Latest Research Questions the Effectiveness of Many Herbal Supplements and Multi-Vitamins-Part X
(4/4/15)- As a follow-up to our item dated 2/14/15 below, GNC, the country’s largest dietary supplement retailer, has agreed to institute stricter testing procedures that exceed quality controls required under federal law. It was one of the 4 retailers of herbal supplements cited by N.Y. State Attorney-General Eric Schneiderman, who accused them of selling products that were fraudulent or contaminated with unlisted ingredients that could pose health risks to consumers.
GNC, which has more than 6,500 retail stores nationwide, said it would use advanced DNA testing to authenticate all of the plants that are used in the store brand herbal supplements, and extensively test the products for common allergens. It will also submit semiannual reports proving that it is complying with the attorney general’s demands.
Under a 1994 federal law, all supplements must carry on their labels the names and amount of every ingredient they contain.
(2/4/15)- New York State attorney general’s office has sent 4 large herbal supplement retailers cease-and-desist letters demanding that they explain what procedures they use to verify the ingredients in the supplements they are selling. The attorney general, Eric T. Schneiderman’s investigation was prompted by an article in the New York Times in 2013 that cited mislabeling and fraud by some supplement manufacturers.
The four retailers are GNC, Target, Walgreens and Walmart .Investigators found that their tests showed that four out of five products did not contain any of the herbs on their labels. The tested products were store brands. But the F.D.A. specifically requires companies to verify that every supplement they manufacture is safe and accurately labeled.
Under a 1994 federal law, supplements are exempt from the strict approval process required for prescription drugs.
(12/3/14)- One of our viewers sent us the following e-mail, but wished to remain anonymous. “This graphic showing the effectiveness (or lack thereof) of popular health supplements may include some of the items you have mentioned on therubins.com:”
(12/21/13)- "Demand for vitamin and mineral supplements has grown markedly in recent years, with domestic sales totaling some $30 billion in 2011.
More than half of Americans used at least one dietary supplement from 2003-06, up from 42 percent from 1988-94, according to national health surveys conducted by the Centers for Disease Control and Prevention.
The most popular products are multivitamin and mineral supplements, which are consumed by some 40 percent of men and women in the United States, according to data from the National Health and Nutrition Examination Survey." (The New York Times)
(5/4/13)- Government toxicologists who were studying the effect of ginko biloba concluded that it caused cancer in lab animals including an excessive number of liver and thyroid cancers, as well as nasal tumors.
Cynthia Rider of the National Toxicology Program was the lead scientist for the study. She asserted: "The liver was a target, the thyroid was a target, and the nose."
The results of the study did not conclude that ginko biloba was dangerous to human.
In the study the mice and the rats were given very high doses of the extract, in fact up to 2,000 milligrams per pound of bodyweight, or just over 900 milligrams per pound of body weight, five times a week. Doses sold for human consumption range from 30 to 120 milligrams, regardless of body size.
(10/23/11)- In our item dated 3/31/09, we referred to Jane Brody's column in the New York Times on the 24th of March entitled "Extra Vitamin E: No Benefit, Maybe Harm". The results of a follow-up study of the Selenium and Vitamin E Cancer Prevention Trial (Select) concluded that whether selenium and vitamin E, either alone or in combination did not lower the risk of a man's getting cancer.
The Select trial was stopped early in 2008 after a review of the data showed no benefit, although there was an indication of increased risk or prostate cancer and diabetes. The latest data, based on a longer-term follow-up of the men in the trial,, found that user's of vitamin E had a 17% higher risk of prostate cancer compared to men who did not take the vitamin.
Dr. Eric Klein, a Cleveland Clinic physician and national study coordinator for the prostate cancer and vitamin E study stated: "There really is not any compelling evidence that taking these dietary supplements above and beyond a normal dietary intake is helpful in any way, and this is evidence that it could be harmful."
The results of this study were published in a recent edition of The Journal of the American Medical Association.
