We thank Dr. Burke (1) for his thoughtful comments and critical review of our research study (2). In responding to his comments, we have addressed each of his stated concerns in order.

First, regarding the level of photo energy delivered, the manufacturer preset our active monochromatic infrared energy (MIRE) units to deliver the recommended 6–8 bars of energy or 1.95 J · cm−2 · min−1 for 30 min (total energy of 58.5 J/cm2), whereas the MIRE units used in the Leonard study (2) delivered 1.3 J · cm−2 · min−1 for 40 min (total energy of 52.0 J/cm2). Therefore, our subjects received slightly more photo energy per treatment than subjects in Leonard’s study, contrary to Dr. Burke’s comments.

Second, we analyzed our data in the same manner as the only other placebo-controlled study (3) to have a more meaningful analysis. However, in our active MIRE group, sensation decreased at 46 of 139 test sites, improved at 54 of 139, and did not change at 39 of 139. In the placebo group, sensation decreased at 28 of 140 sites, improved at 74 of 140, and did not change at 38 of 140.

Third, all subjects in our study had received a diagnosis of diabetes and were being medically managed by their physicians. Peripheral neuropathy was confirmed by monofilament testing, which is standard practice and used by other researchers (3,4). A few subjects in each group were insensitive to the 5.07 monofilament at one of four test sites, but there was no significant difference between groups in mean number of sites sensitive to the 5.07 monofilament at baseline. In regard to Dr. Burke’s comments about group assignment, it is not clear to us why he believes that our results were confounded by the fact that some patients had one leg randomized to receive active MIRE and the other leg randomized to receive placebo MIRE. In the majority of subjects, both legs received the same treatment, but, in any case, we have no reason to question the value of random assignment. In addition, all subjects in the Leonard study (3) had one leg in the active group and the other leg in the placebo group.

Finally, when peforming monofilament testing, we used the “yes-no” method of testing, which is equally accurate and faster than the “forced-choice” method (4). We concur with Dr. Burke that only valid and reliable testing methods should be used.

While it is disappointing to discover that a promising new treatment may not be effective, patient treatment should be based on credible evidence. We hope that more randomized, placebo-controlled studies are conducted to either support or refute the results of our study and to help determine the rightful place of MIRE in the treatment of patients with peripheral neuropathy.

Burke TJ: The effect of monochromatic infrared energy on sensation in subjects with diabetic peripheral neuropathy: a double-blind, placebo-controlled study (Letter).
Diabetes Care
Clifft JK, Kasser RJ, Newton TS, Bush AJ: The effect of monochromatic infrared energy on sensation in subjects with diabetic peripheral neuropathy: a double-blind, placebo-controlled study.
Diabetes Care
Leonard DR, Farooqi MH, Myers S: Restoration of sensation, reduced pain, and improved balance in subjects with diabetic peripheral neuropathy: a double-blind, randomized, placebo-controlled study with monochromatic near-infrared treatment.
Diabetes Care
Mayfield JA, Sugarman JR: The use of Semmes-Weinstein monofilament and other threshold tests for preventing foot ulceration and amputation in persons with diabetes.
J Fam Pract