14) "AS YET UNPROVEN" SUPPLEMENTS
a) Introduction
We're being very careful in our terminology here. The term "unproven" is not synonymous with "doesn't work". To be included as recommendations in the previous chapters the supporting research must have met some very high standards for statistical validity; typically an independent double blind multi-center research study with significant sample sizes and valid statistics which has been verified by other researchers and which has a clear cut "cause and effect". The following "supplements" don't have readily found studies which have that statistical validity and, as such, come under that "as yet unproven" category. It doesn't mean they don't work, it only means we just don't find the evidence convincing enough to recommend that a person with type 2 diabetes use these supplements.
Many supplements base their sale's claims on the "placebo effect". Let us presume three treatment groups are defined for a given piece of research into a given supplement: one group is given the treatment (for instance: a supplement called "Q-10"), one group is given a "placebo" (typically gel tablets with sugar inside), and one group is given nothing. The groups given the placebo and the "Q-10" will typically both do much better than the group that is given nothing. It is human nature to do better with any treatment compared to no treatment at all, the power of the mind is very great. Now if the treatment group that is given the placebo is removed from the study results, the result is a "research study" which shows "Q-10" has a good benefit. Even though the marketers try very hard to sell such "research studies", this book has avoided accepting the results of any research studies which eliminated the placebo test group.
Another statistical conundrum that is utilized by many supplement makers is that it is virtually impossible to statistically prove that any given ingredient doesn't have a beneficial effect. You can't statistically "prove" something doesn't work without some huge numbers of research subjects. In order for a manufacturer to use the terms "prevents", "mitigates, "cures" or "treats" the FDA requires a manufacturer to statistically prove the substance does work, but there are other terms such as "supports", "beneficial", "remedies", "shown", "works" or "helps" that the FDA does not require such proof. A manufacturer could claim that literally anything "supports" weight loss or diabetes control and no researcher could prove them wrong. As long as the ingredients they chose are innocuous enough to do no harm, they can get away with the claim. And it is only the claims that the manufacturer makes that are regulated. An unknowing reporter or author can read the often very misleading claims of the manufacturer and write a piece or even a book where the innocent author uses terms such as "cures" and "treats" to describe the product. And the public is none the wiser. This happens very often.
Note that many reputable medical doctors recommend these supplements. But medical doctors typically are not trained in statistics and tend to give the old "professional courtesy" to their colleagues. Also, unfortunately, some of their colleagues have marketing deals with the firms selling these supplements and thus stand to profit from their sale. If a "naturopathic" or "holistic' doctor sells expensive "individualized diet plans" not covered by insurance or sells naturopathic remedies directly to his or her patients, we recommend finding another doctor. Other doctors just get tired of arguing with the vociferous and totally unreasonable demands of their patients when it comes to supplements, adopting a "if you want to do it, go ahead" attitude. Still other doctors really believe in the efficacy of some of these treatments based on what they have seen in their practice, not on valid research. There are even "naturopathic" doctors seen on national TV, such as Andrew Weil, MD, which advocate their use. Dr. Weil emphasizes that nutritional supplements cannot take the place of a bad diet but can only fill in gaps in a good diet. He markets on his website: Balanced Cal-Mag, Cardio Support Formula, Daily Antioxidant for Optimum Health, Daily Multivitamin for Optimum Health, Energy Support Formula, Evening Primrose Oil, Ginkgo biloba, Glucosamine & Chondroitin, Immune Support Formula, Mood Support Formula, Omega 3 Fatty Acids and Omega 3 Supplements, Vitamin Advisor Complete Daily Pack, Vitamin B Complex, Vitamin C 1000mg, Vitamin D 1000 IU, Vitamin E Complex, Vitamins Online, Weil Juvenon Healthy Aging Support. Typical of Dr. Weil's web pages is:
"One of Doctor Weil's products is Joint (Osteoarthritis) Support- Includes Dr. Weil's Antioxidant & Multivitamin, $72.00 for 30 Daily - Complete Packs. In addition to the Antioxidant and Multivitamin - recommended for everyone as the basic foundation for insurance against nutritional gaps in the diet - the Joint (Osteoarthritis) Support Formula provides Glucosamine along with several proven herbal ingredients to help maintain healthy joint function."
We must admit a certain skepticism when any medical doctor markets their own medications, especially very high priced supplements, the trust factor just kind of evaporates.
This list of "unproven" supplements includes:
1, "antioxidant rich", "phytonutrient rich" and "flavanoid rich" fruits such as purple grapes, black cherries, red apples, blueberries, guava, pomegranate, blackberries, dark plums, and cranberries
2, "antioxidant catechin" rich foods such as green, oolong, black tea, dark chocolate
3, "detoxification" and "colonic cleansing" by using pectins, horsetail, fenegreek, psyllium, milk thistle, wormwood, mineral oil, slippery elm bark, guggulipid, pepperment leaf, marshmallow root, chlorella, apple juice, bentonite, charcoal, and mild laxatives
4, pro-biotic supplements (live yogurt cultures), raw milk, dairy products and other calcium supplements
5, potassium, zinc, vanadyl (vanadium), chromium or selenium supplements
6, multivitamins, vitamin B complex, vitamins A, D, K1, or K2.
