MD, PhD, FMedSci, FRSB, FRCP, FRCPEd.

Mind-body interventions (MBIs) are one of the top ten so-called alternative medicine (SCAM) approaches utilized in pediatrics, but there is limited knowledge on associated adverse events (AE). The objective of this review was to systematically review AEs reported in association with MBIs in children.

Electronic databases MEDLINE, Embase, CINAHL, CDSR, and CCRCT were searched from inception to August 2018. The authors included primary studies on participants ≤ 21 years of age that used an MBI. Experimental studies were assessed for whether AEs were reported on or not, and all other study designs were included only if they reported an AE.

A total of 441 were included as primary pediatric MBI studies. Of these, 377 (85.5%) did not explicitly report the presence/absence of AEs or a safety assessment. In total, there were 64 included studies: 43 experimental studies reported that no AE occurred, and 21 studies reported AEs. A total of 37 AEs were found, of which the most serious were grade 3. Most of the studies reporting AEs did not report on severity (81.0%) or duration of AEs (52.4%).

The authors concluded that MBIs are popularly used in children; however associated harms are often not reported and lack important information for meaningful assessment.

SCAM is far too often considered to be risk-free. This phenomenon is particularly stark if the SCAM in question does not involve physical or pharmacological treatments. Thus MBIs are seen and often waved through as especially safe. Consequently, many researchers do not even bother to monitor AEs in their clinical trials. This might be understandable, but it is nevertheless a violation of research ethics.

This new review is important in that it highlights these issues. It is high time that we stop giving researchers in SCAM the benefit of the doubt. They may or may not make honest mistakes when not reporting AEs. In any case, it is clear that they are not properly trained and supervised. All too often, we still see clinical trials run by amateurs who have little idea of methodology and even less of ethics. The harm this phenomenon does is difficult to quantify, but I fear it is huge.

2 Responses to Adverse effects of mind body therapies in children

  • Adverse events in general are atrociously recorded and reported in SCAM as a whole and it is particularly noteworthy that none of these “holistic” and “caring” modalities has anything resembling VAERS or the “yellow-card” or similar reporting schemes used in conventional medicine – but which scammers love to abuse when they like to pretend that these “associations” represent real proven side-effects long before any such proof is in.

    I think we can surmise why SCAM has not set up any such similar scheme:
    – they don’t care whether or not patients suffer any adverse events – caveat emptor.
    – they lack the knowledge and administrative ability to run any such scheme.
    – they are terrified that if adverse events from SCAM were recorded accurately it would scare prospective patients away.
    – they do not wish to find out what adverse effects their given version of magic fairy dust may produce – ignorance is bliss after all.
    – they are afraid it would provide ammunition for law-suits.
    – they know perfectly well that no SCAMmer would ever admit to causing an adverse event truthfully – after the whole enterprise is run on fiction. Even SCAMmers are not daft enough to think anyone would believe a 0% adverse event rate – after all there is such a thing as the nocebo effect!
    – they are just too busy fleecing punters and doing pretend studies to bother with such window dressing

    It is uncommon for there to be proper attention given to any adverse events in any paper on SCAM – this is not just sloppy and careless: it shows the underlying “belief” system which holds that their given SCAM is magical and can do no harm.

  • I’m still waiting for any evidence for “mind” to appear. Double dissociation of brain and “mind” has not yet been demonstrated.
    Gerald Edelman says it’s just an illusion of consiousness, I heartily agree.
    Any “mind-body” stuff is a SCAM.

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