Use of thermobalancing therapy in ageing male with benign prostatic hyperplasia with a focus on etiology and pathophysiology

Abstract

Introduction: We investigated if “thermobalancing” therapy (TT), using Dr Allen’s therapeutic device (DATD) in men with benign prostatic hyperplasia (BPH), can aid in understanding the etiology and pathophysiology of BPH.

Methods: We compared urinary and other parameters of BPH patients who received TT over 6 months (treatment group) with those of healthy volunteers who had not received the treatment (control group). Dynamics of symptoms and indicators in each group were evaluated in comparison with their data at the beginning and end of the study. Parameters were the International Prostate Symptom Score (IPSS) for urinary symptoms and quality of life (QoL), ultrasound measurement of prostate volume (PV) and uroflowmetry (maximum flow rate, Q_max). TT effectiveness was examined in 124 men with BPH and PV <60 mL. We also investigated the data of five patients with BPH and PV >60 mL.

Results: TT decreased urinary symptoms and PV, increased Q_max and improved QoL in men with BPH, PV <60 mL, and in men with BPH, PV >60 mL.

Conclusions: The present study demonstrated that TT is effective for BPH, suggesting that blood circulation plays a crucial role in its cause. The continuous heat exposure that does not exceed the normal body temperature terminates the trigger of BPH development, “micro-focus” of hypothermia, and the following spontaneous expansion of capillaries. TT could be considered to be a useful tool in BPH treatment.

Keywords:

• Ageing men
• enlarged prostate
• benign prostate hyperplasia
• thermobalancing therapy
• lower urinary tract symptoms
• BPH cause

Introduction

Benign prostatic hyperplasia (BPH) used to be considered as a consequence of aging. Treatment centered on medical/surgical intervention to counteract lower urinary tract symptoms (LUTS). Some medications, such as amsulosin tablets, have shown efficacy with no adverse events [1], and dutasteride has reduced prostate volume with the link to improvement of bone mineral density and elevation of serum testosterone in men with LUTS secondary to BPH [2]. However, medical treatment of BPH is not efficacious, as Fourcade et al. found that 52.8% of men with BPH were dissatisfied with the results of medical treatment conducted according to current international guidelines for BPH [3].

As men get into their 50s and older, they may start to have different signs, such as lower sex drive and sense of vitality, erectile dysfunction, decreased energy, reduced muscle mass and bone density, and anemia, which are usually symptoms of low testosterone that require testosterone replacement therapy (TRT) [4]. As TRT interruption results in worsening of symptoms lifelong TRT may be needed [5]. Investigations of TRT safety have shown that the long-term oral therapy had no harmful effects on IPSS total score and did not change PV and PSA in aging men [6]. In addition to clinical and biochemical parameters, prostate histology and apoptotic index has suggested that TRT does not cause the risk for prostate cancer development [7].

Discovering the cause of prostate gland (PG) enlargement is crucial for BPH treatment. Therefore, it was thought that hormones have a fundamental role in BPH/LUTS development, suggesting that androgens must be present for BPH to occur [8]. However, castrated boys do not develop BPH as they get older [9]. So hormones may be initial triggers to the process of prostate enlargement.

PG inflammation is a frequent histologic finding in PG biopsies, even if clinical signs of prostatitis are absent [10]. Inflammation may contribute to cytokine production via inflammatory cells driving production of local growth factors and angiogenesis in PG tissue [11]. DiBello et al. found a significant association between clinical BPH and the metabolic syndrome (MetS) [12]. The main risk factors for the development of severe LUTS were obesity, high plasma level of fasting blood glucose, hypertension and presence of erectile dysfunction [13]. The impact of the MetS on LUTS is most significant in men with an enlarged PG and/or high levels of prostate-specific antigen [14].

In the last decade, investigations of BPH pathogenesis have focused on vascular dysfunction. For instance, aging could activate risk factors for systemic vascular disease, resulting in disturbed blood flow [15]. Development of prostatic hyperplasia could be associated with prostatic hypoxia [16]. Also, a correlation between pelvic ischemia and LUTS in elderly males [17], and increased pressure in the PG have been suggested [18].

