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 the controlled comparison runs against collagen. Both arms improved from baseline on every clinical measure. Methotrexate did better on the composite response criteria: ACR-20 57.86% against 41.55% and ACR-50 30.82% against 16.89% at 24 weeks, with the DAS28 activity distribution also favouring methotrexate (p=0.019). Among the individual clinical variables at 24 weeks the two arms separated on pain, HAQ and the patient's own assessment, and not on tender joint count, swollen joint count, morning stiffness or the physician's assessment. Methotrexate lowered ESR and CRP; collagen did not. Collagen's advantage was tolerability, with fewer and milder adverse events.

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. Randomisation was two-to-one, 326 to collagen and 177 to methotrexate; 454 of 503 were analysed at 24 weeks. A rheumatoid-arthritis endpoint, not a cartilage one.