Current Safety Data of the Complex Herbal Medicine with Sedative and Cardioprotective Actions

Authors

DOI:

https://doi.org/10.20535/ibb.2018.2.3.143029

Keywords:

Pharmacovigilance, Risk management plan, Hawthorn, Motherwort, Valerian, Melissa

Abstract

Background. The risk management plan is the one of main documents of pharmacovigilance system – a document focuses on the planning of pharmacovigilance activities and minimization of risks. As the use of herbal medicines has increased, so too have the reports of suspected toxicity and adverse events. As many herbal products on the market have not been thoroughly tested for their pharmacology and toxicology, pharmacovigilance has paramount importance in detecting unwanted reactions. One of the herbal preparations widely used to support the cardiovascular system under stress, neurocirculatory dystonia, cardiac neurosis, in the complex treatment of arterial hypertension, angina pectoris, arrhythmia is a complex medicinal product Carvelis, oral drops, solution. The active pharmaceutical ingredients of the drug are: extract from a mixture of hawthorn leaves, flowers and fruit (Сrataegi folii cum flore, fructus extractum); herb extract of canine nettle (Leonuri herbae extractum); melissae herbia extract Melissae herbae extractum); valerian root extract (Valerianae radix extractum).

Objective. Сritical analysis of current scientific data on the benefit/risk ratio of a complex herbal medicine with sedative and cardioprotective effects.

Results. Pathophysiological and epidemiological characteristic of following nosological forms have been analyzed: stress, neurocirculatory dystonia, cardiac neurosis, arterial hypertension, angina pectoris, arrhythmia. Current data on phytopreparation safety and estimation benefit/risk ratio have been generalized. Available clinical data were analyzed for individual phytocomponents or its combinations.

Conclusions. The prevalence, seriousness and severity of the course of all manifestations of neurocirculatory dystonia, stress, nervous excitement, heart neurosis, especially with disproportionate approaches to the treatment of these diseases, is a serious medical and social problem. Given the proven efficacy of the use of Carvelis preparation components, and also that the risks are predictable, and their occurrence can be countered, and if they occur it can be effectively suppress with other drugs, the benefit of using the phytopreparation prevails above the risks.

References

Marchenko A. Pharmacovigilance in Ukraine. Key aspects of drug safety. Apteka. 2017;45.

Bagheri H, Laroche M, Montastruc J. Pharmacovigilance: the new challenges. Thérapie. 2016;71(2):121-2. DOI: 10.1016/j.therap.2016.02.019

Beninger P. Opportunities for collaboration at the interface of pharmacovigilance and manufacturing. Clin Ther. 2017;39(4):702-12. DOI: 10.1016/j.clinthera.2017.03.010

Wise L, Parkinson J, Raine J, Breckenridge A. New approaches to drug safety: a pharmacovigilance tool kit. Nat Rev Drug Discov. 2009;8(10):779-82. DOI: 10.1038/nrd3002

Shaw D, Graeme L, Pierre D, Elizabeth W, Kelvin C. Pharmacovigilance of herbal medicine. J Ethnopharmacol. 2012;140(3):513-8. DOI: 10.1016/j.jep.2012.01.051

Kovalenko VM. Stress and cardiovascular disease: the current state of the problem. Ukr Cardiol J. 2015;1:4-10.

Shcherbatykh YuV. Psychology of stress. Moscow: Eksmo; 2008. 304 p.

Hannah TJ, Stellman SD, Morabia A, Miller-Archie SA, Alper H, Laskaris Z, et al. Cardiovascular disease hospitalizations in relation to exposure to the September 11, 2001 World Trade Center disaster and posttraumatic stress disorder. J Am Heart Assoc. 2013;2(5):e000431. DOI: 10.1161/JAHA.113.000431

Iso H, Date C, Yamamoto A, Toyoshima H, Tanabe N, Kikuchi S, et al. Perceived mental stress and mortality from cardiovascular disease among Japanese men and women: the Japan collaborative cohort study for evaluation of cancer risk sponsored by Monbusho (JACC Study). Circulation. 2002;106(10):1229-36. DOI: 10.1161/01.CIR.0000028145.58654.41

