Vademecum

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Published on Saturday, 15 June 2013

Vademecum

INTRODUCTION

Contrarily to the misinformation broadly spread by the propaganda of the circles of power, the anticancer Di Bella Method (DBM), it is not "alternative" in the common meaning of the term, but it represents the rational integration of medical knowledge definitively acquired and emerging scientific evidence in a clinical freed by economic-political pollutions.

In all solid tumors chemo and/or radiotherapy, on basis of verifiable data and documented by scientific literature, do not have the ability to eradicate the tumor, but in a certain percentage, (which varies in base to the histological characteristics, the staging and tumor localization) can obtain only reductions or remissions of varying duration, penalized by toxicity and the mutagenic effect that selects more aggressive and resistant cancer populations in an organism that is increasingly debilitated by chemotherapy itself.

In many other cases the chemo and/or radio don't even get this deceptive and temporary palliative effect. We emphasize that the answer to the DBM is inversely proportional to the number and intensity of chemo or radiotherapy done, (the higher the number of cycles and the dose of chemo-radiotherapy done, less the MDB can show its effectiveness) and is directly proportional to the precocity of the treatment.

More the beginning of the DBM is precocious in comparison to the beginning of the illness, more rapid and effective is the response. However, in many (obviously not all of them) critical situations and advanced stages, DBM has also allowed us to achieve some improvement in the quality of life, (if the vital functions were not hopelessly compromised), to increase the life expectancy, compared to the median survival reported in the scientific literature in each single individual diseases and stadiums. The scientific evidence of antitumor action of each component of the MDB and enhancing synergy in this multitherapy context , can be found in the scientific medical database PubMed.

These documented scientific confirmations are not yet implemented by the Italian ministerial committees that it doesn't foresee the disbursement of DBM by the National Health Service.

In fact the current government has enacted laws that prevent the patients to appeal in order to obtain the dispensing of DBM even in cases in which they can clearly document the indisputable failure of chemotherapy to which they were unnecessarily subjected to, and the complete and stable healing with DBM.

These dispositions do not have scientific reasons and justifications, in fact typing, e.g., on PubMed: (((somatostatin) OR octreotide) OR somatostatine analogue) AND (cancer OR tumor) therapy, you get several thousand results of publications demonstrating the potential anticancer and tolerability of somatostatin, among them numerous publications of the candidate for the Nobel Prize Pollak MN and the Nobel Prize Schally AV., including: Mechanisms of antineoplastic action of somatostatin analogs, arrived twenty years after the publication of Professor Luigi Di Bella on Pineal Research (to the World Congress of Amsterdam on the pineal 1978), which included somatostatin among its essential components of the anticancer therapy.

Since then, both Pollak and Schally have published dozens of works (not yet enhanced in oncological therapy) on the antitumor efficacy and tolerability of somatostatin in all tumors.

So typing any other component of the DBM like (Retinoid[Title/Abstract]) AND (cancer OR tumor OR neoplasia) or (Melatonin[Title/Abstract]) AND (cancer OR tumor), or (Vitamin D[Title/Abstract]) AND (cancer OR tumor) and so on, we obtain tens of thousands of publications that confirm the scientific side and the effectiveness of each part of the DBM, which anticipated more than 30 years the recent acquisitions of the research, not yet enhanced by the oncology for a serious delay and a dramatic gap between scientific evidence and clinical practice!

A deeper and more complete definition of the DBM and its documented possibilities both preventive and therapeutic, can be found in the publication The Di Bella Method that displays the scientific thought of Professor Di Bella, the principles of the MDB, it's biochemical, molecular, pharmacological and physiological aspect. The potential antineoplastic action of the MDB components is documented by more than 2000 references cited in the text. The book is published by the Mattioli 1885 SpA Publishing House. To the physicians that are interested and make requests to the scientific center of the Foundation Di Bella in Via Marconi 51 - Bologna, Zip 40122 Tel +39 051 239 662 the volume "The Di Bella Method" is sent free of charge, as well as publications (In international scientific journals reviewed by pubmed) of the clinical trials the MDB. These publications are available on the official website of therapy Metodo Di Bella which lists hundreds of Abstract translated, and references.

It would be particularly helpful that the patients before deciding the treatment to follow, could have the possibility to check together with a trusted doctor (who knows medical-scientific English) which are the real possibilities of oncology in their type of disease visiting the site: PDQ® Cancer Information Summaries: Adult Treatment (NCI - National Cancer Institute) the most important oncological clinical reference from all over the world. For each pathology and its stage NCI returns all the therapeutic possibilities chemo or radiotherapic and/or monoclonal antibodies with their prognosis, and median of survival.

