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 evaluat

SUBMITTER: Ide K 

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

REPOSITORIES: biostudies-literature