Evidence map›Paper›PMID 22594858›Full record

Trial reportTrials2012

Thermotherapy. An alternative for the treatment of American cutaneous leishmaniasis.

Liliana López, Martha Robayo, Margarita Vargas, Iván D Vélez

Erratum issued 3 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
In one paragraph

Trial report in Trials, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 3 registered trials, which are not on this map. Cited by 29 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 3 pooled it
6.0field-weighted citation impact, top 4% 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.

NCT04072874 phase1 / phase2withdrawnnot on this mapstarted 2021, after this paper: background citation

Evaluation of the Safety and Clinical Activity of Curaleish Lotion and Cream in the Topical Treatment of Cutaneous Leishmaniasis in Colombia

TypeinterventionalSponsorUniversidad de AntioquiaRan2021 to 2022Enrolled0ConditionsLeishmaniasis, CutaneousArmsExperimental topical (Curaleish Topical)
NCT05094908 phase1active not recruitingnot on this mapstarted 2023, after this paper: background citation

Randomized Clinical Trial to Evaluate the Safety and Therapeutic Response of Two ARNICA TINCTURE Treatment Regimes in the Topical Treatment of Uncomplicated Cutaneous Leishmaniasis in Colombia

TypeinterventionalSponsorUniversidad de AntioquiaRan2023 to 2025Enrolled16ConditionsLeishmaniasis, CutaneousArmsArnica Tincture
NCT06822478 phase3recruitingnot on this mapstarted 2026, after this paper: background citation

Randomized Blinded Clinical Trial to Evaluate the Safety and Efficacy of Arnica Tincture in the Topical Treatment of Cutaneous Leishmaniasis.

TypeinterventionalSponsorUniversidad de AntioquiaRan2026 to 2030Enrolled96ConditionsLeishmaniasis, CutaneousArmsArnica Tincture, Meglumine antimoniate.
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 3 syntheses or guidelines pooled it, 72 citations in OpenAlex.

  1. Interventions for American cutaneous and mucocutaneous leishmaniasis.The Cochrane database of systematic reviews · 2020
    Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Review
  7. Article
  8. Article
  9. Article
  10. Heat therapy for cutaneous leishmaniasis: A literature Review.Journal of research in medical sciences : the official journal of Isfahan University of Medical Sciences · 2021
    Review
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. Review
  19. Article
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

4 authors at 1 institution in 1 country.

Liliana LópezProgram for the Study and Control of Tropical Disease, University of Antioquia, Carrera 53 #61-30, Medellín, Colombia.
Martha Robayo
Margarita Vargas
Iván D Vélez
Universidad de Antioquia · CO

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPentavalent antimonials (Sb5) and miltefosine are the first-line drugs for treating cutaneous leishmaniasis in Colombia; however, toxicity and treatment duration negatively impact compliance and cost, justifying an active search for better therapeutic options. We compared the efficacy and safety of thermotherapy and meglumine antimoniate for the treatment of cutaneous leishmaniasis in Colombia.

methodAn open randomized Phase III clinical trial was performed in five military health centres. located in northwestern, central and southern Colombia. Volunteers with parasitological positive diagnosis (Giemsa-stained smears) of cutaneous leishmaniasis were included. A single thermotherapy session involving the application of 50°C at the center and active edge of each lesion. Meglumine antimoniate was administered intramuscularly at a dose of 20 mg Sb5/kg weight/day for 20 days.

resultsBoth groups were comparable. The efficacy of thermotherapy was 64% (86/134 patients) by protocol and 58% (86/149) by intention-to-treat. For the meglumine antimoniate group, efficacy by protocol was 85% (103/121 patients) and 72% (103/143) by intention-to-treat, The efficacy between the treatments was statistically significant (p 0.01 and < 0.001) for analysis by intention to treat and by protocol, respectively. There was no difference between the therapeutic response with either treatment regardless of the Leishmania species responsible for infection. The side effects of meglumine antimoniate included myalgia, arthralgia, headache and fever. Regarding thermotherapy, the only side effect was pain at the lesion area four days after the initiation of treatment.

conclusionAlthough the efficacy rate of meglumine antimoniate was greater than that of thermotherapy for the treatment of cutaneous leishmaniasis, the side effects were also greater. Those factors, added to the increased costs, the treatment adherence problems and the progressive lack of therapeutic response, make us consider thermotherapy as a first line treatment for cutaneous leishmaniasis.

Indexed as

Hyperthermia, InducedAdultAgedAntiprotozoal AgentsChi-Square DistributionColombiaDrug Administration ScheduleFemaleHealth FacilitiesHumansInjections, IntramuscularKaplan-Meier EstimateLeishmaniasis, CutaneousMaleMeglumineMeglumine AntimoniateAntiprotozoal AgentsMeglumineMeglumine AntimoniateOrganometallic Compounds

Identifiers

PMID22594858
PMCPMC3441257
OpenAlexW2122840008

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.