Correspondence
Alternative Medicine — The Case of Herbal Remedies
N Engl J Med 1999; 340:564-566February 18, 1999
- Article
To the Editor:
With respect to the editorial on alternative medicine by you and Angell (Sept. 17 issue),1 if we look outside our own borders at the policies of other developed countries, we find a more rational approach to herbal medicine. In Germany, physicians are required to have some training in herbal medicine. Considerable research on herbal medicine — including double-blind, placebo-controlled trials — is ongoing.2 Physicians recommend and patients use herbal medicines extensively. Manufacturers are required to meet standards of purity and pharmaceutical activity. Commission E, which has had oversight of herbal medicines and has determined their safety and efficacy, has published 387 monographs (recently translated into English by the American Botanical Council).2 Several other European countries2 also have policies and procedures that allow rational oversight of herbal medicines.
In the United States, herbs are used either as dietary supplements, with minimal standards of safety and efficacy, or as drugs, which require expensive and cumbersome testing procedures. I would argue for a more middle-of-the-road approach that acknowledges the long history of use of many herbal medicines, examines data from many sources including other countries, insists on strict production standards, and requires absolute safety and a classification of efficacy that may vary from “unproved” for some conditions to “demonstrated” for others. The use of the translated Commission E monographs would be very helpful for patients and physicians.
2 ReferencesB. Clair Eliason, M.D.
Medical College of Wisconsin, Milwaukee, WI 53226-05091
Angell M ,Kassirer JP . Alternative medicine -- the risks of untested and unregulated remedies. N Engl J Med 1998;339:839-841
Full Text | Web of Science | Medline2
Blumenthal M, ed. The complete German Commission E monographs: therapeutic guide to herbal medicines. Austin, Tex.: American Botanicals Council, 1998.
To the Editor:
Dietary supplements are not unregulated, as you mistakenly assert in your editorial. In fact, the Food and Drug Administration (FDA) has full authority to require complete and truthful labeling, to require good manufacturing practices, to prohibit contamination with heavy metals, and to take actions to enforce its regulations as necessary. The Dietary Supplement Health and Education Act is no barrier to appropriate FDA action. . . .
The Dietary Supplement Health and Education Act permits dietary-supplement labels to provide consumers with information about the benefits of the product, provided no claims about disease are made. The manufacturer must be able to substantiate these statements, must notify the FDA that they are being made, and must include a disclaimer on the label saying that the statements have not been evaluated by the FDA. These are not unregulated claims, as your editorial implies.
Annette Dickinson, Ph.D.
Council for Responsible Nutrition, Washington, DC 20036-1628To the Editor:
You issue a tough challenge: alternative therapies should be subjected to rigorous testing before being made available. Yet a critical question remains unanswered: Who will fund this testing? The alternative-medicine industry would understandably be reluctant to assist with trials that are too small or narrow in scope to lead to meaningful FDA approval, especially since a negative result would undoubtedly diminish sales. Moreover, the industry would be unlikely to profit greatly from even a strong FDA recommendation or approval, since most alternative therapies are not eligible for a patent. With no possibility of achieving exclusivity in marketing, the alternative-medicine industry would have little financial incentive to pursue testing. . . .
Mehmet Oz, M.D.
Eric Rose, M.D.
Columbia–Presbyterian Medical Center, New York, NY 10032Gerald M. Lemole, M.D.
Medical Center of Delaware, Newark, DE 19713To the Editor:
Over $12 billion is spent on conventional biomedical research, whereas the National Institutes of Health Office of Alternative Medicine has a total budget of only $20 million. That few of the initial studies funded by the Office of Alternative Medicine were ever published (as you note in your editorial) should not be surprising, given that the grants were limited to $30,000 and were often awarded to persons with little research experience. This ill-conceived approach to evaluating alternative treatments was destined to fail. . . .
Dan Cherkin, Ph.D.
Janet Street, M.N., C.P.N.P.
Group Health Cooperative of Puget Sound, Seattle, WA 98101To the Editor:
In response to your editorial, one of the problems is not having a journal that is willing to accept and publish reports on studies of complementary medicine, so that uninformed physicians will be exposed to the infor-mation. . . .
