Patients with osteoarthritis (OA) of the knee may be able to switch from nonsteroidal anti-inflammatory drug (NSAID) therapy to meloxicam or cognitive behavioral therapy without significant differences in pain after about three months, according to a randomized withdrawal trial.
“Nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly prescribed for knee osteoarthritis. However, they are associated with uncertain long-term clinical benefit and significant toxic effects,” the researchers explained in JAMA Internal Medicine.
The Stopping NSAIDs for Arthritis Pain trial included 364 patients who were taking NSAIDs for their arthritis pain most days of the week for at least three months between Sept. 1, 2013, and Sept. 30, 2018. Over a two-week period, patients terminated their current NSAID treatment and took meloxicam 15 mg daily, after which patients who were still eligible were randomized 1:1 to receive either meloxicam or placebo for four weeks. For the next 10 weeks, the meloxicam group continued this course of treatment, and the placebo group was enrolled in a 10-week cognitive behavioral therapy program. The main outcome measure was four-week Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score with a noninferiority margin of 1. Additional outcomes were the area under the curve of the pain score at four weeks and 14-week WOMAC pain score, area under the curve of the pain score, WOMAC disability score, and global impression of change.
Final analysis included 180 patients (mean [SD] age, 58.2 [11.8] years; 161 were male) randomized to the placebo then cognitive behavioral therapy group and 184 patients (mean [SD] age, 58.5 [10.0] years; 154 were male) randomized to receive meloxicam. After four weeks, when adjusting for baseline pain and study site, the estimated between-group mean difference in WOMAC score after four weeks was 1.4 (95% confidence interval [CI], 0.8 to 2.0; noninferiority test P=0.92); after 14 weeks, however, the difference was no longer as significant (0.8; 95% CI, 0.2 to 1.4; noninferiority P=0.28). Also at 14 weeks, the groups did not significantly differ in the global impression of change (mean difference in scores, –0.2; 95% CI, –0.4 to 0.1; P=0.15) or lower extremity disability (0.9; 95% CI, –1.4 to 3.2; P=0.45).
The researchers summarized, “Among patients with knee osteoarthritis, placebo and CBT (after placebo) are inferior to meloxicam. However, the WOMAC pain score differences between the 2 groups were small, and there were no statistically significant differences in participants’ global impression of change or function after 14 weeks.”