mansky
Raphaela
R
National Institute of Arthritis and Musculoskeletal and Skin Diseases and Clinical Center, National Institutes of Health, U.S. Department of Health and Human Services, Bethesda, Maryland 20892-0001, USA. goldbacr@mail.nih.gov
Wilson
Mildred
M
Fleischmann
Roy
R
Olsen
Nancy
N
Silverfield
Joel
J
Kempf
Phillip
P
Kivitz
Alan
A
Sherrer
Yvonne
Y
Pucino
Frank
F
Csako
Gyorgy
G
Costello
Rene
R
Pham
Tuyet Hang
TH
Snyder
Christopher
C
van der Heijde
Désirée
D
Tao
Xuelian
X
Wesley
Robert
R
Lipsky
Peter E
PE
D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D004359:Drug Therapy, Combination; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006801:Humans; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D008517:Phytotherapy / Q000009:adverse effects; D010936:Plant Extracts / Q000009:adverse effects / Q000627:therapeutic use*; D011241:Prednisone / Q000627:therapeutic use; D012460:Sulfasalazine / Q000009:adverse effects / Q000627:therapeutic use*; D029757:Tripterygium
D000894:Anti-Inflammatory Agents, Non-Steroidal; D018501:Antirheumatic Agents; D010936:Plant Extracts; D012460:Sulfasalazine; D011241:Prednisone
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