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Biomedical subjects

U Kern

Publications and source records attributed to U Kern.

20 records · Page 2Linked to original sources
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[Treatment of disorders of cerebral performance in the aged in ambulatory care using bencyclane. Results of a controlled double-blind phase III study versus placebo].

A placebo-controlled, randomized double-blind study conducted at a general practitioner's surgery was designed to investigate the efficacy of bencyclane in 120 outpatients with cerebral dysfunctions based on organic brain syndrome. The study started with a 4-week placebo washout phase and then continued with a 12-week treatment phase. 200 mg Bencyclane-hydrogenfumarate was administered b.i.d. Efficacy was assessed by a doctor's symptom rating (SCAG) and a study nurse's rating (BGP) as well as by two performance tests (CFF and ZVT-G). Data from 106 patients (52 under bencyclane and 54 under placebo) were statistically analysed. More side effects were seen under bencyclane than under placebo, in particular insomnia, headache, akathisia, nausea and vomiting. As an a priori hypothesis, it was stated that after alpha-adjustment there should be a statistically significant difference in symptomatology (SCAG, BGP) and performance (CFF, ZVT-G). With regard to performance, the zero hypothesis could be rejected on the 5% level, and on the 1% level with respect to symptomatology. The experimental error on both the performance and the symptom level was below 6%. The drug effects were significant on a confirmatory level and are considered to be also of clinical relevance.

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PubMedDate not supplied

[Demonstration of bencyclane effects in a clinico-pharmacologic vigilance model].

The effects of 8 weeks' treatment with 2x 200 mg Bencyclan daily were investigated versus placebo in 50 patients. A clinical diagnosis had revealed the onset of organic mental disorders in all patients who, after fulfilling neurophysiologically and neuropsychologically defined screening criteria, were admitted to the trial. The patients were randomly allocated to two parallel groups of 25 for this controlled, double-blind study. Patients had to show 50% subvigil phases in a 15 min resting-EEG recording. We define such behaviour as a neurophysiological disturbance of vigilance. Scores in the Benton test were to be 2 points below the expected value or the NAF-score was to be above a standard value attained in an old people's home (greater than 14). On a neurophysiological level, inference statistical tests indicated effects in line with the hypothesis: A statistically significant difference in favour of Bencyclan was apparent after 8 weeks' treatment when compared with placebo. The Vigilance Index (VI) was higher under Bencyclan than after placebo. We regard the VI as a plausible indicator of vigilance-dependent disturbances in the elderly. On a behavioral level, Bencyclan was tendentially superior with respect to age-dependent complaints and performance-related activatedness, whereby one could not exclude the possibility that there were chance findings. The clear proof of efficacy on the neurophysiological level and the unclear effectiveness on the behavioral level can be attributed to the fact that time- and placebo effects were less marked on the former level. The intensive supervision of the patients led to considerable placebo effects on the behavioral level. Two groups of 25 patients are therefore not sufficient to be able to detect drug effects within a treatment period of only 8 weeks.

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