Can Melatonin Put Your Chronic Pain to Sleep?

By A. Rahman Ford, PNN Columnist

Melatonin is popularly known as the sleep hormone. Less known is its potential to alleviate chronic pain and inflammation.

Melatonin is a natural hormone produced by the pineal gland in the brain. During the day the pineal gland is inactive, but at night it begins to produce melatonin and helps us sleep.

As a supplement, melatonin is widely promoted for its efficacy as a sleep aid. However, its role in reducing inflammation – a major contributor to chronic pain – may be much more important. Many chronic pain conditions are a result of underlying inflammation.

In a recent Nature article, melatonin was called a “master regulator” of inflammation. Several studies have shown that melatonin can regulate activation of the immune system, reducing chronic and acute inflammation.

Research shows that melatonin supplements can modulate inflammation by acting as powerful antioxidants and free radical scavengers. Uncontrolled free radicals in the body can lead to oxidative stress, which can cause inflammation and culminate in diseases that cause chronic pain.

There is a large body of evidence that melatonin is a potent antioxidant, even more potent than vitamins C and E.  It’s been successfully used to treat fibromyalgia and irritable bowel syndrome, diseases associated with high levels of oxidative stress.

400px-Walgreens_Melatonin-2010-20-07.jpg

Melatonin is also a strong antimicrobial, and emerging research shows that some chronic inflammatory conditions may be caused by infections. One study found melatonin effective in treating certain drug-resistant bacteria such as Staphylococcus aureus, Pseudomonas aeruginosa and Acinetobacter baumannii. Similar results were found when testing ten different pathogens, including Escheria coli and Salmonella typhinurium, with melatonin.

Melatonin and Chronic Pain

A therapeutic role for melatonin in the treatment of painful autoimmune conditions has been theorized.  A 2013 study noted that melatonin plays a role in the pathogenesis of conditions such as multiple sclerosis and systemic lupus. In animal models of these diseases, melatonin supplements were found to have protective effects. A 2019 review concurred, concluding that melatonin can serve as a new therapeutic target in treating autoimmune diseases.

A review of the scientific literature on chronic pain syndromes found evidence of melatonin’s efficacy as an analgesic in several conditions including fibromyalgia, irritable bowel syndrome and chronic back pain. Studies also showed melatonin’s effectiveness in treating cluster headaches ad tension headaches.

A small clinical trial of 63 females with fibromyalgia found that melatonin, alone or in combination with the antidepressant amitriptyline, significantly reduced pain when compared to amitriptyline use alone. The authors concluded that the melatonin treatment had a direct effect on the regulation of pain.

There has been some evidence that melatonin supplements can help reduce lower back pain. In a 2015 study, researchers found a significant reduction in pain intensity during movement and at rest in patients with back pain.

Melatonin has also been successful in treating migraines. In an open-labeled clinical trial of 34 patients suffering from migraine, 30 mg of melatonin given 30 minutes before bedtime was found to reduce headache intensity as well as frequency and duration, with significant clinical improvement after one month.

Although the scientific evidence is only slowly emerging, melatonin is a widely-available, inexpensive and safe supplement that may aid you in your fight against chronic pain.

A. Rahman Ford.jpg

A. Rahman Ford, PhD, is a lawyer and research professional. He is a graduate of Rutgers University and the Howard University School of Law, where he served as Editor-in-Chief of the Howard Law Journal.

Rahman lives with chronic inflammation in his digestive tract and is unable to eat solid food.

The information in this column is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Low Dose Naltrexone a ‘Game Changer’

By Alex Smith, Kaiser Health News

Lori Pinkley, a 50-year-old from Kansas City, Mo., has struggled with puzzling chronic pain since she was 15.

She has had countless disappointing visits with doctors. Some said they couldn’t help her. Others diagnosed her with everything from fibromyalgia to lipedema to the rare Ehlers-Danlos syndrome.

