DISEASES

different pathologies
one solution
OBESITY: 16.9% of adult population is overweight
more than 30% of the population is affected by weight problems*
6.5% of the population is affected by DIABETES*
7% of adult population is affected by GERD*
HEART DISEASES: 117 deaths per 100,000 people caused by ischemic heart disease,54 deaths per 100,000 people due to stroke*
HEART DISEASES: 117 deaths per 100,000 people caused by ischemic heart disease, 54 deaths per 100,000 people due to stroke*
PSORIASIS: from 2 to 3% of the population is subject to psoriasis*
DEPRESSION: the costs related to the depression syndrome
are on average 10% of total health care costs*
10% of adult population is affected by CONSTIPATION*
*OCSE

THE PATHOLOGIES

Obesity
Type II diabetes
Gastro-esophageal reflux disease (GERD)
Arterial hypertension
Psoriasis
High heart rate
Generalized anxiety disorder (GAD)
Treatments in use

FUNCTIONAL DISEASES AND NEUROMODULATION

Major and widely spread diseases in the action range of neuromodulation that can be successfully treated and eliminated by the BNM are:
  • Type II diabetes: in Italy 4,9% of people has diabetes (2.980.000 pts), in Europe 52 millions and 350 millions worldwide (2010 data*).
  • GERD: 3 to 7% of western adult population is affected by GERD and the majority is under pharmacological treatment*
  • Obesity: approximately 40% of adult population of western countries is overweight and 2% is pathologically morbid obese*
  • Heart diseases: 117 deaths per 100,000 people caused by ischemic heart disease, 54 deaths per 100,000 people due to stroke*
  • Constipation10% of adult population is affected by the problem*
  • Psoriasis: from 2 to 3% of the population is subject to psoriasis*
  • • Generalized Anxiety Disorder (GAD): 3.1% of U.S. adult population, 32.3% of these cases (e.g., 1.0% of U.S. adult population) are classified as “severe”**
* World Health Organization
**Source: Archives of General Psychiatry. 2005

OBESITY AND THE AUTONOMIC NERVOUS SYSTEM

Advanced scientific research strongly suggests that obesity may be an expression of a neurological disorder of the autonomic nervous system (ANS).

The ANS is the part of the brain that adjusts the automatic and involuntary functions of our body (blood pressure, heart rate and breathing, satiety, bowel movements, etc.). The brain centers responsible for these processes are located in the regions immediately below the cerebral cortex. The autonomic nervous system has two basic components that continuously interact with each other and keep the body in the best condition to adapt to frequent changes of the environment: the sympathetic and the parasympathetic. The sympathetic system is active during anxiety, hunger, fear and aggression, and the parasympathetic is active during digestion, and is associated with peace of mind, rest and general satisfaction.

Inherited from a parent, many individuals have an abnormal imbalance between the sympathetic and the parasympathetic components, with a prevalence of a stronger sympathetic system. Eating physiologically increases the parasympathetic component, giving spontaneous compensation to the patient. A balance between the two components is achieved by eating, and the individual is an innocent victim of an inherited neurological condition. The recent popularity of bariatric surgery is the most obvious sign of the real desperation of the obese patient who fails even to accept the digestive mutilations proposed by the bariatric surgeons.

The accumulation of fat and the increase of body weight are the physiological conditions that, beyond a certain limit, lead to disease, and typical symptoms of metabolic syndrome such as hypertension or type 2 diabetes appear.

