Hossein Arman-Asl1, Amir Hooshang Mohammadpour2,3, Abdolkarim Hamedi4, Seyed Ahmad Emami5, Mohammadreza Abbaspour5, Amirhossein Sahebkar6,7,8,9, Behjat Javadi10. 1. Department of Traditional Pharmacy, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran. 2. Department of Clinical Pharmacy, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran. 3. Pharmaceutical Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran. 4. Infection Control and Hand Hygiene Research Center, Mashhad University of Medical Sciences, Mashhad, Iran. 5. Targeted Drug Delivery Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran. 6. Biotechnology Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran. amir_saheb2000@yahoo.com. 7. Applied Biomedical Research Center, Mashhad University of Medical Sciences, Mashhad, Iran. amir_saheb2000@yahoo.com. 8. Polish Mother's Memorial Hospital Research Institute (PMMHRI), Lodz, Poland. amir_saheb2000@yahoo.com. 9. School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran. amir_saheb2000@yahoo.com. 10. Department of Traditional Pharmacy, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran. javadib@mums.ac.ir.
Abstract
OBJECTIVE: 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. METHODS AND MATERIALS: 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 4 days. 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). RESULTS: 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. CONCLUSION: Olive oil ointment used in this study can be presented as a safe, well-tolerated, and effective herbal preparation in children with functional constipation.
OBJECTIVE: 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. METHODS AND MATERIALS: 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 4 days. 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). RESULTS: 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. CONCLUSION: Olive oil ointment used in this study can be presented as a safe, well-tolerated, and effective herbal preparation in children with functional constipation.