Long term efficacy, safety, and tolerabilitity of low daily doses of isosmotic polyethylene glycol electrolyte balanced solution (PMF-100) in the treatment of functional chronic constipation

Abstract

Aims-To assess the long term therapeutic eVectiveness, safety, and tolerability of low daily doses of isosmotic PEG electrolyte solutions (PMF-100) administered for a six month period for the treatment of functional constipation, in a double blind, placebo controlled, parallel group study. Methods-After an initial four week run in period with PMF-100 (250 ml twice daily; PEG 14.6 g twice daily), 70 patients suVering from chronic constipation (58 females, aged 42 (15) years) with normalised bowel frequency (>3 bowel movements (bm)/ week) were randomly allocated to receive either PMF-100 or placebo, contained in sachets (one sachet in 250 ml of water twice daily) for 20 weeks. Patients were assessed at four week intervals, and reported frequency and modality of evacuation, laxative use, and relevant symptoms on a diary card. At weeks 1, 12, and 24, a physical examination and laboratory tests were performed. Low daily doses of PEG solution are also eVective for the treatment of chronic constipation. The therapeutic eVectiveness of PEG solutions has been assessed for only a few days 5 6 and, more recently, over a two month period in chronic non-organic constipation. 7 In the latter study, PEG solution at a mean daily dose of 440 ml (PEG 25.7 g) was eVective in increasing bowel frequency and accelerating colorectal transit time. It also improved diYcult defecation. The treatment appeared to be eVective for the period of administration and was devoid of significant side eVects. It is not known, however, if prolonged administration of PEG solution at a low daily dose is eVective, safe, and well tolerated for the long term treatment of chronic constipation. Results-CompleteThe aims of this multicentre, double blind, placebo controlled, parallel group study were to assess the therapeutic eVectiveness, safety, and tolerability of low daily doses of isosmotic PEG solutions for the long term treatment of chronic non-organic constipation. Materials and methods PATIENTSPatients seeking medical advice for chronic constipation were investigated over a 24 month period in the outpatient clinics of the participating centres.Inclusion criteria were patients aged 18-75 years and presenting with chronic constipation, defined in accordance with the Rome diagnostic criteria (less than two bowel movements (bm) a week for at least 12 months or the presence of two or more of the following complaints when laxatives and/or enemas were not Abbreviations used in this paper: PEG, polyethylene glycol; bm, bowel movements.

Chronic Constipation: An Evidence-Based Review

“…19 In fact, some studies also reported efficacy at a low dosage of PEG. [145][146][147] For lactulose, at least 2 systematic reviews reported RCTs showing efficacy over placebo, 109,110 and the evidence is considered superior. No randomized, placebo-controlled trials have been conducted with sorbitol, but at least 1 double-blind, randomized, crossover study showed no difference in efficacy when compared with lactulose.…”

Guidelines for the Diagnosis and Treatment of Chronic Functional Constipation in Korea, 2015 Revised Edition

“…119 While osmotic laxatives can generally cause electrolyte disturbances, volume overload, or dehydration, and these medications should be used with caution in patients prone to renal insufficiency or cardiac abnormalities, 131 PEG is considered relatively safe in these respects. Although there have been reports about common adverse events including diarrhea, ab-dominal pain, nausea, and vomiting, no serious adverse events have been reported with long-term PEG treatment.…”

“…Numerous trials have shown both electrolyte-enriched PEG and electrolyte-free PEG to be effective in patients with chronic constipation. 115,[118][119][120][121][122][123][124][125][126][127] A meta-analysis concluded that PEG treatment resulted in a highly significant increase in defecations per week over placebo. 128 In particular, a meta-analysis involving 10 RCTs found that PEG was better than lactulose with respect to the outcomes of stool frequency per week, form of stool, relief of abdominal pain, and the need for additional products.…”

Prukalopride in the Treatment of Chronic Constipation

“…Большинство экспертов по запорам предлагают несколько вариантов лечения хронического запора с первоначальными реко-мендациями по изменению образа жизни, а при неудаче этого подхода предлагают использовать осмотические, увеличивающие объем каловых масс и стимулирующие слабительные. Использование макрогола, бисакодила, гли-цериновых суппозиториев, фосфата натрия и клизмы с арахисовым маслом также является обычной практикой перед использованием относительно инновационных агентов [5][6][7][8][9][10][11][12][13][14][15]. В различных источниках с переменной эффективностью обсуждаются нефармакологические вме-шательства, такие как ритуализирующие привычки для кишечника, терапия биологической обратной связи, пове-денческая терапия, электростимуляция мышц таза, когни-тивная терапия и хирургические пособия на толстой кишке у пациентов с хроническим запором [16][17][18][19].…”