Effect of cream, prepared with Tripterygium wilfordii Hook F and other four medicinals, on joint pain and swelling in patients with rheumatoid arthritis: a double-blinded, randomized, placebo controlled clinical trial.

OBJECTIVE

To investigate the effectiveness a cream onjoint pain and swelling in patients with rheumatoid arthritis (RA). The cream, topically used, in was prepared with Tripterygium wilfordii Hook F (TwHF), Mangxiao (Nalrii Sulfas), Chuanxiong (Rhizoma Chuanxiong), stir-frying with liquid adjuvant Ruxiang (Olibanum), and stir-frying with liquid adjuvant Moyao (Myrrh).

METHODS

Patients were 1∶1 randomized to add-on TwHF cream twice a day or placebo for 4 weeks. The primary endpoint was achievement rate of 20% improvement in American College of Rheumatology criteria (ACR20) at week 4. Secondary endpoints were 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 TwHF cream group and 11.4% (4/35) in placebo group (P = 0.015). Similarly, a higher ACR50 responder proportion was seen in TwHF cream group with 17.1% (6/35) comparing to it in placebo group with 2.9% (1/35) (P = 0.046). The TwHF cream 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). Except 2 skin allergy events in TwHF cream group, no other substantive adverse events were observed.

CONCLUSION

On the short term, TwHF cream is likely to be an effective and safety complimentary treatment in patients with active RA.