Journal of Research in Pharmacy Practice

Abstract Objective: This study aimed to compare the LaxaPlus Barij^® and polyethylene glycol (4000) in pediatric (children 2–15 years old) functional constipation. Methods: The present study is a randomized clinical trial. The study population included patients with functional constipation aged 2–15 years who were referred to the gastrointestinal clinic of Imam Hossein hospital in Isfahan in 2019. Patients were randomly assigned into two treatment groups. Data analysis was performed using SPSS software. The significance level in the present study is considered <0.05. Findings: Sixty children with functional constipation were selected based on the inclusion and exclusion criteria in this study. The present study results showed no significant difference between demographic characteristics, including age, weight, and gender of children with constipation in the two groups (P > 0.05). The present study results showed that both groups' mean stool consistency and the number of bowel movements increased significantly after the intervention (P < 0.05). However, the number of bowel movements in the first group was significantly higher than in the second group (P < 0.05). Conclusion: The present study results showed that both drugs effectively treat children with functional constipation. However, after 8 weeks of intervention, the frequency of bowel movements, pain intensity, and abdominal pain in the group LaxaPlus Barij^® was more effective. However, the level of satisfaction did not differ significantly between the two groups.

Abstract This study aimed to evaluate the effectiveness, safety, and document the reported adverse effect of a herbal-based laxative (Goleghand^®) for the maintenance treatment of functional constipation in young children. Methods: We conducted a randomized clinical trial from April 2019 to September 2020. Children aged 2–15 years with functional constipation defined according to the Rome IV criteria were eligible for study inclusion. Eligible children were randomly allocated to receive polyethylene glycol (PEG) or Goleghand^®. The number and consistency of stools per day, painful defecation, abdominal pain, and fecal incontinence were reported weekly by parents. The statistical analyses were performed by determining means and standard deviations, t-test, Chi-square test, ANOVA repeated measures, and Fisher's exact test, with significance, accepted at the 5% level. Findings: Sixty patients have been enrolled in the study. Parental satisfaction scores did not change significantly in either group or over the follow-up period. Our results showed that the effect of time (P < 0.001) and also the effect of group type (P = 0.01) on the number of fecal defecations was significant. The mean number of defecations increased first and then decreased significantly over time, but this decrease was more significant in the PEG group than in the Goleghand^® group (P = 0.001). Furthermore, the effect of time on the fecal consistency score was significant (P = 0.047). The mean score of fecal consistency in both groups decreased over time. Conclusion: Goleghand^® was similar in efficacy to PEG for 8 weeks of pediatric functional constipation treatment in this randomized clinical trial. Goleghand^® can be considered as a new herbal laxative drug for pediatric functional constipation.