Introduction: Macular edema is
the main cause of low vision in diabetic patients. Laser photocoagulation continues
to be the treatment of choice in conjunction with the use of steroids and anti-angiogenics,
but these treatments include possible ocular complications. The nutritional supplement
Alzer (whose primary active ingredient is Ginkgo
biloba, a powerful antioxidant that acts on vascular factors and oxidative damage,
which are two of the mechanisms implicated in the pathogenesis of diabetic macular
edema), which has been used on other non-diabetic macular conditions, along with
the Diamel nutritional supplement has been shown to be effective on glycemic control
and could represent a treatment alternative for mild to moderate macular edema by
reducing the thickness of the macular retina and preventing the progression of other
more advanced clinical presentations that are harder to treat. Objective: Identify
the effect of Alzer along with Diamel in reduction of the thickness of the macular
retina among patients with mild to moderate diabetic macular edema. Materials
and Methods: A phase II double-blind clinical trial was conducted in 64 patients
with non-severe diabetic macular edema over the course of non-proliferative diabetic
retinopathy, who attended the ophthalmology service of the Institute of Endocrinology
of Havana from January 2016 to December 2016. The treatment was randomly assigned
to two groups: one received Alzer plus Diamel (n=32) and the other group received Alzer placebo + Diamel
placebo (n=
References
[1]
Barría, F. (2008) Diabetes Mellitus: Una Epidemia Mundial. Archivos Chilenos de Oftalmologia, 65, 63-66.
Romero, P., Almena, M., Baget, M., Mendez, I. and Salvat, M. (2005) Actualización en la epidemiología del edema macular diabético. Annals D’Oftalmologia, 13,102-192.
[4]
Charlotte, W., Lardenoye, A., Probst, K., DeLint, P.J. and Rothova, A. (2000) Photoreceptor Function in Eyes with Macular Edema. Investigative Ophthalmology & Visual Science, 41, 4048-4053.
[5]
Ding, J. and Wong, T.Y. (2012) Current Epidemiology of Diabetic Retinopathy and Diabetic Macular Edema. Current Diabetes Reports, 12, 346-354. https://doi.org/10.1007/s11892-012-0283-6
[6]
Nguyen, Q.D., Tatlipinar, S., Shah, S.M., Haller, J.A., Quinlan, E., Sung, J., et al. Vascular Endothelial Growth Factor Is a Critical Stimulus for Diabetic Macular Edema. American Journal of Ophthalmology, 142, 961-969. https://doi.org/10.1016/j.ajo.2006.06.068
[7]
Krohne, T.U., Fauser, S., Kirchhof, B. and Joussen, A.M. (2003) Pathogenesis of Diabetic Macular Edema. Klinische Monatsblätter für Augenheilkunde, 220, 521-525. https://doi.org/10.1055/s-2003-41872
[8]
Lewis, H. (2001) The Role of Vitrectomy in the Treatment of Diabetic Macular Edema. American Journal of Ophthalmology, 131, 123-125. https://doi.org/10.1016/S0002-9394(00)00660-7
[9]
Klein, R., Klein, B.E.K., Moss, S.E. and Cruickshanks, K.J. (1998) The Wisconsin Epidemiologic Study of Diabetic Retinopathy: XVII The 14-Year Incidence and Progression of Diabetic Retinopathy and Associated Risk Factors in Type 1 Diabetes. Ophthalmology, 105, 1801-1815. https://doi.org/10.1016/S0161-6420(98)91020-X
[10]
The Diabetes Control and Complications Trial Research Group (1998) Early Worsening of Diabetic Retinopathy in the Diabetes Control and Complications Trial. JAMA Ophthalmology, 116, 874-886. https://doi.org/10.1001/archopht.116.7.874
[11]
UK Prospective Diabetes Study Group (1998) Tight Blood Pressure Control and Risk of Macrovascular and Microvascular Complications in Type 2 Diabetes: UKPDS 38. British Medical Journal, 317, 703-718. https://doi.org/10.1136/bmj.317.7160.703
[12]
Dowler, J.G., Sehmi, K.S., Hykin, P.G. and Hamilton, A.M. (1999) The Natural History of Macular Edema after Cataract Surgery in Diabetes. Ophthalmology, 106, 663-668. https://doi.org/10.1016/S0161-6420(99)90148-3
[13]
Klein, R., Klein, B.E.K., Moss, S.E. and Cruickshanks, K.J. (1994) The Wisconsin Epidemiology Study of Diabetic Retinopathy: XIV. Ten Year Incidence and Progression of Diabetic Retinopathy. JAMA Ophthalmology, 112, 1217-1228. https://doi.org/10.1001/archopht.1994.01090210105023
[14]
Romero, P., Calviño, O. and del Castillo, D. (2000) Estudio epidemiológico de RD, en un área básica de salud. Archivos de la Sociedad Española de Oftalmología, 75, 147-152.
