DI BELLA METHOD > DRUGS

 
 
Drugs
 
 
 
The therapeutic ingredients of Di Bella’s multi-therapy (MDB) include somatostatine, octreotide, retinoids, Vitamins E, D, C, melatonin, bromocriptine, micro-doses of anti-blastic drugs (at dose levels 100-200 times lower than chemotherapy). Differently from cytotoxic and cytolytic chemotherapy, the mechanism of action of MDB treatment is a pro-apoptopic one.

The absolute majority of the 34,508 published reports on such ingredients – available as of Dec. 22, 2002 on MedLine - National Library of Medicine, and on this website under the section entitled ”MDB-Active Ingredients” – describe MDB effectiveness in countering the key features of cancer biology from onset to progression, that is: high proliferative rate, lack of cell differentiation, hence failure of apoptosis i.e. the main natural anti-blastic mechanism. These features are common to all cancer types

Even in prevention MDB has proved to be effective in respect of major factors of tumor etiopathogenesis, like oxidant agents and free radicals. MDB components like retinoids and other vitamins that help protect the epithelium, like vitamins E and D, are especially recommended in treating epithelial tumors. These vitamins, besides powerfully improving trophicity, integrity and functional recovery of epithelia, strongly limit - together with melatonin - cytotoxic damage caused by ionizing radiations of radiotherapy to neighboring epithelial tissues, as well as oxidative and free radical damage on nuclear DNA, cytosolic organelles and cell membranes.

MDB is therefore an effective, causal solution to cancer, while chemotherapy does not act upon the cause, but rather on the product of the cancerous process, i.e. the tumor cells. Chemotherapy deludingly aims at destroying all tumor cell populations: in fact some of these cells mutate and adjust, becoming more and more drug resistant, and rapidly proliferate in an increasingly weaker body whose anti-blastic, homeostatic and immune mechanisms have been severely, often irreversibly, compromised by chemotherapy.

By countering the manifold and changing etiopathogenic chains of cancerogenesis, MDB treatment helps redress the biological and physiological balance, the upsetting of which allowed the onset of cancer – even in the presence of solid tumors, cancer should always be considered as a systemic disease, with cancerous mass being only the maximum evidenced concentration. With MDB treatment, notably the interaction and synergy of its components, cancer biology reverts to physiological biology. While every single molecule exerts an anti-blastic action, their synergy powerfully improves MDB anti-tumor effectiveness. Somatostatine, bromocriptine and melatonin inhibit both pituitary hormones - like GH, prolactin, powerful and ubiquitous growth factors whose role in cancerogenesis is well documented - and IGF1, TGF, EGF, VEGF, PDGF, NGF, gastrin, FGF, colecistokinin – major factors in cancer etiopathogenesis.

The Di Bella method stems from the need to remedy the substantial inability of chemotherapy to cure cancer, as much is evidenced by the employment of oncological surgery, which would be pointless if chemotherapy were really effective.

 
 
 
 
DRUGS - CRITERIA FOR USE
 
 
Vitamin D3
 

The preparation is commonly found on sale. Dose levels must be adjusted to patient's weight, blood calcium response and stage of disease.



Retinoid Solution
 

The drug is not available for sale like other chemical medications but has to be prepared by a pharmacist. As a galenical preparation it requires special equipment and scientific expertise. Non-polar, hence water insoluble molecules like beta-carotene, retinol, retinoic acid and vitamin E require the use of an organic solvent that must be eliminated at the end of the preparation. The whole process must occur in the presence of nitrogen to avoid oxidation of active ingredients. (read the "Trials" chapter in the "Di Bella Method" section). Complete removal of the organic solvent, e.g. acetone or alcohol, is essential to avoid toxic effects and denaturation of active ingredients. Notably acetone has to be removed totally because of its proven carcinogenic effects triggered by manifold mechanisms, including the induction of cytochrome P450 2E1 (CYP2E1), very active in biologically inducing pro-carcinogenic substances. Other acetone-induced effects include a rise in free radicals and a drop in cellular ATP, which is key to cell apoptosis. The retinoid solution may be properly prepared following Prof. Di Bella's indications (again read the "Trials" chapter under the "Di Bella Method" section). During the 1998 MBD trials traces of acetone were found in all retinoid solutions prepared by the Italian Health Institute, with concentrations in some cases up to 850 mg per liter. These concentrations not only have carcinogenic effects but are also toxic, as much is evidenced by attached reports.



Hydroxyurea
 
Hydroxyurea - included in the variable therapy module - is employed at dose levels of 500 mg daily (up to 1000 mg under special circumstances). It has cytostatic properties and is mainly employed in hematology to treat chronic myeloid leukemia at much higher dose levels than those used in MDB (in the order of 30 mg per kg per day). The drug is also recommended to treat other chronic myeloproliferative syndromes like essential thrombocythemia, polycythemia and homozygote sickle cell anemia. MDB employs hydroxyurea at much lower dose levels than conventional oncology, since the pro-apoptotic and cytostatic properties of the drug can be obtained even with modest, hence better tolerated dosage.   The cytotoxic and cytolytic action typically obtained in chemotherapy with higher dose levels is totally foreign to MDB therapy, where hydroxyurea is above all used because it is able to cross the blood-brain barrier (hence treat brain tumors and other solid tumors). Toxic effects of the drug include medullary depression with anemia, leukopenia, plateletpenia. These can be limited and mitigated to a large extent by other MDB components like vitamins and melatonin. However, severe medullary depressions discourage use of hydroxyurea even in MDB.