7, weight loss supplements: hodia, acai berry, garcinia cambogia
8, the chemicals N-Acetyl-Cysteine, Bromelain, GLA, hydroxycitric acid, Q-10, CoQ10, alpha lipoic acid (ALA), L carnosine, L-arginine, L-tryptophan, L-tyrosine, S-adenosylmethionine (SAMe), MSM, glucosamine and chondroitin
9, herbs such as garlic, ginseng, ginger, ginkgo biloba, rosemary, thyme, nutmeg, sage, turmeric, cumin, chile, capsicum pepper fruit (jalepenos), cayenne peppers, sesame seed, cinnamon, lignins, borage oil, mullein leaf, licorice root, pomegranate extract, banaba leaf extract, gotu kola, burdock, Indian celery seed, areca nuts, mulberry, green-lipped mussel, uva ursi leaf, nettle leaf extract, St. John's wort, bitter melon, fenugreek, milk thistle, curcumin, gymnema sylvestre, meadow rue, eugenia jambolana, tinospora cordifolia, royal jelly (bee pollen), pterocarpus marsupium, kelp, momordica charantia, juniper berries, cedar berries, dandelion root, papaya seed extract, golden seal, raw honey, evening primrose oil, grape seed oil, rice bran oil, olive oil, shitake mushrooms, pine bark extract, etc. (this list could extend to many pages, with each herb being claimed as beneficial for many different ailments, depending on who you believe)
10, wine, beer, coffee (sorry folks!) chocolate (sorry ladies!)
Considering that some of these "supplements" are even recommended by the American Heart Association, the American Diabetes Association and the American Dietetic Association, it is easy to see how poorly done research can take on a life of its own and become the fodder of modern medical urban legends. There was recently an article about the newsmedia in the Ukraine and how poorly it had covered a medical situation there involving a teenager who died of an infection that just happened to coincide with a booster vaccination shot. The article lamented that the newsmedia in the Ukraine did not hold themselves up to the high accuracy standards of the newsmedia in the USA. If you examine much of the "health recommendations" of the newsmedia in the USA using the criteria for meaningful research that is put forth in the appendix, this commentary on high accuracy becomes somewhat tarnished. If we can't find any statistically valid research backing up the use of the supplement, we simply will not recommend it. We fully recognize that this will open us up to tons of emails that border on hate mail but so be it.
Dangerous supplements: These supplements can kill you: aloe, buckthorn, cascara sagrada, rhubarb, senna (yellow dock), ephedra (ma huang), cinnabar, guarana, betel and ate. Most herbal supplements have very small quantities of these herbs but herbs are not regulated and every once and awhile a batch that is too strong slips through. We also recommend staying away from supplements that are combinations of many herbs, it is impossible to know what is really in them. Note that ephedra and cinnabar are illegal in the USA but still can be found in Chinese apothecary shops. The Canadian Health Regulatory body has specifically recommended against: Liquimax Complete Nutrition Multivitamin Formula, Dietary supplements 6-OXO and 1-AD, Ephedra/Ephedrine Products, VPX No Shotgun and BSN Cell Mass Body Building Powders, Red Yeast Rice, Red Yeast Rice/Policosonal Complex and Cholestrix, Liviro3 dietary supplement, Zencore Tabs, dietary supplement MdMt, HS Joy of Love Supplement, FiberChoice plus Multivitamins, V.MAX, Rhino Max, EMPowerPlus, Ocean Plasma Isotonic Living Water and Ocean Plasma Hypertonic Living Water, products containing L-arginine, products containing anabolic steroids, supplements containing methyl-1-testosterone.
On the Website Consumeraffairs.com on October 20, 2006 it was reported:
The Federal Trade Commission (FTC) and the Food and Drug Administration (FDA), working with government agencies in Mexico and Canada, have launched a drive to stop deceptive Internet advertisements and sales of products misrepresented as cures or treatments for diabetes. The joint campaign has so far included approximately 180 warning letters and other advisories sent to online outlets in the three countries. "We will continue working with our partners in the U.S. and internationally to make sure scammers have no place to hide," said Lydia Parnes, Director of the FTCs Bureau of Consumer Protection. "The Internet can be a great source of information, but it also is a billboard for ads that promise miracle cures for diabetes and other serious diseases. Our advice to consumers: Be smart, be skeptical, when evaluating health claims online.""We will not tolerate practices that raise false hopes and bilk consumers of precious health care dollars," said Margaret Glavin, FDAs Associate Commissioner for Regulatory Affairs. "Diabetes requires effective treatments and aggressive management, not bogus and unproven products." The joint diabetes initiative to stop commercial sale of fraudulent therapies originated with a Web surf for "hidden traps" by the International Consumer Protection and Enforcement Network (ICPEN), an organization of law enforcement authorities, members of the Mexico, United States, and Canada Health Fraud Working Group (MUCH), and the attorneys general offices of Alaska, Michigan, Ohio, Virginia, and Wisconsin. MUCH, which consists of regulatory officials from health, consumer and competition protection agencies in the three North American countries, had previously conducted a campaign against fraudulent weight-loss products.
Using the results of the Internet sweep, FTC sent warning letters for deceptive ads to 84 domestic and 7 Canadian Web sites targeting U.S. consumers, and referred an additional 21 sites to other foreign governments. About a quarter of the firms have already changed their claims or removed their pages from the Internet, and several others are in contact with FTC. In addition, FDA has issued warning letters to 24 firms marketing dietary supplement products with claims to treat, cure, prevent or mitigate diabetes The letters warn firms that failure to promptly correct the violations may result in enforcement action without further notice, which may include seizure of violative products and/or injunctions against the manufacturers and distributors.
FTC is launching a new consumer education campaign to teach consumers how to avoid phony diabetes cures. The materials encourage consumers to "Be smart, be skeptical!" and will be available in English, Spanish, and French.
Current Chapter: 14) "AS YET UNPROVEN" SUPPLEMENTS
a) Introduction
b) The Good and the Bad
c) Vitamins and Antioxidants
d) Calcium and Dairy Intake
e) Potassium
f) Phytonutrients, Catechins and Flavonoids
g) Cinnamon
h) Herbal Supplements
i) Other "Panaceas"
j) Alcohol and Coffee
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