期刊论文详细信息
BMC Pediatrics
Efficacy and tolerability of peg-only laxative on faecal impaction and chronic constipation in children. A controlled double blind randomized study vs a standard peg-electrolyte laxative
Salvatore Cucchiara2  Salvatore Oliva2  Giovanni Di Nardo2  Maiullari Erasmo1  Serena Viola3  Francesco Savino3 
[1] Department of Suergery Pediatrics, “Regina Margherita” Children’s Hospital, Azienda Ospedaliera Città della Salute e della Scienza della Città di Torino, Turin, Italy;Pediatric Gastroenterology and Liver Unit, “La Sapienza” University of Rome, Rome, Italy;Department of Pediatrics 1, “Regina Margherita” Children’s Hospital, University of Turin, Azienda Ospedaliera Città della Salute e della Scienza della Città di Torino, Turin, Italy
关键词: Macrogol;    Polyethylene glycol;    Children;    Laxatives;    Constipation;   
Others  :  1170611
DOI  :  10.1186/1471-2431-12-178
 received in 2012-05-09, accepted in 2012-11-08,  发布年份 2012
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【 摘 要 】

Background

PEG-based laxatives are considered today the gold standard for the treatment of constipation in children. PEG formulations differ in terms of composition of inactive ingredients which may have an impact on acceptance, compliance and adherence to treatment. We therefore compared the efficacy, tolerability, acceptance and compliance of a new PEG-only formulation compared to a reference PEG-electrolyte (PEG-EL) formulation in resolving faecal impaction and in the treatment of chronic constipation.

Methods

Children aged 2–16 years with functional chronic constipation for at least 2 months were randomized to receive PEG-only 0.7 g/kg/day in 2 divided doses or 6.9 g PEG-EL 1–4 sachets according to age for 4 weeks. Children with faecal impaction were randomized to receive PEG-only 1.5/g/kg in 2 divided doses until resolution or for 6 days or PEG-EL with an initial dose of 4 sachets and increasing 2 sachets a day until resolution or for 7 days.

Results

Ninety-six children were randomized into the study. Five patients withdrew consent before starting treatment. Three children discontinued treatment for refusal due to bad taste of the product (1 PEG-only, 2 PEG-EL); 1 (PEG-EL) for an adverse effect (abdominal pain). Intent-to-treat analysis was carried out in 49 children in the PEG-only group and 42 in the PEG-EL group.

No significant differences were observed between the two treatment groups at baseline.

Adequate relief of constipation in terms of normalized frequency and painless defecation of soft stools was achieved in all patients in both groups. The number of stools/week was 9.2 ± 3.2 (mean ± SD) in the PEG-only group and 7.8 ± 2.4 in the PEG-EL group (p = 0.025); the number of days with stool was 22.4 ± 5.1 in the PEG-only group and 19.6 ± 7.2 in the PEG-EL group (p = 0.034).

In the PEG-only group faecaloma resolution was observed in 5 children on the second day and in 2 children on the third day, while in the PEG-EL group it was observed in 2 children on the second day, in 3 children on the third day and in 1 child on the fifth day.

Only 2 patients reported mild treatment-related adverse events: 1 child in the PEG-only group had diarrhoea and vomiting and 1 child in the PEG-EL group had abdominal pain requiring treatment discontinuation. The PEG-only preparation was better tolerated as shown by the lower frequency of nausea than in the PEG-EL group.

In the PEG-only group, 96% of patients did not demonstrate any difficulties associated with treatment, as compared with 52% of patients in the PEG-EL group (p < 0.001). Also, the PEG-only formulation taste was better than that of PEG-EL (p < 0.001). The difference between the percentage of subjects who took > 80% of the prescribed dose was in favour of the PEG-only group (98% vs. 88%), though it did not reach a conventional statistical level (p = 0.062).

Conclusion

PEG-only was better tolerated and accepted than PEG-EL in children with chronic constipation. At the higher PEG doses recommended by the manufactures children in the PEG-only group had higher and more regular soft stool frequency than PEG-EL.

