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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

(A) Distribution of results for the modified Naranjo scale. (B) Distribution of results for the modified Food and Drug Administration (FDA) algorithm.
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BMJOPEN2015009038F3: (A) Distribution of results for the modified Naranjo scale. (B) Distribution of results for the modified Food and Drug Administration (FDA) algorithm.

Mentions: The modified Naranjo scale and the modified FDA algorithm are shown in figures 1 and 2. All assessors evaluated 200 case reports using the modified Naranjo scale and the modified FDA algorithm. No results were missing from the case report evaluations. The distribution of evaluation results is shown in figure 3A, B. These case reports were based on voluntary consumer reports, included incomplete reporting and were not standardised for the evaluation of causal relationships. Most of the 200 case reports were categorised as ‘lack of information’ or ‘possible’. The median (range) of cases in ‘lack of information’ using the modified Naranjo scale was 64 (8-143) and the corresponding values using the modified FDA scale were 64 (8-142) cases. The ‘possible’ category included a median (range) of 88 (19-136) cases using the modified Naranjo scale and 90 (17-138) cases using the modified FDA scale. The information on dosage, previous similar events and objective evidence was particularly poorly reported in these case reports. A large proportion of the cases were mild. Skin symptoms such as pruritus (n=56) and gastrointestinal symptoms such as abdominal discomfort (n=62) were the most common. However, two serious adverse events related to hepatic dysfunction were reported. In one serious case, a woman started to take a dietary supplement for weight loss. Two weeks after commencing this treatment, her health deteriorated and she presented at a general hospital. Laboratory analyses revealed abnormal hepatic enzyme results and she was diagnosed with liver dysfunction. This condition resolved after over 2 weeks of hospitalisation. The attending doctor considered that the patient's dietary supplement had caused her liver dysfunction. In another case, a woman had been taking a dietary supplement for weight control for several months and had experienced fatigue for several weeks. She presented at a general hospital, where laboratory analyses revealed abnormal hepatic enzyme results and she was diagnosed with hepatitis. Her attending doctor considered that this was due to the dietary supplement. The patient's hepatitis improved after around 2 weeks’ hospitalisation.


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)

(A) Distribution of results for the modified Naranjo scale. (B) Distribution of results for the modified Food and Drug Administration (FDA) algorithm.
© Copyright Policy - open-access
Related In: Results  -  Collection

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

BMJOPEN2015009038F3: (A) Distribution of results for the modified Naranjo scale. (B) Distribution of results for the modified Food and Drug Administration (FDA) algorithm.
Mentions: The modified Naranjo scale and the modified FDA algorithm are shown in figures 1 and 2. All assessors evaluated 200 case reports using the modified Naranjo scale and the modified FDA algorithm. No results were missing from the case report evaluations. The distribution of evaluation results is shown in figure 3A, B. These case reports were based on voluntary consumer reports, included incomplete reporting and were not standardised for the evaluation of causal relationships. Most of the 200 case reports were categorised as ‘lack of information’ or ‘possible’. The median (range) of cases in ‘lack of information’ using the modified Naranjo scale was 64 (8-143) and the corresponding values using the modified FDA scale were 64 (8-142) cases. The ‘possible’ category included a median (range) of 88 (19-136) cases using the modified Naranjo scale and 90 (17-138) cases using the modified FDA scale. The information on dosage, previous similar events and objective evidence was particularly poorly reported in these case reports. A large proportion of the cases were mild. Skin symptoms such as pruritus (n=56) and gastrointestinal symptoms such as abdominal discomfort (n=62) were the most common. However, two serious adverse events related to hepatic dysfunction were reported. In one serious case, a woman started to take a dietary supplement for weight loss. Two weeks after commencing this treatment, her health deteriorated and she presented at a general hospital. Laboratory analyses revealed abnormal hepatic enzyme results and she was diagnosed with liver dysfunction. This condition resolved after over 2 weeks of hospitalisation. The attending doctor considered that the patient's dietary supplement had caused her liver dysfunction. In another case, a woman had been taking a dietary supplement for weight control for several months and had experienced fatigue for several weeks. She presented at a general hospital, where laboratory analyses revealed abnormal hepatic enzyme results and she was diagnosed with hepatitis. Her attending doctor considered that this was due to the dietary supplement. The patient's hepatitis improved after around 2 weeks’ hospitalisation.

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