Up to 18% of soldiers reported adverse events in expert survey

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The new survey was published online recently and will appear in the March print version of the journal. Food and chemical toxicology​. The report was the work of researchers associated with the US Army and US Navy.

Adverse events associated with many categories

The survey was designed to assess the rate of adverse events experienced by service members of the United States Army, Navy, Air Force, and Marine Corps who use dietary supplements. The survey was distributed to approximately 200,000 active service members, of whom approximately 26,000 responded.

The authors grouped the survey results into broad categories, including before/after training; fat/weight loss; bodybuilding and vitamins/minerals.

The researchers found the following prevalence of more than one adverse event for the following categories:

  • Before/after training 18.3%
  • Fat/weight loss 14.8%
  • Bodybuilding 9.5%
  • Prohormone 8%
  • Protein, amino acid 6.3%
  • MVM (multivitamins, multiminerals) 6%
  • Multivitamin/mineral 5.6%
  • Herbs 4.3%
  • Joint Health 2%

The study also mentions respondents’ experience with individual products. Included in this section of the study are retrospective looks at some negative episodes with supplement use in the military, including an account of the DMAA affair.

Another statement in the conclusion makes it clear that the researchers started with the assumption that supplement use may pose a hazard to active duty personnel.

“The Department of Defense is aware that the use of DS may pose a hazard to the SM and therefore Operation Supplement Safety (a resource maintained by the University of Uniformed Services) provides SMs (service members) information on prohibited supplements and an index to verify efficacy and safety. DSs. This study identified adverse effects reported by users of specific DSs and identifies DSs that may be dangerous,”they concluded.

Expert: Problems with study limit usefulness

Rick Kingston, PharmD, is a professor at the University of Minnesota and vice president of scientific and regulatory affairs for the company SafetyCall International, which helps manage adverse event reports and product recalls for dietary supplements and customers. pharmaceuticals. As such, Kingston has experience in reviewing adverse event data. The current investigation has some issues that make it difficult to say whether it represents a true signal of any kind of safety issue with supplements, he said.

For starters, he said, without knowing how the survey was present to DMs, it’s hard to tell what biases might have been built into the reports. Companies that perform post-market surveillance for safety and reliability have a lot more upside in the game than casual survey respondents.

“The study announcement was not included, so it was unclear how the study was positioned with the SMs. A study designed to investigate adverse effects and promoted as such would likely have a bias because one would expect that SMs who typically use or are inclined to use DS and who have actually experienced adverse or side effects would be willing to participate” he said.

“Additional limitations include that there was no information on how many people stopped using the product due to AE, how severe the effects were, as not all AEs are created equal. “,he said.

Kingston said the study also aimed to find adverse events related to substances his company is rarely called upon to monitor because of their almost universal presumption of safety. This suggests concerns that his company, which now has many years of data relating to safety issues that may arise from post-marketing surveillance, has not observed.

It was also surprising to see ARs attributed to seemingly benign supplements such as those containing echinacea, vitamins C, D, K and B complexes, 100% whey, psyllium, milk thistle and more. ‘others.

The data suggests that each product class and individual product listed in their questionnaire reported adverse reactions within a limited time frame, which is not consistent with other general use surveys or certainly with the data we collect. »,Kingston said.

Putting it all together, Kingston said the survey was of limited use when it came to evaluating the safety of supplements.

Without further precision in terms of the exact nature of adverse effects, effects experienced, and review of incidents to exclude other likely contributing factors, the data is of limited utility,”he concluded.

Source:Food and chemical toxicity
Published online ahead of print doi.org/10.1016/j.fct.2022.112840
Adverse effects associated with the use of specific dietary supplements: the study on the use of dietary supplements by the United States military
Authors: Knapik JJ, et al.

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