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Di Bella Therapy

Other common name(s): Di Bella multitherapy, DBM, MDB

Scientific/medical name(s): none

Description

Di Bella therapy is an alternative cancer treatment developed by an Italian physiologist. It is a mixture of the drugs somatostatin and bromocriptine, as well as vitamins, melatonin, and sometimes low doses of chemotherapy drugs or other substances combined in varying amounts. Therapy is tailored to the type of cancer and the results of blood tests.

Overview

Available scientific evidence does not support claims that Di Bella therapy is effective in treating cancer. It can cause serious and harmful side effects.

How is it promoted for use?

Supporters of Di Bella therapy claim the drug mixture stimulates the body's self-healing properties and can shrink tumors or even cure cancer. It is partly based on the idea that 2 of the body's natural hormones—growth hormone and prolactin—may stimulate cancer growth. One component of the therapy (somatostatin) works against growth hormone, while another (bromocriptine) acts against prolactin. Bromocriptine is a drug approved by the U.S. Food and Drug Administration (FDA) for treating pituitary tumors, Parkinson disease, and fertility problems. Somatostatin is naturally produced in the body, but a similar manmade substance (Octreotide) is sometimes used instead in Di Bella therapy. The inventor claimed he had treated and cured thousands of people who had a variety of cancers and that his formula caused no side effects.

What does it involve?

Patients having Di Bella therapy take the custom-made drug mixture daily. The potency of the mixture and the drugs involved depend on the type of cancer being treated and on the results of blood tests.

What is the history behind it?

Di Bella therapy was invented by Professor Luigi Di Bella, a retired physiologist from Modena, Italy. For several months during 1997 and 1998, Di Bella therapy caused an uproar throughout Italy when a judge in the southern city of Maglie ruled that the government had to pay for Di Bella therapy to treat a two-year-old boy with brain cancer. The child's parents had filed a lawsuit against the Italian Ministry of Health, which had refused to fund the treatment because Di Bella therapy was untested and expensive. A number of similar legal actions followed.

Even though there was no scientific evidence available to prove the benefits of Di Bella therapy, the therapy still had many supporters, and the Italian media quickly spread news about Di Bella's claims and about the lawsuits. Di Bella appeared in many television interviews and was written about in several hundred newspaper articles. Demand for Di Bella's formula depleted the supply of some of its components in many pharmacies, and people with cancer flooded Italian hospitals asking to take part in clinical trials. Thousands of supporters even held rallies in Rome to support government funding of Di Bella therapy.

Finally, bowing to public pressure, the Ministry of Health ordered a clinical study of Di Bella therapy. Some cancer specialists refused to participate for ethical reasons. The results of the clinical trial showed that Di Bella therapy was largely ineffective against cancer. The clinical trial is discussed in greater detail below.

Before the study began, researchers at the University of Parma surveyed more than 1,100 Italian citizens. Of those, 42% believed that Di Bella therapy worked, 53% were unsure, and only 1% thought it was a sham. Of those who responded, 90% had learned about the treatment from television, and only 5% had asked a doctor about it.

After the study results were published, public interest in the treatment decreased, but Di Bella therapy still has many supporters despite lack of evidence of its effectiveness. Di Bella passed away in 2003, but his therapy and variations of it are still available in several countries.

What is the evidence?

Di Bella claimed to have cured thousands of patients, but most of the records he kept could not confirm this claim. There is evidence from laboratory studies that some components of Di Bella therapy, such as melatonin and somatostatin, may have some effect on cancer cells, but it is not clear whether they would have the same effect in the human body. Bromocriptine is approved in the United States for use with mainstream treatment to reduce the size of some pituitary tumors before surgery and during radiation therapy. However, studies have not shown that combining these agents, as is done in Di Bella therapy, is effective in treating cancer.

Italy's Health Ministry conducted a study in 26 medical centers involving nearly 400 patients with different forms of advanced cancer. The final report, which included 395 patients, showed that no tumors went into complete remission (meaning they disappeared completely) and only 3 (less than 1%) went into partial remission (meaning they shrank by at least half). A quarter of the subjects died, and more than half got worse. The researchers concluded that Di Bella therapy did not deserve further clinical testing in patients with advanced cancer. Di Bella and his supporters criticized this study for selecting patients with advanced disease and for varying from his protocols.