Bernard S. Siegel, M.D.
61 Ox Bow Ln., Woodbridge, CT 06525To the Editor:
According to a recent article, up to 137,000 hospitalized Americans die annually and up to 2,711,000 become seriously ill as a result of adverse reactions to “properly prescribed and administered” prescription drugs.1 The authors concluded that, even by the most conservative estimates, adverse drug reactions are the sixth leading cause of death in the United States.
The few adverse reactions to herbs or vitamins reported annually pale in comparison with the many millions of adverse reactions to prescription drugs. What we should really be concerned about is the casual way we physicians, though in an uproar over Americans' use of herbs and vitamins without a prescription, prescribe potentially lethal agents that are now recognized to be the sixth leading cause of death in our nation.
1 ReferencesHoward Posner, M.D.
111 Bala Ave., Bala Cynwyd, PA 190041
Lazarou J ,Pomeranz BH ,Corey PN . Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA 1998;279:1200-1205
CrossRef | Web of Science | Medline
To the Editor:
In your editorial, you decry reliance on anecdotal evidence as a way of establishing the value of alternative medicine, then, ironically, cite several anecdotes involving individual patients purportedly harmed by alternative medicine. Anecdotes do not establish the efficacy, or inefficacy, of a particular medical treatment. However, many centuries of practice, combined with careful observation of the outcomes of treatment, carry validity. In fact, much of what is considered effective medicine — in the East or the West — was developed precisely in this empirical manner. . . .
Daniel Seitz, J.D.
New England School of Acupuncture, Watertown, MA 02472To the Editor:
A paucity of published studies is not equivalent to a lack of interest in the scientific method on the part of providers of complementary and alternative medicine. It may instead reflect the difficulties inherent in investigating entire philosophies of medical care, in contrast to addressing individual constituents of a therapeutic regimen.1 Such challenges are best met through collaborative research supported by teams interested in proving or disproving all potential therapeutic interventions.
The concept of integrative medicine2 represents universal values of health care. Integrative medicine shifts the orientation from curing disease to healing illness. It is based on a partnership between patient and practitioner that addresses well-being as well as seeking remedies. Integrative medicine operates on the premise that prevention is the primary responsibility of the practitioner and appreciates the influences of nutrition and lifestyle on health and illness. It teaches health care providers to honor the subtle, yet complex, interactions of mind, body, spirit, community, and environment. Integrative medicine is the foundation of the practice of good medicine, whether its origins are conventional or alternative, and good medicine is based on open-minded, inquiry-driven good science.
2 ReferencesOpher Caspi, M.D.
Robert B. Lutz, M.D.
Russell H. Greenfield, M.D.
University of Arizona Health Sciences Center, Tucson, AZ 85724-5153To the Editor:
What I find particularly troubling about alternative medicine is the implied message of its supporters that some highly effective therapies are rejected outright by the medical establishment. In fact, what the proponents of alternative medicine are demanding is alternative epidemiology that would accept anecdotes as proof. Your voice in opposition is timely and most welcome.
Michael Katz, M.D.
March of Dimes Birth Defects Foundation, White Plains, NY 10605To the Editor:
We need to determine what we are doing wrong in our market-driven health care system to generate this revitalized interest in alternative medicine. What we can accomplish in the inpatient setting with acutely and seriously ill patients is not necessarily the same as what we can accomplish in the outpatient setting, dealing with patients who have less serious problems. It is in the arena of ambulatory care that the patient–physician relationship is of primary importance, and it is here that our shortcomings are most pronounced. The nature of the relationship between outpatient and physician is often wanting, largely because of the impact of market forces on ambulatory care in all settings, including teaching hospitals. If the traditional fiduciary relationship is a good one, alternative medicine will have less appeal.
Alan Roberts, M.D.