Trial registration

ClinicalTrials.gov: NCT01592734

【 授权许可】

   
2012 Savino et al.; licensee BioMed Central Ltd.

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【 参考文献 】
  • [1]Van Den Berg M, Benninga MA, Di Lorenzo C: Epidemiology of childhood constipation: a systematic review. Am J Gastroenterol 2006, 101(10):2401-2409.
  • [2]Constipation Guideline Committee of the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition: Evaluation and treatment of constipation in infants and children: recommendations of the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition. J Pediatr Gastroenterol Nutr 2006, 43(3):e1-e13.
  • [3]Rubin G, Dale A: Chronic constipation in children. BMJ 2006, 333(7577):1051-1055.
  • [4]Benninga MA, Voskuijl WP, Taminiau JA: Childhood constipation: Is there new light in the tunnel? J Pediatr Gastroenterol Nutr 2004, 39:448-464.
  • [5]Di Palma JA, Cleveland MV, McGowan J, Herrera JL: A randomized, multicenter comparison of polyethylene glycol laxative and tegaserod in treatment of patients with chronic constipation. Am J Gastroenterol 2007, 102(9):1964-1971.
  • [6]DiPalma JA, Cleveland MB, McGowan J, Herrera JL: A comparison of polyethylene glycol laxative and placebo for relief of constipation from constipating medications. South Med J 2007, 100(11):1085-1090.
  • [7]Pashankar DS, Bishop WP: Efficacy and optimal dose of daily polyethylene glycol 3350 for treatment of constipation and encopresis in children. J Pediatr 2001, 139:428-432.
  • [8]Loening-Baucke V: Polyethylene glycol without electrolytes for children with constipation and encopresis. J Pediatr Gastroenterol Nutr 2002, 34:372-377.
  • [9]Youssef NN, Peters JM, Henderson W, et al.: Dose response of PEG 3350 for the treatment of childhood fecal impaction. J Pediatr 2002, 141:410-414.
  • [10]Bekkali NL, van den Berg MM, Dijkgraaf MG, van Wijk MP, Bongers ME, Liem O, Benninga MA: Rectal fecal impaction treatment in childhood constipation: enemas versus high doses oral PEG. Pediatrics 2009, 124(6):e1108-e1115.
  • [11]Lee-Robichaud H, Thomas K, Morgan J, Nelson RL: Lactulose versus polyethylene glycol for chronic constipation. Cochrane Database Syst Rev 2010, 7:CD007570.
  • [12]De Giorgio R, Cestari R, Corinaldesi R, et al.: Use of macrogol 4000 in chronic constipation. Eur Rev Med Pharmacol Sci 2011, 15(8):960-966.
  • [13]Thomson MA, Jenkins HR, Bisset WM, et al.: Polyethylene glycol 3350 plus electrolytes for chronic constipation in children: a double blind, placebo controlled, crossover study. Arch Dis Child 2007, 92(11):996-1000.
  • [14]Hardikar W, Cranswick N, Heine RG: Macrogol 3350 plus electrolytes for chronic constipation in children: a single-centre, open-label study. J Paediatr Child Health 2007, 43(7–8):527-531.
  • [15]Corazziari E, Badiali D, Bazzocchi G, Bassotti G, Roselli P, Mastropaolo G, Lucà MG, Galeazzi R, Peruzzi E: Long term efficacy, safety, and tolerability of low daily doses of isosmotic polyethylene glycol electrolyte balanced solution (PMF-100) in the treatment of functional chronic constipation. Gut 2000, 46(4):522-526.
  • [16]Voskuijl W, de Lorijn F, Verwijs W, Hogeman P, Heijmans J, Mäkel W, Taminiau J, Benninga M: PEG 3350 (Transipeg) versus lactulose in the treatment of childhood functional constipation: a double blind, randomised, controlled, multicentre trial. Gut 2004, 53(11):1590-1594.
  • [17]Nurko S, Youssef NN, Sabri M, Langseder A, McGowan J, Cleveland M, Di Lorenzo C: PEG3350 in the treatment of childhood constipation: a multicenter, double-blinded, placebo-controlled trial. J Pediatr 2008, 153(2):254-261.
  • [18]Dupont C, Leluyer B, Maamri N, et al.: Double-blind randomized evaluation of clinical and biological tolerance of polyethylene glycol 4000 versus lactulose in constipated children. J Pediatr Gastroenterol Nutr 2005, 41:625-633.
  • [19]Dupont C, Leluyer B, Amar F, Kalach N, Benhamou PH, Mouterde O, Vannerom PY: A dose determination study of polyethylene glycol 4000 in constipated children: factors influencing the maintenance dose. J Pediatr Gastroenterol Nutr 2006, 42(2):178-185.
  • [20]Maiullari E, Bianco ER, Cortese MG, et al.: Conservative treatment of children constipation with Macrogol 4000. Minerva Pediatr 2008, 60(4):407-410.
  • [21]Szojda MM, Mulder CJ, Felt-Bersma RJ: Differences in taste between two polyethylene glycol preparations. J Gastrointestin Liver Dis 2007, 16(4):379-381.
  • [22]Pashankar DS, Loening-Baucke V, Bishop WP: Safety of polyethylene glycol 3350 for the treatment of chronic constipation in children. Arch Pediatr Adolesc Med 2003, 157(7):661-664.
  • [23]Candy D, Belsey J: Macrogol (polyethylene glycol) laxatives in children with functional constipation and faecal impaction: a systematic review. Arch Dis Child 2009, 94(2):156-160.
  • [24]Loening-Baucke V, Pashankar DS: A randomized, prospective, comparison study of polyethylene glycol 3350 without electrolytes and milk of magnesia for children with constipation and fecal incontinence. Pediatrics 2006, 118(2):528-535.
  • [25]Davis GR, Santa Ana CA, Morawski SG, Fordtran JS: Inhibition of water and electrolyte absorption by polyethylene glycol (PEG). Gastroenterology 1980, 79(1):35-39.
  • [26]Loening-Baucke V, Krishna R, Pashankar DS: Polyethylene glycol 3350 without electrolytes for the treatment of functional constipation in infants and toddlers. J Pediatr Gastroenterol Nutr 2004, 39(5):536-539.
  • [27]Michail S, Gendy E, Preud'Homme D, et al.: Polyethylene glycol for constipation in children younger than eighteen months old. J Pediatr Gastroenterol Nutr 2004, 39(2):197-199.
  • [28]Pashankar DS, Bishop WP, Loening-Baucke V: Long-term efficacy of polyethylene glycol 3350 for the treatment of chronic constipation in children with and without encopresis. Clin Pediatr (Phila) 2003, 42(9):815-819.
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