Mindfulness-Based Stress Reduction vs Escitalopram for the Treatment of Adults With Anxiety Disorders A Randomized Clinical Trial, 2024, Mete et al

[rvallee]

Mindfulness-Based Stress Reduction vs Escitalopram for the Treatment of Adults With Anxiety Disorders A Randomized Clinical Trial
https://jamanetwork.com/journals/jamapsychiatry/fullarticle/2798510

Abstract

Importance: Anxiety disorders are common, highly distressing, and impairing conditions. Effective treatments exist, but many patients do not access or respond to them. Mindfulness-based interventions, such as mindfulness-based stress reduction (MBSR) are popular and can decrease anxiety, but it is unknown how they compare to standard first-line treatments.

Objective: To determine whether MBSR is noninferior to escitalopram, a commonly used first-line psychopharmacological treatment for anxiety disorders.

Design, Setting, and Participants: This randomized clinical trial (Treatments for Anxiety: Meditation and Escitalopram [TAME]) included a noninferiority design with a prespecified noninferiority margin. Patients were recruited between June 2018 and February 2020. The outcome assessments were performed by blinded clinical interviewer at baseline, week 8 end point, and follow-up visits at 12 and 24 weeks. Of 430 individuals assessed for inclusion, 276 adults with a diagnosed anxiety disorder from 3 urban academic medical centers in the US were recruited for the trial, and 208 completed the trial.

Interventions: Participants were 1:1 randomized to 8 weeks of the weekly MBSR course or the antidepressant escitalopram, flexibly dosed from 10 to 20 mg.

Main Outcomes and Measures: The primary outcome measure was anxiety levels as assessed with the Clinical Global Impression of Severity scale (CGI-S), with a predetermined noninferiority margin of −0.495 points.

Results: The primary noninferiority sample consisted of 208 patients (102 in MBSR and 106 in escitalopram), with a mean (SD) age of 33 (13) years; 156 participants (75%) were female; 32 participants (15%) were African American, 41 (20%) were Asian, 18 (9%) were Hispanic/Latino, 122 (59%) were White, and 13 (6%) were of another race or ethnicity (including Native American or Alaska Native, more than one race, or other, consolidated owing to low numbers). Baseline mean (SD) CGI-S score was 4.44 (0.79) for the MBSR group and 4.51 (0.78) for the escitalopram group in the per-protocol sample and 4.49 (0.77) vs 4.54 (0.83), respectively, in the randomized sample. At end point, the mean (SD) CGI-S score was reduced by 1.35 (1.06) for MBSR and 1.43 (1.17) for escitalopram. The difference between groups was −0.07 (0.16; 95% CI, −0.38 to 0.23; P = .65), where the lower bound of the interval fell within the predefined noninferiority margin of −0.495, indicating noninferiority of MBSR compared with escitalopram. Secondary intent-to-treat analyses using imputed data also showed the noninferiority of MBSR compared with escitalopram based on the improvement in CGI-S score. Of patients who started treatment, 10 (8%) dropped out of the escitalopram group and none from the MBSR group due to adverse events. At least 1 study-related adverse event occurred for 110 participants randomized to escitalopram (78.6%) and 21 participants randomized to MBSR (15.4%).

Conclusions and Relevance: The results from this randomized clinical trial comparing a standardized evidence-based mindfulness-based intervention with pharmacotherapy for the treatment of anxiety disorders found that MBSR was noninferior to escitalopram.

 

[rvallee]

Yet another flawed trial comparing something that doesn't work with another thing that doesn't work and concludes that it's just as good. 0=0=it works! All because they're evaluating both so poorly that all it takes is a bit of bias for something that doesn't work to appear to work. Absurd.

No wonder they can't progress anymore. Only with technology, the rest is completely stagnant, they're stuck doing the same BS rituals over and over again.

 

[Hutan]

Baseline mean (SD) CGI-S score was 4.44 (0.79) for the MBSR group and 4.51 (0.78) for the escitalopram group in the per-protocol sample and 4.49 (0.77) vs 4.54 (0.83), respectively, in the randomized sample. At end point, the mean (SD) CGI-S score was reduced by 1.35 (1.06) for MBSR and 1.43 (1.17) for escitalopram.
At end point, the mean (SD) CGI-S score was reduced by 1.35 (1.06) for MBSR and 1.43 (1.17) for escitalopram.

That average reported reduction (from moderately ill to mildly ill) is in line with what we might expect to see with a placebo.



From the The Clinical Global Impressions Scale - a description of the measure.
The measure is a 'instrument' developed for busy clinicians. It's a single question, basically 'how mentally ill is this patient?' on a scale from 1 to 7.

In clinical research, the CGI is administered by an experienced clinician who is familiar with the disease under study and the likely progression of treatment. Consequently, the CGI rater can make an expert clinical global judgment about the severity of the illness across various time points within the context of that clinical experience. The clinician makes a judgment about the total picture of the patient at each visit: the illness severity, the patient's level of distress and other aspects of impairment, and the impact of the illness on functioning. The CGI is rated without regard to the clinician's belief that any clinical changes are or are not due to medication and without consideration of the etiology of the symptoms.

CGI-Severity (CGI-S). The CGI-Severity (CGI-S) asks the clinician one question: “Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?” which is rated on the following seven-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients.

This rating is based upon observed and reported symptoms, behavior, and function in the past seven days. Clearly, symptoms and behavior can fluctuate over a week; the score should reflect the average severity level across the seven days.

So, between the patient wanting to believe something has improved and the rating clinician knowing that the patient has been treated with one of two treatments that they believe to be effective, it is not at all surprising that there is some improvement. Let alone the impact of reversion to the mean, the likelihood of some participants improving naturally over time.

At least 1 study-related adverse event occurred for 110 participants randomized to escitalopram (78.6%) and 21 participants randomized to MBSR (15.4%).

I note this - 15% of the people doing the mindfulness practice reported adverse events that the investigators accepted were study-related. I haven't read the paper - it could be worth checking out what those harms were.

Also, if 15.4% of a sample is 21, that means that the mindfulness group was initially 136 people.

The primary noninferiority sample consisted of 208 patients (102 in MBSR and 106 in escitalopram)

So, that means 25% of the people in the mindfulness treatment dropped out, didn't complete the treatment. That fact is not acknowledged in the abstract. Instead, they say

Of patients who started treatment, 10 (8%) dropped out of the escitalopram group and none from the MBSR group due to adverse events.

I bet a lot of people reading that abstract quickly would take from that that there were no drop outs from the mindfulness course.

I wonder what the participants felt about the treatments at the followup points. The abstract doesn't tell us.

Yet another flawed trial comparing something that doesn't work with another thing that doesn't work and concludes that it's just as good. 0=0=it works! All because they're evaluating both so poorly that all it takes is a bit of bias for something that doesn't work to appear to work. Absurd.

 

[Joan Crawford]

I've not been able to read this. Ongoing medical muppetry

Over time it'd be likely that anxiety would drop anyway.

No third grouop - wait list control? (not perfect but a try....).

A drop in score is not a good outcome.

Ideally, minimal ongoing disruption due to symptoms usually linked to scoring zero or near to on stress scales is the desired outcome / end state.... And the person has a sense of new knowledge leading to a sense of competence about managing themselves, feelings, etc well. How they react is understandable to them etc etc. Anything less has to be seen as less that ideal and far from a decent attempt.....