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Castel Guelfo di Bologna, Italy

OBJECTIVES: To increase the efficacy and reduce the toxicity of cancer therapy. METHOD: The DBM with MLT, Retinoids, vitamins E, D3, and C has a differentiating, cytostatic, antiangiogenic, immunomodulating, factorially synergic effect, at the same time reinforcing those functions that Physiology considers essential for life. With Somatostatin and/or its analogues, the DBM has an antiproliferative effect, negatively regulating the most powerful mitogenic molecule (GH), receptorially co-expressed and interactive with Prolactin, inhibited by Cabergoline and/or Bromocriptin. The negative regulation of GH extends directly to the GH-dependent growth factors. In breast cancer, the DBM entails the use of estrogen inhibitors and minimal apoptotic, non-cytotoxic and non-mutagenic doses of Cyclophosphamide or Oncocarbide, the tolerability of which is enhanced by MLT and the vitamins in the DBM. RESULTS: Complete and stable cure of 4 cases, and rapid regression of the tumour in another 5 cases with just the DBM (first-line therapy), without surgical intervention. No disease recurrence with the use of the DBM as adjuvant therapy. Five-year survival of 50%, of stage IV cases, considerably higher than the data reported in the literature. A more or less generalised improvement in the quality of life, without any significant and/or prolonged toxicity. CONCLUSIONS: The acknowledgement of the still underestimated scientific evidence, such as the multiple antitumoral mechanisms of action of MLT, the negative regulation of the interactive mitogens GH-GF (GH-dependent growth factors), Prolactin and estrogens, together with the differentiating and homeostatic action of retinoids and Vitamins E, D3, and C and MLT, made it possible to achieve these results. An essential aspect of the mechanism of action on the clinical response is the factorial synergy of the DBM components. © 2011 Neuroendocrinology Letters. Source


Di Bella G.,Di Bella Foundation
Neuroendocrinology Letters | Year: 2010

AIMS: the aim of the Di Bella Method (DBM) is to try to overcome the high toxicity level and the limited efficacy of the current medical treatments for cancer. METHOD: using Melatonin, Retinoids, and vitamins E, D3, and C, components of the extracellular matrix, the DBM reinforces those means that Physiology considers essential for life. Acting together, these differentiating molecules also have an antiangiogenic and antiproliferative effect. Cabergoline and/or Bromocriptin negatively regulate Prolactin, the ubiquitary mitogenic hormone. This effect is reinforced by Somatostatin and/or its analogues by negatively regulating highly mitogenic molecules such as GH and GH-dependent growth factors. RESULTS: the preliminary results are reported of a retrospective observational study on 553 patients treated with the DBM. These data show that the DBM achieved an evident improvement in the quality of life and a considerable increase in the mean survival rates for every disease and stage with respect to the data available in the literature relative to chemotherapy and/or monoclonal antibodies. The result was achieved without any of the known significant toxic effects of chemotherapy and (albeit to a lesser extent with respect to chemotherapy) of monoclonal antibodies. The invalidating causes which removed all scientific credibility from the DBM experiments carried out in Italy in 1998 are also reported. CONCLUSIONS: I considered it of use to inform the scientific community of the rationale, the mechanism of action, the scientific basis and clinical findings of the DBM in order to encourage interest in the prospects opened up by the DBM through innovative formulations of the vitamins and Melatonin and the use of biological molecules with a high degree of antitumoural efficacy and low toxicity such as Somatostatin and its analogues. © 2010 Neuroendocrinology Letters. Source


Di Bella G.,Di Bella Foundation | Mascia F.,Di Bella Foundation | Colori B.,Rizzoli Scientific Research and Care Institute
Neuroendocrinology Letters | Year: 2013

