Biophysical Approach to Chronic Kidney Disease Management in Older Patients

Abstract

Background

Chronic kidney disease (CKD) and its clinical progression are a critical issue in an aging population. Therefore, strategies aimed at preventing and managing the decline of renal function are warranted. Recent evidence has provided encouraging results for the improvement of renal function achieved through an integrated biophysical approach, but prospective studies on the clinical efficacy of this strategy are still lacking. This was an open-label prospective pilot study to investigate the effect of electromagnetic information transfer through the aqueous system on kidney function of older patients affected by stage 1 or 2 CKD.

Methods

Patients received biophysical therapy every 3 months over a 1-year period. Estimated glomerular filtration rate (eGFR) values were calculated using the CKD-Epidemiology Collaboration formula, and were recorded at baseline and at the end of treatment. Overall, 58 patients (mean age 74.8 ± 3.7 years) were included in the study.

Results

At baseline, mean eGFR was 64.6 ± 15.5 mL/min, and it significantly increased to 69.9 ± 15.8 mL/min after 1 year (+5.2 ± 10 mL/min, p<0.0002). The same trend was observed among men (+5.7 ± 10.2 mL/min, p<0.0064) and women (+4.7 ± 9.9 mL/min, p<0.014). When results were analyzed by sex, no difference was found between the 2 groups.

Conclusions

Although further and larger prospective studies are needed, our findings suggest that an integrated biophysical approach may be feasible in the management of older patients with early-stage CKD, to reduce and prevent the decline of renal function due to aging or comorbidities.

Introduction

Chronic kidney disease (CKD) represents a serious concern in the management of geriatric patients either as a primary disease or as a common comorbidity occurring in a growing number of people with complex diseases. CKD is most likely related to aging, and therefore it is becoming increasingly common due to the progressive aging of populations in Western countries. CKD also contributes to the general increase of allostatic load, as a consequence of adaptive stress (1), and to frailty in older people (2), as an expression of complex diseases requiring personalized treatment (3), particularly in aging populations (4). Maintenance of an effective renal function is a key point to preserving systemic homeostasis through effective allostasis (5). According to the allostatic load theory, CKD is the result of the increasing rate of chronic stress-related syndromes in both young and older people (6). CKD represents, indeed, a true price of adaptation according to the allostatic load theory (7). It contributes to a general functional decline (8) and thereby to an increase of cumulative biological risk affecting both morbidity and mortality rates (9). Thus, any integrative strategy aimed at improving the management of renal function should be carefully investigated. We previously reported the long-lasting improvement over a 10-year follow-up of renal function in a case of autoimmune nephritic syndrome, by means of an integrated biophysical approach (10). Similarly, in a previous pilot study, we observed a significant improvement in estimated glomerular filtration rate (eGFR) following an integrated biophysical approach in 30 patients with early-stage CKD treated for a period of 1 year (11).

Biophysical methods are new, interesting, emerging tools in clinical practice, and several studies have shown their potential use in preventing chemotherapy-induced myelotoxicity (12), gonarthrosis (13), low back pain (14), rheumatoid arthritis (15) and other rheumatic diseases (16). Furthermore, these techniques have played a role in modulating metabolic activities (17), in severely compromised, frail patients (18), in chronic constipation and diarrhea (19), in the management of fluctuating asymmetry (20), in smoking cessation (21) and in the management of joint pain, as an effective alternative to pharmacological strategies (22, 23). Biophysical therapies very likely exert their effect through a resonance phenomenon (24): indeed, resonance occurs between therapeutically delivered signals, endogenous or exogenous, and target tissues, organs and/or entire organism, which allows the achievement of local and/or systemic effects simultaneously (25).

Resonance is the general phenomenon that allows communication through the transmission of signals between a transmitter and a receiver. For resonance to occur, the transmitter and the receiver must operate at the same frequency to ensure a selective and effective signals transmission. For example, a tuning fork comes into resonance only with another one that has the same frequency – i.e., the same wavelength. Recently it has been shown how such a model is also active in the selective coupling between a molecule and its own specific receptor. This model has been defined as the resonant recognition model. Also the key and the lock must be in resonance to generate an opening or closing signal. In conclusion, in order to convey information – whether chemical or electromagnetic – able to trigger biological functions, the transmitter and the receiver must be perfectly tuned to each other – in other words, they must to be in resonance.

