SMALL-VOLUME ISOSMOTIC POLYETHYLENE-GLYCOL ELECTROLYTE BALANCED SOLUTION (PMF-100) IN TREATMENT OF CHRONIC NONORGANIC CONSTIPATION

The present multicenter double-blind placebo-controlled trial evaluate s the therapeutic effectiveness of small-volume daily doses of an isos motic polyethylene glycol (PEG) electrolyte solution in the treatment of chronic nonorganic constipation. After a complete diagnostic invest igation, 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 we eks. Patients were assessed at four and eight weeks of treatment, and they reported frequency and modality of evacuation, use of laxatives, and relative symptoms daily on a diary card. Oroanal and segmental lar ge-bowel transit times were assessed with radiopaque markers during th e fourth week of the run-in period and the last week of the treatment period. During the study period, dietary fiber and liquids were standa rdized and laxatives were allowed only after consecutive days without a bowel movement. Of the 55 patients enrolled, fie dropped out, three because of adverse events and two for reasons unrelated to therapy; an other two were excluded from the efficacy analysis because of protocol violations. Of the remaining 48 patients (37 women, age 42 +/- 15 yea rs, mean +/- SD) 23 were assigned to placebo and 25 to PEG treatment. In comparison to placebo, PEG solution induced a statistically signifi cant increase in weekly bowel frequency at four weeks and at the end o f the study (PEG: 4.8 +/- 2.3 vs placebo: 2.8 +/- 1.6; P <0.02), and a significant decrease in straining at defecation (P <0.01), stool cons istency (p <0.02), and use of laxative (P <0.03). Oroanal, left colon, and rectal transit times were significantly shortened as far as abdom inal symptoms and side effects were concerned. In conclusion, PEG solu tion at 250 ml twice a day is effective in increasing bowel frequency. accelerating colorectal times, and improving difficult evacuation in patients with chronic nonorganic constipation and is devoid of signifi cant side effects.