Open communication valuable in weighing alternative medicine requests

How should physicians respond to patients who want to substitute alternative therapies for traditional treatment?

By — Posted Oct. 10, 2011.

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An older patient asks his primary care doctor about using red yeast rice pills to treat his high cholesterol.

Reply: The ethics of approaching patient requests for complementary and alternative medicine is the ethics of good medicine. In 2005, the Institute of Medicine identified "Recognition of Medical Pluralism" as an ethical value for modern medicine. What does that recognition look like? I think it has three key elements: Respect the patient and hear him or her out; acknowledge the knowns and unknowns; and deliberate together to find a workable solution that fits with the patient's values.

The foundation of being a good physician for this patient begins by understanding his perspective. Has the patient been handed a supplement catalog from a relative who sells supplements? Has he recently lost his pharmaceutical coverage and been left facing high costs associated with a brand-name statin? Has he or a close friend experienced adverse effects of statins? Does he believe that "all drug companies are out to get your money?" This first layer of nonjudgmental inquiry is crucial to establishing a shared working framework for further deliberations and an amicable solution.

Our research published in Medical Care in 2010 suggests that physicians' judgments about alternative medicines may be hasty and biased due to lack of familiarity or perceived plausibility of a given therapy. Physicians should acknowledge that the conventional medical system holds no exclusive corner on the truth. Red yeast rice, it turns out, is highly plausible as a therapy for hypercholesterolemia, even within a strictly biomedical framework.

Acknowledging the knowns and unknowns also means looking at the evidence. That evidence shows that, from a safety, efficacy and financial perspective, there is no reason to prefer red yeast rice to a statin. Having a balanced discussion of red yeast rice presupposes that we also know how to have a balanced discussion about statins. Many studies have shown that, in fact, physicians consistently overestimate the benefits of statins. Transparently acknowledging the knowns and the unknowns may be harder than it appears.

If the patient wants a natural approach to healing, wants to avoid one more pill each day and is motivated to change, there is virtually no risk in delaying conventional LDL-lowering therapy for six months. In the spirit of "first do no harm," the most ethical initial approach would be recommending radical dietary change to a Mediterranean or DASH diet and then reassessing therapy after a dietary trial. In this way, the physician can affirm the patient's desire for a "natural" and safe approach to cholesterol management, leaving the question of what pill to take for a later date.

We may suppose that the biggest barrier to this patient's health is creating space in his life for exercise, losing weight and dealing with the stress that gives him sleepless nights. No statin or supplement will create that space. If we can't help patients overcome these broader lifestyle obstacles, we have missed an important opportunity.

The most ethical thing to do in this case is to work within the value structure of the patient, identify win-win opportunities to improve his health through all available options and not oversell what drugs can do. If you have a good conversation, you have done your job, and the outcome of that conversation will be good, regardless of whether he decides that red yeast rice is right for him.

Jon C. Tilburt, MD, assistant professor of biomedical ethics and medicine, Integrative Medicine Program, Mayo Clinic, Rochester, Minn.

Reply: A physician's first ethical obligation is to provide honest, expert medical opinion. Some red yeast rice preparations have been shown to lower LDL cholesterol. This is no mystery: Effective preparations contain adequate quantities of several monacolins, which inhibit cholesterol synthesis. The most plentiful monacolin in red yeast rice is monacolin K, which is identical to the prescription drug lovastatin.

Many such preparations will not lower cholesterol -- also no mystery. Crude botanical products inevitably vary because of different growing, harvesting and preparation conditions. The monacolin content of these preparations varies by 100-fold; some samples contain naturally occurring nephrotoxins. In the U.S., dietary supplements are not held to strict standards of content and labeling. Even occasional products that, like red yeast rice, have useful pharmacologic activity are woefully lacking in quality control. Physicians should advise patients that purified, standardized preparations of well-studied drugs are vastly preferable to crude concoctions.

If the patient has agreed to pharmacologic intervention (a different discussion) but refuses prescription statins in favor of red yeast rice, the physician should explore the patient's reasons. Patients may not know that this rice itself contains statins, that statins are natural, that "natural" doesn't imply safe and effective, that red yeast rice is expensive, that claims of synergy for the constituents of the rice (and other crude products) are speculative and unproven; or that reports of such rice being tolerated by patients who previously experienced statin-associated myalgias are explained by a dose effect.

What if the patient perseveres? It would be reasonable for the physician to offer advice regarding the best way to proceed: The patient could consult a commercial lab that tests proprietary supplements for ingredients and adulterants; and periodic renal function testing (perhaps at the patient's expense) should be added to the usual statin monitoring. The two might agree that the patient will try a prescription statin if the rice trial proves unsuccessful.

What about "medical pluralism" and calls for physicians to be "nonjudgmental?" Pluralism is merely an obscure term for the unremarkable observation that patients' opinions may differ from their doctors'. It does not offer a new way for physicians to respond to such differences; this will continue to be a matter of polite negotiation. Patients want their physicians to offer judgments (that's why they consult them), but physicians can judge popular claims without being rude.

Modern medicine is explicitly linked to science and evidence derived from rigorous clinical trials. A physician need only recognize methods that don't conform to these ideals and know a few broad facts about them -- there is no obligation to gain expertise in countless popular claims. Regarding crude biological products, the broad facts include the hazards discussed above -- that some can interact with prescription drugs, thus making their use a necessary part of the medical history and that claims of effectiveness for most are false (red yeast rice being an exception).

Physicians should know that alternative methods other than biologics have not been found superior to placebos or sham treatments. Some are inherently risky; most are hopelessly implausible. There is no ethical obligation for physicians to recommend any of them.

Misinformation about nonstandard methods is the norm in the public domain, in medical schools and on government websites. When speaking with patients, physicians should avoid the uncritical, promotional and euphemistic language common to such sources. This is a matter of honesty and expertise and, thus, an ethical obligation.

Kimball C. Atwood IV, MD, assistant clinical professor, Tufts University School of Medicine, Boston

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