In neoplastic diseases DBM, like any other medical treatment, cannot promise or guarantee the cure, but in the majority of the neoplasies, can achieve better results with regard to the quality of life and the increase in life expectancy compared with literature data in the same diseases at the same level.

We never get tired repeating that the response to the MDB is directly proportional to the precocity of the treatment in comparison to the onset of the illness, and inversely with the number and intensity of chemotherapy and radiotherapy made.

Another fundamental aspect for a realistic assessment of the potential of the DBM, is the fact that chemotherapy, and radiotherapy alone or associated can invalidate and nullify, partially or completely the response of DBM and its therapeutic effects. As well as the advanced stages and/or critical may nullify the therapeutic effects of the DBM.

Many patients and family members for months or years rely on chemotherapy, and at the end, after the failure of the oncological treatment when the progression of the tumor has reached an unstoppable level, they turn to Metodo Di Bella (DBM). About this the sick and their families have no responsibilities, but the circles of power who manage medicine and have full control of the information, misinforming and censoring the Metodo Di Bella (DBM).

 

Instruction for use of the DBM

The family doctor should be informed about your choice to apply the DBM, which he could approve or not. Except for some components which can be prescribed by your GP (General Practitioner) as (Italian and/or European name) Atiten, Calcium Sandoz, Zofran, Parlodel, Dostinex, most of the drugs of the DBM are not paid (to Italian citizens) by the Italian National Health Service. We are willing to give to the family doctor all the scientific documentation that he will ask about the anticancer action of each individual component of the Di Bella Method and their synergistic effect in the multy therapeutic context of the DBM.

Treatment of the most frequent symptoms and possible side effects that may occur during treatment with Di Bella Method

Nausea, vomiting, diarrhea, fatigue can initially appear in many patients, even not pre-treated with chemo-radiotherapy, or in non-advanced stages of cancer. In these cases generally occurs a progressive and gradual adaptation and improvement within a few weeks.

These symptoms are much more frequent and obvious, particularly in patients in critical stage, advanced especially if pre-treated with chemo/radiotherapy/monoclonal antibodies. Even gastrointestinal disorders (gastritis, gastro-duodenal ulcers, reflux, colitis, dyspepsia, liver digestive deficiencies), or nervous disorders: anxiety, depression, emotional, state of hopelessness and irritability may encourage, strengthen and lead to a greater overestimation of these symptoms which in the vast majority of cases are neither serious nor permanent.

Usually they are expressed with intensity proportional to the stage of the disease at the time when the DBM was begun, and to the damage suffered by functions and vital organs during surgical treatment or chemo/radiation therapy/monoclonal antibodies, or caused by tumor progression and metastatic dissemination in organs and tissues. Even vagal hypertonia (aptitude to nausea or vomiting); metabolic disorders, including diabetes; exocrine pancreatic, hepato digestive and respiratory insufficiencies; cardiovascular diseases, may cause or amplify these symptoms, just as most patients suffering from allergic diathesis may be affected the most.

The most common disorders are: nausea, and/or vomiting, due to the action of somatostatin over secretions and motility of the digestive system. Also possible are bloating, heaviness, dysentery, fatigue, loss of appetite.

Several measures can reduce intensity and duration of these symptoms: the application of the timer for the infusion of somatostatin at least 3 hours after a light evening dinner (reduce decidedly mayonnaise, butter, cream, sauce, sausages, pastries, eliminate fries, wine, beer and spirits). Possibly at mid-afternoon have a light meal, reduced, with fruit, toast or anything else, in order to reduce the evening one.

Prof. Di Bella 3-4 times a week advised to replace pasta or rice with pureed legumes: chickpeas, lentils, peas, beans, broad beans (eliminating the hard to digest skin which cause bloating and meteorism) to which you can add a small amount of blended white meat. The resulting fragmentation promotes and accelerate the digestion. Legumes are rich in protein, low in fat and carbohydrate, molecules preferably used by neoplastic cells.

Ingest little liquids during the meal, drink at will up to 20-30 minutes before the meal or at least 3 hours later. Especially in the first 2 months, adjust the timer to 12 hours. More prolonged is the infusion, the more the effect of somatostatin and/or octreotide is tolerated and effective.

