A randomized controlled double blinded trial to evaluate efficacy of oral administration of black strap molasses (sugarcane extract) in comparison with polyethylene glycol on pediatric functional constipation

Abstract

Ethnopharmacological relevance: As a significant health issue, Functional Constipation (FC) has a high prevalence of 0.7%-29% worldwide. In Persian ethnomedicine, several formulations of sugarcane extracts including faniz, shekar-e- sorkh and black strap molasses have been used to treat pediatric constipation.

Aim of the study: To evaluate efficacy and safety of oral intake of black strap molasses syrup (BSM) on FC in children.

Materials and methods: A randomized controlled double blinded trial was performed on children aged 4-12 years diagnosed with FC according to ROMIII Constipation Measurement Questionnaire. Ninety-two patients were randomly divided in two groups of BSM or PEG syrups (40%) with a dose of 1 mL/kg body weight/day for 1 month. Symptoms were evaluated every two weeks. Possible serological side-effects and changes in children's body weight were investigated. BSM syrup constituents were determined by pharmacognostic methods.

Results: Treatment was successful with both interventions with no significant difference between the groups. Defecation per week was significantly improved in both groups. Symptoms including volitional stool retention, large diameter stool, painful or hard stool and large fecal mass in the rectum decreased significantly two and four weeks after intervention (P < 0.05). There was no significant difference between groups except for the rate of large diameter stool. No side -effects were observed. The BSM naturally contained polyphenols (960 μg/mL), potassium (12430 μg/mL), iron (80 μg/mL) and calcium (3320 μg/mL).

Conclusion: BSM and PEG syrups had similar efficacy on FC. Compared with PEG, BSM syrup contained different natural micronutrients.

Keywords: Black strap molasses; Clinical trial; Constipation; Saccharum officinarum; Sugarcane.