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Herbal Medicines and the Family Physician

BENJAMIN KLIGLER, M.D., M.P.H.
Beth Israel Medical Center
New York, New York

Why should we as family physicians take on the difficult and perplexing task of learning about herbal medicines? There are several reasons. First, with approximately 60 million adult Americans regularly using herbal supplements,¹ the principles of patient-centered and comprehensive care require that we ask our patients about this practice. The recent American Medical Association recommendations on alternative medicine include the suggestion that all physicians become better informed about the use of unconventional therapies.² In my own practice, I have found that my willingness to discuss the use of herbal medicines has greatly added to the feeling of collaboration with my patients and to my understanding of their health beliefs and practices.

See Article in this issue.

The second reason to inform ourselves about herbal medicine is that, as noted in the article by Zink and Chaffin in this issue of American Family Physician,³ herbal supplements and conventional medications may have significant interactions and, unless we inquire about the use of herbs and begin to document such interactions and complications, we will not be able to deal with these complexities responsibly. For example, two case reports of bleeding complications in patients taking ginkgo biloba have been published⁴; since ginkgo is known to be an inhibitor of platelet activating factor, these reports are of some concern. Should patients taking warfarin or aspirin be taking ginkgo? Should patients taking vitamin E, which also may have antiplatelet activity, be taking ginkgo?

Another example involves St. John's wort, which is thought to have both monoamine oxidase inhibition activity and an effect on serotonin pathways.⁵ Does this mean that St. John's wort should not be used in combination with conventional antidepressants? Is there a risk of serotonin syndrome if this herb is used in combination with selective serotonin reuptake inhibitors (SSRIs)? A recent letter to American Family Physician described a case of lethargy in a woman who used paroxetine (Paxil) in combination with St. John's wort.⁶ Does this represent a cause-and-effect relationship, or is it coincidence?

These pressing questions will not be answered until we routinely begin to inquire about patients' use of herbs and collect data on outcomes and complications. Many elderly patients are taking ginkgo in addition to aspirin; many patients use St. John's wort in combination with SSRIs, in hopes of lowering their dose of the conventional medication and reducing side effects. What should we recommend in these situations?

Individual published case reports will not adequately answer these questions. The post-marketing data collection system that prompted the withdrawal of dexfenfluramine (Redux) does not exist for herbal products, and the first step in creating it will be routinely documenting data on use of herbal medicines. The next step, of course, will be a move by the U.S. Food and Drug Administration (FDA) and the manufacturers of herbal medicines to establish a coordinated system for data collection on both the adverse effects and the beneficial outcomes of these products.

The final reason for taking on the task of teaching ourselves about botanical medicines is the many clinical situations in which they might prove useful. Herbs might provide an effective alternative when conventional medicines have not been well-tolerated because of side effects. For example, a patient with benign prostatic hyperplasia who does not tolerate the alpha blockers or finasteride (Proscar) might receive relief from his symptoms by taking saw palmetto: a recent European multicenter study⁷ of 1,098 men with benign prostatic hyperplasia showed that saw palmetto and finasteride had similar benefits on both subjective and objective outcome measures.⁷ Although some concern exists that saw palmetto may affect prostate-specific antigen levels, this effect has not been proved in any of the major trials, nor have any other significant adverse effects been reported.

Another common situation in which botanical medicines could be useful is when the indications for use of a conventional medication are borderline, but both the physician and the patient feel that some treatment is indicated. An example of this situation might be a 40-year-old man with a family history of heart disease but no other significant risk factors and a low-density lipoprotein (LDL) cholesterol level of 162 mg per dL (4.20 mmol per L) despite maximal diet therapy. This patient might be a good candidate for a trial of garlic supplements, which have been shown to reduce both total cholesterol levels and LDL cholesterol levels in a number of studies.⁸ Here again, the risk is insignificant, because no major adverse effects of garlic have been reported in any of the clinical trials, and the use of a botanical medicine expands the options available to the physician and the patient.

More research on the utility and safety of herbal medicines is desperately needed. The Office of Alternative Medicine of the National Institutes of Health (NIH) is currently co-funding major trials of St. John's wort for the treatment of depression and ginkgo biloba for the treatment of dementia, but this effort only represents a beginning. In 1997, the Commission on Dietary Supplements Labels, appointed by President Clinton to advise the administration on how to regulate herbal products more appropriately, recommended the establishment of a "natural products drug review procedure," and a joint industry/FDA effort to track adverse effects in post-marketing surveillance.⁹ As physicians and teachers in search of a rational, evidence-based practice of primary care, it behooves us to advocate for a greater role for the FDA, the NIH and the herbal supplement industry in collecting data on outcomes of herbal medicine use, both adverse and beneficial.

