Apr 27 2012
Consumer Reports (CR) and its Health Newsletter provide sound advice about nutrition and medicine, with one exception: their recommendations concerning alternative therapies, especially dietary supplements. With regard to dietary supplements, part of the problem is the failure of CR to make a distinction between authentic dietary supplements, such as multivitamins and minerals, and non-vitamin, non-mineral medicinal products. For example, the September 2010 issue of CR contains a table listing “Eleven supplements to consider”. The list includes calcium and vitamin D supplements, and St. John’s wort and Pygeum herbals.
The nomenclatural confusion was created by the Dietary Supplement Health and Education Act of 1994 (DSHEA), which was termed “The Snake Oil Protection Act” by the New York Times. DSHEA, which was passed after a massive lobbying campaign by industry, arbitrarily designated herbals and other traditional medicinal products as dietary supplements. Herbals are used worldwide as medicines and in Europe some are available by prescription only.
The purpose of the Act was to prevent the Food and Drug Administration (FDA) from effectively regulating those products, and it succeeded brilliantly. Sales of dietary supplements rose from $4 billion annually in 1994 to $28 billion in 2007, and reports of severe adverse events caused by those products rose in parallel (1). Another consequence of DSHEA is that designating herbals as dietary supplements misleads consumers about their medicinal nature and conceals their potential for causing severe adverse effects.
The selling points for herbals are that as “natural” products they are safer and gentler than the powerful “foreign” chemicals in purified medications, and they possess unique qualities not found in conventional medications. Dr. Varro Tyler, an expert in the medicinal use of plants, termed those unfounded claims “paraherbalism”, and described herbals as “crude drugs of vegetable origin” (2). In reality, the active ingredients of plants are chemicals that are similar or identical to conventional medications, and many of the latter were first identified in plant extracts. It is no more “natural” to swallow dozens of chemicals in a plant extract than to ingest a single purified chemical – a drug is a drug. Before discussing CR’s advice about supplements, it is necessary to consider briefly basic differences between herbals and conventional medications.
The first issue is: what’s in the bottle? Safe and effective use of medications requires consistency in composition and biological activity. Prescription and over-the counter medications approved by the FDA are purified compounds whose activity is known. By contrast, the biological activities of herbals can’t be standardized because for the most part their active ingredient(s) have not been identified. Some herbals are standardized based on marker compounds, such as ginsenosides in ginseng. However, Consumer Reports (November 1995) found a 10-fold variation in the ginsenoside content of ginseng products, and aptly termed the variability “herbal roulette”. Moreover, many “all-natural” herbal remedies, especially those sold for sexual dysfunction or weight loss, are adulterated with undeclared prescription drugs. In a letter to supplement manufacturers, FDA commissioner Dr. Margaret Hamburg noted that in recent years the FDA has issued consumer warnings about nearly 300 products (3). She stated that “These tainted products can cause serious adverse events, including strokes, organ failure and death.”
A second concern is: what is the evidence that herbals are effective? Belief in the efficacy of herbals is based partly on their traditional use and partly on clinical trials funded by manufacturers. Reviews of those trials have pointed out their poor quality and very strong positive bias (4,5). Recent independently-funded trials of popular herbals, including echinacea, black cohosh, saw palmetto and ginkgo biloba, have been uniformly negative.
A third issue is the safety of herbals. Unlike clinical trials of purified medications, herbal trials have not included laboratory tests to detect damage to the liver and kidney, and until recently manufacturers were not required to report adverse effects to the FDA. Despite the lack of an effective reporting system, there are numerous reports of severe adverse effects caused by herbals, and the FDA recently estimated their annual frequency at 50,000 (6). Herbals may also cause adverse effects because of their interaction with conventional medications. St John’s wort decreases the levels of many common medications because it increases the activity of enzymes that inactivate them. The elderly are at particular risk because of chronic illnesses and their frequent use of prescription medications.
In summary, in the absence of sound evidence about the efficacy of herbals beyond a placebo effect, uncertainty about their activity and purity, and growing information about their adverse effects, their use should be discouraged.
