Dr. Gabay has received consulting fees, speaking fees, and/or honoraria from IBSA, Roche, MSD, Pfizer, and Bristol-Myers Squibb (less than $10,000 each).
Symptomatic effects of chondroitin 4 and chondroitin 6 sulfate on hand osteoarthritis: A randomized, double-blind, placebo-controlled clinical trial at a single center†
Version of Record online: 28 OCT 2011
Copyright © 2011 by the American College of Rheumatology
Arthritis & Rheumatism
Volume 63, Issue 11, pages 3383–3391, November 2011
How to Cite
Gabay, C., Medinger-Sadowski, C., Gascon, D., Kolo, F. and Finckh, A. (2011), Symptomatic effects of chondroitin 4 and chondroitin 6 sulfate on hand osteoarthritis: A randomized, double-blind, placebo-controlled clinical trial at a single center. Arthritis & Rheumatism, 63: 3383–3391. doi: 10.1002/art.30574
ClinicalTrial.gov identifier: NCT00291499.
- Issue online: 28 OCT 2011
- Version of Record online: 28 OCT 2011
- Accepted manuscript online: 6 SEP 2011 10:40AM EST
- Manuscript Accepted: 26 JUL 2011
- Manuscript Received: 25 JAN 2011
- Institut Biochimique SA (IBSA)
- Pambio-Noranco, Switzerland
To evaluate the symptomatic effects of highly purified chondroitin 4 and chondroitin 6 sulfate (CS) therapy in patients with osteoarthritis (OA) of the hand.
This investigator-initiated, single-center, randomized, double-blind, placebo-controlled clinical trial included 162 symptomatic patients with radiographic evidence of hand OA (American College of Rheumatology criteria). Inclusion criteria included patient's assessment of global spontaneous hand pain of at least 40 mm on a 0–100-mm visual analog scale (VAS) and functional impairment of at least 6 (0–30 scale) on the Functional Index for Hand OA (FIHOA) in the most symptomatic hand. Patients received either 800 mg of CS (n = 80 patients) or placebo (n = 82 patients) once daily for 6 months and were analyzed in an intent-to-treat approach. The two primary outcomes were the change in the patient's assessment of global spontaneous hand pain and in hand function (by FIHOA score) from baseline to month 6. Secondary outcomes were improvement in grip strength, duration of morning stiffness, acetaminophen consumption, and the investigator's global impression of treatment efficacy.
There was a significantly more pronounced decrease in the patient's global assessment of hand pain in the CS group than in the placebo group (difference VAS scores −8.7 mm; P = 0.016). Hand function improved significantly more in the CS group than in the placebo group (difference in FIHOA scores −2.14; P = 0.008). There was a statistically significant between-group difference in favor of CS for the duration of morning stiffness and for the investigator's global impression of treatment efficacy. Changes in grip strength, acetaminophen consumption, and safety end points were not significantly different between the two groups.
This study demonstrates that CS improves hand pain and function in patients with symptomatic OA of the hand and shows a good safety profile.