Oral domperidone has no additional effect on chronic functional constipation in children: A randomized clinical trial
Background Chronic constipation represents a common problem in children. The treatment of functional constipation is challenging. Some studies have investigated the effect of prokinetic agents as potential therapies for motility disorders of the lower gastrointestinal tract with paradoxical results....
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Published in | Indian journal of gastroenterology Vol. 33; no. 2; pp. 125 - 130 |
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Main Authors | , , |
Format | Journal Article |
Language | English |
Published |
India
Springer India
01.03.2014
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Subjects | |
Online Access | Get full text |
ISSN | 0254-8860 0975-0711 0975-0711 |
DOI | 10.1007/s12664-013-0375-5 |
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Abstract | Background
Chronic constipation represents a common problem in children. The treatment of functional constipation is challenging. Some studies have investigated the effect of prokinetic agents as potential therapies for motility disorders of the lower gastrointestinal tract with paradoxical results. The present study aimed to investigate the effect of oral domperidone in the treatment of chronic functional constipation in children.
Method
A total of 105 children with chronic functional constipation (according to Rome III criteria) who were referred to the Pediatric Gastroenterology Clinic were recruited in this double-blind randomized clinical trial. The study subjects were randomly divided into two groups, the first of which received polyethylene glycol (PEG) solution 0.6 g/kg/day two times a day for 6 months and domperidone syrup 0.15 mL/kg three times a day for 3 months (case group) while the second one received PEG with the same dose for 6 months and placebo for 3 months with the same dose (control group). The two groups were compared regarding their symptoms and Rome III criteria through 1, 3, and 6 months following therapy. Primary outcome was response to treatment, and a response was defined as decrease in signs and symptoms that did not fulfill Rome III criteria. Secondary outcome measures were side effects during the course of treatment.
Results
A significant difference was observed both before and after PEG and domperidone treatment and before and after PEG and placebo treatment regarding Rome III criteria. There was no significant difference in response to treatment between the two study groups during 1 (
p
= 1), 3 (
p
= 0.799), and 6 (
p
= 0.403) month follow up periods. Also, the two groups were not significantly different regarding the Rome III criteria during the mentioned follow up periods. There were no side effects during the course of treatment.
Conclusion
There was no additional effect of domperidone as adjunct to PEG in the treatment of children with constipation. |
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AbstractList | Chronic constipation represents a common problem in children. The treatment of functional constipation is challenging. Some studies have investigated the effect of prokinetic agents as potential therapies for motility disorders of the lower gastrointestinal tract with paradoxical results. The present study aimed to investigate the effect of oral domperidone in the treatment of chronic functional constipation in children.BACKGROUNDChronic constipation represents a common problem in children. The treatment of functional constipation is challenging. Some studies have investigated the effect of prokinetic agents as potential therapies for motility disorders of the lower gastrointestinal tract with paradoxical results. The present study aimed to investigate the effect of oral domperidone in the treatment of chronic functional constipation in children.A total of 105 children with chronic functional constipation (according to Rome III criteria) who were referred to the Pediatric Gastroenterology Clinic were recruited in this double-blind randomized clinical trial. The study subjects were randomly divided into two groups, the first of which received polyethylene glycol (PEG) solution 0.6 g/kg/day two times a day for 6 months and domperidone syrup 0.15 mL/kg three times a day for 3 months (case group) while the second one received PEG with the same dose for 6 months and placebo for 3 months with the same dose (control group). The two groups were compared regarding their symptoms and Rome III criteria through 1, 3, and 6 months following therapy. Primary outcome was response to treatment, and a response was defined as decrease in signs and symptoms that did not fulfill Rome III criteria. Secondary outcome measures were side effects during the course of treatment.METHODA total of 105 children with chronic functional constipation (according to Rome III criteria) who were referred to the Pediatric Gastroenterology Clinic were recruited in this double-blind randomized clinical trial. The study subjects were randomly divided into two groups, the first of which received polyethylene glycol (PEG) solution 0.6 g/kg/day two times a day for 6 months and domperidone syrup 0.15 mL/kg three times a day for 3 months (case group) while the second one received PEG with the same dose for 6 months and placebo for 3 months with the same dose (control group). The two groups were compared regarding their symptoms and Rome III criteria through 1, 3, and 6 months following therapy. Primary outcome was response to treatment, and a response was defined as decrease in signs and symptoms that did not fulfill Rome III criteria. Secondary outcome measures were side effects during the course of treatment.A significant difference was observed both before and after PEG and domperidone treatment and before and after PEG and placebo treatment regarding Rome III criteria. There was no significant difference in response to treatment between the two study groups during 1 (p = 1), 3 (p = 0.799), and 6 (p = 0.403) month follow up periods. Also, the two groups were not significantly different regarding the Rome III criteria during the mentioned follow up periods. There were no side effects during the course of treatment.RESULTSA significant difference was observed both before and after PEG and domperidone treatment and before and after PEG and placebo treatment regarding Rome III criteria. There was no significant difference in response to treatment between the two study groups during 1 (p = 1), 3 (p = 0.799), and 6 (p = 0.403) month follow up periods. Also, the two groups were not significantly different regarding the Rome III criteria during the mentioned follow up periods. There were no side effects during the course of treatment.There