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Know Your Supplements - Some Can Hurt You, Some Might Help

By Chris Thomas, cancerpage.com

Supplements that might fight cancer.
The jury is still out on these.
Supplements that help immune system.
Supplements that don"t fight cancer.
Anti-depressants.
The role of the FDA.
Sources.

COMMON SENSE ON SUPPLEMENTS
VITAMINS, MINERALS, AMINO ACIDS, HERBS AND BOTANICALS

This article is part of series on cancerpage.com related to household and lifestyle carcinogens and what we can do to reduce our risks and enhance treatment benefits. A previous article focused on how food can increase or lower cancer risks, while this article delves into dietary supplements of interest to cancer patients. Throughout the series we have focused on carcinogens and not other health hazards around the home and in our food. Continuing this focus, we now address alternative supplements that may help fight against cancer and do not discuss other supplements unrelated to cancer. (For example, many experts recommend calcium for older people especially, but not for cancer prevention.)

EXPERTS AGREE

According to the National Institutes of Health’s National Center for Complementary and Alternative Medicine, Americans are engaged in a vast, uncontrolled experiment as they spend $4 billion dollars a year on herbal remedies, vitamins, and supplements, which are not monitored by any government agency and most of which have not been studied at all. Approximately 3,400 different vitamin and mineral supplement products are on the market, according to American Dietetic Association. So Americans are taking supplements that are not regulated by the government and that lack scientific evidence of being worth the cost.

Common Sense Approach to Supplements

Studies have shown that people who take supplements also tend to exercise regularly, eat right, and otherwise maintain a healthy lifestyle, such as not drinking and smoking. Maintaining a healthy lifestyle has been consistently associated with fewer illnesses and quicker recoveries. Proving that a particular supplement caused any effect is the challenge for research on supplements. No one can be very sure that a specific supplement caused benefit in the fight against cancer rather than other factors such as environment, genes, previous or current lifestyle, coinciding health conditions, and so on. Anecdotal reports, case studies, studies of populations’ diets and cancer rates are less reliable evidence than giving people supplements in double-blind, placebo-controlled studies. At this point, the only reliable fact is that no supplement has been clearly proven to cure any cancer.

Food Is Better Source of Nutrients Than Supplements

The American Dietetic Association recommends eating a wide variety of foods to obtain essential nutrients. This is consistent with recommendations of the American Cancer Society, the National Academy of Science, the American Medical Association, the American Institute of Nutrition, and the American Society for Clinical Nutrition. The National Cancer Institute of NIH has never recommended that people take supplements. But when cancer patients cannot eat a healthy diet or if their immune systems are impaired by treatments, then they may benefit from supplements.

For example, while foods with carotenes fruits and vegetablesmay help in the fight against cancer and may strengthen the immune system, carotene supplements may not, which is consistent with the advice of many experts who point out that supplements are not a substitute for a good diet.

As referenced in the cancerpage.com article on "Cancer and Food," Johns Hopkins University researcher Dr. Paul Talalay published results showing broccoli to be a particularly effective vegetable containing naturally occurring substances called phytochemicals, which are a defense against cancer, according to Talalay. One serving of leafy greens is estimated to contain over 100 different phytochemicals. Research has also found the high levels of lycopene in tomatoes may reduce prostate cancer risk.

Dark yellow and orange vegetables and fruits such as carrots, sweet potatoes, and cantaloupe and dark-green leafy vegetables such as broccoli, spinach, and collard greens are all thought to fight cancer. While there are many different elements in such foods, including beta-carotene, alpha-carotene, and lutein, scientists are not always sure which element is fighting the cancer.

The vitamins, minerals and phytochemicals found in these foods work together in complex ways to fight cancer, researchers said. The findings of studies of individual supplements found no link - good or bad - between beta-carotene in pill form and certain cancers. "The failure of these single-agent studies may cause people to lose sight of the central concept behind the research. That concept is synergy, by which different substances work together to produce a considerably stronger effect than they could individually," said Ritva Butrum, Ph.D., and Vice-President for Research at American Institute for Cancer Research.

