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 ⩽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...

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Published in:Arthritis and rheumatism 1996-01, Vol.39 (1), p.41-51
Main Authors: Sieper, Joachim, Kary, Sonja, Sörensen, Helmut, Alten, Rieke, Eggens, Ulrich, Hüge, Werner, Hiepe, Falk, Kühne, ANDREA, Listing, Joachim, Ulbrich, Norbert, Braun, Jürgen, Zink, Angela, Mitchison, Nicholas Avrion
Format: Article
Language:English
Subjects:
Administration, Oral
Adult
Aged
Animals
Arthritis, Rheumatoid - complications
Arthritis, Rheumatoid - pathology
Arthritis, Rheumatoid - therapy
Biological and medical sciences
Bones, joints and connective tissue. Antiinflammatory agents
Cattle
Collagen - administration & dosage
Collagen - adverse effects
Double-Blind Method
Female
Humans
Male
Medical sciences
Middle Aged
Pharmacology. Drug treatments
Treatment Outcome
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Summary: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 A total of 14 patients had to be withdrawn from the study: 2 because of side effects (nausea) and 12 because of lack of efficacy.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.
ISSN:0004-3591
1529-0131
DOI:10.1002/art.1780390106