Evidence map›Paper›PMID 18286187›Full record

Trial reportPloS one2008

Safety and efficacy of methylene blue combined with artesunate or amodiaquine for uncomplicated falciparum malaria: a randomized controlled trial from Burkina Faso.

Augustin Zoungrana, Boubacar Coulibaly, Ali Sié, Ingeborg Walter-Sack, Frank P Mockenhaupt, Bocar Kouyaté, R Heiner Schirmer, Christina Klose, Ulrich Mansmann, Peter Meissner and 1 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00354380 (Safety and Efficacy of Methylene Blue Combined With Artesunate or Amodiaquine for Malaria Treatment in Children of Burkina Faso), which is not on this map. Cited by 43 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed, 2 pooled it
9.8field-weighted citation impact, top 2% 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.

NCT00354380 phase2completednot on this map

Safety and Efficacy of Methylene Blue Combined With Artesunate or Amodiaquine for Malaria Treatment in Children of Burkina Faso: a Pilot Study

TypeinterventionalSponsorHeidelberg UniversityRan2006 to 2006ConditionsMalariaArmsMethylene blue, Artesunate, Amodiaquine
3 · Its place in the literature

Who cites it

43 citing papers in PubMed, 2 syntheses or guidelines pooled it, 94 citations in OpenAlex.

  1. Evaluating the safety of oral methylene blue during swallowing assessment: a systematic review.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2021
    Pooled it
  2. Pooled it
  3. Pharmacokinetics andAntimicrobial agents and chemotherapy · 2020
    Trial
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  10. Article
  11. Malaria: past, present, and future.Signal transduction and targeted therapy · 2025
    Review
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  13. Article
  14. Review
  15. TheFASEB journal : official publication of the Federation of American Societies for Experimental Biology · 2019
    Article
  16. Article
  17. Article
  18. Drugs that reduce transmission of falciparum malaria.The Lancet. Infectious diseases · 2018
    Article
  19. Review
  20. 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

11 authors at 4 institutions in 2 countries.

Augustin ZoungranaCentre de Recherche en Santé de Nouna, Nouna, Burkina Faso.
Boubacar Coulibaly
Ali Sié
Ingeborg Walter-Sack
Frank P Mockenhaupt
Bocar Kouyaté
R Heiner Schirmer
Christina Klose
Ulrich Mansmann
Peter Meissner
Olaf Müller
Heidelberg University · DECentre de Recherche en Santé de Nouna · BFCharité - Universitätsmedizin Berlin · DELudwig-Maximilians-Universität München · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBesides existing artemisinin-based combination therapies, alternative safe, effective and affordable drug combinations against falciparum malaria are needed. Methylene blue (MB) was the first synthetic antimalarial drug ever used, and recent studies have been promising with regard to its revival in malaria therapy. The objective of this study was to assess the safety and efficacy of two MB-based malaria combination therapies, MB-artesunate (AS) and MB-amodiaquine (AQ), compared to the local standard of care, AS-AQ, in Burkina Faso. METHODS AND

findingsOpen-label randomised controlled phase II study in 180 children aged 6-10 years with uncomplicated falciparum malaria in Nouna, north-western Burkina Faso. Follow-up was for 28 days and analysis by intention-to-treat. The treatment groups were similar in baseline characteristics and there was only one loss to follow-up. No drug-related serious adverse events and no deaths occurred. MB-containing regimens were associated with mild vomiting and dysuria. No early treatment failures were observed. Parasite clearance time differed significantly among groups and was the shortest with MB-AS. By day 14, the rates of adequate clinical and parasitological response after PCR-based correction for recrudescence were 87% for MB-AS, 100% for MB-AQ (p = 0.004), and 100% for AS-AQ (p = 0.003). By day 28, the respective figure was lowest for MB-AS (62%), intermediate for the standard treatment AS-AQ (82%; p = 0.015), and highest for MB-AQ (95%; p<0.001; p = 0.03).

conclusionsMB-AQ is a promising alternative drug combination against malaria in Africa. Moreover, MB has the potential to further accelerate the rapid parasite clearance of artemisinin-based combination therapies. More than a century after the antimalarial properties of MB had been described, its role in malaria control deserves closer attention.

trial registrationClinicalTrials.gov NCT00354380.

Indexed as

AmodiaquineArtemisininsArtesunateBurkina FasoDrug-Related Side Effects and Adverse ReactionsDrug Therapy, CombinationDysuriaHumansMalaria, FalciparumMethylene BlueSesquiterpenesTreatment OutcomeVomitingAmodiaquineArtemisininsArtesunateMethylene BlueSesquiterpenes

Identifiers

PMID18286187
PMCPMC2238815
OpenAlexW1965599026

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.