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Comparison Between the Cassia Fistula`s Emulsion With Polyethylene Glycol (PEG4000) in the Pediatric Functional
Mohammad Reza Esmaeilidooki1, Seyyed Ali Mozaffarpur2, Mohaddese Mirzapour2
1Department of Pediatrics, Non-Communicable Pediatric Disease Research Center, Babol University of Medical Sciences, Babol, IR Iran.
Insights
Cassia fistula emulsion (CFE) is as effective as Polyethylene glycol (PEG4000) for treating pediatric functional constipation (FC). Both treatments showed significant improvement with no major side effects in children.
Area of Science:
- Pediatric Gastroenterology
- Pharmacology
- Clinical Trial Research
Background:
- Pediatric functional constipation (FC) presents a significant challenge due to limited effective therapeutic options.
- Investigating novel and established treatments is crucial for improving pediatric care.
Purpose of the Study:
- To compare the efficacy of Cassia fistula emulsion (CFE) against Polyethylene glycol 4000 (PEG4000) in treating functional constipation in children.
- To evaluate the safety profile of both CFE and PEG4000 in this pediatric population.
Main Methods:
- A randomized, open-label, controlled clinical trial involving 109 children aged 2-15 years diagnosed with FC.
- Participants received either CFE or PEG4000 for 4 weeks, with outcomes assessed based on Rome III criteria, defecation frequency, stool consistency, and pain.
- Key parameters including defecation frequency, pain severity, stool consistency, fecal incontinence, and retentive posturing were compared between groups and against baseline values.
Main Results:
- After 4 weeks, 86.5% of children receiving CFE and 77.1% receiving PEG4000 achieved remission from FC criteria.
- While both treatments improved constipation symptoms, CFE demonstrated a significantly higher frequency of defecation compared to PEG4000 (10.96 vs. 6.9, P < 0.0001).
- No clinically significant adverse effects were reported for either CFE or PEG4000, indicating a favorable safety profile for both interventions.
Conclusions:
- Cassia fistula emulsion (CFE) presents comparable effectiveness to Polyethylene glycol 4000 (PEG4000) for the 4-week treatment of pediatric functional constipation.
- Both CFE and PEG4000 are safe and effective options for managing FC in children, with CFE showing a potential advantage in improving defecation frequency.
Background:
There are few effective drugs for pediatric functional constipation (FC).
Objectives:
Comparing the effectiveness of Cassia fistula's emulsion (CFE) with Polyethylene glycol (PEG4000) in FC; and evaluation of safety of both drugs in the treatment of FC.
Materials And Methods:
A randomized open label, prospective, controlled, parallel-group clinical trial was carried on 109 children (M/F: 63/46; mean age ± SD: 59.7 ± 28.8 months) in Amirkola children's hospital, Babol, Iran. The inclusion criteria were based on diagnosis of FC according to the Rome III criteria and age range between 2 - 15 years. They received CFE or PEG randomly for 4 weeks. Frequencies of defecation, severity of pain, consistency of stool, fecal incontinence and retentive posturing were compared between the two groups and with baselines. Children were counted as improved when they exited from Rome III criteria of FC.
Results:
Fifty seven patients were assigned to receive PEG and 52 patients received CFE. After 4weeks of medication, 86.5% of children in CFE group and 77.1% in PEG group (RR = 1.121, CI95%:0.939 - 1.338) exited from the criteria of FC. All measurable criteria improved in both groups without any significant difference, except in the frequency of defecation that in CFE group (10.96 ± 5.7) was significantly more than PEG group (6.9 ± 3.5) (P < 0.0001). Compliances of PEG were significantly better in the 2 first weeks (P = 0.002, 0.008) but not in third and fourth week (P = 0.061, 0.062). None of these two drugs cause clinically significant side effects.
Conclusions:
CFE can be as effective as PEG in the 4-weeks treatment of children with FC.
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