A Closer Look At The Research Behind MIRE Therapy

By Lawrence Lavery, DPM, MPH

What About The Flaws In Study Design And Analysis?

One of the most interesting aspects of the studies that evaluate MIRE is the consistent and often large placebo effect. There is an improvement in SWM testing in the sham group in all three randomized clinical trials. The strong placebo effect is probably the reason the uncontrolled retrospective and prospective studies had positive results.1-6 In Leonard’s study, there is such a strong placebo effect that when one compares pre- and post- intragroup comparisons, the Michigan Neuropathy Screening Questionnaire shows a significant change in active and sham treatment groups.7 Arnall’s study reports as much as a 70 percent improvement in SWM results in the sham treatment group.8    Both Leonard and Arnall only compared pre- and post-therapy results within the active or within the sham groups.7,8 There was no analysis that compared outcomes between treatment groups. Since there was such a large placebo effect in the sham treatment group, there is not a significant difference between active and sham therapy at the end of the studies. For instance, in the Leonard study, researchers correctly identified 2.4 out of five SWM sites in the active group and 3.0 out of five sites in the sham group.7    Clifft and colleagues provide the only report that compares outcomes between sham and active treatment groups.9 Clifft did not identify any significant difference between MIRE treatment and sham treatment.    Intent to treat (ITT) is a basic tenet of evaluating data from clinical trials. Essentially, ITT dictates that researchers include every patient who is randomized into a study in the analysis. It stops investigators from eliminating those who did not get a good result, were not compliant or had a negative response for some other reason.    Leonard, et al., did not provide an analysis of the entire study population. They separately reported outcomes and provided analysis for patients with severe neuropathy and less severe neuropathy.7 The group with severe neuropathy did not benefit from MIRE therapy. Leonard’s results primarily focused on patients with less severe neuropathy or patients who could feel the 300 g SWM. Monochromatic infrared light energy did not have any benefit among people with severe neuropathy. This seems like a very odd way to dichotomize the study population. There is a very wide range among patients who can feel between 10 and 300 g of force.

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