Small volume isosmotic polyethylene glycol electrolyte balanced solution (PMF-100) in treatment of chronic nonorganic constipation

Abstract

The present multicenter double-blind placebo-controlled trial evaluates the therapeutic effectiveness of small-volume daily doses of an isosmotic polyethylene glycol (PEG) electrolyte solution in the treatment of chronic nonorganic constipation. After a complete diagnostic investigation, patients still constipated at the end of a four-week placebo-treatment run-in period were enrolled and randomized to receive either placebo or PEG solution 250 ml twice a day for the following eight weeks. Patients were assessed at four and eight weeks of treatment, and they reported frequency and modality of evacuation, use of laxatives, and relevant symptoms daily on a diary card. Oroanal and segmental large-bowel transit times were assessed with radiopaque markers during the fourth week of the run-in period and the last week of the treatment period. During the study period, dietary fiber and liquids were standardized and laxatives were allowed only after five consecutive days without a bowel movement. Of the 55 patients enrolled, five dropped out, three because of adverse events and two for reasons unrelated to therapy; another two were excluded from the efficacy analysis because of protocol violation. Of the remaining 48 patients (37 women, age 42 +/- 15 years, mean +/- SD), 23 were assigned to placebo and 25 to PEG treatment. In comparison to placebo, PEG solution induced a statistically significant increase in weekly bowel frequency at four weeks and at the end of the study (PEG: 4.8 +/- 2.3 vs placebo: 2.8 +/- 1.6; P < 0.002) and a significant decrease in straining at defecation (P < 0.01), stool consistency (P < 0.02), and use of laxatives (P < 0.03). Oroanal, left colon, and rectal transit times were significantly shortened by PEG treatment. There was no difference between controls and PEG-treated patients as far as abdominal symptoms and side effects were concerned. In conclusion, PEG solution at 250 ml twice a day is effective in increasing bowel frequency, accelerating colorectal transit times, and improving difficult evacuation in patients with chronic nonorganic constipation and is devoid of significant side effects.

Evaluation of gastrointestinal transit in clinical practice: position paper of the American and European Neurogastroenterology and Motility Societies

“…Acceleration of CTT with ROM was associated with improvement in bowel symptoms in constipated patients in several clinical trials that evaluated polyethylene glycol, 80 tegaserod, 81 and prucalopride.…”

Guidelines for the Diagnosis and Treatment of Chronic Functional Constipation in Korea, 2015 Revised Edition

“…Numerous trials have shown both electrolyte-enriched PEG and electrolyte-free PEG to be effective in patients with chronic constipation. 115,[118][119][120][121][122][123][124][125][126][127] A meta-analysis concluded that PEG treatment resulted in a highly significant increase in defecations per week over placebo. 128 In particular, a meta-analysis involving 10 RCTs found that PEG was better than lactulose with respect to the outcomes of stool frequency per week, form of stool, relief of abdominal pain, and the need for additional products.…”

Effectiveness of laxatives in adults

“…2 Laxatives with an osmotic eVect appear to be consistently associated with significant improvements in frequency, consistency, straining, and pain compared with placebo based on the results of two systematic reviews 2 3 and additional small trials. [47][48][49][50] There is little evidence for diVerences in eVectiveness between osmotic laxatives and other treatments. Two small hospital based RCTs compared polyethylene glycol (PEG) 3350 with lactulose 51 and ispaghula (Konsyl), 52 respectively.…”