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Comparing Benefits to Risks in Integrative Medicine pt 2

Integrative Medicine combines mainstream medical therapies and CAM therapies for which there is some high-quality scientific evidence of safety and effectiveness.” National Center for Complementary and Alternative Medicine at the National Institutes of Health

Martin Rossman, MD

Thank you for all your responses to my last email – it looks like there’s a lot of interest in this issue and related issues.

While responses were overwhelmingly positive to last week’s “Do No Harm” article, one respected colleague opined that no form of medicine is completely risk-free, and all interventions have potential harm. Two others wrote saying that they had, in fact, been harmed from ‘alternative medicine’ approaches, so let me address these important comments.

In discussing these principles of treatment I am assuming that practitioners are competent, ethical, and have good judgment. This lets us compare the value of approaches, rather than the quality of the practitioner, which is, in itself, a critical issue. Assuming competence and good judgment, there is certainly the risk of harm from “alternative” approaches, because anything that is not conventional can be labeled “alternative,” and there are a lot of wacky ideas out there about healing. In most cases, though, the major risk of pursuing reasonable alternatives is the risk of not accurately identifying conditions that are best treated by conventional medicine.

That is exactly why good, experienced Integrative Medicine physicians are important. When you study and practice two or more forms of medicine, you get a very different perspective of what constitutes medicine in the larger sense of the word. This broader perspective is especially important in working with people with chronic illnesses, hard to diagnose or treat illnesses, or in helping people cultivate wellness . A good Integrative Physician can help you find and navigate your path to healing through the maze of competing approaches to medicine.

For instance, I see many people with breast cancer. Most of the time I am educating them about the value of nutritional, mind/body, and Chinese medicine support because those things have been demonstrated to help people go through conventional treatments with fewer adverse effects, and they are often neglected in the conventional approach. On the other hand, I am sometimes consulted by people who don’t want to have a biopsy of a breast mass, or, already having been diagnosed with cancer, believe that they can cure themselves through diet, meditation, nutrition, Chinese medicine, or other alternative approaches. While that might theoretically be possible, there is no real evidence to support that idea, and conventional treatment has a very high success rate. With these patients, I spend a lot of time educating them about the medical case for treatment. While the natural healing approaches will not directly harm them, and in fact will usually be very helpful to them, avoiding the medical treatment is very likely to have dangerous and even fatal consequences.

So I agree with those that wrote that there are no risk-free interventions, including doing nothing. All interventions are context-sensitive – figuring out the right thing, or the safest and most effective thing to do at any given time is the skill that a good Integrative Physician or other health guide, whatever their orientation needs to bring to the table.

So how do we assess the likelihood of benefit and the likelihood of risk? We look to the accumulated data of science and of human experience. There are various ways to assess risk/benefit ratio but one I have found very useful in my practice is the SORT (Strength of Recommendation Taxonomy) rating for the evidence. This comes from the medical textbook “Integrative Medicine“, edited by Dr. David Rakel at the University of Wisconsin.

A simplified summary follows:

Grading Evidence of Effectiveness

Grade A Based on consistent, good quality, patient oriented evidence. (Systemic Review or meta-analysis showing benefit, Cochrane review with clear recommendation, high quality patient oriented randomized controlled trial. Example: Acupuncture for Nausea and vomiting

Grade B Based on Inconsistent or limited quality patient oriented evidence. Example: Ginger for osteoarthritis

Grade C Based on consensus, usual practice, opinion, disease oriented evidence (Study showing a reduction in blood sugar but no studies in patients to show benefit in patients with diabetes.)

Grading the Potential Harm

Unlike grading for evidence, there is no unified, acceptable grading system for harm, but here is a suggested way.

Grade 3 (Most Harm) A therapy with the potential to result in death or permanent disability. Example: Major surgery under general anesthesia or Carcinogenic effects of the botanical Aristolochia (Birthwort)

Grade 2 (Moderate Harm) A therapy have the potential to cause reversible side effects or interact in a negative way with other therapies. Example: Pharmaceutical or nutraceutical side effects.

Grade 1 (Least Harm) A therapy with little if any risk of harm. Example: Eating more vegetables, increasing exercise, elimination diets, encouraging social connection.

Based on the grading system, we will have 5 potential combinations representing the ‘weight’ of the evidence and the ‘weight’ of the harm. An A1 ranking means use with impunity, and A2 and B1 ranks make sense to employ as well. Ranks of A3, B2, and C1 require more consideration, while B3, and C2 would require a good deal of thought. It would not make much sense to use treatments with a C3 rating in light of the high risk and poor evidence of effectiveness.

This method is of course not perfect but it can guide us to using safer interventions first, as long as there is no significant risk to not using the riskier intervention. And it brings into focus that the treatments that require the highest level of effectiveness are any that have 3 risk ratings – as many pharmaceuticals and a few nutraceuticals do.

In general, what you find is that most natural, nutritional, energy-based and mind/body therapies rarely have A level evidence available but do have B or C. This is because it costs a fortune to get A level data and nobody can afford to fund the kinds of studies that yield it without the potential of a very high level patent-protected payoff, which generally only apply to pharmaceuticals or certain medical devices.

Some (but far fewer than you would think) pharmaceutical treatments have level A evidence, but many have a 3 harm level. When a life is at risk from an acute or emergency situation, grade 3 risk may need to be tolerated, but when situations are chronic there is very often time to see what safer, more natural alternatives have to offer.

More next time. Let me know what you think.

P.S. It is March and time to schedule your Spring equinox acupuncture “tune-up” if you come at the seasonal changes.

P.P.S. Oops! I gave the wrong time for my KPIX interview last time, which was fortunate because it was very short and not great. The KRON TV interview and another good one for the American Health Journal are on the www.worrysolution.com site under the “Media” tab

PS Dr. Rossman’s private practice website is http://www.drrossman.info/

 

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