Comparing the Effect of a Herbal-based Laxative (Goleghand®) and Polyethylene Glycol on Functional Constipation among Children: A Randomized Controlled Trial

Hosein Saneian; Saeedeh Ghaedi; Fatemeh Famouri; Majid Khademian; Najmeh Ahmadi; Mohammadreza Memarzadeh; Somayeh Sadeghi; Peiman Nasri

doi:10.4103/jrpp.JRPP_20_133

Comparing the Effect of a Herbal-based Laxative (Goleghand®) and Polyethylene Glycol on Functional Constipation among Children: A Randomized Controlled Trial

J Res Pharm Pract. 2021 May 13;10(1):43-49. doi: 10.4103/jrpp.JRPP_20_133. eCollection 2021 Jan-Mar.

Authors

Hosein Saneian^{1

2}, Saeedeh Ghaedi¹, Fatemeh Famouri^{1

2}, Majid Khademian^{1

2}, Najmeh Ahmadi¹, Mohammadreza Memarzadeh³, Somayeh Sadeghi⁴, Peiman Nasri^{1

2}

Affiliations

¹ Metabolic Liver Disease Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.
² Child Growth and Development Research Center, Research Institute for Primordial Prevention of Non-Communicable Disease, Isfahan University of Medical Sciences, Isfahan, Iran.
³ Medical Plant Research Center of Barij, Kashan, Iran.
⁴ Acquired Immunodeficiency Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.

Abstract

Objective: 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.

Keywords: Child; Constipation; Herbal-based Laxative; Polyethylene glycol.