Alberto Foletti1,2, Paolo Baron2, Mario Cozzolino3,4. 1. Clinical Biophysics International Research Group, Lugano, Switzerland. 2. Institute of Translational Pharmacology, National Research Council-CNR, Rome, Italy. 3. Department of Health Sciences, University of Milan, Milan, Italy. mario.cozzolino@unimi.it. 4. Renal Division, ASST Santi Paolo e Carlo, Milan, Italy. mario.cozzolino@unimi.it.
Abstract
BACKGROUND:Chronic Kidney Disease (CKD) and its clinical evolution are an emerging issue, due to an increasingly aging population. Consequently, the evaluation of integrative strategies to manage the decline in renal function is warranted. The previous evidence indicates that a biophysical integrated approach can significantly improve renal function. Nevertheless, controlled trials assessing the clinical efficacy of this strategy are still needed. METHODS: A 12-month controlled study was designed to assess the clinical outcome of a group of elderly patients affected by stage II/IIIa CKD randomly assigned to eithercontrol or biophysical treatment. In addition to the standard treatment with renin-angiotensin-aldosterone system inhibitors, the biophysical group underwent electromagnetic information transfer through aqueous system procedure every 3 months. Estimated glomerular filtration rate (eGFR), according to CKD-epidemiology collaboration formula, was calculated at baseline and every 3 months. RESULTS:A total of 238 patients were included in the study, 118 (73.9 ± 3.8 years) in the biophysical therapygroup and 120 (74.6 ± 4.2 years) in the control group. At baseline, mean eGFR was 69 ± 11.8 ml/min in the biophysical group and 70.7 ± 11.5 ml/min in the control group. After 1 year, eGFR was 74.1 ± 12.3 ml/min in the biophysical group, compared to 66.3 ± 11.9 ml/min in the control group, with a statistically significant difference between groups (p < 0.0001). The observed improvement in eGFR in the biophysical group was independent of age, gender, and antihypertensive treatment. CONCLUSION: This study shows a potential contribution of a biophysical integrated strategy to support renal function against its natural decline in the elderly, warranting further clinical evaluation.
RCT Entities:
BACKGROUND:Chronic Kidney Disease (CKD) and its clinical evolution are an emerging issue, due to an increasingly aging population. Consequently, the evaluation of integrative strategies to manage the decline in renal function is warranted. The previous evidence indicates that a biophysical integrated approach can significantly improve renal function. Nevertheless, controlled trials assessing the clinical efficacy of this strategy are still needed. METHODS: A 12-month controlled study was designed to assess the clinical outcome of a group of elderly patients affected by stage II/IIIa CKD randomly assigned to either control or biophysical treatment. In addition to the standard treatment with renin-angiotensin-aldosterone system inhibitors, the biophysical group underwent electromagnetic information transfer through aqueous system procedure every 3 months. Estimated glomerular filtration rate (eGFR), according to CKD-epidemiology collaboration formula, was calculated at baseline and every 3 months. RESULTS: A total of 238 patients were included in the study, 118 (73.9 ± 3.8 years) in the biophysical therapy group and 120 (74.6 ± 4.2 years) in the control group. At baseline, mean eGFR was 69 ± 11.8 ml/min in the biophysical group and 70.7 ± 11.5 ml/min in the control group. After 1 year, eGFR was 74.1 ± 12.3 ml/min in the biophysical group, compared to 66.3 ± 11.9 ml/min in the control group, with a statistically significant difference between groups (p < 0.0001). The observed improvement in eGFR in the biophysical group was independent of age, gender, and antihypertensive treatment. CONCLUSION: This study shows a potential contribution of a biophysical integrated strategy to support renal function against its natural decline in the elderly, warranting further clinical evaluation.