A separate study of 38,000 women in Iowa found a higher risk of dying during a 19-year period among older women who used multivitamins and other supplements compared with women who did not use them, according to a recent report in the Archives of Internal Medicine. The researchers concluded: "Based on existing evidence we see little justification for the general and widespread use of dietary supplements."
(2/14/10)- The results of a study that appeared in a recent edition of The Journal of the American College of Cardiology warn that popular herbs and supplements do not mix well with common heart drugs. They can also be dangerous for patients taking statins, blood thinners and blood pressure medications.
Dr. Arshad Jahangir, senior author of the paper added that popular supplements such as St. John's wort and even garlic and ginger do not mix well with many medications.
St. John's wort raises blood pressure and heart rate, and garlic and ginger increase the risk of bleeding in patients on blood thinners. Even grapefruit juice can be risky, increasing the effects of calcium-channel blockers and statins.
Soy milk, licorice, aloe vera and green tea were listed as products that can decrease the effectiveness of warfarin. Garlic supplements could potentially increase the risk of bleeding
(8/31/09)- TheGene Smart Omega-3 Index measures the amount of EPA and DHA omega-3 fatty acids in red blood cell membranes and is expressed as the percent of total fatty acids. The results of the test are represented as a score that a significant body of research indicates may be an independent predictor of heart disease - with a score of 4 percent or less indicating a high risk, and a score of 8 percent or more indicating a relatively low risk.
Floyd "Ski" Chilton, PhD, a pioneer in inflammatory disease and omega-3 research and a professor of Physiology and Pharmacology at Wake Forest University School of Medicine states: "This test is the most convenient, affordable and effective way to measure omega-3 levels," and added "It is important to measure omega-3 levels, so individuals can determine whether their dietary intake of this important nutrient needs to be adjusted."
(3/31/09)- Jane Brody's column in the New York Times on the 24th of March entitled "Extra Vitamin E: No Benefit, Maybe Harm" summarizes the case against any beneficial effects from taking extra doses of vitamin E and vitamin C.
In this article, we have gone over many of the studies that show that there
is no benefit to taking extra dosages of vitamin E or vitamin C. In the column
"In November 2004, the American Heart Association warned that while the small amounts of vitamin E found in multivitamins and foods were not harmful, taking 400 International Units a day or more could increase the risk of death. The highest recommended dietary allowance for vitamin E is 28.5 IU, for women who are breast feeding."
Ms. Brody went on to discuss the Heart Outcomes Prevention Evaluation trials in 2005, which looked at about 10,000 patients 55 and older with vascular disease or diabetes. That study concluded that there was no heart benefit from taking 400 I.U.'s of vitamin E daily for an average of seven years. It was also concluded that there were no differences in cancer incidence or deaths during the 7 year follow-up that could be attributed to vitamin E.
In the article she went on to discuss the results of the Physicians' Health Study that were released in November 2008. In that study 14,651 men 50 and older were followed for up to 8 years. That study concluded that there was no beneficial effect from taking 400 I.U.'s of vitamin E every other day on improving cardiovascular health.
Please see our item dated 8/24/07 below for the report on an additional study that also determined that there was no beneficial implications from taking extra doses of vitamin E. or vitamin C.
(2/25/09)- Are there positive advantages for one's health in taking "megadoses" of essential vitamins as proposed by Linus Pauling, the Nobel-Prize-winning biochemist 40 years ago? For those of us who believe in the beneficial side of the argument, and who practice what they preach, there is no doubt that having a positive mental attitude as to it "helping" should continue to ingest to their hearts content. Although there have been some studies that indicated that "megadosing" can be harmful to your health, there is no credible scientific information that this is so.
On the other hand there have been several studies recently that have failed to show that taking extra vitamins, in pill form, help prevent chronic disease or prolong life.
The results of a recent study that tracked over 161,000 older women who were in the Women's Health Initiative for 8 years, that was published in The Archives of Internal Medicine found that there were no health benefits as a result of "megadosing".
