Evidence map›Paper›PMID 29627926›Full record

Observational studyDrug safety2018

The Burden of Adverse Drug Reactions Due to Artemisinin-Based Antimalarial Treatment in Selected Ugandan Health Facilities: An Active Follow-Up Study.

Helen Byomire Ndagije, Victoria Nambasa, Leonard Manirakiza, Donna Kusemererwa, Dan Kajungu, Sten Olsson, Niko Speybroeck

Open access · hybridAbstract readObservational Study
In one paragraph

Observational study in Drug safety, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 2 pooled it
7.5field-weighted citation impact, top 3% 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

12 citing papers in PubMed, 2 syntheses or guidelines pooled it, 35 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. Article
  6. The Regulatory Effects of Traditional Chinese Medicine on Ferroptosis.Oxidative medicine and cellular longevity · 2022
    Review
  7. Review
  8. Observational
  9. Article
  10. Article
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  12. Cardiotoxicity and Cardioprotection by Artesunate in Larval Zebrafish.Dose-response : a publication of International Hormesis Society
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 4 institutions in 3 countries.

Helen Byomire NdagijeNational Pharmacovigilance Centre, National Drug Authority, Kampala, Uganda. hbyomire@nda.or.ug.ORCID http://orcid.org/0000-0001-5802-4791
Victoria NambasaNational Pharmacovigilance Centre, National Drug Authority, Kampala, Uganda.
Leonard ManirakizaNational Pharmacovigilance Centre, National Drug Authority, Kampala, Uganda.
Donna KusemererwaNational Pharmacovigilance Centre, National Drug Authority, Kampala, Uganda.
Dan KajunguMakerere University Centre for Health and Population Research (MUCHAP), Iganga, Kampala, Uganda.
Sten OlssonSten Olsson Pharmacovigilance Consulting, Uppsala, Sweden.
Niko SpeybroeckInstitute of Health and Society (IRSS), Université Catholique de Louvain, Brussels, Belgium.
Ericsson (Sweden) · SEMakerere University · UGUCLouvain · BEUganda National Meteorological Authority · UG

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionUganda has rapidly increased access to antimalarial medicines in an effort to address the huge malaria disease burden. Pharmacovigilance information is important to guide policy decisions.

objectivesThe purpose of this study was to establish the burden of adverse drug reactions (ADRs) and associated risk factors for developing ADRs to artemisinin-based antimalarial treatment in Uganda.

methodsAn active follow-up study was conducted between April and July 2017 in a cohort of patients receiving treatment for uncomplicated malaria in the Iganga, Mayuge, and Kampala districts.

resultsA total of 782 patients with a median age of 22 years (58.6% females) were recruited into this study, with the majority recruited from public health facilities (97%). Diagnostic tests before treatment were performed for 76% of patients, and 97% of patients received artemether/lumefantrine. The prevalence of ADRs was 22.5% (176/782); however, the total number of ADRs was 245 since some patients reported more than one ADR. The most commonly reported reactions were general body weakness (24%), headache (13%), and dizziness (11%). Women were more likely to develop an ADR (adjusted odds ratio [aOR] 1.8, 95% confidence interval [CI] 1.1-2.9), urban dwellers were more likely to develop an ADR than rural residents (aOR 9.9, 95% CI 5.4-17.9), and patients with comorbidities were more likely to develop an ADR than those without (aOR 7.4, 95% CI 4.4-12.3).

conclusionThe burden of ADRs is high among women and in patients from urban settings and those with comorbidities. Such risk factors need to be considered in order to optimise therapy. Close monitoring of ADRs is key in implementation of the malaria treatment policy.

Indexed as

Anti-Infective AgentsAntimalarialsArtemisininsCohort StudiesCommunity Health CentersDrug-Related Side Effects and Adverse ReactionsFemaleFollow-Up StudiesHumansLongitudinal StudiesMaleTreatment OutcomeUgandaAnti-Infective AgentsAntimalarialsartemisininArtemisinins

Identifiers

PMID29627926
PMCPMC6061396
OpenAlexW2796055571

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.