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Methods for estimating causal relationships of adverse events with dietary supplements.

ABSTRACT: OBJECTIVE:Dietary supplement use has increased over past decades, resulting in reports of potentially serious adverse events. The aim of this study was to develop optimised methods to evaluate the causal relationships between adverse events and dietary supplements, and to test these methods using case reports. DESIGN:Causal relationship assessment using prospectively collected data. SETTING AND PARTICIPANTS:4 dietary supplement experts, 4 pharmacists and 11 registered dietitians (5 men and 14 women) examined 200 case reports of suspected adverse events using the modified Naranjo scale and the modified Food and Drug Administration (FDA) algorithm. PRIMARY OUTCOME MEASURES:The distribution of evaluation results was analysed and inter-rater reliability was evaluated for the two modified methods employed using intraclass correlation coefficients (ICC) and Fleiss' ?. RESULTS:Using these two methods, most of the 200 case reports were categorised as 'lack of information' or 'possible' adverse events. Inter-rater reliability among entire assessors ratings for the two modified methods, based on ICC and Fleiss' ?, were classified as more than substantial (modified Naranjo scale: ICC (95% CI) 0.873 (0.850 to 0.895); Fleiss' ? (95% CI) 0.615 (0.615 to 0.615). Modified FDA algorithm: Fleiss' ? (95% CI) 0.622 (0.622 to 0.622). CONCLUSIONS:These methods may help to assess the causal relationships between adverse events and dietary supplements. By conducting additional studies of these methods in different populations, researchers can expand the possibilities for the application of our methods.

SUBMITTER: Ide K

PROVIDER: S-EPMC4663420 | biostudies-literature | 2015 Nov

REPOSITORIES: biostudies-literature

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Methods for estimating causal relationships of adverse events with dietary supplements.

Ide Kazuki K Yamada Hiroshi H Kitagawa Mamoru M Kawasaki Yohei Y Buno Yuma Y Matsushita Kumi K Kaji Masayuki M Fujimoto Kazuko K Waki Masako M Nakashima Mitsuyoshi M Umegaki Keizo K

BMJ open 20151125 11

<h4>Objective</h4>Dietary supplement use has increased over past decades, resulting in reports of potentially serious adverse events. The aim of this study was to develop optimised methods to evaluate the causal relationships between adverse events and dietary supplements, and to test these methods using case reports.<h4>Design</h4>Causal relationship assessment using prospectively collected data.<h4>Setting and participants</h4>4 dietary supplement experts, 4 pharmacists and 11 registered dieti ...[more]

PMID: 26608636

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Project description:BACKGROUND:Dietary supplements, such as herbal or complementary nutritional products and micronutrients (vitamins and minerals), are commonly used in the United States, yet national data on adverse effects are limited. METHODS:We used nationally representative surveillance data from 63 emergency departments obtained from 2004 through 2013 to describe visits to U.S. emergency departments because of adverse events related to dietary supplements. RESULTS:On the basis of 3667 cases, we estimated that 23,005 (95% confidence interval [CI], 18,611 to 27,398) emergency department visits per year were attributed to adverse events related to dietary supplements. These visits resulted in an estimated 2154 hospitalizations (95% CI, 1342 to 2967) annually. Such visits frequently involved young adults between the ages of 20 and 34 years (28.0% of visits; 95% CI, 25.1 to 30.8) and unsupervised children (21.2% of visits; 95% CI, 18.4 to 24.0). After the exclusion of unsupervised ingestion of dietary supplements by children, 65.9% (95% CI, 63.2 to 68.5) of emergency department visits for single-supplement-related adverse events involved herbal or complementary nutritional products; 31.8% (95% CI, 29.2 to 34.3) involved micronutrients. Herbal or complementary nutritional products for weight loss (25.5%; 95% CI, 23.1 to 27.9) and increased energy (10.0%; 95% CI, 8.0 to 11.9) were commonly implicated. Weight-loss or energy products caused 71.8% (95% CI, 67.6 to 76.1) of supplement-related adverse events involving palpitations, chest pain, or tachycardia, and 58.0% (95% CI, 52.2 to 63.7) involved persons 20 to 34 years of age. Among adults 65 years of age or older, choking or pill-induced dysphagia or globus caused 37.6% (95% CI, 29.1 to 46.2) of all emergency department visits for supplement-related adverse events; micronutrients were implicated in 83.1% (95% CI, 73.3 to 92.9) of these visits. CONCLUSIONS:An estimated 23,000 emergency department visits in the United States every year are attributed to adverse events related to dietary supplements. Such visits commonly involve cardiovascular manifestations from weight-loss or energy products among young adults and swallowing problems, often associated with micronutrients, among older adults. (Funded by the Department of Health and Human Services.).

Project description:Microalgal food supplements are becoming increasingly popular due to their promising biological effects and high nutritional value, evidenced in in vitro, in vivo, and human studies. Some products of this kind have, however, raised controversies concerning their safety. At the same time, not much is known about the frequency of adverse events following the use of microalgal supplements, potential factors that may influence them, and general characteristics and behaviours of the consumer group. The present study aimed to fill this gap and surveyed a group of Polish consumers of microalgal products (n = 150) using an online questionnaire. As found, microalgal supplements (Spirulina, Chlorella, and Aphanizomenon) were popular in groups representing lacto-ovo-vegetarianism and veganism and were consumed predominantly for nutritional, immune-boosting, and detoxifying purposes. Their use was rarely discussed with specialists; the Internet constituted the most important source of information regarding these supplements. The most frequently self-reported health-beneficial effects of supplementation included the following: increased immunity, higher vitality, improved hair and skin quality, and better general well-being. Diarrhoea, nausea, abdominal pain, and skin rash were among the most often reported adverse events. Pre-existing medical conditions, namely renal failure and hypothyroidism, but not Hashimoto's thyroiditis, were associated with increased occurrence of side effects. Those individuals who had consulted specialists as to the use of supplements reported adverse events significantly less often. A strikingly high frequency of side effects and very low consumer satisfaction were reported by a group of consumers supplementing Aphanizomenon-based products. In summary, the present study highlights that microalgal consumers may benefit from additional warnings of potential side effects and from consulting a qualified health specialist prior to use.

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Methods for estimating causal relationships of adverse events with dietary supplements.

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Methods for estimating causal relationships of adverse events with dietary supplements.

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