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      Clinical efficacy and safety of polyethylene glycol 3350 versus liquid paraffin in the treatment of pediatric functional constipation

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          Abstract

          Background and the purpose of the study

          Functional constipation is prevalent in children. Recently polyethylene glycol has been introduced as an effective and safe drug to treat chronic constipation. There are only a few clinical trials on comparison of PEG and liquid paraffin in childhood constipation. The purpose of this study was to evaluate clinical efficacy and safety of PEG 3350 solution and liquid paraffin in the treatment of children with functional constipation in Sari Toba clinic during the period of 2008–2009.

          Methods

          Children with a history of functional constipation were subjects of this study. One hundred and sixty children of 2–12 years old with functional constipation were randomized in two PEG and paraffin treatment groups. Patients received either 1.0–1.5 g/kg/day PEG 3350 or 1.0–1.5 ml/kg/day liquid paraffin for 4 months. Clinical efficacy was evaluated by stool and encopresis frequency/week and overall treatment success rate was compared in two groups.

          Results and major conclusion

          Compared with the baseline, defecation frequency/ week increased significantly and encopresis frequency meaningfully decreased in two groups during the period of the study. Patients using PEG 3350 had more success rate (mean: 95.3%±3.7) compared with the patients in paraffin group (mean: 87.2%±7.1) (p=0.087). Administration of PEG 3350 were associated with less adverse events than liquid paraffin. In conclusion in treatment of pediatric functional constipation, regarding clinical efficacy and safety, PEG 3350 were at least as effective as liquid paraffin and but less adverse drug events.

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          Most cited references20

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          Evaluation and treatment of constipation in infants and children: recommendations of the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition.

          (2006)
          Constipation, defined as a delay or difficulty in defecation, present for 2 or more weeks, is a common pediatric problem encountered by both primary and specialty medical providers. The Constipation Guideline Committee of the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) has formulated a clinical practice guideline for the management of pediatric constipation. The Constipation Guideline Committee, consisting of two primary care pediatricians, a clinical epidemiologist, and pediatric gastroenterologists, based its recommendations on an integration of a comprehensive and systematic review of the medical literature combined with expert opinion. Consensus was achieved through Nominal Group Technique, a structured quantitative method. The Committee developed two algorithms to assist with medical management, one for older infants and children and the second for infants less than 1 year of age. The guideline provides recommendations for management by the primary care provider, including evaluation, initial treatment, follow-up management, and indications for consultation by a specialist. The Constipation Guideline Committee also provided recommendations for management by the pediatric gastroenterologist. 2006 Lippincott Williams & Wilkins, Inc.
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            PEG 3350 (Transipeg) versus lactulose in the treatment of childhood functional constipation: a double blind, randomised, controlled, multicentre trial.

            Recently, polyethylene glycol (PEG 3350) has been suggested as a good alternative laxative to lactulose as a treatment option in paediatric constipation. However, no large randomised controlled trials exist evaluating the efficacy of either laxative. To compare PEG 3350 (Transipeg: polyethylene glycol with electrolytes) with lactulose in paediatric constipation and evaluate clinical efficacy/side effects. One hundred patients (aged 6 months-15 years) with paediatric constipation were included in an eight week double blinded, randomised, controlled trial. After faecal disimpaction, patients or =6 years started with 2 sachets/day. Primary outcome measures were: defecation and encopresis frequency/week and successful treatment after eight weeks. Success was defined as a defecation frequency > or =3/week and encopresis < or =1 every two weeks. Secondary outcome measures were side effects after eight weeks of treatment. A total of 91 patients (49 male) completed the study. A significant increase in defecation frequency (PEG 3350: 3 pre v 7 post treatment/week; lactulose: 3 pre v 6 post/week) and a significant decrease in encopresis frequency (PEG 3350: 10 pre v 3 post/week; lactulose: 8 pre v 3 post/week) was found in both groups (NS). However, success was significantly higher in the PEG group (56%) compared with the lactulose group (29%). PEG 3350 patients reported less abdominal pain, straining, and pain at defecation than children using lactulose. However, bad taste was reported significantly more often in the PEG group. PEG 3350 (0.26 (0.11) g/kg), compared with lactulose (0.66 (0.32) g/kg), provided a higher success rate with fewer side effects. PEG 3350 should be the laxative of first choice in childhood constipation.
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              A randomized, prospective, comparison study of polyethylene glycol 3350 without electrolytes and milk of magnesia for children with constipation and fecal incontinence.

              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. 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. 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. 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.
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                Author and article information

                Journal
                Daru
                DARU
                DARU : Journal of Faculty of Pharmacy, Tehran University of Medical Sciences
                Tehran University of Medical Sciences
                1560-8115
                2008-2231
                2011
                : 19
                : 2
                : 154-158
                Affiliations
                [1 ]Pharmaceutical Sciences Research Center, School of Pharmacy
                [2 ]Department of Pediatrics, School of Medicine
                [3 ]Department of Clinical Pharmacy, School of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran
                Author notes
                Article
                DARU-19-154
                3232099
                22615652
                2c2d1b01-9511-4132-a4f8-737e6e0bce58
                © 2011 Tehran University of Medical Sciences

                This work is licensed under a Creative Commons Attribution-NonCommercial 3.0 Unported License which allows users to read, copy, distribute and make derivative works for non-commercial purposes from the material, as long as the author of the original work is cited properly.

                History
                : 04 August 2010
                : 17 April 2011
                : 18 April 2011
                Categories
                Original Article

                Pharmacology & Pharmaceutical medicine
                defecation,mineral oil.,lactoluse,encopresis
                Pharmacology & Pharmaceutical medicine
                defecation, mineral oil., lactoluse, encopresis

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