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Comparison Between the Cassia Fistula`s Emulsion With Polyethylene Glycol (PEG4000) in the Pediatric Functional Constipation: A Randomized Clinical Trial

BACKGROUND: There are few effective drugs for pediatric functional constipation (FC). OBJECTIVES: Comparing the effectiveness of Cassia fistula’s emulsion (CFE) with Polyethylene glycol (PEG4000) in FC; and evaluation of safety of both drugs in the treatment of FC. MATERIALS AND METHODS: A randomize...

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Autores principales: Esmaeilidooki, Mohammad Reza, Mozaffarpur, Seyyed Ali, Mirzapour, Mohaddese, Shirafkan, Hoda, Kamalinejad, Mohammad, Bijani, Ali
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Kowsar 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5027133/
https://www.ncbi.nlm.nih.gov/pubmed/27660721
http://dx.doi.org/10.5812/ircmj.33998
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author Esmaeilidooki, Mohammad Reza
Mozaffarpur, Seyyed Ali
Mirzapour, Mohaddese
Shirafkan, Hoda
Kamalinejad, Mohammad
Bijani, Ali
author_facet Esmaeilidooki, Mohammad Reza
Mozaffarpur, Seyyed Ali
Mirzapour, Mohaddese
Shirafkan, Hoda
Kamalinejad, Mohammad
Bijani, Ali
author_sort Esmaeilidooki, Mohammad Reza
collection PubMed
description BACKGROUND: There are few effective drugs for pediatric functional constipation (FC). OBJECTIVES: Comparing the effectiveness of Cassia fistula’s emulsion (CFE) with Polyethylene glycol (PEG4000) in FC; and evaluation of safety of both drugs in the treatment of FC. MATERIALS AND METHODS: A randomized open label, prospective, controlled, parallel-group clinical trial was carried on 109 children (M/F: 63/46; mean age ± SD: 59.7 ± 28.8 months) in Amirkola children’s hospital, Babol, Iran. The inclusion criteria were based on diagnosis of FC according to the Rome III criteria and age range between 2 - 15 years. They received CFE or PEG randomly for 4 weeks. Frequencies of defecation, severity of pain, consistency of stool, fecal incontinence and retentive posturing were compared between the two groups and with baselines. Children were counted as improved when they exited from Rome III criteria of FC. RESULTS: Fifty seven patients were assigned to receive PEG and 52 patients received CFE. After 4weeks of medication, 86.5% of children in CFE group and 77.1% in PEG group (RR = 1.121, CI95%:0.939 - 1.338) exited from the criteria of FC. All measurable criteria improved in both groups without any significant difference, except in the frequency of defecation that in CFE group (10.96 ± 5.7) was significantly more than PEG group (6.9 ± 3.5) (P < 0.0001). Compliances of PEG were significantly better in the 2 first weeks (P = 0.002, 0.008) but not in third and fourth week (P = 0.061, 0.062). None of these two drugs cause clinically significant side effects. CONCLUSIONS: CFE can be as effective as PEG in the 4-weeks treatment of children with FC.
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spelling pubmed-50271332016-09-22 Comparison Between the Cassia Fistula`s Emulsion With Polyethylene Glycol (PEG4000) in the Pediatric Functional Constipation: A Randomized Clinical Trial Esmaeilidooki, Mohammad Reza Mozaffarpur, Seyyed Ali Mirzapour, Mohaddese Shirafkan, Hoda Kamalinejad, Mohammad Bijani, Ali Iran Red Crescent Med J Research Article BACKGROUND: There are few effective drugs for pediatric functional constipation (FC). OBJECTIVES: Comparing the effectiveness of Cassia fistula’s emulsion (CFE) with Polyethylene glycol (PEG4000) in FC; and evaluation of safety of both drugs in the treatment of FC. MATERIALS AND METHODS: A randomized open label, prospective, controlled, parallel-group clinical trial was carried on 109 children (M/F: 63/46; mean age ± SD: 59.7 ± 28.8 months) in Amirkola children’s hospital, Babol, Iran. The inclusion criteria were based on diagnosis of FC according to the Rome III criteria and age range between 2 - 15 years. They received CFE or PEG randomly for 4 weeks. Frequencies of defecation, severity of pain, consistency of stool, fecal incontinence and retentive posturing were compared between the two groups and with baselines. Children were counted as improved when they exited from Rome III criteria of FC. RESULTS: Fifty seven patients were assigned to receive PEG and 52 patients received CFE. After 4weeks of medication, 86.5% of children in CFE group and 77.1% in PEG group (RR = 1.121, CI95%:0.939 - 1.338) exited from the criteria of FC. All measurable criteria improved in both groups without any significant difference, except in the frequency of defecation that in CFE group (10.96 ± 5.7) was significantly more than PEG group (6.9 ± 3.5) (P < 0.0001). Compliances of PEG were significantly better in the 2 first weeks (P = 0.002, 0.008) but not in third and fourth week (P = 0.061, 0.062). None of these two drugs cause clinically significant side effects. CONCLUSIONS: CFE can be as effective as PEG in the 4-weeks treatment of children with FC. Kowsar 2016-05-11 /pmc/articles/PMC5027133/ /pubmed/27660721 http://dx.doi.org/10.5812/ircmj.33998 Text en Copyright © 2016, Iranian Red Crescent Medical Journal http://creativecommons.org/licenses/by-nc/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/) which permits copy and redistribute the material just in noncommercial usages, provided the original work is properly cited.
spellingShingle Research Article
Esmaeilidooki, Mohammad Reza
Mozaffarpur, Seyyed Ali
Mirzapour, Mohaddese
Shirafkan, Hoda
Kamalinejad, Mohammad
Bijani, Ali
Comparison Between the Cassia Fistula`s Emulsion With Polyethylene Glycol (PEG4000) in the Pediatric Functional Constipation: A Randomized Clinical Trial
title Comparison Between the Cassia Fistula`s Emulsion With Polyethylene Glycol (PEG4000) in the Pediatric Functional Constipation: A Randomized Clinical Trial
title_full Comparison Between the Cassia Fistula`s Emulsion With Polyethylene Glycol (PEG4000) in the Pediatric Functional Constipation: A Randomized Clinical Trial
title_fullStr Comparison Between the Cassia Fistula`s Emulsion With Polyethylene Glycol (PEG4000) in the Pediatric Functional Constipation: A Randomized Clinical Trial
title_full_unstemmed Comparison Between the Cassia Fistula`s Emulsion With Polyethylene Glycol (PEG4000) in the Pediatric Functional Constipation: A Randomized Clinical Trial
title_short Comparison Between the Cassia Fistula`s Emulsion With Polyethylene Glycol (PEG4000) in the Pediatric Functional Constipation: A Randomized Clinical Trial
title_sort comparison between the cassia fistula`s emulsion with polyethylene glycol (peg4000) in the pediatric functional constipation: a randomized clinical trial
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5027133/
https://www.ncbi.nlm.nih.gov/pubmed/27660721
http://dx.doi.org/10.5812/ircmj.33998
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