Pinkley has taken opioids a few times after surgeries, but they never helped her underlying pain. Recently she joined a growing group of patients using an outside-the-box remedy: naltrexone. It is typically used to treat addiction to opioids or alcohol, in pill form or as a monthly shot.

As the medical establishment attempts a huge U-turn after two disastrous decades of pushing long-term opioid use for chronic pain, scientists have been struggling to develop safe, effective alternatives.

When naltrexone is used to treat addiction in pill form, it’s prescribed at 50 milligrams. But chronic pain patients say it helps their pain at doses of less than a tenth of that.

Low-dose naltrexone (LDN) has lurked for years on the fringes of medicine, and its zealous advocates worry it may be stuck there. Naltrexone, which can be produced generically, is not even manufactured at the low doses that seem best for pain patients.

Instead, patients go to compounding pharmacies or resort to DIY methods — YouTube videos and online support groups show people how to turn 50 mg pills into a low-dose liquid.

Some doctors prescribe it off label even though it’s not FDA-approved for pain.

naltrexone-500x500.jpg

University of Kansas pain specialist Dr. Andrea Nicol recently started prescribing LDN to her patients, including Pinkley. Nicol explained that for addiction patients it works by blocking opioid receptors — some of the brain’s most important feel-good regions. So it prevents patients from feeling high and can help patients resist cravings.

At low doses of about 4.5 mg, however, naltrexone seems to work differently.

“What it’s felt to do is not shut down the system, but restore some balance to the opioid system,” Nicol said.

Some of the hype over low-dose naltrexone has included some pretty extreme claims with limited research to back them, like using it to treat multiple sclerosis and neuropathic pain or even using it as a weight-loss drug.

In the past two years, however, there’s been a significant increase in new studies published on low-dose naltrexone, many strengthening claims of its effectiveness as a treatment for chronic pain, though most of these were small pilot studies.

Dr. Bruce Vrooman, an associate professor at Dartmouth’s Geisel School of Medicine, authored a recent review of low-dose naltrexone research.

Vrooman said that, when it comes to treating some patients with complex chronic pain, low-dose naltrexone appears to be more effective and well-tolerated than the big-name opioids that dominated pain management for decades.

Those patients may report that this is indeed a game changer. It may truly help them with their activities, help them feel better.
— Dr. Bruce Vrooman

“Those patients may report that this is indeed a game changer,” Vrooman said. “It may truly help them with their activities, help them feel better.”

So how does it work? Scientists think that for many chronic pain patients the central nervous system gets overworked and agitated. Pain signals fire in an out-of-control feedback loop that drowns out the body’s natural pain-relieving systems.

They suspect that low doses of naltrexone dampen that inflammation and kick-start the body’s production of pain-killing endorphins — all with relatively minor side effects.

Drug Companies Not Promoting LDN

Despite the promise of naltrexone, its advocates say, few doctors know about it. The low-dose version is generally not covered by insurance, so patients typically have to pay out-of-pocket to have it specially made at compounding pharmacies.

Advocates worry that the treatment is doomed to be stuck on the periphery of medicine because, as a 50-year-old drug, naltrexone can be made generically.

Patricia Danzon, a professor of health care management at the Wharton School at the University of Pennsylvania, explains that drug companies don’t have much interest in producing a new drug unless they can be the only maker of it.

“Bringing a new drug to market requires getting FDA approval, and that requires doing clinical trials,” Danzon said. “That’s a significant investment, and companies — unsurprisingly — are not willing to do that unless they can get a patent and be the sole supplier of that drug for at least some period of time.”

And without a drug company’s backing, a treatment like low-dose naltrexone is unlikely to get the promotional push out to doctors and TV advertisements that has made household names of drugs like Humira and Chantix.

 “It’s absolutely true that once a product becomes generic, you don’t see promotion happening, because it never pays a generic company to promote something if there are multiple versions of it available, and they can’t be sure that they’ll capture the reward on that promotion,” Danzon said.

