Evidence map›Paper›PMID 26936182›Full record

ArticleDrug safety2016

Allergy-Like Immediate Reactions with Herbal Medicines: A Retrospective Study Using Data from VigiBase®.

Jitka Pokladnikova, Ronald H B Meyboom, Ricarda Meincke, David Niedrig, Stefan Russmann

Abstract read
PubMed Publisher
In one paragraph

Article in Drug safety, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Review
  4. Review
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Jitka PokladnikovaDepartment of Social and Clinical Pharmacy, Faculty of Pharmacy in Hradec Kralove, Charles University in Prague, Heyrovskeho 1203, 50005, Hradec Kralove, Czech Republic. jitka.pokladnikova@faf.cuni.cz.
Ronald H B MeyboomWHO Collaborating Centre for International Drug Monitoring, Uppsala Monitoring Centre, Uppsala, Sweden.
Ricarda MeinckeDepartment of Social and Clinical Pharmacy, Faculty of Pharmacy in Hradec Kralove, Charles University in Prague, Heyrovskeho 1203, 50005, Hradec Kralove, Czech Republic.
David NiedrigDivision of Clinical Pharmacology and Toxicology, University Hospital Zurich, Zurich, Switzerland.
Stefan RussmannDivision of Clinical Pharmacology and Toxicology, University Hospital Zurich, Zurich, Switzerland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionHerbal medicines are used worldwide and with an increasing popularity in Western countries. Although often perceived as 'naturally safe', herbals may cause severe adverse drug reactions (ADRs), with immediate allergic reactions being particularly life threatening.

objectivesThe aim of this study was to analyse immediate allergy-like ADRs to herbals documented in VigiBase®, the WHO international pharmacovigilance database.

methodsThe documentation of all suspected ADRs in association with herbal exposure reported to VigiBase® from 1969 to August 2014 was retrieved. Among all reports in which WHO-ART reaction terms were indicative of acute allergic reactions, those classified as 'suspect' with a documented causality assessment and latency time of ≤1 day were selected. For the most frequent specific herbal-ADR combinations, the information component (IC) as a measure of disproportionality based on Bayesian statistics was calculated.

resultsWe identified 757 reports out of 1039 ADRs. Products with mixed herbals (36.0 %) as well as those administered orally (63.2 %) were predominant. The most frequent reactions were urticaria and rash (49.2 %). Anaphylactic reactions accounted for 9.5 %. Disproportionally frequent reporting of mouth edema (IC = 1.81) and anaphylactic reactions (IC = 1.24) to Phleum pretense were noted.

conclusionOur findings indicate that herbal medicines for oral use carry a risk of causing immediate allergy-like ADRs. Studies using the Vigibase® database can identify specific combinations of particular herbs and adverse reactions. Healthcare professionals and patients should be aware of these risks and report any serious adverse experiences.

Indexed as

AdolescentAdultAdverse Drug Reaction Reporting SystemsAgedAnaphylaxisDatabases, FactualDrug-Related Side Effects and Adverse ReactionsFemaleHerbal MedicineHumansHypersensitivityMaleMiddle AgedPharmacovigilancePlants, MedicinalRetrospective Studies

Identifiers

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.