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About The Metabolic Approach™

Origins & Evolution

Metabolism: What Are We Talking About?

Preserving Cellular Structures and Functions.

The Early Treatment Option.

Healthcare Professionals and The Metabolic Approach™.

Science and Products: the Must of Quality.

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Origins & Evolution.

In prehistoric times, the only treatments available were natural substances. Religious belief and empirical experience upheld the use of such plants as chamomile, valerian and corn poppy to treat specific diseases. These remedies were used by shamans, medicine men who combined empirical knowledge with mystical belief. Modern medicine was born in Greece in the fifth century B.C. However, the medicinal use of natural substances maintained a "magical" character for centuries. In fact, little changed from the first attempt to classify natural therapeutic substances (the Ebers papyrus of 1550 B.C.) up until the Renaissance, when empirical data was still confused with Hermetic practices and alchemy. The Paracelsian principle "similia similibus curantur" (treat like with like) reflects this speculative approach to natural therapies. From the Renaissance forward, changes began to take place. Rediscovery of the Greek heritage and the beginnings of the scientific approach to nature laid the foundation for the study of human anatomy and physiology.

While the scientific paradigm began to change, pharmacological therapeutics remained the same. Lack of understanding of the human cellular functions left doctors without a scientific basis on which to improve the way they used natural substances. Treatment practices changed radically at the end of the 19th century, when organic chemists began to synthesize new drugs with specific properties.

Doctors reinforced the scientific basis of their authority, leaving aside mystical or religious heritage. The discovery of antibiotics, an unprecedented weapon for fighting previously invincible enemies and dramatically improving both quality of life and longevity, is a classic example of the achievements that were realized through this process. The pharmacological revolution was indeed a big step forward in one sense, but it also had its drawbacks.

While the approach of the ancient Greeks took into account the patient as a whole, i.e. the overall condition of the patient, sometimes the modern approach to disease leads to labeling a person as "suffering from x" and then treat the patient accordingly. The attention paid to specific symptoms can involve the risk of overlooking the patient’s entire condition.
The latter approach doesn’t consider the fact that, particularly in Western countries, the majority of diseases represent the final manifestation of an often lengthy process, which can vary considerably from patient to patient. Although radical and extremely important improvements in the cure of diseases have been achieved, the individually based approach should not be neglected and maintaining good health shouldn’t give way to treating ill health.

Metabolism: What Are We Talking About?

Metabolism is the set of all the biochemical reactions that occur in our cells.

It is responsible for the building of the body and for all of the chemical and physical transformations which occur in it. Vital functions such as growth, movement and reproduction depend on it. The Metabolic Approach™ aims at restoring and preserving cell functions as well as structures by focusing on specific metabolic pathways. 
For instance The Metabolic Approach™ allows to modulate a number of cellular functions, treat alterations at the molecular level, addressing them at an early stage (even before symptoms show up), and tailor treatments to the each person's specific needs.

An important part of research worldwide has focused on the role of metabolic compounds (those occurring naturally in the human metabolism) involved in energy production, such as carnitine CoQ10, omega 3 fatty acids, and many other compounds.

L- carnitine (a metabolic compound that naturally occurs in our cells and is found predominantly in meat, but is also produced by our body) and its derivatives, like acetyl L carnitine and propinyl L carnitine, are definitely amongst the most thoroughly researched dietary supplements worldwide. Carnitines are essential to the production of the right amount of ATP as they shuttle fatty acids, the primary cellular fuel, across the inner mitochondrial membrane.

L-carnitine has been the subject of more than 30 years of studies in Europe and abroad, and it could serve as model for the type of research that we believe should be conducted on all supplements currently available to healthcare professionals and consumers.

L-carnitine has been studied so extensively because of its development as a pharmaceutical drug in some countries. It has been the subject of many double-blind, parallel group, placebo-controlled, multi-center trials, and as a result, we now have clinical evidence that L-carnitine has significant health benefits.

One of L-carnitine’s most interesting uses is in extending survival rates of patients with heart problems. In one study of 70 patients with moderate to severe heart failure caused by dilated cardiomyopathy, survival was statistically significant for those who were randomly assigned to receive L-carnitine instead of a placebo. Specifically, 63 patients were still alive three years after the study first began. But while there were six deaths in the placebo group, there was only one death in the L-carnitine group. The researchers concluded that L-carnitine appears to possess considerable potential for the long-term treatment of patients with heart failure attributable to dilated cardiomyopathy.

