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[Forlax in the treatment of childhood constipation: a randomized, controlled, multicenter clinical study]
Bao-Xi Wang1, Mao-Gui Wang, Mi-Zu Jiang
1Department of Pediatrics, Tangdu Hospital, Fourth Military Medical University, Xi'an 710038, China. erkewbx@fmmu.edu.cn
Insights
Polyethylene glycol 4000 (Forlax) effectively treats constipation in children over 8 years old. This randomized trial showed Forlax improved bowel movements and relieved abdominal pain more than lactulose, with no serious side effects.
Area of Science:
- Pediatric Gastroenterology
- Pharmacology
- Clinical Trials
Background:
- Constipation is a common gastrointestinal issue in children.
- Effective and safe treatment options are crucial for pediatric patients.
Purpose of the Study:
- To evaluate the therapeutic efficacy and safety of polyethylene glycol 4000 (Forlax) for treating constipation in children aged 8 years and older.
Main Methods:
- A randomized, multicenter trial comparing Forlax (20 g/d) to lactulose (15 mL/d) for 2 weeks in 216 children with constipation.
- Outcomes assessed included bowel movement frequency, stool consistency, clinical remission rates, and abdominal symptoms.
Main Results:
- Forlax significantly increased bowel movement frequency and improved stool consistency compared to lactulose.
- The clinical complete remission rate for constipation was higher with Forlax (72%) versus lactulose (41%) by week 2.
- Abdominal pain resolved in 75% of patients on Forlax, compared to 57% on lactulose.
Conclusions:
- Polyethylene glycol 4000 (Forlax) demonstrates significant safety and effectiveness in treating constipation in children over 8 years old.
- Forlax offers a superior treatment option for pediatric constipation, showing better efficacy in symptom resolution and remission rates.
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.
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