[15]
The Diabetes Control and Complications Trial Research Group (1993) The Effect of Intensive Treatment of Diabetes on the Development and Progression of Long-Term Complications in Insulin-Dependent Diabetes Mellitus. The New England Journal of Medicine, 329, 977-986. https://doi.org/10.1056/NEJM199309303291401
[16]
Klein, B.E., Moss, S.E., Klein, R. and Surawicz, T.S. (1991) The Wisconsin Epidemiologic Study of Diabetic Retinopathy: XIII. Relationship of Serum Cholesterol to Retinopathy and Hard Exudates. Ophthalmology, 98, 1261-1265. https://doi.org/10.1016/S0161-6420(91)32145-6
(1985) Photocoagulation for Diabetic Macular Edema Early Treatment Diabetic Retinopathy: Study Report Number 1 Early Treatment Diabetic Retinopathy Study Research Group. Archives of Ophthalmology, 103, 1796-1806. https://doi.org/10.1001/archopht.1985.01050120030015
[19]
Browning, D.J. (2004) Interobserver Variability in Optical Coherence Tomography for Macular Edema. American Journal of Ophthalmology, 137, 1116-1117.
[20]
Browning, D.J., Glassman, A.R., Aiello, L.P., Bressler, N.M., Bressler, S.B., Danis, R.P., et al. (2008) Optical Coherence Tomography Measurements and Analysis Methods in Optical Coherence Tomography Studies of Diabetic Macular Edema. Ophthalmology, 115, 1366-1371. https://doi.org/10.1016/j.ophtha.2007.12.004
[21]
Danis, R.P., Glassman, A.R., Aiello, L.P., Antosszyk, A.N., Beck, R.W., Browning, D.J., et al. (2006) Diurnal Variation in Retinal Thickening Measurement by Optical Coherence Tomography in Center-Involved Diabetic Macular Edema. JAMA Ophthalmology, 124, 1701-1707. https://doi.org/10.1001/archopht.124.12.1701
Barría, F., Martínez, F. And Verdaguer, J. (2016) Actualización de la Guía clínica de Retinopatía Diabética para Latinoamérica. http://www.icoph.org/dynamic/attachments/resources/guiaclinicaretinopatiadiabetica2016.pdf
[24]
Diabetic Retinopathy Clinical Research Network (2015) Aflibercept, Bevacizumab or Ranibizumab for Diabetic Macular Edema. The New England Journal of Medicine, 372, 1193-1203. https://doi.org/10.1056/NEJMoa1414264
[25]
Jacinto, J.E., Cisnero, S., Arevalo, D., Ontiveros, D.O., Cortes, S., Mendoza, G., et al. (2017) Combinación de antiangiogénico y esteroides intravítreos en el tratamiento del edema macular diabético. Revista Médica MD, 9, 25-31.