Dr. Kligler is assistant professor in the Department of Family Medicine at Albert Einstein College of Medicine and teaches in the Beth Israel Residency Program in Urban Family Practice. He is co-chair of the Alternative Medicine Interest Group in the Society of Teachers of Family Medicine and is a founding member of the American Association of Medical Colleges Special Interest Group on Alternative Medicine.

REFERENCES

1. Survey on use of herbs in America. Prevention 1997. Rodale, Emmaus, Pa.
2. American Medical Association, House of Delegates policy statement 1997, resolution H-480.973. AMA policy on alternative medicine. Chicago, AMA, 1997.
3. Zink T, Chaffin J. Herbal 'health' products: what family physicians need to know. Am Fam Physician 1998;58:1133-40.
4. Kleijnen J, Knipschild P. Ginkgo biloba. Lancet 1992; 340:1136-9.
5. Upton R, ed. St John's wort: Hypericum perforatum. Am Herbal Pharmacopoeia 1997;20.
6. Gordon JB. SSRIs and St John's wort: possible toxicity? (letter). Am Fam Physician 1998;57:950-1.
7. Carraro JC, Raynaud JP, Koch G, Chisholm GD, DiSilverio F, Teillac P, et al. Comparison of phytotherapy (Permixon) with finasteride in the treatment of benign prostatic hyperplasia: a randomized international study of 1,098 patients. Prostate 1996;29:231-40.
8. Warshafsy S, Kamer R, Sivak SL. Effect of garlic on total serum cholesterol: a meta-analysis. Ann Intern Med 1993;119:599-605.
9. Leigh E. Commission on Dietary Supplements Labels releases draft report to public. HerbalGram 1997;40:29.

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Drug Treatment for URIs: Back to the Drawing Board

CAROLINE WELLBERY, M.D.
Georgetown University School of Medicine
Washington, D.C.

Mallory's now legendary explanation of why he was climbing Mt. Everest, "Because it's there," may also be the only good reason that we have for using antibiotics or other drugs in the treatment of most upper respiratory tract infections (URIs). As is meticulously documented by the collaborative effort of the Centers for Disease Control and Prevention on the judicious use of antimicrobial agents, first appearing in Pediatrics earlier this year^1-6 and now published in this and the following issue of American Family Physician^7,8 in abbreviated, modified form, antibiotic treatment of many common upper respiratory conditions is unnecessary.

See Article in this issue.

The treatment principles described by Dowell and colleagues,⁷ which propose setting more stringent limitations on antibiotic use in children, are supported by observations regarding the natural history of such illnesses, among them otitis media with effusion and sinusitis, and by an exhaustive, qualitative review of studies evaluating treatment efficacy.

In other areas of medicine, physicians are admonished for not doing enough--for example, physicians are not adequately prescribing angiotensin converting enzyme inhibitors in the prevention and treatment of left ventricular dysfunction, or multiple-drug therapy for the eradication of Helicobacter pylori. It may be more difficult, however, to convince physicians to do less, when despite our physician's oath to "first do no harm," our training has always emphasized intervention.

So what should we be prescribing for symptoms of upper respiratory tract infection? According to the evidence, not much. A recent study on antihistamine-decongestant combinations for upper respiratory infections in children shows no difference in symptom improvement between preschool children receiving placebo and children receiving combination treatment.⁹ In 1997, the Committee on Drugs of the American Academy of Pediatrics issued a statement reviewing the efficacy of antitussive treatments for children and found no well-designed study demonstrating superiority of these preparations over placebo. On the contrary, the only randomized, controlled trial of dextromethorphan, codeine and placebo showed no difference among these modalities in reducing acute cough.¹⁰

Adults fare better with the use of decongestants and antihistamines in attaining modest relief of rhinorrhea and reduction of cough. However, the search for additional effective medications to alleviate or shorten the duration of upper respiratory symptoms continues, with contradictory study findings. Recently, a meta-analysis¹¹ of studies on the efficacy of zinc lozenges reported an equal number of trials showing a benefit versus no benefit when compared with placebo. The study concluded that evidence is insufficient to support the routine use of zinc in the treatment of colds.

