New polyethylene glycol laxative for treatment of constipation in adults: A randomized, double-blind, placebo-controlled study

Background,This study evaluated the safety and effectiveness of a new polye thylene glycol (PEG) laxative (MiraLax, Braintree Laboratories Inc, Braintr ee, Mass) in 23 patients reporting a history of constipation. Methods, After a 7-day placebo control period, patients were randomized int o a double crossover trial of placebo versus 17 g of PEG daily for 4 days. Patient maintained a stool diary. Results, Daily ingestion of a 17 g dose of PEG increased mean daily bowel m ovement frequency to once per day by the last 7 days of the 14-day treatmen t period. This was a statistically significant improvement over placebo, wh ich provided about 1 bowel movement every 2 days during the last week of th erapy. Patient diary ratings of related subjective symptoms were improved w ith PEG treatment over placebo. Both investigator and patients rated PEG th erapy superior to placebo. No clinically significant changes in blood chemi stry complete blood count (CBC), or urinalysis were observed. Conclusions, Daily therapy with 17 g of PEG laxative for 14 days resulted i n a significant improvement in bowel movement frequency in constipated pati ents relative to placebo by the second week of treatment.