Oral type II collagen in the treatment of rheumatoid arthritis. A six-month double blind placebo-controlled study

Objective To evaluate the efficacy of oral chicken type N collagen (CII) in the treat ment of rheumatoid arthritis (RA). Methods Sixty patients with clinically active RA of long duration (mean 7.2 +/- 5.5 years) were treated for 6 months with oral chicken CII at 0.25 mg/day (n = 31) or with placebo (n = 29) in a double-blind randomized study. Results The response rate to treatment of the collagen-created group, based on the ACR 20% criteria was higher than that of the control group but this differe nce was not statistically significant at any time. Intention-to-treat (ITT) analysis did not show statistically significant improvement in any of the several secondary outcome measures over the 6 months of the study in the co llagen-treated-patients in comparison with the placebo-treated group. Howev er, in 2 collagen-treated patients we observed a clinical remission accordi ng to the criteria of the American Rheumatism Association. Conclusion Our study seems to show that the oral treatment of RA patients with chicken CII is ineffective and results in only small and inconsistent benefits. Fu rthermore, our results raise the possibility that in a sub-group of patient s oral collagen administration, usually considered devoid of harmful effect s, may actually induce disease flares.