Benefit of an extract of Tripterygium Wilfordii Hook F in patients with rheumatoid arthritis

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Arthritis Rheum. 2002 Jul;46(7):1735-43.

Benefit of an extract of Tripterygium Wilfordii Hook F in patients with

rheumatoid arthritis: a double-blind, placebo-controlled study.

Tao X, Younger J, Fan FZ, Wang B, Lipsky PE.

Autoimmunity Branch, National Institute of Arthritis and Musculoskeletal

and Skin Diseases, NIH, Bethesda, land 20892, USA.

OBJECTIVE: To examine the safety and efficacy of an extract of

Tripterygium wilfordii Hook F (TWHF) in the treatment of patients with

rheumatoid arthritis (RA). METHODS: An ethanol/ethyl acetate extract from

the roots of TWHF was prepared and used in a prospective, double-blind,

placebo-controlled study in patients with longstanding RA in whom

conventional therapy had failed. Patients were randomly assigned to receive

either placebo or low-dose (180 mg/day) or high-dose (360 mg/day) extract

for 20 weeks, followed by an open-label extension period. Clinical responses

were defined as 20% improvement in disease activity according to the

American College of Rheumatology criteria. Side effects were actively

queried and recorded at each visit. RESULTS: A total of 35 patients were

enrolled in the trial; 21 patients completed the 20-week study. One patient

from each group withdrew because of side effects. Twelve, 10, and 10

patients in the placebo, low-dose, and high-dose groups, respectively,

completed at least 4 weeks of treatment. Of these patients, 8 and 4 in the

high-dose and low-dose groups, but none in the placebo group, met criteria

for clinical response. Four, 4, and 7 patients in the placebo, low-dose, and

high-dose groups, respectively, were enrolled in the open-label extension;

of these, 2, 4, and 5 patients, respectively, met criteria for clinical

response. The most common side effect was diarrhea, which caused 1 patient

in the high-dose group to withdraw from the trial. No patients withdrew

because of adverse events during the open-label extension. CONCLUSION: The

ethanol/ethyl acetate extract of TWHF shows therapeutic benefit in patients

with treatment-refractory RA. At therapeutic dosages, the TWHF extract was

well tolerated by most patients in this study.