The drugmaker Alkermes has had huge success with its exclusive rights to the extended-release version of naltrexone, called Vivitrol. In a statement for this story, the company said it hasn’t seen enough evidence to support the use of low-dose naltrexone to treat chronic pain and therefore is remaining focused on opioid addiction treatment.

Lori Pinkley said it’s frustrating that there are so many missing pieces in the puzzle of understanding and treating chronic pain, but she, too, has become a believer in naltrexone.

She’s been taking it for about a year now, at first paying $50 a month out-of-pocket to have the prescription filled at a compounding pharmacy. In July, her insurance started covering it.

“I can go from having days that I really don’t want to get out of bed because I hurt so bad,” she said, “to within a half-hour of taking it, I’m up and running, moving around, on the computer, able to do stuff.”

A recent review by British researchers found that LDN is safe to use and more clinical studies are needed on its potential uses. PNN readers have shared their positive experiences using LDN to treat Interstitial Cystitis and fibromyalgia.

The LDN Research Trust includes a list of LDN-friendly doctors and pharmacies on its website.

This story is part of a partnership that includes KCUR, NPR and Kaiser Health News, a nonprofit news service covering health issues. KHN is an editorially independent program of the Kaiser Family Foundation, which is not affiliated with Kaiser Permanente.

Fibromyalgia Researchers, It’s Time to Stop Watching the Flowers Grow!

By Donna Gregory Burch

As a fibromyalgia warrior and blogger, I read a lot of articles about new research findings. I continue to be amazed by how much time and money are wasted by researching the obvious or studying the same treatments over and over again.

After all, how many times do we need to prove meditation can reduce fibromyalgia pain? Didn’t we figure that out years ago?

I really thought I’d seen it all until an article entitled, “The Power of Flowers May Ease Fibromyalgia Symptoms,” showed up in my inbox last month.

As I read it, I literally said out loud: “Are you kidding me?”

In case you haven’t read the article, it summarizes a recent Israeli study in which 61 women with fibromyalgia completed a 12-week flower design course presented by a trained florist. At the end of the course, Tel-Aviv University researchers reported “quite amazing” improvements in the women’s fibromyalgia symptoms.

Yep, you read that right: The researchers claim arranging a few daisies and baby’s breath in a vase actually improves fibromyalgia.

Now, I don’t doubt for a minute that flower arranging is relaxing and could have a calming effect on the central nervous system. That, in turn, could lead to a reduction in pain and other fibro symptoms.

But so could watching butterflies or painting rocks.

While I think it’s wonderful researchers are looking at non-pharmaceutical treatments for fibromyalgia, studies like this completely invalidate the seriousness of our condition. These types of studies make it seem like almost anything will fix fibro, and that is just not reality.

people-2566739_640.jpg

Because of the stigma of fibromyalgia, we already struggle to prove to our doctors and loved ones that we’re really sick. What do you think the average person is going to think when they read flower arranging helps fibromyalgia? While I’m sure the researchers had good intentions, this study makes a complete mockery and joke out of an extremely painful, life-sucking condition.

In my mind, I think back to all of those doctors who tried to give me anti-depressants and anti-anxiety medications when I complained about unexplained pain, fatigue, bladder urgency, neuropathy and a long list of other symptoms. The message was clear: “It’s all in your head. You’re just a stressed out, middle-aged woman who needs to chill out.”

What happens when these same doctors read the Israeli study? I can envision them now referring their patients to the nearest community college for classes on cupcake baking and basket-weaving. As if we weren’t frustrated enough with the conventional medical system!

The truth is we don’t need more BS fibromyalgia studies like this one. We need researchers to get serious! We need them to take a deep dive into the minds and bodies of fibromyalgia patients and figure out what causes us to feel like a three-day-old warmed over microwave dinner.

