[Design and evaluation of the controlled clinical trial/demonstrated by an efficacy test of the combination pentosan polysulphate/nicotinic acid in disturbed cerebral circulation (author's transl)].

Design and evaluation of the controlled clinical trial are thoroughly discussed by giving an example for testing a sodium pentosan polysulphate/nicotinic acid combination (Compuron). 60 patients with cerebral vascular disorders were randomly allocated to the two treatments and received medication over a period of eight weeks. A detailed biostatistical analysis of the data led to the following conclusions: 1. Regarding the target symptoms headache, nausea, sleep disturbance, reduced alertness, reduced ability for contacts and moods significant differences in favor of the active medication beginning with the sixth treatment week. 2. Regarding the psychological tests substantial and statistically highly significant (P less than 0.001) therapeutic effects. 3. Statistically significant decrease of the cholesterol and triglycerides level, absolutely as well as relative to placeo medication. 4. No treatment related side effects during the entire trial period of eight weeks.