One decade ago, I suggested that spontaneous expansion of capillaries is the basis of PG enlargement, chronic prostatitis and kidney stones [19,20]. Constriction of capillaries in response to an irritating trigger leads to local “micro-hypothermia” which, in turn, becomes a constant irritant and makes the disease chronic. To eliminate this “hub” of micro-hypothermia, blood flow increases through spontaneous expansion of the capillary network locally. Formation of new capillaries is, essentially, the growth of excess tissue. Hence, long-term hypothermia in the PG leads to its continuous enlargement. “Thermobalancing” therapy (TT) was invented to stop such spontaneous tissue growth [21].

TT using Dr Allen’s therapeutic device (DATD) aims to improve blood circulation in the PG. DATD provides a method of treating an affected PG by the application of a special mixture of waxes (“thermoelement”) topically to the coccyx area upon its projection. TT was used as monotherapy for 6 months in a trial involving 124 men with BPH, and confirmed the effectiveness and safety of TT [22]. Here, we investigated the effect of long-term use of DATD on patients with an enlarged PG to provide information on the etiology and pathophysiology of BPH.

Materials and methods

Study design

The Ethics Committee of Yerevan State Medical University (Yerevan, Armenia) approved the protocol of this clinical observational study based on TT using DATD. We compared urinary and other parameters of BPH patients who received TT over 6 months (treatment group) with those of healthy volunteers who had not received the treatment (control group). Dynamics of symptoms and indicators in each group were evaluated in comparison with their data at the beginning and the end of the study.

Evaluation

Baseline evaluations were a full physical examination, medical history, digital rectal examination, serum biochemistry, measurement of prostate-specific antigen and electrolytes, urinalysis and renal function tests. Evaluations were made at baseline and 6 months after treatment. International Prostate Symptom Score – Quality of Life (IPSS) scores for urinary symptoms (UrS) and quality of life (QoL) were used in men with BPH. Prostate volume (PV) was measured at baseline and 6 months after treatment by a US-9000E2 ultrasound scanner (Rising Medical Equipment, Beijing, China). The standard ellipsoid formula (length × width × height × 0.52) was used to determine prostate volume. Uroflowmetry (maximum urinary flow rate (Q_max, mL/s) reflected the rate of urinary flow (Sanuro2UL, Santron Meditronic, Maharashtra, India). We have not used a bladder wall thickness test (BWT), which is an effective tool to evaluate response to medical treatment in patients with LUTS [23], as changes in Q_max, we have investigated the significant correlation with BWT [24]. There are no diagnostic tools for the investigation, a sexual function such as overnight erection test, blood test on low testosterone levels or others were methodically used during this study.

Participants and interventions

Of 226 men with BPH with PV <60 mL, we selected 124 patients. 80 men were excluded because their PV was >60 mL or they had severe comorbidities; 10 preferred to undergo surgery for BPH; 4 had suspected PG cancer; 8 were lost to follow-up.

DATD

Men who met the inclusion criteria of the study had treatment for BPH using DATD. The latter was attached to the coccyx area of the patient.

Results

Baseline characteristics of the study cohort

The baseline characteristics of the study cohort are shown in Supplementary Table 1.

Urinary symptoms

In the control group, the mean IPSS–UrS score increased from 13.45 ± 3.254 to 14.35 ± 3.396 whereas, in the treatment group, it decreased from 14.33 ± 3.399 to 4.73 ± 2.754 at the end of the observation period (Figure 1). For the control group, the z value was −6.018 at a significance level of 0.000 (i.e. p < 0.001). For the treatment group, the z value was −9.674 at a significance level of 0.000 (i.e. p < 0.001). Hence, DATD decreased urinary symptoms significantly whereas, in the absence of treatment, urinary symptoms worsened significantly.

Figure 1. The dynamics of urinary symptoms (UrS) and quality of life (QoL) in 124 men with BPH after thermobalancing therapy and in the control group by the International Prostate Symptom Score (IPSS).

QoL

In the control group, the mean IPSS − QoL score increased from 3.43 ± 0.956 to 3.76 ± 0.983 whereas, in the treatment group, it decreased from 3.91 ± 0.755 to 1.39 ± 1.110 (Figure 1). For the control group, the z value was −5.286 at a significance level of 0.000 (i.e. p < 0.001). For the treatment group, the z value was −9.672 at a significance level of 0.000 (i.e., p < 0.001). These results suggested that DATD treatment improved QoL whereas, in the control group, QoL worsened.

