Polyethylene glycol 3350 in occasional constipation: A one-week, randomized, placebo-controlled, double-blind trial

Abstract

AIM: to evaluate the efficacy and safety of polyethylene glycol (PEG) 3350 in subjects with self-reported occasional constipation. METHODS:Eligible subjects ≥ 17 years of age were randomized to receive either placebo or PEG 3350 17 g once daily in this multicenter, double-blind trial. Evaluations were conducted before (baseline) and after a 7-d treatment period. The primary efficacy variable was the proportion of subjects reporting complete resolution of straining and hard or lumpy stools. Secondary efficacy variables assessed the severity of the subjects' daily bowel movement (BM) symptoms, and preference of laxatives based on diary entries, visual analog scale scores, and questionnaires. RESULTS:Of the 203 subjects enrolled in the study, 11 had major protocol violations. Complete resolution was noted by 36/98 (36.7%) subjects in the PEG 3350 group and 23/94 (24.5%) in the placebo group (P = 0.0595). The number of complete BMs without straining or lumpy stools was similar between both groups. Subjects receiving PEG 3350 experienced significant relief in straining and reduction in hardness of stools over a 7-d period (P < 0.0001). Subjects reported that PEG 3350 had a better effect on their daily lives, provided better control over a BM, better relief from constipation, Author contributions: McGraw T contributed to the conception, design and planning of the study, data acquisition and analysis, interpretation of results, drafting the manuscript, and critically reviewing and revising the manuscript in terms of intellectual content.Institutional review board statement: The study was reviewed and supervised by Allendale IRB for all sites.Clinical trial registration: This study is registered at https:// clinicaltrials.gov/ct2/show/NCT00770432. The registration identification number is NCT00770432.Informed consent statement: Written informed consent was obtained from all subjects prior to any study-related procedures. Conflict-of-interest statement:McGraw T was an employee of Merck & Co., Inc., Kenilworth, NJ, United States when the study was conducted. Merck & Co. was involved in study design; in the collection, analysis, and interpretation of data; in the writing of the report; and in the decision to submit the article for publication. Data sharing statement:No additional data are available.Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work noncommercially, and license their derivative works on different terms, provided the original work is properly cited and the use is noncommercial. See: http://creativecommons.org/licenses/by-nc/4.0/ Randomized Clinical Trialcramping, and bloating, and was their preferred laxative. Adverse events (AEs) were balanced between the PEG 3350 and the placebo groups. No deaths, serious AEs, or discontinuations due...

Macrogol (polyethylene glycol) 4000 without electrolytes in the symptomatic treatment of chronic constipation: a profile of its use

“…successful treatment, stool frequency, consistency and straining, patient/physician assessments of treatment, etc.) improved to a significantly ( p < 0.05) greater extent with macrogol 3350 than with placebo in the treatment of current constipation [ 37 ], occasional constipation [ 38 ], chronic constipation [ 39 ], medication-induced constipation [ 40 ] and childhood constipation [ 41 ]. Relative to placebo, significant improvements in constipation-related outcomes were shown within the first few weeks of macrogol 3350 treatment in trials of 1-week to 6-months’ duration [ 37 – 41 ], with improvements being maintained with treatment for 6 months [ 39 ].…”

Prevalence and patterns of laxative use in subjects with self-reported constipation: results from a multinational digestive health survey

“…Furthermore, subjects could report episodes of constipation without accounting for other constipation-specific symptoms as is common for occasional constipation. 13 …”

Recognizing and Defining Occasional Constipation: Expert Consensus Recommendations

“…By contrast, the definition of OC does not have a similar consensus. Some recent working OC definitions have included the following:Constipation (straining with lumpy or hard stools or no bowel movement in the past 48 hours) that does not resolve on its own with time vs chronic sufferers needing prescription medication and/or medical intervention (31);At least 2 of the following in the past 2 weeks: ≤3 defecations/wk, and/or straining, lumpy or hard stools, sensation of incomplete evacuation or obstruction or blockage, or manual maneuvers to facilitate at least 25% of defecations (32);<3 bowel movements/wk for at least 2 weeks (but not for >12 weeks in the past 6 months). Presence of at least 1 other bowel symptom of constipation in at least 25% of defecations: hard stools or complete lack of loose or watery stools, straining during defecation, feeling of incomplete evacuation, abdominal discomfort, and bloating/distension (33).…”

“…Constipation (straining with lumpy or hard stools or no bowel movement in the past 48 hours) that does not resolve on its own with time vs chronic sufferers needing prescription medication and/or medical intervention (31);…”