A Pharmacological Study of the Sleep-inducers from the Clinical Viewpoint:Double-blind comparison of D-58 SI and nitrazepam, with some findings on the placebo response

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The clinical efficacy of new benzodiazepine derivative, D-58SI (20mg), was compared with that of nitrazepam (10 mg) and placebo in insomniac patients by the double-blind and cross-over method. The subjects employed were 63 inpatients suffering from moderate to severe sleep disturbances with psychosomatic or internal diseases.<BR>Global judgement revealed that D-58SI and nitrazepam showed a significantly greater effect (p<0.01) on sleep disturbance than did placebo. No significant difference was found between D-58SI and nitrazepam<BR>Among the test items on the questionnaire, the onset and duration of sleep differed most significantly from those obtained with placebo . In every item, D-58SI showed no characteristic feature different from nitrazepam . The adverse effects with these drugs were not significantly different from those with placebo .<BR>The "double-blind placebo" was found to be significantly more effective than either single-blind or washout placebo . When subjects were divided into neurotic and non-neuroic groups by the psychological test, both the drugs and placebo were less effective in the former group than in the latter.
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