Diabetes Health Nov 6, 2012 Penny Hildreth: Finally Facing Diabetes Brenda Neugent http://www.diabeteshealth.

com/read/2012/11/06/7699/penny-hildreth-finally-facing-diabetes/

Penny Hildreth

It was more than two decades ago, and Penny Hildreth was already feeling overwhelmed by life when she learned that she hadtype 1 diabetes. She was pregnant with her second child and worried about the babys safety after a car accident that had left Hildreth with a broken collarbone, a broken rib, and a punctured spleen. It was the spleen injury that ultimately led to her diagnosis of diabetes, but she was more concerned about the baby, a little girl who was born healthy despite the automobile accident. I always say that shes my miracle, says the 46-year-old Portland resident.

Given her circumstances, diabetes wasnt at the top of the list of concerns for Hildreth, who virtually ignored the diagnosis for the first 10 years. I refused to come to terms that I had diabetes, she says. I ate wrong and I didnt exercise. Instead, the stressed mom of two turned to alcohol and drugs, putting her diabetes on the back burner. But when Hildreth decided to enter a recovery program in 1997, her diabetes revealed itself after doing unnoticed damage for 15 years. I started feeling the effects of my diabetes then, she says. And I knew I had to start taking control of my life. Even as she began a 12-step program and found www.SpecOpsComm.com

a sponsor, she was experiencing the added stress of vision problems and kidney issues, as well as foot pain that alternated between painful tingling and lack of sensation.

It didnt keep me from doing what I needed to do, she says of the burning and tingling brought on by diabetic neuropathy. But I noticed it when I sat down. Eventually, she had no feeling at all in her feet. When she visited a podiatrist, she was surprised when he pulled a piece of glass from her foot the size of an infants fingernail. She had not felt a thing.

Soon after, Hildreth started taking Metanx, a food supplement infused with B complex vitamins that almost immediately made a difference in how she felt. I noticed that my burning had stopped, she says. Its one of the biggest miracles, to have feeling back in my feet. Being in recovery forced Hildreth to look at her diabetes differently, and now, the grandmother of four puts herself and her health on the front burner. Im still young, and I have a lot to live for, she says. I did not want this disease to get the better of me. I had to stop fighting it so that it wouldnt destroy me. With the support of her husband, Michael, her son, Doug, and her daughter, Michelle, Hildreth is able to make healthy choices and keep her stress levels down to ensure that her blood sugar levels stay in check. Having diabetes is a 24-hour-a-day challenge, but, like my recovery, I take it one day at a time, she says. Every day I wake up and I get a choice: Am I going to do whats right or do whats wrong? And when I do make those good choices, Im on top of the world and I feel good.

Hildreth visits a podiatrist every six weeks to treat a foot ulcer on her left foot, so these days she rarely forgets that she has diabetes. But forgetting isnt as important to her as it once was. I used to look at my diabetes as a negative impact on my life, she says. Now, I view it as a positive. It forces me to take care of myself more than the average person. It forces me to make the right choices.

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Medical Food Treats Neuropathy Diabetes Health Clay Wirestone Feb 18, 2011

http://www.diabeteshealth.com/read/2011/02/17/7058/medical-food-treats-neuropathy/

Of all diabetic complications, neuropathy is one of the scariest and most difficult to treat. Nerve damage in the feet, leading to numbness or pain and, in severe cases, to foot ulcers or amputations, affects up to 60 percent of diabetics, according to recent research. Various kinds of treatment are available, many of them treating the pain of neuropathy. But the real challenge of the complication isn't pain -- it's the loss of sensation itself. That's what can lead to the worst outcomes, and it's what a medical product called Metanx aims to treat. Manufactured by Louisiana-based Pamlab, Metanx is a medical food, a substance available by prescription that works to improve blood flow in the small blood vessels that keep nerves in the feet responsive. The product has shown success in scientific trials. "Research has demonstrated a significant increase in epidermal nerve fiber density after six months of Metanx treatment," the company says, and research is continuing. A study published late last year in Reviews in Neurological Diseases suggested that patients treated with the medical food regained some sensation lost to neuropathy. What's in a tablet of the product? It's essentially a vitamin, but one that contains active forms of nutrients that the body can use. Most B vitamins bought over the counter have to be converted by the body into their active forms to have any benefit. That can mean that patients who take vitamins for their health sometimes don't get all of the benefits -according to Pamlab, nearly half of the population can't fully translate folic acid into its active, beneficial form: L-methylfolate. Metanx does the job on its own, and adds in some other vitamins for good measure. Company literature says that "the bioefficacy of one Metanx tablet can be compared to taking 19 folic acid tablets (1 mg each) two B12 tablets (1 mg each), and two B6 tablets (25 mg each)." www.SpecOpsComm.com