Nabi H, Kivimäki M, Batty G, Shipley M, Britton A, Brunner E, et al. Increased risk of coronary heart disease among individuals reporting adverse impact of stress on their health: the Whitehall II prospective cohort study. Europ Heart J. 2013;34(34):2697-2705. DOI: 10.1093/eurheartj/eht216

Alhurani AS, Dekker R, Ahmad M, Miller J, Yousef KM, Abdulqader B, et al. Stress, cognitive appraisal, coping, and event free survival in patients with heart failure. Heart Lung. 2018;47(3):205-10. DOI: 10.1016/j.hrtlng.2018.03.008

Blumenthal JA, Feger BJ, Smith PJ, Watkins LL, Jiang W, Davidson J, et al. Treatment of anxiety in patients with coronary heart disease: rationale and design of the UNWIND randomized clinical trial. Am Heart J. 2016;176:53-62. DOI: 10.1016/j.ahj.2016.03.003

Scott S, Thompson J. Drugs acting on the heart: heart failure and coronary insufficiency. Anaesthesia Intens Care Med. 2012;13(8):378-83. DOI: 10.1016/j.mpaic.2012.05.008

Loganovsky K. Vegetative-vascular dystonia and osteoalgetic syndrome or chronic fatigue syndrome as a characteristic after-effect of radioecological disaster. J Chronic Fatigue Syndrome. 2000;7(3):3-16. DOI: 10.1300/J092v07n03_02

Sidorenko GI. Neurocirculatory dystonia (does this disease exist?) Kardiologiia. 2003;43(10):93-8.

Smetanina KI, Ryazanova RM. Phytotherapeutic approach to treatment of cardiac neuroses. Phytotherapy (Ukraine). 2004;3:7-15.

Frolova NL, Chutko LS, Surushkina SIu. Neurocirculatory asthenia: psychoautonomic features and treatment possibilities. Zh Nevrol Psikhiatr Im SS Korsakova. 2012;112(12):51-4.

Amos T, Stein DJ, Ipser JC. Pharmacological interventions for preventing post-traumatic stress disorder (PTSD). Cochrane Database Syst Rev. 2014 Jul 8;7:CD006239. DOI: 10.1002/14651858.CD006239.pub2

Hernandorena I, Duron E, Vidal J, Hanon O. Treatment options and considerations for hypertensive patients to prevent dementia. Expert Opinion on Pharmacotherapy. 2017;18(10):989-1000. DOI: 10.1080/14656566.2017.1333599

Lackland D, Weber M. Global burden of cardiovascular disease and stroke: hypertension at the core. Canad J Cardiol. 2015;31(5):569-71. DOI: 10.1016/j.cjca.2015.01.009

Parati G, Antonicelli R, Guazzarotti F, Paciaroni E, Mancia G. Cardiovascular effects of an earthquake: direct evidence by ambulatory blood pressure monitoring. Hypertension. 2001;38(5):1093-5. DOI: 10.1161/hy1101.095334

Tobin KJ. Stable Angina Pectoris: What does the current clinical evidence tell us? J Am Osteopat Assoc. 2010;110(7):364-70.

Hombach V, Hoher M, Kochs M, Eggeling T, Schmidt A, Hopp H, et al. Pathophysiology of unstable angina pectoris – correlations with coronary angioscopic imaging. Europ Heart J. 1988;9(suppl N):40-5. DOI: 10.1093/eurheartj/9.suppl_N.40

Sedighi M, Bahmani M, Asgary S, Beyranvand F, Rafieian-Kopaei M. A review of plant-based compounds and medicinal plants effective on atherosclerosis. J Res Med Sci. 2017;22:30. DOI: 10.4103/1735-1995.202151

Orekhov A, Ivanova E. Cellular models of atherosclerosis and their implication for testing natural substances with anti-atherosclerotic potential. Phytomedicine. 2016;23(11):1190-7. DOI: 10.1016/j.phymed.2016.01.003

Dimsdale JE. Psychological stress and cardiovascular disease. J Am College Cardiol. 2008;51(13):1237-46. DOI: 10.1016/j.jacc.2007.12.024

Dolzhenko MN. Three names for one disease, or how to treat a vegetative crisis? Arterial Hypertension (Ukraine). 2008;1:55-62.

