[Forlax in the treatment of childhood constipation: a randomized, controlled, multicenter clinical study].

Abstract

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.

• Authors: Bao-Xi Wang, Mao-Gui Wang, Mi-Zu Jiang, Chun-Di Xu, Cai-Hong Shao, Li-Ying Jia, Zhi-Hua Huang, Xiao-Hua Xu
• Journal: Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics (Zhongguo Dang Dai Er Ke Za Zhi) Vol. 9 Issue 5 Pg. 429-32 (Oct 2007) ISSN: 1008-8830 [Print] China
• PMID: 17937851 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Cathartics
• Polyethylene Glycols
• Lactulose

Topics

• Adolescent
• Cathartics (adverse effects, therapeutic use)
• Child
• Constipation (therapy)
• Female
• Humans
• Lactulose (therapeutic use)
• Male
• Polyethylene Glycols (adverse effects, therapeutic use)