There is a striking difference between CR’s critical, evidence-based evaluation of conventional medical treatments and health beliefs, and its soft standards concerning alternative therapies. An example of the former is a critique of conventional “health truths” in the January 2012 issue, in which the limitations of routine screening for prostate cancer were noted, as well as the lack of evidence for the health benefits and possible hazards of multivitamins.
In contrast, recommendations for considering the use of herbals and non-vitamin, non-mineral supplements are hedged by noting that “there is some evidence supporting their use” or that “small trials suggest benefit”. Some recent recommendations include black cohosh and soy for relief of menopausal symptoms, saw palmetto for benign prostate enlargement (February 2012), and glucosamine for arthritis. Those recommendations are based on industry-funded trials, whose deficiencies were noted above, and the negative findings of more rigorous independent trials were overlooked. Moreover, potential hazards, such as the association of black cohosh consumption with severe inflammation of the liver are overlooked.
In its recommendations for herbals to consider, CR states repeatedly that a mark of approval from the United States Pharmacopeia (USP) verifies “the quality, purity and potency of its raw ingredients or finished product”. That is the standard terminology USP uses for products that it analyzes and approves, but it is only partially accurate when applied to botanical products. The USP analysis uses chromatographic procedures to verify the source of the botanical extract, and the absence of contamination with microbial products and heavy metals (7). However, since the active ingredients of most botanicals have not been identified, analysis of marker compounds provides no information regarding the pharmacological activity or “potency” of the product. Moreover, the USP does not test for the presence of purified drugs, which are potentially dangerous contaminants.
Consumer Reports also promotes the use of other alternative therapies. The September 2011 issue contains an article entitled “Alternative Therapies. More than 45,000 readers tell us what helped”. In an online survey subscribers were asked to rate how well conventional and alternative therapies worked for 12 common health problems. For osteoarthritis, 46% of responders who used chiropractic felt the treatment helped a lot, as did 25% of those who used glucosamine/chondroitin. For back pain, 65% who used chiropractic and 41% who used acupuncture felt that those therapies helped a lot. An assessment of the evidence supporting those treatments was provided by the Natural Medicine Comprehensive Database (NMCD). The NMCD assessment of evidence, which is based on their review of published clinical trials, doesn’t take into account the poor methodological quality and strong positive bias of most of those trials (4,5). Glucosamine was rated by NMCD as “likely effective” for osteoarthritis, but an analysis of published trials revealed that all industry-supported trials were positive and all independently-funded trials were negative (8). Chiropractic and acupuncture were rated as “possibly effective” for back pain. There is little evidence for a specific effect of chiropractic manipulation, and recent evidence indicates that acupuncture for pain is a placebo treatment (9, 10). The article also contains testimonials to the dramatic benefits provided by chiropractic and acupuncture.
What significance should be attached to the responders’ belief that they received specific benefits from alternative treatments? Many health problems are self-limited, and placebos may be effective for relief of pain. In a clinical trial of glucosamine for osteoarthritis of the knee, 60% of patients who received a placebo pill met the criteria for a positive outcome, and glucosamine was no better than placebo (11). A recent study of patients with asthma provides another illustration of placebo effects (12 ). Patients received treatment with either an inhaler containing a bronchodilator, a placebo inhaler, sham acupuncture or no treatment. Patients in all three treatment groups reported equal subjective improvement compared to no treatment, but only patients who received the bronchodilator exhibited improvement in an objective test of lung function. Another problem with article is that conventional medications, such as “mainstream vitamins and minerals” and stress reduction, were included in the category of alternative therapies. Although the article does note that “our results do not take into account the power of the placebo effect”, the message conveyed by the survey is that some alternative therapies are effective. Moreover, the article provides information to assist readers to locate acupuncturists and chiropractors
The different standard used by CR Health Reports to evaluate conventional and alternative treatments is based, in part, on its choice of consultants. A list of some of the experts consulted, “health authorities and medical researchers”, is included in each issue. Most consultants are highly qualified academics and health professionals. However, in the April 2011 issue, which contains an article on popular nutritional supplements, one of the consultants listed is the editor of NMCD, whose shortcomings were noted above.
