title: Randomized clinical trial: macrogol/PEG 3350 plus electrolytes for treatment of patients with constipation associated with irritable bowel syndrome.
abstract: OBJECTIVE
  Polyethylene glycol (PEG) 3350 plus electrolytes (PEG 3350+E) is an established treatment for constipation and has been proposed as a treatment option for constipation associated with irritable bowel syndrome (IBS-C). This study aimed to compare the efficacy and safety of PEG 3350+E vs. placebo in adult patients with IBS-C.
  
  
  METHODS
  Following a 14-day run-in period without study medication, patients with confirmed IBS-C were randomized to receive PEG 3350+E (N=68) or placebo (N=71) for 28 days. The primary endpoint was the mean number of spontaneous bowel movements (SBMs) per day in the last treatment week.
  
  
  RESULTS
  In both groups, mean weekly number of SBMs (±s.d.) increased from run-in. The difference between the groups in week 4 (PEG 3350+E, 4.40±2.581; placebo, 3.11±1.937) was statistically significant (95% confidence interval: 1.17, 1.95; P<0.0001). Although mean severity score for abdominal discomfort/pain was significantly reduced compared with run-in with PEG 3350+E, there was no difference vs. placebo. Spontaneous complete bowel movements, responder rates, stool consistency, and severity of straining also showed superior improvement in the PEG 3350+E group over placebo in week 4. The most common drug related treatment-emergent adverse events were abdominal pain (PEG 3350+E, 4.5%; placebo, 0%) and diarrhoea (PEG 3350+E, 4.5%; placebo, 4.3%).
  
  
  CONCLUSIONS
  In IBS-C, PEG 3350+E was superior to placebo for relief of constipation, and although a statistically significant improvement in abdominal discomfort/pain was observed compared with baseline, there was no associated improvement compared with placebo. PEG 3350+E is a well-established and effective treatment that should be considered suitable for use in IBS-C.
authors.affiliation: Department of Gastroenterology, John Radcliffe Hospital, Oxford, UK.
authors.forename: R W
authors.initials: RW
authors.lastname: Chapman
authors.forename: V
authors.initials: V
authors.lastname: Stanghellini
authors.forename: M
authors.initials: M
authors.lastname: Geraint
authors.forename: M
authors.initials: M
authors.lastname: Halphen
mesh_terms: D015746:Abdominal Pain / Q000188:drug therapy*; D000293:Adolescent; D000328:Adult; D000368:Aged; D003248:Constipation / Q000150:complications / Q000188:drug therapy*; D004311:Double-Blind Method; D004573:Electrolytes / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D043183:Irritable Bowel Syndrome / Q000150:complications / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D004573:Electrolytes; D011092:Polyethylene Glycols