Trial reportPLoS neglected tropical diseases2010
A randomized controlled trial of local heat therapy versus intravenous sodium stibogluconate for the treatment of cutaneous Leishmania major infection.
Trial report in PLoS neglected tropical diseases, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers, 4 of them syntheses that pooled 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.
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
35 citing papers in PubMed, 4 syntheses or guidelines pooled it, 98 citations in OpenAlex.
- Interventions for Old World cutaneous leishmaniasis.The Cochrane database of systematic reviews · 2017Pooled it
- Interventions for Old World cutaneous leishmaniasis.The Cochrane database of systematic reviews · 2017Pooled it
- Efficacy of thermotherapy to treat cutaneous leishmaniasis: a meta-analysis of controlled clinical trials.PloS one · 2015Pooled it
- Species-directed therapy for leishmaniasis in returning travellers: a comprehensive guide.PLoS neglected tropical diseases · 2014Pooled it
- A phase II multicenter randomized study to evaluate the safety and efficacy of combining thermotherapy and a short course of miltefosine for the treatment of uncomplicated cutaneous leishmaniasis in the New World.PLoS neglected tropical diseases · 2022Trial
- Efficacy, Safety and Cost-Effectiveness of Thermotherapy in the Treatment ofThe American journal of tropical medicine and hygiene · 2017Trial
- A randomized controlled phase IIb wound healing trial of cutaneous leishmaniasis ulcers with 0.045% pharmaceutical chlorite (DAC N-055) with and without bipolar high frequency electro-cauterization versus intralesional antimony in Afghanistan.BMC infectious diseases · 2014Trial
- Trial
- Bone Marrow-Derived Mesenchymal Stem Cells Alleviate Cutaneous Leishmaniasis by Promoting M2 Macrophage Polarization and Skin Tissue Repair in a Murine Model.Biomolecules · 2026Article
- Alternative Non-Drug Treatment Options of the Most Neglected Parasitic Disease Cutaneous Leishmaniasis: A Narrative Review.Tropical medicine and infectious disease · 2023Review
- Field-Deployable Treatments For Leishmaniasis: Intrinsic Challenges, Recent Developments and Next Steps.Research and reports in tropical medicine · 2023Review
- How I Approach Leishmaniasis: Diagnosis and Treatment in the United States.Journal of the Pediatric Infectious Diseases Society · 2022Article
- Cutaneous Leishmaniasis: A 2022 Updated Narrative Review into Diagnosis and Management Developments.American journal of clinical dermatology · 2022Review
- Establish an allele-specific real-time PCR for Leishmania species identification.Infectious diseases of poverty · 2022Article
- Treatment of Cutaneous Leishmaniasis and Insights into Species-Specific Responses: A Narrative Review.Infectious diseases and therapy · 2022Review
- Detection of cutaneous leishmaniasis in three communities of Oti Region, Ghana.PLoS neglected tropical diseases · 2021Article
- Heat therapy for cutaneous leishmaniasis: A literature Review.Journal of research in medical sciences : the official journal of Isfahan University of Medical Sciences · 2021Review
- Application of laser for treatment of cutaneous leishmaniasis: a review of literature.Lasers in medical science · 2020Review
- Failure of an Innovative Low-Cost, Noninvasive Thermotherapy Device for Treating Cutaneous Leishmaniasis Caused byThe American journal of tropical medicine and hygiene · 2019Observational
- Exploiting knowledge on pharmacodynamics-pharmacokinetics for accelerated anti-leishmanial drug discovery/development.Expert opinion on drug metabolism & toxicology · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundCutaneous Leishmania major has affected many travelers including military personnel in Iraq and Afghanistan. Optimal treatment for this localized infection has not been defined, but interestingly the parasite is thermosensitive. METHODOLOGY/PRINCIPAL
findingsParticipants with parasitologically confirmed L. major infection were randomized to receive intravenous sodium stibogluconate (SSG) 20mg/kg/day for ten doses or localized ThermoMed (TM) device heat treatment (applied at 50 degrees C for 30 seconds) in one session. Those with facial lesions, infection with other species of Leishmania, or more than 20 lesions were excluded. Primary outcome was complete re-epithelialization or visual healing at two months without relapse over 12 months. Fifty-four/56 enrolled participants received intervention, 27 SSG and 27 TM. In an intent to treat analysis the per subject efficacy at two months with 12 months follow-up was 54% SSG and 48% TM (p = 0.78), and the per lesion efficacy was 59% SSG and 73% TM (p = 0.053). Reversible abdominal pain/pancreatitis, arthralgias, myalgias, headache, fatigue, mild cytopenias, and elevated transaminases were more commonly present in the SSG treated participants, whereas blistering, oozing, and erythema were more common in the TM arm. CONCLUSIONS/SIGNIFICANCE: Skin lesions due to L. major treated with heat delivered by the ThermoMed device healed at a similar rate and with less associated systemic toxicity than lesions treated with intravenous SSG. CLINICAL
trial registrationClinicalTrials.gov NCT 00884377.
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What OpenQuestion holds
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.