Abstract
A double-blind randomized clinical trial was performed comparing the therapeutic effects of Actovegin® versus placebo in elderly patients with organic brain syndrome. In addition to the necessary basic internal medicine therapy, 40 geriatric patients received daily intravenous infusions of 250 ml Actovegin® 20 % p.i., and 20 patients received 250 ml 0.9 % saline solution as placebo over a period of four weeks. Of the patient sample, 58 % were hospitalized for simple dementia (ICD-9: 290.0) and 42 % due to senile dementia with depressive or paranoid symptoms (ICD-9: 290.2). Based on the Syndrome Short Test (SKT) and the Sandoz Clinical Assessment Geriatric Scale (SCAG) score, the patients suffered from mild to moderate dementia. The therapeutic effect on the total SCAG score and the Clinical Global Impression (CGI) were the primary study variables. The scores for the SCAG subscales and the SKT score served as secondary variables. The mean total SCAG score in the drug group decreased from 56.3 at the start of therapy to 36.3 points at the end of therapy, and in the placebo group the total score went from 61.2 to 52.0 (p < 0.01). The CGI showed that with Actovegin®, 70 % of the patients experienced "distinct improvement" or "improvement" compared to only 35 % with such results in the placebo group. The SCAG subscales and the total SKT score also demonstrated the superior effects of Actovegin® compared to placebo. Moreover, the therapy group treated with Actovegin® showed greater improvements in social behavior and mental performance than did the placebo group. In addition, the relatively low rate of side-effects with Actovegin® would suggest a very favorable benefit-risk ratio for the drug.
