Despite claims of curative qualities and intense media and public pressure for free access to a popular alternative cancer treatment, Italian researchers made a sobering discovery that the treatment is not effective. The cocktail of medications and vitamin supplements, known as the Di Bella Multitherapy (MDB), which has been hailed as a miracle cure for cancer, was proven unsuccessful and even potentially dangerous to patients. Two scientific studies, a commentary, and an editorial in the November 15 issue of Cancer discredit the popular Italian alternative cancer treatment theory, warn about the dangers of using unproven treatments, and suggest that American health providers further research the potential benefits and dangers of alternative and complementary therapy.
A retrospective study failed to produce any evidence of efficacy of the MDB anticancer strategy in terms of prolonging survival. Phase II clinical trials showed that less than 1% of patients treated with MDB had only a partial response to treatment.
Di Bella Multitherapy was developed by Luigi Di Bella, a physiologist in Modena, Italy. Dr. Di Bella insists that he can cure up to 100% of cancer patients and that the condition of dying patients can improve with his treatment. Dr. Di Bella further claims that over the past 20 years he has treated more than 10,000 cancer patients with a mixture of vitamin supplements and prescription drugs. Dr. Di Bella has not published peer-reviewed evidence of his claims, but he did cooperate in a retrospective study ordered by the Italian government.
Long-Term Survival Is Not Improved by MDB
In an article by Eva Buiatti, MD, of the Epidemiology Unit, Azienda USL Firenze in Florence, Italy, and colleagues, survival for patients treated with MDB between 1971 and 1997 was compared with survival in individually matched cancer cases from the ITACARE database, a pool of Italian cancer registries.
A total of 314 patients were entered into the study. Of these participants, only 4 received MDB as the sole anticancer therapy. Five-year survival rates for children with leukemia and adult cancer patients were both 29.4%. The 10-year survival rate for children was 19.6%, with a 16% survival rate for adults. Cancer patients treated with MDB survived only half as long as patients who received conventional therapies. The authors recognize that such poor results may be attributable to a selection of less curable cases in the Di Bella series, patients' not adhering to chemotherapy and other conventional therapies, or a combination of both.
"MDB patients showed lower survival probability over both the short term and the long term for all cancer sites considered," writes Buiatti regarding the retrospective study. "Differences were statistically significant for cancer amenable to treatment, such as female breast cancer, and adult leukemia, and for all cancers combined. Although these very poor results may be at least partially attributed to selection of advanced cases, they clearly exclude the efficacy of MDB treatment, as initially claimed."
MDB Fails to Cure Patients
Less than 1% of patients treated with MDB in Italian clinical trials had a partial response to this treatment. From March to July 1998, Italian researchers enrolled patients from 26 cancer centers in phase II clinical trials to evaluate MDB. This study, by Giuseppe Traversa, MD, of the Istituto Superiore di Sanita in Rome, Italy, examined the treatment's ability to fight disease in patients with different kinds of cancer and in patients who were critically ill. Only 3 of 386 patients studied had partial responses, and no patients experienced complete remission.
"With only 3 partial responses among 386 patients, the results of the trials were considered incompatible with the initial claim that MDB might represent a cure for any type of cancer," affirms Traversa. "The possibility that, for a specific cancer among those included in the trials, there might be a therapeutic efficacy of clinical interest is also remote."
MDB Regimen Included 100 Compounds
Over 2 decades, Dr. Di Bella prescribed more than 100 different drugs as part of the MDB treatment. He eventually refined the prescribed regimen to a combination of less than 10 elements: somatostatin (or its synthetic equivalent, octreotide); melatonin; and a "syrup" of bromocriptin, beta-carotene, alpha-tocopherol, vitamin D, ascorbic acid, and retinoic acid. In some cases he also added low doses of cyclophosphamide, hydroxyurea, or another cytotoxic agent to the mix.
