The efficacy of Laennec in combination therapy of asthenic depressions in clinical practice

Depressive spectrum disorders remain one of the most significant problems in modern clinical medicine. Despite the abundance of available treatment methods, a significant proportion of patients do not achieve complete remission, which negatively affects their prognosis.

Objective: to evaluate the antidepressant, anti-asthenic and pro-cognitive effects of Laennec human placenta hydrolysate (hPH) when added to basic psychopharmacotherapy in patients with monopolar depression.

Material and methods. The study was conducted at the Clinic of Psychosomatic Medicine at Sechenov University. It included patients with a verified diagnosis of monopolar depression and indications for the prescription of Laennec hPH (steatohepatitis, recurrent herpes, atopic dermatitis). The sample consisted of 60 patients. Patients were randomised into two groups of 30 people (active and control groups). Both groups received antidepressant therapy in accordance with the current recommendations of the Ministry of Health of Russia. Patients in the active group also received a course of Laennec hPH infusions, while those in the control group received a course of intravenous sham of this drug. The patients' condition was assessed before the start of therapy and 4 and 12 weeks after the start of therapy using the MADRS, MFI-20, DSST and USEFO psychometric scales.

Results. Both groups showed positive dynamics on all scales studied after 4 and 12 weeks of therapy. However, significant differences in antidepressant effect between the groups were recorded only after 12 weeks of therapy (11.2±1.6 vs. 11.5±1.9 after 4 weeks and 5.6±0.9 vs. 10.6±1.0 after 12 weeks; p<0.05). Similar results were obtained with regard to the severity of asthenia symptoms (48.1±3.67 vs. 53.0±3.54 at week 4 and 33.5±2.61 vs. 51.7±3.29 at week 12; p<0.05). Cognitive functioning indicators also showed a slightly greater improvement in the active group on both scales – DSST and USEFO.

Conclusion. The addition of Laennec hPH to basic antidepressant therapy leads to the development of a delayed but significant antidepressant, antiasthenic and pro-cognitive effect against the background of significant positive dynamics in the clinical and laboratory symptoms of diseases that are indications for the use of the drug (steatohepatitis, atopic dermatitis, recurrent herpes).

1. Romanov DV, Petelin DS, Volel BA. Depression in neurological practice. Meditsinskiy sovet = Medical Council. 2018;(1):38-45. doi: 10.21518/2079-701X-2018-1-38-45 (In Russ.).

2. Volel BA, Troshina DV. Somatic depression with cognitive impairment in a female patient with hypertension. Nevrologiya, neiropsikhiatriya, psikhosomatika = Neurology, Neuropsychiatry, Psychosomatics. 2017;9(4):60-4. doi: 10.14412/2074-2711-2017-4-60-64 (In Russ.)].

3. Zhang Y, Jia X, Yang Y, et al. Change in the global burden of depression from 1990–2019 and its prediction for 2030. J Psychiatr Res. 2024 Oct;178:16-22. doi: 10.1016/j.jpsy-chires.2024.07.054. Epub 2024 Aug 2.

4. Bromet E, Andrade LH, Hwang I, et al. Cross-national epidemiology of DSM-IV major depressive episode. BMC Med. 2011 Jul 26;9:90. doi: 10.1186/1741-7015-9-90

5. Ferrari AJ, Charlson FJ, Norman RE, et al. Burden of depressive disorders by country, sex, age, and year: findings from the global burden of disease study 2010. PLoS Med. 2013 Nov;10(11):e1001547. doi: 10.1371/journal.pmed.1001547. Epub 2013 Nov 5.

6. Volel' BA, Troshina DV, Fomicheva AV, et al. Impact of mental disorders on adherence to therapy in patients with atrial fibrillation. Kardiologiya i serdechno-sosudistaya khirurgiya = Russian Journal of Cardiology and Cardiovascular Surgery. 2020;13(6):530-8. doi: 10.17116/kardio202013061530 (In Russ.)].

7. Zhdanava M, Pilon D, Ghelerter I, et al. The Prevalence and National Burden of Treatment-Resistant Depression and Major Depressive Disorder in the United States. J Clin Psychiatry. 2021;82(2):20m13699. doi: 10.4088/JCP.20m13699

8. Bairamova SP, Petelin DS, Akhapkin RV, et al. The endogenic neurosteroid system and its role in the pathogenesis and therapy of mental disorders. Research Results in Pharmacology. 2023;9(1):61-9. doi: 10.18413/rrpharmacology.9.10015

9. Tang Y, Purkayastha S, Cai D. Hypothalamic microinflammation: a common basis of metabolic syndrome and aging. Trends Neurosci. 2015 Jan;38(1):36-44. doi: 10.1016/j.tins.2014.10.002. Epub 2014 Nov 14.

10. Volel BA, Makukh EA, Lebedeva MV, et al. Clinical and laboratory markers of asthenic syndrome in patients with sarcoidosis. Vrach. 2016;27(7):74-6 (In Russ.).

11. Yirmiya R. The inflammatory underpinning of depression: An historical perspective. Brain Behav Immun. 2024 Nov;122:433-43. doi: 10.1016/j.bbi.2024.08.048. Epub 2024 Aug 26.

12. Torshin IYu, Gromova OA. Worldwide experience of the therapeutic use of the human placental hydrolytes. Eksperimental'naya i klinicheskaya gastroenterologiya = Experimental and Clinical Gastroenterology. 2019;1(10):79-89. doi: 10.31146/1682-8658-ecg-170-10-79-89 (In Russ.).

