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

Vladimir Anatolevich Parfenov, Pavel Rudolfovich Kamchatnov, Dina Rustemovna Khasanova, Enver Ibragimovich Bogdanov, Tatiana Markovna Lokshtanova, Aleksandr Vitalevich Amelin, Natalya Nikolaevna Maslova, Nataliia Vyacheslavovna Pizova, Galina Nikolaevna Belskaya, Evgeny Robertovich Barantsevich, Gulsum Abdurahmanovna Duchshanova, Saltanat Ualihanovna Kamenova, Oleg Vladimirovich Kolokolov, Alexey Borisovich Glazunov, Vladimir Anatolevich Parfenov, Pavel Rudolfovich Kamchatnov, Dina Rustemovna Khasanova, Enver Ibragimovich Bogdanov, Tatiana Markovna Lokshtanova, Aleksandr Vitalevich Amelin, Natalya Nikolaevna Maslova, Nataliia Vyacheslavovna Pizova, Galina Nikolaevna Belskaya, Evgeny Robertovich Barantsevich, Gulsum Abdurahmanovna Duchshanova, Saltanat Ualihanovna Kamenova, Oleg Vladimirovich Kolokolov, Alexey Borisovich Glazunov

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 (pgroup 1/placebo = 0.0055, pgroup 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).

Conflict of interest statement

All authors received an investigator grant from OOO NPF Materia Medica Holding to conduct the CT of Tenoten mentioned in this article.

© 2021. The Author(s).

Figures

Figure 1
Figure 1
Patient flow diagram. TS total set, SP safety population set.
Figure 2
Figure 2
The change in the mean HAM-A score after 4, 8, 12 weeks. ITT-set. *p = 0.044 vs Placebo; **p = 0.027 vs Placebo; #p = 0.0155 vs Placebo; ##p < 0.0001 vs Placebo, t-test.
Figure 3
Figure 3
The percentage of patients with remission of anxiety symptoms after 4, 8, 12 weeks. ITT-set. #p = 0.007 vs Placebo.

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