OBJECTIVE: To evaluate the objective clinical response and the safety of the combined administration of somatostatin, melatonin, retinoids, vitamin D3, dopamine subtype 2 receptor (D2R) agonists and low doses of cyclophosphamide, associated with androgen ablation, in patients with a histological diagnosis of prostate adenocarcinoma (Pac). MATERIALS AND METHODS: The clinical data of 30 patients with non-invasive and metastatic prostate cancer, who attended our institution over a period of more than 5 years, were retrospectively reviewed. RESULTS: 16 patients satisfied the evaluation criteria. Median age: 64 years. Disease stages: 8 patients (50%) were in Stage II. For advanced stages (Stage IV), secondary lesions were located in the bones and lymph nodes. Taken together, an overall objective response (OR) [Complete response (CR) + Partial Response (PR)] was achieved in 69% of the patients, with 88% of objective clinical benefit [CR+PR+SD]. For local Prostate Cancer group, an OR was achieved in 87.5% of patients (7 cases; 53-98; 95% CI), with CR in 62.5% (5 cases, 31-86; 95% CI). In metastatic disease, the OR was 50% (4 cases; 21-78; 95% CI), with a 20% of CR (2 cases; 7-59; 95% CI) and 75% of clinical benefit. CONCLUSIONS: This preliminary study shows that patients with early and advanced forms of prostate cancer, not previously treated by surgery and/or chemo-radiotherapy, can achieve a more than positive clinical benefit with the protocol foreseen by the Di Bella Method. Further clinical investigations are strongly recommended. © 2013 Neuroendocrinology Letters. Source


Di Bella G.,Di Bella Foundation | Mascia F.,Di Bella Foundation | Gualano L.,Private Laboratory of Physiology | Di Bella L.,Private Laboratory of Physiology
International Journal of Molecular Sciences | Year: 2013

Melatonin (N-acetyl-5-methoxytryptamine, MLT), the main hormone produced by the pineal gland, not only regulates circadian rhythm, but also has antioxidant, anti-ageing and immunomodulatory properties. MLT plays an important role in blood composition, medullary dynamics, platelet genesis, vessel endothelia, and in platelet aggregation, leukocyte formula regulation and hemoglobin synthesis. Its significant atoxic, apoptotic, oncostatic, angiogenetic, differentiating and antiproliferative properties against all solid and liquid tumors have also been documented. Thanks, in fact, to its considerable functional versatility, MLT can exert both direct and indirect anticancer effects in factorial synergy with other differentiating, antiproliferative, immunomodulating and trophic molecules that form part of the anticancer treatment formulated by Luigi Di Bella (Di Bella Method, DBM: somatostatin, retinoids, ascorbic acid, vitamin D3, prolactin inhibitors, chondroitin-sulfate). The interaction between MLT and the DBM molecules counters the multiple processes that characterize the neoplastic phenotype (induction, promotion, progression and/or dissemination, tumoral mutation). All these particular characteristics suggest the use of MLT in oncological diseases. © 2013 by the authors; licensee MDPI, Basel, Switzerland. Source


Di Bella G.,Di Bella Foundation | Colori B.,Rizzoli Scientific Research and Care Institute | Mascia F.,Di Bella Foundation
Neuroendocrinology Letters | Year: 2012

OBJECTIVES: Lymphomas are the main form of haematological neoplasms, representing 55.6% of all tumours of the blood. Overall, they account for 5.3% of all malignant tumours (excluding basal and squamous cell skin cancer) in Italy with a prevalence constantly increasing at a rate of 3% per year. From a histological point of view, they represent a vast heterogeneous group of haematological diseases, their staging being based on defined cyto-morphological and anatomo-pathological criteria. Although the combined use of standard approaches can provide good response rates, recurrence is particularly frequent in patients undergoing traditional treatment, with critical and often irreversible side effects such as myelosuppression and a high frequency of opportunistic infections and sterility. Numerous epidemiological studies and preclinical data have for some time now reported the anticancer effects of molecules such as Melatonin, Retinoids, Vitamins E, D3, and C, Somatostatin and prolactin inhibitors in neoplastic diseases. There are, however, very few publications on the combined effects of these substances in vivo. METHODS: We report an observational study carried out on 55 patients affected by various forms of lymphoma, treated with the biological therapy known as the Di Bella Method (DBM). The 1, 3 and 5-year survival rates are reported, together with any signs of toxicity. RESULTS: The DBM treatment achieved partial or complete objective responses in a shorter time and in greater percentages if administered as first-line therapy. The adjuvant treatment increased survival time and improved quality of life with respect to the data reported in the literature for the same types and stages of lymphoma. CONCLUSION: Overall, the treatment was well tolerated, with minor and transient side effects. The patients were able to continue the treatment at home, carrying out their normal activities without problems. © 2012 Neuroendocrinology Letters. Source

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