Pamlab has recently raised the alarm about a vitamin combination being prescribed as a generic alternative to Metanx. It strongly disagrees with the switch, writing in an open letter that the alternative doesn't contain an active form of folate and, indeed, doesn't appear in a listing of FDA-approved generic drugs. The best advice for diabetics, of course, is to keep tight control to prevent complications from happening at all. Regular visits with your doctor can help detect problems early on. But the prescription treatment available through Metanx offers another avenue of care for patients and physicians. *** Sources: http://www.metanx.com/WhatIsMetanx http://www.metanx.com/media/nosubstitute/Metanx Website Letter.pdf

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Symptoms and Tips for Diabetes Nerve Damage Peripheral neuropathy can be a painful and difficult-to-treat complication of diabetes. Here's help to manage the frustrating sensations it causes. Fall 2012 Diabetic Living Magazine By Winnie Yu
http://www.diabeticlivingonline.com/complications/other/symptoms-and-tips-for-diabetes-nerve-damage/?page=1

Deborah Grona wasn't sure she'd ever do the two-step again. After years of unrelenting pain from diabetic neuropathy, the 59-year-old medical transcriptionist found herself back on the dance floor last New Year's Eve. Even more surprising, she had forgotten to take her pain medicine that night -- and her feet didn't hurt. "When I sat down, I thought it had to be the excitement of the evening," says Deborah, who lives in San Antonio, runs her own business, and has type 2 diabetes. The next morning, she awoke shocked to realize that she'd had a good night's sleep and was still feeling no pain in her legs or feet. Maybe the prescription supplement she'd been taking was kicking in. Maybe, after four years, her agony had ended. A Common Problem According to The Neuropathy Association, 60-70 percent of all people with diabetes (PWDs) develop peripheral neuropathy, a disorder of the motor, sensory, and autonomic nerves that connect the spinal cord to muscles, skin, and internal organs. The condition typically causes weakness, numbness, tingling, and pain in the hands and feet. About 30 percent of all peripheral neuropathy cases are related to diabetes; even people with prediabetes can develop it. No one knows exactly what causes the damage. Having high blood glucose for a long time appears to be a major factor, but nerve damage may also come from excess insulin or another metabolic change, says Todd Levine, M.D., codirector of the Peripheral Neuropathy Clinic at Banner Good Samaritan Medical Center in Phoenix. Medicine Can Help Just like the symptoms, the course of peripheral neuropathy varies. For some, the pain comes

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and goes and progresses slowly over years. For others, it is debilitating right away and can worsen quickly. For Deborah, the troubles began in 2007 with tingling in her feet. It soon turned into pain so persistent that she could not sleep through the night. She cut back her work hours and gave up dancing. She even sold her house because it hurt too much to walk on the ceramic tile. "It felt like someone was holding a blowtorch to my feet," she says. Unfortunately, there is no cure for damaged nerves. The condition can be controlled with lifestyle strategies and medications. Over-the-counter pain relievers may help, and some people find relief by taking antidepressants, such as amitriptyline (Elavil) or desipramine (Norpramin). The medicine somehow helps block the pain, but it can take several weeks to become effective, if at all. Some doctors prescribe anticonvulsants, such as pregabalin (Lyrica), for peripheral neuropathy pain. A recent study, however, found that for study participants with "inadequate pain control," the drug didn't significantly lessen nerve pain. Pfizer, the drug's maker, says it will conduct further analyses. Deborah finally got relief about a year after she started taking Metanx, a prescription pill that contains vitamins B6 and B12 and folic acid. The U.S. Food and Drug Administration classifies Metanx as a medical food. Metanx increases the production of nitric oxide, a vasodilator, which helps improve blood flow and repair damaged nerves. These days, Deborah has cut back on her pain meds. She's also working more hours and dancing the two-step again. To improve her overall health, she is eating better and has started walking on a treadmill twice a day. She said she has noticed a big difference in her feet. "Feeling my toes now is just amazing."

