Treatment of the alcoholic organic brain syndrome with EMD 21657. A derivative of a pyritinolmetabolite: double-blind clinical, quantitative EEG and psychometric studies.

The efficacy of EMD 21657--a derivative of a pyritinolmetabolite--with regard to the improvement of the organic brain syndrome (OBS) of chronic alcoholics was investigated in a double-blind study utilizing clinical, psychometric and quantitative EEG evaluation. Nineteen patients received 3 x 300 mg EMD and 21 patients 3 x 1 dragee placebo for 6 weeks. The groups did not differ in regard to age, sex, weight, height, alcohol anamnesis or IQ. The hospitalized patients were examined before as well as at the end of the second, fourth and sixth week of drug treatment. While the overall evaluation by the psychiatrist and patients at the end of the period of treatment did not show marked intergroup differences, the clinical global impression scale and the OBS rating scale demonstrated that both groups showed a significant reduction in their OBS and that improvement with EMD 21657 therapy was significantly superior to the one with placebo. Psychometric analysis also exhibited a significant superiority of EMD in regard to the general, associative, numeric and total verbal memory, concentration and attention variability. Psychovisual memory and the quantative aspects of attention showed opposite findings. Flickerlight fusion frequency, reaction time and after-image did not change significantly. The psychomotor activity improved significantly more with EMD than placebo; this was especially pronounced in the left hand. Affect and mood improved also more with EMD than placebo. Side effects were observed more frequently under active treatment and were characterized by temporary headaches. Power spectral density analysis of the EEG revealed in both groups a decrease of delta, fast alpha and beta activities and an increase in theta and slow alpha activity, but changes during EMD treatment more frequently reached the level of statistical significance than with placebo. The most consistant finding was the theta augmentation under EMD treatment. It was concluded that EMD 21657 is a CNS-effective drug with pronounced nootropic and slight thymotropic properties.