Gonzalez Regimen (PDQ®): Complementary and alternative medicine - Patient Information [NCI]

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Gonzalez Regimen

Overview

  • The Gonzalez regimen, developed by Dr. Nicholas Gonzalez, involves taking pancreatic enzymes thought to have anticancer activity. The regimen also includes prescribed diets, nutritional supplements, and coffee enemas (see Question 1).
  • The Gonzalez regimen is based on the theory that pancreatic enzymes help the body get rid of toxins (harmful substances) that lead to cancer (see Question 3).
  • A few studies have examined the effect of pancreatic enzymes in animals with implanted cancers, but it is not possible to test many other parts of the Gonzalez regimen this way. (see Question 5).
  • In an early small study of Dr. Gonzalez's patients with advancedpancreatic cancer, he reported that patients on his regimen lived longer than most people with the same type of cancer (see Question 6).
  • A later nonrandomized, controlled clinical trial compared the effectiveness of standard treatment with that of the Gonzalez regimen in patients whose pancreatic cancer could not be removed by surgery. Patients treated with standard chemotherapy survived an average of 14 months and patients treated with the Gonzalez regimen survived only an average of 4.3 months. In addition, patients treated with chemotherapy reported a better quality of life than those treated with the Gonzalez regimen (see Question 6).
  • The US Food and Drug Administration has not approved the Gonzalez regimen as a cancer treatment (see Question 8).

Questions and Answers About the Gonzalez Regimen

What is the Gonzalez regimen?

The Gonzalez regimen is a complex treatment plan based on the role of enzymes, vitamins, minerals, and other dietary factors. The developer of the regimen, Dr. Nicholas Gonzalez, promotes it as a treatment for advancedpancreatic cancer. Supporters of the Gonzalez regimen say it fights cancer in these ways:

  • Helping the body get rid of cancer-causing toxins taken in from the environment and processed foods.
  • Balancing the part of the nervous system that controls automatic body functions such as heartbeat, blood pressure, digestion, and breathing.
  • Keeping the immune system healthy.

Some key parts of the regimen include the following:

  • Taking a freeze-driedpancreatic enzyme that is made from pigs. This is said to be the main cancer-fighter in the regimen.
  • Taking a large number of nutritional supplements, including magnesium citrate, papaya, vitamins, and other minerals.
  • Eating a special diet of mainly organic foods.
  • Taking coffee enemas twice a day.
What is the history of the discovery and use of the Gonzalez regimen as a complementary and alternative treatment for cancer?

In 1902, James Beard, a Scottish physician, suggested that pancreatic enzymes might control and kill cancer cells. Later, William Kelley, a dentist, further developed Dr. Beard's ideas and published the results of his own practice. Impressed by these findings, Dr. Gonzalez began working closely with Dr. Kelley. The Gonzalez regimen combines the work of Dr. Gonzalez and Dr. Kelley with the theories and practice of Dr. Max Gerson. Dr. Gerson also treated cancer with diet and nutritional supplements.

What is the theory behind the claim that the Gonzalez regimen is useful in treating cancer?

Supporters of the Gonzalez regimen believe that toxins (harmful substances) in the environment and in processed foods cause cancer to form in the body. These toxins are said to build up in tissues of the body, preventing important body processes from working correctly and letting cancer develop. The theory is that if these toxins could be destroyed and removed from the body, cancer would stop growing.

The pancreas secretes enzymes, proteins that help digest food. The Gonzalez regimen is based on the theory that pancreatic enzymes also help the body get rid of toxins that lead to cancer. The coffee enemas are added because they are believed to improve the liver's ability to remove toxins from the body.

The diets used in the Gonzalez regimen are planned for each patient's metabolic type. Metabolic typing is a theory that people fall into one of three groups based on the main type of food (protein, carb, or mixed) that their bodies need to stay healthy. The developer uses certain tests, including looking at the patient's hair under a microscope, to decide a patient's metabolic type. The theory is that a diet that is correct for the patient's metabolic type will keep the body healthy and better able to prevent or fight cancer.

How is the Gonzalez regimen administered?

The pancreatic enzyme is taken by mouth, in a capsule. Between 130 and 160 doses of other nutritional supplements are taken by mouth each day. The patients also eat a special diet and have coffee enemas twice a day.

Have any preclinical (laboratory or animal) studies been conducted using the Gonzalez regimen?

