Comparison of Polyethylene Glycol (Peg 3350) and Lactulose in Functional Constipation in Children (1- 4 Years): A Double Blinded- Randomised Controlled Trial
Creators
- 1. Assistant Professor, Geetanjali Medical College and Hospital, Udaipur, Rajasthan, India
- 2. Professor and unit head, Department of Pediatrics, Geetanjali Medical College and Hospital, Udaipur, Rajasthan, India
- 3. Associate Professor, Department of Pediatrics, Geetanjali Medical College and Hospital, Udaipur, Rajasthan, India
- 4. Resident, Department of Pediatrics, Geetanjali Medical College and Hospital, Udaipur, Rajasthan, India
Description
Introduction: Functional constipation is a common problem confronted by Paediatricians in today’s time. It is important for the child’s physical and mental health that an early evaluation with prompt treatment is given. The objective of the study was to compare the efficacy of polyethylene glycol 3350 versus lactulose in treatment of functional constipation in children from age 1-4 years. Aims: To compare the safety and efficacy of polyethylene glycol 3350 (PEG) and lactulose for the treatment of functional constipation in children (1-4 years). Objective: (1) To compare the effectiveness of polyethylene glycol and lactulose in the treatment of functional constipation in children. (2) To compare the short term (up to 12 weeks) adverse effects of both the drugs in the treatment of functional constipation in children. Methods: A randomized controlled trial was conducted in Pediatric department, at a tertiary care hospital, Udaipur, Rajasthan, over a period of February 2021-July2022, after obtaining permission from ethical committee of the institute. Total 70 children (age 1-4years) with functional constipation according to Rome IV criteria were included in the study. Polyethylene glycol 3350 was given in one group while lactulose was given to another group. Improvement in number and consistency of stools according to Bristol scale at 4, 8 and 12 weeks was considered as primary outcome and adverse events were the measure of secondary outcome. Results: Among 70 children, with 35 children in each group, results by 12th week in PEG 3350 group showed 8.6 to be mean number of stools per week and lactulose group showed 7.1. PEG3350 group showed statistically significant difference when compared to lactulose group (P value = 0.0001). At 12 weeks, PEG 3350 group showed 4.5 to be the mean stool consistency (Bristol scale) per week and lactulose group showed 3.9 per week with a statistically significant on comparison (P value = 0.038). Common side effects observed in both groups were bloating and abdominal pain. Conclusion: Polyethylene glycol 3350 is a safer and more effective alternative to lactulose in the treatment of functional constipation in children. Both PEG 3350 and lactulose were successful in treatment, although the PEG 3350 group significantly showed more efficacy and low and mild overall rates of adverse events.
Abstract (English)
Introduction: Functional constipation is a common problem confronted by Paediatricians in today’s time. It is important for the child’s physical and mental health that an early evaluation with prompt treatment is given. The objective of the study was to compare the efficacy of polyethylene glycol 3350 versus lactulose in treatment of functional constipation in children from age 1-4 years. Aims: To compare the safety and efficacy of polyethylene glycol 3350 (PEG) and lactulose for the treatment of functional constipation in children (1-4 years). Objective: (1) To compare the effectiveness of polyethylene glycol and lactulose in the treatment of functional constipation in children. (2) To compare the short term (up to 12 weeks) adverse effects of both the drugs in the treatment of functional constipation in children. Methods: A randomized controlled trial was conducted in Pediatric department, at a tertiary care hospital, Udaipur, Rajasthan, over a period of February 2021-July2022, after obtaining permission from ethical committee of the institute. Total 70 children (age 1-4years) with functional constipation according to Rome IV criteria were included in the study. Polyethylene glycol 3350 was given in one group while lactulose was given to another group. Improvement in number and consistency of stools according to Bristol scale at 4, 8 and 12 weeks was considered as primary outcome and adverse events were the measure of secondary outcome. Results: Among 70 children, with 35 children in each group, results by 12th week in PEG 3350 group showed 8.6 to be mean number of stools per week and lactulose group showed 7.1. PEG3350 group showed statistically significant difference when compared to lactulose group (P value = 0.0001). At 12 weeks, PEG 3350 group showed 4.5 to be the mean stool consistency (Bristol scale) per week and lactulose group showed 3.9 per week with a statistically significant on comparison (P value = 0.038). Common side effects observed in both groups were bloating and abdominal pain. Conclusion: Polyethylene glycol 3350 is a safer and more effective alternative to lactulose in the treatment of functional constipation in children. Both PEG 3350 and lactulose were successful in treatment, although the PEG 3350 group significantly showed more efficacy and low and mild overall rates of adverse events.
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Additional details
Dates
- Accepted
-
2023-12-26
Software
References
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