Topical diclofenac patch in patients with knee osteoarthritis:A randomized, double-blind, controlled clinical trial
P. Brühlmann, B.A. Michel
Department of Rheumatology and Physical Medicine, University Hospital Zurich Switzerland
ABSTRACT
Objective
To assess the efficacy and safety of a diclofenac hydroxyethylpyrrolidine (DHEP) patch in the treatment of
symptomatic osteoarthritis (OA) of the knee joint.
Methods
A double-blind, randomised, placebo-controlled trial was carried out on 103 outpatients for 2 weeks. The main
efficacy parameters were spontaneous pain and Lequesne's Index. Secondary endpoints were walking time over
a standard distance, global assessment of efficacy and tolerability, and paracetamol consumption.
Results
The active treatment group showed a significant improvement in pain, Lequesne's Index, and the physician's and patient's global assessment of efficacy. For these parameters the difference between groups was statistically
significant in favour of the DHEP patch. Adverse reactions were seen in a small number of probands and were
similar in both groups.
Conclusions
The results of this trial suggest that the DHEP patch appears to be an effective and safe treatment for patients
suffering from symptomatic knee OA.
Key words
Knee osteoarthritis, diclofenac-hydroxyethylpyrrolidine, topical patch, Lequesne index.
Please address reprint requests and correspondence to: P. Brühlmann, MD, Department of Rheumatology and Physical Medicine, University Hospital Zürich, Gloriastrasse 25, CH-8091 Zürich, Switzerland.
Clin Exp Rheumatol 2003; 21: 193-198.
© Copyright Clinical and Experimental
Rheumatology 2003.