Burchinsky SG. Small neuroleptics in the pharmacotherapy of psychosomatic disorders. Health of Ukraine. 2012;3(22):24-5.

Burchinsky SG. The possibilities of complex pharmacotherapy of autonomic dysfunction and psychoemotional imbalance. Family Medicine (Ukraine). 2014;5(55):25-30.

Ghicavii V, Podgurschi L, Pogonea I, Rakovski T. Peculiarities of using drugs in the elderly. Moldov Med J. 2017;60(4):20-4. DOI: 10.5281/zenodo.1106597

Rosic S, Kendic S, Rosic M. Phytoestrogens impact on menopausal symptomatology. Materia Socio-Medica. 2013;25(2):98-100. DOI: 10.5455/msm.2013.25.98-100

Wojtczak D, Kasznicki J, Drzewoski J. Pros and cons of polypharmacy in elderly patients with diabetes. Clin Diabetol. 2017;6(1):34-8. DOI: 10.5603/DK.2017.0006

Phipps J, O'Kennon R, Lance R. Hawthorns and medlars. Portland: Timber Press; 2003.

Furey A, Tassell M, Kingston R, Gilroy D, Lehane M. Hawthorn (Crataegus spp.) in the treatment of cardiovascular disease. Pharmacognosy Rev. 2010;4(7):32. DOI: 10.4103/0973-7847.65324

Bernatoniene J, Trumbeckaite S, Majiene D, Baniene R, Baliutyte G, Savickas A, et al. The effect of crataegus fruit extract and some of its flavonoids on mitochondrial oxidative phosphorylation in the heart. Phytotherapy Res. 2009;23(12):1701-7. DOI: 10.1002/ptr.2815

Fong H, Bauman J. Hawthorn. J Cardiovasc Nursing. 2002;16(4):1-8. DOI: 10.1097/00005082-200207000-00002

Rigelsky JM, Sweet BV. Hawthorn: Pharmacology and therapeutic uses. Am J Health-System Pharmacy. 2002;59:417-22.

Eggeling T, Regitz-Zagrosek V, Zimmermann A, Burkart M. Baseline severity but not gender modulates quantified Crataegus extract effects in early heart failure – a pooled analysis of clinical trials. Phytomedicine. 2011;18(14):1214-9. DOI: 10.1016/j.phymed.2011.06.022

Pittler MH, Guo R, Ernst E. Hawthorn extract for treating chronic heart failure. Cochrane Database Syst Rev. 2008;(1):CD005312. DOI: 10.1002/14651858.CD005312.pub2

Assessment report on Crataegus spp., folium cum flore. Based on Article 16d(1), Article 16f and Article 16h of Directive 2001/83/EC as amended (traditional use). 13 October 2014. EMA/HMPC/159076/2014. Committee on Herbal Medicinal Products (HMPC).

Schenwick JP. Phytoantioxidants in clinical practice. Drugs Clin Ther. 2008;14:46-59.

Babushkina AV. Combination preparation Kratal in the treatment of cardiovascular diseases. Ukr Med J. 2010;4(7-8):1-15.

Zhang RH, Liu ZK, Yang DS, Zhang XJ, Sun HD, Xiao WL. Phytochemistry and pharmacology of the genus Leonurus: the herb to benefit the mothers and more. Phytochemistry. 2018;147:167-83. DOI: 10.1016/j.phytochem.2017.12.016

Wojtyniak K, Szymański M, Matławska I. Leonurus cardiaca L. (motherwort): a review of its phytochemistry and pharmacology. Phytother Res. 2013;27(8):1115-20. DOI: 10.1002/ptr.4850

Shang X, Pan H, Wang X, He H, Li M. Leonurus japonicus Houtt.: ethnopharmacology, phytochemistry and pharmacology of an important traditional Chinese medicine. J Ethnopharmacol. 2014;152(1):14-32. DOI: 10.1016/j.jep.2013.12.052

Liu XH, Pan LL, Zhu YZ. Active chemical compounds of traditional Chinese medicine Herba Leonuri: Implications for cardiovascular diseases. Clin Exp Pharmacol Physiol. 2012;39(3):274-82. DOI: 10.1111/j.1440-1681.2011.05630.x

Assessment report on Leonurus cardiaca L., herba. 6 May 2010 EMA/HMPC/127430/2010 Committee on Herbal Medicinal Products (HMPC).