Signs & Symptoms of Peripheral Neuropathy -- Lack of sensation in your feet -- Pain that worsens at night and improves when you get up -- Difficulty climbing up and down stairs Most people with diabetic peripheral neuropathy won't have any symptoms at all, says Allen Jacobs, D.P.M., a podiatrist in St. Louis. "Unless it's extreme, the majority of people wont know they have it." Only an annual comprehensive exam that assesses your skin, muscles, bones, circulation, and sensations in your feet can determine if you have it. The American Diabetes Association recommends all PWDs be screened for peripheral neuropathy at least once a year. Healthy lifestyle strategies play a key role in controlling pain and complications. Here's what experts recommend: -- Keep your blood glucose under tight control. Aim for a fasting and before-meal blood glucose level of 70-130 mg/dl and below 180 after eating. Keep your A1C level at 7 percent or lower. Hitting these goals may slow progression of nerve pain and reduce existing symptoms.

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-- Be as active as possible. Doing just 20 minutes of aerobic exercise a day can help lower your blood glucose level and reduce pain. If you already have some nerve damage in your feet, you may not want to walk. Try swimming, bicycling, or seated exercises. -- Consider prescription medications. Many types of drugs are prescribed to treat pain, including some antidepressants, anti-epileptics, analgesics, selective serotonin reuptake inhibitors, and opioid painkillers. -- Limit alcohol intake. It's fine to have an occasional drink, but daily alcohol can worsen nerve pain. 5 Ways to Prevent Nerve Damage 1. Get your blood glucose level within your target range and keep it there. 2. Eat a healthful diet with lots of fruits and vegetables to be sure your body is getting essential vitamins. 3. Ask your health care provider to screen for peripheral neuropathy every year. 4. Check your feet daily for injuries, ulcers, and infections. Wear shoes that fit well to prevent sores. 5. Exercise often to keep your nervous system working well.

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KENS5-TV March 19th, 2012 S.A. diabetic patients find nerve damage relief with 'medical food' By Wendy Rigby

http://www.kens5.com/news/local/SA-diabetic-patients-find-nerve-damage-relief-with-medical-food-143374726.html

SAN ANTONIO -- People who suffer with diabetic neuropathy know the pain it can cause. Now, some patients are finding welcome relief with a prescription vitamin. Uncontrolled high blood sugar can lead to nerve damage in the feet, creating numbness, tingling and pain. Its an all too common condition called neuropathy. As a podiatrist in San Antonio, Dr. Robert Castillo has no shortage of diabetic patients. Now, hes prescribing patients a B-complex vitamin called Metanx, a prescription pill considered a medical food. It improves nerve health by increasing circulation, but also increasing nutrients to the nerves to help them recover from damage from neuropathy, Castillo explained. San Antonian Deborah Grona, 59, has been diabetic since 1998. She suffered from intense neuropathy pain. The damage was so great, she was maxed out of pain medications. Her doctor told her she could be at risk for amputation. I was immobile, Grona said. I was walking only from my bedroom to my home office and back. Then Grona tried Metanx. For people with a deficit of folic acid, Metanx can provide significant relief in four to twelve weeks. Grona said she is back to dancing, something she hasnt been able to do for years. I was having a good time, she commented. My family noticed. Everyone noticed that I was walking better.

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Castillo has been prescribing Metanx for several years now to more than a hundred patients with good success. It was very little side effects as well, Castillo stated. It actually gives them a little more energy so theyre usually pretty enthusiastic when they first start it. Its a pretty easy way to start therapy for neuropathy. While medication can be important for treating neuropathy, doctors say then number one step diabetics can take to deal with the problem is to control their blood sugar levels.

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AACE: Rx Food May Ease Diabetic Neuropathy MedPage Today Todd Neale April 16, 2011 Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco
http://www.medpagetoday.com/MeetingCoverage/AACE/25970

SAN DIEGO -- A prescription medical food that provides active forms of folate and vitamins B 6 and B 12 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 B 12 , 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

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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%). Fonseca reported that he has received honoraria for his role as a data safety and monitoring board member from Xoma and salary support for his role as a salsalate trial principal investigator from the NIH.

Primary source: American Association of Clinical Endocrinologists

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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.

