Rx Food May Ease Diabetic Neuropathy

[Guest guest]

A prescription medical food that provides active forms of folate and

vitamins B6 and B12 may provide some relief for patients with diabetic

peripheral neuropathy, a placebo-controlled trial showed.

But Metanx -- which contains L-methylfolate calcium, pyridoxal-5'-phosphate,

and methylcobalamin -- did not improve the primary endpoint of the

perception of vibration compared with placebo, according to Vivian Fonseca,

MD, of Tulane University in New Orleans.

There were, however, some important improvements on secondary endpoints of

neuropathic symptoms and health-related quality of life, he reported at the

American Association of Clinical Endocrinologists meeting here.

In an interview, he said he thinks the results warrant further study,

perhaps with a different primary endpoint.

Fonseca said Metanx -- which is approved by the FDA and is indicated for the

management of the nutritional requirements of patients with endothelial

dysfunction, elevated homocysteine levels, or both who present with symptoms

of diabetic peripheral neuropathy or lower extremity ulcerations -- might

affect neuropathy because of the role vitamins play in nerve metabolism.

Many diabetic patients have vitamin deficiencies, he said, noting that

metformin lowers level of vitamin B12, which might affect nerve function.

" It's not something we've paid a lot of attention to, but it might

contribute in some way to the patient's neuropathy being worse, " said

Fonseca, who is president-elect for medicine and science of the American

Diabetes Association.

For now, clinicians might consider using Metanx for their patients with

diabetic peripheral neuropathy to see whether it makes the patients feel

better, he said.

" It's available and there's nothing else " for diabetic neuropathy, Fonseca

said, who acknowledged that because of the failure of Metanx to affect

vibration perception there is no objective way to tell whether it is

working.

But, he said, " ultimately what matters is that the patients get better. "

The trial was a 24-week, double-blind, placebo-controlled study of 214

patients with type 2 diabetic peripheral neuropathy and a baseline vibration

perception threshold of 25 to 45 volts. Their mean age was 62.6 (range 25 to

80), the mean duration of diabetes was 11.5 years, and symptoms of

neuropathy were present for an average of 6.1 years.

Either Metanx or placebo was taken orally twice a day. Medication compliance

exceeded 95% in both groups.

Patients were allowed to use other medications for diabetic peripheral

neuropathy as long as the doses remained constant during the study.

After 24 weeks, there was no difference between the groups in vibration

perception threshold.

" It did not change, but that's okay, " Fonseca said. " There is no study for

any drug in neuropathy that changes things like nerve conduction or

vibration consistently in humans. "

There was, however, greater improvement with Metanx than with placebo on the

Neuropathy Total Symptom Score-6 (at both 16 and 24 weeks), the Neuropathy

Disability Score (at 16 weeks), and the mental component of the Short

Form-36 Health Survey (at 24 weeks) (*P*<0.05 for all).

Fonseca said that the doses of vitamins in Metanx will not cause toxicity,

and that adverse events were infrequent in both arms of the study. No

patients withdrew because of adverse events.

The most common combined adverse events were infections and infestations

(5.6%), injury, poisoning, and procedural complications (4.2%), and general

disorders and administration site conditions (3.3%).

LINK<http://www.medpagetoday.com/MeetingCoverage/AACE/25970?utm_content= & utm_med\

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*Primary source: *American Association of Clinical Endocrinologists

Source reference:

Fonseca V, et al " A 24-week, double-blind, placebo-controlled, multicenter

study of Metanx in patients with diabetic peripheral neuropathy (DPN) " AACE

2011; Abstract 212.

--

Ortiz, MS, RD

*The FRUGAL Dietitian* <http://www.thefrugaldietitian.com>

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