Polyethylene glycol 4000 vs. lactulose for the treatment of neurogenic constipation in myelomeningocele children: a randomized-controlled clinical trial.
OBJECTIVE
To compare the therapeutic effectiveness and tolerability of low daily doses of polyethylene glycol 4000 vs. lactulose in the treatment of neurogenic constipation in children with myelomeningocele.


METHODS
Sixty-seven children with chronic neurogenic constipation were randomized allocated to receive either polyethylene glycol 4000 (0.50 g/kg) or lactulose (1.5 g/kg) for 6 months. Patients or their parents reported frequency and modality of evacuation and side effects on a diary card. Primary outcome was bowel frequency > or =3/week, and the second one was side effects at the end of treatment.


RESULTS
Complete remission of constipation was reported by a significantly (P < 0.01) higher number of patients treated with polyethylene glycol compared with lactulose. At the end of the study, 46% patients of polyethylene glycol group and 22% of the lactulose group were asymptomatic. Compared with lactulose, patients treated with polyethylene glycol reported higher bowel frequency (5.1 vs. 2.9 bowel movements/week, P < 0.01) and reduction of encopresis. Neither lactulose nor polyethylene glycol caused clinically-significant serious side effects and palatability was similar.


CONCLUSIONS
Polyethylene glycol 4000 compared with lactulose provided a higher success rate, without significant side effects, for the treatment of constipation in myelomeningocele children.
Rendeli
C
C
Department of Paediatric Science, Catholic University Medical School, Rome, Italy. c.rendeli@libero.it
Ausili
E
E
Tabacco
F
F
Focarelli
B
B
Pantanella
A
A
Di Rocco
C
C
Genovese
O
O
Fundarò
C
C
D000704:Analysis of Variance; D002400:Cathartics / Q000627:therapeutic use*; D002648:Child; D003248:Constipation / Q000150:complications* / Q000188:drug therapy; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007792:Lactulose / Q000627:therapeutic use*; D008297:Male; D008591:Meningomyelocele / Q000150:complications* / Q000188:drug therapy; D011092:Polyethylene Glycols / Q000627:therapeutic use*; D012997:Solvents / Q000627:therapeutic use*; D018709:Statistics, Nonparametric; D016896:Treatment Outcome
D002400:Cathartics; D012997:Solvents; D011092:Polyethylene Glycols; D007792:Lactulose