[26]
Stefaniotou, M., Aspiotis, M., Kalegeropoulos, C., Christodoulos, A., Psylla, M., Ioachim, E., et al. (2004) Vitrectomy Ressults for Diffuse Diabetic Macular Edema with and without Inner Limiting Membrane Removal. European Journal of Ophthalmology, 14, 137-143. https://doi.org/10.1177/112067210401400209
[27]
Ramos, M., Gutiérrez, M.R., Pupo, G., Cerón, M.I., Hernández, A., Perera, E. (2018) Láser micropulsado IRIDEX IQ 577 nm. Revista Cubana de Oftalmología, 31, 112-122.
[28]
Závorková, M. and Procházková, L. (2015) Treating Diabetic Macular Edema by a Micropulse Laser—First Findings. Ceska a Slovenska Oftalmologie, 71, 223-228.
[29]
Muller, W.E., Eckert, A., Eckert, G.P., Fink, H., Friedland, K., Gauter, S., et al. (2019) Therapeutic Efficacy of the Ginkgo Special Extract EGb761® within the Framework of the Mitochondrial Cascade Hypothesis of Alzheimer’s Disease. The World Journal of Biological Psychiatry, 20, 173-189. https://doi.org/10.1080/15622975.2017.1308552
[30]
Lebuisson, D.A., Leroy, L. and Rigal, G. (1986) Treatment of Senile Macular Degeneration with Ginkgo Biloba Extract. A Preliminary Double-Blind, Drug versus Placebo Study. La Presse Médicale, 15, 1556-1558.
[31]
Evans, J.R. (2013) Ginkgo Biloba Extract for Age-Related Macular Degeneration. Cochrane Database of Systematic Reviews, Article No. CD001775. https://doi.org/10.1002/14651858.CD001775.pub2
[32]
Hernández, V., López, R. and Almansa, I. (2019) Progesterone, Lipoic Acid, and Sulforaphane as Promising Antioxidants for Retinal Diseases: A Review. Antioxidants, 8, 53. https://doi.org/10.3390/antiox8030053
[33]
Hernández Yero, J.A. and Vargas González, D. (2007) Utilidad de Diamel en pacientes con diabetes mellitus tipo 2 en tratamiento combinado con glibenclamida. Avances en Diabetología, 23, 49-55.
[34]
Cabrera, E., Orlandi, N., Padrón, Y., Arranz, C., Olano, R., Machado, M., Hernández, J.A., Calderín, R. and Domínguez, E. (2013) Effect of Diamel in Patients with Metabolic Syndrome: A Randomised Double-Blinded Placebo-Controlled Study. Journal of Diabetes, 5, 180-191. https://doi.org/10.1111/1753-0407.12007
[35]
Gutiérrez, A., Lavandero, A., Ramos, M.E. and Martínez, E. (2007) Estrés oxidativo, alimentación y suplementación antioxidante en patología ocular: Historia breve y visión futura. Revista Cubana de Oftalmología, 20. http://scielo.sld.cu/scielo.php?script=sci_arttext&pid=S0864-21762007000200016
[36]
Wong, T.Y., Sun, J., Kawasaki, R., Ruamviboonsuk, P., Gupta, N., Lansingh, V.C., Maia, M., Mathenge, W., Moreker, S., Muqit, M.M.K., Resnikoff, S., Verdaguer, J., Zhao, P., Ferris, F., Aiello, L.P. and Taylor, H.R. (2018) Guidelines on Diabetic Eye Care: The International Council of Ophthalmology Recommendations for Screening, Follow-up, Referral, and Treatment Based on Resource Settings. Ophthalmology, 125, 1608-1622. https://doi.org/10.1016/j.ophtha.2018.04.007
[37]
Baker, C.W., Glassman, A.R., Beaulieu, W.T., Antoszyk, A.N., Browning, D.J., Chalan, K.U., et al. (2019) Effect of Initial Management with Aflibercept vs Laser Photocoagulation vs Observation on Vision Loss among Patients with Diabetic Macular Edema Involving the Center of the Macula and Good Visual Acuity: A Randomized Clinical Trial. JAMA, 321, 1880-1894. https://doi.org/10.1001/jama.2019.5790