Neuromuscular DiseasesNeuromuscular DiseasesНервно-мышечные болезни2222-87212413-0443Publishing House ABV Press15210.17650/2222-8721-2016-6-2-41-46ORIGINAL REPORTSОРИГИНАЛЬНЫЕ ИССЛЕДОВАНИЯComparative randomized open-label trial on efficacy and safety of Persen® and Persen® Night herbal extracts in patients with short-term insomniaОткрытое сравнительное рандомизированное исследование эффективности и безопасности применения растительных препаратов Персен® и Персен® Ночь у пациентов с кратковременной инсомниейRachinA. P.РачинА. П.
Russian Federation
7851377@gmail.comRussian Scientific Center for Medical Rehabilitation and SPA Medicine, Ministry of Health of RussiaФГБУ «Российский научный центр медицинской реабилитации и курортологии» Минздрава России32 Novy Arbat St., Моscow, 121099, RussiaРоссия, 121099, Москва, ул. Новый Арбат, 32050720166241460507201605072016Copyright ©; 2016, Rachin A.P.Copyright ©; 2016, Рачин А.П.2016Rachin A.P.Рачин А.П.https://creativecommons.org/licenses/by/4.0https://nmb.abvpress.ru/jour/article/view/152

Herbal sedatives serve an alternative to antipsychotics and hypnotics aimed to alleviate symptoms of anxious disorders and insomnia. Valeriana officinalis L., Mentha piperita L. and Melissa officinalis are most widely used in neurology as sedatives of herbal origin. We present the results of a randomized open-label trial on efficiency and safety of Persen® and Persen® Night containing extracts of the above mentioned plants in patients with short-term insomnia. The study consisted of 60 subjects of 18–65 y.o. (mean 42.4 ± 6.9 y.o.) with short-term insomnia due to adjustment disorder or mixed anxiety-depressive disorders: 30 of them got Persen® 2 tablets a day and 30 – Persen® Night, 1 capsule 30–60 min before sleep during 4 weeks. The majority (76.5 %) of patients referred the onset of insomnia with psychosocial traumatic stressor. Persen® Night’s main action was found on superficial sleep, number of night awakenings, sleep onset rate. At the end of the therapy with this substance 39.7 % of patients fell asleep in 10–15 min, and 92.2 % – in 30 min, accordingly, while for Persen® at 17.4 and 80.3 % accordingly (р < 0.05). In the meantime Persen® decreased the bad sleep perception at awakening and day somnolence, mostly attributed to the mood improvement and decrease of anxiety. Levels of efficacy and safety for both substances were significant, allowing to regard them as potential phytotherapeutic agent in the treatment of insomnia and mixed anxiety-depressive disorders.

Persen®Persen® Nightshort-term insomniaadjustment disordermixed anxiety-depressive disordersПерсен®Персен® Ночькратковременная инсомниярасстройства адаптациикоморбидное тревожно-депрессивное расстройство1. Вейн А.М., Елигулашвили Т.С., Полуэктов М.Г.. Синдром апноэ во сне и другие расстройства дыхания, связанные со сном: клиника, диагностика, лечение. М.: Эйдос Медиа, 2002. 310 с. [Veyn А.М., Еligulashvili Т.S., Poluektov М.G. Night apnoe syndrome and other sleep related breath disorders: clinic, diagnosis, treatment. Мoscow: Eydos Меdiа, 2002. 310 p. (In Russ.)].Вейн А.М., Елигулашвили Т.С., Полуэктов М.Г.. Синдром апноэ во сне и другие расстройства дыхания, связанные со сном: клиника, диагностика, лечение. М.: Эйдос Медиа, 2002. 310 с. [Veyn А.М., Еligulashvili Т.S., Poluektov М.G. Night apnoe syndrome and other sleep related breath disorders: clinic, diagnosis, treatment. Мoscow: Eydos Меdiа, 2002. 310 p. (In Russ.)].2. Ohayon M.M., Shapiro C.M., Kennedy S.H. Differentiating DSM-IV anxiety and depressive disorders in the general population: comorbidity and treatment consequences. Can J Psychiatry. 2000;45(2):166–72. PMID: 10742876.Ohayon M.M., Shapiro C.M., Kennedy S.H. Differentiating DSM-IV anxiety and depressive disorders in the general population: comorbidity and treatment consequences. Can J Psychiatry. 