was no additional effect of domperidone as adjunct to PEG in the treatment of children with constipation.CONCLUSIONThere was no additional effect of domperidone as adjunct to PEG in the treatment of children with constipation. Background Chronic constipation represents a common problem in children. The treatment of functional constipation is challenging. Some studies have investigated the effect of prokinetic agents as potential therapies for motility disorders of the lower gastrointestinal tract with paradoxical results. The present study aimed to investigate the effect of oral domperidone in the treatment of chronic functional constipation in children. Method A total of 105 children with chronic functional constipation (according to Rome III criteria) who were referred to the Pediatric Gastroenterology Clinic were recruited in this double-blind randomized clinical trial. The study subjects were randomly divided into two groups, the first of which received polyethylene glycol (PEG) solution 0.6 g/kg/day two times a day for 6 months and domperidone syrup 0.15 mL/kg three times a day for 3 months (case group) while the second one received PEG with the same dose for 6 months and placebo for 3 months with the same dose (control group). The two groups were compared regarding their symptoms and Rome III criteria through 1, 3, and 6 months following therapy. Primary outcome was response to treatment, and a response was defined as decrease in signs and symptoms that did not fulfill Rome III criteria. Secondary outcome measures were side effects during the course of treatment. Results A significant difference was observed both before and after PEG and domperidone treatment and before and after PEG and placebo treatment regarding Rome III criteria. There was no significant difference in response to treatment between the two study groups during 1 ( p = 1), 3 ( p = 0.799), and 6 ( p = 0.403) month follow up periods. Also, the two groups were not significantly different regarding the Rome III criteria during the mentioned follow up periods. There were no side effects during the course of treatment. Conclusion There was no additional effect of domperidone as adjunct to PEG in the treatment of children with constipation. Chronic constipation represents a common problem in children. The treatment of functional constipation is challenging. Some studies have investigated the effect of prokinetic agents as potential therapies for motility disorders of the lower gastrointestinal tract with paradoxical results. The present study aimed to investigate the effect of oral domperidone in the treatment of chronic functional constipation in children. A total of 105 children with chronic functional constipation (according to Rome III criteria) who were referred to the Pediatric Gastroenterology Clinic were recruited in this double-blind randomized clinical trial. The study subjects were randomly divided into two groups, the first of which received polyethylene glycol (PEG) solution 0.6 g/kg/day two times a day for 6 months and domperidone syrup 0.15 mL/kg three times a day for 3 months (case group) while the second one received PEG with the same dose for 6 months and placebo for 3 months with the same dose (control group). The two groups were compared regarding their symptoms and Rome III criteria through 1, 3, and 6 months following therapy. Primary outcome was response to treatment, and a response was defined as decrease in signs and symptoms that did not fulfill Rome III criteria. Secondary outcome measures were side effects during the course of treatment. A significant difference was observed both before and after PEG and domperidone treatment and before and after PEG and placebo treatment regarding Rome III criteria. There was no significant difference in response to treatment between the two study groups during 1 (p = 1), 3 (p = 0.799), and 6 (p = 0.403) month follow up periods. Also, the two groups were not significantly different regarding the Rome III criteria during the mentioned follow up periods. There were no side effects during the course of treatment. There was no additional effect of domperidone as adjunct to PEG in the treatment of children with constipation. |
Author | Askarian, Mehrdad Dehghani, Seyed Mohsen Kaffashan, Heidar Ali |
Author_xml | – sequence: 1 givenname: Seyed Mohsen surname: Dehghani fullname: Dehghani, Seyed Mohsen email: dehghanism@sums.ac.ir organization: Gastroenterohepatology Research Center, Shiraz Transplant Research Center, Nemazee Teaching Hospital – sequence: 2 givenname: Mehrdad surname: Askarian fullname: Askarian, Mehrdad organization: Department of Community Medicine, School of Medicine, Shiraz University of Medical Sciences – sequence: 3 givenname: Heidar Ali surname: Kaffashan fullname: Kaffashan, Heidar Ali organization: Gastroenterohepatology Research Center, Shiraz Transplant Research Center, Nemazee Teaching Hospital |
BackLink | https://www.ncbi.nlm.nih.gov/pubmed/23996739$$D View this record in MEDLINE/PubMed |
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Cites_doi | 10.1097/00005176-199708000-00012 10.1097/00005176-199902000-00020 10.1136/adc.2007.128769 10.1136/gut.28.8.1033 10.1186/1471-230X-8-38 10.1590/S0100-879X2003001000016 10.1097/01.mpg.0000233159.97667.c3 10.1016/j.coph.2006.07.004 10.1111/j.1572-0241.2007.01255.x 10.1097/01.mpg.0000181188.01887.78 10.1111/j.1572-0241.2006.00771.x 10.1007/BF01311229 10.2165/00003495-199447010-00008 10.1016/S0022-3476(00)90046-5 10.1002/mds.870120618 10.1007/BF02063252 10.2165/00002018-199512060-00004 10.5056/jnm.2011.17.1.35 10.1053/j.gastro.2005.08.063 10.1097/01.mpg.0000232574.41149.0a 10.1097/00005176-200104001-00017 10.1016/j.jpeds.2008.01.039 10.1016/S0022-3476(00)90039-8 10.1002/14651858.CD007780.pub2 10.1007/BF02238599 |
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Chronic constipation represents a common problem in children. The treatment of functional constipation is challenging. Some studies have... Chronic constipation represents a common problem in children. The treatment of functional constipation is challenging. Some studies have investigated the... |
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SubjectTerms | Administration, Oral Child Child, Preschool Chronic Disease Constipation - drug therapy Domperidone - administration & dosage Dopamine Antagonists - administration & dosage Female Gastroenterology Hepatology Humans Laxatives - administration & dosage Male Medicine Medicine & Public Health Original Article Polyethylene Glycols - administration & dosage Treatment Outcome |
Title | Oral domperidone has no additional effect on chronic functional constipation in children: A randomized clinical trial |
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