Research in a laboratory or using animals is done to find out if a drug, procedure, or treatment is likely to be useful in humans. These preclinical studies are done before any testing in humans is begun. Animal studies of the Gonzalez regimen looked at the effect of pancreatic enzymes in cancer treatment, but did not study the regimen as a whole. There has been preclinical testing on the effects of pancreatic enzymes in several cancers:

  • In 1999, an animal study tested the effect of different doses of pancreatic enzymes taken by mouth on the growth and metastasis (spread) of breast cancer in rats. Some of the rats received magnesium citrate in addition to the enzymes. Rats receiving the enzymes were compared to rats that did not receive the enzymes.
    • Results showed that the enzyme did not affect growth of the primary tumor (where the cancer started).
    • The cancer spread to the most places in the rats that received the highest dose of enzymes.
    • The cancer spread to the fewest places in the rats that received the lowest dose of enzymes plus magnesium citrate.
  • Another animal study looked at the effects of pancreatic enzymes on survival rates and tumor growth in rats with pancreatic cancer. Rats receiving the enzyme treatment lived longer, had smaller tumors and fewer signs of disease, and were more active than the rats in the control group, which did not receive the enzyme.
Have any clinical trials (research studies with people) of the Gonzalez regimen been conducted?

Nicholas Gonzalez, a New York physician, first studied his regimen in 11 patients who had advanced pancreatic cancer. In 1993, he reported selected results of the study to the National Cancer Institute (NCI). Patients treated with the Gonzalez regimen lived a median of 17 months, which is longer than usual for patients with this disease. Most patients with advanced pancreatic cancer live less than a year.

Because of the small number of patients in the study, and for other reasons, the NCI and the Office of Alternative Medicine (OAM) decided that the results were not clear and prospective studies were encouraged. In prospective studies, patients are followed forward in time. The NCI and the National Center for Complementary and Alternative Medicine (NCCAM) sponsored a second study with a much larger number of patients. This was a 7-year clinical study that included patients who had stage II, stage III, or stage IV pancreatic cancer that could not be removed by surgery.

In this study, one group of patients followed the Gonzalez regimen while another group was given standard treatment (chemotherapy). Results in the two groups were compared to see if the Gonzalez regimen works better than the standard treatment and if it has bad side effects. Results of the study were reported in the peer-reviewed Journal of Clinical Oncology in August 2009. Patients treated with standard chemotherapy survived a median of 14 months and patients treated with the Gonzalez regimen survived a median of 4.3 months. Patients treated with chemotherapy reported a better quality of life than those treated with the Gonzalez regimen. Dr. Gonzalez published comments on his Web site.

Have any side effects or risks been reported from the Gonzalez regimen?

The reported side effects of treatment with the Gonzalez regimen are the following:

  • Gas, bloating, and digestion problems.
  • Flu-like symptoms.
  • Low-grade fever.
  • Muscle aches.
  • Skin rashes.

There is no information on the side effects of the coffee enemas taken twice a day. Taking too many enemas of any kind can cause changes in normal blood chemistry, chemicals that occur naturally in the body and keep the muscles, heart, and other organs working properly.

Is the Gonzalez regimen approved by the US Food and Drug Administration (FDA) for use as a cancer treatment in the United States?

The FDA has not approved the Gonzalez regimen as a cancer treatment.

Pancreatic cancer is usually not found early enough to be cured. Most pancreatic cancer patients live for 5 years or less. Patients with advanced pancreatic cancer usually live for less than 1 year. Patients with any stage of pancreatic cancer may want to think about taking part in a clinical trial.

Changes To This Summary (01 / 08 / 2010)

The PDQcancer information summaries are reviewed regularly and updated as new information becomes available. This section describes the latest changes made to this summary as of the date above.

Editorial changes were made to this summary.

General CAM Information

Complementary and alternative medicine (CAM)—also referred to as integrative medicine—includes a broad range of healing philosophies, approaches, and therapies. A therapy is generally called complementary when it is used in addition to conventional treatments; it is often called alternative when it is used instead of conventional treatment. (Conventional treatments are those that are widely accepted and practiced by the mainstream medical community.) Depending on how they are used, some therapies can be considered either complementary or alternative. Complementary and alternative therapies are used in an effort to prevent illness, reduce stress, prevent or reduce side effects and symptoms, or control or cure disease.

Unlike conventional treatments for cancer, complementary and alternative therapies are often not covered by insurance companies. Patients should check with their insurance provider to find out about coverage for complementary and alternative therapies.

Cancer patients considering complementary and alternative therapies should discuss this decision with their doctor, nurse, or pharmacist as they would any therapeutic approach, because some complementary and alternative therapies may interfere with their standard treatment or may be harmful when used with conventional treatment.

Evaluation of CAM Approaches

It is important that the same rigorous scientific evaluation used to assess conventional approaches be used to evaluate CAM therapies. The National Cancer Institute (NCI) and the National Center for Complementary and Alternative Medicine (NCCAM) are sponsoring a number of clinical trials (research studies) at medical centers to evaluate CAM therapies for cancer.

