Reconciling Combination Therapy With EBM: Where Do We Go From Here?

Author(s): 
By Kathleen Satterfield, DPM

   One will not find combination therapies mentioned in evidence based medicine (EBM) journals or in research trials. In fact, one will rarely find combination therapies mentioned in many trade publications either. Purists often claim this concept presents a mixed message. How can one track performance and outcomes if he or she is using combination therapies? What component worked?

   Detractors sometimes call the practice of using combination therapy “the shotgun approach.” They say it does not denote much finesse and represents excess. Proponents weigh in on the other side with the declaration that it is more important to provide a patient with a successful treatment than being concerned about which component of the treatment was most beneficial.

   It is an admonition that we often hear when dealing with heel pain as there is perhaps no other podiatric complaint that is treated more often with combination therapy. When a patient arrives in exquisite pain, which has been present for months, few podiatrists would use a single line of treatment for this patient. Most would deliver some unique combination of nonsteroidal antiinflammatories (NSAIDs), steroids, taping, padding, orthotics and perhaps physical therapy modalities in order to maximize the patient’s immediate relief.

Combination Therapy: It May Not Be Ideal But Is The Reality

The detractors point to valid reasons why combination therapy is not preferred. Some of these reasons are as follows.

   • Research is often funded by industry and the economic reality of the situation is that industry interests are not well served by combination therapy trials. Industry wants a clear-cut example of the impact of the product, whether it is a device or a pharmaceutical.

   • Educators want EBM to prove effectiveness. The Cochrane Collaboration and the Oxford group, two respected EBM coalitions, look for singularity in trials for tracking outcomes specifically correlated to a particular product or action.
   • Government agencies — such as the Food and Drug Administration (FDA), the National Institutes of Health (NIH) and others — also want individualized trials in order to draw specific conclusions.

   However, the purist approach is rarely the reality, especially when it comes to treating complications in patients with diabetes. Seasoned physicians, with the wisdom of their experience over the years, will often combine therapies in order to maximize results. Over the past two months, lecturers and experienced practitioners at a variety of educational conferences offered examples of combination therapy for the needs of patients with diabetes.

Weighing Combination Approaches To Neuropathy

   Years ago, there were few treatment options for neuropathy, a common symptom of uncontrolled diabetes, and patients often left the office without a prescription in hand. Physicians would lend a sympathetic ear but had little more than oral tricyclic antidepressants to use and these were not always successful in curbing the progression of painful neuropathy.

   Pharmaceutical companies recognized that and have now offered other oral medications including anti-epileptics such as pregabalin (Lyrica, Pfizer) and antidepressants including duloxetine HCl (Cymbalta, Eli Lilly).

   However, not every podiatrist is equally comfortable in prescribing these medications for their patients and would like an alternative with fewer side effects.

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