Polyethylene glycol (PEG) 3350 (MiraLAX) is currently approved for the short-term treatment of occasional constipation. This study was designed to compare the safety and efficacy of PEG laxative versus placebo over a 6-month treatment period in patients with chronic constipation.
Study subjects who met defined criteria for chronic constipation were randomized in this double-blind, placebo-controlled, parallel, multicenter study to receive PEG laxative as a single daily dose of 17 g or placebo for 6 months. Baseline constipation status was confirmed during a 14-day observation period. As a primary efficacy variable, treatment success was defined as relief of modified ROME criteria for constipation for 50% or more of their treatment weeks. Various secondary measures were assessed. An Interactive Voice Response System (IVRS) recorded daily bowel movement experience and study efficacy and safety information. Laboratory testing at baseline and monthly for the study duration was analyzed for hematology, blood chemistry including amylase, GGT, uric acid, lipids, and urinalysis.
A total of 304 patients were enrolled and received treatment at one of 50 centers. Successful treatment according to the primary efficacy variable was seen in 52.0% of PEG and 11% of placebo subjects (P < 0.001). Similar efficacy was seen in a subgroup of 75 elderly subjects. According to the primary efficacy definition (based on individual treatment weeks), 61% of PEG treatment weeks versus 22% of the placebo weeks were successful (P < 0.001). There were no significant differences in laboratory findings or adverse events except for the gastrointestinal category where diarrhea, flatulence, and nausea were the most frequent with PEG although they were not individually statistically significant compared with placebo. Similar results were observed when analyzed for differences due to gender, race, or age.
PEG laxative is safe and effective for use in patients with chronic constipation for 6 months.
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The authors thank the following investigators for their involvement in conducting this study:
Greg Anderson, M.D., Gastroenterology Research of Greater Cincinnati, Cincinnati
Charles F. Barish, M.D., Wake Research Associates, LLC, Raleigh
Daniel Brune, M.D., nTouch Research, Peoria
Antonio Caos, M.D., Central Florida Clinical Studies, Inc., Ocoee
Christopher Chappel, M.D., FPA Clinical Research, Kissimmee
David C. Chua, M.D., Summit Center of Clinical Research, Oakbrook Terrace
Teresa Coats, M.D., Benchmark Research, Austin
Barry Collins, M.D., Advanced Clinical Research, LLC, Pell City
Michael Collins, M.D., Clinical Research Consultants, Inc., Hoover
Richard Craven, M.D., East Coast Clinical Research, LLC, Virginia Beach
Adnan Dahdul, M.D., FutureCare Studies, Inc., Springfield
Steven G. Desautels, M.D., Mountain West Gastroenterology, Salt Lake City
Scott Becker, M.D., Austin Gastroenterology, PA, Austin
W. Travis Ellison, M.D., Radiant Research, Greer
Jack S. Faintuch, M.D., Radiant Research, Lake Worth
R. David Ferrera, M.D., Sacramento Research Medical Group, Sacramento
Chester L. Fisher, M.D., Health Research of Hampton Roads, Inc., Newport News
Elizabeth M. Gallup, M.D., JD, MBA, and Monica Pierson, M.D., Radiant Research, Kansas City, Overland Park
Mark Gotfried, M.D., PACT, Glendale
Jorge L. Herrera, M.D., University of South Alabama, Mobile
Darrell T. Herrington, D.O., Benchmark Research, San Angelo
John A. Hoekstra, M.D., Ph.D., National Clinical Research, Richmond
Walter Hood, M.D. and Stephen Gordon, M.D., Comprehensive NeuroScience, Inc., Atlanta
Marvin Lawrence, M.D., Maryland Digestive Disease Research, LLC, Laurel
Samuel Lederman, M.D., Radiant Research, Inc., West Palm Beach
Michael Levine, M.D., Radiant Research, Marietta
Margarita Nunez, M.D., Comprehensive NeuroScience, Inc., St. Petersburg
Jenny Liu, M.D., and Jeffrey Kaladas, M.D., Urgentmed, P.C., South Bound Brook
Barry Lubin, M.D., Hampton Roads Center for Clinical Research, Norfolk
F. Timm McCarty, D.O., Radiant Research, Scottsdale
John McNerney, M.D., Tucson Gastroenterology Specialists, Tucson
Mitchell D. Meyer, M.D., Wilmington Health Associates, Wilmington
David J. Morin, M.D., Tricities Medical Research, Bristol
Michael Noss, M.D., Radiant Research, Cincinnati
Peter M. Pardoll, M.D. and Sheldon Sheinert, M.D., Center for Digestive Diseases, St. Petersburg
Peter B. Platzer, M.D., Holston Medical Group, Kingsport
Patricia Reiff, M.D., Radiant Research, Phoenix
Dennis Riff, M.D., Advanced Clinical Research Institute, Anaheim
John Rubino, M.D., Multi-Specialty Research Association of North Carolina, Raleigh
Douglas Schumacher, M.D., Radiant Research, Columbus
William Seger, M.D., Benchmark Research, Fort Worth
Marc Shepard, M.D., nTouch Research, Washington
Timothy Smith, M.D., Mercy Health Research, St. Louis
Jonathan Simon Staub, M.D., Wilmington Health Associates, Wilmington
Miguel Trevino, M.D., Innovative Research of West Florida, Inc, Largo
Lawrence Wruble, M.D., Memphis Gastroenterology Group, Memphis
Thomas D. Bianchi, M.D., Community Medical Plaza, Tallassee