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 A total of 14 patients had to be withdrawn from the study: 2 because of side effects (nausea) and 12 because of lack of efficacy.


CONCLUSIONS
Only a minority of patients responded to treatment with oral type II collagen. These results justify further efforts to identify which patients will have good response to such therapy.
Sieper
J
J
Deutsches Rheuma Forschungszentrum, Berlin, Germany.
Kary
S
S
Sörensen
H
H
Alten
R
R
Eggens
U
U
Hüge
W
W
Hiepe
F
F
Kühne
A
A
Listing
J
J
Ulbrich
N
N
Braun
J
J
Zink
A
A
Mitchison
N A
NA
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000818:Animals; D001172:Arthritis, Rheumatoid / Q000150:complications / Q000473:pathology / Q000628:therapy*; D002417:Cattle; D003094:Collagen / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome
D003094:Collagen