Comparison Between the Cassia Fistula‘s Emulsion With Polyethylene Glycol (PEG4000) in the Pediatric Functional Constipation: A Randomized Clinical Trial
نویسندگان
1 Department of Pediatrics, Non-Communicable Pediatric Disease Research Center, Babol University of Medical Sciences, Babol, IR Iran
2 Department of Traditional Iranian Medicine, Faculty of Traditional Iranian Medicine, Babol University of Medical Sciences, Babol, IR Iran
3 Social Health Research Center, Babol University of Medical Sciences, Babol, IR Iran
4 Department of Traditional Iranian Medicine, Faculty of Traditional Iranian Medicine, Babol University of Medical Sciences, Babol, IR Iran
5 Department of Traditional Iranian Medicine, Faculty of Traditional Iranian Medicine, Babol University of Medical Sciences, Babol, IR Iran
6 School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, IR Iran
doi
چکیده
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 evaluationof 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 ondiagnosis 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 betweenthe 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 childrenin 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 inboth groups without any significant difference, except in the frequency of defecation that in CFE group (10.965.7)wassignificantlymore 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.
