ABSTRACT
OBJECTIVE: Iron deficiency anemia (IDA) in patients with heart disease is correlated with decreased exercise capacity and poor health-related quality of life, and predicts worse cardiovascular outcomes, especially for elderly patients. IDA can worsen cardiac function that can be monitored with Heart Rate Variability (HRV) analysis, providing important information about cardiac health. In a recent study we explored the effect and the tolerability of the administration of Ferric Sodium EDTA in combination with vitamin C, folic acid, copper gluconate, zinc gluconate and selenomethionine (Ferachel Forte®) in "frailty" patients with secondary anemia and low kidney failure, by analysing the HRV frequency domain. The aim of the present study is the further confirmation of the safety of the already evaluated intervention, by analysing non-linear domain of HRV. PATIENTS AND METHODS: In this pilot study we enrolled 52 "frailty" elderly patients, with a recent diagnosis of secondary anemia due to iron deficiency, with Class II New York Heart Association (NYHA) hypertensive heart disease, low kidney failure, and atherosclerosis. The patients were divided in 2 groups: Group A (N=23 patients) received oral administration of Ferric Sodium EDTA in combination with vitamin C, folic acid, copper gluconate, zinc gluconate and selenomethionine (Ferachel Forte®) 2 tabs/day, containing 60 mg of Fe3+, for 24 days; Group B (N=29 patients) received intravenous administration of ferrous gluconate 63 mg/day added to saline solution, while they were hospitalized (15±5 days). We evaluated laboratory values of hemoglobin (Hb) and sideremia levels. Furthermore, we measured ECG signals before and after treatment, using non-linear analysis techniques. RESULTS: Both intravenous and oral treatments evaluated in this study, were effective and safe about the cardiovascular risk in "frailty" elderly patients, as resulted from non-linear HRV analysis. Efficacy results showed that hemoglobin and sideremia levels after treatments are significantly increased. The HRV non-linear analysis showed that all parameters evaluated, except for the SD1 values in the Group A, were not affected by treatments, confirming the absence of cardiovascular risk of the therapy. CONCLUSIONS: Non-linear HRV evaluation confirmed that oral administration of Ferric Sodium EDTA, in combination with vitamin C, folic acid, copper gluconate, zinc gluconate and selenomethionine (Ferachel forte®) did not impact the cardiovascular risk, without causing adverse events typically reported with other iron supplementation therapies, both oral and intravenous.
Subject(s)
Anemia, Iron-Deficiency/drug therapy , Ascorbic Acid/therapeutic use , Ferric Compounds/therapeutic use , Folic Acid/therapeutic use , Frailty/complications , Gluconates/therapeutic use , Heart Diseases/complications , Heart Rate/drug effects , Iron Chelating Agents/therapeutic use , Selenomethionine/therapeutic use , Aged , Aged, 80 and over , Anemia, Iron-Deficiency/blood , Anemia, Iron-Deficiency/complications , Anemia, Iron-Deficiency/diagnosis , Ascorbic Acid/adverse effects , Drug Combinations , Edetic Acid/adverse effects , Edetic Acid/therapeutic use , Female , Ferric Compounds/adverse effects , Folic Acid/adverse effects , Frail Elderly , Frailty/diagnosis , Frailty/physiopathology , Gluconates/adverse effects , Heart Disease Risk Factors , Heart Diseases/diagnosis , Heart Diseases/physiopathology , Humans , Iron Chelating Agents/adverse effects , Male , Pilot Projects , Renal Insufficiency/complications , Renal Insufficiency/diagnosis , Renal Insufficiency/physiopathology , Risk Assessment , Selenomethionine/adverse effects , Time Factors , Treatment OutcomeABSTRACT
Probiotics (bacteria or yeasts) were defined by the Food Agricultural Organization (FAO) and the World Health Organization (WHO) joint report as live microorganisms which when administered in adequate amounts (in food or as a dietary supplement) confer a health benefit on the host. The best-demonstrated potential clinical benefits of probiotic agents, specifically in the pediatric population, are in the prevention and management of acute diarrhea, antibiotic associated diarrhea, and evidence is mounting on their potential benefits in atopic disease, inflammatory bowel conditions, and necrotizing enterocolitis. Their beneficial effects seem to be strain specific, thus, pooling data from different strains may result in misleading conclusions. Because there was no international consensus on methodology to assess efficiency and safety of probiotics, in 2001 the FAO/WHO undertook work to compile and evaluate the scientific evidence on functional and safety aspects of probiotics. International criteria have been developed to formulate unequivocal criteria for probiotic bacterial strains and products that contain them. More recently, the European Food Safety Authority (EFSA) highlighted as critical factors for probiotic health claim submissions genetic typing, internationally recognised naming protocols and evidence of consistency in the final product.