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Doctoral Thesis
DOI
https://doi.org/10.11606/T.17.2020.tde-08022021-143038
Document
Author
Full name
Ivan Coelho Machado
E-mail
Institute/School/College
Knowledge Area
Date of Defense
Published
Ribeirão Preto, 2020
Supervisor
Committee
Carmona, Fabio (President)
Koch, Vera Hermina Kalika
Manso, Paulo Henrique
Nogueira, Paulo Cesar Koch
Title in Portuguese
Curcuma longa L. (açafrão-da-terra, Zingiberaceae) não altera o curso da doença na síndrome nefrótica idiopática da infância: um ensaio clínico randomizado
Keywords in Portuguese
Açafrão
Corticosteroides
Fitoterapia
Pediatria
Síndrome nefrótica
Abstract in Portuguese
Introdução: A busca por novas terapias no tratamento da síndrome nefrótica idiopática da infância (SNII), com menos efeitos colaterais que a terapia padrão com corticosteroides, é um desafio que pode ter novas frentes abertas com o uso Curcuma longa L. (Zingiberaceae), devido seu efeito anti-inflamatório. Métodos: Ensaio clínico de alocação aleatória, duplo cego, controlado por placebo, fase IV, com pacientes de um único centro universitário de nefrologia infantil, com diagnóstico de SNII, entre um e 18 anos de idade, comparando o grupo que recebeu extrato hidroetanólico de C. longa por 6 a 12 meses em relação ao placebo. O desfecho primário foi a mudança de comportamento da doença em relação à dose de corticosteroides. Resultados: Entre fevereiro de 2018 e janeiro de 2019 foram recrutados 44 pacientes, randomizados 40 e analisados 27 (15 C. longa, 12 placebo) em análise intention-to-treat. Não houve efeitos colaterais graves. Não houve diferença entre os grupos C. longa e placebo na análise estatística em relação à mudança de comportamento da doença (p: 0,67), à quantidade de recidivas (RRa 0,70; IC95% 0,13; 3,70) e recaídas (recidivas não completas) (RRa 38,38; IC95% 1,26; 1170,22), e à dose de corticosteroide acumulada (p: 0,47). Discussão: Não houve diferença entre os pacientes do grupo Curcuma longa em relação ao grupo placebo no tratamento da SNII.
Title in English
Curcuma longa L. (turmeric, Zingiberaceae) does not change disease course of childhood idiopathic nephrotic syndrome: A randomized clinical trial
Keywords in English
Corticosteroids
Herbal medicine
Nephrotic syndrome
Pediatrics
Turmeric
Abstract in English
Introduction: The search for new therapies for the treatment of childhood idiopathic nephrotic syndrome (CINS), with fewer side effects than the standard treatment with corticosteroids, is a challenge that may be overcome with the use of Curcuma longa L. (Zingiberaceae), due to its anti-inflammatory effect. Methods: This is a double-blind, placebo-controlled, phase IV, randomized clinical trial, with patients from a single university pediatric nephrology center, diagnosed with CINS, from one to 18 years old, comparing the group that received hydroethanolic extract of C. longa for 6 to 12 months, to placebo. The primary outcome was the change in behavior regarding steroids dose. Results: Between February 2018 and January 2019, 44 patients were recruited, 40 were randomized and 27 were analyzed (15 C. longa, 12 placebo) in an intention-to-treat analysis. There were no serious adverse events. There was no difference between C. longa and placebo in the statistical analysis regarding the change in disease behavior (p: 0.67), in the number of relapses (aRR 0.70, 95% CI 0.13, 3.70) and partial relapses (aRR 38.38, 95% CI 1.26, 1170.22) and accumulated corticosteroid dose (p: 0.47). Discussion: There was no difference between the subjects of the Curcuma longa group in relation to the placebo group in the treatment of CINS.
 
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IVANCOELHOMACHADO.pdf (561.85 Kbytes)
Publishing Date
2021-03-24
 
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