We need real solutions – treatments that get to the root cause of our illness – not a new hobby!

donnasnowday.jpg

Donna Gregory Burch lives with fibromyalgia and chronic Lyme disease. Donna covers news, treatments, research and practical tips for living with fibromyalgia and Lyme on her blog, FedUpwithFatigue.com. You can also find her on Facebook and Twitter.

Donna is an award-winning journalist whose work has appeared online and in newspapers and magazines throughout Virginia, Delaware and Pennsylvania. She lives in Delaware with her husband and their many fur babies.

Don’t Add to My Pain

By Mia Maysack, PNN Columnist

This month I celebrate the anniversary of finally getting a fibromyalgia diagnosis, after years of fighting to “earn” it. To my lifelong course of chronic migraine was added a heaping side dish of a nerve disorder.

Intractable pain is a constant state of being for me, whether I use essential oils, think positive, drink pickle juice for 40 days and nights, or even if someone belittles, disbelieves, mocks or minimizes it.    

People often say things like "I wouldn't be able to make it” if their head hurt like mine does every day. For many, there's no possible way to imagine what it is like, but I'm finding that those who cannot relate at all often have the most opinions about it.

Others wonder how I've been able to accomplish what I have while under the persistent weight of brain discomfort. The answer is simple: Because I've had no other choice!

When not entirely incapacitated, head pain for me has been managed with a grateful attitude and a mind over matter approach. Unfortunately, when navigating matters of the physical body, more restrictions apply.  Neither deep breaths nor the tapping of my ruby red slippers will get me up or down the stairs when I'm unable to walk. 

Many around me have taken all of this personally, because the extent of the hardships I face have left me trapped behind closed doors more than ever. 

Instead of stopping by or reaching out to check in, entire relationships have changed -- primarily because my ailments have yet to be acknowledged, let alone respected.

Only recently did others finally begin to grasp the concept of my migraine and cluster headaches.

bigstock-Woman-Having-Abdominal-Pain-54072550.jpg

But wrapping their minds around something else? Especially when I lack the energy and desire to continually attempt to justify or explain? Forget about it. 

One thing about me is that I rarely ever complain. I'm known to seek out silver linings and hand the light I find over to the next person in need. I count my blessings on a regular basis and never lose sight as to how much worse things could be or how they can change in the blink of an eye.

So, when attempting to bare my soul while being met with judgment, doubt, questioning or just flat out disregarded, I wonder if those who respond that way ever stop to reflect. Shifting blame toward me or my conditions for our lack of fellowship or communication doesn’t help the relationship.   

Not long ago I was out at a dinner, constantly having to shift in the chair or get up to stand, while repeatedly being reminded what we're conversing about due to brain fog. All the while my head is banging and I can barely eat because the nausea from attempting to ignore everything else was heightening.   

The dear one I'm out with mentions another friend who endures similar circumstances. He proceeds to explain how he's had to carry this person out of places and into their home due to the extent of their fatigue. Hearing this tears me up because I can literally feel for them.  

But instead of using this opportunity to bond, my emotion was met with ridicule: "You are SO sensitive! I cannot talk about ANYTHING with you!"  

It felt like insult to injury, that they'd demonstrate compassion for another but then put me down.   

Before that, someone else I love labeled my chronic pain as a "placebo effect." More recently, even after discussing my disability hearing, a friend wondered if I had a gym membership because they didn’t want to work out alone.  

Not that it is blasphemous to bring up the topic of exercise, but it showed a lack of empathy. If I am in need of using a cane, not always able to drive, experience muscle failure and soreness to the touch, what about that signifies my readiness to lift weights or hop on a treadmill?

I used to go out dancing regularly, but the last time was about 24 months ago for an ex co-worker's bachelorette party -- whose actual wedding I ended up missing because of all this. Another homie of mine hasn't replied to me since I'd been forced to cancel attending her kid’s birthday party at the last minute.  

Quite honestly, if I keep in contact with just about anyone, it's because I initiate the connection. Many have flat out stopped talking to me altogether because my consistent need for self-care is an inconvenience for them.  