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Podiatry Today Brian McCurdy May 2011 Issue

http://www.podiatrytoday.com/may-2011?page=1

A new study in Reviews in Neurological Disorders notes that patients with diabetic neuropathy may achieve improved cutaneous sensation by taking a combination of L-methylfolate, methylcobalamin and pyridoxal 5-phosphate (Metanx, Pamlab). Researchers studied 20 patients with type 2 diabetes who took Metanx twice a day for four weeks and then once a day for 48 more weeks. The study says patients experienced statistically significant improvements in tactile and discriminatory static testing at the left and right great toe and in the heel. Authors noted the greatest improvement occurred between baseline and one year of treatment. The combination of L-methylfolate, methylcobalamin and pyridoxal 5-phosphate provides patients with the benefits of increased nitric oxide production and increased flow mediated dilation, according to lead study author Mackie Walker, Jr., DPM. He says the supplement improves endothelial function, addressing the postulated underlying pathophysiology of diabetic peripheral neuropathy. When one considers the true cost of the symptomatic treatment medication regimes, such as pregabalin (Lyrica, Pfizer) and duloxetine (Cymbalta, Eli Lilly), Dr. Walker says Metanx is very affordable. Since diabetic peripheral neuropathy is the leading cause of amputation, the opportunity to reverse or even slow down the progression of this process is of tremendous benefit to the cost burden of diabetic peripheral neuropathy to the healthcare system overall, says Dr. Walker, who practices in the Podiatry Division at Carolina Musculoskeletal Institute in Aiken, S.C. Dr. Walker says patients tolerate Metanx as well as placebo. Of the literally thousands of prescriptions I have written for Metanx, I can count on one hand the number of patients who could not tolerate it, he adds.

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Medical Food for Diabetic Peripheral Neuropathy thediabetesresource.com Allie Beatty November 10, 2011

http://www.thediabetesresource.com/your-diabetes-health/medical-food-for-diabetic-peripheral-neuropathy/

In a world of diabetic peripheral neuropathy where drugs might be overkill and a supplement might be useless - what is an effective solution when neither a drug nor a supplement can make a difference? Diabetic peripheral neuropathy is a complication of diabetes resulting in numbing, tingling, and sometimes painful sensations in the feet and hands. Currently a few treatment options to address the symptoms of the condition are available but wouldnt it be prudent to take the bull by the horns and slay the dragon where it lives? Enter the medical food revolution Metanx. A medical food is a practical solution between a drug and a supplement. A drug is prescribed by a doctor to mitigate the symptoms of a condition. A supplement is designed to be used by otherwise healthy individuals and it is not necessary to be under the guidance of a doctor. A medical food is specifically formulated for the management of a specific condition and prescribed by a doctor. In the case of Metanx, it was developed to address the distinct nutritional requirements of diabetic peripheral neuropathy. It is available by prescription from your doctor. For a short video (1:08) click here to see how Metanx works. Metanx is currently available by prescription from your doctor. As you would with any other prescription your local pharmacy should carry it. Its not a snake oil product, either. Its totally legit! I even went so far as to call my local pharmacy to see if they have it. Yes sir, they do! Next step? Who to ask for the prescription: my endocrinologist, my neurologis, or my transplant doctort? They all have prescription pads. A few years back my neurologist suggested I take Foltx: a B6, B12, and folic acid combo pill.. I didnt notice a difference after taking the pill for a few months so I stopped taking it. Metanx is specifically designed to assist in enhancing blood flow and encouraging nerve regrowth and repair. The components of Metanx include an easier-to-assimilate version of the vitamins. Results have been reported by some people within a week. Others report it takes up to 4 months to feel restored sensation, easing of pain and better sleep. Diabetic peripheral neuropathy is not pretty. It affects your ability to heal, your balance, and your sensitivity to touch . Theres no elegant way to put it peripheral neuropathy challenges you in ways that you dont need in your life.

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A human tale of diabetic peripheral neuropathy: a few years ago I was getting ready to go out with friends. In the frenzy of the hubbub I didnt notice kicking my coffee table. The next morning I woke up with a Vienna sausage for a toe. Apparently I broke my toe. At the time, I was a card-carrying member of diabetes for 24+ years. I spent 3 days in the hospital getting IV-antibiotics to ensure I didnt get a bone infection. Yay! I still have 10 toes but the coordination of a toddler. The moral of this story? Nothing good comes from diabetic peripheral neuropathy. If something can be done to avoid a manifestation of irreparable harm why not do something about it now? Joni Mitchell never lies: you dont know what youve got till its gone. Pave paradise with Metanx. Visit the Your Diabetes Health section of our website for more resources about health.

