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

Parfenov V.A. Kamchatnov P.R. Khasanova D.R. Bogdanov E.I. Lokshtanova T.M. Amelin A.V. Maslova N.N. Pizova N.V. Belskaya G.N. Barantsevich E.R. Duchshanova G.A. Kamenova S.U. Kolokolov O.V. Glazunov A.B.
December 2021 Nature Research

Scientific Reports
2021 #11 Issue 1

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).

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I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russian Federation
Pirogov Russian National Research Medical University, Moscow, Russian Federation
Kazan State Medical University, Kazan, Russian Federation
Pirogov Samara City Clinical Hospital №1, Samara, Russian Federation
Pavlov Medical University, Saint Petersburg, Russian Federation
Smolensk State Medical University, Smolensk, Russian Federation
Clinical Hospital №8, Yaroslavl, Russian Federation
Research Center of Neurology, Moscow, Russian Federation
Khoja Akhmet Yassawi International Kazakh-Turkish University, Turkestan, Kazakhstan
Department of Medicine, Al-Farabi Kazakh National University, Almaty, Kazakhstan
Razumovsky State Medical University, Saratov, Russian Federation
Pirogov Medical University, Moscow, Russian Federation

I.M. Sechenov First Moscow State Medical University (Sechenov University)
Pirogov Russian National Research Medical University
Kazan State Medical University
Pirogov Samara City Clinical Hospital №1
Pavlov Medical University
Smolensk State Medical University
Clinical Hospital №8
Research Center of Neurology
Khoja Akhmet Yassawi International Kazakh-Turkish University
Department of Medicine
Razumovsky State Medical University
Pirogov Medical University

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