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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

      Objectives

      To compare the effectiveness of a mixture of acacia fiber, psyllium fiber, and fructose (AFPFF) with polyethylene glycol 3350 combined with electrolytes (PEG+E) in the treatment of children with chronic functional constipation (CFC); and to evaluate the safety and effectiveness of AFPFF in the treatment of children with CFC.

      Study design

      This was a randomized, open label, prospective, controlled, parallel-group study involving 100 children (M/F: 38/62; mean age ± SD: 6.5 ± 2.7 years) 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.

      Results

      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.

      Conclusions

      In this randomized study, we did not find any significant difference between the efficacy of 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.
      AFPFF (Acacia fiber, psyllium fiber, and fructose), BSFS (Bristol Stool Form Scale), CFC (Chronic functional constipation), PEG (Polyethylene glycol), PEG+E (Polyethylene glycol 3350 combined with electrolytes)
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          In the article, “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,” by Quitadamo et al, J Pediatr 2012;161:710-15, an affiliation was inadvertently omitted. All authors are affiliated with the Italian Society for Pediatric Gastroenterology, Hepatology, and Nutrition (SIGENP).
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