A number of studies have consistently shown that obtaining nutrients from foods is more effective than from supplements.

Dispelling the Myths

The assumption that supplements are "natural" and therefore safe is wrong. For example, laetrile is natural, but a poison. Also, many people may be surprised to learn that no government agency regulates supplements - unless there are injuries. Because a supplement is neither a food nor a medicine, the US Food and Drug Administration (FDA) does not control its sale, unless an illness, injury, or death can be attributed to it. For these reasons, common sense is needed.

President Richard Nixon declared the war against cancer 30 years ago. The race against death for finding cures has, on occasion, led to premature optimism. For example, at one point researchers said that soy protein lowered breast cancer risk, but then reports suggested that soy protein may actually increase the risk of cancer in certain women at certain times.

While research on the associations among diet, health, and disease has reaped invaluable information, preliminary findings must be viewed with caution. Further, such reports have shifted attention from several more pressing issues about which nearly all experts agree: eat a balanced diet, don’t take mega-doses of any supplement, and talk to your doctor about any supplements if you are in treatment for cancer.

SUPPLEMENTS WITH SOME EVIDENCE OF FIGHTING CANCER

Green Tea Extracts

The National Cancer Institute reports that researchers (See Sugiyama, Sadzuka) say green tea (Camellia sinensis) may enhance antitumor activity in mice. In addition, the National Center for Complementary and Alternative Medicines reports that tea, particularly green tea, contains polyphenols, natural chemicals that may act as antioxidants.

Gilberto Santana-Rios, Ph.D., a Research Associate with the Linus Pauling Institute, told cancerpage.com that "We are looking for the key but we haven’t found it yet. Possibly it’s because of a class of chemicals called polyphenols." There are [also] more polyphenols that may explain why it’s a better cancer inhibitor, Santana-Rios told cancerpage.com.

PC-SPES for Prostate

PC-SPES, a mixture of extracts from eight different herbs, is effective in some patients with hormonally related advanced prostate cancer, according to study results reported in the November 1, 2000 Journal of Clinical Oncology. However, more research is needed.

"There may exist literally hundreds of unique compounds in an herbal mixture such as PC-SPES," according to Dr. Eric J. Small, from the University of California at San Francisco, "making it difficult to identify the active agents."

After taking three 320-mg capsules of PC-SPES daily, researchers found that up to 88% of the men had decreased serum PSA levels after one year. For additional info, click here to see additional articles on cancerpage.com focused on alternative and complementary medicine.

Vitamin E

The latest analysis from a large prevention trial conducted by the National Cancer Institute (NCI) and the National Public Health Institute of Finland shows that long-term use of a moderate-dose vitamin E supplement substantially reduced prostate cancer incidence and deaths in male smokers. The findings are published in the March 18, 1998, issue of the Journal of the National Cancer Institute. However, vitamin E did not seem to be associated with reduced incidence of lung cancer and was associated with increased rates of bladder, stomach, and other cancers, according to the American Cancer Society’s "Complementary and Alternative Methods."

The Alpha-Tocopherol, Beta-Carotene Cancer Prevention Study (ATBC) showed that 50- to 69-year-old men who took about three times the Recommended Dietary Allowance of alpha-tocopherol (vitamin E) every day for 5 to 8 years had 32 percent fewer diagnoses of prostate cancer and 41 percent fewer prostate cancer deaths than did men who did not receive vitamin E. (Also see Beta-Carotene below for increased cancer risk in smokers.)

Tomatoes and Lycopene

Although there are no double-blind studies on tomatoeslycopene, the results of observational studies are striking. One study followed 47,894 men for 4 years. Subjects who ate large amounts of tomatoes or tomato sauce had lower rates of prostate cancer. (See Gionvannucci E. Tomatoes, tomato-based products, lycopene, and cancer: review of the epidemiological literature. J Natl Cancer Inst. 1999; 91:317-331.)

