Polyethylene glycol 3350 plus electrolytes for chronic constipation: a 2-week, randomized, double-blind, placebo-controlled study with a 52-week open-label extension

Abstract

Background Although polyethylene glycol 3350 plus electrolytes (PEG3350 + E) is the most widely used osmotic laxative in Europe, prospective data on its long-term (over 6 months) safety and efficacy are not available to date. Methods Japanese patients with chronic constipation were randomized to receive PEG3350 + E or placebo for 2 weeks orally. Following this, the patients received PEG3350 + E in the 52-week extension study. The starting dose was 13.7 g/day dissolved in 125 mL of water, and dose titration was allowed (upper limit 41.1 g/day) according to the patient’s bowel condition. The primary efficacy endpoint was the change from baseline in frequency of spontaneous bowel movements (SBMs) at week 2 in the double-blind study. Secondary endpoints and adverse events were assessed. Safety and efficacy were also assessed in the extension study. Results Among 204 patients who provided informed consent, 156 were randomized and included in the full analysis. The frequency of SBMs was significantly higher with PEG3350 + E [least squares mean (LSM) 4.3, 95% confidence interval (CI) 3.6–4.9] compared with placebo (LSM 1.6, 95% CI 1.2–2.1; P < 0.0001). A total of 153 patients entered the extension study; PEG3350 + E led to a sustained improvement in bowel function. The common adverse drug reactions during the entire study period were mild gastrointestinal disorders (abdominal pain 4.5%, diarrhea 3.8%, nausea 3.2%, abdominal distension 2.6%). Conclusions Treatment with PEG3350 + E resolved constipation in the short term, was well tolerated, and led to sustained improvement in bowel function in the long-term treatment of Japanese patients with chronic constipation. Clinical trial registration number Japic CTI-163167.

The Efficacy of Short-Duration Polyethylene Glycol plus Electrolytes for Improving Bowel Preparation of Colonoscopy in Patients with Chronic Constipation

“…Regarding stool consistency, in the previous study, the rates of improvement in stool consistency (BSFS 3, 4, and 5) at the first and second weeks were 87.3% and 80.0%, respectively, which was comparable to that in our study (90.6%) [ 18 ]. The authors analyzed the rates of complete SBMs, defined as SBMs with a feeling of complete evacuation, and the rates in the first and second weeks were 23.8% and 37.5%, respectively.…”

“…The number of SBMs/week in the PEG group taking PEG for 4 weeks was 4.40 ± 2.58 compared to 3.11 ± 1.93 in the placebo group ( p < 0.00001) [ 17 ]. A recent Japanese RCT using the same dose of PEG3350+E as our study involved 80 patients taking PEG+E, with a mean age of 44.3 ± 11.6 years old and 88.8% females [ 18 ]. The baseline number of SBMs/week was 1.6 ± 0.9, which increased during the first and second week of PEG3350+E prescription to 3.36 (95% confidence interval (CI): 2.81-3.92) and 4.27 (95% CI: 3.36-4.92), respectively, with responder rates of 80.0% and 86.3%, respectively.…”

“…The changes in stool consistency according to the Bristol stool form scale (BSFS) were also analyzed according to previous number of BMs, gender, and age [ 18 ]. The BSFS is a global standard for the evaluation of the stool shape (range of 1 to 7).…”

Polyethylene glycol 3350 plus electrolytes for pediatric chronic constipation: An open‐label clinical study in Japan

“…Recently, it was reported that PEG3350+E significantly resolved constipation compared with placebo in the 2-week, randomized, double-blinded confirmatory phase of a PEG3350+E study, and the efficacy of PEG3350+E lasted for the entire 52-week extension phase, with good tolerability in Japanese adults with chronic constipation. 29…”

The effectiveness of acupoint herbal patching for functional constipation

“…Anorectal biofeedback, transformational infection, nerve stimulation, colonial surgery and other treatments have brought significant economic burdens and thus considerable healthcare utilization to patients. [ 8 – 10 ] At the same time, FC seriously impairs the physical and mental health of patients and affects their quality of life [ 11 ] . Therefore, many people, including those who do not improve with existing medications or suffer many side effects, are interested in complementary and alternative medicine.…”