Mindfulness-Based Program Plus Amygdala and Insula Retraining for the Treatment of Women with Fibromyalgia: A Pilot RCT, 2021, Sanabria-Mazo et al

Ashok Gupta is citing this study as 'proof' that his programme is a cure for ME/CFS.

Given that he is now actively targeting Covid LongHaulers, I thought it best to bring this to the attention of S4ME's resident experts. According to the comments on this youtube video, there are allegedly "3 RCTs in progress" into the effectiveness of the Gupta Programme on ME/CFS.

-----------

Abstract:

The lack of highly effective treatments for fibromyalgia (FM) represents a great challenge for public health. The objective of this parallel, pilot randomized controlled trial (RCT) was two-fold: (1) to analyze the clinical effects of mindfulness plus amygdala and insula retraining (MAIR) compared to a structurally equivalent active control group of relaxation therapy (RT) in the treatment of FM; and (2) toevaluate its impact on immune-inflammatory markers and brain-derived neurotrophic factor (BDNF)in serum.

A total of 41 FM patients were randomized into two study arms: MAIR (intervention group)and RT (active control group), both as add-ons of treatment as usual.

MAIR demonstrated significantly greater reductions in functional impairment, anxiety, and depression, as well as higher improvements in mindfulness, and self-compassion at post-treatment and follow-up, with moderate to large effect sizes.

Significant decreases in pain catastrophizing and psychological inflexibility and improvements in clinical severity and health-related quality of life were found at follow-up, but not at post-treatment,showing large effect sizes.

The number needed to treat was three based on the criteria of≥50% Fibromyalgia Impact Questionnaire (FIQ) reduction post-treatment. Compared to RT, the MAIR showed significant decreases in BDNF. No effect of MAIR was observed in immune-inflammatory biomarkers (i.e., TNF-α, IL-6, IL-10, and hs-CRP).

In conclusion, these results suggest that MAIR, as an adjuvant of treatment-as-usual (TAU), appears to be effective for the management of FM symptoms and for reducing BDNF levels in serum.

Paragraph breaks added for easier reading.

https://www.guptaprogram.com/wp-content/uploads/2020/10/jcm-09-03246.pdf

 

During the first session, one group receives:

While the other receives:

So it's already clear what is expected of patients in the other group. Can you guess which one the good treatment is?

 

Yet more proof that nobody reads those papers or cares what's in them. They may as well described this as a quantum effect and it would make no difference. Just random buzzwords to make it sound pseudomedical.

Hell let's skip all the pretense and call this whole thing quantum mindful healing. It sounds just as amazing as it sounds BS and frankly makes no difference.

 

I think the researchers tried to do something seriously with their data, but as they point out, there is the golden effect of the therapist-researcher on the subjects. They might have explored the placebo response generated by the therapist involved by using different therapists and see how that affected data.

A high percentage of these women deemed moderately affected were employed. Hmm. That would signal mildly affected to me.

Perhaps these interventions gave the participants (and how long did these patients have fibro?) a sense of control over their pain. Perhaps a false sense of control.

In my experience a fibro-flare (that PEM-like super worsening, that bombardment of the brain with pain signals) does arise spontaneously.

To decrease the frequency of fibro flares, one could teach patients to rest more (rest those muscles that are huge pain generators). Teach them to pay attention to the subtle increase in pain signals that means: back off from activity, or the stressors (emotional, social, etc.).

In any case, you can't 'train the brain' after the pain signals are generated to stop accepting them. Backward thinking, literally. This study is more of a general anxiety intervention. Or maybe you can train your brain, who knows.

 

Upon more reflection: this mindfulness stuff and teaching about fear and anxiety's effects are incredibly naive a propos decreasing pain in fibromyalgia. Fibromyalgia is not a normal phenomenon where relaxation brings a good deal of relief.

Fibromyalgia which is the generation of aberrant peripheral pain signals which are then amplified in the spinal cord and brain and are not quelled normally either by enough by descending pain modulation.

To believe, naively that teaching about anxiety, fear and the nervous system is going to have a clinical effect on the levels of pain bombardment is, frankly, ludicrous.

 

I applaud these researchers for subjecting one of these often discussed but rarely studied brain retraining programmes to empirical scrutiny.

It's difficult to interpret the BDNF result due to the large baseline difference between trial arms in the % of patients on antidepressants (10% vs 36%) since antidepressants affect BDNF levels.

 

The idea that someone would refer to a trial as involving "amygdala and insula retraining" seems pretty ridiculous. I mean, whatever is happening, why call it that when you have no idea?

 

How would one determine that the amygdala and insula are being retrained?

Has anyone actually checked that the treatment has a specific effect on the amygdala and insula?

 

Even when there may be some effect I think there may be room for a wide range of interpretation of what is happening and why. I often wonder with the use of these medical terms if there really is a comprehensive understanding that accounts for all of the various functions of these organs.

Somehow I very much doubt it.

 

my bullshit meter just went up the roof

 

I don't think it's ok to allow a title like that to pass peer review. Although I gather that's what he calls the program, so in that sense it's the name of the training even though it has nothing to do with the science itself.

 

I may start to post this thermometer whenever I spot a bullshit meter exploding.

 

The effect size they report is enormous: a cohen's d of 1.34.

For a comparison of effect size for some common treatments see here: How effective are common medications: ... meta-analyses of major drugs, 2015, Leucht et al | Science for ME (s4me.info)