[Forlax in the treatment of childhood constipation: a randomized, controlled, multicenter clinical study].
OBJECTIVE
To determine the therapeutic effectiveness and safety of polyethylene glycol 4000 (forlax) in the treatment of constipation in children over 8 years old.


METHODS
This study was designed as a randomized, positive medicine (lactulose) controlled multicenter trial. A total of 216 children with constipation from 8-18 years old from 7 hospitals across China who were matched with a uniform entry criteria were enrolled in this study. The 216 patients were randomized to receive either oral forlax (20 g/d, n=105) or lactulose (15 mL/d, n=111) for 2 weeks. The therapeutic effects, including bowel movement frequency, stool consistency, clinical complete remission rate of constipation and abdominal symptoms, and the safety of forlax and lactulose were evaluated at 1 and 2 weeks of treatment.


RESULTS
The median weekly frequency of bowel movement in the forlax group increased by 4 and 5 times respectively after 1 and 2 weeks of treatment, and increased by 3 and 4 times in the lactulose group (P < 0.05). The stool consistency of the two groups was both improved significantly after treatment. The Bristol score of stool consistency of the forlax and lactulose groups were 3.41+/-1.11 and 3.64+/-1.33 respectively (P < 0.05) after 1 week of treatment, and were 4.26+/-0.89 and 3.63+/-1.33 respectively (P < 0.05) after 2 weeks of treatment. The clinical complete remission rate of constipation in the forlax and lactulose groups was 70% and 40% respectively (P < 0.05) by week 1 of treatment, and that was 72% and 41% respectively (P < 0.05) by week 2 of treatment. Abdominal pain disappeared in 75% of patients in the forlax group but in only 57% in the lactulose group by week 2 of treatment (P < 0.05). No serious adverse events happened and no abnormalities were found in laboratory tests and physical examinations in the two groups after medication.


CONCLUSIONS
Forlax is safe and effective in the treatment of constipation in children over 8 years old.
Wang
Bao-Xi
BX
Department of Pediatrics, Tangdu Hospital, Fourth Military Medical University, Xi'an 710038, China. erkewbx@fmmu.edu.cn
Wang
Mao-Gui
MG
Jiang
Mi-Zu
MZ
Xu
Chun-Di
CD
Shao
Cai-Hong
CH
Jia
Li-Ying
LY
Huang
Zhi-Hua
ZH
Xu
Xiao-Hua
XH
D000293:Adolescent; D002400:Cathartics / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D003248:Constipation / Q000628:therapy*; D005260:Female; D006801:Humans; D007792:Lactulose / Q000627:therapeutic use; D008297:Male; D011092:Polyethylene Glycols / Q000009:adverse effects / Q000627:therapeutic use*
D002400:Cathartics; D011092:Polyethylene Glycols; D007792:Lactulose