Evidence map›Paper›PMID 28704363›Full record

Trial reportPLoS neglected tropical diseases2017

Uniform multidrug therapy for leprosy patients in Brazil (U-MDT/CT-BR): Results of an open label, randomized and controlled clinical trial, among multibacillary patients.

Gerson Oliveira Penna, Samira Bührer-Sékula, Lígia Regina Sansigolo Kerr, Mariane Martins de Araújo Stefani, Laura Cunha Rodrigues, Marcelo Grossi de Araújo, Andrea Machado Coelho Ramos, Ana Regina Coelho de Andrade, Maurício Barcelos Costa, Patricia Sammarco Rosa and 5 more

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in PLoS neglected tropical diseases, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00669643 (Independent Study to Establish the Efficacy of the Six Doses Uniform MDT Regimen), which is not on this map. Cited by 29 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 6 pooled it
–field-weighted citation impact
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.

NCT00669643 phase4completednot on this map

Independent Study to Establish the Efficacy of the Six Doses Uniform MDT Regimen (U-MDT) for Leprosy Patients

TypeinterventionalSponsorUniversity of BrasiliaRan2007 to 2016Enrolled859ConditionsLeprosyArmsPB 6 doses - Rifampicin and Dapsone, PB 6 doses - Rifampicin, Clofazimine and Dapsone, MB 12 doses - Rifampicin, Clofazimine and Dapsone, MB 6 doses - Rifampicin, Clofazimine and Dapsone
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 6 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Trial
  8. Trial
  9. Article
  10. Article
  11. Article
  12. Leprosy.Nature reviews. Disease primers · 2024
    Review
  13. Article
  14. Article
  15. Article
  16. Article
  17. Leprosy treatment: Can we replace opinions with research?PLoS neglected tropical diseases · 2020
    Article
  18. Article
  19. Leprosy stigma & the relevance of emergent therapeutic options.The Indian journal of medical research · 2020
    Article
  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

15 authors.

Gerson Oliveira PennaTropical Medicine Centre, University of Brasília, Brasília, and Fiocruz Brasília, Brazil.ORCID http://orcid.org/0000-0001-8967-536X
Samira Bührer-SékulaTropical Pathology and Public Health Institute, Federal University of Goiás, Goiânia, Goiás, Brazil.
Lígia Regina Sansigolo KerrDepartment of Public Health. Federal University of Ceará, Fortaleza, Ceará, Brazil.
Mariane Martins de Araújo StefaniTropical Pathology and Public Health Institute, Federal University of Goiás, Goiânia, Goiás, Brazil.
Laura Cunha RodriguesDepartment of Infectious and Tropical Diseases. London School of Hygiene and Tropical Medicine, London England.
Marcelo Grossi de AraújoDermatology Department, Clinical Hospital of Federal University of Minas Gerais, Belo Horizonte, Brazil.
Andrea Machado Coelho RamosDermatology Department, Clinical Hospital of Federal University of Minas Gerais, Belo Horizonte, Brazil.
Ana Regina Coelho de AndradeDermatology Department, Clinical Hospital of Federal University of Minas Gerais, Belo Horizonte, Brazil.
Maurício Barcelos CostaMedicine Faculty-Federal University of Goiás, Goiânia, Goiás, Brazil.
Patricia Sammarco RosaLauro de Souza Lima Institute, Baurú, São Paulo, Brazil.
Heitor de Sá GonçalvesDona Libânia Dermatology Centre, Ceará, Fortaleza, Ceará, Brazil.
Rossilene CruzTropical Dermatology and Venerology Alfredo da Matta Foundation, Manaus, Amazonas, Brazil.
Maurício Lima BarretoOswaldo Cruz Foundation-Gonçalo Muniz Research Institute, Salvador, Bahia, Brazil.
Maria Araci de Andrade PontesDona Libânia Dermatology Centre, Ceará, Fortaleza, Ceará, Brazil.
Maria Lúcia Fernandes PennaEpidemiology and Biostatistics Department, Federal University Fluminense, Niterói, Rio de Janeiro, Brazil.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLeprosy control is based on early diagnosis and multidrug therapy. For treatment purposes, leprosy patients can be classified as paucibacillary (PB) or multibacillary (MB), according to the number of skin lesions. Studies regarding a uniform treatment regimen (U-MDT) for all leprosy patients have been encouraged by the WHO, rendering disease classification unnecessary. METHODOLOGY AND

findingsAn independent, randomized, controlled clinical trial conducted from 2007 to 2015 in Brazil, compared main outcomes (frequency of reactions, bacilloscopic index trend, disability progression and relapse rates) among MB patients treated with a uniform regimen/U-MDT (dapsone+rifampicin+clofazimine for six months) versus WHO regular-MDT/R-MDT (dapsone+rifampicin+clofazimine for 12 months). A total of 613 newly diagnosed, untreated MB patients with high bacterial load were included. There was no statistically significant difference in Kaplan-Meyer survival function regarding reaction or disability progression among patients in the U-MDT and R-MDT groups, with more than 25% disability progression in both groups. The full mixed effects model adjusted for the bacilloscopic index average trend in time showed no statistically significant difference for the regression coefficient in both groups and for interaction variables that included treatment group. During active follow up, four patients in U-MDT group relapsed representing a relapse rate of 2.6 per 1000 patients per year of active follow up (95% CI [0·81, 6·2] per 1000). During passive follow up three patients relapsed in U-MDT and one in R-MTD. As this period corresponds to passive follow up, sensitivity analysis estimated the relapse rate for the entire follow up period between 2·9- and 4·5 per 1000 people per year.

conclusionOur results on the first randomized and controlled study on U-MDT together with the results from three previous studies performed in China, India and Bangladesh, support the hypothesis that UMDT is an acceptable option to be adopted in endemic countries to treat leprosy patients in the field worldwide.

trial registrationClinicalTrials.gov: NCT00669643.

Indexed as

AdolescentAdultAgedAged, 80 and overBrazilChildChild, PreschoolClofazimineDapsoneDrug Therapy, CombinationFemaleHumansInfantInfant, NewbornLeprostatic AgentsLeprosy, MultibacillaryClofazimineDapsoneLeprostatic AgentsRifampin

Identifiers

PMID28704363
PMCPMC5526599

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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.