Ginkgo biloba special extract EGb 761® in generalized anxiety disorder and adjustment disorder with anxious mood:: A randomized, double-blind, placebo-controlled trial

Ginkgo biloba special extract EGb761 (R), an anti-dementia drug, enhances cognitive functioning and stabilizes mood in cognitively impaired elderly subjects. Moreover, EGb 761 (R) had been found to alleviate symptoms of anxiety in people with mental decline, therefore it was now tested for clinical efficacy in younger patients suffering from anxiety. One hundred and seven patients with generalized anxiety disorder (GAD, n = 82) or adjustment disorder with anxious mood (ADWAM, n = 25) according to the diagnostic and statistical manual of mental disorders, third edition - revised (DSM-III-R) were randomized to daily doses of 480 mg EGb 761 (R), 240 mg EGb 761 (R) or placebo for 4 weeks. Intention-to-treat (ITT) analyses were performed on the primary outcome measure, the Hamilton rating scale for anxiety (HAMA), and the secondary variables, the clinical global impression of change (CGI-C), the Erlangen anxiety tension and aggression scale (EAAS), the list of complaints (B-L'), and the patient's global rating of change. The HAMA total scores decreased by -14.3 (+/- 8.1), -12.1 (+/- 9.0) and -7.8 (+/- 9.2) in the high-dose EGb 761 (R), the low-dose EGb 761 (R) and the placebo group, respectively. Changes were significantly different from placebo for both treatment groups with p = 0.0003 (high-dose group) and p = 0.01 (low-dose). Regression analyses revealed a dose-response trend (p = 0.003). EGb 761 (R) was significantly superior to placebo on all secondary outcome measures. It was safe and well tolerated and may thus be of particular value in elderly patients with anxiety related to cognitive decline. (c) 2006 Elsevier Ltd. All rights reserved.