In October 2008 a study of 35,000 men concluded that there were no benefits towards lowering the risk of prostate cancer shown for individuals who took high doses of vitamin E and selenium. Dr. Eric Klein, national study coordinator for the study, and who is also chairman of the Cleveland Clinic's Glickman Urological and Kidney Institute stated: "The public's belief in the benefits of vitamins and nutrient is not supported by the available scientific data."
In another study, the results of which were published last year, that tracked almost 15,000 male physicians for a decade found that there was no difference in cancer or heart disease rates among those taking vitamins E and C compared with those taking a placebo.
(1/9/09)- Randomized controlled trial research results appearing in JAMA, Nov. 12, 2008; 300(18):2123-2133) concluded: "In this large, long-term trial of male physicians, neither vitamin E nor vitamin C supplementation reduced the risk of major cardiovascular events. These data provide no support for the use of these supplements for the prevention of cardiovascular disease in middle-aged men."
(12/9/08)- In an editorial appearing in JAMA (May 7, 2008; 299 (17):2077-2078), Dr. Eva Lonn states: "The trials completed to date do not provide clear evidence of any beneficial effects of B vitamin supplementation in coronary heart disease risk prevention" The trials included the Vitamins Intervention for Stroke Prevention (VISP), and the Heart outcomes Prevention Evaluation (HOPE-2) trials. Dr. Lonn concludes that "B vitamin supplements cannot currently be recommended for the prevention of CVD events (with the exceptions of rare genetic disorders)..."
(8/24/07)-In a recent study that involved more than 8,000 women at risk for heart disease, with an average age of 61, researchers determined that they received little benefit from taking vitamin C, E or beta carotene. Experts do believe however, that a nutritious diet rich in these vitamins protect the body's cardiovascular system by counteracting compounds known as "free radicals".
Free radicals can build up in the body and can damage artery linings, encourage blood clots and alter the function of blood vessels. Nancy Cook of Brigham and Women's Hospital and Harvard Medical School was the lead author for the study. The results of the study were recently published in the Archives of Internal Medicine.
Only a combination of vitamins C and E conferred a slightly lower risk of stroke compared with placebos. The participants were tracked for roughly nine years for fatal heart disease, heart attacks, strokes and heart-related surgery. Heart disease is the leading cause of death in the industrialized world.
(1/9/07)- A recent study of the effectiveness of B12 supplements concluded that it was not effective in preventing strokes, heart attacks and /or death in people with a history of vascular disease. Many health professionals felt that since B12 reduces the blood levels of homocysteine, which is a risk factor for cardiovascular events, it would therefore be helpful in reducing the risk of heart problems.
The study examined 12 other studies with 16,598 participants who had a pre-existing illness. The 12 studies all showed that people who took B12 supplements reduced their homocysteine levels, but there was no correlation between the amount of reduction in blood levels and the risk of heart attack, coronary heat disease, stroke or mortality from any cause.
The study also concluded that there was no difference between those who took the supplements and participants in a control group who took no supplements. Dr. Lydia A. Bazzano, the lead author and an assistant professor of epidemiology at the Tulane University School of Public Health and Tropical Medicine went on to say: "The things people have to do are hard; they have to quit smoking, exercise, lose weight, (and) eat properly,"
Although Kelly A. Condefer, M.D., wrote an article on this topic on January 25, 2002, we at therubins feel that it would be helpful to anyone interested in this subject to go back and read the article. At that time Dr. Condefer was a Visiting Clinical Research Fellow, in the Department of the Elderly at the University of Bristol, in the UK. You can locate the article "Vitamins, Dietary Supplements and Cognition: Making Informed Decisions".
(11/16/06)- Dear Mr. ( )
As a follow up to my previous email, I am sending a copy of the abstract of
a dissertation done at Howard University that may address some of your
questions and a copy of an article that you may find interesting.