OBESITY COSTS

In terms of costs (direct and indirect), statistics from US WIN (Weight-control Information Network) clearly state that on average, people who are considered obese pay 42% more in health care costs than normal-weight individuals:
- Medicare pays $95 more for an inpatient service, $693 more for a non-inpatient service, and $608 more for prescription drugs in comparison with normal-weight patients
-Medicaid pays $213 more for an inpatient service, $175 more for a non-inpatient service, and $230 more for prescription drugs in comparison with normal-weight patients
- Private insurers pay $443 more for an inpatient service, $398 more for a non-inpatient service, and $284 more for prescription drugs in comparison with normal-weight patients

TYPE 2 DIABETES

TYPE 2 DIABETES Type 2 diabetes is a metabolic disorder that is characterized by high blood glucose in the context of insulin resistance. The classic symptoms are excess thirst, frequent urination, and constant hunger. Type 2 diabetes makes up about 90% of all diabetes. Rates of type 2 diabetes have increased markedly over the last 50 years in parallel with obesity: as of 2010 there are approximately 285 million people with the disease compared to around 30 million in 1985. Long-term complications from high blood sugar can include heart disease, strokes, diabetic retinopathy where eyesight is affected, kidney failure (which may require dialysis), poor circulation of limbs leading to amputations, and nonketotic hyperosmolar coma.

TYPE 2 DIABETES COSTS AND STATISTICS

Diabetes prevalence has been increasing steadily over the past two decades, along with an aging European population, increasing, high obesity prevalence and changing ethnic make-up. Within EU5 countries, Germany has the highest diabetes prevalence at 8.9%, followed by Spain (8.1%), France (6.4%), the UK (6.1%) and Italy (4.8%). In 2010, the direct cost burden of people with diabetes was highest in Germany, in part due to the greater diabetes population, at €43.2 billion, followed by the UK (€20.2 [£13.8] billion), France (€12.9 billion), Italy (€7.9 billion) and Spain (€5.4 billion) (data from Diabetes expenditure, burden of disease and management in 5 EU countries, LSE Health, London School of Economics). Specifically on Type 2 diabetes, “Type 2 study” is the first coordinated attempt to measure total healthcare costs of Type 2 (non-insulin-dependent) diabetes mellitus in Europe. The study evaluated more than 7000 patients with Type 2 diabetes in eight countries -- Belgium, France, Germany, Italy, the Netherlands, Spain, Sweden and the United Kingdom (surce: http://www.ncbi.nlm.nih.gov/pubmed/12136405).

A bottom-up, prevalence-based design was used, which optimized the collection of data at the national level while maintaining maximum international comparability. Effort was made to ensure consistency in terms of data specification, data collection tools and methods, sampling design, and the analysis and reporting of results. Results are reported for individual countries and in aggregate for the total study population. The total direct medical costs of Type 2 diabetes in the eight European countries was estimated at EUR 29 billion a year (1999 values). The estimated average yearly cost per patient was EUR 2834 a year. Of these costs, hospitalizations accounted for the greatest proportion (55%, range 30-65%) totaling EUR 15.9 billion for the eight countries. During the 6-month evaluation period, 13% of the Type 2 diabetic patients were hospitalized, with an average of 23 days in hospital projected annually. In contrast, drug costs for managing Type 2 diabetes were relatively low, with antidiabetic drugs and insulin accounting for only 7% of the total healthcare costs for Type 2 diabetes. Type 2 diabetes mellitus is a common disease and the prevalence is expected to increase considerably in the future, especially in developing countries. Current comprehensive economic data on the costs of diabetes are required for policy decisions to optimize resource allocation and to evaluate different approaches for disease management.

GASTRO ESOPHAGEAL REFLUX (GERD)

Gastroesophageal reflux is the slipping upward and towards the oral cavity of the digestive contents into the esophagus. It is a physiological phenomenon that occasionally occurs after meals with moderate symptoms. Gastroesophageal reflux disease (GERD) occurs when symptoms become frequent and clinically relevant, or produce complications. In 2012 the International Foundation for Functional Gastrointenstinal Disorders estimated that GERD costs the U.S. nearly $2 Billion each week in lost productivity (http://digestive.niddk.nih.gov/statistics/statistics.aspx#specific).

