NUTRARET: Effect of 2-Year Nutraceutical Supplementation on Redox Status and Visual Function of Patients With Retinitis Pigmentosa: A Randomized, Double-Blind, Placebo-Controlled Trial

Oxidative stress plays a major role in the pathogenesis of retinitis pigmentosa (RP). The main goal of this study was to evaluate the effect of 2-year nutritional intervention with antioxidant nutraceuticals on the visual function of RP patients. Secondly, we assessed how nutritional intervention affected ocular and systemic redox status. We carried out a randomized, double-blind, placebo-controlled study. Thirty-one patients with RP participated in the study. RP patients randomly received either a mixture of nutraceuticals (NUT) containing folic acid, vitamin B6, vitamin A, zinc, copper, selenium, lutein, and zeaxanthin or placebo daily for 2 years. At baseline and after 2- year of the nutritional supplementation, visual function, dietetic-nutritional evaluations, serum concentration of nutraceuticals, plasma and aqueous humor concentration of several markers of redox status and inflammation were assessed. Retinal function and structure were assessed by multifocal electroretinogram (mfERG), spectral domain-optical coherence tomography (SD-OCT) and automated visual field (VF) tests. Nutritional status was estimated with validated questionnaires. Total antioxidant capacity, extracellular superoxide dismutase (SOD3), catalase (CAT), and glutathione peroxidase (GPx) activities, protein carbonyl adducts (CAR) content, thiobarbituric acid reactive substances (TBARS) formation (as indicator of lipid peroxidation), metabolites of the nitric oxide (NOX) and cytokine (interleukin 6 and tumor necrosis factor alpha) concentrations were assessed by biochemical and immunological techniques in aqueous humor or/and blood. Bayesian approach was performed to determine the probability of an effect. Region of practical equivalence (ROPE) was used. At baseline, Bayesian analysis revealed a high probability of an altered ocular redox status and to a lesser extent systemic redox status in RP patients compared to controls. Twenty-five patients (10 in the treated arm and 15 in the placebo arm) completed the nutritional intervention. After 2 years of supplementation, patients who received NUT presented better retinal responses (mfERG responses) compared to patients who received placebo. Besides, patients who received NUT showed better ocular antioxidant response (SOD3 activity) and lower oxidative damage (CAR) than those who received placebo. This study suggested that long-term NUT supplementation could slow down visual impairment and ameliorate ocular oxidative stress.This work was supported by the Spanish Ministry of Economy, Industry, and Competitiveness (MINECO) Carlos III Health Institute (ISCIII) (Grant numbers: PI15/00052 and PI18/00252) and co-funded by the European Regional Development Fund (FEDER)/European Social Fund “A way to make Europe”/”Investing in your future.” It was also supported by the IIS La Fe-UV PROGRAMA VLC-BIOMED-I (NUTRARET) and by RETINA COMUNIDAD VALENCIANA. LO-G had an ISCIIIMedicin

The relevance of words: dangerous drugs or hazardous drugs? A proposal of a new term

Carta al DirectorRecientemente han aparecido con cierta frecuencia en los medios de comunicación algunas noticias acerca de los riesgos que, para las personas que los manipulan, entrañan un grupo de medicamentos que, alternativamente, vienen siendo denominados «peligrosos» o «biopeligrosos». La terminología anglosajona distingue claramente entre dangerous drugs (medicamentos peligrosos para el paciente) y hazardous drugs (medicamentos de riesgo, aquellos cuya manipulación inadecuada puede suponer un riesgo para los profesionales)1, y en su utilización contextual queda perfectamente definido a qué se está haciendo alusión en cada momento.En español, en el contexto de la seguridad laboral, se acepta la definición de sustancia peligrosa como aquella que puede provocar daño en la persona que lo manipula (p. ej. un citostático)2. Menos claro está el concepto de medicamento o sustancia biopeligrosa, que no viene recogido en la legislación pero que asociamos (impropiamente) con aquellos agentes cuya acción nociva sobre el manipulador tiene que ver con la posible exposición a agentes vivos infecciosos (p. ej. la vacuna BCG) o sus toxinas (p. ej. la toxina botulínica). Esta polisemia del término peligroso puede, en nuestra opinión, inducir a confusión, porque ¿acaso no son peligrosos la atropina, el potasio intravenoso, la digoxina parenteral o una perfusión de amiodarona? ¿A qué nos referimos cuando hablamos de que el nitroprusiato es un medicamento peligroso? ¿A su toxicidad para el paciente o para el manipulador? ¿Es necesario definir el contexto para saber a qué nos estamos refiriendo? Nos parece sumamente alejado de los fines de la terminología técnico-científica exigir esfuerzos intelectivos adicionales al profesional que la utiliza.N