Another CR medical adviser is Joseph Mosquera, MD, who is the clinical director of an integrative medical program. The terminology used to describe belief-based medical practices has evolved from “alternative” to “complementary and alternative” to “integrative”. The agenda of integrative programs is to introduce safe and effective alternative therapies into education for health care professionals. I recently reviewed the poor quality of integrative curricula, and pointed out the lack of oversight of integrative programs by health profession schools (13).
The selection of alternative medicine advocates as consultants, rather than independent scientists and physicians, is a decision made by the editorial boards of CR and CR Reports on Health. That is a departure from CRs’ policy of avoiding bias and conflicts of interest, and from its mission to “empower consumers to protect themselves”. Empowering consumers to make informed decicisions about health care requires providing them with the soundest information available. The need for better consumer education was noted in a recent report from the United States Government Accountability Office that documented the prevalence of deceptive marketing practices and illegal health claims made for dietary supplements (14). As a respected source of information for consumers, CR should use the same high standard of evidence for evaluating alternative therapies that it employs for other medical treatments.
About the Author
Donald M. Marcus is an Emeritus Professor of Medicine and Immunology at Baylor College of Medicine in Houston. A graduate of Columbia University College of Physicians & Surgeons, he did his medical residency and postdoctoral training in Immunology at Columbia. He is a rheumatologist and formerly directed Rheumatology divisions at Albert Einstein College of Medicine and at Baylor. For the last 12-13 years he has taught medical students and physicians an evidence-based approach to complementary and alternative medicine (CAM), and published papers about CAM, especially dietary supplements.
- Bent S. Herbal medicine in the United States: Review of efficacy, safety and regulation. J Gen Intern Med. 2008;23(6): 854-9.
- Robbers, J.E. and Tyler, V.E. (1999). Tyler’s Herbs of Choice. – The Therapeutic Use of Phytomedicinals. The Hawthorne Press, Inc. New York.
- Hamburg, MA. Letter to manufacturers of dietary supplements. HYPERLINK “http://www.fda.gov” http://www.fda.gov December 15, 2010.
- Bausell, RB. Snake Oil Science. The Truth About Complementary and Alternative Medicine. Oxford University Press, New York, 2007.
- Singh S., Ernst E. Trick or Treatment? The Undeniable Facts About Alternative Medicine. W.W. Norton & Co., 2008
- Dietary Supplements. FDA Should Take Further Actions to Improve Oversight and Consumer Understanding. United States Government Accountability Office. GAO-09-250, January 2009
- United States Pharmacopeia, USP Dietary Supplement Compendium 2009-2010, 1st edition.
- Vlad VC, LaValley MP, McAlindon TE, Felson DT. Glucosamine for pain in osteoarthritis. Why do trial results differ? Arth Rheum 2007; 56:2267-77.
- Madsen MV, Gotzsche PC, Hrobjartsson A. Acupuncture treatment for pain: systematic review of randomised clinical trials with acupuncture, placebo acupuncture, and no acupuncture groups. BMJ 2009;338:a3115 doi:10.1136/bmj.a3115
- Marcus, DM. Is acupuncture for pain a placebo treatment? The Rheumatologist 2010; 4: 27-35
- Clegg DO, Reda DJ, Harris CL, Klein MA, O’Dell JR, Hooper MM et al. Glucosamine, chondroitin sulfate, and the two in combination for painful knee osteoarthritis. N Engl J Med 2006; 354:795-808
- Wechsler ME, Kelley JM, Boyd IOE, Dutile S, Marigowda G, Kirsch I et al. Active albuterol or placebo, sham acupuncture, or no intervention in asthma. N Eng J Med 2011; 365:119-26.
- Marcus DM, McCullough L. How good is the evidence in evidence-based integrative medicine? Acad Med. 2009; 84(9):1229-34.
- Herbal Dietary Supplements. Examples of Deceptive or Questionable Marketing Practices and Potentially Dangerous Advice. United States Government Accountability Office. GAO-10-662T, May 2010
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