Controlled Clinical Trial of Sedative—Anticholinergic Drugs in Patients with the Irritable Bowel Syndrome

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Abstract
Patients (16) with long-standing irritable bowel syndrome of moderate severity were studied using a controlled, double-blind crossover method. Five sedative-anticholinergic drug combinations and a placebo were tested. The subjective response was assessed with 4 subjective methods to include an increasing number of response variables. The patients preferred 30 mg phenobarbital plus 8 mg belladonna (P-B) to placebo (P = 0.02). Of 10 patients, 5 were helped in varying degrees with placebo, while 10 of 15 were variously helped with P-B (P = 0.07). The 10 prominent-symptoms method revealed that subjective symptoms such as nervousness, sleep difficulties and tiredness were experienced as greater problems than diarrhea. The factor analysis method documented a strong placebo response. Simpler evaluation methods such as drug preference and a 5-choice method appear more likely to show a positive drug effect, while the inclusion of a larger number of variables appears to emphasize the placebo portion of the response. These observations may help explain some of the apparent discrepancies between the conclusions of some controlled clinical trials and subsequent clinical experience.