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WWL-TV November 23, 2011 New treatment for neuropathy pain caused by type 2 diabetes By Meg Farris http://www.wwltv.com/news/health/New-treatment-for-type-2-diabetes-134422068.html NEW ORLEANS - There is a high number of people in this area who have type 2 diabetes, and that condition can affect the nerves in the feet and legs, causing wounds that don't heal and even amputations. But now a local company, and a local doctor from Tulane, believe they have a potential treatment. Mother and fifth grade school teacher, Susan Doell, was diagnosed with type 2 diabetes right before Hurricane Katrina. "Well, it didn't surprise me because there's a hereditary factor there, but also I had gestational diabetes," said Doell, who lives in Metairie. Over the years, the medicine didn't control her blood sugar that well, so this year she began taking insulin injections. But earlier on, within a year of her diagnosis, she noticed tingling sensations in her feet. Her diabetes was causing nerve damage called neuropathy. "I started feeling the tingling, the tingling that you get and then you don't notice it at first because it's a slow onset. It's like one day, it almost feels like pins and needles at some point and then it gets to be where it's not as active. You don't feel that, that tingle anymore. It's more of a dull tingle," Doell described. Later it progressed to stabbing pains. "It's all of a sudden you can be sitting there and then you just want to like jump out of your skin and it's only in one spot. I remember the first time that I felt it. I was driving and it was in my right foot and you're in the middle of Veterans Highway (Blvd.) and there's no place to go and you have to drive like this and you just want to scream and holler and there's nothing you can do about it," she remembers. "Neuropathy is extremely common in people with diabetes. The estimates for about 60, 70 percent of people sometime over their lifetime will have some nerve damage. Sometimes pain is good because it tells you there's something wrong and if you don't feel it, it's very dangerous because those people

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are at risk for amputations," explained Dr. Vivian Fonseca the Chief of Endocrinology at Tulane Medical Center. Complications of the foot is the number one reason why people with diabetes go to the hospital. In fact every day in the United States, 225 people with diabetes, that's almost enough to fill up a 747 jet, have a lower limb amputation. There's medicine for neuropathy pain but nothing for numbness and nothing that shows the damaged nerve can change or get better. But now a company in Covington called Pamlab, LLC., believes it is the first to have a possible treatment. "The patients were starting to feel their feet again and feel the tingling and the burning that they had completely lost when they were at the stage of having no feeling whatsoever, and not even knowing they'd drive a nail through their foot and not even know they'd done it," said Harold Koch, the Senior Vive-President of Scientific Affairs and Chief Scientific Officer of Pamlab, LLC. It's a medical food called Metanx. The small purple pill is a higher dose of three types of vitamin B found naturally in food. You need a prescription since it's not the synthetic or over-the-counter supplement form of vitamin B. Double-blinded scientific studies were recently done at six sites across the U.S. to test it. Dr. Fonseca was the lead investigator. "There was actually a small improvement with placebo because sometimes when you come in frequently to the doctor, you feel a little better. But there was a significantly better improvement with this drug," Dr Fonseca said of the findings with Metanx. "We're not only treating pain to an extent, but we're also treating the actual condition itself by increasing the blood flow, bringing sensation back," said Koch. Pennington Biomedical Research Center in Baton Rouge did the same study on rats and could see improvements in the nerve's structure. Dr. Fonseca says while Metanx is safe, he would like to see more studies because there are unanswered questions. As for Susan, she says her daily routine, and even walking, is easier using Metanx. "When I'm not on it, I know that there's a difference. That's basically what I can tell you," said Doell. The pills cost $80 a month. Some insurance companies will pay a small amount toward the cost. One is taken two times a day. Another free follow-up study on Metanx will start in January. Doctors are looking for people with diabetes who have nerve pain, numbness, tingling and/or burning, and shooting and/or stabbing pains in their feet. Call toll free 1-888-831-7333 to see if you qualify. Dr. Fonseca hopes to publish his study and findings in a scientific journal. One is reviewing his study now.

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Pamlab says it wants to increase awareness of the most common diabetes complication, diabetic neuropathy. Many foot complications can be prevented with thorough foot care. Here are some simple tips for diabetes patients. Check your feet daily for cuts, sores, bruises, or any abnormalities. Use a mirror or have a family member assist if needed. Wash your feet daily using WARM water and soap. Test water temperature with your elbow, as hot water can burn your hands and feet (without you realizing it because of nerve damage). If your feet are cold at night, wear socks; do not use a heating pad or hot water bottles. Never go barefooted, especially outdoors.

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