Glyconutrients and cognition, perception, and memory
by Stancil, Atiya Njeri, PhD, HOWARD UNIVERSITY, 2005, 55 pages; 3184894
Abstract: Research on the role of glyconutrients in cell structure and function has led to a greater understanding of the origin of disease and behavioral dysfunction. Our concern was with the influence of glyconutritionals on cognition, perception, and memory ability in college students. Two experiments were conducted based on the results of an EEG study done by Wang, Pivik and Dykman (2002), which showed increases in power frequency bands in the frontal lobes associated with alertness, focused arousal, executive function, and emotion related to glyconutrient consumption. In Experiment 1, 30 Introduction to Psychology students at Howard University were used as subjects. Subjects were given the Raven's Progressive Matrices Test, The Stroop Test, and a perceptual discrimination task. In Experiment 2, 32 Introduction to Psychology students at Howard University were used as subjects. Subjects were given a Reading Span task and an Operation-word Span task as measures of working memory. In Experiment 1, results of a paired t-test showed that there were significant differences in performance between the placebo and the glyconutrient in participant accuracy on the perceptual discrimination task. In Experiment 2, the results of paired t-test did not show significant differences in performance for the treatment conditions. Results of an independent t-test, however, indicated a significant difference in performance between the placebo and the glyconutrients on the Reading Span Task for the first test session. The present experiment demonstrates the efficacy of glyconutrients in augmenting memory and perceptual processes in humans.
Glyconutrients by Ray Sahelian, M.D. ( health and nutrition information index )
I start suspecting
that there is something not right about the promotion of a product - such as
glyconutrients - when there is hardly any studies published on Medline
regarding glyconutrient supplementation by itself and its effects on human
health and cancer prevention and treatment, yet the internet abounds with
websites promoting the concept or the products. I can only find two published
studies on glyconutrients. Both of these studies have been done in vitro - basically
a test tube study - as opposed to a live human study, and one study could
well be a fraud.
Mannatech and Glyconutrients
(3/28/06)-Homocysteine level, an amino acid that many health professionals believed to be as important and dangerous a risk factor for heart disease and stroke was the subject of 3 studies that were reported on recently. It is also an accepted hypothesis that the B vitamins, namely: vitamin B12, vitamin B6, and foliic acid, could protect against high homocysteine levels, which in turn would mean less risk of heart attack or stroke.
The results of the three studies however showed that by decreasing the homocysteine level, the number of patients having cardiovascular problems did not decrease. There are no known harmful affects from taking the B vitamins.
All three studies showed that the vitamin regimens drove patients' homocysteine levels down by nearly one-third. All three studies however did not show any decrease in the amount of cardiovascular problems in the group receiving the vitamin B pills from those who only received a placebo.
"The evidence is clear that this type of vitamin therapy is really not effective in reversing or benefiting advanced vascular disease", said the hypothesis's father, Dr. Kilmer McCully of the V.A, Boston Health Care System in West Roxbury, Mass.
The Canadian Institutes of Health Research sponsored one of the studies. It involved 5,522 men and women 55 or older who had diabetes or had had a heart attack or had documented heart disease. The patients in this study were monitored for five years. The second of the studies involved 3,749 men and women ages 30 to 85 that had recently had a heart attack. It was known as the Norwegian Vitamin Trial, and it lasted for three years and four months.
The third study involved 3,680 stroke patients, some of whom were randomly chosen to take the vitamins.
(3/16/06)- The Glucosamine/chondroitin Arthritis Intervention Trial, or GAIT, which cost $12.5 million, was the largest ever study of the supplements. The study was financed by the National Center for Complementary and Alternative Medicine and the National Institute of Arthritis and Musculoskeletal and Skin Diseases. . Dr. Daniel E. Clegg, the chief of rheumatology at the University of Utah School of Medicine was the lead author of the study.
It turns out that the first GAIT trial isn't over yet. About one-half of the 1,583 original enrolled patients will be treated for an additional 18 months. Researchers will compare X-rays taken at the beginning of the study and after one and two years to determine if the treatments result in any noticeable changes in the knee joint. Results are expected in about a year.
Glucosamine is derived from shellfish, and chondroitin is made from cow cartilage.
