Volume 162, 13 March 2015, Pages 1–6
Review
Characterizing the human equivalent dose of herbal medicines in animal toxicity studies ☆
Abstract
Ethnopharmacological relevance
Herbal
medicines have been generally believed to be safe. With the increasing
use of herbal medicine worldwide, however, the safety of traditional
herbal drugs frequently becomes a medical issue.
Aim of the study
This
study was aimed to characterize the safe dose of herbal medicines
through the systematic review for “human equivalent dose (HED)” from
animal-based toxicity studies.
Methods and materials
A
literature search for animal-based toxicity studies of herbal medicines
in eight databases, including PubMed and Embase, was performed without
language restriction. From the “no observed adverse effect level
(NOAEL)” of each animal study, HED values were then calculated according
to the composition (single or multiple herbs) and indication of the
medicines.
Results
Among 729
relevant articles identified in the initial screening, 112 (233 studies
comprising 105 single-herb and 128 multiple-herb studies) that met our
inclusion criteria were finally reviewed. The total average HED value
(from mouse, rat, rabbit and dog) was 278.1±358.0 mg/kg, and the values
for single- and multiple-herb studies were 322.7±488.4 mg/kg and
241.5±189.2 mg/kg, respectively. When the studies were analyzed
according to herbal drug indication, drugs used for revitalization had
the highest HED value (433.0±265.2 mg/kg), while those for infectious
diseases had the lowest (110.6±118.6 mg/kg).
Conclusions
Our
results provide important information regarding the safe dose of herbal
medicines; thus, these data offer researchers and practitioners
information critical for drug development or clinical application.
Graphical abstract
Keywords
- Adverse drug reaction;
- HED;
- Herbal medicine;
- NOAEL safety
- ☆
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- Corresponding author. Tel.:
+82 42 229 6723; fax: +82 42 257 6398.
- 1
- These authors contributed equally to this work.
Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.