13. Pirogova IYu, Neuimina TV, Suchkova OV, et al. Laennec (Human placenta hydrolyzate) in monotherapy of mixed etiology of steatohepatitis. Eksperimental'naya i klinicheskaya gastroenterologiya = Experimental and Clinical Gastroenterology. 2023;(8):37-47. doi: 10.31146/1682-8658-ecg-216-8-37-47 (In Russ.).

14. Tran VT, Torshin IYu, Gromova OA. An open-label, controlled trial of the efficacy and safety of Laennec to improve liver function in patients with non-alcoholic fatty liver disease. Eksperimental'naya i klinicheskaya gastroenterologiya = Experimental and Clinical Gastroenterology. 2023;(8):48-56. doi: 10.31146/1682-8658-ecg-216-8-48-56 (In Russ.).

15. Gromova OA, Torshin IYu, Gilels AV, et al. Human placenta preparations: fundamental and clinical studies. Vrach. 2014;(4):67-72 (In Russ.).

16. Lee KK, Choi WS, Yum KS, et al. Efficacy and safety of human placental extract solution on fatigue: a double-blind, randomized, placebo-controlled study. Evid Based Complement Alternat Med. 2012;2012:130875. doi: 10.1155/2012/130875. Epub 2011 Sep 28.

17. Glazachev OS, Dudnik EN. Effects of Human Placenta Extract Laennec on Quality of Life and Physical Performance in Patients with Chronic Fatigue Syndrome. Int J Emerg Mental Health Hum Resilience. 2017;19(3).

18. Drevets WC, Wittenberg GM, Bullmore ET, Manji HK. Immune targets for therapeutic development in depression: towards precision medicine. Nat Rev Drug Discov. 2022 Mar;21(3):224-44. doi: 10.1038/s41573-02100368-1. Epub 2022 Jan 17.

19. Rizk MM, Bolton L, Cathomas F, et al. Immune-Targeted Therapies for Depression: Current Evidence for Antidepressant Effects of Monoclonal Antibodies. J Clin Psychiatry. 2024 Jun 24;85(3):23nr15243. doi: 10.4088/JCP.23nr15243

20. Jakobsen JC, Katakam KK, Schou A, et al. Selective serotonin reuptake inhibitors versus placebo in patients with major depressive disorder. A systematic review with meta-analysis and Trial Sequential Analysis. BMC Psychiatry. 2017 Feb 8;17(1):58. doi: 10.1186/s12888-016-1173-2. Erratum in: BMC Psychiatry. 2017 May 3;17(1):162. doi: 10.1186/s12888-017-1311-5

21. Lopez-Lopez JA, Davies SR, Caldwell DM, et al. The process and delivery of CBT for depression in adults: a systematic review and network meta-analysis. Psychol Med. 2019 Sep;49(12):1937-47. doi: 10.1017/S003329171900120X. Epub 2019 Jun 10.

22. Ragimova AA, Petelin DS, Avseytseva TYu, et al. Mental disorders in cervical dystonia – clinical heterogeneity, impact on disease severity and quality of life. Nevrologiya, neiropsikhiatriya, psikhosomatika = Neurology, Neuropsychiatry, Psychosomatics. 2022;14(6):20-4. doi: 10.14412/2074-2711-2022-6-20-24 (In Russ.).

23. Petelin DS, Volel' BA. Recent approaches to the diagnosis and therapy of monopolar depression. Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova = S.S. Korsakov Journal of Neurology and Psychiatry. 2023;123(10):33-41. doi: 10.17116/jnevro202312310133 (In Russ.).

24. Romanov DV, Volel BA, Petelin DS. Approaches to therapy for depressions in neurology: prospects for the use of agomelatine. Nevrologiya, neiropsikhiatriya, psikhosomatika = Neurology, Neuropsychiatry, Psychosomatics. 2018;10(4):101-10. doi: 10.14412/2074-2711-2018-4-101-110 (In Russ.).

25. Golovacheva VA, Parfyonov VA. Depression in neurological practice: prevalence, diagnosis, treatment standards and new options for pharmacotherapy. Meditsinskiy sovet = Medical Council. 2015;(5):55-61. doi: 10.21518/2079-701X-2015-5-55-61 (In Russ.).

26. Golovacheva VA, Parfenov VA, Zakharov VV. Treatment for chronic daily headache by using auxiliary and alternative methods. Nevrologiya, neiropsikhiatriya, psikhosomatika = Neurology, Neuropsychiatry, Psychosomatics. 2015;7(2):35-41. doi: 10.14412/2074-2711-2015-2-35-41 (In Russ.).

27. Maksimov VA, Torshin IYu, Chuchalin AG, et al. An experience of using Laennec in patients at high risk of a cytokine storm with COVID-19 and hyperferritinemia. Pulmonologiya. 2020;30(5):587-98. doi: 10.18093/0869-0189-2020-30-5-587-598 (In Russ.).

28. Sarno E, Moeser AJ, Robison AJ. Neuroimmunology of depression. Adv Pharmacol. 2021;91:259-92. doi: 10.1016/bs.apha.2021.03.004. Epub 2021 Apr 26.

29. Swaab DF, Bao AM, Lucassen PJ. The stress system in the human brain in depression and neurodegeneration. Ageing Res Rev. 2005 May;4(2):141-94. doi: 10.1016/j.arr.2005.03.003