Many health professionals are not willing to write off the effective benefits of either of the supplements. One of the subgroups involved in the study had moderate to severe pain. In this subgroup, which had only 350 patients, 79% of the glucosamine/chondroitin 72 users reported their pain had dropped by at least 20% after treatment. Only 69% of the patients taking Celebrex reported similar benefits.
About 66% of the patients in this subgroup taking glucosamine alone felt better, while 61% of those taking just chondroitin alone felt better. That compares with 54% of the placebo subgroup who experienced some pain relief.
Long-term use of nonsteroidal anti-inflammatory drugs, or NSAIDs, such as ibuprofen, found in Advil, or naproxin, found in Aleve is highly risky. Each year, side effects from NSAIDs cause nearly 103,000 hospitalizations, and 16,500 deaths. NSAIDs also increase the risk of stomach ulcers, or erosions in the small intestine.
(3/2/06) -The following is a question that was emailed to us recently from
one of our viewers. We thought the question was such an interesting one that we
have included it, and Harold Rubin's, response thereto.
----- Original Message -----
Sent: Monday, February 27, 2006 2:59 PM
I recently read articles on the use of certain nutrients for health. I am a 65 year old male.
I take saw palmetto for my prostate. The article said saw palmetto does not help an enlarged prostate. My prostate is normal. Will it encourage a normal prostate to stay normal?
Also, I take glucosamine and controtin for my joints. The article said it does not help an arthritic condition. Will taking the nutrients discourage arthritis from forming?
Thank for your help,
Response by Harold Rubin
Dear ( )
(Before I answer your question, I must disclose that this writer takes both supplements you mention in your question)
You are correct in noting that recent studies have indicated that saw palmetto and glucosamine do not outperform placebos. Does that mean you should stop taking these two supplements? This is a question only you can answer. In both of these studies there was a subgroup of individuals who were helped by the supplement, despite the overall indication of no help. The placebo effect in these studies is also interesting, i.e. people were helped who thought they were taking the placebo (no medication) but thought they were on the supplement. What role does the mind (our belief system) have in aiding or hampering effects of supplements? This needs much research.
The question you seem to be asking is whether these supplements will prevent the occurrence of problems. Will it prevent a "normal" prostate from becoming benign or cancerous? There are too many factors to be able to answer that in any way. The first factor is the time you start taking the supplement e.g. 65 years of age, 55 years of age or even younger. Genetic history is another factor, along with life-long nutritional experience, physical exercise, handling of stress, sleep patterns etc. In general, the studies indicate that they do not help. The conclusion being that you are wasting your money. But maybe you are the person who it could help???
What we think it boils down to is (1). whether you can afford the supplements from a budget point of view. (2). whether you note any side or adverse effects taking the supplements. (3). whether you believe in supplements. (4) what are the alternatives (5). and whether concomitant with taking the supplements you lead a healthy life. It may be the synergistic effect of all these factors that help retard the development of problems, but do not prevent them from occurring. Aging is still not understood, but it sure does expose us to medical conditions that result in stressful times.
According to an article in The Nutrition Business Journal, Americans spent $734 million on glucosamine and chondroitin in 2004, making them two of the most widely used dietary supplements in this country. A large federal study has determined that the supplements are being used to alleviate arthritic pain, the money in effect is being wasted.
The Glucosamine/chondroitin Arthritis Intervention Trial, or GAIT, was the largest ever study of the supplements.
The study enrolled 1,583 patients with osteoarthritis of the knee who were randomly assigned to one of five groups for a 24-week period of time. Some of the patients took glucosamine, some took chondroitin and some took both. The rest of the patients in the study were either given a placebo, or celecoxib, which is also known as Celebrex.
No statistical improvement was found in those patients who took the glucosamine, chondroitin, or combination of the two. The patients who took the celecoxib were found to have had a statistically significant improvement in their symptoms. Dr. Daniel E. Clegg, the chief of rheumatology at the University of Utah School of Medicine was the lead author of the study. Dr. Clegg cautioned that addition studies would have to be conducted before the effectiveness of glucosamine and chondroitin could be finalized.