In case of nausea or vomiting in the morning ingesting the retinoids solution, give one tablet of - Italian and/or European name - Zofran 8mg (or Ondasterone-based analogues only!) at least 60-90 minutes before taking the retinoids solution. If this is insufficient, move to 8 mg by intramuscular injection.

PAY ATTENTION PLEASE: other antiemetics commonly used in these diseases as Plasil, Peridon, Litican, Levopraid and so on (respectively with Metoclopramide, Domperidone Alizapride, Levosulpirie) are clearly contraindicated because they increase prolactin, which together with the growth hormone GH, forms the so-called "GH-Prolactin axis", which represents the maximum boost to the proliferation and neoplastic progression!

It is clearly and absolutely contraindicated also the smoking that notoriously represents a strong neoplastic inductor because of the hydrocarbon that contains (Benzopyrene), while nicotine is a promoter of angiogenesis, essential step of neoplastic progression.

Usually (with the exception for some cardiovascular pathology) there are no contraindications for 2-3 coffees per day, which on the contrary may contain drowsiness induced in some cases, especially for the first month, by melatonin.

If there is persistent diarrhea, (in addition to the regular use of milk enzymes, and the limiting for 1-2 weeks the consumption of retinoids only in the morning) suspend the use of calcium in bags until the remission of the diarrhea, and rise to the maximum (12 hours) the duration of the infusion of somatostatin. In these cases take 1 tablet of Dissenten or Imodium (or loperamide-based analogues, in capsules or effervescent tablets or orosoluble tablets) at the first rush repeating a tablet at every evacuation. Generally it takes 3-4 tablets per day, however if the condition persists do not exceed 6 tablets per day. In such cases, to facilitate digestion, add Creon 10,000 or analogues, 1 tablet in the morning, 2 at noon and in the evening (active substance: pancrelipasi). In these cases it is good to associate for 3 days Clioquinol 125mg capsules (galenic formulation produced by pharmacists equipped for the prepartion of the DBM medicines), 3 tablets morning and evening (6 per day) along with one tablet of Bimixin (or analogues based on neomycin sulfate + Bacitracin) morning and evening x 3 days and two tablets of Lysozyme 500mg x meal (6 per day). This combination of medicines is effective in cases of diarrhea induced by intestinal pathogenic germs.

Even in the event of intestinal fermentations, bloating, heaviness, meteorism it is indicated a tablet of Creon 10,000 in the morning, 2 at midday, 2 in evening, with meals until the resolution of symptoms, repeating the administration if the disorder recurs. In obstinate forms of diarrhea even a tablet morning and evening of Antispasmin Colic in various cases is useful.

In the presence of acidity, reflux, gastritis, use products based on: Omeprazole (e.g.: Antra or Losec), Lansoprazole (e.g.: Prevacid or Lansoxecc), Esomeprazole (e.g.: Axagon or Nexiumecc), Pantoprazole (e.g.: Pantopan, Pantorc etc), Rabeprazole sodium (Pariet) or the corrisponding generic analogues, in dosages of 10 mg to 40 mg, at the discretion of the GP. Otherwise with the same indications, Ranitidine 300mg (Zantac or similar) 1 tablet per day etc, eventually combining as needed antacids based on Maalox (or analogues based on  magnesium hydroxide) in case of reflux Gaviscon a spoon 3 times a day (or analogues based on sodium alginate and bicarbonate). For abdominal pain, colics, are suitable Buscopan and/or Antispasmin Colic (or analogues based on hyoscine butylbromide or on belladonna extract 1% hyoscyamine + Papaverine Chlorhydrate).

In some cases, more frequently in latent or confirmed forms of diabetes (diabetes frequently precedes and promotes the onset of neoplasias), by the effect of Somatostatin, there may be a slight increase of blood sugar that usually does not reaches alarming levels. This increase can also occur in cases where the DBM involves the use of Synachten. If despite a limited intake of carbohydrates (sugars) high levels of blood sugar are still observed, it is recommended whenever possible, the use of oral hypoglycemic agents based on Metformin, which has shown some anti-tumor activity.

We also explain in brief how to treat diseases intercurrent in the course of application of the DBM in illness such as flus, colds, respiratory or digestive tract deseases.

