A Randomized, Prospective, Comparison Study of a Mixture of Acacia Fiber, Psyllium Fiber, and Fructose vs Polyethylene Glycol 3350 with Electrolytes for the Treatment of Chronic Functional Constipation in Childhood
The Journal of Pediatrics, 06/12/2012
Quitadamo P et al. – In this randomized study, they did not find any significant difference between the efficacy of acacia fiber, psyllium fiber, and fructose (AFPFF) and PEG+E in the treatment of children with CFC. Both medications were proved to be safe for CFC treatment, but PEG+E was better accepted by children.Methods
- This was a randomized, open label, prospective, controlled, parallel-group study involving 100 children who were diagnosed with CFC according to the Rome III Criteria.
- Children were randomly divided into 2 groups: 50 children received AFPFF (16.8 g daily) and 50 children received PEG+E (0.5 g/kg daily) for 8 weeks.
- Primary outcome measures were frequency of bowel movements, stool consistency, fecal incontinence, and improvement of other associated gastrointestinal symptoms.
- Safety was assessed with evaluation of clinical adverse effects and growth measurements.
- Compliance rates were 72% for AFPFF and 96% for PEG+E. A significant improvement of constipation was seen in both groups.
- After 8 weeks, 77.8% of children treated with AFPFF and 83% of children treated with PEG+E had improved (P = .788).
- Neither PEG+E nor AFPFF caused any clinically significant side effects during the entire course of the study period.