What is the Appropriate Threshold for Applying a New Therapy or Clinical Approach?

One of the key challenges clinicians of Integrative Medicine is determining the level of evidence we need before applying a new therapy or therapeutic concept to a patient. Clearly conventional medicine and CAM have had very different thresholds. Conventional medicine currently perusing the holy grail of "evidence based medicine" would prefer meta-analysis documentation of efficacy before regular clinical use. Of course, a relatively limited portion of conventional practice actually meets this standard (the exact percentage is the subject of considerable controversy and discussion, but is likely less than 25%). While CAM would prefer the same level of documentation, less documentation of efficacy is available.

 

Everyday we are faced with patients who do not fit into traditional patterns of disease and have not been treated effectively with conventional treatments. Research has shown that the average patient seeing a CAM provider is sicker than those in a conventional practice, I’ve not seen research determining if they are indeed, as I assert, more complex or present with less clear diagnoses (a PubMed search also found none). Nonetheless, these are the patients we see and we are challenged to develop effective treatment protocols without controlled trials that match our real patients. The Jones, et al. article on Healthy Aging in Integrative Medicine: A Clinician's Journal (issue 2.6) highlights this challenge: there is a growing body of evidence on the possibly extremely important role of genomic testing to guide lifestyle and nutritional protocols to optimize health and longevity. However, there are no long-term (or even short-term!) clinical studies documenting the clinical efficacy of the this approach. The theory makes sense and the research on specific lifestyles and supplemental nutrients is sound, but not only has integration of these not been tested, the single agent bias of the National Institutes of Health (NIH) and the cost of long-term studies will likely prohibit the needed clinical research for the foreseeable future.

 

So how do we decide? I am reminded of glucosamine sulfate and osteoarthritis. While this is now about to become the standard of care in conventional medicine, I started successfully using glucosamine sulfate on patients over a decade ago. I was willing to use it despite limited research since it appeared non-toxic and worked consistently with the body’s own healing processes. These two considerations resulted in my having a relatively low threshold. However, using an agent typical of conventional medicine which carries the burden of significant toxicity, especially when it interferes with normal body processes, appropriately requires a much higher threshold before use. As this Integrative Medicine evolves, I believe it critical to establish appropriate thresholds for use dependent on the safety and mechanisms of action of the therapies being considered.