Objectives: The aim of this study was to compare the clinical efficacy and tolerance of polyethylene glycol 3350 (PEG) and lactulose for the treatment of functional constipation in infants and children. Methods: This randomized, multicenter study covered 12 weeks of treatment and 4 weeks of follow-up of patients with functional constipation. Patients were randomized (central randomization) to receive either PEG or lactulose. The primary end points were the number of defecations per week after 12 weeks of treatment and improvement in stool consistency of at least 2 points in the Bristol scale. The secondary end point was the presence of adverse events. Bowel movements ≥ 3 per week and stool consistency ≥ 2 (Bristol scale) were considered as successful treatment. Results: We enrolled 102 patients (M 57, F 45) aged 3.62 ± 1.42 years and 88 completed the study. At week 12, good clinical outcome was achieved in 98% (PEG) and 90% (lactulose). The PEG group had more defecations per week compared with the lactulose group [7.9 ± 0.6 vs. 5.7 ± 0.5, p = 0.008] and both groups had similar frequency of defecation with pain (5% vs. 5%; p = 0.9), stool retention (7% vs. 10%; p = 057), large volume of stools (30% vs. 31%; p = 0.9) and hard stools (7% vs. 13%; p = 0.58). There were more patients with side effects in the lactulose group (15 vs. 23, p = 0.02), mostly bloating and abdominal pain. Conclusions: PEG 3350 is more effective and causes fewer side effects than lactulose in the treatment of constipation in infants and children. Clinical Trial Registration: clinicaltrials.gov, NCT03177434 Address correspondence and reprint requests to Dorota Jarzębicka, MD, ul. Aleja Dzieci Polskich 20, 04-730 Warsaw (e-mail: dorota.jarzebicka@wp.pl). Received 22 May, 2018 Accepted 11 October, 2018 Funding Source: No funding was secured for this study. Financial Disclosure: The authors have no financial relationships relevant to this article to disclose. Conflicts of Interest: PEG 3350 for patients was delivered by Vitis Pharma, Poland. The authors have no conflicts of interest relevant to this article to disclose. Table of Contents Summary This study compared the clinical efficacy and tolerance of PEG 3350 and lactulose for the treatment of functional constipation in infants and children. Contributors' Statement Page Dorota Jarzeębicka: collected data, conceptualized and designed the study, designed the data collection instruments, drafted the initial manuscript, reviewed, revised and final approved the manuscript. Joanna Sieczkowska-Gołub: collected data, drafted the initial manuscript, reviewed and revised the manuscript. Jarosław Kierkusś: conceptualized and designed the study, designed the data collection instruments, coordinated and supervised data collection, and critically reviewed the manuscript Piotr Czubkowski: designed the data collection instruments, carried out the analyses, drafted the initial manuscript, reviewed and revised the manuscript. Monika Kowalczuk-Krystoń: collected data, drafted the initial manuscript, reviewed and revised the manuscript. Maciej Pelc: collected data, drafted the initial manuscript, reviewed and revised the manuscript. Dariusz Lebensztejn: conceptualized and designed the study, coordinated and supervised data collection, and critically reviewed and revised the manuscript. Bartosz Korczowski: conceptualized and designed the study, coordinated and supervised data collection, and critically reviewed the manuscript. Piotr Socha: conceptualized and designed the study, carried out the analyses, drafted the initial manuscript, reviewed and revised the manuscript. Grzegorz Oracz: conceptualized and designed the study, designed the data collection instruments, coordinated and supervised data collection, and critically reviewed the manuscript. All authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work. © 2018 by European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology,
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