Some evidence suggests that lycopene may also help prevent lung, colon, and breast cancer as well. In one study, elderly Americans who ate a diet high in tomatoes had 50% fewer cancers overall than those who did not. Animal studies have also found some cancer-preventative benefits with lycopene.

In contrast to other statements in this series about supplements not being as effective as obtaining nutrients from foods, lycopene supplements do seem to have some positive effects.

    Garlic

    Epidemiological studies, in which researchers survey peoples" diets and health, indicated that eating cooked or raw garlic -- but not garlic supplements -- was linked to agarlic decreased risk of stomach and intestinal cancer. Various forms of garlic seem to reduce blood clotting and neutralize free radicals. Evidence from observational studies suggests that garlic may help prevent cancer, particularly cancer of the stomach and colon.

    In one trial, the Iowa Women"s Study, a group of 41,837 women were questioned about their lifestyle habits in 1986, and then followed in subsequent years. At the four-year follow-up, questionnaires showed that women whose diets included significant quantities of garlic were approximately 30% less likely to develop colon cancer. (See Steinmetz KA, Kushi LH, Bostick RM, et al. Vegetables, fruit, and colon cancer in the Iowa Women"s Health Study. Am J Epidemiol. 1994;139:1-15.) These observational studies do not prove that garlic is responsible for reducing the rates of cancer, but do call for more research.

    According to the Physicians’ Desk Reference for Herbal Medicines, garlic is antibacterial, antimycotic, and lipid-lowering and these "effects of garlic are proven." It can be used for inflammation of the mouth and pharynx and a "tendency to infection."

    Selenium

    Some studies indicate that deaths from cancer, including lung, colorectal, and prostate cancers, are lower among people with higher selenium blood levels or intake. Also, the incidence of nonmelanoma skin cancer is significantly higher in areas of the United States with low soil selenium levels.

    The effect of selenium supplementation on the recurrence of these types of skin cancers was studied in seven dermatology clinics in the U.S. from 1983 through the early 1990s. While supplementation with 200 mcg selenium daily did not affect recurrence of skin cancer, it did significantly reduce total mortality and mortality from cancers. In addition, incidence of prostate cancer, colorectal cancer, and lung cancer was lower in the group given selenium supplements.

    However, not all studies have shown a relationship between selenium status and cancer. In 1982, over 60,000 participants of the Nurses Health Study did not find any apparent benefit of higher selenium levels.

    These conflicting results emphasize the need for additional research on the relationship between selenium and chronic diseases such as cancer. However, like many vitamins and minerals, most people get most of what they need from standard American diets. A portion of many common foods will give you most of a the Minimum Daily Requirement for selenium, from spaghetti and sauce, macaroni and cheese, oatmeal, bread, beef, chicken and tuna. So taking a supplement is probably not necessary.

    Also, the Cancer Prevention Journal reports on the research of Dr. Parviz Ghadirian, in Quebec, Canada. His abstract says in part: between 1989 and 1993, his team studied 1,048 patients with colon, breast, and prostate cancers and a control group matched for age and gender. Analyzing toenail samples for their selenium concentrations, they found no association between toenail selenium and breast cancer or prostate cancer, though they did observe a statistically significant inverse association between toenail selenium level and the risk of colon cancer suggesting that lower selenium is associated with reduced colon cancer.

    Tamoxifen May Positively Interact With Vitamins E and C

    A team of researchers in India found early preliminary evidence that vitamins C and E may be helpful for women who are taking the drug tamoxifen for breast cancer.

    Tamoxifen is an "anti-estrogen" used in women with breast cancer. Although this drug can be quite effective, it also has the effect of raising levels of triglycerides (fat) in the blood. This, in turn, would be expected to lead to an increased risk of heart disease and strokes. Researchers found that adding vitamin C (500mg/day) and vitamin E (400mg/day) substantially reduced triglyceride levels. In addition, the vitamins improved levels of total cholesterol, LDL ("bad") cholesterol, and HDL ("good") cholesterol.

