Symptom Management for Distal Sensory Peripheral Neuropathy in T2DM: A Preliminary RCT using Moxibustion

Abstract

Distal sensory peripheral neuropathy (DSP) is a chronic, painful condition in the lower limbs of many individuals with Type 2 Diabetes (T2DM). DSP is the most prevalent complication of T2DM. Moxibustion, a traditional Chinese medicine therapy, offers a non-invasive and promising treatment for DSP pain. This study examined Traditional and Smokeless Moxibustion in a prospective, randomized, placebo-and waitlist-controlled, subject-and evaluator-blinded, parallel-group clinical trial. Participants received twice weekly moxibustion treatments for three weeks and were followed for two months. Participants in this preliminary study completed symptom diaries, Gracely Pain Scale (GPS), Subjective Peripheral Neuropathy Scale (SPNS), and Clinical Global Impression Scale (CGIS) patient-rated outcomes. In both Traditional and Smokeless Moxibustion groups, not control groups, GPS symptom severity decreased from baseline to end of treatment, and the benefit was sustained for two months post-treatment, p< 0.001. In treated groups, all three SPNS characteristics (pain, pins/needles, numbness) decreased by >3 severity levels at the end of treatment and were unchanged from baseline in control groups, p <0.001. Traditional and Smokeless Moxibustion show promise as a non-invasive and non-pharmacologic therapy in DSP symptoms associated with T2DM. Standards for Reporting Interventions in Controlled Trials of Acupuncture-Moxibustion (STRICTA-M) guided the development and design of this study.