Lack of efficacy of oral bovine type II collagen added to existing therapy in rheumatoid arthritis.
OBJECTIVE
To investigate the efficacy of oral type II collagen (CII) in the treatment of rheumatoid arthritis (RA), when added to existing therapy.


METHODS
Patients with active RA (n = 190) were randomized into a 6-month, double-blind, placebo-controlled trial. Patients continued to take their current arthritis medications. Patients received either placebo or bovine CII, 0.1 mg/day for 1 month, then 0.5 mg/day for 5 months.


RESULTS
There were no significant differences between the baseline characteristics of either group. The primary response parameter was the American College of Rheumatology (ACR) preliminary definition of improvement in RA (ACR 20). There was no statistically significant difference in the ACR 20 after 6 months (20.0% of placebo patients; 16.84% of bovine CII patients). There were significant differences in several clinical variables after treatment, all favoring the placebo group.


CONCLUSIONS
Oral solubilized bovine CII, added to existing therapy, did not improve disease activity in patients with RA.
McKown
K M
KM
Department of Medicine, The University of Tennessee, Department of Veterans Affairs Medical Center, Memphis 38163, USA.
Carbone
L D
LD
Kaplan
S B
SB
Aelion
J A
JA
Lohr
K M
KM
Cremer
M A
MA
Bustillo
J
J
Gonzalez
M
M
Kaeley
G
G
Steere
E L
EL
Somes
G W
GW
Myers
L K
LK
Seyer
J M
JM
Kang
A H
AH
Postlethwaite
A E
AE
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000818:Animals; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy* / Q000473:pathology; D002417:Cattle; D003094:Collagen / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007596:Joints / Q000187:drug effects / Q000473:pathology; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
D018501:Antirheumatic Agents; D003094:Collagen