The study was financed by the National Center for Complementary and Alternative Medicine and the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Glucosamine and chondroitin are substances found naturally in our joints. Glucosamine is a modifiend sugar that is thought to play a role in the formation and repair of cartilage. Chondrotin is part of a large protein, proteoglycan that provides elasticity to cartilage.
Dr. Stephen E. Strauss, director of the Alternative Medicine and the National Institute of Arthritis and Musculoskeletal and Skin Diseases, a sponsor of the study, said a national survey in 2002 found that about 5.2 million Americans had used one or both supplements in the preceding year. Veterinarians prescribe glucosamine and chondroitin for treatment of pets with arthritis.
Top Selling Supplements in 2004
in billions of dollars
2. Meal replacements
3. Sports nutrition
5. Vitamin B
6. Vitamin C
8. Vitamin E
Source: Nutrition Business Journal
(2/17/06)- About 2.5 million American males take the herbal supplement saw palmetto for their enlarged prostate problem. A recent study concluded that the supplement was no more helpful in alleviating the problem than was a placebo. The multistudy analysis was performed by the Cochrane Collaboration, a nonprofit group that specializes in reviewing medical literature. Stephen Bent, professor of medicine at the University of California, San Francisco, was the main author of the study.
The study involved 225 men over the age of 49 with moderate to severe benign prostate hyperplasia (BPH), who were randomly assigned to either the saw palmetto or a placebo group. Those who received the saw palmetto received a capsule dosage of 180 mgs, twice a day. The patients did not know which group they had been assigned to.
Saw palmetto is an extract from the berry of the American dwarf palm tree, common in Florida and the southeastern part of this country. The National Institutes of Health sponsored the study. It is estimated that more than half of all Americans over 29 years of age suffers from BPH.
There are two drugs that have been approved by the FDA to treat BPH-finasteride and terzosin-but they both cost triple the cost of saw palmetto, which sells for about $5 to $15 for a month's supply of the supplement.
Saw palmetto is the third-highest-selling herbal supplement in the U.S. with annual sales of about $100 million to $120 million. Garlic, which is used for high cholesterol levels, and echinacea, which is used to treat cold symptoms are the leading herbal supplement sellers in this country are the number one and number two selling herbal supplements in this country according to the American Botanical Council, an educational organization focusing on the science-based use of herbs..
Patients took the capsules for a year. Symptoms were assessed through a questionnaire and by measuring of the size of the prostate gland and the volume of urine left, as well as other tests. The study found no significant difference between the placebo and the saw palmetto group.
A prior study analysis of 21 trials involving over 3,000 men found that the saw palmetto did provide "mild to moderate improvement" in symptoms with fewer adverse events than finasteride.
Please see our article: "Prostatis"
(10/27/05)- The cold and flu season are upon us, and so the media is seeing a big jump in ads from the herbal supplement manufacturers with claims about the effectiveness of their products to prevent or even reduce the symptoms of colds and the flu. As scientists delve more deeply into the workings of the immune system, they are finding evidence that it is the complex interaction of nutrients in food that helps the body build its defenses against disease and infections.
Single nutrients ad cocktails of nutrients consumed alone can't provide the same benefits that can be provided by adhering to a healthy food regimen. Large doses of some supplements such as selenium, zinc, vitamin A, vitamin B6 and vitamin e may even harm and suppress the immune response. The most effective way to prevent the spread of the flu and colds is through frequent washing on one's hands, and by adhering to a healthy diet regimen.
In a paper that was published this year in the Journal of the American Medical Association, researchers under Simin Nikbin Meydani, director of the nutritional immunology laboratory at Tufts University' Jean Mayer USDA Human Nutrition Research Center concluded that dietary supplements do not work as effectively in dealing with preventing the onslaught of a cold or the flu as does a healthy diet.
A healthy diet is the best way to fight the onslaught and effects of a cold or the flu.
