Background/Purpose:  Tripterygium wilfordii Hook F (TwHF), a traditional Chinese herb, is widely used in China for treating Rheumatoid Arthritis (RA), but limited only for eldly RA patients because of its reproductive system toxicity. We were inspired by external therapy, an immemorial therapy for thousands of years, and took its advantage to make TwHF topically in order to get an effective and safe treatment for active RA patients.

Methods: In this 4-week double-blinded, randomized, placebo controlled clinical trial, patients were 1:1 randomized to add-on topical TwHF twice a day or placebo for 4 weeks. The primary endpoint was the rate of achievement of 20% improvement in the American College of Rheumatology criteria (ACR20) at week 4. Secondary endpoints were 50% improvement in the ACR criteria (ACR50), 28-joint count Disease Activity Score (DAS28) improvement and safety profiles. Statistical analyses were performed using intention to treat analysis (ITT) set．

Results:  A total of 70 active RA patients were enrolled. At week 4, the ACR20 was 34.3% (12/35) in topical TwHF group and 11.4% (4/35) in placebo group (P=0.015). Similarly, a higher ACR50 responder proportion was seen in topical TwHF group with 17.1% (6/35) comparing to it in placebo group with 2.9% (1/35) (P=0.046). The topical TwHF group also had more improvement than the placebo group on DAS28-ESR (1.1 vs 0.5, P=0.001), DAS28-CRP (1.4 vs 0.7, P=0.001), tender joint count (5.5 vs 2.6, P=0.018), swollen joint count (3.5 vs 1.6, P=0.003) and Physician’s global assessment (25.8 vs 13.0, P=0.002), as well as C-reactive protein (11.2 vs 2.7, P=0.048). Initial effect onset time of pain and swelling reductions were significantly shorter in topical TwHF group with Means of both 7 days (range: 2.5 hours to 11 days and 1 to 21 days, respectively) than those of 11 and 17 days (range: 4 to 24 days and 4 to 28 days, respectively) in placebo group (P=0.022, P<0.001), respectively. There were 2 adverse slight skin allergy events in topical TwHF group. No substantive differences in adverse events were observed.

Conclusion:  Topical TwHF is an effective and safety complimentary treatment in patients with active RA.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/tripterygium-wilfordii-hook-f-applied-topically-in-patients-with-active-rheumatoid-arthritis/