Received: 09.02.2022; Accepted: 06.06.2022; Published on-line: 15.06.2022
Use of Vasavital® in patients with diabetic retinopathy
Khramenko N. I. 1, Umanets M. M. 1, Medvedovska N. V. 2,
Levytska G. V. 1, Rozanova Z. A. 1
1 SI "The Filatov Institute of Eye Diseases and Tissue Therapy of the N AMS of Ukraine"; Odesa (Ukraine) Received 09.02.2022 Accepted 06.06.2022
2 National Academy of Medical Science of Ukraine; Kyiv (Ukraine)
Khramenko NI, Umanets MM, Medvedovska NV, Levytska GV, Rozanova ZA. Use of Vasavital® in patients with diabetic retinopathy. http://doi.org/10.31288/oftalmolzh202232431
Background: Diabetic retinopathy (DR) is a major cause of visual impairment or blindness among working-age adults worldwide. For years, researchers around the world have been trying to develop new effective pharmaceutical methods of treatment for preclinical and early DR.
Purpose: To examine the effect of a one-month course of Vasavital on the function of the visual system and ocular hemodynamics (using ophthalmic rheography) in patients with non-proliferative and proliferative diabetic retinopathy (NPDR and PPDR, respectively).
Material and Methods: Forty-seven type 2 diabetes patients with DR and moderate glycemic control were divided into those with NPDR (group 1 of 15 patients; 30 eyes) and those with PPDR (group 2 of 17 patients; 34 eyes). The control group was composed of 15 volunteers (30 eyes) of similar age having no systemic or eye disease. Patients received a one-month course of Vasavital-only therapy at a dose of one capsule twice a day as an outpatient treatment. They received visual acuity assessment, intraocular pressure measurement, ophthalmoscopy, biomicroscopy, perimetry, systemic blood pressure and pulse measurement, optical coherence tomography and fluorescein angiography, and ocular hemodynamics was assessed by ophthalmic rheography. Eleven patients (22 eyes) with NPDR and ten patients (20 eyes) with PPDR underwent electrophysiological studies of electrically evoked phosphene threshold (EEPT) and critical frequency of phosphene disappearance (CFPD), before and after a course of Vasavital treatment.
Results: Patients reported that a one-month course of Vasavital was well-tolerated, with no new complaints. In addition, no side effects were observed. After treatment, the function of the photopic afferent system as assessed by light sensitivity at minutes 0 to 7 of adaptation improved by 33.3%-40% in patients with NPDR and by 27.2%-33.3% in patients with PPDR. In addition, there was a decrease in EEPT by 18% and 7.7%, respectively, and an increase in CFPD by 28.2% and 24.7%, respectively, for patients in groups 1 and 2. Moreover, ocular pulse blood filling improved by 27.7% in patients with NPDR and by 17.3% in patients with PPDR, and vascular tone in large-caliber vessels decreased by 8% in the former patients.
Conclusion: A one-month Vasavital course administered to patients with DR had a positive effect on the visual system function and ocular circulation parameters, which provides grounds for the use of the Ginkgo biloba-based preparation as a monotherapy or as part of a combined treatment for initial functional changes in the visual system in DR.
Keywords: diabetic retinopathy, Vasavital, visual system function, ophthalmic rheography
1.NCD Risk Factor Collaboration (NCD-RisC). Worldwide trends in diabetes since 1980: a pooled analysis of 751 population-based studies with 4.4 million participants. Lancet. 2016 387;1513–30.
2.Saeedi P, Petersohn I, Salpea P, Malanda B, Karuranga S, Unwin N, et al. IDF Diabetes Atlas Committee. Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: Results from the International Diabetes Federation Diabetes Atlas, 9th edition. Diabetes Res Clin Pract. 2019 Nov;157:107843.
3.Klein BE. Overview of epidemiologic studies of diabetic retinopathy. Ophthalmic Epidemiol. 2007 Jul-Aug;14(4):179-83.
4.World Health Organization. Blindness and vision impairment. World Health Organization. February 26, 2021. Available from: https://www.who.int/news-room/fact-sheets/detail/blindness-and-visual-im...
5.Yau JW, Rogers SL, Kawasaki R, Lamoureux EL, Kowalski JW, Bek T, et al. Meta-Analysis for Eye Disease (META-EYE) Study Group. Global prevalence and major risk factors of diabetic retinopathy. Diabetes Care. 2012 Mar; 35(3):556-64.
7.Bucolo C, Marrazzo G, Platania CB, Drago F, Leggio GM, Salomone S. Fortified extract of red berry, Ginkgo biloba, and white willow bark in experimental early diabetic retinopathy. J Diabetes Res. 2013;2013:432695.
8.Bungau S, Abdel-Daim MM, Tit DM, Ghanem E, Sato S, Maruyama-Inoue M, et al. Health Benefits of Polyphenols and Carotenoids in Age-Related Eye Diseases. Oxid Med Cell Longev. 2019 Feb 12; 2019:9783429.
9.Srinivasan K. Chapter 42 - polyphenols in vision and eye health. In: Preedy V. R., editor. Handbook of Nutrition, Diet and the Eye. San Diego, CA, USA: Academic Press; 2014. pp. 413–421.
10.Bucolo C, Marrazzo G, Platania CB, Drago F, Leggio GM, Salomone S. Fortified extract of red berry, Ginkgo biloba, and white willow bark in experimental early diabetic retinopathy. J Diabetes Res. 2013;2013:432695.
