Medline ® Abstracts for References 36,62,68,69
of 'Chronic functional constipation and fecal incontinence in infants and children: Treatment'
Treatment of faecal impaction with polyethelene glycol plus electrolytes (PGE + E) followed by a double-blind comparison of PEG + E versus lactulose as maintenance therapy.
Candy DC, Edwards D, Geraint M
J Pediatr Gastroenterol Nutr. 2006;43(1):65.
OBJECTIVES: To assess the efficacy of polyethylene glycol 3350 plus electrolytes (PEG + E; Movicol) as oral monotherapy in the treatment of faecal impaction in children, and to compare PEG + E with lactulose as maintenance therapy in a randomised trial.
PATIENTS AND METHODS: An initial open-label study of PEG + E in the inpatient treatment of faecal impaction (phase 1), followed by a randomised, double-blind comparison between PEG + E and lactulose for maintenance treatment of constipation over a 3-month period (phase 2) in children aged 2 to 11 years with a clinical diagnosis of faecal impaction.
RESULTS: Disimpaction on PEG + E was achieved in 58 (92%) of 63 of children (89% of 2-4 year olds and 94% of 5-11 year olds) without additional interventions. A maximum dose of 4 sachets (for 2-4 year olds) or 6 sachets (for 5-11 year olds) was required; median time to disimpaction was 6 days (range, 3-7 days). Seven children (23%) reimpacted whilst taking lactulose, whereas no children reimpacted while taking PEG + E (P = 0.011). The total incidence rate of adverse events seen was higher in the lactulose group (83%) than in the PEG + E group (64%).
CONCLUSIONS: PEG + E is safe and highly effective in the management of childhood constipation. It allows a single orally administered laxative to be used for disimpaction without recourse to invasive interventions. It is significantly more effective than lactulose as maintenance therapy, both in efficacy in treating constipation and efficacy in preventing the recurrence of faecal impaction.
Paediatric Gastroenterology Service, Royal West Sussex NHS Trust, Chichester, UK. email@example.com
Double-blind randomized evaluation of clinical and biological tolerance of polyethylene glycol 4000 versus lactulose in constipated children.
Dupont C, Leluyer B, Maamri N, Morali A, Joye JP, Fiorini JM, Abdelatif A, Baranes C, Benoît S, Benssoussan A, Boussioux JL, Boyer P, Brunet E, Delorme J, François-Cecchin S, Gottrand F, Grassart M, Hadji S, Kalidjian A, Languepin J, Leissler C, Lejay D, Livon D, Lopez JP, Mougenot JF, Risse JC, Rizk C, Roumaneix D, Schirrer J, Thoron B, Kalach N
J Pediatr Gastroenterol Nutr. 2005;41(5):625.
OBJECTIVES: To assess the safety of a polyethylene glycol (PEG) 4000 laxative without additional salts in pediatric patients.
STUDY DESIGN: This was a 3-month multicenter, randomized, double-blind, double-dummy, lactulose-controlled, parallel study enrolling 96 ambulatory constipated children aged 6 months to 3 years, treated daily with 4-8 g PEG or 3.33 g-6.66 g lactulose. Total protein, albumin, iron, electrolytes, and vitamins B9 (folates), A and D (25OHD3) were measured in blood before and after treatment (day 84) in a central laboratory.
RESULTS: The percentage of children with at least one value out of normal range at day 84 with respect to baseline status (with or without at least one value out of normal range), i.e. the primary endpoint, was 87% and 90% in the PEG and lactulose groups, respectively, without any difference between groups. The whole blood parameters showed no qualitative or quantitative treatment-related changes. Vitamin A values were above normal range in 56% and 41% of children at baseline versus 33% and 36% at day 84 in the PEG and lactulose groups, respectively. Iron values were similarly under normal range in 47% and 51% at baseline versus 42% and 51% at day 84. Clinical tolerance was similar for both treatments except for vomiting and flatulence, which were significantly higher with lactulose. Significantly higher improvements were evidenced with PEG regarding stool consistency, appetite, fecaloma and use of additional laxatives.
CONCLUSION: This 3-month study in 96 constipated children aged 6 months to 3 years confirms the long-term tolerance of PEG 4000 in pediatrics and indicates a PEG efficacy similar to or greater than that of lactulose.
