OBJECTIVE: To assess the efficacy of Lacteol Fort, an antidiarrheal drug, 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. This 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. Four patients were dropped for loss of materials used in the study and seven for lack of compliance. The patient's initial state was assessed using a questionnaire relating to six criteria: abdominal pain, bloating or gas, daily number of stools, consistency, mucus content, and general physical state. During the treatment, these criteria were evaluated daily by the patients themselves. RESULTS: All investigated criteria were scored, and then a daily mean index was calculated. The statistical 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: This double-blind, placebo-controlled, cross-over trial demonstrated that Lacteol Fort leads to a statistically significant therapeutic benefit in 50% of patients, when taking into consideration all of the six selected clinical criteria considered representative of IBS.
RCT Entities:
OBJECTIVE: To assess the efficacy of Lacteol Fort, an antidiarrheal drug, 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. This 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. Four patients were dropped for loss of materials used in the study and seven for lack of compliance. The patient's initial state was assessed using a questionnaire relating to six criteria: abdominal pain, bloating or gas, daily number of stools, consistency, mucus content, and general physical state. During the treatment, these criteria were evaluated daily by the patients themselves. RESULTS: All investigated criteria were scored, and then a daily mean index was calculated. The statistical 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: This double-blind, placebo-controlled, cross-over trial demonstrated that Lacteol Fort leads to a statistically significant therapeutic benefit in 50% of patients, when taking into consideration all of the six selected clinical criteria considered representative of IBS.