Cyclophosphamide
 
Cyclophosphamide - included in the variable therapy module - is employed at dose levels of 50 mg once a day during meals, up to a maximum of 2 administrations per day. It is a nitrogen mustard alkylating agent, used at minimum dose levels in MDB treatment as opposed to those usually employed with chemotherapy. Conventional treatment of certain types of cancer may even envisage direct intravenous infusion of cyclophosphamide up to 10 g. In comparison, MDB dose levels are 50-100 mg per day, that is 100-200 times lower than in chemotherapy. Even the ways of administration, exclusively oral in MDB, and preferably intravenous in chemotherapy, radically change therapeutic response. In fact,  50-100 mg dose levels produce a pro-apoptotic effect on the tumor cell, i.e. induction of programmed cell death.


Cabergoline
 

Cabergoline - included in the fixed therapy module - is employed in the place of bromocriptine when the latter is not tolerated, at dose levels of 0.5 mg. per week, which can be increased in special cases of tumor progression and metastatic dissemination, especially in prolactin-dependent and hormone-dependent tumors. It is recommended in treating all types of cancer because it is a strong inhibitor of growth factors and interacts synergically with somatostatine, its synthetic analogues, and melatonin. It  is  especially effective in tumors mostly influenced by prolactin as a growth factor.



Bromocriptine
 

Bromocriptine - included in the fixed therapy module - is employed at dose levels of 2.5 mg administered 2-3 times a day during meals. It is recommended in treating all types of cancer because it is a strong inhibitor of growth factors and interacts synergically with somatostatine, its synthetic analogues and melatonin. It is especially effective in tumors mostly influenced by prolactin as a growth factor. Side effects include nausea, which mainly occurs  with a single and fasting administration per day. Such side effects may be avoided by fractioning drug administration during meals.



Melatonin
 

In order to obtain maximum bioavailability melatonin is prepared galenically in capsules with adenosine and glycine. Natural melatonin is "connected" to adenosine by hydrogen. Average dose levels are about ten 2 mg capsules daily, to be ingested during the day with a greater concentration in the evening. The antioxidant, anti-free radicals, anti-proliferation, anti-metastatic and pro-apoptotic effects of this molecule have been extensively described in world medical literature thus confirming the rationale of melatonin in the context of a multi-therapeutic approach to treat cancer.



Somatostatine - Octreotide
 

The biological product somatostatine-14 (tetradecapeptide) may be administered subcutaneously by means of a syringe pump over ten hours' time, during the night. Intravenous administration, always by means of a syringe pump, is also possible and definitely more effective in some cases, though more laborious. Average dosage in adults is approximately 3 mg per day.

Somatostatine is available for sale as a chemical preparation and thanks to initiatives promoted by patients treated with MDB, the average price dropped from 516,000 lire (approx. 260.00 euros) per vial in 1998, to the current 18.00 euros (with daily administration). The 8 amino acid synthetic analogue of somatostatine, namely octreotide, is also commonly available as a chemical preparation. Octreotide is employed with the same criteria of somatostatine-14, but at dose levels of 1 mg per day. Because the half-life (period during which the drug exerts its action) of somatostatine-14 is only a couple of minutes, continuous intravenous infusion is needed to keep drug concentrations effective for at least 8-10 hours.

While the half-life of octreotide well exceeds one hour, this nonetheless administration by means of a rate controlled infusion device is essential to avoid, or considerably limit gastro-intestinal symptoms like nausea, abdominal pain, etc. typically caused by rapid administration.

During MDB trials, as much was stated by officials of the Italian Health Institute (see the "Trials" chapter under the "Di Bella Method" section), only very few patients were granted the use of a syringe pump. Yet, their gastro-intestinal symptoms were disgracefully attributed to the substance rather than to its mistaken administration, no to speak of the impaired effectiveness of the drug.

Up until relatively recent times slow-release somatostatine analogues were produced in 10 mg, 20 mg, 30 mg packages and entailed a very high cost of about 1,700 euros per month. A single intramuscular injection of these analogues allows to cover 10, 20 and 30 days respectively. Because the drug remains dormant until it reaches effective concentrations, shorter intervals between injections are advisable (e.g. 27 days rather than 30 days for 30 mg injections).

More and more published reports on somatostatine, its receptors, radio diagnosis and immune-histochemical methods and RT-PCR techniques to identify such receptors, have been helpful to better clarify the mechanisms of action of both somatostatine and its analogues. There are also numerous scientific reports describing receptor properties and characteristics of the various cancer types. Since octreotide is definitely more effective on receptors 2 and 5 than somatostatine-14 and considering the latter's receptor affinity, an ever greater definition of receptors for every cancer type would be desirable to devise more targeted and effective treatment.



Vitamin C
 

Vitamin C may be administered both as a galenical product (much cheaper) or a chemical medication at dose levels of at least 2 g or more per day.