Introduction: Extreme and severe cases of constipation can lead to faecal impaction. Current therapies are often both ineffective and unpleasant. The objective of this trial was to evaluate the efficacy and safety of Movicol, a polyethylene glycol (PEG) + electrolyte solution (PEG+E), as treatment for severe constipation and faecal impaction.
Patients: 56 patients (aged 17 to 88 years) with a history of chronic constipation and presenting with no bowel movement for three to four days (severe constipation), or no bowel movement for at least five days (faecal impaction), were enrolled at three centres in Taiwan. Faecal loading was confirmed in all patients by abdominal and rectal examination or abdominal radiography. Patients were excluded from the study if they had a gastrointestinal obstruction, evidence of delayed gastric emptying, or if their constipation was secondary to severe inflammatory bowel disease.
Treatment: All patients followed the same regimen: up to eight 13.8 g sachets of PEG+E (two at a time in 250 ml water; maximum of 1L/day) over a 4-6 h period each day, with 1-1.5 h between each dosing. Duration of treatment was for up to three days. EFFICACY ENDPOINTS AND RESULTS: Patients with either improvement (passage of a moderate to large volume of stool within four days of treatment initiation) or complete resolution (passage of moderate to large volumes of faecal matter plus the disappearance of palpable faecal masses in the abdomen and/or rectum) were considered responders. Based on bowel movement data recorded by the patients, an excellent response rate was obtained: 50/56 patients had a successful response to treatment (89.3%; 95% confidence intervals [CIs] 77.4% to 95.6%); there were 39 complete responders and 11 patients showed improvement. Investigator assessment of response was almost the same: 87.5% (95% CIs 75.3% to 94.4%). All bowel movement measurements (stool volume, number of evacuations, stool form and ease of evacuations) showed a positive improvement by Day 2. Median duration of treatment was two days. The incidence of adverse events was low, even for those side-effects such as abdominal pain and bloating, which are known undesirable consequences of PEG+E administration. No patient discontinued from the study because of an adverse event.
Conclusion: PEG+E, administered orally at a dose equivalent to eight 13.8 g sachets (1 L) per day over three days, was a highly effective and well tolerated therapy for the treatment of severe constipation and faecal impaction.