Citation

Sharma V, Gelin LFF, Sarkar IN. Bioinformatics and Biology Insights 2020; 14.

Copyright

(Copyright © 2020)

DOI

10.1177/1177932220921350

PMID

unavailable

Abstract

The efficacy and safety of herbal supplements suffer from challenges due to non-uniform representation of ingredient terms within biomedical and observational health data sources. The nature of how supplement data are reported within Spontaneous Reporting Systems (SRS) can limit analyses of supplement-associated adverse events due to the use of incorrect nomenclature or failing to identify herbs. This study aimed to extract, standardize, and summarize supplement-relevant reports from two SRSs: (1) Food and Drug Administration Adverse Event Reporting System (FAERS) and (2) Canada Vigilance Adverse Reaction (CVAR) database. A thesaurus of plant names was developed and integrated with a mapping and normalization approach that accommodated misspellings and variants. The reports gathered from FAERS between the years 2004 and 2016 show 185,915 herbal and 7,235,330 non-herbal accounting for 2.51%. The data from CVAR found 36,940 reports of herbal and 503,580 non-herbal reports between the years 1965 and 2017 for a total of 6.83%. Although not all cases were actual adverse events due to numerous variables and incomplete reporting, it is interesting to note that the herbs most frequently reported and significantly associated with adverse events were as follows: Avena sativa (Oats), Cannabis sativa (marijuana), Digitalis purpurea (foxglove), Humulus lupulus (hops), Hypericum perforatum (St John's Wort), Paullinia cupana (guarana), Phleum pretense (timothy-grass), Silybum marianum (milk thistle), Taraxacum officinale (Dandelion), and Valeriana officinalis (valerian). Using a scalable approach for mapping and resolution of herb names allowed data-driven exploration of potential adverse events from sources that have remained isolated in this specific area of research. The results from this study highlight several herb-associated safety issues providing motivation for subsequent in-depth analyses, including those that focus on the scope and severity of potential safety issues with supplement use. © The Author(s) 2020.

Language: en

Keywords

human; cannabis; suicidal ideation; depression; psychosis; suicide attempt; drug overdose; fatigue; vomiting; mental disease; cognitive defect; tachycardia; unclassified drug; neutropenia; Cannabis sativa; anxiety disorder; urine retention; constipation; nonhuman; confusion; diarrhea; nausea; tremor; delirium; acute kidney failure; hypertension; side effect; withdrawal syndrome; asthenia; heart disease; immunopathology; respiratory failure; paresthesia; Hypericum perforatum; dizziness; pancytopenia; unspecified side effect; Hypericum perforatum extract; urinary tract infection; herbaceous agent; dysarthria; Article; unconsciousness; hypokalemia; hyperkalemia; skin disease; taxonomy; multiple myeloma; valerian; ascites; hepatobiliary disease; joint swelling; garlic extract; adverse event; pharmacovigilance; Adverse Event Detection; alfalfa; Avena sativa extract; cranberry; Curcuma longa extract; Digitalis purpurea; Digitalis purpurea extract; flax; ginger extract; guarana; guarana extract; herbal; Humulus lupulus; Humulus lupulus extract; hypophagia; indexing; Linum usitatissimum extract; Medicago sativa extract; oat; Phleum pratense; Phleum pratense extract; Senna alexandrina; Senna alexandrina extract; Silybum marianum; sinecatechins; soybean extract; Spontaneous Reporting Systems; Taraxacum officinale; Taraxacum officinale extract; Vaccinium macrocarpon extract; Vaccinium myrtillus extract; Valeriana officinalis