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

Ide K, Yamada H, Kitagawa M, Kawasaki Y, Buno Y, Matsushita K, Kaji M, Fujimoto K, Waki M, Nakashima M, Umegaki K - BMJ Open (2015)

Bottom Line: Dietary supplement use has increased over past decades, resulting in reports of potentially serious adverse events.Causal relationship assessment using prospectively collected data. 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.Modified FDA algorithm: Fleiss' κ (95% CI) 0.622 (0.622 to 0.622).

View Article: PubMed Central - PubMed

Affiliation: Department of Drug Evaluation & Informatics, Graduate School of Pharmaceutical Sciences, University of Shizuoka, Shizuoka, Japan.

No MeSH data available.


Related in: MedlinePlus

Modified Naranjo scale.
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BMJOPEN2015009038F1: Modified Naranjo scale.

Mentions: The modified Naranjo scale is shown in figure 1. The phrase ‘drug’ in the Naranjo scale was changed to ‘dietary supplement’. The section in question 3 of the Naranjo scale pertaining to a specific antagonist was deleted. Questions regarding placebo and blood (or other fluid) concentrations were excluded. In addition to these changes, the scoring for questions pertaining to readministration and confirmation by objective evidence was changed by adding one point for positive answers to the original version of the Naranjo scale. The adverse event reports were assigned to a probability category using the total scores as follows: ≥9 highly probable, 5–8 probable, 3–4 highly possible, 1–2 possible, ≤0 unlikely. Case reports lacking information about time relationships were excluded and categorised as ‘lack of information’.


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

Ide K, Yamada H, Kitagawa M, Kawasaki Y, Buno Y, Matsushita K, Kaji M, Fujimoto K, Waki M, Nakashima M, Umegaki K - BMJ Open (2015)

Modified Naranjo scale.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4663420&req=5

BMJOPEN2015009038F1: Modified Naranjo scale.
Mentions: The modified Naranjo scale is shown in figure 1. The phrase ‘drug’ in the Naranjo scale was changed to ‘dietary supplement’. The section in question 3 of the Naranjo scale pertaining to a specific antagonist was deleted. Questions regarding placebo and blood (or other fluid) concentrations were excluded. In addition to these changes, the scoring for questions pertaining to readministration and confirmation by objective evidence was changed by adding one point for positive answers to the original version of the Naranjo scale. The adverse event reports were assigned to a probability category using the total scores as follows: ≥9 highly probable, 5–8 probable, 3–4 highly possible, 1–2 possible, ≤0 unlikely. Case reports lacking information about time relationships were excluded and categorised as ‘lack of information’.

Bottom Line: Dietary supplement use has increased over past decades, resulting in reports of potentially serious adverse events.Causal relationship assessment using prospectively collected data. 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.Modified FDA algorithm: Fleiss' κ (95% CI) 0.622 (0.622 to 0.622).

View Article: PubMed Central - PubMed

Affiliation: Department of Drug Evaluation & Informatics, Graduate School of Pharmaceutical Sciences, University of Shizuoka, Shizuoka, Japan.

No MeSH data available.


Related in: MedlinePlus