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

Sara Tavassoli,Mehrdad Karimi,Amir Naddaf,Ali Ghobadi,Mohsen Shati,Kambiz Eftekhari,Alireza Abbassian,Vincenzo De Feo

doi:10.1155/2021/9915289

Abstract

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.

Highlights

Constipation is a great health challenge in childhood. e precise prevalence is hard to determine, but it is estimated that about 0.7% to 29.6% of children suffer from constipation [1]. e majority of affected children (90%) have functional constipation (FC) [2]. e etiology of Functional constipation (FC) is multifactorial and results from the interaction of several factors such as genetics, lifestyle, and psychological factors [3, 4]
Polyethylene glycol (PEG) is a laxative usually considered as the first-line treatment based on ESPGHAN/NASPGHAN guidelines [11]. is polymer does not metabolize in the intestines, causes an osmotic gradient, and subsequently keeps fluids in the lumen of the colon, thereby softening and loosening the stools to accelerate defecation [12]
E study design was approved by the Review Board and the Ethical Committee of Tehran University of Medical Sciences (TUMS)

Summary

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. E 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. 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). Conclusion. e findings of this investigation indicated that VFS is an effective and relatively safe medication to be used in the treatment of pediatric FC

Introduction

Methods

Results

Disclosure