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Does Anodyne Light Therapy Improve Peripheral Neuropathy in Diabetes? A Double Blind, Sham Controlled Randomized Trial to Evaluate Monochromatic Infrared Photo Energy

¹ Department of Surgery, Texas A&M University Health and Science, Center College of Medicine, Scott and White Hospital, Temple, TX, USA

ABSTRACT

Objective: To determine the efficacy of Anodyne Monochromatic Infrared Photo Energy (MIRE) in-home treatments over a 90-day period to improve peripheral sensation and self-reported quality of life in persons with diabetes mellitus.

Methods: This was a double blinded randomized, sham controlled clinical trail. We randomized 69 persons with diabetes and vibration perception threshold between 20-45 volts into two treatment groups. Patients were randomly assigned to active or sham treatment groups. Sixty patients (120 limbs) completed the study. Anodyne units were used at home every day for 40 minutes for 90 days. We evaluated nerve conduction velocities, vibration perception threshold, Semmes Weinstein Monofilaments (SWM) (4, 10, 26, and 60 gram monofilaments), the Michigan Neuropathy Screening Instrument (MNSI), 10 cm visual analog pain scale, and the Neuropathy Quality of Life Instrument. We used a nested repeated measures MANOVA design. Two sites (great toe and fifth metatarsal) were tested on both the left and right feet of each patient, so, two feet were nested within each patient, and two sites were nested within each foot. To analyze the ordinal SWM scores, we used a nonparametric factorial analysis for longitudinal data.

Results: There were no significant differences in measures for quality of life, Michigan Neuropathy Screening Instrument, VPT, SWM, or NCV's in active or sham treatment groups (p>0.05).

Summary: Anodyne MIRE therapy was no more effective than sham therapy in the treatment of sensory neuropathy in persons with diabetes.

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				"Anodyne Therapy" for Diabetic Neuropathy -- No Benefit Journal Watch (General), March 6, 2008; 2008(306): 2 - 2. [Full Text]