Dr. Mehmet Oz, a professor of cardiac surgery at New York's Columbia University does however recommend a single multivitamin if it contains the following ingredients: at least 800 mgs of folate, 400 international units-or Ius-of vitamin D, 1,200 mgs of calcium and 400 mgs of magnesium. We are not aware as to why a professor of cardiac surgery is an expert in this field, but nevertheless we pass his suggestions along to our readers so that they may judge the matter for themselves.
(9/2/02)- Monitoring the main stream professional research on herbal supplements, we find more studies that are calling into question the advertised effectiveness of these supplements. The herbal supplement market has grown to about $4.2 billion in sales last year and shows no signs of declining despite the negative publicity.
Local newspapers are full of ads for "anti-aging" herbal supplements and senior citizens extolling the use these supplements. At the same time critical articles are appearing that are well summarized in the statement by Ron Davis, a member of the American Medical Associations Board of Trustees, "There’s more evidence that calls into question their efficacy than evidence that argues persuasively that these products are effective."
Is it not that the medical community is not at arms length distance from the pharmaceutical industry? We know that some well established medications had their roots in scientific examination of the active ingredient in the herbal supplement. Highly respected research scientists continue to examine these supplements for their active ingredient so that they can develop drugs that will help the consumer.
The effect on memory of Ginkgo biloba was challenged by a study conducted by Paul Solomon, which suggested no measurable memory benefits or related cognitive function benefits in healthy volunteers who were not suffering from any cognitive impairment at the beginning of the research.
Independent repetition of this study needs to be done. No conclusions can be reached about slowing down the progress of memory impairment from this one study. The four pharmaceutical companies that market FDA approved medications for mild to moderate Alzheimer’s disease advertise a seemingly positive "effect" on memory. Alternatively, we still can ask the question as to whether the mild/moderate group of Alzheimer’s disease individuals could benefit from use of Ginkgo biloba in a similar fashion or as an adjunct to conventional medications.
More studies will have to be done for clarification of this issue. Ginkgo biloba will continue to be bought by a large cohort group of the elderly concerned about the aging memory process and feeling that this is a product that "promises" results as opposed to what conventional medicine has to offer.
As we have previously written, Kava is now being banned by many countries throughout the world. In March of this year, Canada joined Germany and Singapore in banning the sale of this anti-stress supplement due to a link to liver damage. The U.S. Food and Drug Administration has issued a warning, but has not banned this herbal supplement. What evidence does the FDA need to pull this product from the market? Does this tell us anything about the herbal supplement lobby and the effects of such lobbies on our health?
The American Medical Association and consumer groups have asked that Ephedra, taken for weight loss, be banned because of continuing reports of heart attacks and stroke in individuals taking this supplement.
Echinacea was shown to have no significant effect on the incidence or severity of colds in a study conducted in the year 2000, but no action has been taken on this supplement as of this writing.
There has always been a strong outcry of "snake oil" medicine directed at the herbal supplement industry from many vocal professional groups? (We wonder how many of these groups or individuals get there funding from the pharmaceutical industry?) In Europe, herbal supplements have been a mainstay of the medical community.
This is especially true in Germany, where a special commission evaluates all supplements and this has been the source of many of the claims of American herbal supplement marketers. Many feel that the standards for approval in the United States are more rigid than in Europe. The claim has been made that the FDA is relaxing some of its standards in order to speed up the approval process at the risk of fully testing the safety of some medication.
An answer to the recent rash of professional articles may be that the National Institute of Health is placing more money in nutrition-related research. Also the Office of Dietary Supplements has had immense budget increases in the last five years. More controlled trials are now being done than ever before. The results of these studies should tell us more about the safety and efficacy of these supplements.
Another answer may lie in events that are happening in the pharmaceutical industry. Many of their "blockbuster" drugs are in the sundown phase of their patent lifespan. Supplements are competitors of these drugs. A way to beat your competitor is to downgrade the effectiveness of his/her product even though the product may be cheaper and have equal effect. (Note how many new medications enter the market that are equal in effectiveness to an older medication, but may have fewer side effects while costing quite a lot more. This may account for the fact that they have instituted a cost-benefit factor in evaluating new medications.) The more the products out there, the lower the sales of the pharmaceutical conventional drugs when they reach the over the counter market. Secondly, the prices of medications are soaring, making individuals look around for alternative sources of medications.