2000;45(2):166–72. PMID: 10742876.3. Chokroverty S. Sleep-disordered breathing in neuromuscular disorders: a condition in search of recognition. Muscle Nerve 2001;24(4):451–5. PMID: 11268015.Chokroverty S. Sleep-disordered breathing in neuromuscular disorders: a condition in search of recognition. Muscle Nerve 2001;24(4):451–5. PMID: 11268015.4. Bhat S., Gupta D., Chokroverty S. Sleep disorders in neuromuscular diseases. Neurol Clin 2012;30(4):1359–87. DOI: 10.1016/j.ncl.2012.08.010. PMID: 23099142.Bhat S., Gupta D., Chokroverty S. Sleep disorders in neuromuscular diseases. Neurol Clin 2012;30(4):1359–87. DOI: 10.1016/j.ncl.2012.08.010. PMID: 23099142.5. Ramezani R.J., Stacpoole P.W. Sleep disorders associated with primary mitochondrial diseases. J Clin Sleep Med 2014;10(11):1233–9. DOI: 10.5664/ jcsm.4212. PMID: 25325607.Ramezani R.J., Stacpoole P.W. Sleep disorders associated with primary mitochondrial diseases. J Clin Sleep Med 2014;10(11):1233–9. DOI: 10.5664/ jcsm.4212. PMID: 25325607.6. Aboussouan L.S. Sleep-disordered breathing in neuromuscular disease. Am J RespirCrit Care Med 2015;191(9): 979–89. DOI: 10.1164/rccm.201412- 2224CI. PMID: 25723731.Aboussouan L.S. Sleep-disordered breathing in neuromuscular disease. Am J RespirCrit Care Med 2015;191(9): 979–89. DOI: 10.1164/rccm.201412- 2224CI. PMID: 25723731.7. Fernandes O.E., Nacif S.R., Alves P.N. et al. Sleep disorders in patients with myasthenia gravis: a systematic review. J PhysTher Sci 2015;27(6):2013–8. DOI: 10.1589/jpts.27.2013. PMID: 26180370.Fernandes O.E., Nacif S.R., Alves P.N. et al. Sleep disorders in patients with myasthenia gravis: a systematic review. J PhysTher Sci 2015;27(6):2013–8. DOI: 10.1589/jpts.27.2013. PMID: 26180370.8. Милованова О.А., Гунченко М.М., Волкова Е.А. и др. Эффективность применения препарата Персен в терапии локальных и распространенных тиков в педиатрической практике. Практика педиатра 2010;17–21. [Мilovanovа О.А., Gunchenkо М.М., Volkovа Е.А. et al. Persen efficiency in the therapy of local and generalized facial spasms in the pediatric practice. Praktika pediatra = Pediatrician’s Practice 2010;17–21. (In Russ.)].Милованова О.А., Гунченко М.М., Волкова Е.А. и др. Эффективность применения препарата Персен в терапии локальных и распространенных тиков в педиатрической практике. Практика педиатра 2010;17–21. [Мilovanovа О.А., Gunchenkо М.М., Volkovа Е.А. et al. Persen efficiency in the therapy of local and generalized facial spasms in the pediatric practice. Praktika pediatra = Pediatrician’s Practice 2010;17–21. (In Russ.)].9. Барнаулов О.Д., Поспелова М.Л. Фитотерапия в неврологии. СПб.: Н-Л, 2009. 320 с. [Barnaulov О.D., Pospelovа М.L. Phitotherapy in neurology. Saint Petersburg: N-L, 2009. 320 p. (In Russ.)].Барнаулов О.Д., Поспелова М.Л. Фитотерапия в неврологии. СПб.: Н-Л, 2009. 320 с. [Barnaulov О.D., Pospelovа М.L. Phitotherapy in neurology. Saint Petersburg: N-L, 2009. 320 p. (In Russ.)].10. Мальмберг С.А., Огурцова Е.А. Эффективность препарата Персен при субпороговых тревожных расстройствах у подростков. Consilium medicum. Педиатрия 2008;(2):31–5. [Маl’mberg S.А., Оgurtsovа Е.А. Persen efficiency at subthreshold anxious disorders and teenagers. Consilium medicum. Pediatriya = Consilium Medicum. Pediatrics 2008;(2):31–5. (In Russ.)].Мальмберг С.А., Огурцова Е.А. Эффективность препарата Персен при субпороговых тревожных расстройствах у подростков. Consilium medicum. Педиатрия 2008;(2):31–5. [Маl’mberg S.А., Оgurtsovа Е.А. Persen efficiency at subthreshold anxious disorders and teenagers. Consilium medicum. Pediatriya = Consilium Medicum. Pediatrics 2008;(2):31–5. (In Russ.)].11. Пекониди А.В., Вострокнутов Н.В. Применение Персена при психосоматических расстройствах у детей. Врач 2009;(7):54–6. [Peconidi А.V., Vostroknutov N.V. Persen at children’s psychosomatic disorders. Vrach = Physician 2009;(7):54–6. (In Russ.)].Пекониди А.В., Вострокнутов Н.В. Применение Персена при психосоматических расстройствах у детей. Врач 2009;(7):54–6. [Peconidi А.V., Vostroknutov N.V. Persen at children’s psychosomatic disorders. Vrach = Physician 2009;(7):54–6. (In Russ.)].12. Рачин А.П., Сергеев А.В. Персен: возможности применения при тревожных расстройствах и нарушениях сна. Фарматека 2008(8):27–30. [Rachin А.P., Sergeev А.V. Persen: application possibilities at anxious and sleep disorders. Pharmateka = Pharmateca 2008;(8):27–30. (In Russ.)].