For some of these most frequent pathologies in cold seasons, (cold, flu, cough, pharyngitis, bronchitis) is good to keep in the house, ready for use, some products that are compatible with the DBM, effective and tolerated as Lysozyme 500mg tablets and injections of Immunoglobulins (Berigoblin 5ml or analogues, to keep in the fridge!), which would require variable waiting time. Not all pharmacies have Lysozyme as medicinal nor they prepare it as galenic formulation. By the frequent mutations that have the flu viruses over the course of a year, influenza vaccines can rarely have a real effectiveness, for the improbable coincidence between antigenic character of the virus and the vaccine, more frequently the vaccine induces a misdirection of the patient's immune system aggravating the situation. It is essential an immediate intensive and continuous use of Lysozyme at the earlyest symptoms of cold, pharyngitis, flu; that shortens the course considerably, restricts the complications, symptoms and relapses, significantly enhances the effect of antibiotics and limits their use. It is good therefore always to keep at home some bottle of 500mg Lysozyme, which acts on all viruses and many protozoa and bacteria. Lysozyme is a component of natural immunity (C4), has no toxicity, neither acute nor chronic, and also acts on some germs responsible for intestinal disorders.

For respiratory diseases you should keep at home and use at the first symptoms in addition to Lysozyme, also the Betadine mouthwash for repeated and prolonged gargles (without diluting the product), at least 3-4 times a day.

To cleanse the nasal cavity and shorten the course of rhinopharyngitis, sinusitis, flus, besides the products mentioned, are also useful nasal wash 3-4 times a day with physiological and/or saline solutions.

In case of cough, catarrh, bronchitis, it is appropriate to use aerosol with broad-spectrum antibiotics the type of Glazidim or Timecef (or analogues based on ceftazidime or cefodizime) in vials of 1g. Prepare the product as for injection by diluting the lyophilized with solvent and use 1/2 vial morning and evening for at least 6 days. The administration by aerosol significantly decreases the percentage of antibiotic assimilated compared to oral or intramuscular administration, but effectively acts on upper aerodigestive epithelia.

If there is bronchospasm, breathlessness, difficulty breathing, asthmatic crisis, in the aerosol ampoule associate 1\2 vial of Pulmist (or analogues based on Flunisolide) and 10 drops of Broncovaleas (or analogues based on Salbutamol). PAY ATTENTION PLEASE: the Broncovaleas is contraindicated presence of tachycardias, extra systoles, risk of fibrillations.

In primary or metastatic lung cancer it is prudent to keep an oxygen cylinder at home and do, in case of respiratory difficulty, in addition to the aforementioned aerosols, Seretide spray 25/250 (or analogues based on Salmeterol - Fluticasone) doing 2 applications by mouth, breathing in deeply and holding the breath for as much as possible.

If the Lysozyme, nasal washes, aerosols, Betadine (Iodopovidone or analogues) mouthwash are insufficient to resolve the flu symptoms within 3-4 days, do an intramuscular injection of Immunoglobulins (Beriglobin 5 ml or analogues) one vial per day for 2 days the third after a week (keep refrigerated). The gamma globulin gives an immediate increase of immune defence capability. In Italy it is not available in pharmacies, as it is only intended for hospital use, whereas can be found regularly abroad.

Use Tachipirin or Novalgin for fever (or analogues based on paracetamol or metamizole) unless it has been observed evidences of allergies to these products.

Can occur, in some cases, an anemia (lack of red blood cells and hemoglobin) and/or leukopenia (a lowering of white blood cells) especially in patients pretreated with chemotherapy/radiotherapy, and/or in critical stage, advanced that usually recedes when administering erythropoietin (Eprex 10,000 or analogues) which is recommended if the hemoglobin (benchmark) drops below 11. If there is leukopenia (lack of white blood cells) and if these fall under 3500 it is useful the subcutaneous injection of Myelostim or analogues. The prescription issued by the undersigned, letterhead and signed shall be valid in all respects, but does not entail free provision of medicines by the National Health Service. The prescription may be renewed by the GP or by doctors who cooperate in the application of the DBM. As all prescriptions, including the products available abroad like immunoglobulins.

Growth factors of red blood cells (Eprex or analogues) or white (Myelostim or analogues), the medicines indicated in hormone-dependent cancers, such as Femara, Aromasin, Arimidex, Decapeptyl, Enantone, Casodex etc, can be prescribed by any doctor, but the "treatment plan" for their free provision - in Italy - must be prescribed by a hematologist or oncologist or endocrinologist of National Health Service. Neither myself nor a doctor who isn't hematologist or oncologist or endocrinologist affiliated or employed by the National Health Service can formulate treatment plans for the free provision of these products or of Somatostatin and/or analogues like Octreotide, Sandostatin and Longastatin. The undersigned, for the large number of patients to be followed and scientific commitments has very narrow margins of time and has no chance to do medico-legal examinations, appeals, reports, bureaucratic procedures, certifications etc.

