Goldbach-Mansky R, Wilson M, Fleischmann R, et al. Comparison of Tripterygium wilfordii Hook F versus sulfasalazine in the treatment of rheumatoid arthritis. Ann Intern Med. 2009;151(4): 229-240.
Rheumatoid arthritis is an inflammatory disease of the joint lining (or synovial membrane), which causes pain and swelling of the diarthrodial joint. Uncontrolled rheumatoid arthritis results in progressive joint damage and subsequent disability and increased mortality. A better understanding of the immune mechanisms that perpetuate inflammation has led to the development of effective therapies to treat this condition. Although these therapies have been shown to be clinically efficacious, many patients do not achieve clinically meaningful responses or experience adverse effects and discontinue treatment. In traditional Chinese medicine, extracts of the roots from tripterygium (thunder god vine; Tripterygium wilfordii) have shown therapeutic benefit in the treatment of autoimmune and inflammatory disorders and cancer. The potent inhibition of proinflammatory genes by tripterygium in a small placebo-controlled study prompted the present multicenter, double-blind, randomized trial, which compared the efficacy of sulfasalazine with that of a standard extract of tripterygium in patients with rheumatoid arthritis.
This study was conducted
between March 2004 and October 2005 at 11 US centers in 121 patients with
established (at least 6 months) active rheumatoid arthritis per the criteria of
Only 62 subjects (37 tripterygium, 25 sulfasalazine) completed the 24-week study. Significantly more of the sulfasalazine subjects withdrew due to lack of efficacy or adverse effects (P < 0.001). Approximately 68% of the tripterygium group and 36% of the sulfasalazine group who completed the study achieved an ACR 20 response (P = 0.02). Similarly, approximately 54% of the tripterygium group and 4% of the sulfasalazine group achieved an ACR 50 response, and approximately 38% of the tripterygium group and 4% of the sulfasalazine group achieved an ACR 70 response at 24 weeks (P < 0.001 and P = 0.002, respectively). The mean improvement in the DAS 28 score was 2.4 points in the tripterygium group and 1.5 points in the sulfasalazine group (P < 0.001). Significantly greater improvements in disability, pain, patient's and physician's global assessments of health, ESR, and C-reactive protein concentrations were observed in the tripterygium group than in the sulfasalazine group beginning at 2 weeks. A significantly greater improvement in the number of swollen and tender joints was observed in the tripterygium group than in the sulfasalazine group beginning at 8 weeks.
Radiographic scores indicated no progression in mean joint space narrowing or erosion in the tripterygium group. Compared with the sulfasalazine group, significantly greater decreases in interleukin-6 were observed at 24 weeks (P = 0.037) in the tripterygium group and in rheumatoid factor at 4 weeks in the tripterygium group (P < 0.001). Blood pressure, body weight, and cortisol and adrenocorticotropic hormone concentrations did not change significantly with treatment. Of note, total cholesterol concentrations increased significantly in the tripterygium group (P < 0.001); high-density-lipoprotein cholesterol increased by 53% and low-density-lipoprotein concentrations by 48%, but the ratio remained unchanged. The frequency of adverse events reported related to the drugs was not significantly different between groups (tripterygium 57% and sulfasalazine 61% of patients in the groups).
The authors conclude that "treatment with a standardized extract from the peeled roots of the Chinese herbal remedy [tripterygium] administered over 24 weeks may be both effective and safe in treating patients with active rheumatoid arthritis. The rapid improvement in function and pain and the profound effect on inflammation may make this extract an attractive and affordable alternative to currently available agents." Further studies need to evaluate the impact on cholesterol levels, long-term effects and toxicities, and combination with other antirheumatic therapies.
—Brenda Milot, ELS