Evidence-based guideline: treatment of painful diabetic neuropathy.

Evidence-based guideline: treatment of painful diabetic neuropathy.
Report of the American Academy of Neurology, the American Association of Neuromuscular and Electrodiagnostic Medicine, and the American Academy of Physical Medicine and Rehabilitation.

[Link to free full-text guideline at National Guideline Clearinghouse]

Bril V, England J, Franklin GM, Backonja M, Cohen J, Del Toro D, Feldman E, Iverson DJ, Perkins B, Russell JW, Zochodne D. Evidence-based guideline: treatment of painful diabetic neuropathy. Report of the American Academy of Neurology, the American Association of Neuromuscular and Electrodiagnostic Medicine, and the American Academy of Physical Medicine and Rehabilitation. Neurology 2011 May 17;76(20):1758-65. [PubMed ® abstract] [Free full-text Neurology article PDF]

[Excerpts]

Major Recommendations

Definitions of the levels of the recommendations (A, B, C, U) and classification of the evidence (Class I-IV) are [available online].

In Patients with Painful Diabetic Neuropathy (PDN), What Is the Efficacy of Pharmacologic Agents to Reduce Pain and Improve Physical Function and Quality of Life (QOL)?

Anticonvulsants

Conclusions

Based on consistent Class I evidence, pregabalin is established as effective in lessening the pain of PDN. Pregabalin also improves QOL and lessens sleep interference, though the effect size is small. Based on one Class I study, gabapentin is probably effective in lessening the pain of PDN. Based on 2 Class II studies, sodium valproate is probably effective in treating PDN. Lamotrigine is probably not effective in treating PDN. Based on Class II evidence, oxcarbazepine is probably not effective in treating PDN. There is conflicting Class III evidence for the effectiveness of topiramate in treating PDN. Based on Class III evidence, lacosamide is possibly not effective in treating PDN. The degree of pain relief afforded by anticonvulsant agents is not associated with improved physical function.

Recommendations

  1. If clinically appropriate, pregabalin should be offered for the treatment of PDN (Level A).
  2. Gabapentin and sodium valproate should be considered for the treatment of PDN (Level B).
  3. There is insufficient evidence to support or refute the use of topiramate for the treatment of PDN (Level U).
  4. Oxcarbazepine, lamotrigine, and lacosamide should probably not be considered for the treatment of PDN (Level B).

Clinical Context

Although sodium valproate may be effective in treating PDN, it is potentially teratogenic and should be avoided in diabetic women of childbearing age. Due to potential adverse effects such as weight gain and potential worsening of glycemic control, this drug is unlikely to be the first treatment choice for PDN.

Antidepressants

Conclusions

Based on 3 Class I and 5 Class II studies, the antidepressants amitriptyline, venlafaxine, and duloxetine are probably effective in lessening the pain of PDN. Venlafaxine and duloxetine also improve QOL. Venlafaxine is superior to placebo in relieving pain when added to gabapentin. There is insufficient evidence to determine whether desipramine, imipramine, fluoxetine, or the combination of nortriptyline and fluphenazine are effective for the treatment of PDN.

Recommendations

  1. Amitriptyline, venlafaxine, and duloxetine should be considered for the treatment of PDN (Level B). Data are insufficient to recommend one of these agents over the others.
  2. Venlafaxine may be added to gabapentin for a better response (Level C).
  3. There is insufficient evidence to support or refute the use of desipramine, imipramine, fluoxetine, or the combination of nortriptyline and fluphenazine in the treatment of PDN (Level U).

Opioids

Conclusions

Based on one Class I study, dextromethorphan is probably effective in lessening the pain of PDN and improving QOL. Based on Class II evidence, morphine sulfate, tramadol, and oxycodone controlled release are probably effective in lessening the pain of PDN. Dextromethorphan, tramadol, and oxycodone controlled-release have moderate effect sizes, reducing pain by 27% compared with placebo.

Recommendations

Dextromethorphan, morphine sulfate, tramadol, and oxycodone should be considered for the treatment of PDN (Level B). Data are insufficient to recommend one agent over the other.

Clinical Context

The use of opioids for chronic nonmalignant pain has gained credence over the last decade due to the studies reviewed in this article. Both tramadol and dextromethorphan were associated with substantial adverse events (e.g., sedation in 18% on tramadol and 58% on dextromethorphan, nausea in 23% on tramadol, and constipation in 21% on tramadol). The use of opioids can be associated with the development of novel pain syndromes such as rebound headache. Chronic use of opioids leads to tolerance and frequent escalation of dose.

Other Pharmacologic Agents

Conclusions

Based on Class I and Class II evidence, capsaicin cream is probably effective in lessening the pain of PDN. Based on Class III studies, there is insufficient evidence to determine if intravenous lidocaine is effective in lessening the pain of PDN. Based on Class III evidence, the Lidoderm patch is possibly effective in lessening the pain of PDN. Based on Class I evidence, clonidine and pentoxifylline are probably not effective for the treatment of PDN. The evidence for the effectiveness of mexiletine is contradictory; however, the only Class I study of this agent indicates that mexiletine is probably ineffective for the treatment of PDN. There is insufficient evidence to determine whether vitamins and α-lipoic acid are effective for the treatment of PDN. Based on Class I evidence, isosorbide dinitrate spray is probably effective for the treatment of PDN.

Recommendations

  1. Capsaicin and isosorbide dinitrate spray should be considered for the treatment of PDN (Level B).
  2. Clonidine, pentoxifylline, and mexiletine should probably not be considered for the treatment of PDN (Level B).
  3. The Lidoderm patch may be considered for the treatment of PDN (Level C).
  4. There is insufficient evidence to support or refute the usefulness of vitamins and α-lipoic acid in the treatment of PDN (Level U).

Clinical Context

Although capsaicin has been effective in reducing pain in PDN clinical trials, many patients are intolerant of the side effects, mainly burning pain on contact with warm/hot water or in hot weather.

In Patients with PDN, What Is the Efficacy of Nonpharmacologic Modalities to Reduce Pain and Improve Physical Function and QOL?

Electrical Stimulation, Magnetic Field Treatment, Other Interventions

Conclusion

Based on a Class I study, electrical stimulation is probably effective in lessening the pain of PDN and improving QOL. Based on single Class I studies, electromagnetic field treatment, low-intensity laser treatment, and Reiki therapy are probably not effective for the treatment of PDN. There is not enough evidence to support or exclude a benefit of amitriptyline plus electrotherapy in treating PDN.

Recommendations

  1. Percutaneous electrical nerve stimulation should be considered for the treatment of PDN (Level B).
  2. Electromagnetic field treatment, low-intensity laser treatment, and Reiki therapy should probably not be considered for the treatment of PDN (Level B).
  3. Evidence is insufficient to support or refute the use of amitriptyline plus electrotherapy for treatment of PDN (Level U).

[Link to free full-text guideline at National Guideline Clearinghouse]

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