Abstract
Abstract The existing treatment of somatoform dysfunction (SD), reaction to severe stress (RSS) and adjustment disorders (AjD) is insufficiently effective and safe. Anxiolytic drug Tenoten (Materia Medica Holding) is shown to be effective in clinical trials (CT). Objectives The aim of multicenter double-blind placebo-controlled randomized CT was to investigate the safety and efficacy of Tenoten in the anxiety treatment of adults with SD, RSS, AjD and other neurotic disorders (oNDs). Methods 390 adults with SD, RSS and AjD or oNDs with the Hospital Anxiety and Depression scale-anxiety (HADS-A) score≥11 were randomized into 4 groups (Tenoten group 14 tablets/day n=127; Tenoten group 3 8 tablets/day n=131, combined Placebo group 2+4 n= 132). The changes from baseline in the mean Hamilton Anxiety Rating Scale (HAM-A) score in groups 1 and 3 after 12 weeks was the primary outcome. Results The decrease in the HAM-A score from 18.81±5.81 to 7.26±4.63 (group 1) and from 18.38±4.3 to 6.40±4.02 (group 3) was observed post-treatment (p group 1/placebo =0.0055, p group 3/placebo <0.0001). The mean changes in the scores in the groups 1, 3 and the Placebo were 11.25, 11.91 and 9.71, respectively. In total, 46 AEs (28 AEs in the Tenoten groups, 18 in the Placebo) were registered in 37 patients (20 in the Tenoten groups, and 17 in the Placebo). No differences in frequency of AEs between groups were found. Conclusions Tenoten was shown to be significantly more effective than placebo in the anxiety treatment of adults with SD, RSS, AjD and oNDs (clinicaltrials.gov NCT03036293).