New Treatment May Offer Hope for Diabetics

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New Treatment May Offer Hope for Diabetics

ST. PAUL, MN -- Nerve growth factor, a protein that lengthens the survival of nerve cells, may reduce nerve damage in diabetes patients, according to an article in the September issue of Neurology, the scientific journal of the American Academy of Neurology.

This nerve damage, called neuropathy, is common in diabetes patients and often results in loss of sensation, primarily in the feet. Symptoms can include pain, numbness or burning and loss of coordination. Patients can lose the ability to feel heat, cold or pain, and may not notice injuries to the feet. Infections can develop, and are sometimes serious enough to require amputation.

"We hope this treatment will address the underlying problem and improve the condition of these nerves," said neurologist and study author Stuart Apfel, MD, of Albert Einstein College of Medicine in Bronx, NY. "Right now we can only treat the symptoms, we can't treat the neuropathy itself."

The study involved 250 people with diabetic neuropathy, age 18 to 60, from 15 sites around the country. Of those, 82 people received a placebo and 168 received the drug, which is called recombinant human nerve growth factor. All received injections three times per week for six months.

Those patients taking the drug were more responsive to heat, cold and other sensations compared to those receiving a placebo. When asked whether their symptoms had improved during the study, about 75 percent of those receiving the drug responded positively, compared to 49 percent of those on placebo.

"Many patients said they had dramatic improvements in their levels of pain and discomfort," Apfel said.

The most common side effect experienced was mild to moderate discomfort at the injection site. Because of this side effect, most people receiving the drug correctly guessed that they were receiving the drug and not the placebo, and most of those examining the study participants correctly guessed whether a patient was receiving the drug or placebo.

"This can be a criticism of the study, but we don't feel the results were compromised," Apfel said. "The results that showed the beneficial effect of the drug were objective measures; the more subjective measures did not show a beneficial effect."

Researchers are now studying more than 1,000 patients for at least a year to see whether the drug again shows a benefit for patients. This time the placebo injection also gives patients mild discomfort at the injection site so patients and examiners won't know whether they're receiving placebo or the drug.

Researchers aren't clear how nerve growth factor may restore function to these nerves. Diabetes may affect the body's ability to produce nerve growth factor, which occurs naturally. It may also affect the body's ability to transport the naturally occurring nerve growth factor from the skin tissue back to the nerve cells. "Injecting the nerve growth factor allows it to go directly to the nerve cells that need it," Apfel said.

Half of all patients who have had diabetes for 20 years or more develop this type of nerve damage.

This study was funded by Genentech, Inc., which manufactures recombinant human nerve growth factor.

Improving care for patients with neurological disorders through education and research is the goal of the American Academy of Neurology, an association of more than 15,000 neurologists and neuroscience professionals.

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