11.Ponomarchuk VS, Konovalova NV, Khramenko Ni. Clinical experience of the use of Vasavital® in dry age-related macular degeneration and ischemic optic neuropathy. J Ophthalmol (Ukraine). 2021;1:38-45.
12.Pasyechnikova NV, Naumenko VO, Zborovska OV. [Clinical classification of and laser strategy for diabetic macular edema]. Odeskyi medychnyi zhurnal. 2009; 116 (6):77-9. Ukrainian.
13.Ponomarchuk VS. [Diagnostics using electrical phosphenes in ophthalmology]. Odesa: Astroprint; 2018. Russian.
14.Ritch R. Potential role for Ginkgo biloba extract in the treatment of glaucoma. Med Hypotheses. 2000 Feb;54(2):221-35.
15.Labkovich M, Jacobs EB, Bhargava S, Pasquale LR, Ritch R. Ginkgo Biloba Extract in Ophthalmic and Systemic Disease, With a Focus on Normal-Tension Glaucoma. Asia Pac J Ophthalmol (Phila). 2020 May-Jun;9(3):215-225.
16.Koltermann A, Hartkorn A, Koch E, Fürst R, Vollmar AM, Zahler S. Ginkgo biloba extract EGb 761 increases endothelial nitric oxide production in vitro and in vivo. Cell Mol Life Sci. 2007 Jul;64(13):1715-22.
17.Wu YZ, Li SQ, Zu XG, Du J, Wang FF. Ginkgo biloba extract improves coronary artery circulation in patients with coronary artery disease: contribution of plasma nitric oxide and endothelin-1. Phytother Res. 2008 Jun;22(6):734-9.
18.Huang SY, Jeng C, Kao SC, Yu JJ, Liu DZ. Improved haemorrheological properties by Ginkgo biloba extract (Egb 761) in type 2 diabetes mellitus complicated with retinopathy. Clin Nutr. 2004 Aug;23(4):615-21.
19.Zhang Y, Liu J, Yang B, Zheng Y, Yao M, Sun M, et al. Ginkgo biloba Extract Inhibits Astrocytic Lipocalin-2 Expression and Alleviates Neuroinflammatory Injury via the JAK2/STAT3 Pathway After Ischemic Brain Stroke. Front Pharmacol. 2018 May 16;9:518.
20.Ilieva I, Ohgami K, Shiratori K, Koyama Y, Yoshida K, Kase S, et al. The effects of Ginkgo biloba extract on lipopolysaccharide-induced inflammation in vitro and in vivo. Exp Eye Res. 2004 Aug;79(2):181-7.
21.Mahadevan S, Park Y. Multifaceted therapeutic benefits of Ginkgo biloba L.: chemistry, efficacy, safety, and uses. J Food Sci. 2008 Jan;73(1):R14-9.
22.Song L, Zhang J, Lai R, Li Q, Ju J, Xu H. Chinese Herbal Medicines and Active Metabolites: Potential Antioxidant Treatments for Atherosclerosis. Front Pharmacol. 2021 May 13;12:675999.
23.Wu C, Zhao X, Zhang X, Liu S, Zhao H, Chen Y. Effect of Ginkgo biloba extract on apoptosis of brain tissues in rats with acute cerebral infarction and related gene expression. Genet Mol Res. 2015 Jun 11;14(2):6387-94.
24.Zhao M, Wang XX, Wan WH. Effects of the ginkgo biloba extract on the superoxide dismutase activity and apoptosis of endothelial progenitor cells from diabetic peripheral blood. Genet Mol Res. 2014 Jan 14;13(1):220-7.
25.Watanabe CM, Wolffram S, Ader P, Rimbach G, Packer L, Maguire JJ, et al. The in vivo neuromodulatory effects of the herbal medicine ginkgo biloba. Proc Natl Acad Sci USA. 2001 Jun 5;98(12):6577-80.
26.Nakayama M, Aihara M, Chen YN, Araie M, Tomita-Yokotani K, Iwashina T. Neuroprotective effects of flavonoids on hypoxia-, glutamate-, and oxidative stress-induced retinal ganglion cell death. Mol Vis. 2011;17:1784-93.
27.Apaydin C, Oğuz Y, Ağar A, Yargiçoğlu P, Demir N, Aksu G. Visual evoked potentials and optic nerve histopathology in normal and diabetic rats and effect of ginkgo biloba extract. Acta Ophthalmol (Copenh). 1993 Oct;71(5):623-8.
28.Doly M, Droy-Lefaix MT, Bonhomme B, Braquet P. Effet de l'extrait de Ginkgo biloba sur l'électrophysiologie de la rétine isolée de rat diabétique [Effect of Ginkgo biloba extract on the electrophysiology of the isolated retina from a diabetic rat]. Presse Med. 1986 Sep 25;15(31):1480-3.
29.Tian J, Liu Y, Chen K. Ginkgo biloba Extract in Vascular Protection: Molecular Mechanisms and Clinical Applications. Curr Vasc Pharmacol. 2017;15(6):532-548.
Corresponding author: Nataliia Khramenko, firstname.lastname@example.org
Disclaimer: The views expressed in this article are those of the authors
Source of support: Vazavital® was provided by the Ukrainian Pharmaceutical Company.
Conflict of Interest Statement: All authors have no conflict of interest