Nootropic drugs for correction of cognitive functions through the focus of evidence-based medicine (literature review)
Abstract
Relevance. In today's world, the first cause of death is pathology of the cardiovascular system. Vascular disease is influenced by many factors: lack of sleep, physical inertia, poorly balanced diet, obesity, heart disease. The fast pace of life forces a person to be in permanent stress, so as not to miss anything and have time for all the goals. This is why there is a demand for excipients and substances that could improve the peak of human cognitive abilities, maintain psychological stability. Today, the pharmaceutical market offers drugs that, according to pharmaceutical marketers, have solutions to the problems outlined above. These substances are classified to group of nootropic drugs (racetams).
Objective. Review of high quality research on the effectiveness of nootropic drugs.
Materials and methods. The literature review was performed using such scientometric databases as: PubMed, Cochrane Library, Scopus, BMJ Evidence-Based Medicine, Ingecta, Web of Science, UpToDate. The review included studies of randomized trials, placebo-controlled randomized trials, meta-analyzes, and systematic reviews. Data meet criteria A and B of evidence-based medicine. In the absence of high quality studies, studies with a lower level of evidence were selected. The search was made by topics: improving of cognitive functions, improving ability to work, improving sleep, improving mood, treatment of mental and psychiatric pathologies (Alzheimer's disease, dementia with various etiologies, depression), application in pediatrics.
Results. The literature review included more than 40 high quality studies, but no conclusive evidence was found on the effectiveness of any drug.
Conclusions. Data on the undeniable efficacy in relation to the cognitive functions of any of these nootropic drugs were not found in any study. In the treatment of Alzheimer's disease, some (Cerebrolysin, Nicergoline) drugs show controversial results of efficacy and safety. They require continued clinical research and they need to be approved by the FDA.
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References
Oganov R.G. Basics of Evidence-Based Medicine. Textbook for the system of postgraduate and additional professional education of doctors. Moscow, 2010, 136 p.
Ricci S., Celani M, Cantisani, T., Righetti E. Piracetam for acute ischaemic stroke. The Cochrane Database of Systematic Reviews (Complete Reviews). 2002. https://www.doi.org/10.1002/14651858.cd000419
Flicker L., Grimley Evans J. Piracetam for dementia or cognitive impairment. Cochrane Database of Systematic Reviews. 2004. https://www.doi.org/10.1002/14651858.cd001011
Hofmeyr G. J., Kulier R. Piracetam for fetal distress in labour. Cochrane Database of Systematic Reviews. 2012. https://www.doi.org/10.1002/14651858.cd001064.pub2
Greener J., Enderby P., Whurr R. Pharmacological treatment for aphasia following stroke. Cochrane Database of Systematic Reviews. 2001. https://www.doi.org/10.1002/14651858.cd000424
Malykh A. G., Sadaie M. R. Piracetam and Piracetam-Like Drugs. Drugs. 2010, no. 70, pp. 287–312. https://www.doi.org/10.2165/11319230-000000000-00000
Fang Y., Qiu Z., Hu W. et al. Effect of piracetam on the cognitive performance of patients undergoing coronary bypass surgery: A meta-analysis. Experimental and Therapeutic Medicine. 2013, no. 7, pp. 429–434. https://www.doi.org/10.3892/ETM.2013.1425
Zvejniece L., Svalbe B., Vavers E. et al. S-phenylpiracetam, a selective DAT inhibitor, reduces body weight gain without influencing locomotor activity. Pharmacology Biochemistry and Behavior. 2017, no. 160, pp. 21–29.
Kovalchuk V.V., Skoromets A.A., Kovalchuk I.V. et al. The effect of phenotropil on the degree of recovery of patients after a stroke. Journal of Neurology and Psychiatry. S.S. Korsakov. Special issues. 2010, no. 38, p. 110.
Avula B., Chittiboyina A. G., Sagi S. et al. Identification and quantification of vinpocetine and picamilon in dietary supplements sold in the United States. Drug Testing and Analysis. 2015, no. 8, pp. 334–343.
Owen D. R., Wood D. M., Archer J. R. H., Dargan P. I. Phenibut (4-amino-3-phenyl-butyric acid): Availability, prevalence of use, desired effects and acute toxicity. Drug and Alcohol Review. 2015, no. 35, pp. 591–596.
Wong A., Little M., Caldicott D. et al. Analytically confirmed recreational use of Phenibut (β-phenyl-γ-aminobutyric acid). Clinical Toxicol. 2015, no. 53, pp. 783–784.
Li C., Sundararajan K. An uncommon case of phenibut toxicity in an intensive care unit. Int J Med Pharm Case Reports. 2015, no. 5, pp. 1–6.
McCabe D., Bangh S., Arens A., Cole J. Phenibut exposures and clinical effects reported to a regional poison center. The American Journal of Emergency Medicine. 2019, no. 11, pp. 2066–2071. https://www.doi.org/10.1016/J.AJEM.2019.02.044
Nair M. K., George B., Jeyaseelan L. Nair M. K. Pyritinol for post asphyxial encephalopathy in term babies – a randomized double-blind controlled trial. Indian Pediatr. 2009, no. 46, pp. 37–42.
