DiPalma, J.A., Cleveland, M.B., McGowan, J., & Herrera, J.L. (2007b). A randomized, multi-centered, placebo-controlled trial of polyethylene glycol laxative for chronic treatment of chronic constipation. American Journal of Gastroenterology, 102, 1436–1441.doi: 10.1111/j.1572-0241.2007.01199.x
To compare the safety and efficacy of polyethylene glycol (PEG) versus placebo over a six-month treatment period in patients with chronic constipation.
PEG 3350 (Miralax®) laxative 17 g or placebo was administered daily for six months. Patients were randomly assigned in a 2:1 ratio to PEG or placebo. This was a subjects mixed study. Medication was administered in 8 oz of juice or another beverage. Bisacodyl 10 mg (5 mg tablets) was used as rescue medication for severe discomfort related to constipation. Fiber was prohibited. Other nonconstipating medications were allowed.
50 centers in the United States
This was a double-blind, placebo-controlled, parallel, randomized controlled trial.
PEG is safe and effective in management of constipation in adults and older adults for up to six months.
The study focused on chronic constipation and lacked focus on cancer or opioid-induced constipation.