CBT, placebo inferior to NSAIDs for knee osteoarthritis

In patients with knee osteoarthritis, placebo followed by cognitive behavioral therapy were inferior to meloxicam, according to research published in JAMA Internal Medicine.

“Despite their limited benefits, NSAIDs are the most commonly prescribed medications for [osteoarthrisis],” Liana Fraenkel, MD, MPH, professor adjunct of rheumatology at Yale School of Medicine, and colleagues wrote. “The widespread use of NSAIDs for [osteoarthritis] warrants scrutiny because of the significant toxic effects associated with this class of medications.”

Fraenkel and colleagues conducted a two-phase, noninferiority randomized withdrawal trial to determine whether discontinuing NSAIDs and undergoing cognitive behavioral therapy (CBT) was more effective than continuing NSAIDs in patients with knee osteoarthritis.

Participants stopped taking their current NSAID and switched to a daily 15-mg dose of meloxicam for a run-in period of 2 weeks. Those who were still considered eligible were randomly assigned to placebo or to continue meloxicam for 4 weeks. Then, the placebo group underwent a 10-week phone-based CBT program, and the meloxicam group continued its treatment.

The researchers used the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score to measure participants’ symptoms at 4 weeks and again at 14 weeks.

A total of 364 patients with a mean age of 58.2 years were enrolled in the study. Of those, 180 were assigned to placebo and CBT and 184 were assigned to meloxicam.

Fraenkel and colleagues found that the estimated mean difference in WOMAC score at 4 weeks between the groups was 1.4 (95% CI, 0.8-2.0; noninferiority test P = 0.92).

At week 14, the mean difference between the placebo and CBT group and the meloxicam group was 0.8 (95% CI, 0.2-1.4; noninferiority P = .28).

After 14 weeks, there was not a statistically significant difference between groups on global impression of change in pain (mean difference in scores = –0.2; 95% CI,–0.4 to 0.1; P = .15) or in extremity disability (mean difference in scores = 0.9; 95% CI, –1.4 to 3.2; P = 0.4).

Fraenkel and colleagues wrote that while placebo and CBT were inferior to meloxicam, “clinicians may inform patients that the pain score differences between the [two] groups are smaller than those considered to be clinically important and that there are no meaningful differences in patients’ perceptions of whether they have improved or not or in how they are functioning after 14 weeks.”

They noted that the results provide clinicians with data supporting shared decision-making and to reassure patients who are considering tapering NSAIDs in favor of a self-management approach like CBT.