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

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Abstract
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 ⩽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 A total of 14 patients had to be withdrawn from the study: 2 because of side effects (nausea) and 12 because of lack of efficacy.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.