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Despite negative trial resutls, the data support the posibility of tapering off NSAIDs and the plausibility of self-management approaches like CBT.
Liana Fraenkel, MD, MPH
Placebo followed by cognitive behavioral therapy (CBT) was inferior to meloxicam among patients with knee osteoarthritis.
Pain score differences, however, were small, and there were no statistically significant differences in participants’ perception of change or function after 14 weeks.
Liana Fraenkel, MD, MPH, and a team of investigators evaluated whether discontinuing nonsteroidal anti-inflammatory drugs (NSAIDs) and engaging in in a telephone-based cognitive behavioral therapy program was noninferior to continuing NSAIDs for patients with knee osteoarthritis. They conducted a multicenter randomized withdrawal trial for 364 patients.
Participants were veterans with knee osteoarthritis who were enrolled in 1 of several VA medical centers or health systems. Eligibility criteria included being at least 20 years old, radiographic evidence of knee osteoarthritis, and use of an NSAID other than daily aspirin for knee pain on most days of the months for at least the past 3 months. Potential participants were identified from electronic health record (EHR) data.
All participants discontinued their NSAID and took the study drug, blue gel capsule, once a day with their breakfast. To remain eligible, participants had to report taking the study drug on at least 10 days. The participants also had to deny developing adverse events, deny using arthritis medications for knee pain other than acetaminophen or other approved medications, and did not report worsening knee pain.
Following a run-in-period, the investigators randomly assigned participants to the meloxicam or placebo group in a 1:1 ratio. The active capsules included 15 mg of meloxicam, and both groups received a blue gel capsule.
CBT was delivered in 10 modules over 10 weeks through 30- to 45-minite telephone calls with an experienced psychologist using a treatment manual modified for knee osteoarthritis. The program consisted of 1 introductory module, 8 pain coping skills modules—deep breathing and visual imagery, progressive muscle relaxation, physical activity and bodily mechanics, identifying and balancing unhealthy thoughts, managing stress, time-based pacing, and sleep hygiene—and ended with a module emphasizing skill consolidation and relapse prevention.
Those unblinded to the CBT groups received handouts for the pain coping skills in the treatment, a CD for deep breathing and progressive muscle relaxation, and sheets to track goals and coping skills.
The primary study outcome was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score 4 weeks after randomization. Additional outcomes included the area under the curve of the pain score after 4 weeks, the WOMAC disability score, and the global impression of change after treatment at 14 weeks.
The investigators included 364 patients overall. A total of 180 participants—161 men—with a mean age of 58.2 years old were randomized to receive placebo followed by CBT. There were 184 participants—154 men—with a mean age of 58.5 years old who were randomized to receive meloxicam.
The estimated mean difference in WOMAC pain score between the placebo and meloxicam groups after 4 weeks was 1.4 (95% CI, .8-2; noninferiority test P=.92). The adjusted mean difference in WOMAC pain score between the placebo followed by CBT group and meloxicam group at week 14 was .8 (95% CI, .2-1.4; noninferiority test P=.28).
Fraenkel and the team did not see a statistically significant difference in the global impression of change (mean score difference, -.2; 95% CI, -.4 to .1; P=.15) or lower extremity disability (mean score difference, .9; 95% CI, -1.4 to 3.2; P=.45) between the 2 groups after 14 weeks.
Overall, the team found placebo followed by CBT was inferior to meloxicam. The pain score differences were smaller than those considered clinically important.
“Although the overall results of the trial are negative, they provide clinicians with data to support shared decision-making and reassure patients willing to taper NSAIDs and consider self-management approaches, such as CBT,” the investigators concluded.
The study, “Nonsteroidal Anti-inflammatory Drugs vs Cognitive Behavioral Therapy for Arthritis Pain,” was published in JAMA Internal Medicine.