Bereczki D., Fekete I. Vinpocetine for acute ischaemic stroke. Cochrane Database of Systematic Reviews. 2008. https://www.doi.org/10.1002/14651858.cd000480.pub2
Szatmári S., Whitehouse P. Vinpocetine for cognitive impairment and dementia. Cochrane Database of Systematic Reviews Review - Intervention. 2003. https://www.doi.org/10.1002/14651858.CD003119
Zhang W., Huang Y., Li Y. et al. Efficacy and Safety of Vinpocetine as Part of Treatment for Acute Cerebral Infarction: A Randomized, Open-Label, Controlled, Multicenter CAVIN (Chinese Assessment for Vinpocetine in Neurology) Trial. Clinical Drug Investigation. 2016, no. 36, pp. 697–704.
M. V. Putilina, O. A. Baranova. The results of the multicenter observational program "GLOBUS" on the study of the prevalence of vertigo and treatment schemes in outpatient clinics. Journal of Neurology and Psychiatry named after S.S. Korsakov. 2014, vol. 114, no. 5, pp. 33—38.
E. I. Chukanova. Efficacy of cavinton in the treatment of patients with chronic blood flow insufficiency. Russian multicenter clinical-epidemiological program "CALIPSO"]. Journal of Neurology and Psychiatry named after S.S. Korsakov. 2010, vol. 110, no. 12, pp. 49—52.
Fioravanti M., Flicker L. Nicergoline may improve cognition and behavioural function of people with mild to moderate dementia. Cochrane Database of Systematic Reviews. 2001.
Saletu B., Garg A., Shoeb A. Safety of Nicergoline as an Agent for Management of Cognitive Function Disorders. BioMed Research International. 2014, pp. 1–6. https://www.doi.org/10.1155/2014/610103
Ziegler D. Treatment of Symptomatic Polyneuropathy With Actovegin in Type 2 Diabetic Patients : To evaluate the efficacy and safety of actovegin in patients with diabetic polyneuropathy. Diabetes Care. 2009, vol. 32, no. 8, pp. 1479–1484.
A. Guekht, I. Skoog, S. Edmundson et al. ARTEMIDA Trial (A Randomized Trial of Efficacy, 12 Months International Double-Blind Actovegin) : A Randomized Controlled Trial to Assess the Efficacy of Actovegin in Poststroke Cognitive Impairment. Stroke. 2017, vol. 48, no. 5, pp. 1262-1270.
G. Reurink, GJ Goudswaard, JL Tol et al. Therapeutic interventions for acute hamstring injuries: a systematic review. British Journal of Sports Medicine. 2011, vol. 46, no. 2, pp. 103-109.
Martí-Carvajal A. J., Knight-Madden J. M., Martinez-Zapata M. J. Interventions for treating leg ulcers in people with sickle cell disease. Cochrane Database of Systematic Reviews. 2014. https://www.doi.org/10.1002/14651858.cd008394.pub3
Cui S., Chen N., Yang M. et al. Cerebrolysin for vascular dementia. Cochrane Database of Systematic Reviews. 2019. https://www.doi.org/10.1002/14651858.CD008900.pub3
Liliya Eugenevna Ziganshina, Tatyana Abakumova, Ludivine Vernay. Cerebrolysin for acute ischaemic stroke. Cochrane Database of Systematic Reviews. Cochrane Stroke Group. 2017. https://www.doi.org/10.1002/14651858.CD007026.pub5
Zhang C., Chopp M., Cui Y. et al. Cerebrolysin enhances neurogenesis in the ischemic brain and improves functional outcome after stroke. Journal of Neuroscience Research. 2010, no. 88, pp. 3275–3281.
Zhang Y., Chopp M., Meng Y. et al. Improvement in functional recovery with administration of Cerebrolysin after experimental closed head injury. Journal of Neurosurgery. 2013, no. 118, pp. 1343–1355.
Dafin F. M. Neuroprotection and neuroplasticity – A holistic approach and future perspectives. Journal of the Neurological Sciences. 2007, vol. 257, no. 1, pp. 38–43.
M. Dafin F., H. Wolf-Dieter, H. Volker et al. Cerebrolysin and recovery after stroke (CARS): A randomized, placebo-controlled, double-blind, multicenter, phase II clinical study. Stroke. 2016, no. 47, pp. 151–159. https://www.doi.org/10.1161/STROKEAHA.115.009416
Genton P., Van Vleymen B. Piracetam and levetiracetam: close structural similarities but different pharmacological and clinical profiles. Epileptic Disorders. 2000, no. 2, pp. 99–105.
M. Dafin F, F. Stefan, H. Volker et al. Efficacy and safety of cerebrolysin in neurorecovery after moderate-severe traumatic brain injury: results from the CAPTAIN II trial. Neurol Sci. 2020, no. 41, pp. 1171–1181. https://www.doi.org/10.1007/s10072-019-04181-y
C. Shuhui, C. Ning, Y. Mi et al. Cerebrolysin for vascular. Cochrane Database of Systematic Reviews. 2019. DOI: 10.1002/14651858.CD008900.pub3
Ohsuga S., Ohsuga H., Takeoka T. et al. Metabolic acidosis and hypoglycemia during calcium hopantenate administration - report on 5 patients. Clinical Neurology. 1989, no. 29, pp. 741–746.
Kajita M., Iwase K., Matsumoto M. et al. Clinical and biochemical studies in a case of acute encephalopathy associated with calcium hopanthenate administration. Brain and Development. 1990, no. 22, pp. 267–273.
