Evidence map›Paper›PMID 27139441›Full record

Trial reportThe American journal of tropical medicine and hygiene2016

Adverse Events from a Randomized, Multi-Arm, Placebo-Controlled Trial of Mebendazole in Children 12-24 Months of Age.

Serene A Joseph, Antonio Montresor, Martín Casapía, Lidsky Pezo, Theresa W Gyorkos

Open access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The American journal of tropical medicine and hygiene, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 2 pooled it
1.7field-weighted citation impact, top 18% of its field
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

6 citing papers in PubMed, 2 syntheses or guidelines pooled it, 9 citations in OpenAlex.

  1. Meta-analysis and public policy: Reconciling the evidence on deworming.Proceedings of the National Academy of Sciences of the United States of America · 2024
    Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. Article
  6. Effectiveness and Tolerability of 3-Day Mebendazole Treatment ofCurrent therapeutic research, clinical and experimental · 2018
    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 at 4 institutions in 3 countries.

Serene A JosephDepartment of Epidemiology, Biostatistics and Occupational Health, McGill University, Montréal, Québec, Canada. Division of Clinical Epidemiology, Research Institute of the McGill University Health Centre, Montréal, Québec, Canada.
Antonio MontresorDepartment of Control of Neglected Tropical Diseases, World Health Organization, Geneva, Switzerland.
Martín CasapíaAsociación Civil Selva Amazónica, Iquitos, Peru.
Lidsky PezoAsociación Civil Selva Amazónica, Iquitos, Peru.
Theresa W GyorkosDepartment of Epidemiology, Biostatistics and Occupational Health, McGill University, Montréal, Québec, Canada. Division of Clinical Epidemiology, Research Institute of the McGill University Health Centre, Montréal, Québec, Canada. theresa.gyorkos@mcgill.ca.
Asociación para la Conservación de la Cuenca Amazónica · PEMcGill University · CAMcGill University Health Centre · CAWorld Health Organization · CH

Funding

World Health Organization 001
6 · The paper itself

Abstract

Large-scale deworming interventions, using anthelminthic drugs, are recommended in areas where the prevalence of soil-transmitted helminth infection is high. Anthelminthic safety has been established primarily in school-age children. Our objective was to provide evidence on adverse events from anthelminthic use in early childhood. A randomized multi-arm, placebo-controlled trial of mebendazole, administered at different times and frequencies, was conducted in children 12 months of age living in Iquitos, Peru. Children were followed up to 24 months of age. The association between mebendazole administration and the occurrence of a serious or minor adverse event was determined using logistic regression. There was a total of 1,686 administrations of mebendazole and 1,676 administrations of placebo to 1,760 children. Eighteen serious adverse events (i.e., 11 deaths and seven hospitalizations) and 31 minor adverse events were reported. There was no association between mebendazole and the occurrence of a serious adverse event (odds ratio [OR] = 1.21; 95% confidence interval [CI] = 0.47, 3.09) or a minor adverse event (OR = 0.84; 95% CI = 0.41, 1.72). Results from our trial support evidence of safety in administering mebendazole during early childhood. These results support World Health Organization deworming policy and the scaling up of interventions to reach children as of 12 months of age in endemic areas.

Indexed as

AnthelminticsChild, PreschoolDouble-Blind MethodFeasibility StudiesHelminthiasisHumansInfantLogistic ModelsMebendazoleMultivariate AnalysisPeruPrevalenceSocioeconomic FactorsSoilAnthelminticsMebendazoleSoil

Identifiers

PMID27139441
PMCPMC4944715
OpenAlexW2345825478

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.