Duration of therapy: It is not possible to preset a cure period the duration of which is related to the response to the DBM.

Self-management by patients or changes to the DBM by doctors who do not have experience or in-depth knowledge of the DBM may cause serious harm, often not recoverable and irreversible.

As long as the neoplastic disease in ongoing the treatment should be continued with any variations made by the undersigned based on the outcome and blood chemical and instrumental diagnostics. If you get the complete remission, the elimination of all symptoms caused by the neoplastic disease and with all the diagnostics exams it is ascertained and documented the absence of cancer, the treatment will not be abruptly interrupted, but gradually reduced under strict control of the undersigned. It is important to insist on this concept and emphasize it most clearly: when you get full and stable healing, the treatment not be interrupted absolutely, but is to be planned by the doctor who administers the DBM, a gradual and slow reduction under careful supervision, with monitoring of all blood chemical and instrumental parameters. When it is ascertained and documented the stability of the complete healing and somatostatin and the other components of the DBM have gradually been suspended, you permanently leave a spoonful of the compound of retinoids in the morning with Atiten and some pills of Melatonin at night that everyone theoretically should take to implement an effective and scientifically documented prevention of tumors.

 

A GENERIC FIRST MENTION ON THE MEDICINES

The therapy is home-based. The medicines administration is mainly orally except for the somatostatin (analogue to octeoctride) which should be dosed through a timed syringe under the skin. On the contrary, the octeoctride (commercial name Sandostatine or Longastatine LAR), in its packagings at slow release and with long-term effect are to be dosed intramuscularly. Other medicines to be dosed by injection may become necessary under certain circumstances.

The DBM (Di Bella Method) is composed either by Medicines produced by the Pharmaceutical Industry and available in any pharmacy or "galenics", prepared by pharmacists, called "preparing pharmacists", which have laboratories, specially equipped in order to produce and pack medicines, which can be normally prescribed by a doctor, otherwise not available or available at very high prices. We indicate specialized pharmacies which gathered experience in the preparations of the DBM (Di Bella Method) galenics which used to cooperate directly with its founder Professor Luigi Di Bella and or attending at conventions about DBM or received direct and detailed instructions by the Professor Di Bella.

A perfect preparation is difficult and complex and it needs a profound knowledge and a wide pharmaceutical knowledge along with the availability of a specially equipped laboratories. From time to time we perform a random check on sampled pharmacies thanks to tests lead by qualified Chemical Institute and one Italian University. Those pharmacies must have at disposal systems of lyophilization, systems of nitrogen cylinders, mixers of viscous liquids, micronisers for Retinoic Acid (ATRA), pressing machine at high pressure, machines for blistering and for the preparation of injectable molecules and must have a sterilized room and so on!

The DBM galenics are: Retinoic Solution (Axerophthol palmitate; All-trans retinoic acid (ATRA); beta-Carotene; alpha tocopheryl acetate) and biological DBM Melatonin  (the Melatonin has a chemical bond with Adenosine and Glycine). These galenics were created by Professor Luigi Di Bella by combining biological molecules to biochemical features and with the ratios in order to exalt the anti-cancer, immunostimulant and anti-degenerative effects. If packed and dosed according to Professor Di Bella instructions, they do not have toxic effects even for dosing which lasts over the years. These galinics must be prepared strictly ensuring the following criteria:

  1. Using only the most pure substances, which have controlled quality;
  2. Strictly following the preparation standards codified by Professor Di Bella;
  3. Having at disposal adequate rooms and equipment.

The quality of the medicines is obviously very important in order to obtain an optimal therapeutic response! A preparation which in any way does not meet the DBM standards and a wrong dosing (as it occurred during the pseudo-experimentation in 1998) clearly compromise the results!

 

WHERE AND HOW THE MEDICINES SHOULD BE STORED UP

For the other medicines, must be followed the instructions available in their packages.

