Trial reportMalaria journal2005
Safety of the methylene blue plus chloroquine combination in the treatment of uncomplicated falciparum malaria in young children of Burkina Faso [ISRCTN27290841].
Trial report in Malaria journal, 2005. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers, 3 of them syntheses that pooled it.
What it found
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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.
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.
Who cites it
33 citing papers in PubMed, 3 syntheses or guidelines pooled it, 61 citations in OpenAlex.
- 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 · 2021Pooled it
- Efficacy and safety of methylene blue in the treatment of malaria: a systematic review.BMC medicine · 2018Pooled it
- Prevalence, genetic variants and clinical implications of G-6-PD deficiency in Burkina Faso: a systematic review.BMC medical genetics · 2017Pooled it
- Trial
- High absolute bioavailability of methylene blue given as an aqueous oral formulation.European journal of clinical pharmacology · 2009Trial
- Strong gametocytocidal effect of methylene blue-based combination therapy against falciparum malaria: a randomised controlled trial.PloS one · 2009Trial
- Efficacy of amodiaquine in the treatment of uncomplicated falciparum malaria in young children of rural north-western Burkina Faso.Malaria journal · 2008Trial
- Trial
- Methylene blue for malaria in Africa: results from a dose-finding study in combination with chloroquine.Malaria journal · 2006Trial
- G6PD Variants and Haemolytic Sensitivity to Primaquine and Other Drugs.Frontiers in pharmacology · 2021Review
- Antidotal effects of methylene blue against cyanide neurological toxicity: in vivo and in vitro studies.Annals of the New York Academy of Sciences · 2020Article
- Analysis of the active fraction of IranianIranian journal of basic medical sciences · 2020Article
- A Study of Synergy of Combination of Eosin B with Chloroquine, Artemisinin, and Sulphadoxine-Pyrimethamine onJournal of tropical medicine · 2020Article
- Revisiting the physiological effects of methylene blue as a treatment of cyanide intoxication.Clinical toxicology (Philadelphia, Pa.) · 2018Article
- Differential activity of methylene blue against erythrocytic and hepatic stages of Plasmodium.Malaria journal · 2018Article
- A high susceptibility to redox imbalance of the transmissible stages of Plasmodium falciparum revealed with a luciferase-based mature gametocyte assay.Molecular microbiology · 2017Article
- The Interactions of P-Glycoprotein with Antimalarial Drugs, Including Substrate Affinity, Inhibition and Regulation.PloS one · 2016Article
- Potent Ex Vivo Activity of Naphthoquine and Methylene Blue against Drug-Resistant Clinical Isolates of Plasmodium falciparum and Plasmodium vivax.Antimicrobial agents and chemotherapy · 2015Article
- Efficacy of intravenous methylene blue, intravenous artesunate, and their combination in preclinical models of malaria.Malaria journal · 2014Article
- PharmGKB summary: methylene blue pathway.Pharmacogenetics and genomics · 2013Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors at 3 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundSafe, effective and affordable drug combinations against falciparum malaria are urgently needed for the poor populations in malaria endemic countries. Methylene blue (MB) combined with chloroquine (CQ) has been considered as one promising new regimen.
objectivesThe primary objective of this study was to evaluate the safety of CQ-MB in African children with uncomplicated falciparum malaria. Secondary objectives were to assess the efficacy and the acceptance of CQ-MB in a rural population of West Africa.
methodsIn this hospital-based randomized controlled trial, 226 children (6-59 months) with uncomplicated falciparum malaria were treated in Burkina Faso. The children were 4:1 randomized to CQ-MB (n = 181; 25 mg/kg CQ and 12 mg/kg MB over three days) or CQ (n = 45; 25 mg/kg over three days) respectively. The primary outcome was the incidence of severe haemolysis or other serious adverse events (SAEs). Efficacy outcomes were defined according to the WHO 2003 classification system. Patients were hospitalized for four days and followed up until day 14.
resultsNo differences in the incidence of SAEs and other adverse events were observed between children treated with CQ-MB (including 24 cases of G6PD deficiency) compared to children treated with CQ. There was no case of severe haemolysis and also no significant difference in mean haemoglobin between study groups. Treatment failure rates were 53.7% (95% CI [37.4%; 69.3%]) in the CQ group compared to 44.0% (95% CI [36.3%; 51.9%]) in the CQ-MB group.
conclusionMB is safe for the treatment of uncomplicated falciparum malaria, even in G6PD deficient African children. However, the efficacy of the CQ-MB combination has not been sufficient at the MB dose used in this study. Future studies need to assess the efficacy of MB at higher doses and in combination with appropriate partner drugs.
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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.