    However, these results are preliminary and the study was not a double blind, placebo-controlled trial. More rigorous clinical trials are needed to determine whether tamoxifen users really should add vitamins E and C to their diets. (See Babu JR, Sundravel S, Arumugam G, et al. Salubrious effect of vitamin C and vitamin E on tamoxifen-treated women in breast cancer with reference to plasma lipid and lipoprotein levels. Cancer Letter 2000;151:1-5.)

    THE JURY IS STILL OUT ON MANY SUPPLEMENTS

    It is difficult to isolate the affects of a supplement and prove that it causes an outcome, because it is necessary to rule out the affects of other concurrent cancer treatments, other genetic and dietary issues, and other environmental factors. Nevertheless, the studies go on and sometimes they find conflicting evidence.

    Beta-Carotene Defined

    Beta-carotene is a member of a larger family of nutrient enzymes (termed carotenoids) of which there are over 500. Some examples of other carotenes are lutein and zeaxanthin found in spinach, kale, and broccoli; and lycopenes found in tomatoes and pink grapefruit. Scientists are studying the interaction of various carotenes and other nutrients, such as phytochemicals, in helping prevent diseases.

    Beta-Carotene Evidence

    The experience with beta-carotene supplements could be a lesson to all who want to take supplements. Beta-carotenes were widely popularized as anti-cancer supplements for many years, but the evidence was anecdotal or otherwise lacking in scientific method. Then, a more rigorous study published in the Archives of Dermatology found that beta-carotene supplements did not protect men against non-melanoma skin cancer as originally touted. In addition, researchers more precisely investigated whether beta-carotene supplements could reduce cancer incidence.

    One of the earliest completed trials found no beneficial effects, and an unexpected higher incidence of lung cancer and of total mortality with use of beta-carotene supplements in male Finnish smokers. One NCI report said smokers should avoid taking beta-carotene supplements. Since the Finnish study, another randomized, placebo-controlled study has indicated that supplementation with beta-carotene has no effect on incidence of colorectal adenoma. Everyone who takes supplements may want to consider this sequence of events as they consider taking supplements.

    Research published in the Journal of the National Cancer Institute in December, 1999 found that patients who took beta-carotene did not show a significant reduction in cancers or heart disease.

    In the Physicians" Health Study at Harvard, 22,000 male physicians were given beta-carotene for 12 years. The findings showed no benefit or harm of beta-carotene.

    Antioxidants

    Antioxidants are agents with the ability to deactivate naturally occurring toxic compounds in the body called free radicals. You can get antioxidants in the foods you eat or by taking supplements. The body also produces its own antioxidants.

    Vitamins

    Vitamins A, C, E, beta-carotene, and the mineral selenium function as antioxidants. Free radicals (also called oxidants) are highly unstable molecules that can damage cell membranes and scramble the genetic information (DNA) in cells, which MAY start a chain reaction that leads to cancer.

    The FDA is under court order to make a determination on whether supplement makers can claim, "consumption of antioxidant vitamins may help reduce the risk of certain cancers." A decision has been promised by late February 2001. Late last year, the FDA sent a letter to attorneys representing a number of dietary supplement makers claiming "The agency has continued to work steadily on the claim." The letter went on to say the process "has been complicated by the large number of new human studies that were conducted since FDA"s original 1991-93 review."

    Extremely large doses of antioxidants like vitamins C, and E, and Selenium in supplement form could lead to health problems, concludes a National Academy of Sciences’ Institute of Medicine panel.

    In an interview with cancerpage.com, panel member Dr. Raymond Burk of Vanderbilt University Medical Center, said that taking large doses of supplements is not necessary. "You can achieve these levels of antioxidant intake with a good healthy diet and that generally would include a good bit of fruits and vegetables." And besides, Burk said, "There were no conclusions that any of these [antioxidant] nutrients protected against cancer specifically." Burk said there have been studies on the cancer fighting potential of antioxidants but he called the findings inconclusive.

