Abstract
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 lBS 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.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 1579-1585 |
| Number of pages | 7 |
| Journal | American Journal of Gastroenterology |
| Volume | 91 |
| Issue number | 8 |
| State | Published - Aug 1996 |
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ASJC Scopus subject areas
- Gastroenterology
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Treatment of irritable bowel syndrome with lacteol fort : A randomized, double-blind, cross-over trial. / Halpern, Georges M.; Prindiville, Thomas P; Blankenburg, Marlese; Hsia, Thomas; Gershwin, M. Eric.
In: American Journal of Gastroenterology, Vol. 91, No. 8, 08.1996, p. 1579-1585.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Treatment of irritable bowel syndrome with lacteol fort
T2 - A randomized, double-blind, cross-over trial
AU - Halpern, Georges M.
AU - Prindiville, Thomas P
AU - Blankenburg, Marlese
AU - Hsia, Thomas
AU - Gershwin, M. Eric
PY - 1996/8
Y1 - 1996/8
N2 - 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 lBS 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.
AB - 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 lBS 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.
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UR - http://www.scopus.com/inward/citedby.url?scp=0029738351&partnerID=8YFLogxK
M3 - Article
C2 - 8759665
AN - SCOPUS:0029738351
VL - 91
SP - 1579
EP - 1585
JO - American Journal of Gastroenterology
JF - American Journal of Gastroenterology
SN - 0002-9270
IS - 8
ER -