The objective of this study was to assess clinical efficacy and safety of proproten in anxiety disorders in comparison with diazepam. A multicenter randomized open-label comparative trial was conducted in four clinical centers in Russia. A total of 247 male and female outpatients (mean age – 38.8-t-0.7; baseline HAM-A – 28.0±0.4) who met IDC-10 criteria for general anxiety disorder, mixed anxiety and depressive disorder, mixed anxiety and depressive reaction, and neurasthenia were randomly assigned to receive proproten ( 127 pts, 6-12 tablets/day) or diazepam (120 pts, 15mg/day) in a 4-week study. Symptoms of the anxiety disorders were evaluated at baseline, day 7, day 14 and day 28. Primary endpoints were Hamilton Anxiety scale (HAM-A) total score, response (~>50% reduction in HAM-A score) and remission rates (HAM-A ~<7). State- Trait Anxiety Inventory scale (STAI) was the secondary endpoint. The study demonstrated good clinical efficacy and safety of proproten (6-12 tablets/day) in anxiety disorders in comparison to diazepam (15mg/day). The mean baseline-to-endpoint decreases in total HAM-A score in the patients given proproten (-15.3±0.6) was comparable to the decrease in those given diazepam (-17.6+0.6). Effect of proproten rose gradually: as early as week 1, proproten did not significantly reduce the total HAM-A score compared with diazepam and almost equaled diazepam at week 4. The number of responders to proproten and diazepam were 69.3% and 78.3% respectively. The complete remission rate for both preparations was rather low (diazepam – 20.8%; proproten – 12.6%), as a four-week period is a short one to reach remission. Diazepam caused adverse reactions in 40.0% of patients (proproten – 5.5%). The most frequent adverse events reported for diazepam were somnolence, dizziness and headache. There were no serious adverse events reported by patients given proproten, and no withdrawal syndrome was associated with proproten treatment. These results indicate that proproten is an effective and safe treatment for anxiety disorders. In this treatment schedule, proproten does not appear to cause adverse reactions and the withdrawal symptoms often associated with the benzodiazepines.
E.N. BiriukovaI, N. TimofeevS, N.Mosolov. P.3.041 Clinical and neurophysiological efficacy of neurofeedback in the combined therapy of anxiety disorders resistant to psychopharmacotherapy. European Neuropsychopharmacology, Volume 15, Supplement 2, 2005, Pages S162-S163.