RESEARCH - A randomized, double-blind, multicenter, controlled clinical trial of chicken type II collagen in patients with RA

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Arthritis Rheum. 2008 Jun 24;59(7):905-910.

A randomized, double-blind, multicenter, controlled clinical trial of

chicken type II collagen in patients with rheumatoid arthritis.

Zhang LL, Wei W, Xiao F, Xu JH, Bao CD, Ni LQ, Li XF.

Anhui Medical University, Key Laboratory of Antiinflammatory and

Immunopharmacology in Anhui Province, Hefei, China.

OBJECTIVE: To assess the efficacy and safety of chicken type II

collagen (CCII) in rheumatoid arthritis (RA) compared with

methotrexate (MTX). METHODS: We conducted a prospective, 24-week,

followup, multicenter, double-blind, controlled study of CCII (0.1

mg/day) versus MTX (10 mg/week) in patients with active RA. Clinical

assessments were performed at screening and at 12, 18, and 24 weeks of

treatment. RESULTS: A total of 236 RA patients were included; 211

patients (89.4%) completed the 24-week followup. In both groups there

was a decrease in pain, morning stiffness, tender joint count, swollen

joint count, Health Assessment Questionnaire score, and investigator

and patient assessment of function; all differences were statistically

significant. In the MTX group, erythrocyte sedimentation rate and

C-reactive protein level decreased. Rheumatoid factor did not change

in either group. At 24 weeks, 68.57% of patients in the CCII group and

83.02% in the MTX group met the American College of Rheumatology 20%

improvement criteria (ACR20), and 40.95% and 57.54%, respectively, met

the ACR50 criteria. The ACR20 and ACR50 response rates in the CCII

group were lower than those in the MTX group, and this difference was

statistically significant (P < 0.05). Gastrointestinal symptoms were

common in both groups. There were fewer and milder side effects in the

CCII group than the MTX group. The difference in incidence of adverse

events between the 2 groups was statistically significant (P < 0.05).

CONCLUSION: CCII is effective in the treatment of RA. CCII is well

tolerated, and the incidence of adverse events of CCII is lower than

that of MTX.

PMID: 18576295

http://www.ncbi.nlm.nih.gov/pubmed/18576295

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