A Randomized, Multicenter, Placebo-Controlled Trial of Polyethylene Glycol Laxative for Chronic Treatment of Chronic Constipation

DiPalma, Jack A.; Cleveland, Mark; McGowan, John; Herrera, Jorge

doi:10.1111/j.1572-0241.2007.01199.x

Cited by 187 publications

(152 citation statements)

References 10 publications

Supporting

Mentioning

129

Contrasting

Unclassified

Order By: Relevance

“…The current study demonstrated that in subjects with self-reported occasional constipation, there is no significant difference between PEG 3350 and placebo in achieving relief from straining and reduction in hardness of stools experienced during BMs. PEG 3350 was generally well tolerated; AEs were similar in incidence and severity (mostly mild) between treatment groups, in line with previous reports [19,[22][23][24][25][26] . The present study used the subject's own estimation of treatment effect to evaluate whether treatment with PEG 3350 led to resolution of straining and lumpy/hard stools compared with placebo.…”

Section: Discussionsupporting

confidence: 76%

“…Also, bad defecation practices such as deferring the urge to defecate could resulted in a loss of significance between treatment arms. In the study of PEG 3350 [25] for the treatment of chronic constipation, PEG 3350 was successful in treating constipation, where success was defined as a subject experiencing ≥ 3 satisfactory BMs per week and having no more than one of the remaining three Rome III symptoms. The same study also reported that PEG-treated subjects had higher incidences of complete spontaneous BMs over placebo [25] .…”

Section: Discussionmentioning

confidence: 99%

“…In the study of PEG 3350 [25] for the treatment of chronic constipation, PEG 3350 was successful in treating constipation, where success was defined as a subject experiencing ≥ 3 satisfactory BMs per week and having no more than one of the remaining three Rome III symptoms. The same study also reported that PEG-treated subjects had higher incidences of complete spontaneous BMs over placebo [25] . In the present study, PEG 3350 was better, but not significantly different (P = 0.595) than placebo in producing a complete BM devoid of straining and hard/lumpy stools.…”

Section: Discussionmentioning

confidence: 99%

“…Preference questionnaires were presented as binary outcomes and analyzed using CMH and ANOVA. [27,28] , tegaserod [29] , prucalopride, lubiprostone, and linaclotide [30] , as well as PEG [19,[22][23][24][25] for the treatment of chronic constipation. However, there are no reports on the effectiveness of PEG 3350 for the treatment of occasional constipation.…”

Section: Discussionmentioning

confidence: 99%

“…PEG 3350 is effective in the treatment of constipation in adults, having been shown to significantly increase the frequency of BMs, improve the symptoms of constipation [22][23][24][25][26] , and reduce cramping and gas [19] . The Food and Drug Administration (FDA) approved PEG 3350 (MiraLAX ® ) on October 6, 2006 (NDA 22-015) for use as a nonprescription laxative for relief from occasional constipation (irregularity).…”

Section: Miralaxmentioning

confidence: 99%

See 4 more Smart Citations

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

McGraw

2016

WJGPT

View full text Add to dashboard Cite

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...

show abstract

Section: Discussionsupporting

confidence: 76%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Miralaxmentioning

confidence: 99%

See 3 more Smart Citations

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

McGraw

2016

WJGPT

View full text Add to dashboard Cite

show abstract

Lactulose vs Polyethylene Glycol for Treatment of Hepatic Encephalopathy

Tapper

2015

JAMA Intern Med

View full text Add to dashboard Cite

Introduction: Hepatic Encephalopathy is one of the most common causes of hospitalization for cirrhotic patients.Lactulose has long been used as the standard therapy for the treatment of acute HE. This study evaluated the efficacy of PEG as compared with lactulose for the initial treatment of HE. Aims and Objective:(1) To compare efficacy of PEG 3350 electrolyte solution over lactulose in patients admitted for hepatic encephalopathy. (2) To determine whether treatment with PEG will reduce duration of hospital stay, and whether PEG can be an effective additional treatment option for HE. Material and methods: This prospective, randomized, comparative study was conducted in the Department of Gastroenterology Medical Trust hospital, Kochi-Kerala India, over a period of two year from May 2015-April 2017 following its approval by the Institutional ethical committee. 50 patients with cirrhosis and altered mental status attributed to HE were randomized to a standard lactulose protocol or a PEG protocol (25 in each group). Interventions: Patients in the PEG group (n=25) received 2 L of PEG orally or via NG tube as a single dose over 4 hours. Patients in the lactulose group (n=25) received 20-30 g lactulose orally or via NG tube for 3 or more doses over 24 hours, or a single dose of 200 g lactulose via rectal tube. Grade of HE was determined prior to treatment and again at 24 hours using the Hepatic Encephalopathy Scoring Algorithm (HESA). After 24 hours, all patients received lactulose per the standard of care. Main outcomes and measures: The primary end point was an improvement of 1 or more in HE grade at 24 hours, determined using the Hepatic Encephalopathy Scoring Algorithm (HESA), ranging from 0 (normal clinical and neuropsychological assessments) to 4 (coma). Secondary outcomes included time to HE resolution and overall length of stay. Results: In our study, the gender distribution among two study groups showed a male predominant. Majority of HE patients were found in age group of 55-64 years. The most common underlying etiology of Liver Cirrhosis was Alcoholic liver disease 70%, Cryptogenic 14%, followed by Hepatitis C. The most common precipitant for Hepatic encephalopathy was GI Bleeding, followed by Constipation and Sepsis. The two groups were comparable in terms of baseline laboratory parameters. All patients were of Child Turcot Pugh (CTP) class C, with a Mean MELD score of 19.08 ± 2.23 in PEG group vs. 18.76 ± 2.36 in Lactulose group (p-value=0.625, NS). Majority of the patients were in grade 3 encephalopathy 58% (29/50), followed by grade 2 in 32% (16/50) at the time of presentation. A significant difference was seen between two groups in terms of mean change in grade of encephalopathy (HESA score) after 24 hours of therapy, with 1.00 ± 1.04 in PEG group compared to 1.76 ± 0.87 in lactulose group, with a significant p-Jo u r n a l of Hepat o lo g y an d Ga st ro i n te stin al D is o rd e rs

show abstract

Constipation and Constipation Syndromes

Bharucha

Grover

2012

Textbook of Clinical Gastroenterology and Hepatology

View full text Add to dashboard Cite

A Randomized, Multicenter, Placebo-Controlled Trial of Polyethylene Glycol Laxative for Chronic Treatment of Chronic Constipation

Abstract: PEG laxative is safe and effective for use in patients with chronic constipation for 6 months.

Cited by 187 publications

References 10 publications

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

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

Lactulose vs Polyethylene Glycol for Treatment of Hepatic Encephalopathy

Constipation and Constipation Syndromes

Contact Info

Product

Resources

About