In another randomized, double-blind, placebo controlled study, researchers found that the early and long-term administration of L-carnitine attenuates progressive left ventricular dilation after acute anterior myocardial infarction (MI). Left ventricular dilation is a powerful predictor of progressive functional deterioration that ultimately culminates in heart failure and death. Results of this study showed significant, consistent reductions in end-diastolic volume and end-systolic volume in patients who received L-carnitine compared with placebo. The study is continuing to assess the efficacy of L-carnitine in reducing the combined incidence of death and heart failure at six months.

In recent years, scientists have also been studying evidence that both L-carnitine and acetyl L carnitine improve motility and other quality parameters of sperm.

Preserving Cellular Structures and Functions.

Over the past 20 years, classical pharmacology continued to develop and genetics began to shape new medical perspectives.
A renewed attention was then paid to the processes that lead to disease and ageing. Researchers focused on metabolism and began to examine, at the cellular and molecular level, alterations that would give way over time to illness or ageing, such as impairment of energy production, defense/repair from free radical-related damage and substrate production.
All of this may offer the solution to a number of health problems.

The Metabolic Approach™ to these problems aims at restoring and preserving cell function as well as structures by focusing on specific metabolic pathways.
The plusses of this approach are:

• it targets the problem at the molecular level and

• allows the early treatment of alterations, before symptoms show up;

• patients can receive treatments tailored to their specific needs, since metabolic alterations vary considerably from patient to patient even though symptoms may be similar;

• it can be used in conjunction with classical drugs to help restore the body's response to them or decrease adverse drug reactions (for instance, in case of congestive heart failure if a proper metabolic support to heart muscle cells is implemented in due time, a lower dosage of digitalis could be used to achieve the same therapeutic effect or the administration of the drug could be started later during the course of the disease).

The Early Treatment Option.

Just as disease begins at the metabolic level, so too does health. Cellular metabolism should be a primary target in the treatment of most diseases and age-related conditions, as well as in the improvement of overall health necessitated by the demands of our modern lifestyles.

Unlike solutions that can only be implemented when molecular and cellular disturbances have shown up with symptoms, metabolic compounds can effectively be used at a far earlier stage.
The aim of their supplementation is not merely to treat symptoms, but to support metabolic functions in order to prevent or minimize cellular alterations which would ultimately evolve into organ malfunction or damage.

In other words, we can use the targeted supplementation of such compounds as a real “early treatment” option and counter the silent period of “micro” alterations in cellular functions that lead to “macro” alterations that impact the organism as a whole. In doing so, we can address problems in their earliest states, when all or most of them are still at the metabolic level. In actual facts The Metabolic Approach™ to health and well-being can delay, if not eliminate, the onset of symptoms and lead to a substantial improvement in the quality of life.

Healthcare Professionals and The Metabolic Approach™.

The general public has clearly already embraced the use of dietary supplements. But since most people do not have an understanding of the human metabolism, they end up taking an uninformed approach to dietary supplement use.

In order for The Metabolic Approach™ to be truly effective, physicians will also have to become involved and play a major role in it. Like prescription drugs, dietary supplements must be precisely targeted to individual needs because metabolic changes vary considerably from person to person. Therefore, doctors should begin shifting some of their attention from the “crisis management” approach of treating symptoms, and focus instead on the long, silent period when chronic and degenerative diseases are only just developing and early treatment is still an option. During this period dietary supplements could be used alone, whereas once symptoms become evident they can be administered in conjunction with drugs.

The early treatment option is not to be confused with prevention: taking care of an existing problem is very different from preventing one.

Science and Products: the Must of Quality.

But before all the above can happen, dietary supplements must meet high product-quality standards and be backed by the strong science that the medical community demands. Clearly, physicians will not endorse the use of dietary supplements until they are considered both safe and medically effective. It is clear that much more than anecdotal evidence is needed in order for physicians and pharmacists to make recommendations and for consumers to make informed decisions. From the clinical efficacy stand point dietary supplements must be dealt with just as drugs: their efficacy must be proved through controlled clinical trials. In our company a lot of resources are allotted to this end.

It is also crucial that product be realized according to good manufacturing practices, or GMPs. These guidelines cover every aspect of the manufacturing process, from the training of workers to the use of equipment. At sigma-tau HealthScience we voluntarily apply pharmaceutical GMPs to all our products.

We believe that only products developed according to these high quality controls and standards and supported by strong clinical evidence should be made available to consumers and physicians.