Long term efficacy, safety, and tolerabilitity of low daily doses of isosmotic polyethylene glycol electrolyte balanced solution (PMF-100) in the treatment of functional chronic constipation
E Corazziaria,
D Badialia,
G Bazzocchib,
G Bassottic,
P Rosellic,
G Mastropaolod,
M G Lucàd,
R Galeazzie,
E Peruzzie
aDipartimento di Scienze Cliniche, Università "La Sapienza" Roma, Italy, bDipartimento di Medicina Interna e Gastroenterologia, Ospedale Bellaria, Università degli Studi di Bologna, Italy, cDipartimento di Medicina Clinica e Sperimentale, Università degli Studi di Perugia, Italy, dDipartimento di Scienze Chirurgiche e Gastroenterologiche, Università degli Studi di Padova, Italy, eDivisione di Gastroenterologia Ospedale "Umberto I", Ancona, Italy
Dr E Corazziari, Dipartimento di Scienze Cliniche, Università "La Sapienza", Policlinico Umberto I Clinica Medica II, Viale del Policlinico, 00161 Rome, Italy
AIMS To assess the long term therapeutic effectiveness, safety, and tolerability of low daily doses of isosmotic PEG electrolyte solutions (PMF-100) administered for a six month period for the treatment of functional constipation, in a double blind, placebo controlled, parallel group study.
METHODS After an initial four week run in period with PMF-100 (250 ml twice daily; PEG 14.6 g twice daily), 70 patients suffering from chronic constipation (58 females, aged 42 (15) years) with normalised bowel frequency (>3 bowel movements (bm)/week) were randomly allocated to receive either PMF-100 or placebo, contained in sachets (one sachet in 250 ml of water twice daily) for 20 weeks. Patients were assessed at four week intervals, and reported frequency and modality of evacuation, laxative use, and relevant symptoms on a diary card. At weeks 1, 12, and 24, a physical examination and laboratory tests were performed.
RESULTS Complete remission of constipation was reported by a significantly (p<0.01) higher number of patients treated with PMF-100 compared with placebo at each four week visit. At the end of the study, 77% of the PMF-100 group and 20% of the placebo group were asymptomatic. Compared with placebo, patients treated with PMF-100 reported hard/pellety stools and straining at defecation less frequently, a significantly higher bowel frequency (week 12: 7.4 (3.1) v 4.3 (2.5) bm/week, 95% CI 1.64, 4.42; week 24: 7.4 (3.2)v 5.4 (2.1) bm/week, 95% CI 0.13,3.93), reduced consumption of laxative/four weeks (week 12: 0.7 (2.7)v 2.2 (3.3), 95% CI −2.29, 0.03; week 24: 0.2 (0.8) v 1.4 (2), 95% CI −2.07, −0.023), reduced mean number of sachets used (week 12: 33 (13)v 43 (12), 95% CI −17.24, 4.56; week 24: 33 (13) v 44 (12), 95% CI −19.68, −2.24), and reduced number of drop outs for therapy failure (16v 3; p<0.005). Adverse events, physical findings, laboratory values, palatability, and overall tolerance of the solutions did not differ between groups.
CONCLUSIONS Administration of small daily doses of isosmotic PEG electrolyte balanced solutions was effective over a six month period for the treatment of functional constipation. A mean daily dose of approximately 300 ml of PEG solution (PEG 17.52 g) appeared to be safe, well tolerated, and devoid of significant side effects.
tolerability
http://dx.doi.org/10.1136/gut.46.4.522
Abbreviations used in this paper:
British Society of Gastroenterology