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Adverse Events of Mind-Body Interventions in Children: A Systematic Review
Meagan Lyszczyk1, Mohammad Karkhaneh2, Kerri Kaiser Gladwin3
1Department of Medicine, University of Alberta, Edmonton, AB T6G 2G3, Canada.
Insights
Mind-body interventions (MBIs) are common in pediatrics, but safety data is lacking. This review found most pediatric MBI studies do not report adverse events, hindering safety assessments.
Area of Science:
- Pediatric Complementary and Alternative Medicine
- Mind-Body Interventions Safety
- Adverse Event Reporting
Background:
- Mind-body interventions (MBIs) are increasingly used in pediatric care.
- There is a significant gap in understanding the adverse events (AEs) associated with pediatric MBIs.
Purpose of the Study:
- To systematically review adverse events reported in studies of mind-body interventions in children.
- To assess the quality of safety reporting in pediatric MBI research.
Main Methods:
- Systematic review of electronic databases (MEDLINE, Embase, CINAHL, CDSR, CCRCT) from inception to August 2018.
- Inclusion of primary studies on participants aged 21 years or younger using MBIs.
- Analysis of AE reporting, including presence/absence, severity, and duration.
Main Results:
- Out of 441 primary pediatric MBI studies, 85.5% failed to report AEs or safety assessments.
- Of 64 studies reporting on AEs, 43 indicated no AEs occurred, and 21 reported a total of 37 AEs.
- Most studies reporting AEs lacked details on severity (81.0%) and duration (52.4%).
Conclusions:
- Pediatric mind-body intervention studies frequently lack adequate reporting of adverse events.
- The absence of comprehensive safety data limits the meaningful assessment of risks associated with pediatric MBIs.
- Further research is needed to establish standardized safety reporting for pediatric MBIs.
Abstract:
Mind-body interventions (MBIs) are one of the top ten complementary 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. In this systematic review the electronic databases MEDLINE, Embase, CINAHL, CDSR, and CCRCT were searched from inception to August 2018. We 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. There were 64 included studies: 43 experimental studies reported that no AE occurred, and 21 studies reported AEs. There were 37 AEs 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%). MBIs are popularly used in children; however associated harms are often not reported and lack important information for meaningful assessment.
