Effectiveness of Mind–Body Intervention for Inflammatory Conditions: a 26-Week Randomized, Non-Blinded, Parallel-Group Trial, 2021, Nguyen et al

Abstract

Biopsychosocial intervention has been suggested as a complementary treatment strategy for patients with chronic conditions. We compared the effect of a mind–body intervention (MBI), relative to treatment-as-usual (TAU) on WHO-5 Well-being Index during an intensive period of 12 weeks and follow-up at week 26 among patients with either psoriasis (PsO) or rheumatoid arthritis (RA). The MBI was based on the ‘Relaxation Response Resiliency Program’ and the ‘Open and Calm Program’, as well as ‘Mindfulness Based Stress Reduction’ (MBSR). The trial was randomized, management-as-usual, and controlled. Statistical analyses were based on the intention-to-treat population using repeated measures and mixed effects models (NCT03888261).

We screened 39 potential participants, 35 of which (PsO, n = 20; RA, n = 15) met the eligibility criteria and were randomized: 17 in the MBI group and 18 in the TAU group. Attrition from the intervention program was 19%, with 65% of MBI patients and 71% of TAU patients completing the outcome assessments. After 12 weeks, a statistically significant difference in WHO-5 was observed between the groups (p = 0.019). However, according to the protocol, during the entire trial period, the average (least squares mean values) WHO-5 score was higher although not statistically significant in the MBI group (65.3) compared with the TAU group (59.1), corresponding to a between-group difference over 26 weeks of 6.15 (95% CI: −0.26 to 12.56; p = 0.060). All things considered, adding biopsychosocial intervention to clinical practice to patients with conditions, such as PsO and RA, could potentially improve health-related quality of life.

Open access, https://www.mdpi.com/2077-0383/10/14/3107/htm

 

Not statistically significant means that the treatment did not work. Unless the results are identical in each group one has to be higher than the other but it has no meaning for care.

There have been so many studies done yet they are all negative or show just a slight effect. It is like adding up your savings, no amount of recounting will make the total higher.

 

Or it means the effect is too small to be detected with the given sample size.

But if you need 100 people to demonstrate a small effect, chances are the intervention is almost useless anyway.

 

As long as the generic and unreliable primary outcome is not considered. Or anything is considered really.

Is this really what medicine wants to be about? Being more expensive alternative medicine? Because this is far more expensive than non-official alternative medicine and it's just as useless.

What is even the point of pretending this is research when even when they have negative findings they argue that it could potentially be useful, even though this is allegedly what they should be doing? Because no one trusts findings in this field unless they validate their own opinions. So in the end all these people are doing is studying themselves and the versions of illness they invented in their minds, complete navel-gazing.

 

This is especially true of a trial design that maximizes performance bias, and even more so for subjective outcomes. The control group did not receive any particular attention, while the intervention group was "intensive[ly]" cared for by the therapists:

We compared the effect of a mind–body intervention (MBI), relative to treatment-as-usual (TAU) on WHO-5 Well-being Index during an intensive period of 12 weeks
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The abstract fairly reported the results per the trial protocol, which is more than can be said for most publications in this field. Unfortunately, it should be the norm, not the exception -- and the conclusion was positively spun.