Comparison of the Low Dose Polyethylene Glycol with Lactulose and Magnesium Hydroxide in Constipated Children. A Multicentric Randomized Clinical trial

This study was designed to compare the efficacy and safety of very low dose of polyethylene glycol 3350 (PEG) with magnesium hydroxide (MOM) and lactulose in functional constipation of children. A total number of 468 patients 1-15 year old with chronic constipation entered a randomized comparative multicenteric trial. Subjects were healthy outpatients who had hard, painful or <= 3 stools per week. Their parents were given a teaching pamphlet about constipation, diet and toilet training. The patients were allocated to 3 treatment groups; lactulose (70%) 1ml/kg/day/BID, MOM (400mg/5ml) 1ml/kg/day/BID, and PEG (40%) 1ml/kg/day/BID. The dose was adjusted up to three times depending on responding. Treatment scheduled for two months and data were collected on 2ed, 4th and 8th weeks. 354 patients completed the trial. After eight weeks, patients in the PEG groups had higher number of bowel movement (Pv<0.001) and low straining at stool (Pv<0.001) than patients in two others groups. Patient's adherences with PEG were better than lactulose and magnesium hydroxide (Pv<0.001). Soiling and blood on stool declined significantly in three groups (Pv<0.001) without differences among. There were no serious adverse effects. Thus low dose of polyethylene glycol 3350 was more effective than lactulose and similar to M. O. M for the treatment of functional constipation and better tolerated without any significant adverse events in children. [Gheibi Sh, Imanieh MH, Haghighat M, Niknahad H, Sayyafan MS, Moatamed F, Saneian MH, Karami H, Esmaeili Dooki MR. Comparison of the Low Dose Polyethylene Glycol with Lactulose and Magnesium Hydroxide in Constipated Children. A Multicentric Randomized Clinical trial. Life Sci J 2012;9(4):5344-5350] (ISSN: 1097-8135). http://www.lifesciencesite.com. 794