Updated guidelines from the American Academy of Neurology (AAN) advise against prescribing opioids for painful diabetic neuropathy (PDN) — but note that several other oral and topical therapies may help ease pain.
PDN is very common and can greatly affect an individual's quality of life, guideline author Brian Callaghan, MD, University of Michigan in Ann Arbor, noted in a news release.
"So this guideline aims to help neurologists and other doctors provide the highest quality patient care based on the latest evidence," Callaghan said.
The recommendations update the 2011 AAN guideline on the treatment of PDN. The new guidance was published online December 27 in Neurology and has been endorsed by the American Association of Neuromuscular & Electrodiagnostic Medicine.
To update the guideline, an expert panel reviewed data from more than 100 randomized controlled trials published from January 2008 to April 2020.
The panel notes that more than 16% of individuals with diabetes experience PDN, but it often goes unrecognized and untreated.
The guideline recommends clinicians assess patients with diabetes for peripheral neuropathic pain and its effect on their function and quality of life.
Before prescribing treatment, health providers should determine if the patient also has mood or sleep problems as both can influence pain perception.
The guideline recommends offering one of four classes of oral medications found to be effective for neuropathic pain: tricyclic antidepressants such as amitriptyline, nortriptyline, or imipramine; serotonin-norepinephrine reuptake inhibitors (SNRIs) such as duloxetine, venlafaxine, or desvenlafaxine; gabapentinoids such as gabapentin, or pregabalin; and/or sodium channel blockers such as carbamazepine, oxcarbazepine, lamotrigine, or lacosamide.
All four classes of medications have "comparable effect sizes just above or just below our cutoff for a medium effect size" (standardized median difference, 0.5), the panel notes.
In addition, "new studies on sodium channel blockers published since the last guideline have resulted in these drugs now being recommended and considered as effective at providing pain relief as the other drug classes recommended in this guideline," said Callaghan.
When an initial medication fails to provide meaningful improvement in pain, or produces significant side effects, a trial of another medication from a different class is recommended.
Pain Reduction, Not Elimination
Opioids are not recommended for PDN. Not only do they come with risks, there is also no strong evidence they are effective for PDN in the long term, the panel writes.
"Current evidence suggests that the risks of the use of opioids for painful diabetic neuropathy therapy outweigh the benefits, so they should not be prescribed," Callaghan said.
For patients interested in trying topical, nontraditional, or nondrug interventions to reduce pain, the guideline recommends a number of options including capsaicin, glyceryl trinitrate spray, and Citrullus colocynthis. Ginkgo biloba, exercise, mindfulness, cognitive behavioral therapy, and tai chi are also suggested.
"It is important to note that the recommended drugs and topical treatments in this guideline may not eliminate pain, but they have been shown to reduce pain," Callaghan said.
"The good news is there are many treatment options for painful diabetic neuropathy, so a treatment plan can be tailored specifically to each person living with this condition," he added.
Along with the updated guideline, the AAN has also published a new AAN Polyneuropathy Quality Measurement Set to assist neurologists
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and other healthcare providers in treating patients with PDN.
The updated guideline was developed with financial support from the AAN.
Neurology. Published online December 27, 2021.
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To update the 2011 American Academy of Neurology (AAN) guideline on the treatment of painful diabetic neuropathy (PDN) with a focus on topical and oral medications and medical class effects.
The authors systematically searched the literature from January 2008 to April 2020 using a structured review process to classify the evidence and develop practice recommendations using the AAN 2017 Clinical Practice Guideline Process Manual.
Gabapentinoids (standardized mean difference [SMD] 0.44; 95% confidence interval [CI], 0.21–0.67), serotonin-norepinephrine reuptake inhibitors (SNRIs) (SMD 0.47; 95% CI, 0.34–0.60), sodium channel blockers (SMD 0.56; 95% CI, 0.25–0.87), and SNRI/opioid dual mechanism agents (SMD 0.62; 95% CI, 0.38–0.86) all have comparable effect sizes just above or just below our cutoff for a medium effect size (SMD 0.5). Tricyclic antidepressants (TCAs) (SMD 0.95; 95% CI, 0.15–1.8) have a large effect size, but this result is tempered by a low confidence in the estimate.
Clinicians should assess patients with diabetes for PDN (Level B) and those with PDN for concurrent mood and sleep disorders (Level B). In patients with PDN, clinicians should offer TCAs, SNRIs, gabapentinoids, and/or sodium channel blockers to reduce pain (Level B) and consider factors other than efficacy (Level B). Clinicians should offer patients a trial of medication from a different effective class when they do not achieve meaningful improvement or experience significant adverse effects with the initial therapeutic class (Level B) and not use opioids for the treatment of PDN (Level B).
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