Hôpital Saint-Vincent-de-Paul, Service de Néonatologie, Paris, France. firstname.lastname@example.org
A randomized, prospective, comparison study of polyethylene glycol 3350 without electrolytes and milk of magnesia for children with constipation and fecal incontinence.
Loening-Baucke V, Pashankar DS
OBJECTIVE: Our aim was to compare 2 laxatives, namely, polyethylene glycol 3350 without electrolytes and milk of magnesia, evaluating the efficacy, safety, acceptance, and 1-year outcomes.
METHODS: Seventy-nine children with chronic constipation and fecal incontinence were assigned randomly to receive polyethylene glycol or milk of magnesia and were treated for 12 months in tertiary care pediatric clinics. Children were counted as improved or recovered depending on resolution of constipation, fecal incontinence, and abdominal pain after 1, 3, 6, and 12 months. An intent-to-treat analysis was used. Safety was assessed with evaluation of clinical adverse effects and blood tests.
RESULTS: Thirty-nine children were assigned randomly to receive polyethylene glycol and 40 to receive milk of magnesia. At each follow-up visit, significant improvement was seen in both groups, with significant increases in the frequency of bowel movements, decreases in the frequency of incontinence episodes, and resolution of abdominal pain. Compliance rates were 95% for polyethylene glycol and 65% for milk of magnesia. After 12 months, 62% of polyethylene glycol-treated children and 43% of milk of magnesia-treated children exhibited improvement, and 33% of polyethylene glycol-treated children and 23% of milk of magnesia-treated children had recovered. Polyethylene glycol and milk of magnesia did not cause clinically significant side effects or blood abnormalities, except that 1 child was allergic to polyethylene glycol.
CONCLUSIONS: In this randomized study, polyethylene glycol and milk of magnesia were equally effective in the long-term treatment of children with constipation and fecal incontinence. Polyethylene glycol was safe for the long-term treatment of these children and was better accepted by the children than milk of magnesia.
Division of General Pediatrics, University of Iowa, Iowa City, Iowa, USA. email@example.com
A randomised, double-blind study of polyethylene glycol 4000 and lactulose in the treatment of constipation in children.
Treepongkaruna S, Simakachorn N, Pienvichit P, Varavithya W, Tongpenyai Y, Garnier P, Mathiex-Fortunet H
BMC Pediatr. 2014;14:153. Epub 2014 Jun 19.
BACKGROUND: Chronic constipation is frequent in children. The objective of this study is to compare the efficacy and safety of PEG 4000 and lactulose for the treatment of chronic constipation in young children.
METHODS: This randomised, double-blind study enrolled 88 young children aged 12 to 36 months, who were randomly assigned to receive lactulose (3.3 g per day) or PEG 4000 (8 g per day) for four weeks. The primary efficacy variable was stool frequency during the fourth week of treatment. Secondary outcomes were the number and frequency of subjective symptoms associated with defecation at each visit.
RESULTS: Stool frequency was comparable in the two groups at baseline (lactulose: 0.7±0.5; PEG 4000: 0.5±0.55). Mean stool frequency increased from 0.70±0.50 stools/day at baseline to 0.80±0.41 at Week 4 in the lactulose group and from 0.50±0.55 to 1.10±0.55 stools/day in the PEG 4000 group. A significant difference was observed in the adjusted mean change from baseline, which was 0.15 stools/day in the lactulose group and 0.51 stools/day in the PEG 4000 group, with a least-squares mean difference of 0.36 stools/day [95% CI: 0.16 to 0.56]. With respect to secondary outcome variables, stool consistency and ease of stool passage improved more in the PEG 4000 group (p = 0.001). The incidence of adverse events was similar in both groups, the majority of which were mild.
CONCLUSIONS: PEG 4000 has superior efficacy to lactulose for the treatment of chronic constipation in young children and is well tolerated.
TRIAL REGISTRATION: US National Institute of Health Clinical Trials database; study NCT00255372 first registered 17th November 2005.
Department of Paediatrics, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Rama 6 Road, Bangkok 10400, Thailand. firstname.lastname@example.org.