Clinical Science
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Oral type II collagen treatment in early rheumatoid arthritis. A double-blind, placebo-controlled, randomized trial
Joachim Sieper MD,
Sonja Kary MD, Helmut Sörensen MD, Rieke Alten MD, Ulrich Eggens MD,
Werner Hüge MD, Falk Hiepe MD, ANDREA Kühne, Joachim Listing PhD, Norbert Ulbrich PhD, Jürgen Braun MD,
Angela Zink PhD, Nicholas Avrion Mitchison PhD,
Corresponding Author
Joachim Sieper MD
Deutsches Rheuma Forschungszentrum, Berlin, Klinikum Benjamin Franklin, Free University, Berlin, Germany
Department of Medicine, Rheumatology, Klinikum Benjamin Franklin, Hindenburgdamm 30, 12200 Berlin, GermanySearch for more papers by this authorUlrich Eggens MD
Klinikum Benjamin Franklin, Free University, Berlin
Search for more papers by this authorJürgen Braun MD
Klinikum Benjamin Franklin, Free University, Berlin
Search for more papers by this authorNicholas Avrion Mitchison PhD
Deutsches Rheuma Forschungszentrum, Berlin
Search for more papers by this authorJoachim Sieper MD,
Sonja Kary MD, Helmut Sörensen MD, Rieke Alten MD, Ulrich Eggens MD,
Werner Hüge MD, Falk Hiepe MD, ANDREA Kühne, Joachim Listing PhD, Norbert Ulbrich PhD, Jürgen Braun MD,
Angela Zink PhD, Nicholas Avrion Mitchison PhD,
Corresponding Author
Joachim Sieper MD
Deutsches Rheuma Forschungszentrum, Berlin, Klinikum Benjamin Franklin, Free University, Berlin, Germany
Department of Medicine, Rheumatology, Klinikum Benjamin Franklin, Hindenburgdamm 30, 12200 Berlin, GermanySearch for more papers by this authorUlrich Eggens MD
Klinikum Benjamin Franklin, Free University, Berlin
Search for more papers by this authorJürgen Braun MD
Klinikum Benjamin Franklin, Free University, Berlin
Search for more papers by this authorNicholas Avrion Mitchison PhD
Deutsches Rheuma Forschungszentrum, Berlin
Search for more papers by this authorAbstract
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.
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