Oral type II collagen treatment in early rheumatoid arthritis - A double-blind, placebo-controlled, randomized trial

Objective. To investigate the efficacy of oral type II collagen in the treatment of early rheumatoid arthritis (RA). Methods. Ninety patients with RA (disease duration less than or equal to 3 years) were treated for 12 weeks with oral bovine type II collagen at 1 mg/day (n = 30) or 10 mg/day (n = 30) or with placebo (n = 30), in a double-blind randomized study. Results. There was no significant difference between the 3 groups in terms of response to treatment, However, we observed a higher prevalence of responders in the type II collagen-treated groups: 7 responders in the 10-mg type II collagen group and 6 in the 1-mg group, versus 4 in the placebo group, Furthermore, 3 patients in the 10-mg type II collagen group and 1 patient in the 1-mg type II collagen group, but no patients in the placebo group, had very good response. A total of 14 patients had to be withdrawn from the study: 2 because of side effects (nausea) and 12 because of lack of efficacy. Conclusion. Only a minority of patients responded to treatment with oral type II collagen, These results justify further efforts to identify which patients will have a good response to such therapy.