Pharmaceutical manufacturers often play up the fact that herbal supplements do not take the same rigorous FDA path to approval and that supplements generally cannot be removed from the market until they have been shown to be harmful. This creates an aura of suspicion (hokum) around the supplement and taking of these supplements are attributed to "health nuts", a term that has negative connotations despite the highly satisfying goal of physical health. Could these "health nuts" not be pioneers in the Ponce de Leon search for the fountain of youth? This dream has been with us for eons as reflected in Methuselah in the bible, the Greek and Roman gods, the cultural myths of many civilizations, and fantasies expressed in our media etc.
Adverse reactions to the supplements make for good press. Yet, the same thing is true for FDA approved medications. A recent article in The Wall Street Journal ((August 29, 2002, p. D3) "Deadly Errors Dog Procedures At Doctors’ Offices and Clinics" indicated that 8% of medical mistakes resulted from prescription errors in dosage, choice, allergy or interaction. When you consider that there were approximately 521 million outpatient visits in the year 2000, the 8% looms as a big number of possible problems with approved medications.
With many herbal supplements, there are no benchmarks to measure success of the product. The words used to quantify the effectiveness of the supplement are vague. This also appears true in some of the studies of the effects of FDA approved drugs to combat symptoms of Alzheimer’s disease. We note that the National Institute of health has launched a study to investigate measures designed for use in Alzheimer's disease prevention trials.
The new measures will be evaluated in 650 non-demented subjects enrolled in a simulated Alzheimer's disease primary prevention trial. Once enrolled, subjects will be followed for four years with annual clinical evaluations and interim six-month phone calls. As any researcher will tell you, long-term studies are hard and expensive to do. Subjects drop out, other contaminating factors enter the picture over time, and synergistic effects occur etc. which make it hard to sustain the study. Yet, such studies are indispensable if we are to deal with effects of medications or herbal supplements.
What is to be done about this situation? There is no question that herbal supplement manufacturers will have to clean up their industry in light of studies that indicate different levels of the supplement in different manufacturer’s product. (See our previous articles in this series) There is a need for the FDA to monitor more closely the claims advertised by the herbal supplement, something that the industry resists, desiring to monitor itself, a questionable ethical dilemma.
The National Institute on Aging is sponsoring a study to investigate measures designed for use in Alzheimer's disease prevention trials. The new measures will be evaluated in 650 non-demented subjects enrolled in a simulated Alzheimer's disease primary prevention trial. Once enrolled, subjects will be followed for four years with annual clinical evaluations and interim six-month phone calls. Once benchmark standards are established, conventional medications and herbal supplements must adapt these as the gold standard to measure their product and not complain about too much government interference.
In the long run, nothing beats good research and continuous validation of that research. More money needs to be spent on basic research on the systemic process of aging. In the meantime, each of us has to make a decision as to what we will use to enhance our health/treat our illness. This decision should only be made when one is in possession of the latest research information and specifically in consultation with your treating physician, who has training in both conventional and complementary medicine
Please See: Herbs and Dietary Supplements-St. John's Wort-Part I
St. John’s Wort -Herbs and Dietary Supplements-Part II-Ephedra
Phytomedicine or Herbalist-What is It?-Part III
Herbal Medicine and Botanical Supplements Caveat-Part IV
Treating Osteoarthritis with Dietary Supplements-Part V
St John's Wort: Does It Help Treat Depression-Part VI
Herbal Products:Use With Caution-Part VII
Kava: Safety Alert-Part VIII
Herbal Usage for Hormone Replacement Therapy-Part IX
FOR AN INFORMATIVE AND PERSONAL ARTICLE ON PRACTICAL SUGGESTIONS WHEN SELECTING A NURSING HOME SEE OUR ARTICLE "How to Select a Nursing Home"
Harold Rubin, MS, CRC, ABD
updated April 4, 2015