A multicenter, double-blind, randomized, controlled phase III clinical trial of chicken type II collagen in rheumatoid arthritis

Wei W, Zhang LL, Xu JH, Xiao F, Bao CD, Wang RC · Arthritis Research & Therapy

The largest trial in this literature, and it settles the therapeutic question against collagen. Both arms improved, but chicken type II collagen was significantly INFERIOR to methotrexate on every efficacy measure: ACR-20 41.55% vs 57.86%, ACR-50 16.89% vs 30.82%, and DAS28 all favouring methotrexate. Its one advantage was fewer and milder side effects.

Population

Patients with rheumatoid arthritis, multicentre, China

Intervention

Chicken type II collagen 0.1 mg/day for 24 weeks

Comparator

Methotrexate 10 mg weekly (no placebo arm)

Limitations

No placebo arm, so the within-group improvement cannot be separated from natural history and placebo response. The authors' conclusion that collagen 'is effective' rests on that uncontrolled within-group change; the controlled comparison shows inferiority to standard therapy.