 

WHEN AND HOW SHOULD BE TAKEN

It is basic to literally follow the detailed indications provided in the therapy prescription:

 

MOST COMMON SIDE EFFECTS. HOW TO REDUCE OR AVOID THEM

The DBM does not use toxic active ingredients or which cause damage to the body, especially in the indicated doses, as it is the Biological Therapy for antonomasia. In spite of this, for reasons different from the toxic valency, especially during the very first period of the therapy, some side effects may appear, which gradually disappear after some time.

The medicines which may cause side effects are:

  1. Somatostatin and/or octreotide (the one which must be dosed on a daily bases with slow release through a timed syringe);
  2. Parlodel (Bromocriptine) and Dostinex (Cabergoline) but in less cases;
  3. Anti-extrogen/aromatase inhibitors (in case of breast or prostate cancer);
  4. Calcium (and sometimes Vitamin C/Ascorbic acid).

The DBM doctor usually indicates detailed standards in order to avoid problems.

These notes are meant to help those who first approach the therapy and might get questions:

  1. Somatostatin / Octreotide: if the recommended cautions are not properly followed, nausea, various intestinal disorder, aerophagia or bothering feeling of fullness may arise;

    A) In order to avoid what it is above described it is highly recommended to have a light dinner in terms of quality and quantity, the most possible dry (see below in the text food recommendations). 3 hours must pass between the meal and the beginning of the somatostatin infusion;

    B) It is necessary to start with the dosing indicated in the prescription (usually 1 mg for the somatostatin) gradually up to up and running therapy with 3 mg for the somatostatin and 1 mg for the octeoctride to be dosed at slow release through the timed syringe;

    C) It is necessary to remember that, in order to avoid any inconvenience, three basic rules must be followed: 3 hours must occur between the meal and the beginning of the somatostatin or octeoctride dosing – the lasting of the infusion which must be regulated to 12 hours at the beginning and than to 11 or 10 hours down to not less than 9 hours.

    If it is necessary to get an anti-nausea, Zofran is recommended as other emetics counteract with the action of Bromocriptine and Cabergoline and increasing Prolactine, an hormon interactive with the growth hormone to increase the cancer growth;

    D) Octreotide at slow release (commercially is available Sandostatine or Longastatine LAR): as before stated, it is octreotide to be injected intramuscularly instead of the daily basis, according to the frequency and doses prescribed by the DBM doctor. Normally the Octoctride LAR does not cause any inconvenience. For any further detail it is enough to follow the instructions listed inside the packaging and/or asking to an very expert nurse and to read these instructions: use of Octreotide LAR.

  2. Inhibitors of prolactine. Parlodel needs a gradual adaptation which occurs through increasing doses, as indicated in the prescription, in order to allow the body to get used to it.

    The Dostinex (which normally is prescribed ½ pill twice per week), normally does not cause any inconvenience. In most of the cases both medicines are needed for the therapy;

  3. Calcium Sandoz: besides the assumption with full stomach, it is necessary to follow the exact increasing doses prescribed. The tolerability to high doses depends on each single patient;
  4. Vitamin C / Ascorbic acid: it must be remembered that it needs to be melt uniquely in mineral water and not in the water from the tap, even if filtered. In fact the chlorine normally inside this kind of water would damage the pharmacological action of the medicine. It must be taken during the meal or right after in order to avoid problems and with a gradual dosing.

    We remind you also that it is mandatory to use plastic spoons and little spoons. A plastic little spoon contains 2-2,5 mg of Ascorbic Acid. The choice of the speciality (we highly recommend to use ONLY pharmaceutical products and NOT the ones produced by para pharmacies or herbalist's shops); on top this choice of pure substances allow money savings. Some may tolerate one better than the other.

  5. Melatonin: always keep in mind that DBM Melatonin is very different from the one easily available at the pharmacies or para pharmacies or at herbalist's shops with various formulas. Indeed the DBM Melatonin is a formula melatonine-adenosina-glycine which allows a better bioavailability and the most effective anticancer response and must be bought only by specific pharmacists provided with freeze-drying machines, pressing machine at high pressure and machines for blistering, just like the Retinoic Solution special equipment are needed.

    The common Melatonina (not DBM!) it is not solvable in the water and it is an obstacle to bioavailability. The DBM Melatonin can be easily melt into the water (apart from very little and not significant residues, mainly due to the excipients). The DBM Melatonine perfectly prepared should be solvable into water. The packaging must be only in blisters in order to store it and save it from degradation and oxidation (unless a lyophilized Melatonine in small bottles and to be diluted with physiological solution and to be taken horally). The Melatonine is fully non toxic and has no side effect. The only symptom which may be felt at the very beginning is drowsiness, which than disappear.

