TREATMENT OF IRRITABLE-BOWEL-SYNDROME WITH LACTEOL-FORT - A RANDOMIZED, DOUBLE-BLIND, CROSS-OVER TRIAL

Objective: To assess the efficacy of Lacteol Fort, an antidiarrheal dr ug, in patients suffering from the chronic intestinal disease known as irritable bowel syndrome (IBS), Design: The randomized, double-blind, cross-over trial versus placebo was carried out from 1992 to 1994, Th is trial consisted of administering a 6-wk treatment with a first drug (Lacteol Fort or placebo), followed by a wash-out period of 2 wk, and then the administration of a second drug for a further 6 wk (placebo or Lacteol Fort), Among the 29 patients eligible after recruitment, 18 adults with well documented IBS fulfilled the inclusion criteria, Fou r patients were dropped for loss of materials used in the study and se ven for lack of compliance, The patient's initial state was assessed u sing a questionnaire relating to six criteria: abdominal pain, bloatin g or gas, daily number of stools, consistency, mucus content, and gene ral physical state, During the treatment, these criteria were evaluate d daily by the patients themselves, Results: All investigated criteria were scored, and then a daily mean index was calculated, The statisti cal analysis of the daily mean index values showed that the number of patients (nine cases) obtaining better results with Lacteol Fort than with placebo was statistically significant (p = 0.018), Conclusions: T his double-blind, placebo-controlled, cross-over trial demonstrated th at Lacteol Fort leads to a statistically significant therapeutic benef it in 50% of patients, when taking into consideration all of the six s elected clinical criteria considered representative of IBS.