We integrated the current gold standard treatment of early-stage CKD in older patients with electromagnetic information transfer through the aqueous system to assess whether it could be of any supplementary benefit in the management of this disease.

Methods and Materials

Study design and population

This was an open-label prospective pilot study, which included patients aged ≥70 years, presenting with stage 1 or 2 CKD (i.e., eGFR >60 mL/min). Exclusion criteria were concomitant diabetes, use of corticosteroid drugs or continuous use of nonsteroidal antiinflammatory drugs. See Table I for main characteristics of the study group. All patients provided informed consent prior to any study-specific procedure. The study was conducted in accordance with the Declaration of Helsinki.

Table I

Characteristics of the sample population

Hypertension (%)	Cardiovascular disease (%)	Diabetes (%)	Mean age (years)	Sex (M/F)	ACE inhibitor/ARB (%/%)
100%	51.17%	0%	74.8 ± 3.7	28/30	72.4%/58.6%

ACE = angiotensin-converting enzyme; ARB = angiotensin receptor blocker.

Evaluation of estimated glomerular filtration rate

After careful evaluation of the methods currently available (26), we employed the CKD-Epidemiology Collaboration (CKD-EPI) formula (27), a simple and quick method that allows estimation of GFR by inserting the value of the patient's serum creatinine into a dedicated website portal (http://www.mdrd.com), or by using tables (28), along with sex, race and age. Here, we took advantage of the website portal. eGFR was calculated at baseline (i.e., before start of treatment), and serum samples for creatinine level assessment were obtained every 3 months, to monitor eGFR before each administration of the biophysical therapy and at the end of the 1-year period.

Biophysical therapy procedure

A 2-step protocol was applied to each patient. First, the regulation therapy program was selected on the touch screen of the Med Select 729 device (Wegamed, GmbH, Essen, Germany) to record the endogenous input signals at the renal site. Then the therapeutic electromagnetic output signals were delivered on an electromagnetic, full-body carpet on which the patient lay for 10 minutes. Next, the basic drainage therapy program was selected from the touch screen of the Med Select 729 device to record the endogenous input signals at the renal region and deliver the therapeutic output signals at the kidney site for 10 minutes. Concomitantly, the output therapeutic signals were recorded on a commercially available aqueous system (Nomabit Base, Named SRL, MB Italy) by placing the solution into the special built-in output coil of the Med Select 729 device. This medical equipment operates in the low frequency range (between 0 and 20 kHz) using a magnetic field with an intensity in the range of the earth's magnetic field, with a maximum output of 50 μT. It allows the recording of input signals through 2 electrodes, and the delivery of the output signals to the patient through 2 magnetic electrodes for local use (i.e., to the target anatomical location), or through a magnetic carpet where the patient can lie down (in this way the entire body can be treated). This equipment can therefore simultaneously deliver both a local and systemic treatment. Details for the recording circuit and procedures (i.e., electromagnetic information transfer through the aqueous system) have been described previously (29). The Nomabit Base aqueous solution was subsequently self-administered by the patient, to allow the recorded therapeutic information to be delivered based on a weekly plan beginning with a single drop on Monday and increasing by 1 drop/day up to 6 drops on Saturday; no therapy was administered on Sundays (23). The Nomabit Base solution is composed of oligo minerals and is currently used as a food supplement. This aqueous solution is provided with a dropper and stored in an aluminum-shielded container, which ensures that the signals are preserved in the aqueous solution and are protected from environmental, thermal and electromagnetic pollution. This is an off-label use of a common dietary supplement, which is already suited to be stored for a long period of time (up to 3 months after opening, as indicated by the manufacturer), which avoids the risk of altering its characteristics.

Statistical analysis

Student's paired t-test was used to compare mean differences in eGFR values in patients from baseline and 1 year, while Student's unpaired t-test was used to compare differences in eGFR between male and female patients. Statistical analysis was performed using Instat Software (GraphPad, San Diego, CA, USA). A p value <0.05 was considered statistically significant.

Results

Patient population and effect of biophysical therapy on eGFR

A total of 58 patients (mean age 74.8 ± 3.7 years; range 70–88 years), 48.3% men (n = 28) were included. All of the recruited patients completed the follow-up without any dropouts. No relevant changes in clinical conditions occurred in the patients during the year of observation, and no relevant changes in the traditional therapy were made. The mean score for eGFR (according to the CKD-EPI formula (27)), was 64.6 ± 15.6 mL/min at baseline and 68.9 ± 15.8 at the end of the study 12 months later, with a highly significant increase of 5.2 ± 10 mL/min, equivalent to an improvement of 8.8% ± 17.7% (p<0.0002; Fig. 1).