    In contrast to Dr. Burk’s statement that there is no proof antioxidants reduce cancer’s affects or risks, Dr. Andrew Weil, a well known figure in the complementary and alternative medicine community, says antioxidants "cannot do you any harm, and it may safeguard your immune system and retard aging while giving you protection from cancer."

    Weil counsels cancer patients to take an "antioxidant cocktail" that includes: Vitamin C, 200 to 500 mg. His web site indicates ascorbic acid, vitamin C, saturate the body"s tissues, and this range of doses is enough to protect against cancer, heart disease and other chronic illnesses. He recommends higher dosages for those not getting at least five servings of fruits and vegetables as part of their daily diet:

    • Vitamin E: 400 to 800 IUs a day.
    • Selenium: 200 micrograms a day. Selenium is a trace mineral with antioxidant and anticancer properties, according to Weil.
    • Lycopene, the red pigment in tomatoes helps prevent prostate cancer.

    NCI says Vitamin E and beta-carotene are antioxidant compounds that "may prevent carcinogens from damaging DNA." In the July 1999 magazine Oncology, naturopathic physician Dan Labriola warned that there might be risks in combining antioxidants with chemotherapy.

    Everyone agrees: if you have cancer, consult your physician before taking antioxidants or any other supplements.

    Shark Cartilage

    The use of shark cartilage as a cancer treatment has drawn attention because of the popular belief that sharks don’t get cancer. However, this is not true. Scientific literature compiled in 1933, 1948, and 1969 document that such cartilaginous fish did develop cancers. The results of a majority of studies using shark cartilage have not been convincing. Results from the phase II shark cartilage study, published in November 1998, concluded that oral shark cartilage given as a single agent was ineffective in 47 patients with advanced breast, colon, lung, or prostate cancer. A phase III double blind, placebo-controlled clinical trial sponsored by the National Cancer Institute began in 1999.

    In September 2000, Danish researcher Dr. Lene Adrian reported, "The evidence that shark cartilage has no place in cancer treatment is growing stronger. I would not recommend it, since is has no convincing effect, it produces gastrointestinal side effects and it is expensive."

    Mistletoe

    Mistletoe has been used for centuries for its medicinal properties. It appears in legend mistletoefrequently as a panacea and interest in mistletoe as an anticancer drug began in the 1920s.

    There is no evidence of mistletoe destroying cancer cells. Investigations of mistletoe"s ability to inhibit cancer cell growth in animal models have yielded mixed results, depending on the extract used, the dose, the method of administration, and the type of cancer evaluated. Research continues.

    There is substantial evidence of mistletoe"s ability to modulate the human immune system and results of animal studies suggest that mistletoe may be beneficial in decreasing the side effects of chemotherapy and radiation therapy and that it may counteract the effects of drugs used to suppress the immune system.

    Numerous forms of mistletoe have been used in animal and human studies with minimal side effects. However, there have been reports of seizures, slowing of the heart rate, abnormally high or low blood pressure, vomiting, and death after eating mistletoe plants and berries.

    Saw Palmetto

    While there is no evidence that saw palmetto fights cancer, there may be some benefits for palmettoprostate cancer patients. The National Center for Complementary and Alternative Medicine at NIH has reported studies on the herb saw palmetto taken by many men to relieve symptoms of prostate enlargement like frequent urination. Dr. Timothy J. Wilt, of the Veterans Affairs Center for Chronic Diseases in Minneapolis, evaluated 18 studies, and found that saw palmetto worked better than a placebo and as well as a prescription drug, finasteride, also called Proscar for the condition. The herb had fewer side effects and costs $15 a month, compared with $68 for the prescription.

