A multi-center, double-blind, randomized controlled trial has been carried out to compare the efficacy of two preparations of similar pharmacologic properties largely used in the symptomatic treatment of the Irritable Bowel Syndrome. The two preparations used were: (A) the association of propantheline bromide 15 mg plus bromazepam, 1.5 mg, and (B) that of octilonium bromide 20 mg plus diazepam 2 mg. Each preparation was given t.i.d. for 30 days. Thirty-four patients were randomly assigned to receive preparation A, and 31 to preparation B. The following somatic signs and symptoms were analyzed in all patients: abdominal discomfort, alterations in bowel habits (constipation and/or diarrhea), bloating, flatulence, borborygmi, nausea and/or vomiting, indigestion, epigastric pain, heartburn. In addition, patients performed tests for the self-assessment of their psychological status, in order to define their emotional profile and its changes in relation to the drug treatment. All patients underwent clinic visits at time 0, and at 15 and 30 days thereafter (i.e. at mid-point and at the end of the study). During visits, the signs and symptoms were scored on previously designed sheets, and the self assessment psychological tests were conducted. Patients compliance was considered of paramount importance in assessing the efficacy of the two preparations being compared, especially in view of the type of patients studied, who are often noncompliant or poorly compliant to long-term treatment. From this point of view, patients on preparation A showed an excellent compliance to treatment. 91.2% of the patients in this group completed the period of treatment, as compared with 77.4% of the patients on preparation B. Every time a different response between the two treatment groups was observed, both for somatic and for psychological symptoms, patients on preparation A fared better than those on preparation B. In conclusion, the association propantheline bromide-bromazepam is at least as effective as that octilonium-diazepam for the treatment of patients with IBS. To show the possible superiority of the former above the latter in a statistically significant manner, one would need a sample size far larger than that of the present study.
|Number of pages||8|
|Publication status||Published - 1991|
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