Fig. 1

Estimated glomerular filtration rate (eGFR) values at baseline and after 1-year follow-up.

When the data were analyzed by sex, mean eGFR score among men was 65.5 ± 16.1 mL/min at baseline and 71.3 ± 16.6 mL/min at the end of the study, with an increase of 5.7 ± 10.2 mL/min, corresponding to a rise of 10.3% ± 16.6%, which was highly significant (p<0.0064; Fig. 2). The mean eGFR score in women was 63.8 ± 15.2 mL/min at baseline and 68.5 ± 15.1 after 1 year, with a highly significant increase of 4.7 ± 9.9 mL/min, equivalent to a 9.4% ± 19% improvement (p<0.014; Fig. 2).

Fig. 2

Estimated glomerular filtration rate (eGFR) values at baseline and after 1 year, in male and female patients. CKD EPI = Chronic Kidney Disease-Epidemiology Collaboration.

No difference in eGFR values was observed between men and women at baseline or after 1 year (p = 0.67 and p = 0.51, respectively; Fig. 2). No side effects were reported during the 1-year study period.

Discussion

The aim of this pilot study was to identify a novel potential synergistic strategy for the treatment of older patients presenting with early-stage (i.e., stage 1 or 2) CKD. The use of the electromagnetic information transfer of endogenously produced therapeutic signals seems to represent a promising and feasible therapeutic tool in clinical practice: The physician delivers a single 20-minute treatment to the patient every 3 months, which equates to a total of 80 minutes delivered across the entire 1-year period. This protocol could represent a novel approach aimed at saving clinical resources and patients' time. Interestingly, a very significant increase in eGFR values as calculated from the CKD-EPI equation was observed. In addition, no side effects or adverse reactions were reported over the 1-year period of treatment. This pilot study provides evidence that a biophysical approach to early-stage CKD may be feasible due to the fact that it is rapid, safe and the effect is long lasting.

These results corroborate our previous findings demonstrating an improvement in renal function in a case of autoimmune nephritic syndrome (10) and in a case series of patients with early-stage CKD (11). CKD prevalence is progressively increasing in the general population (30), in adults (31) and especially in the older patients (32). A reduction in eGFR rate correlates with all-cause mortality and the incidence of cardiovascular disease, even in a low-risk population (33), and it is significantly impacting public health (34). Therefore, any rapid, noninvasive approach aimed at maintaining or increasing eGFR rate should be considered as an integrative and useful tool to manage public health and aid successful aging.

There are several limitations to the present study that need be addressed. The sample size was smaller than desired. There were insufficient data (variables, not sample size) to perform logistic regression analysis. Furthermore, we performed a univariate analysis, but no association was observed between age and difference at baseline or 1-year follow-up. This very likely means that the observed trend of increase of eGFR was quite homogeneous in our small population regardless of baseline age.

A greater sample size would have permitted a more robust analysis and the possibility of examining the association between reduction in eGFR following biophysical therapy and individual clinical characteristics using logistic regression analysis. However, the sample population was relatively homogenous (age range 70–88 years and 48.3% male), strengthening the possibility that confounding factors may not have greatly influenced the observed findings. Indeed, our sample population was relatively homogeneous for age and sex. Considering the other clinical parameters: Diabetes was an exclusion criterion for this study, all patients received antihypertensive medications, and none of the patients needed a surgical or transcutaneous procedure for a major cardiovascular disease during the observation period. Patients included in the present study represented those with early-stage CKD (stages 1 and 2) in the older population. However, despite the relatively short study period (i.e., 12 months), we were still able to observe a significant increase in eGFR. Further studies in larger and more patient populations including those with later stages of CKD are warranted. Whether this integrative therapeutic approach can have an impact on overall survival still remains to be determined.

This preliminary pilot study suggests that the integration of a biophysical framework in current management of older patients presenting with early-stage CKD might lead to a significant improvement in eGFR rate over a 1-year follow-up. Electromagnetic information transfer through the aqueous system is a rapid, safe and long-lasting integrated biophysical approach that may represent a synergistic and personalized tool (3,4) to reduce global functional decline through improvement in eGFR and consequently decrease the risk of disease burden (9). The protocol presented here may also support increasing resilience instead of frailty (35) even in the older population.