TITLE:
Efficacy of Alzer® and Diamel, Nutritional Supplements, in the Prevention of Severe Diabetic Macular Edema
AUTHORS:
Juana Elvira Maciques Rodríguez, Maria Emoé Pérez Muñoz, Eduardo Cabrera Rode, Laura Rosa Redondo Piño, Raísa Beltrán Sainz, Teresa González Calero, Manuel Licea Puig, Juan Lence Anta, Rosaralis Paneca Santiesteban, Yordanka Marrero Álvarez, Eduardo Sanz Navares
KEYWORDS:
Alzer, Diamel, Ginkgo Biloba, Macular Edema, Macular Thickness, Nutritional Supplement
JOURNAL NAME:
Open Journal of Ophthalmology,
Vol.10 No.4,
November
12,
2020
ABSTRACT: 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 = 32). All patients
were given an initial clinical evaluation, blood testing and ophthalmological evaluation
at the start of treatment and after one year of follow-up. Results: There
was a clinical improvement in the macular thickness upon the conclusion of the study
in the patients treated with Alzer and Diamel. This decrease in thickness was statistically
significant in the left eye. There was no decrease
in visual acuity one year after treatment. Adverse events were mild and
uncommon. Conclusions: Severe macular edema did not evolve in the Alzer
and Diamel group. The clinical, but not statistically significant, success
obtained in the experimental group proves the protocol hypothesis regarding the
efficacy of the product being researched. The positive results in this small sample
lead to the suggestion of performing larger-scale studies (Phase III). The
clinical trial was registered in Clinical Trials.gov Identifier: NCT03533478.