The randomized clinical trial results of the anxiety treatment in patients with somatoform dysfunction and neurotic disorders

Abstract

The existing treatments for somatoform dysfunction (SfD), reaction to severe stress (RSS), and adjustment disorders (AjD) are insufficiently effective and safe. Anxiolytic drug Tenoten proved effective in clinical trials (CT). The aim of this multicenter double-blind placebo-controlled randomized CT was to investigate the safety and efficacy of Tenoten in the treatment of anxiety in adults with SfD, RSS, AjD and other neurotic disorders (oNDs). 390 adult patients with SfD, RSS and AjD or oNDs with the Hospital Anxiety and Depression scale-anxiety (HADS-A) score ≥ 11 were randomized into 4 groups (n = 127 in Tenoten group 1 (4 tablets/day); n = 131 in Tenoten group 3 (8 tablets/day), n = 132 in combined Placebo group 2 + 4). The changes from baseline in the mean Hamilton Anxiety Rating Scale (HAM-A) score in groups 1 and 3 after 12 weeks were the primary outcome. The decrease of the HAM-A score from 18.81 ± 5.81 to 7.26 ± 4.63 (in group 1) and from 18.38 ± 4.3 to 6.40 ± 4.02 (in group 3) was observed post-treatment (p_{group 1/placebo} = 0.0055, p_{group 3/placebo} < 0.0001). Overall, 46 adverse events (28 in the Tenoten groups and 18 in the Placebo) were reported without any difference between the study groups. Tenoten performed significantly more effective than placebo in the anxiety treatment of adults with SfD, RSS, AjD and oNDs (clinicaltrials.gov NCT03036293).