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.
RCT Entities:
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.
Authors: Samuel Nurko; Nader N Youssef; Mahmoud Sabri; Annette Langseder; John McGowan; Mark Cleveland; Carlo Di Lorenzo Journal: J Pediatr Date: 2008-03-19 Impact factor: 4.406