Comparative efficacy of polyethylene glycol 3350 monotherapy against polyethylene glycol 3350 plus sodium picosulfate combined therapy in treating fecal impaction in pediatric functional constipation patients
Keywords:Bristol stool scale, Disimpaction, Functional constipation, Polyethylene glycol, OME IV criteria, Sodium picosulfate
Background: Functional constipation (FC) is a common pediatric problem worldwide. The management of FC comprises of a short initial disimpaction phase followed by long-term maintenance phase. Currently, polyethylene glycol (PEG) is considered as standard disimpaction therapy in pediatric FC patients. The aim of our study was to compare the efficacy of polyethylene glycol 3350 monotherapy with polyethylene glycol 3350 and sodium picosulfate combined therapy in treating fecal impaction in pediatric FC patients.
Methods: All children (aged >1 year) diagnosed with FC as per ROME IV criteria and presenting to the out-patient department of pediatric gastroenterology, hepatology and nutrition unit of a tertiary health centre in north Indian Himalayan state were randomized into two open label, prospective, parallel groups, namely group A (receiving PEG 3350 monotherapy) and group B (receiving combined PEG 3350 plus sodium picosulfate therapy), over a period of 13 months. The outcome was evaluated as successful disimpaction with onset of loose/watery stools (Type-7 of Bristol stool chart scale). The success rates and mean time to disimpaction for two groups were computed and compared.
Results: Eighty-one patients were randomized into two groups. The mean time to disimpaction was found to be significantly lower (p<0.001) for group B (2.37±1.16 days) when compared to group A (4.00±1.43 days). There was successful resolution of impaction in both groups. No adverse events were reported in either group.
Conclusions: Combined PEG 3350 and sodium picosulfate therapy significantly reduces the disimpaction time when compared with PEG 3350 monotherapy in pediatric population, however both the therapies appear similar in achieving successful disimpaction.
Taitz LS, Wales JK, Urwin OM, Molnar D. Factors associated with outcome in management of defecation disorders. Arch Dis Child. 1986;61(5):472-7.
Koppen IJN, Vriesman MH, Saps M, Rajindrajith S, Shi X, van Etten-Jamaludin FS, et al. Prevalence of functional defecation disorders in children: a systematic review and meta-analysis. J Pediatr. 2018;198:121-30.e6.
Bhatia V, Deswal S, Seth S, Kapoor A, Sibal A, Gopalan S. Prevalence of functional gastrointestinal disorders among adolescents in Delhi based on Rome III criteria: A school-based survey. Indian J Gastroenterol. 2016; 35:294-8.
Kondapalli CS, Gullapalli S. Constipation in children: incidence, causes in relation to diet pattern and psychosocial aspects. Int J Contemp Pediatr. 2018;5(1):6-13.
Tambucci R, Quitadamo P, Thapar N, Zengeri L, Caldaro T, Staiano A, et al. Diagnostic tests in pediatric constipation. J Pediatr Gastroenterol Nutr. 2018;66(4):e89-98.
Hyams JS, Di Lorenzo C, Saps M, Shulman RJ, Staiano A, van Tilburg M. Childhood functional gastrointestinal disorders: child/adolescent. Gastroenterology. 2016;150(6):1456-68.
Yachha SK, Srivastava A, Mohan N, Bharadia L, Sarma MS. Management of childhood functional constipation: consensus practice guidelines of Indian Society of Pediatric Gastroenterology, Hepatology and Nutrition and Pediatric Gastroenterology Chapter of Indian Academy of Pediatrics. Indian Pediatr. 2018;55(10):885-92.
Acharyya BC, Bhattacharyya C, Mukhopadhyay M, Acharyya S. Polyethylene glycol plus electrolytes with stimulant laxative in paediatric faecal disimpaction: a randomised controlled study. Pediatr Gastroenterol Hepatol Nutr. 2021;24(2):230-7.
Tabbers MM, DiLorenzo C, Berger MY, Faure C, Langendam MW, Staiano A, et al. Evaluation and treatment of functional constipation in infants and children: evidence-based recommendations from ESPGHAN and NASPGHAN. J Pediatr Gastroenterol Nutr. 2014;58(2):258-74.
Voskuijl W, de Lorijn F, Verwijs W, Hogeman P, Heijmans J, Makel W, et al. PEG 3350 (Transipeg) versus lactulose in the treatment of childhood functional constipation: a double-blind, randomized, controlled, multicenter trial. Gut. 2004;53(11):1590-94.
Koppen IJN, Broekaert IJ, Wilschanski M, Papadopoulou A, Ribes-Koninckx C, Thapar N, et al. Role of polyethylene glycol in the treatment of FC in children. J Pediatr Gastroenterol Nutr. 2017;65(4):361-3.
Sharkey KA, MacNaughton WK. Gastrointestinal motility and water flux, emesis, and biliary and pancreatic disease. In: Brunton LL, Dandan RH, Knollmann BC, eds. Goodman and Gilman’s: The Pharmacological Basis of Therapeutics. 13th edn. New York: McGraw Hill; 2018:921-944.
Youssef NN, Peters JM, Henderson W, Shultz-Peters S, Lockhart DK, Di Lorenzo C. Dose response of PEG 3350 for the treatment of childhood fecal impaction. J Pediatr. 2002;141(3):410-4.
Jordan-Ely J, Hutson JM, Southwell BR. Disimpaction of children with severe constipation in 3-4 days in a suburban clinic using polyethylene glycol with electrolytes and sodium picosulphate. J Pediatr Child Health. 2015;51(12):1195-8.