HYPERTENSION

Hypertension, i.e. high blood pressure, is a clinical condition in which the blood pressure in the arteries of the systemic circulation is too high. This results in increased work for the heart. The blood pressure is represented by two values: the systolic and the diastolic pressure. The systolic is the result of heart muscle contraction and the diastolic of the blood vessels elastic return, in between two beats. Normal blood pressure, at rest, should range between 90 and 140 mm Hg for the systolic and between 50 and 85 mm Hg for the diastolic. Hypertension is when the blood pressure is 140/90 mmHg or higher.

Hypertension is classified as either primary (essential) or secondary.

Approximately 90-95% of cases are "primary hypertension" (no evident medical causes). The remaining 5-10% of cases is "secondary hypertension" and are the consequence of kidneys, arteries, heart or endocrine diseases.

Hypertension, even though moderate, is a risk factor for early death caused by stroke, myocardial infarction, heart failure, arterial aneurysms, peripheral arterial disease.

Changes in diet and lifestyle can significantly improve the control of blood pressure. However, drug treatment is often necessary when those changes are ineffective or inadequate.

PSORIASIS

Psoriasis is a chronic skin disorder characterized by a rapid turnover of skin cells with marked exfoliation. It is purely hereditary and, interestingly, is commonly associated with other diseases of the metabolic syndrome.
It is interesting that scientific literature shows evidence of linkages between pathological hypertone of the sympathetic system and psoriasis.

HIGH HEART RATE (Tachycardia)

The higher the sympathetic tone at rest and higher is the heart rate. If it is true that the number of heart beats per minute mark the time limit of our lives, we understand why the very long-lived people have a low heart rate. Lower the resting heart rate lengthens life expectancy.

GENERALIZED ANXIETY DISORDER

GAD is an anxiety disorder associated with hypertone of the sympathetic system that is characterized by excessive, uncontrollable and often irrational worry about everyday things that is disproportionate to the actual source of worry. For diagnosis of this disorder, symptoms must last at least 6 months. This excessive worry often interferes with daily functioning, as individuals suffering GAD are overly concerned about everyday matters such as health issues, money, death, family problems, friendship problems, interpersonal relationship problems, or work difficulties. Individuals often exhibit a variety of physical symptoms, including fatigue, fidgeting, headaches, nausea, numbness in hands and feet, muscle tension, muscle aches, difficulty swallowing, bouts of difficult breathing, difficulty concentrating, trembling, twitching, irritability, agitation, sweating, restlessness, insomnia, hot flashes, rashes, and the inability to fully control the anxiety. These symptoms must be consistent and on-going for at least six months for a formal diagnosis of GAD to be made. In the U.S., 3.1% of the adult population suffers from GAD, and 32.3% of these cases are classified as “severe.” About 43% of those suffering from GAD receive permanent healthcare, however 18.9% receive inadequate treatment.
**source - Archives of General Psychiatry. 2005
**National Institutes of Health (http://www.nimh.nih.gov/health/topics/generalized-anxiety-disorder-gad/index.shtml)

TREATMENTS IN USE

The main existing medical therapies for the relevant functional diseases are bariatric surgery and pharmacological treatments.

Main Bariatric Surgery Techniques


MALABSORPTIVE PROCEDURES

  • Biliopancreatic diversion
  • Jejunoileal bypass
  • Endoluminal sleeve

RESTRICTIVE PROCEDURES

  • Vertical banded gastroplasty
  • Adjustable gastric band
  • Sleeve gastrectomy
  • Intragastric balloon
  • Gastric plication

MIXED PROCEDURES

  • Gastric bypass
  • Sleeve gastrectomy with duodenal switch

Main pharmacological treatments

Therapies generally associated to the diseases linked to the metabolic syndrome are based on pharmacological treatments.

The table below is a brief representation of some of the main molecules and drugs that are commonly used as of today on a consolidated base.

The table is not meant to be exhaustive or in any way an indication or suggestion in how to deal with the presented diseases.

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