Documentation of an instrument for assessment of subjective CNS-related symptoms during cardiovascular pharmacotherapy.

The aim of this work was to develop and initiate the documentation of an instrument for the assessment of subjective CNS-related symptoms occurring during cardiovascular pharmacotherapy. The self-applied questionnaire developed for minor symptom evaluation (MSE profile) includes 24 items and uses a visual analogue scale to record symptoms. Three different studies were performed using a total of 86 healthy volunteers. Based on a subjective grouping followed by principal component analysis to confirm the grouping, three dimensions-contentment (eight items), vitality (five items), and sleep (three items)-were formed. The Cronbach's alpha coefficient, used to evaluate the internal consistency of these dimensions, was found to be 0.90, 0.88, and 0.85, respectively. To validate the MSE profile, the subjective symptoms of two classes of drugs with well-known symptom profiles, a nonselective, beta-blocker (propranolol) and a benzodiazepine (oxazepam), were compared in placebo-controlled randomized double-blind crossover studies. The obtained results indicate that the symptom profiles were different but were compatible with the previously reported effects of these compounds. It can be concluded that the MSE profile is practical, useful, and sensitive enough to also detect subtle drug-induced effects.

RCT Entities:   Population Interventions Outcomes