A Clinical Evaluation of the Effects of a New Psychotropic Agent, Mexazolam (CS-386) on Psychosomatic Diseases and Neurosis : A comparative study with oxazolam, using the double-blind method

Abstract

A new benzodiazepino oxazole agent, named Mexazolem, is an agent with anti-anxiety effect developed by Central Institute of Sankyo Co., Ltd. In Japan. The double blind test of the drug was carried out using Oxazolam as an active control agent by multiclinical trial in 23 institutions in Japan. The subjects of this double-blind test were 165 patients with either psychosomatic diseases or various kind of neurosis. Mexazolam was administered to 82 patients and Oxazolam to the other 83. There were no statistically singnificant differences in background factors between both groups.The target mental symptoms were anxiety, tension and insomnia, physical symptoms, such as dizziness, nausea, chest pain and dullness of the head were also checked simultaneously.The rate of final global improvement (FGIR) was 75.6% in the cases of maxazolam and 63.8% in oxazolam.Concerning target diseases, Mexazolam showed marked effectiveness against essential hypertension and peptic ulcer which should be dealt with as psychosomatic disease, and also irritable colon, and autonomic nervous dystonia.Anxiety neurosis and organ neurosis were considered as suitable indications of this agent. The side effects of drowsiness and giddiness were seen frequently than in the control drug. However, they were not so severe in any of the cases studied nor comparable to those caused by other anti-anxiety drugs. According to the above mentioned results, Mexazolam seems to be a more effective drug than oxazolam and its usefulness for psychosomatic disease and neurosis was confirmed.