PV

In the control group, the mean PV increased from 45.54 mL to 50.85 mL whereas, in the treatment group, it decreased from 45.19 mL to 31.86 mL (Figure 2). For the control group, the z value was –8.727 at a significance level of 0.000 (i.e. p < 0.001). Hence, there was a significant increase in PV in the control group. For the treatment group, the z value was –9.669 at a significance level of 0.000 (i.e. p < 0.001). Hence, DATD reduced PV significantly whereas, in the control group, PV increased.

Figure 2. The changes in ultrasound prostate volume (PV) mL and uroflowmetry – Q_max mL/s parameters in 124 men with BPH after thermobalancing therapy & control group.

Q_max

In the control group, the mean Q_max decreased from 7.95 ± 2.871 to 7.7 ± 2.695 mL/s whereas, in the treatment group, the mean Q_max increased from 8.10 ± 3.041 to 17.73 ± 4.392 mL/s (Figure 2). For the control group, the z value was −1.929 at a significance level of 0.054 (i.e. p > 0.05), suggesting no significant difference. For the treatment group, the z value was −9.621 at a significance level of 0.000 (i.e., p < 0.001), suggesting a significant increase in Q_max. These results suggested that DATD increased Q_max significantly whereas, in the control-group, a significant difference in Q_max was not observed.

Symptoms and parameters in men with BPH and PV >60 mL

The age of all men with BPH and PV >60 mL was >70 years (Table 1). DATD used as long-term monotherapy decreased PV and increased Q_max, which led to an improvement in QoL. Even though PV decreased significantly in all cases, PG size remained large. Hence, patients with PV >60 mL should use DATD for a longer period. The exact time period must be tailored to each patient because PG size may vary considerably. Also, no side effects were associated with DATD use.

Table 1. Changes in prostate volume (PV, mL) and uroflowmetry (maximum urinary flow rate, Q_max, mL/s), and International Prostate Symptom Score (IPSS) for urinary symptoms (UrS) and quality of life (QoL), in men with BPH (PV >60 mL) upon thermobalancing therapy.

Changes in PV-mL, Qmax mL/s, and IPSS scores of UrS and QoL in men with BPH (PV >60 mL) after thermobalancing therapy
Patients	1	2	3	4	5
No Dates	1 July 2014– 3 November 2014	22 July 2014– 18 February 2015	3 February 2014– 3 November 2014	18 March 2014– 10 March 2015	31 March 2014– 24 March 2015
Age in years	73	79	75	73	77
IPSS – UrS	14–4	6–2	12–3	16.5–6	12.5–7
IPSS – QoL	4–1	3–1	4–0	14–4	4–3
PV, mL	93–70	154–90	84–52	74–51	110–88
Qmax, mL/s	11.2–14	13–14.4	9.7–15.5	7.2–10.3	5.8–6.8

Discussion

The present study demonstrated that TT decreased UrS and PV, increased Q_max and improved QoL in men with BPH, PV <60 mL, and in men with BPH, PV >60 mL. These outcomes suggest that TT is effective for BPH.

This was not a randomized clinical study. Having a “placebo” or “sham” group as controls could have provided more statistical rigor with regard to outcomes. However, most men with BPH suffer from depression and anxiety, their health-related QoL is considered poor, and their psychological wellbeing affected severely [25,26]. Six month may be considered as a short period of time for taking tablets/placebo but long for using something attached to the body. Therefore, proposing that men with BPH should wear a “placebo belt” for 6 months that does not alleviate symptoms would be very difficult. Usually, patients with BPH felt symptom relief within weeks of wearing DATD, and used the device as required.

Results in the control group showed that after 6 months they were almost the same, except increased PV. These data are in accordance with other studies confirming the progressive nature of BPH, with symptom progression being the most common manifestation [27].

Investigations on BPH pathogenesis have looked at inflammation [28]. Recently, Jack revealed that reducing chronic inflammation is a target for BPH treatment [29]. Other scholars have studied the association between the MetS and LUTS in patients with BPH. The MetS is associated with an increased risk of storage symptoms in patients with benign prostate enlargement (BPE). The MetS and its metabolic components could be involved in LUTS − BPE pathogenesis [30]. Also, the MetS with an increase in number of risk factors for the MetS (especially hypertension and hypertriglyceridemia) increase the likelihood of having moderate-to-severe LUTS in middle-aged men with high PV [31].

