The present study randomized Japanese patients with chronic constipation to receive polyethylene glycol 3350 + electrolytes (PEG 3350 + E) or placebo for 2 weeks orally. They were then given PEG 3350 + E in the 52-week extension study. The initial dose was given as 13.7 g/day dissolved in 125 mL of water, and dose titration was allowed (upper limit 41.1 g/day) considering the patients bowel condition. The change from baseline in frequency of spontaneous bowel movements (SBMs) at week 2 in the double-blind study was recorded. Furthermore, adverse events, safety and efficacy were also assessed in the extension study.

The full analysis randomized 156 patients. The frequency of SBMs was found to be markedly higher with PEG 3350 + E than with the placebo. In 153 patients who entered the extension study; PEG 3350 + E caused a sustained improvement in bowel function. The common adverse drug reactions recorded during the entire study period were mild gastrointestinal disorders including abdominal pain in 4.5%, diarrhea in 3.8%, nausea in 3.2% and abdominal distension in 2.6%.Thus, treatment with PEG 3350 + E can resolve constipation in the short term, is well tolerated, and causes sustained improvement in bowel function in the long-term treatment of patients with chronic constipation.

Source: Nakajima A, et al. J Gastroenterol. 2019;54(9):792-803.