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.
OBJECTIVE
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.


METHODS
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.
Department of Pediatrics, University "Federico II," Naples, Italy.
Paolo
P
Quitadamo
Paola
P
Coccorullo
Eleonora
E
Giannetti
Claudio
C
Romano
Andrea
A
Chiaro
Angelo
A
Campanozzi
Emanuela
E
Poli
Salvatore
S
Cucchiara
Giovanni
G
Di Nardo
Annamaria
A
Staiano
D002648:Child; D002675:Child, Preschool; D003248:Constipation / Q000188:drug therapy*; D004043:Dietary Fiber / Q000008:administration & dosage*; D004338:Drug Combinations; D004573:Electrolytes / Q000737:chemistry / Q000627:therapeutic use*; D005260:Female; D005632:Fructose / Q000008:administration & dosage*; D006801:Humans; D054368:Laxatives / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D011092:Polyethylene Glycols / Q000737:chemistry / Q000627:therapeutic use*; D011446:Prospective Studies; D011620:Psyllium / Q000008:administration & dosage*
D004043:Dietary Fiber; D004338:Drug Combinations; D004573:Electrolytes; D054368:Laxatives; D005632:Fructose; D011092:Polyethylene Glycols; D011620:Psyllium