    At least seven double-blind studies involving a total of about 500 people have compared the benefits of saw palmetto against placebo over a period of 1 to 3 months. In these studies, the herb significantly improved urinary flow rate and most other measures of prostate disease. A double-blind study followed 1,098 men who received either saw palmetto or the drug Proscar over a period of 6 months. The treatments were equally effective, but while Proscar lowered PSA levels and caused a slight worsening of sexual function on average, saw palmetto caused no significant side effects. (See Carraro JC, Raynaud JP, Koch G, et al. Comparison of phytotherapy (Permixon®) with finasteride in the treatment of benign prostate hyperplasia: a randomized international study of 1,098 patients. Prostate. 1996;29:231–240.)

    The Gonzalez Protocol

    This unusual regimen is named after New York immunologist Nicholas Gonzalez, MD, and it involves cancer of the pancreas. Pancreatic cancer has one of the lowest survival rates of all cancers. Dr. Gonzalez’s patients receive pancreatic enzymes orally every four hours and at mealtime for 16 days. Patients also receive up to 150 pills daily in the form of dietary supplements such as magnesium citrate, papaya plus, vitamins, minerals, trace elements, and animal glandular products. Coffee enemas are also administered daily. It’s a complex routine that calls for dietary restrictions with the key ingredient being pancreatic enzymes from pigs.

    "What I do is controversial," said Dr. Gonzalez, "but our early results have convinced the National Cancer Institute to fund a clinical trial."

    Patients’ diets are also controlled as they eat quantities of raw fruits, raw and lightly steamed vegetables, juices, and plant-based proteins, such as cereals and nuts, including 20 almonds a day. No red meat or chicken is allowed, but patients can have some fish. No refined grain products and no white sugar are allowed. (For further description of the diet and procedures, see Dr. Gonzalez’s web site: http://www.dr-gonzalez.com/intouch_articles.htm.)

    Camphor or "714-X"

    The supplement was developed over 30 years ago in a privately funded laboratory in Quebec, Canada, where it continues to be produced. According to the National Cancer Institute, the theory behind camphor as an anti-cancer agent is "that microorganisms distinct from bacteria, viruses, and fungi exist normally in the blood and play a role in cancer development. These microorganisms, which are called ‘somatids,’ are said to exist in multiple forms, some of which appear only in individuals affected by degenerative diseases or cancer. The somatid theory of cancer development is not widely accepted." The camphor component of 714-X is purportedly attracted to cancer cells, where added nitrogen is released, thus preventing tumor cells from depleting the nitrogen required by normal cells, including immune system cells, for proper metabolism. (According to the American Cancer Society, the promoter of 714-X has been convicted of practicing medicine without a license in France and has continuing legal problems with Canadian authorities.)

    According to the NCI, no clinical trials or case reports have been published in scientific journals to support the efficacy or safety of 714-X. Some initial studies have begun. The primary component of 714-X is camphor that has been chemically altered. It is available, but not approved for therapeutic use in Canada; it is also used in Mexico, and some European countries. FDA has not approved 714-X for use in the United States as a medicine.

    PROVEN TO STREGNTHEN THE IMMUNE SYSTEM

    CoQ 10

    A large amount of laboratory and animal model data on coenzyme Q10 (CoQ10) has accumulated since 1962. Research into this compound was awarded the Nobel Prize in chemistry in 1978. The National Cancer Institute reports that some of the accumulated data show that CoQ10 stimulates animal immune systems, leading to higher antibody levels and increased resistance to infection. Research subsequently delineated the antioxidant properties of CoQ10. According to the American Cancer Society, one study found some "protective effects" for the heart during chemotherapy. A number of small studies have found modest anti-cancer benefits from CoQ10, but more research is needed.

    SUPPLEMENTS PROVEN NOT TO FIGHT CANCER

    Sometimes supplements may not cause harm-they simply don"t work. For example, the Archives of Dermatology reported that beta-carotene did not protect men against non-melanoma skin cancer as originally promoted, although beta-carotenes may improve one’s immune system.

    Hydrazine Sulfate

    The drug has been investigated as a chemotherapy agent in the last 30 years. In the ‘80s, NCI conducted studies of hydrazine sulfate as a single agent and found no evidence of anti-tumor activity. Four additional studies sponsored by NCI in the ‘90s found no significant evidence of benefits to cancer patients. In view of these results, NCI recommended against further evaluation of hydrazine sulfate.