A study was also published on the survival rates of cancer patients treated by Di Bella from 1971 to 1997. A review of 248 of his records (the 16% of his patients for whom good records were kept) showed that the treatment did not improve their survival, and may have had a negative effect compared to the outcome for similar patients receiving standard treatment.

In a small uncontrolled study published in 2001, Italian researchers treated 20 low-grade non-Hodgkin lymphoma patients with a regimen similar to that used in Di Bella therapy. It included cyclophosphamide, a drug often used in conventional chemotherapy regimens for lymphomas. After almost 2 years, 7 of the patients had a complete response, while in 5 patients the tumors advanced. In the other 8 patients, the lymphoma shrank slightly or stayed the same. It is not clear how much of a role the cyclophosphamide played in this study. The study did not include any control group, so it is uncertain whether patients receiving the standard treatment would have fared better. In addition, the results have not been duplicated by further research. And because of substantial advances in mainstream treatment of low-grade lymphoma during the past few years, few, if any, oncologists would now consider Di Bella therapy to be a reasonable treatment choice for this type of cancer.

Another small uncontrolled study of Di Bella therapy was published in 2006. This study of 28 patients with advanced lung cancer reported an improvement in cough, shortness of breath, pain, fatigue, and insomnia. However, results were based on notes from doctor-patient consultations, rather than standardized measures of patient-reported outcomes. Notably, the article does not mention the number of patients with partial or complete tumor responses or whose disease remained stable, and therefore provides minimal information about the effectiveness of this regimen.

Are there any possible problems or complications?

These substances may have not been thoroughly tested to find out how they interact with medicines, foods, or dietary supplements. Even though some reports of interactions and harmful effects may be published, full studies of interactions and effects are not often available. Because of these limitations, any information on ill effects and interactions below should be considered incomplete.

Side effects of Di Bella therapy may include nausea, vomiting, diarrhea, increased blood sugar levels, low blood pressure, sleepiness, and neurological symptoms. Some components of Di Bella therapy may interact with pain and blood pressure medicines, as well as certain antibiotic or antiviral medicines. People with diabetes and women who are pregnant or breastfeeding should not use this method. Relying on this type of treatment alone and avoiding or delaying conventional medical care for cancer may have serious health consequences.

Additional resources

More information from your American Cancer Society

The following information on complementary and alternative therapies may also be helpful to you. These materials may be found on our Web site (www.cancer.org) or ordered from our toll-free number (1-800-ACS-2345).

Dietary Supplements: What Is Safe?

The ACS Operational Statement on Complementary and Alternative Methods of Cancer Management

Complementary and Alternative Methods and Cancer

Placebo Effect

Learning About New Ways to Treat Cancer

Learning About New Ways to Prevent Cancer

References

Bertelli G. Di bella therapy was worthless.. 2003. Accessed at: www.quackwatch.org/01QuackeryRelatedTopics/Cancer/dibella.html on June 11, 2008.

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.

Italian Study Group for the Di Bella Multitherapy Trials. Evaluation of an unconventional cancer treatment (the Di Bella multitherapy): results of phase II trials in Italy. BMJ.

1999;318:224-228.

Memorial Sloan-Kettering Cancer Center. About Herbs: Di Bella Multitherapy. 2006. Accessed at: http://www.mskcc.org/mskcc/html/69203.cfm on August 27, 2008.

Norsa A, Martino V. Somatostatin, retinoids, melatonin, vitamin D, bromocriptine, and cyclophosphamide in advanced non-small-cell lung cancer patients with low performance status. Cancer Biother Radiopharm. 2006 Feb;21(1):68–73.

Todisco M, Casaccia P, Rossi N. Cyclophosphamide plus somatostatin, bromocriptin, retinoids, melatonin and ACTH in the treatment of low-grade non-Hodgkin's lymphomas at advanced stage: results of a phase II trial. Cancer Biother Radiopharm. 2001 Apr;16(2):171-177.

Note: This information may not cover all possible claims, uses, actions, precautions, side effects or interactions. It is not intended as medical advice, and should not be relied upon as a substitute for consultation with your doctor, who is familiar with your medical situation.


Last Medical Review: 11/01/2008
Last Revised: 11/01/2008