Bronchodilators have been studied to determine if they have a role in treating acute cough, a condition in which antibiotics have been dismally ineffective. Support for the use of bronchodilators has been contradictory. Two small studies found statistically significant improvement with albuterol (Proventil) over placebo in the treatment of acute bronchitis.¹² However, most recently, a study of 104 adults treated with oral albuterol¹³ showed more side effects and no difference in efficacy between albuterol-treated subjects and control subjects.

Despite weak scientific evidence supporting the use of such adjunct medications in relieving upper respiratory symptoms, over-the-counter remedies are nevertheless used abundantly. One survey¹⁴ showed that in a 30-day period, as many as 54 percent of three-year-olds in the United States were given over-the-counter medications, of which two thirds were cough and cold preparations. It is perhaps precisely this lack of efficacy of treatment that drives parents to seek additional relief for their child's symptoms from antibiotic therapy, thus making the physician's job of limiting these agents even more formidable.

Given the physician's limited options in selecting remedies for colds and coughs, especially for children, proper education remains an essential recourse in treating these ailments. Going against most of what for years we have been taught to practice, physicians must now test a new motto: Don't just do something, stand there! The physician must indeed stand his or her ground and help patients understand when pharmacologic intervention does more harm than good. The telephone number given by Dowell⁷ provides access to educational materials that are useful to both patients and physicians, and may aid well-meaning, caring physicians in avoiding the stigma of therapeutic nihilism. Finally, in weighing the options, the physican may decide that cold remedies in low doses rarely cause dangerous side effects. Recommending them, along with antipyretics, chicken soup and rest, would at least be less harmful than prescribing antibiotics for conditions that do not warrant them.

Dr. Wellbery is an assistant professor in the Department of Family Medicine at Georgetown University School of Medicine, Washington, D.C. She is assistant deputy editor of American Family Physician.

REFERENCES

1. Dowell SF, Marcy SM, Phillips WR, Gerber MA, Schwartz B. Principles of judicious use of antimicrobial agents for pediatric upper respiratory tract infections. Pediatrics 1998;101:163-5.
2. Dowell SF, Marcy SM, Phillips WR, Gerber MA, Schwartz B. Otitis media--principles of judicious use of antimicrobial agents. Pediatrics 1998;101: 165-71.
3. Schartz B, Marcy SM, Phillips WR, Gerber MA, Dowell SF. Pharyngitis--principles of judicious use of antimicrobial agents. Pediatrics 1998;101:171-4.
4. O'Brien KL, Dowell SF, Scwartz B, Marcy SM, Phillips WR, Gerber MA. Acute sinusitis--principles of judicious use of antimicrobial agents. Pediatrics 1998;101:174-7.
5. O'Brien KL, Dowell SF, Schwartz B, Marcy SM, Phillips WR, Gerber MA. Cough illness/bronchitis--principles of judicious use of antimicrobial agents. Pediatrics 1998;101:178-81.
6. Rosenstein N, Phillips WR, Gerber MA, Marcy SM, Schwartz B, Dowell SF. The common cold--principles of judicious use of antimicrobial agents. Pediatrics 1998;101:181-4.
7. Dowell SF, Schwartz B, Phillips WR. Appropriate use of antibiotics for URIs in children: part 1. Otitis media and acute sinusitis. Am Fam Physician 1998; 58:1113-23.
8. Dowell SF, Schwartz B, Phillips WR. Principles of judicious use of antimicrobial agents for pediatric upper respiratory tract infections: part II. Cough, pharyngitis and the common cold. Am Fam Physician 1998;58:in press.
9. Hutton N, Wilson MH, Mellits ED, Baumgardner R, Wissow LS, Bonuccelli C, et al. Effectiveness of an antihistamine-decongestant combination for young children with the common cold: a randomized, controlled clinical trial. J Pediatrics 1991; 118:125-30.
10. American Academy of Pediatrics Committee on Drugs. Use of codeine and dextromethorphan-containing cough remedies in children. Pediatr 1997; 99:918-20.
11. Jackson JL, Peterson C, Lesho E. A meta-analysis of zinc salts lozenges and the common cold. Arch Intern Med 1997;10:2373-6.
12. Mackay D. Treatment of acute bronchitis in adults without underlying lung disease. J Gen Intern Med 1996;11:557-62.
13. Littenberg B, Wheeler M, Smith DS. A randomized controlled trial of oral albuterol in acute cough. J Fam Pract 1996;42:49-53.
14. Kogan MD, Pappas G, Yu SM, Kotelchuck M. Over-the-counter medication use among preschool-age children. JAMA 1994;272:1025-30.

Copyright © 1998 by the American Academy of Family Physicians.
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