Patients Fought for Free Access to MDB
MDB costs approximately 7500 Euros, or US$7961, for 1 month of treatment. Because Dr. Di Bella had not proven MDB in clinical trials, patients were unable to obtain free access to the regimen through the Italian healthcare system. When cancer patients and their relatives claimed that the government was discriminating against the poor by refusing to pay for treatments, their protests drew intense media attention.
From December 1997 through January 1998, 36% of prime time television news in Italy was devoted to the Di Bella case. Between 91% and 100% of those interviewed on television expressed positive views about the treatment. In these programs, Dr. Di Bella repeated his claims of 100%-cure probability and argued that he was unable to validate his results because the medical establishment had conspired against him and against identifying a cure.
Within months, requests for MDB had peaked to an all-time high and several hundred patients received free access to the treatment by Italian court order. Public demand for MDB finally persuaded the Italian Minister of Health to agree to consider free access to the treatment if clinical trials could prove its efficacy.
Complementary and Alternative Medicines Warrant Careful
In this issue of Cancer, American and Italian scientists report that, despite lacking in concrete supportive evidence and being potentially dangerous, a variety of complementary and alternative approaches are embraced by the mass media and public. In the United States, the desire for greater access to complementary and alternative treatments also is growing. Approximately 42% of Americans used some form of complementary and alternative medicine in 1997, and spent an estimated $21.2 million on approaches such as biofeedback, guided imagery, acupressure, massages, vitamins, herbs, dietary supplements, magnets, crystals, and others.
The US government is currently considering ways to improve public access to complementary and alternative medicine. A commentary in this issue, by Barrie R. Cassileth, PhD, of Memorial Sloan-Kettering Cancer Center in New York City, and colleagues points out that the US House Committee on Government Reform currently is holding hearings to assess whether the federal government is doing enough to facilitate public access to alternative therapies.
This increased public interest and susceptibility reflect the greater awareness of and openness to complementary and alternative medicine. They are also alarming in the face of mounting evidence that the available information, supplemented by unfounded claims, which may result in life-and-death decisions, is often inaccurate. Ultimately, the proclaimed wonder cures may cause more harm than benefit, as the Di Bella case demonstrates.
"The ready availability of information, much of it misleading or false, seems to be everywhere. Books, catalogs, the Internet, and television commercials all promote unsubstantiated claims for products and practitioners that can cure cancer," comments Cassileth. "Billions of dollars are spent annually for unproved products and services. Most waste precious time as well as money, may produce harm, and few offer even a remote promise of success."
As explanation for the Di Bella popularity in Italy, researchers also consider that some patients with advanced-stage cancers, who are aware of the limited efficacy of chemotherapy, may seek alternative therapies to escape the harsh adverse effects of conventional treatments.
Cancer is caused by both internal and external factors. Scientific evidence suggests that up to one-third of the 563,100 cancer deaths expected to occur in 1999 will be related to nutrition and could be prevented. Since the occurrence of cancer increases with age, most cases affect adults middle-aged or older. Screening examinations, conducted regularly by a healthcare professional, can result in the detection of cancer of the breast, colon, rectum, cervix, prostate, testis, oral cavity, and skin at earlier stages, when treatment is more likely to be successful.
Scientists strongly recommend that more research be conducted to assess potential benefits of alternative and complementary treatments, and to dispel popular myths that may be cheating patients out of receiving the best treatment possible.
Buiatti E, Arniani S, Verdecchia A, Tomatis L. Results from a historical survey of the survival of cancer patients given Di Bella Multitherapy. Cancer. 1999;86:2143-2149.
Traversa G, Maggini M, Menniti-Ippolito F, et al. The unconventional Di Bella cancer treatment: a reflection on the Italian experience. Cancer. 1999;86:1903-1911.
Cassileth BR. Alternative and complementary medicine: separating the wheat from the chaff [commentary]. Cancer. 1999;86:1900-1902. Calabresi P. Medical alternatives to alternative medicine [editorial]. Cancer. 1999;86:1887-1889.