What they don't know is that all of this is so real. The other day, I purposefully went outside in the rain to pre-shower, because with Mother Nature's help the chore felt slightly less daunting. 

Having been dealt this hand and then being left to cope on your own has a way of demonstrating the extent of one’s strength they may not have realized they had. I am thankful for everything that broke me because that’s what I am made of.

I now declare unapologetically that all of this has forced me to change. Nothing is welcome in my life that adds more hurt or disrupts my peace. My hope is that everyone reading this reaches the same conclusion and thereby a level of freedom.    

img1539183317715.jpg

Mia Maysack lives with chronic migraine, cluster headaches and fibromyalgia. Mia is the founder of Keepin’ Our Heads Up, a Facebook advocacy and support group, and Peace & Love, a wellness and life coaching practice for the chronically ill.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Are You Paying Too Much for Pregabalin?

By Pat Anson, PNN Editor

It didn’t take long for cheaper generic versions of pregabalin to take a bite out of Pfizer’s monopoly of Lyrica, a drug widely used to treat fibromyalgia, diabetic neuropathy and other types of chronic pain.

Last month the U.S. Food and Drug Administration gave approval to rival drug makers to begin selling generic pregabalin after Pfizer’s patent on Lyrica expired. According to FiercePharma, Pfizer lost about a third of the market for pregabalin to 16 competitors by the end of July.  

It’s not hard to see why. According to Healthcare Bluebook, a 60-day supply of 75mg Lyrica sells for a “fair price” of $472. That compares to generic versions that sell for about $28.

“The price that most patients pay is set by insurers. The cost difference for patients between brand-name Lyrica and generic pregabalin may vary depending on the patients’ insurance plan, the state in which their prescription is filled, or the pharmacy where they pick up their prescription,” said Steven Danehy, a Pfizer spokesman.

bigstock-Pouring-capsules-from-a-pill-b-46714792.jpg

As of August 9, Lyrica still had about 43% of the market for pregabalin, but that’s likely to change as patients, doctors and insurers became more aware of the significant difference in price.

Pregabalin is approved by the FDA for the treatment of pain associated with shingles, spinal cord injury, fibromyalgia, and diabetic peripheral neuropathy. It is also commonly prescribed "off label" for other types of chronic pain.

Pregabalin is a Schedule V controlled substance, which means it has a low potential for abuse. In recent years, however, there is growing concern that pregabalin and its sister drug gabapentin (Neurontin) are being abused and overprescribed.

The drugs, which belong to a class of nerve medication called gabapentinoids, were originally developed to treat epilepsy, not pain. Prescriptions for gabapentinoids have tripled over the past 15 years as more doctors prescribed them as “safer” alternatives to opioids.

Deaths involving gabapentinoids have increased in the UK, Australia and Canada, where some addicts have learned the drugs can heighten the euphoric effect of heroin and other opioids. The drugs were recently classified as controlled substances in the UK.

Pain Is Not a Competition

By Mia Maysack, PNN Columnist

Recently I chose to step away from one of the last support group forums I belonged to because it continually felt less than supportive.  

“Pain is pain” may be the motto of our community, yet there are persistent comparisons that consistently belittle someone’s reality in some shape or form.  It’s like a competition to see who has the most pain.

To serve as one example, “cluster migraine” is not a scientific term, though it is a phrase I use to convey the type of pain that I feel -- an inclusion of multiple beasts (chronic migraine, cluster headache and fibromyalgia) that are not to be confused as the same or even similar, but co-exist within me nonetheless.

There's no doubt that cluster headache is one of the most excruciating conditions known to humankind. If you haven’t gone through it -- there is no possible way to fully comprehend it.  This does not mean that migraine is any less valid or any less painful.

We all seek validation in having our perception understood and it is frustrating that we consistently battle general stigma and then turn around and cast the same judgment onto each other. Cluster or migraine aside, it’s like a whole new attack.   

