Topical NSAID Relieves Pain of Osteoarthritis: Diclofenac Treatment Rated as Very Good or Excellent by 48% of Patients, Compared with 37% for Placebo

By Walsh, Nancy | Clinical Psychiatry News, May 2008 | Go to article overview

Topical NSAID Relieves Pain of Osteoarthritis: Diclofenac Treatment Rated as Very Good or Excellent by 48% of Patients, Compared with 37% for Placebo


Walsh, Nancy, Clinical Psychiatry News


BOSTON -- Topical administration of diclofenac sodium gel was associated with statistically significant and clinically meaningful improvements in symptoms of hand osteoarthritis in a multicenter, double-blind trial, Dr. Roy Altman reported at the annual meeting of the American College of Rheumatology.

A total of 385 patients aged 40 years and older with symptomatic osteoarthritis (OA) in the dominant hand and less intense or no symptoms in the nondominant hand were randomized to receive diclofenac sodium gel or a placebo vehicle, 2 g to each hand, four times daily for 8 weeks. To have been eligible for the study, patients had to have had OA pain for 12 months or more, with two or more painful episodes in one or more finger joints requiring the use of an oral or topical nonsteroidal anti-inflammatory drug or salicylate during at least one of these episodes.

At baseline, pain in the dominant hand had to be rated at 40 mm or greater on a 100-mm visual analog scale, and after a 7-day washout pain rating had to increase by 15 mm.

The study took place in 65 U.S. centers. The active gel or the vehicle was to be applied to the base of the thumb and to each digit, and rescue acetaminophen was permitted in doses up to 4 g/day for aches at sites other than the hand.

Three-quarters of the patients were women, mean age was 64 years, and mean body mass index was 28.

The primary efficacy outcome measures, assessed at weeks 4 and 6, were pain intensity during the previous 24 hours, total score on the Australian/Canadian (AUSCAN) Osteoarthritis Hand Index, which is a validated, self-administered questionnaire that assesses pain, disability, and joint stiffness in OA, and global rating of disease activity.

Statistically significant benefits were seen in the diclofenac gel group at weeks 4 and 6 on osteoarthritis pain intensity and the AUSCAN index, and on global rating at week 6, compared with vehicle.

The treatment effect also was clinically meaningful, with differences in the total AUSCAN index of 6.3 mm and 7.1 mm at weeks 4 and 6, Dr. Altman wrote in his poster presentation. Patients in the active treatment group took 0.9 500-mg acetaminophen tablets per day and patients in the vehicle group took 1.1 tablets per day.

The overall incidence of adverse events was slightly higher in the active treatment group, at 52%, compared with the vehicle group, at 44%, according to Dr. Altman of the University of California, Los Angeles. Most side effects were mild to moderate in intensity. …

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