Conventional approaches to cancer treatment have generally been studied for safety and effectiveness through a rigorous scientific process that includes clinical trials with large numbers of patients. Less is known about the safety and effectiveness of complementary and alternative methods. Few CAM therapies have undergone rigorous evaluation. A small number of CAM therapies originally considered to be purely alternative approaches are finding a place in cancer treatment—not as cures, but as complementary therapies that may help patients feel better and recover faster. One example is acupuncture. According to a panel of experts at a National Institutes of Health (NIH) Consensus Conference in November 1997, acupuncture has been found to be effective in the management of chemotherapy-associated nausea and vomiting and in controlling pain associated with surgery. In contrast, some approaches, such as the use of laetrile, have been studied and found ineffective or potentially harmful.

The NCI Best Case Series Program, which was started in 1991, is one way CAM approaches that are being used in practice are being investigated. The program is overseen by the NCI's Office of Cancer Complementary and Alternative Medicine (OCCAM). Health care professionals who offer alternative cancer therapies submit their patients' medical records and related materials to OCCAM. OCCAM conducts a critical review of the materials and develops follow-up research strategies for approaches deemed to warrant NCI-initiated research.

Questions to Ask Your Health Care Provider About CAM

When considering complementary and alternative therapies, patients should ask their health care provider the following questions:

  • What side effects can be expected?
  • What are the risks associated with this therapy?
  • Do the known benefits outweigh the risks?
  • What benefits can be expected from this therapy?
  • Will the therapy interfere with conventional treatment?
  • Is this therapy part of a clinical trial?
  • If so, who is sponsoring the trial?
  • Will the therapy be covered by health insurance?

To Learn More About CAM

NATIONAL CENTER FOR COMPLEMENTARY AND ALTERNATIVE MEDICINE (NCCAM)

The National Center for Complementary and Alternative Medicine (NCCAM) at the National Institutes of Health (NIH) facilitates research and evaluation of complementary and alternative practices, and provides information about a variety of approaches to health professionals and the public.

NCCAM Clearinghouse
Post Office Box 7923 Gaithersburg, MD 20898–7923
Telephone: 1–888–644–6226 (toll free) 301–519–3153 (for International callers)
TTY (for deaf and hard of hearing callers): 1–866–464–3615
Fax: 1–866–464–3616
E-mail: info@nccam.nih.gov
Web site: http://nccam.nih.gov

CAM ON PUBMED

NCCAM and the NIH National Library of Medicine (NLM) jointly developed CAM on PubMed, a free and easy-to-use search tool for finding CAM-related journal citations. As a subset of the NLM's PubMed bibliographic database, CAM on PubMed features more than 230,000 references and abstracts for CAM-related articles from scientific journals. This database also provides links to the Web sites of over 1,800 journals, allowing users to view full-text articles. (A subscription or other fee may be required to access full-text articles.) CAM on PubMed is available through the NCCAM Web site. It can also be accessed through NLM PubMed bibliographic database by selecting the "Limits" tab and choosing "Complementary Medicine" as a subset.

OFFICE OF CANCER COMPLEMENTARY AND ALTERNATIVE MEDICINE

The NCI Office of Cancer Complementary and Alternative Medicine (OCCAM) coordinates the activities of the NCI in the area of complementary and alternative medicine (CAM). OCCAM supports CAM cancer research and provides information about cancer-related CAM to health providers and the general public via the NCI Web site.

NATIONAL CANCER INSTITUTE (NCI) CANCER INFORMATION SERVICE

U.S. residents may call the NCI Cancer Information Service toll free at 1-800-4-CANCER (1-800-422-6237) Monday through Friday from 9:00 am to 4:30 pm. A trained Cancer Information Specialist is available to answer your questions.

FOOD AND DRUG ADMINISTRATION

The Food and Drug Administration (FDA) regulates drugs and medical devices to ensure that they are safe and effective.

Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
Telephone: 1–888–463–6332 (toll free)
Web site: http://www.fda.gov/

FEDERAL TRADE COMMISSION

The Federal Trade Commission (FTC) enforces consumer protection laws. Publications available from the FTC include:

  • Who Cares: Sources of Information About Health Care Products and Services
  • Fraudulent Health Claims: Don't Be Fooled
Consumer Response Center
Federal Trade Commission
CRC-240
Washington, DC 20580
Telephone: 1-877-FTC-HELP (1-877-382-4357) (toll free)
TTY (for deaf and hearing impaired callers): 202-326-2502
Web site: http://www.ftc.gov/

Date Last Modified: 2010-01-08


If you want to know more about cancer and how it is treated, or if you wish to know about clinical trials for your type of cancer, you can call the NCI's Cancer Information Service at 1-800-422-6237, toll free. A trained information specialist can talk with you and answer your questions.


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