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Diabetic neuropathy treatment guide unveiled.

Most classes of medications that are used to treat painful diabetic neuropathy include drugs that have at best a moderate level of evidence to support their effectiveness or have insufficient evidence to support or refute their use, according to a new guideline.

The guideline gives no higher levels of evidence of effectiveness than those in its assessments of studies of vitamins, alpha-lipoic acid, medications absorbed through the skin, and electrical nerve stimulation and other devices. The anticonvulsant drug pregabalin was the only treatment that had strong evidence in support of its effectiveness (Neurology 2011 April 11 [doi:10.1212/WNL.0b013e3182166ebe]).

Painful diabetic neuropathy affects 16% of the estimated 25 million people with diabetes in the United States, yet "many of the patients don't tell their doctors about their pain, and if they do, they don't get well treated," lead author Dr. Vera Bril said in an interview.

A wide variety of purported treatments exist for this condition, she added, but "it's confusing to grasp the entire published literature in this area to know what you should do if you want to use evidence-based medicine.

Experts from the American Academy of Neurology, the American Association of Neuromuscular and Electrodiagnostic Medicine, and the American Academy of Physical Medicine and Rehabilitation made treatment recommendations based on a review of 79 studies and rated each recommendation based on strength of evidence.

For example, in the anticonvulsant category, the panel found strong evidence for pregabalin as an agent to reduce pain and improve physical function and quality of life (level A), moderate evidence for gabapentin and sodium valproate (level B), and insufficient evidence to support or refute the use of topiramate (level U).

In the antidepressants category, the panel found moderate evidence to support the use of amitriptyline, venlafaxine, and duloxetine (level B), weak evidence for adding venlafaxine to gabapentin for better response (level C), and insufficient evidence to support or refute the use of desipramine, imipramine, fluoxetine, or the combination of nortriptyline and fluphenazine (level U).

"It's not just one drug or one approach to consider," emphasized Dr. Bril, professor and chair of neurology at the University of Toronto. "You have to tailor your choice to your patient and his or her clinical status."

In the opioids category, the panel found moderate evidence for the use of dextromethorphan, morphine sulphate, tramadol, and oxycodone (level B). "Opioids should be used carefully," she advised.

The panel found moderate evidence for the use of capsaicin and isosorbide dinitrate spray (level B), weak evidence for the Lidoderm patch (level C), and insufficient evidence to support or refute the usefulness of vitamins and alpha-lipoic acid (level U).

Moderate evidence was found to support the use of percutaneous electrical nerve stimulation (level B), but the studies were negative for electromagnetic field treatment, low-intensity laser treatment, and Reiki therapy.

Dr. Bril disclosed that she has received research support from Talecris Biotherapeutics, Eisai Inc., Pfizer Inc., Eli Lilly & Co., and Johnson & Johnson.


Guideline 'Should Have Some Sway'

This guideline is a great tool for busy clinicians to use, and it comes from an authoritative, respected source of neurology expertise. That should have some sway with patients and third-party payers that reimburse for prescription medications.

It's difficult for physicians to individually assess the efficacy of different medicines and treatments for painful diabetic neuropathy because the requirements of conducting rigorous, evidence-based study are quite extensive. Not only are these studies very expensive, but they require a lot of time and many resources. Most physicians are not in a situation where they can even begin to consider that kind of research on their own.

Not only does the guideline provide the evidence for the agents that work, it also notes when there is insufficient evidence to support or refute the use of certain treatments, as in the case of a number of vitamins and alpha-lipoic acid.

The guideline also notes that there is moderate evidence to support the use of low-intensity laser treatment. This is important, because companies are marketing low-intensity laser machines to consumers at a cost of up to several thousand dollars per unit. Overall, the guideline is easy to digest and is presented in an accessible format for clinicians who take care of patients with this common problem as well as patients affected by this common painful type of neuropathy

DR. BENN E. SMITH is a neurologist at the Mayo Clinic in Scottsdale, Ariz.


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Title Annotation:ENDOCRINOLOGY
Author:Brunk, Doug
Publication:Internal Medicine News
Date:May 1, 2011
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