SLR - October 2009 - Andrea Roemer
Reference:
Yuan R-Y, Sheu J-J, Yu J-M, et al. (2009). Botulinum toxin for diabetic neuropathic pain: a randomized double-blind crossover trial. Neurology, 72, 1473–1478.
Scientific Literature Review
Reviewed by: Andrea Roemer, DPM, MS
Residency Program: VA-Southern Arizona Health Care System
Podiatric Relevance:
This study shows the effectiveness of botulinum toxin injections for reduction of diabetic peripheral neuropathic pain in the feet.
Methods:
Fifty units of Botulinum toxin type A (BoNT/A) were injected intradermally into 12 specific sites on the dorsal aspect of 18 patients with diabetic neuropathic foot pain. A placebo was given in the same fashion to 18 different patients to serve as a control. After 12 weeks, each participant was crossed over to receive a second injection with the other treatment. This was done in a double-blinded fashion. Before and after the injections, a visual analog scale (VAS) was used to assess pain, the Chinese version of the Pittsburgh Sleep Quality Index (CPSQI) was used to assess sleep quality, and the Short Form-36 (SF-36) questionnaire was used to assess quality of life.
Results:
Forty-four point four percent of the BoNT/A group had a VAS pain reduction of three or more within the 12 week period, compared to no response in the placebo group. There was improvement in the CPSQI-assessed sleep quality at 1, 4, 8, and 12 weeks after the BoNT/A injection versus placebo, but only the measurement at 4 weeks showed significant improvement to p< 0.05 (as measured with astudent t test). The SF-36 questionnaire results showed no significant differences in the quality of life of the two groups.
Conclusions:
Botulinum toxin type A significantly reduced diabetic neuropathic pain and improved sleep quality in this small population cohort.