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Selected Summaries Indian Pediatrics 2000;37: 917-918 |
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Cisapride for the Treatment of Constipation in Children |
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[Nurko S, Garcio Aranda JA, Worona LB, Zlochisty O. Cisapride for the treatment of constipation in children: A double blind study. J Pediatrics 2000; 136: 35-40] Constipation is a distressing problem in children. It is considered as one of the nonspecific conditions and treated vaguely by most of the physicians. Although constipation may be characteristically seen in some disease processes (e.g., Hirschsprung’s disease, hypo-thyroidism) its exact etiology and patho-physiology in children has not been well defined. Generalized colonic dysfunction may explain delayed colonic transit. Various forms of therapies have been tried which include senna, milk of magnesia, high fiber diet and now more recently prokinetic agents such as Cisapride. The role of Cisapride in treating constipation in children still remains to be established. A double blinded, randomized placebo controlled study was conducted in 36 consti-pated children aged between 2-16 years to evaluate the role of cisapride. Constipation was defined as <3 bowel movements per week, chronic constipation as constipation lasting for minimum of 6 months, and spontaneous bowel movements (SBM) as bowel movements occuring in >48 hours after administration of laxatives. In all patients underlying causes as Hirschsprung’s disease, anismus or other congenital gastrointestinal abnormalities were excluded. Patients were carefully chosen and randomized to receive either cisapride or placebo. Medications were administered as oral suspension as 0.2 mg/kg/dose three times a day for 12 weeks but increased to 0.3 mg/kg/dose thrice a day if no response was noticed in 8 weeks. During the study period, enemas and laxatives were avoided until deemed essential because of fecal impaction. The SBM were recorded in a diary. The patients were seen at 2, 4, 8 and 12 weeks after starting therapy. Response was defined as >3 SBM/week with no fecal soiling and no use of laxatives for at least 2 weeks. Failure was defined as 2 episodes of fecal impaction requiring disimpaction or not fulfilling the above criteria for response after 12 weeks of therapy. Total gastrointestinal transit time (TGTT) and baseline anorectal manometry were recorded in all patients and repeated at completion of study. Thirteen out of seventeen patients in Cisapride group (76%) and 8/19 (37%) in placebo group met the criteria and this difference was significant (p <0.03). Even though these were significant changes before and after cisapride administra-tion the total number of SBM’s, fecal soiling episodes, laxatives used or number of patients with encopresis were not different from patients who received placebo. Only 11 in cisapride and 16 in placebo group completed measurement of TGTT which showed significant inverse correlation between the final TGTT and bowel movement frequency (r = – 0.667; p <0.001). There was a significant decreae in TGTT before and after Cisapride administration (from 115.0 ± 3.7 to 77.0 ± 11.1 hours; p = 0.003); whereas there was no difference in placebo group (112.5 ± 4.9 hours to 95.4 ± 9.8 hours; p >0.1). The odds ratio for response to Cisapride was 8.2 times higher (95% CI; 1.3 to 49.4) than the placebo. The overall mean time to response in Cisapride group was 9.1 ± 0.8 weeks (95% CI; 7.4 to 10.8 weeks).
Parents attach great importance to their children’s successful stooling. In fact anxious parents may even remember their child’s exact stooling time, duration and interestingly the amount. So apart from the behavioral inter-ventions, medications are used to relieve the child of this distressing problem. Although the authors in the study have concluded that Cisapride is effective in treating constipation in children and placed it as second line treatment considering its potential side effects; i.e., prolonging QT interval, the study could not clearly depict the effectiveness of the drug in these patients. Decrease in TGTT as demons-trated by significant (p <0.003) value in Cisapride group only shows pharmacological effect of the drug. The actual problem of constipation which is interpreted mainly from final number of SBM’s, fecal soiling episode, episodes of encopresis and percentage decrease in the laxative use were not significantly decreased in the Cisapride group, though there is a trend in improvement in these variables. It will be too early to conclude that Cisapride is effective in constipation in children. Moreover, the authors themselves state that Cisapride mainly helps in lesser degrees of constipation. This study however can act as a step forward for treating constipation in children and may be some more studies will settle some of the controversies related to Cisapride. Further, an increase in number of patients studied can establish the statistical significance if any, in above mentioned variables. Two earlier open labeled studies have suggested that Cisapride is effective in treatment of encopresis(1) and in children with intractable constipation(2). Support of the successful use of cisapride for treating childhood constipation comes from two double-blinded trials(3,4) where it was shown that TGTT was decreased and stool frequency increased with drug ingestion. Another trial however, did not support the successful treatment of constipation with Cisapride in children(5). Probably the doses used were low and the follow up was inadequate (8 weeks). Until the time new and safer prokinetic agents with more selective action on colonic motility are available, pediatricians should judiciously select patients needing pharmacological support for hard stools.
Shishir Kumar Bhatnagar,
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