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Primary results of Clinical Trial for Uniform Multidrug Therapy for Leprosy Patients in Brazil (U-MDT/CT-BR): reactions frequency in multibacillary patients
Maria Lucia Fernandes Penna
  Maria Lucia Fernandes Penna
Affiliation
Epidemiology and Biostatistics Department, Universidade Federal Fluminense, Rio de Janeiro, Brazil
Correspondence to: Gerson Oliveira Penna, Núcleo de Medicina Tropical, Universidade de Brasília. Campus Universitário Darcy Ribeiro - Caixa Postal 4517 - Asa Norte - Brasília - DF, CEP 70.904-970 (e-mail: gpenna@gpenna.net)
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d,*
Samira Bü hrer-sékula
  Samira Bü hrer-sékula
Affiliation
Tropical Pathology and Public Health Institute, Federal University of Goias, Goiania, Goias, Brazil
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e
Maria araci de Andrade pontes
  Maria araci de Andrade pontes
Affiliation
Dona Libânia Dermatology Centre, Fortaleza, Ceará, Brazil
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b
Rossilene Cruz
  Rossilene Cruz
Affiliation
Tropical Dermatology and Venerology Alfredo da Matta Foundation, Manaus, Amazonas, Brazil
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c
Heitor de sá Gonçalves
  Heitor de sá Gonçalves
Affiliation
Dona Libânia Dermatology Centre, Fortaleza, Ceará, Brazil
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b
Gerson oliveira Penna
  Gerson oliveira Penna
Affiliation
Tropical Medicine Centre, University of Brasília, Brasília DF, Brazil
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a
Settings:

Many believe that the regular treatment for multibacillary (MB) leprosy cases could be shortened. A shorter treatment, allowing for uniform treatment for all cases, makes case classification superfluous and therefore simplifies leprosy control.

 Objective:

To evaluate the association of the treatment duration with the frequency of reactions among MB patients.

 Methods:

An open-label randomised clinical trial to compare the present routine treatment with one lasting six months. Patients were recruited between March 2007 and February 2012. We analysed the frequency of first reaction with the Kaplan-Meier method and of recurrent reaction with a Poisson regression, using the treatment group and baciloscopic index level (BI) as independent variables. Logistic regression was used to evaluate the statistical association of different reaction types and the treatment group.

 Results:

Among those with BI < 3, we found a statistical significant difference of reaction frequencies between the treatment groups from 6 to 18 months since the beginning of treatment. This difference disappears at 2 years after the start of treatment. Multiple reactions were associated with the treatment group and with BI ≥ 3. No specific types of reactions were associated with treatment duration.

 Conclusion:

Although this is the first report of U-MDT/CT-BR, the results presented here support the possibility of use of UMDT in the field.
Cite this article
Maria Lucia Fernandes Penna, Samira Bü hrer-sékula, Maria araci de Andrade pontes, Rossilene Cruz, Heitor de sá Gonçalves, Gerson oliveira Penna;
Primary results of Clinical Trial for Uniform Multidrug Therapy for Leprosy Patients in Brazil (U-MDT/CT-BR): reactions frequency in multibacillary patients; Leprosy Review; 2012; 83; 3; 308-319; DOI: 10.47276/lr.83.3.308
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DOI: 10.47276/lr.83.3.308

articleview.journal_title: Leprosy Review
articleview.publisher: British Leprosy Relief Association
articleview.publisher_location: Colchester, UK
articleview.article_date_pre accepted on 11 October 2012 and articleview.pub_on 01 September 2012
© Lepra 2012
LEPROSY
Leprosy Review
0305-7518
British Leprosy Relief Association
Colchester, UK
00-308
0305-7518/12/064053+12
10.47276/lr.83.3.308
Original Papers
Primary results of Clinical Trial for Uniform Multidrug Therapy for Leprosy Patients in Brazil (U-MDT/CT-BR): reactions frequency in multibacillary patients
M. L. F. Penna et al.
U-MDT Leprosy clinical trial Brazil
Fernandes PennaMaria Lucia
d
Bü hrer-sékulaSamira
e
Andrade pontesMaria araci de
b
CruzRossilene
c
GonçalvesHeitor de sá
b
PennaGerson oliveira
a
a
Tropical Medicine Centre, University of Brasília, Brasília DF, Brazil
b
Dona Libânia Dermatology Centre, Fortaleza, Ceará, Brazil
c
Tropical Dermatology and Venerology Alfredo da Matta Foundation, Manaus, Amazonas, Brazil
d
Epidemiology and Biostatistics Department, Universidade Federal Fluminense, Rio de Janeiro, Brazil
e
Tropical Pathology and Public Health Institute, Federal University of Goias, Goiania, Goias, Brazil
Correspondence to: Gerson Oliveira Penna, Núcleo de Medicina Tropical, Universidade de Brasília. Campus Universitário Darcy Ribeiro - Caixa Postal 4517 - Asa Norte - Brasília - DF, CEP 70.904-970 (e-mail: )
01092012
83
3
308
319
11102012
© Lepra
2012
Settings:
Many believe that the regular treatment for multibacillary (MB) leprosy cases could be shortened. A shorter treatment, allowing for uniform treatment for all cases, makes case classification superfluous and therefore simplifies leprosy control.
Objective:
To evaluate the association of the treatment duration with the frequency of reactions among MB patients.
Methods:
An open-label randomised clinical trial to compare the present routine treatment with one lasting six months. Patients were recruited between March 2007 and February 2012. We analysed the frequency of first reaction with the Kaplan-Meier method and of recurrent reaction with a Poisson regression, using the treatment group and baciloscopic index level (BI) as independent variables. Logistic regression was used to evaluate the statistical association of different reaction types and the treatment group.
Results:
Among those with BI < 3, we found a statistical significant difference of reaction frequencies between the treatment groups from 6 to 18 months since the beginning of treatment. This difference disappears at 2 years after the start of treatment. Multiple reactions were associated with the treatment group and with BI ≥ 3. No specific types of reactions were associated with treatment duration.
Conclusion:
Although this is the first report of U-MDT/CT-BR, the results presented here support the possibility of use of UMDT in the field.