    Hydrazine has been associated with liver and kidney toxicity. In December 2000, the Annals of Internal Medicine reported on the case of a cancer patient who had refused all conventional treatments for his sinus cancer and instead obtained hydrazine sulfate through an alternative medicine Web site. According to the report, the patient took the drug for four months before discontinuing it. Two weeks later, the man was admitted to the hospital with evidence of kidney and liver failure. Seven days into his hospitalization, the patient began vomiting blood and died despite aggressive treatment, the authors report. The autopsy showed widespread death of tissue in the kidneys and liver of the patient.

    Laetrile

    Laetrile/amygdalin (mandelonitrile beta-D-gentiobioside) is produced in Mexico and is made from crushed apricot pits. Sometimes it is referred to as Vitamin B17. Laetrile was evaluated in two studies sponsored by NCI and published in 1975. None of the solid tumors or leukemias investigated responded to amygdalin at any dose tested. No statistically significant increase in animal survival was observed in any of the treatment groups. Similar results were obtained in another study. Amygdalin at every dose level tested produced no response. NCI concluded that no further investigation of laetrile was warranted.

    Laetrile can also be dangerous. The side effects associated with laetrile treatment mirror the symptoms of cyanide poisoning including nausea and vomiting, headache, liver damage, hypotension, and difficulty walking due to damaged nerves, mental confusion, coma, and death.

    A detailed report on one NCI study was published in The New England Journal of Medicine in 1982 confirming previous findings. Then, on March 24, 1987, a Federal judge signed an order making it illegal to import laetrile into the United States even for the treatment of patients with very advanced cancer or for the treatment of cancer pain.

    In spite of this history, as recently as November 2000, according to the FDA, Christian Brothers of Whitestone, New York and its president, Jason Vale, signed a permanent decree in US District Court in Brooklyn, New York agreeing "to stop manufacturing, processing, and distributing its amygdalin products." The FDA noted that "there are no published clinical studies which demonstrate that laetrile is safe and effective, and cancer patients who take it sometimes forgo conventional therapies to their detriment."

    Cancell/Entelev

    In 1978 and 1980, NCI conducted animal studies on Cancell/Entelev and determined that the mixture lacked substantial antitumor activity. In 1989, the FDA was granted a permanent injunction against both principal manufacturers of Cancell/Entelev, prohibiting them or their agents from distributing the mixture, which was judged an unapproved new drug. In 1990 and 1991, NCI researchers tested samples of Cancell/Entelev. On the basis of negative results from these investigations, it was concluded that no further study of Cancell/Entelev was warranted.

    ANTI-DEPRESSANT HERBS

    Anti-depressants are included here since many cancer patients experience depression and because there is a concern about interactions with chemotherapies.

    SAMe

    SAMe is neither a drug nor an herb; as S-adenosylmethionine, it is a molecule involved in numerous metabolic pathways. SAMe (pronounced sammy) has been available as a prescription drug for a number of years in Italy, Spain, Germany, and elsewhere.

    An analysis of a 13 placebo-controlled, double blind studies revealed that "the efficacy of SAMe in treating depressive syndromes and disorders is superior to that of placebo and comparable to that of standard tricyclic anti-depressants," as reported in the PDR for Herbal Medicines.

    St. John"s Wort

    St. John"s wort is used in Germany, where doctors prescribed almost 66 million daily doses in 1994 for psychological complaints. In fact, German doctors prescribe St. John"s wort about 20 times more often than Prozac, St. Johnone of the most widely prescribed anti-depressants in the United States, according to the National Center for Complementary and Alternative Medicine at NIH. The PDR for Herbal Medicine indicates studies have demonstrated that the antidepressive effect may be due to the presence of a monoamine oxidase inhibiting function in the active agents. Other studies referenced by the PDR for Herbal Medicines have shown that the affect may work in the same way Prozac works, by inhibiting the reuptake of seratonin.