One person could say migraine is worse because it can literally be never-ending, whereas cluster headache episodes are considerably shorter in length. 

The next person states that it doesn't get any more terrible than cluster headache as they're called suicide headaches for good reason. 

upset-3079062_640.jpg

Then someone else shares they have lost someone to migraine as well. Point is, there's a spectrum.  

By eliminating the unnecessary tone of competition (that no one should want to “win” anyway), we make room for discovering the similarities we all share. One being that whichever way this sh*t pie gets sliced, it stinks!

Nobody wants or deserves to be shunned just because their truth is different. And no one gets to degrade how someone else views the world. Whether or not we agree, there should be a sense of camaraderie throughout our planet that is severely lacking. It most certainly shouldn't be among us Spoonies.  

Fixating on how an individual thinks does not benefit our cause. That same focused energy on the bigger picture could create lasting change -- like how the word “headache” isn't an accurate depiction of any brain disease or disorder to begin with. And if it were, aspirin would have cured it long ago, right? 

It’s imperative we avoid contributing to the very issue we want to solve by joining forces and declaring that we are more than just suffering patients. We are actual people living with the disability inflicted by these conditions.

And since we’re already in the fight for our lives, let's make sure it’s together and not against one another.

img1539183317715.jpg

Mia Maysack lives with chronic migraine, cluster headaches and fibromyalgia. Mia is the founder of Keepin’ Our Heads Up, a Facebook advocacy and support group, and Peace & Love, a wellness and life coaching practice for the chronically ill.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

FDA Approves First Generics for Lyrica

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration has approved the first generic versions of Lyrica (pregabalin), a medication widely prescribed for the treatment of fibromyalgia, diabetic neuropathy and other types of chronic pain.

Lyrica has been a blockbuster drug for Pfizer since its approval in 2004, generating revenue of $4.6 billion annually. The recent expiration of Pfizer’s patent on Lyrica opened the door to much cheaper generic competitors.

A one year supply of Lyrica currently costs about $2,800 in the United States, according to Healthcare Bluebook, while a similar dose of pregabalin under the UK’s National Health Service costs about $74.

Lyrica2.jpg

“Today’s approval of the first generics for pregabalin, a widely-used medication, is another example of the FDA’s longstanding commitment to advance patient access to lower cost, high-quality generic medicines,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.

“The FDA requires that generic drugs meet rigorous scientific and quality standards. Efficiently bringing safe and effective generics to market so patients have more options to treat their conditions is a top priority for the FDA.”

The FDA granted approvals for generic pregabalin to 9 drug makers: Alembic Pharmaceuticals, Alkem Laboratories, Amneal Pharmaceuticals, Dr. Reddy’s Laboratories, InvaGen Pharmaceuticals, MSN Laboratories, Rising Pharmaceuticals, Sciegen Pharmaceuticals, and Teva Pharmaceuticals.

Pfizer’s patent for Lyrica CR — an extended released version of Lyrica — remains in effect until April, 2021.

Side Effects

The most common side effects for Lyrica are dizziness, somnolence, dry mouth, swelling, blurred vision, weight gain and difficulty concentrating. Lyrica’s warning label also cautions users that the drug may cause suicidal thoughts in about 1 in 500 people.

Pregabalin is classified as Schedule V controlled substance in the U.S., which means it has a low potential for abuse. In recent years, however, there is growing concern that pregabalin and its sister drug gabapentin (Neurontin) are being abused and overprescribed. The drugs were recently classified as controlled substances in the UK.

Pregabalin and gabapentin were originally developed to prevent epileptic seizures, but their use has tripled over the past 15 years as more doctors prescribed them off-label as “safer” alternatives to opioids.

A recent study in the British Medical Journal found the drugs increase the risk of suicide, overdose and traffic accidents in younger people. The risks were strongest for those taking pregabalin and were most pronounced among adolescents and young adults aged 15 to 24. Patients aged 55 and older taking gabapentinoids were not at greater risk.