March 20, 2017
The Journal of Pain
TAKE-HOME MESSAGE
- In this study, 369 patients with painful diabetic peripheral neuropathy and stable HbA1c scores <11% were randomized to receive a one-time, 30-minute application of the 8% capsaicin patch or a placebo patch to a painful area on the foot. Patients then reported pain and sleep at weeks 2, 4, 8, and 12 after the patch application. The authors found significant improvement in pain scores in the patients who received the capsaicin patch compared with placebo starting at 2 weeks and continuing through the duration of the study period. Patients also reported a significant improvement in sleep. There were minimal adverse events, mostly transient local site reactions, similar to findings with this patch in other groups.
- This is the first double-blind study of the 8% capsaicin patch in diabetes, with careful blinding and fairly rigorous exclusion criteria, and will likely influence expansion of the number of patients in whom this treatment is considered.– Sarah Matteson Kranick, MD
Written by David Rakel MD, FAAFP
8% Capsaicin Patch for Painful Diabetic Neuropathy
This industry-sponsored study randomized 369 individuals to 30 minutes daily of prescription-strength 8% capsaicin patch (n = 186) vs placebo (n = 183) for 12 weeks. Each participant was pretreated with an analgesic cream prior to patch application.
Capsaicin started to work in 19 days vs 72 days with placebo. Sleep disturbance from painful peripheral neuropathy improved. Local irritation was most severe on treatment days 2 to 6, with significant reduction after 13 days. There was also no evidence of a negative effect on sensory perception.
Previous research (The ELEVATE study) showed that capsaicin 8% was noninferior to pregabalin for pain relief and worked quicker with fewer side effects.
With the growing risk of harm with polypharmacy, particularly in our diabetic patients, it is nice to have a topical therapy at our disposal.
Abstract
This 12-week study evaluated the efficacy and safety of capsaicin 8% patch versus placebo patch in painful diabetic peripheral neuropathy (PDPN). Patients aged 18 years or older with PDPN were randomized (1:1) to one 30-minute treatment (capsaicin 8% patch or placebo patch) to painful areas of the feet. Overall, 369 patients were randomized (capsaicin 8% patch, n = 186; placebo patch, n = 183). Percentage reduction in average daily pain score from baseline to between weeks 2 through 8 (the primary end point) was statistically significant for capsaicin 8% patch versus placebo (-27.4% vs -20.9%; P = .025); improvements in pain were observed from week 2 onward. Versus placebo, patients treated with capsaicin 8% patch had a shorter median time to treatment response (19 vs 72 days) and modest improvements in sleep interference scores from baseline to between weeks 2 through 8 (P = .030) and weeks 2 through 12 (P = .020). Apart from application site reactions, treatment-emergent adverse events were similar between groups. No indications of deterioration in sensory perception of sharp, cold, warm, or vibration stimuli were observed. In patients with PDPN, capsaicin 8% patch treatment provided modest pain relief and sleep quality improvements versus a placebo patch, similar in magnitude to other treatments with known efficacy, but without systemic side effects or sensory deterioration.
PERSPECTIVE
To our knowledge, this is the first study of the capsaicin 8% patch versus placebo in patients with PDPN to show that one 30-minute capsaicin treatment provides modest improvements in pain and sleep quality. Results confirm the clinical utility of the capsaicin 8% patch in the diabetic population.
Story Source
Journal Abstract