Yeh et al.[32], in univariate analysis, age, cigarette smoking, alcohol consumption, physical activity and PV significantly correlated with the severity of LUTS, but the presence or any components of MS did not. Results of multivariate analysis showed that aging, cigarette smoking, lack of regular exercise and larger PV were independent predictors for moderate/severe LUTS [32]. Hence, inflammation and the MetS could be triggers for the constriction of capillaries with the development of a focus of micro-hypothermia. Continuous expansion of the capillary network could lead to PG growth and cause/worsen urinary symptoms.

Using DATD, the thermoelement is applied tightly to the skin. This approach overcomes the skin barrier and spreads heat energy toward the PG, terminates the focus of micro-hypothermia, and reverses PG enlargement gradually. TT is the only noninvasive treatment that targets the underlying cause of BPH continuously for a prolonged period of time (days, months or years) to reduce PV and relieve symptoms [33]. It was also found that TT helps men to recover from chronic prostatitis [34] confirming its positive impact on the prostate tissue, which is important as chronic prostatic inflammation can correlate with prostate volume and weight [35].

Thus, TT can play a crucial part in the prevention of the development and progression of BPH, particularly for moderate-to-low LUTS secondary to PG enlargement. TT is different from using heating treatments because the energy source is the body, so the temperature does not exceed the normal range of body temperature. Exposure to heating and cooling even for a short period of time are stressful and dangerous to health [36].

Based on the role of inflammation in BPH development, nonsteroidal anti-inflammatory drugs (NSAIDs) are prescribed sometimes. However, NSAIDs are associated with side effects in the gastrointestinal tract. Furthermore, these drugs can damage gastric and duodenal mucosa, and even the esophagus [37]. Certain NSAIDs can increase the risk of heart attack and stroke, especially if used long-term [38].

In the last decade, the necessity of medical/surgical treatment of BPH has been challenged. BPH/LUTS should not be viewed as an inevitable disease of older people but as part of the aging process that can be prevented [39]. Therefore, recommendations on the evaluation and treatment of LUTS in older men are in demand. BPH treatment should be holistic, and may include conservative measures, lifestyle interventions and behavioral modifications, as well as medication and surgery [40].

Russo et al say [41], BPH/LUTS may be considered as a complex disorder that can also be discovered in the earlier stage. Primum non- “nocere” (first do no harm) should always be kept in mind, and therefore the counteraction of previous metabolic alterations should be the milestone of BPH/LUTS treatment. The next challenges of urologists should be the contrast of early onset of BPH/LUTS and the development of new target therapies in men at risk [41].

The BPH/LUTS management currently programed on the medicine/surgical base: mild or nonbothersome symptoms of BPH do not require treatment; bothersome symptoms are managed with lifestyle modifications, medications, and surgery; and dietary supplements, such as saw palmetto, pygeum, cernilton and beta sitosterols, and acupuncture are not recommended for the management of BPH [42].

The effectiveness of TT allows us to suggest that blood circulation has a primary role in the etiology and pathophysiology of BPE/BPH. DATD spreads energy to the PG. Hence, the PG shrank because TT could reverse pathologic angiogenesis (i.e. terminating spontaneous expansion of capillaries). DATD was free from side effects, so it can have an important role in prevention of the development and progression of BPH. Hence, TT could be considered to be a useful tool in BPH treatment.

Conclusions

We considered 6-month period is long for using “placebo belt” attached to the body, therefore observational study was used. The present research demonstrated that TT decreased UrS and PV, increased Q_max and improved QoL in men with BPH, PV <60 mL, and in men with BPH, PV >60 mL. These outcomes suggest that TT is effective for BPH affecting its cause by improving blood flow in the prostate due to continuous heat exposure that does not exceed the normal body temperature. TT could be considered to be a useful tool in BPH treatment.

Declaration of interest

The author declares that there are no competing interests in writing of this article. Simon Allen applied to the US Patent and Trademark Office (USPTO) in 2009 “Therapeutic Device and Method”, and patent was granted by USPTO in 2016. Dr Allen has not received reimbursements, fees, funding or salary relating to the content of this manuscript.

Supplementary material available online.

Acknowledgements

We are grateful to the staff of the Department of Urology of the Yerevan State Medical University and the Mikaelyan Institute of Surgery (Yerevan, Armenia) for their help in supervision of patients during the study; and to reviewers/editors of the Ageing Male Journal for their constructive suggestions that improved the article.