    Clinical trials have found a reduction of symptoms with St. John"s wort comparable to conventional anti-depressants. An analysis of 23 European clinical studies of St. John"s wort that was published in the British Medical Journal in 1996 concluded that the herb has anti-depressive effects in cases of mild to moderate depression, but it has not been tested on more severe depressions. However, it is hard to interpret some studies as definite proof of the efficacy of St. John"s wort, because of various technical research issues.

    The U.S. FDA has issued a warning to consumers about St. John’s wort, contending that the herbal supplement interferes with the action of certain drugs used to treat a range of illnesses, including cancer.

    SAFETY AND THE ROLE OF THE FDA

    Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market.

    Generally, manufacturers do not need to register with the FDA nor get FDA approval before producing or selling dietary supplements. Manufacturers must make sure that product label information is truthful and not misleading.

    Since manufacturers do not need FDA approval to sell their supplement products, the FDA does not keep a list of manufacturers or products. The FDA focuses only on public health emergencies and products that may have caused injury or illness. The FDA reviews dietary supplements less than other products it regulates, such as drugs and the many additives used in conventional foods.

    Dietary supplements are not medicines. A medicine is intended to treat or prevent diseases and must undergo clinical studies to determine its effectiveness and safety. The FDA must review these data and authorize the drug"s use before it is marketed. A product sold as a dietary supplement and touted in its labeling as a new treatment or cure for a specific disease or condition would be considered an unauthorized--and thus illegal--drug. (Changing the label to remove the words "treatment" and "cure" makes it a legal product to sell.)

    Under DSHEA, once a dietary supplement is marketed, FDA has the responsibility for proving that it is unsafe before it can take action to restrict the product"s use. This was the case when, in June 1997, FDA limited the amount of ephedrine alkaloids in dietary supplements (marketed as ephedra, Ma huang, Chinese ephedra, and epitonin, for example) and warned consumers about hazards associated with use of dietary supplements containing the ingredients.

    To approve an herbal product as a drug, the FDA requires the manufacturer to provide the same proof of safety and efficacy as other new drugs. But because that testing can cost millions of dollars, herb manufacturers usually will not pursue such approvals because their plant products usually are not patentable. The herb manufacturer may never recover the costs of testing much less make a profit.

    US Pharmacopeia

    While buying dietary supplements, consumers can be somewhat reassured of quality and purity if they choose products with "USP" or "NF" on the label. Federal law requires such products to comply with the standards in United States Pharmacopeia (USP) and the National Formulary (NF).

    The National Academy of Science issues the Recommended Dietary Allowance (RDA) of supplements and most experts are satisfied that these doses are adequate.

    Interactions With Conventional Medicines

    The National Center for Complementary and Alternative Medicine (NCCAM) at NIH has reported that 18% of individuals taking prescription drugs were concurrently using herbals or high dose vitamin products, or both. They estimated that 15 million adults are at risk for potential interactions among prescription drugs and the dietary supplements. The frequency and extent of adverse drug reactions or even positive, synergistic efficacy due to concurrent use is unknown, according to NCCAM.

    THE RESEARCH CONTINUES

    In October 2000, the National Center for Complementary and Alternative Medicine awarded $16 million to eight projects that will put several popular alternative therapies through the rigors of scientific investigation.

    At one of the centers, Johns Hopkins Center for Cancer Complementary Medicine, research projects will focus on the anti-oxidant effects of herbs on cancer; the anti-oxidant and anti-inflammatory properties of soy and tart-cherry in controlling pain; and PC-SPES in men with prostate cancer.

    "We realize from our patients that our patients want to know [about alternative treatments] but there really isn’t the scientific data to help us to know what to say to the patient," Dr. Adrian Dobs, the head of the Johns Hopkins projects told cancerpage.com. "This is the beginning of trying to do really good research on complementary and alternative interventions," she said.

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