PEG 3350 (Transipeg) versus lactulose in the treatment of childhood functional constipation: a double blind, randomised, controlled, multicentre trial.
BACKGROUND
Recently, polyethylene glycol (PEG 3350) has been suggested as a good alternative laxative to lactulose as a treatment option in paediatric constipation. However, no large randomised controlled trials exist evaluating the efficacy of either laxative.


OBJECTIVE
To compare PEG 3350 (Transipeg: polyethylene glycol with electrolytes) with lactulose in paediatric constipation and evaluate clinical efficacy/side effects.


METHODS
One hundred patients (aged 6 months-15 years) with paediatric constipation were included in an eight week double blinded, randomised, controlled trial.


METHODS
After faecal disimpaction, patients <6 years of age received PEG 3350 (2.95 g/sachet) or lactulose (6 g/sachet) while children > or =6 years started with 2 sachets/day. Primary outcome measures were: defecation and encopresis frequency/week and successful treatment after eight weeks. Success was defined as a defecation frequency > or =3/week and encopresis < or =1 every two weeks. Secondary outcome measures were side effects after eight weeks of treatment.


RESULTS
A total of 91 patients (49 male) completed the study. A significant increase in defecation frequency (PEG 3350: 3 pre v 7 post treatment/week; lactulose: 3 pre v 6 post/week) and a significant decrease in encopresis frequency (PEG 3350: 10 pre v 3 post/week; lactulose: 8 pre v 3 post/week) was found in both groups (NS). However, success was significantly higher in the PEG group (56%) compared with the lactulose group (29%). PEG 3350 patients reported less abdominal pain, straining, and pain at defecation than children using lactulose. However, bad taste was reported significantly more often in the PEG group.


CONCLUSIONS
PEG 3350 (0.26 (0.11) g/kg), compared with lactulose (0.66 (0.32) g/kg), provided a higher success rate with fewer side effects. PEG 3350 should be the laxative of first choice in childhood constipation.
Department of Paediatric Gastroenterology and Nutrition, Emma Children's Hospital, Academic Medical Centre, Amsterdam, the Netherlands. w.p.voskuijl@amc.nl.
W
W
Voskuijl
F
F
de Lorijn
W
W
Verwijs
P
P
Hogeman
J
J
Heijmans
W
W
Mäkel
J
J
Taminiau
M
M
Benninga
D000293:Adolescent; D002400:Cathartics / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D003248:Constipation / Q000188:drug therapy* / Q000503:physiopathology; D003672:Defecation / Q000187:drug effects; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004573:Electrolytes / Q000009:adverse effects / Q000627:therapeutic use*; D004688:Encopresis / Q000188:drug therapy; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007223:Infant; D007792:Lactulose / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D011092:Polyethylene Glycols / Q000009:adverse effects / Q000627:therapeutic use*; D011379:Prognosis; D016896:Treatment Outcome
D002400:Cathartics; D004573:Electrolytes; C033608:Golytely; D011092:Polyethylene Glycols; D007792:Lactulose