Medical College of Georgia, Augusta, GA 30912-3104To the Editor:
While attending a conference on alternative (complementary) medicine, which was organized by one of the most respected medical schools in New York City, I realized why this conference was so popular. During the coffee breaks and lunch hour, I discovered that a large number of participants were driven to learn the new “science” in order to build an “herbalist” practice, which is outside the control of and not currently reimbursed by managed care. Many were also interested in the profitable sale of these untested products to their patients. Poor reimbursement by health-maintenance organizations is driving doctors to practice a regressive form of medicine.
Robert R. Weiss, M.D.
Bethpage Ob-Gyn, Bethpage, NY 11714Author/Editor Response
Drs. Angell and Kassirer reply:
Although Germany, unlike the United States, requires that herbal remedies meet certain standards of purity, that does not speak to the question of efficacy. For proof of efficacy, the German government deliberately sets lower standards for herbal remedies than for conventional drugs. Germany's celebrated Commission E monographs, referred to by Dr. Eliason, contain no citations whatsoever to scientific studies.1 No scientist or clinician should accept such ex cathedra pronouncements, regardless of their source, without references to the evidence on which they are based. We are also skeptical of the frequent claim that there is a rich scientific literature available only in German. Important scientific advances find their way into all languages, particularly English.
Dr. Dickinson is in error. The Dietary Supplement Health and Education Act allows dietary supplements, unlike conventional drugs, to be sold without FDA approval. That is why they are required to have a disclaimer on the label.
Contrary to the statement by Oz et al., herbal remedies can be patented if a new use is documented. We agree, however, that the dietary-supplement industry has little incentive to fund rigorous studies, since the law permits them to sell their products without doing so.
Dr. Siegel's charge that medical journals will not publish studies of alternative medicine comes out of thin air. Journals compete avidly to publish important new clinical research, if it is rigorously done. As we indicated in our editorial, the problem with the studies funded by the Office of Alternative Medicine in 1993 was not their size, as suggested by Dr. Cherkin and Ms. Street, but their quality. We agree that the National Institutes of Health (not just the Office of Alternative Medicine) needs to fund rigorous studies of widely used alternative remedies.
The FDA weighs the risks of drugs against the benefits. Although adverse drug reactions take a heavy toll, as pointed out by Dr. Posner, highly risky drugs are generally approved only if they are likely to be effective in treating serious diseases. Unfortunately, we know very little about either the risks or the benefits of dietary supplements, since adverse effects may not be reported.
Anecdotes cannot establish efficacy or the frequency of adverse reactions, but they can be an early warning. The anecdotes Mr. Seitz refers to were not simply reports of ill effects after ingesting dietary supplements; the authors also identified constituents in the dietary supplements (e.g., lead and Digitalis lantana) that are known to cause precisely the clinical manifestations described.
Caspi et al. miss the mark. Patients ingest dietary supplements because they expect some benefit from them. The question is not one of philosophy, but is simply whether the supplement produces the desired effect at an acceptable level of risk. As Dr. Katz emphasizes, that question can be answered only by scientific research, for which there is no alternative.
We agree with Dr. Roberts and Dr. Weiss that our market-driven health care system fosters the use of alternative medicine.
1 ReferencesMarcia Angell, M.D.
Jerome P. Kassirer, M.D.- Citing Articles (4)
Citing Articles
1
Douglas J Rhee, George L Spaeth, Jonathan S Myers, William C Steinmann, James J Augsburger, Lauren J Shatz, Annette K Terebuh, Julie A Ritner, L.Jay Katz. (2002) Prevalence of the use of complementary and alternative medicine for glaucoma. Ophthalmology 109:3, 438-443
CrossRef2
Eric A. Jackson, Tina Kanmaz. (2001) An Overview of Information Resources for Herbal Medicinals and Dietary Supplements. Journal of Herbal Pharmacotherapy 1:1, 35-61
CrossRef3
David J. Kroll. (2001) Concerns and Needs for Research in Herbal Supplement Pharmacotherapy and Safety. Journal of Herbal Pharmacotherapy 1:2, 3-23
CrossRef4
Joseph I. Boullata, Angela M. Nace. (2000) Safety Issues with Herbal Medicine. Pharmacotherapy 20:3, 257-269
CrossRef
