Effectiveness of Viola Flower Syrup Compared with Polyethylene Glycol in Children with Functional Constipation: A Randomized, Active-Controlled Clinical Trial

BACKGROUND: Functional constipation (FC) is a health concern that is prevalent in the pediatric population. It lowers the quality of life and increases the probability of comorbidities. As a complementary modality, herbal medicine has been considered useful in a variety of conditions. Persian medicine (PM) resources mention the Viola flower as an effective herb in treating constipation. The purpose of the current trial was to evaluate the efficacy of Viola flower syrup (VFS) compared with polyethylene glycol (PEG) in children with functional constipation. METHODS: This randomized, active-controlled, single-center trial was conducted on 140 children aged between 4 and 10 years with confirmed FC according to Rome III criteria. Participants were randomly assigned to receive either VFS or PEG for four weeks. Independent t-test and general linear model (GLM) repeated measures analysis of variance were used to determine the intergroup difference, and paired sample t-test was used to evaluate the intragroup difference. RESULTS: After four weeks of intervention, 133 individuals (66 in VFS and 67 in the PEG group) were analyzed. Results of both groups demonstrated significant improvement in all measured criteria at the end of the study compared to baseline (P < 0.001). No significant difference was observed between the two groups at baseline or at the end of the study (P > 0.05), except for fecal retention at baseline (P=0.028). Participants in the PEG group experienced more side effects compared to the VFS group. CONCLUSION: The findings of this investigation indicated that VFS is an effective and relatively safe medication to be used in the treatment of pediatric FC.