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In a recent study (Treatments for Anxiety: Meditation and Escitalopram [TAME]), an 8-week treatment using mindfulness-based stress reduction (MBSR) was well-tolerated and noninferior to the antidepressant Escitalopram to treat adults with anxiety disorders. Investigators sought to ascertain whether Escitalopram, a popular first-line psychopharmacological treatment for anxiety disorders, is noninferior to MBSR. The noninferiority design of this study encompassed a predetermined noninferiority margin.
At the baseline visit, the week eight end point, and the follow-up visits at twelve and twenty-four weeks, the outcome assessments were carried out by a blinded clinical interviewer. Of the 430 volunteers who were evaluated for inclusion, 276 adults who had been diagnosed with an anxiety condition were recruited for the experiment, and 208 of them finished it. Enrolled subjects were randomly allocated to eight weeks of the weekly MBSR course or Escitalopram, with flexible doses ranging from 10 to 20 mg. Clinical Global Impression of Severity scale (CGI-S), having a preset noninferiority margin of -0.495 points, was used to measure anxiety levels as the key endpoint.
With a mean (standard deviation [SD]) age of 33 (13) years, the key noninferiority sample included 208 patients (102 in MBSR and 106 in Escitalopram). Notably, 156 volunteers (75%) were female; 41 volunteers (20%) were Asian; 32 volunteers (15%) were African American; 122 volunteers (59%) were White; 18 volunteers (9%) were Hispanic/Latino; and 13 volunteers (6%) were of another race or ethnicity.
In this randomized clinical trial, the baseline mean (SD) CGI-S score was 4.49 (0.77) for MBSR arm and 4.54 (0.83) for the Escitalopram arm in the randomized sample, and 4.44 (0.79) vs 4.51 (0.78), respectively, in the per-protocol sample. At the end point, the mean (SD) CGI-S score for MBSR and Escitalopram decreased by 1.35 (1.06) and 1.43 (1.17) respectively. The difference between the groups was -0.07 (0.16). Since the lower bound of the interval was inside the predetermined noninferiority margin of -0.495, this indicated that MBSR was non-inferior to Escitalopram in this comparison.
On the basis of improvement in CGI-S score, the secondary intent-to-treat analyses with imputed data similarly demonstrated the noninferiority of MBSR compared to Escitalopram. Ten (8%) of the volunteers who began treatment discontinued it due to adverse events in the Escitalopram group. However, none in the MBSR group dropped out owing to adverse events. For 110 participants (78.6%) in the Escitalopram group and 21 participants (15.4%) in the MBSR group, at least one study-associated adverse event occurred. Hence, the standardized evidence-based mindfulness-based intervention exhibits comparable effectiveness to Escitalopram to combat highly distressing anxiety disorders.
JAMA Psychiatry
Mindfulness-Based Stress Reduction vs Escitalopram for the Treatment of Adults With Anxiety Disorders: A Randomized Clinical Trial
Elizabeth A Hoge et al.
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