According to Dr. Di Bella, MDB is a combination of somatostatin, melatonin, a suspension of beta carotene, alpha tocopherol, and retinoic acid, bromocriptine, cyclophosphamide in low doses, vitamin D, and ascorbic acid. Because of extensive media coverage in Italy of patients treated successfully with MDB, the Italian Ministry of Health supported studies to determine whether it is an effective therapy. Eva Buatti, MD, of the epidemiology unit of the Direzione Santaria Azienda USL, in Florence, Italy, and her colleagues followed patients who had been treated with MDB from 1971 to 1997.

"Results from this study do not support any evidence of the efficacy of the anticancer strategy proposed by Dr. Di Bella in terms of the survival of this historical series of cancer patients," wrote the researchers. "This result should be considered conclusive as far as the cases examined are concerned. These, however, represent a large, nonbiased sample of the whole Di Bella therapeutic experience."

The researchers obtained their information from a database of Italian cancer registries. There were 3,076 records reviewed in the study. "A matching with up to four randomly selected cases from the database was attempted for each MDB patient, with the aim of comparing observed survival with one of the Italian registries’cancer cases," the researchers wrote.

The study participants were matched according the following criteria: cancer occurrence in the same site; gender; age within five years for common cancers, 10 years for less common cancers; period of diagnosis within 1.5 years for common sites, three years for less common sites; and that they were alive at the first date on which the patient entered MDB therapy.

Of the 314 patients entered into the study, only four had MDB therapy as their first choice of therapy. Of these, two died in less than 12 months; one patient with chronic myeloid leukemia died after four years; and one is still alive after two years of follow-up.

When MDB patients were compared with patients in the database of Italian cancer registries, five-year survival rates for children with leukemia and adult cancer patients was significantly lower in the MDB patients than in the database patients with childhood leukemia, breast carcinoma, and adult leukemia, and for all cancer patients combined, according to the researchers. "Twenty-seven MDB patients survived 10 years or longer after diagnosis. In only three cases was this long survival unexpected," the researchers wrote. In other words, the MDB treatment did not improve survival.

Dr. DiBella's therapy has been popular for a number of years, despite being unproven, said Barrie R. Cassileth, PhD, of Memorial Sloan-Kettering Cancer Center and a member of the American Cancer Society’s (ACS) advisory group on alternative and complementary methods of cancer management, in an accompanying commentary. "It was an untested product defended with religious fervor by patients. Anecdotal reports describing miraculous cures, rather than scientific data, were used to support its value. These characteristics describe not only Di Bella’s long unstudied cancer treatment, but also most other 'alternative' cancer methods."

She added that until research proves the value of these "alternative therapies," they will remain "alternative" and not mainstream or used widely in hospitals and cancer centers.