 

DETAILED DESCRIPTION OF SOMATOSTATIN AND OCTREOTIDE INFUSION

ESSENTIALS ON THE AUTOMATED SYRINGE PUMP: what it is, how it works, why it is used, how much it costs, where to find it

The automated syringe pump is a small device that pushes the piston of a 10 ml syringe (filled with somatostatin or normal octreotide, and physiological solution) for the time being set. Basically, a tiny motor is run for the desired time, ranging between eight and twelve hours, starting in the evening (as said, two hours and a half/three after the end of dinner) and running while sleeping. Supplied with the syringe pump there should be a little bag to be fastened at the chest with a cloth belt.

Syringe-pump1
Syringe-pump1
Syringe-pump2
Syringe-pump2
Syringe-pump3
Syringe-pump3

Butterfly-G25

Butterfly Needle G25 Short (60cm kink-resistant tube)

Butterfly-G25

Of course it is necessary to stock up an adequate quantity of "winged needles" (see Butterfly-G25 figure) 10 mm long, attached by a tiny tube to the syringe nozzle.

The operating manual is usually included in the package (for details, see also the detailed description available at: ___insert link___)

The use of the automated syringe pump is indispensable:

  1. To allow the gradual and optimal absorption of somatostatin (or octreotide) during the night, the period during which it is produced in our body, in much higher percentage, the GH, the growth hormone, the main responsible for the development of the tumor mass;
  2. In order to avoid adverse symptoms. In the absence of automated syringe pump, the patient would experience acute symptoms (vomiting, diarrhea, uncontrollable nausea). During the 1998 DBM ministerial trial, in the majority of patients they did not use the automated syringe pump, instead they directly injected somatostatin nullifying its effect and debiting as DBM toxicity the symptoms of nausea and vomiting caused by the incorrect administration;
  3. Some patients, concerned about the high cost of LAR, believe that they cannot afford the cost of the treatment, and give up. Somatostatin, injected with automated syringe pump, is effective and sufficient; the use of LAR is useful, but not essential, as it accelerates and enhances the therapeutic response. It has character of necessity, in association with somatostatin only in specific pathologies and in certain stages, and often only for 4-5 months. In conclusion, many healed completely just with somatostatin. Being able to bear the expense, and associating for periods of a few months "somatostatin + LAR" especially at the beginning, you may have more rapid responses. The retail price of the usually recommended somatostatin (currently Hikma, national production) is 14,90 € per maximum daily dose (some pharmacists make discounts that bring the price to 12-13 €). The package includes 3 vials of 1 mg. So the daily cost at the maximum dosage (3 mg.) is between 12 and 13 € (360 € monthly);

Octreotide LAR has a considerably higher cost, although there is an important alternative to contain it (see below). About the specialties, there are two analogous drugs: Sandostatin (Novartis) and Longastatin (Italfarmaco). The price is the same.

Octreotide for infusion by timed syringe (not intramuscular LAR): pack of 1 mg (maximum daily dose) € 105.22 (discountable at the pharmacy); pack of 3 vials of 0.5 mg € 180.10. You can count on significant savings by ordering octreotide for infusion by timed syringe to a specialized pharmacy in Rome (equipped with lyophilization plant, vials making and sterile chamber) well-equipped, which purchases the pure active substance from the chemical manufacturer of the pure substance and makes it available to patients at prices far lower (about half). The pharmacy is Farmacia Crimi, Piazza Bologna, 19-20, Rome, Tel. 06/44.29.11.50 or 06/44.24.38.75, that ships to domicile upon acquisition of the prescription.

Octreotide Lar for intramuscular use 10mg €786.64 (discount up to €629); Lar 20mg: €1,355.95; Lar 30mg: €1,761.93. During the first period of "attack" of the therapy the doctor will advise you about what dosage of Lar may be sufficient to use.

 

Use of octreotide - somatostatin of 8 amino acids - LAR (Long-Acting Release)

(Keep the product in the refrigerator!)

The product is a somatostatin analogue composed of eight amino acids, also present in the blood, which inhibits the production of growth hormone (known as somatotropin or GH). This hormone is the main responsible of both our growth, from childhood to adulthood, and that of the tumor.