Рачин А.П., Сергеев А.В. Персен: возможности применения при тревожных расстройствах и нарушениях сна. Фарматека 2008(8):27–30. [Rachin А.P., Sergeev А.V. Persen: application possibilities at anxious and sleep disorders. Pharmateka = Pharmateca 2008;(8):27–30. (In Russ.)].13. Saeed S.A., Bloch R.M., Antonacci D.J. Herbal and dietary supplements for treatment of anxiety disorders. Am Fam Physician 2007;76(4):549–56. PMID: 17853630.Saeed S.A., Bloch R.M., Antonacci D.J. Herbal and dietary supplements for treatment of anxiety disorders. Am Fam Physician 2007;76(4):549–56. PMID: 17853630.14. Lakhan S.E., Vieira K.F. Nutritional and herbal supplements for anxiety and anxiety-related disorders: systematic review. Nutr J 2010;9:42. DOI:10.1186/1475- 2891-9-42. PMID: 20929532.Lakhan S.E., Vieira K.F. Nutritional and herbal supplements for anxiety and anxiety-related disorders: systematic review. Nutr J 2010;9:42. DOI:10.1186/1475- 2891-9-42. PMID: 20929532.15. Donath F., Quispe S., Diefenbach K. et al. Critical evaluation of the effect of valerian extract on sleep structure and sleep quality. Pharmacopsychiatry 2000;33(2):47–53. PMID: 10761819.Donath F., Quispe S., Diefenbach K. et al. Critical evaluation of the effect of valerian extract on sleep structure and sleep quality. Pharmacopsychiatry 2000;33(2):47–53. PMID: 10761819.16. Wheatley D. Stress-induced insomnia treated with kava and valerian: singly and in combination. Hum Psychopharmacol 2001;16(4):353–56. PMID: 12404572.Wheatley D. Stress-induced insomnia treated with kava and valerian: singly and in combination. Hum Psychopharmacol 2001;16(4):353–56. PMID: 12404572.17. Wheatley D. Medicinal plants for insomnia: a review of their pharmacology, efficacy and tolerability. J Psychopharmacol 2005;19(4):414–21. PMID: 15982998.Wheatley D. Medicinal plants for insomnia: a review of their pharmacology, efficacy and tolerability. J Psychopharmacol 2005;19(4):414–21. PMID: 15982998.18. Kennedy D.O., Little W., Haskell C.F. et al. Anxiolytic effects of a combination of Melissa officinalis and Valeriana officinalis during laboratory induced stress. Phytother Res 2006;20(2):96–102. PMID: 16444660.Kennedy D.O., Little W., Haskell C.F. et al. Anxiolytic effects of a combination of Melissa officinalis and Valeriana officinalis during laboratory induced stress. Phytother Res 2006;20(2):96–102. PMID: 16444660.19. Bhattacharyya D., Jana U., Debnath P.K. et al. Initial exploratory observational pharmacology of Valeriana wallichii on stress management: a clinical report. Nepal Med Coll J 2007;9(1):36–9. PMID: 17593676.Bhattacharyya D., Jana U., Debnath P.K. et al. Initial exploratory observational pharmacology of Valeriana wallichii on stress management: a clinical report. Nepal Med Coll J 2007;9(1):36–9. PMID: 17593676.20. Bent S., Padula A., Moore D. et al. Valerian for sleep: a systematic review and meta-analysis. Am J Med 2006;119(12):1005–12. PMID: 17145239.Bent S., Padula A., Moore D. et al. Valerian for sleep: a systematic review and meta-analysis. Am J Med 2006;119(12):1005–12. PMID: 17145239.21. Cases J., Ibarra A., FeuilleWre N. et al. Pilot trial of Melissa officinalis L. leaf extract in the treatment of volunteers suffering from mild-to-moderate anxiety disorders and sleep disturbances. Med J Nutrition and Metab 2011;4(3):211–8. PMID: 22207903.Cases J., Ibarra A., FeuilleWre N. et al. Pilot trial of Melissa officinalis L. leaf extract in the treatment of volunteers suffering from mild-to-moderate anxiety disorders and sleep disturbances. Med J Nutrition and Metab 2011;4(3):211–8. PMID: 22207903.22. Fernandes O.E., Nacif S.R., Alves P.N. et al. Sleep disorders in patients with myasthenia gravis: a systematic review. J PhysTher Sci 2015;27(6):2013–8. DOI: 10.1589/jpts.27.2013. PMID: 26180370.Fernandes O.E., Nacif S.R., Alves P.N. et al. Sleep disorders in patients with myasthenia gravis: a systematic review. J PhysTher Sci 2015;27(6):2013–8. DOI: 10.1589/jpts.27.2013. PMID: 26180370.