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FDA Approves Capsaicin for Treatment of DPN of the Feet  


Capsaicin (8%), a topical, non-systemic, non-opioid pain treatment delivered as an office procedure in the form of a patch placed directly onto the skin, has been approved by the FDA. Its use is for treating neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet in adults but should not be dispensed to patients for self-administration or handling. Capsaicin has no known drug-drug interactions. The most common adverse reactions include application site reactions such as erythema, pain, and pruritus, the majority of which are transient and self-limited. Pain associated with diabetic neuropathy is an extremely challenging condition to diagnose, treat, and manage effectively, having a significant quality of life impact. 


DPN affects around 28% of all patients diagnosed with diabetes, and approximately half of those with DPN will experience the debilitating manifestations of painful DPN in their lifetime. In the U.S., one fourth of the health expenditure on diabetes is spent on diabetic peripheral neuropathy and is estimated to be more than $10 billion annually. (Regina Schaffer, Endocrine Today, 7/21/2020) 


Leonard A. Levy, DPM, MPH , Ft. Lauderdale, FL

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From: Doug Richie, DPM


Dr. Kesselman appropriately calls upon our profession to train students, residents, and academic podiatrists to conduct research and provide “counterpoints” to systematic reviews such as the recent article published in the British Journal of Sports Medicine.  I must point out that two of the best randomized clinical trials published (cited in the BJSM paper) which studied custom foot orthoses and treatment of plantar heel pain were conducted by podiatrists:


Landorf KB, Keenan AM, Herbert RD. Effectiveness of foot orthoses to treat plantar fasciitis: a randomized trial. Arch Intern Med. 2006; 166(12):1305–1310.


Wrobel JS, Fleischer AE, Crews RT, Jarrett B, Najafi B. A randomized controlled trial of custom foot orthoses for the treatment of plantar heel pain. J Am Podiatr Med Assoc. 2015; 105(4):281-94.


Both of these studies had the same conclusions as the recent BJSM study which failed to show any superiority of custom foot orthoses in the treatment of plantar heel pain. There are many reasons why these studies fail to show the outcomes we all experience in day-to-day clinical practice.


In regard to Dr. Kesselman’s call, the best researchers in our own profession have already attempted to provide “counterpoint” in the academic arena and have unfortunately failed to show the superiority of custom foot orthotic therapy to treat plantar heel pain. Instead of relying on rigid statistical analysis of large groups of patients, perhaps we can take a new approach which identifies sub-groups of patients who actually do respond to custom foot orthotic therapy in a very positive way?


Doug Richie, DPM, Seal Beach, CA

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