Evaluation of the Anti-constipation Effects of Abdominal Application of Olive Oil Ointment in Children 1-4Years Old: A Pilot Placebo-Controlled, Double-Blind, Randomized Clinical Trial.

Abstract

With a prevalence of 0.7 to 29.6%, functional constipation (FC) is a common pediatric complaint worldwide. Current therapeutic strategies for FC mainly include prevention and treatment of fecal impaction, by administration of oral laxatives or rectal medications. However, these agents have been reported to have limited efficacy and a number of serious side effects. In traditional Persian medicine, local application of olive oil was used to relieve childhood constipation. In this pilot placebo-controlled, double-blind, randomized clinical trial, the laxative effects of the external use of olive oil ointment in 1- to 4-year-old children with functional constipation were investigated. Forty patients with FC were randomly assigned in olive oil ointment or placebo groups, receiving either an ointment containing 85% olive oil or a comparable placebo or an ointment containing 85% liquid paraffin adjusted to have color and odor similar to those of intervention ointment, twice a day for 4days. Rome III criteria for functional gastrointestinal disorders (FGIDs) were used to identify eligible patients from three hospitals. The primary outcome measure was treatment success, defined as ≥1 spontaneous stools per day, without episodes of fecal impaction at endpoint (day 4). The secondary outcome measure was the frequency of fecal incontinence, abdominal discomfort or flatulence, painful defecation, and dermal irritations (adverse effect). Improvements in stool frequency started from day 1 and continued up to day 4 (end of the study) and were significantly greater in patients receiving olive oil ointment in comparison with placebo group (p<0.05). No adverse effect (including fecal incontinence, painful defecation, gripe and skin reaction, etc.) was reported in intervention and placebo groups during the study. Olive oil ointment used in this study can be presented as a safe, well-tolerated, and effective herbal preparation in children with functional constipation.