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Polyethylene glycol with electrolytes safe, effective for IBS-related constipation
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Patients with IBS-related constipation experienced significantly better outcomes than placebo recipients after treatment with polyethylene glycol 3350 with electrolytes in a recent study.
In a multicenter, double blind, parallel-group prospective study, researchers randomly assigned patients with IBS-associated constipation (IBS-C) to placebo (n=71) or polyethylene glycol 3350 with electrolytes (PEG 3350+E; n=68) for 28 days, after a 14-day run-in period without treatment, between Dec. 5, 2008 and Nov. 30, 2009. All participants were adults, with IBS-C diagnosed within the prior 3 months and symptom onset 6 months or longer before diagnosis.
Patients recorded the number of daily spontaneous bowel movements (SBMs), plus spontaneous complete bowel movements (SCBMs), stool consistency and symptoms of straining, abdominal discomfort and/or pain and bloating via diary cards. The mean daily number of SBMs during the study’s last week was the primary endpoint.
After run-in, mean weekly SBMs increased in both groups, but the number was larger at week 4 in the PEG 3350+E group (4.4 ± 2.581 SBMs vs. 3.11 ± 1.937; P<.0001). Significant improvements to stool consistency, straining severity and spontaneous complete bowel movements also occurred in the treated group at 4 weeks compared with placebo recipients. PEG 3350+E recipients indicated a significant reduction in abdominal pain compared with the run-in period, but the difference between groups was not significant.
More treated than placebo recipients experienced adverse events (38.8% vs. 32.9%). Common study-related events included abdominal pain and diarrhea. No serious events or treatment-related deaths occurred.
“This prospective, controlled study confirmed the effectiveness of PEG 3350+E for the relief of IBS-C,” the researchers concluded. “Although a statistically significant improvement in abdominal discomfort/pain was observed with baseline, symptoms of abdominal discomfort/pain and also of bloating did not improve compared with placebo. Unlike other laxatives, however, PEG 3350+E did not exacerbate them. Given these effects, PEG 3350+E should be considered a suitable treatment for those with IBS-C.”
Disclosure: Researchers Marc Halphen, MD, and Mike Geraint, MB, ChB, are employees of Norgine Ltd, which funded the study. Researchers Roger W. Chapman, MD, and Vincenzo Stanghellini, MD, serve as consultants for Norgine.
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