Kornievskaya VG, Sur SV, Lesik IP. Valerian medicinal essential oil. Pharmaceut J (Ukraine). 2000;3:95-9.

Wagner H. Phytomedicine research in Germany. Environ Health Perspect. 1999;107:779–819. DOI: 10.1289/ehp.99107779

Leach MJ, Page AT. Herbal medicine for insomnia: a systematic review and meta-analysis. Sleep Med Rev. 2015;24:1-12. DOI: 10.1016/j.smrv.2014.12.003

Bega D, Malkani R. Alternative treatment of restless legs syndrome: an overview of the evidence for mind-body interventions, lifestyle interventions, and neutraceuticals. Sleep Med Rev. 2016;17:99-105. DOI: 10.1016/j.sleep.2015.09.009

Waldschütz R, Klein P. The homeopathic preparation Neurexan vs. valerian for the treatment of insomnia: an observational study. Sci World J. 2008;8:411-20. DOI: 10.1100/tsw.2008.61

Hubner R, van Haselen R, Klein P. Effectiveness of the homeopathic preparation Neurexan compared with that of commonly used valerian-based preparations for the treatment of nervousness/restlessness – an observational study. Sci World J. 2009;9:733-45. DOI: 10.1100/tsw.2009.95

Taavoni S, Nazem Ekbatani N, Haghani H. Valerian/lemon balm use for sleep disorders during menopause. Complement Ther Clin Pract. 2013;19(4):193-6. DOI: 10.1016/j.ctcp.2013.07.002

Assessment report on Valeriana officinalis L., radix and Valeriana officinalis L., aetheroleum. 7 July 2015 EMA/HMPC/150846/2015 Committee on Herbal Medicinal Products (HMPC).

Kennedy DO, Scholey AB, Tildesley NT, Perry EK, Wesnes KA. Modulation of mood and cognitive performance following acute administration of Melissa officinalis (lemon balm). Pharmacol. Biochem. Behav. 2002;72:953-964.

Shakeri A, Sahebkar A, Javadi B. Melissa officinalis L. – a review of its traditional uses, phytochemistry and pharmacology. J Ethnopharmacol. 2016;188:204-28. DOI: 10.1016/j.jep.2016.05.010

Сommittee on herbal medicinal products (hmpc), community herbal Мonograph on melissa officinalis l., folium, London, 8 may 2007 doc. ref. emea/hmpc/5341/2007.

Prihodko VY. Clinical experience of using the drug Karvelis in patients of different age groups with autonomic dysfunction. Health of Ukraine. 2014;19:38-9.

Ross SM. Psychophytomedicine: an overview of clinical efficacy and phytopharmacology for treatment of depression, anxiety and insomnia. Holist Nurs Pract. 2014;28:275-80. DOI: 10.1097/HNP.0000000000000040

Luo S, Mai L, Zhu Z. Separation and determination of alkaloids of Leonurus cardiaca. Zhongyao Tongbao. 1985;10(1):32-5.

Kosyakova LE. Healing plants: A handbook of folk and practical phytotherapy. Yaroslavl: Verkhne-Volzhskoye Publishing House; 1993. 272 p.

Downloads

Published

2018-10-02

How to Cite

1.
Gorchakova N, Heimuller E, Galkin A. Current Safety Data of the Complex Herbal Medicine with Sedative and Cardioprotective Actions. Innov Biosyst Bioeng [Internet]. 2018Oct.2 [cited 2024Mar.29];2(3):163-74. Available from: http://ibb.kpi.ua/article/view/143029

Issue

Section

Articles