It is also essential for the activation of other powerful and ubiquitous tumor growth factors such as EGF, epidermal growth factor, VEGF, vascular, IGF1 insulin-like etc. Therefore, the inhibition of GH, mitogenic factor and potentially inducer of cancer, meets a clearly logical criterion, well documented in literature, supported by with clinical and experimental findings.

Failure to use (except in rare exceptions) of this antitumoral molecule of the DBM is a serious rupture between scientific evidence and clinical oncology practice, which rules it out.

It can be used to strengthen the action of somatostatin (14 amino acids) to be injected subcutaneously in the evening, 3 hours after dinner with timed syringe, or as alternative to somatostatin.

Since the product is of slow release, it can easily solidify if not diluted properly. The packages of 10 mg cover between 7 and 10 days, those of 20 mg between 16 and 20 days, those of 30 mg from 25 to 28 days. It is prepared to be gradually diluted in the blood, slowly releasing the active ingredient. For this reason, if the preparation does not carefully follow the included instructions, the syringe may tend to get easily stuck during the injection or the product to solidify in the course of preparation. Therefore, we urge you to repeatedly read and carefully follow the following instructions:

  1. The product should be removed from the refrigerator at least 15-20 minutes before use to allow the syringe and the solvent to reach room temperature. After removing the protection capsule from the phial of LAR, gently tap the bottom of the bottle on a hard surface to settle the whole product to the bottom of the phial;
  2. Remove the protective cap from the syringe containing the solvent. Insert a needle on the syringe;
  3. Disinfect the rubber stopper with cotton and alcohol then introduce the needle through the center of the rubber stopper;
  4. Slowly inject the solvent into the bottle, making it pour slowly down the side without moving the powder. Do not directly inject the solvent in the powder. Remove the needle from the phial;
  5. Do not shake the bottle until the solvent has not soaked all of the powder (after about 2-5 minutes). Without overturning the bottle, check the powder on the walls and bottom of the phial. If dry spots persist, allow the solvent to wet the powder without shaking;
  6. Once the solvent has evenly soaked the powder, shake the bottle with moderate circular movements for about 30-60 seconds, until you get a uniform and milky suspension. Do not shake excessively as this may cause flocculation of the suspension and make it unusable!
  7. Immediately reinsert the needle into the rubber stopper and placing the phial on a hard surface at an angle of about 45', slowly draw the content of the bottle into the syringe. Do not capsize the bottle when filling the syringe as it may affect the quantity drawn. It is normal for a small amount of suspension to remain on the walls and bottom of the bottle. This is a calculated excess;
  8. Immediately replace the needle so far used with the other one included in the package;
  9. The product must be administered immediately after the preparation of the suspension. Slowly turn the syringe upside down in order to maintain a uniform suspension. Purge the syringe of any air!
  10. Disinfect the injection site with an alcohol swab. Slowly and with constant pressure perform a deep intramuscular injection in the right or left gluteal, after having drawn to make sure you are not in a blood vessel. If the needle gets clogged, insert a new needle of the same diameter [1.1 mm, gauge 19]. The LAR must only be administered by deep intramuscular injection and never intravenously. In case of accidental involvement of a blood vessel, insert a new needle and change the injection site.

 

Some dietary advice

Nowadays there is abundance of dispensers of dietary suggestions, much more categoric as less competent.

In general, the cancer patient must strive as much as possible to protect the fundamental hepatic and gastro-intestinal functionality, often damaged by previous toxic therapies or previous anomalies.

Prof. Luigi Di Bella used to recommend each patient a diet tailored on their personal situation. From our side we can only recall a few tips, generalized and of great profile.

Along with the above, can succor - if recommended by the prescribing physician - some harmless drug aid. In particular it should be noted that a gut in order greatly reduces the likelihood of adverse events related to the administration of somatostatin and other drugs of the DBM. It may be useful "to keep at home" fresh milk enzymes (those for refrigerator) and Clioquinol, powerful and well tolerated intestinal disinfectant. Even the seemingly banal yeast (cubes from the supermarket - ½ cube dissolved in a few fingers of lightly sugared water on an empty stomach - or fresh baker's yeast) can give a great contribution to an adequate intestinal flora.

We also remember - although it is a thing related to other issues – that the use of Lysozyme (available in pharmacies as a specialty or as galenic at the preparer pharmacists) can be invaluable as preventive measure in periods at higher risk of viral infection (colds, seasonal influences etc.). The drug is completely free of side effects.

 

Lastly: some advice of a general nature