A Gut Feeling About Fibromyalgia

By Pat Anson, PNN Editor

Over the years there’s been a lot of speculation about what causes fibromyalgia – everything from gluten and genetics to childhood trauma, spinal fractures and a weakened immune system.

About 5 million Americans suffer from fibromyalgia, a poorly understood disorder characterized by deep tissue pain, fatigue, mood swings and insomnia. It can take years for a patient to be diagnosed and treatments are often ineffective – in part because of uncertainty about what actually causes fibromyalgia.

For the first time, researchers at McGill University Health Centre in Montreal have found an association between gut bacteria and fibromyalgia. It’s not clear whether the microbes cause fibromyalgia or if they are a symptom, but the discovery opens the door to new forms of treatment and diagnosis. The findings are being reported in the journal Pain.

"We found that fibromyalgia and the symptoms of fibromyalgia — pain, fatigue and cognitive difficulties — contribute more than any of the other factors to the variations we see in the microbiomes of those with the disease,” said lead author Amir Minerbi, MD, of the Alan Edwards Pain Management Unit at McGill University Health Centre. 

“We also saw that the severity of a patient's symptoms was directly correlated with an increased presence or a more pronounced absence of certain bacteria - something which has never been reported before."

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Minerbi and his colleagues enrolled 156 women in their study – about half had fibromyalgia and the rest were a healthy control group. Participants were interviewed and gave stool, blood, saliva and urine samples, which were then compared.

Researchers found that the two groups had strikingly different types and amounts of gut bacteria. Nineteen different species of bacteria were found in either greater or lesser quantities in the gut microbiomes of fibromyalgia patients than in the healthy control group.

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For example, Faecalibacterium prausnitzii, one of the most abundant and well-studied bacteria in the human gut, was found to be depleted in fibromyalgia patients. It is believed to block pain and inflammation in the intestines.

Other bacteria associated with irritable bowel syndrome, chronic fatigue syndrome and interstitial cystitis were found to be abundant in the fibromyalgia patients, but not in the healthy control group.  

The bacterial differences don’t appear to be related to diets, lifestyles or genetics, since some of the healthy participants lived in the same house as the fibromyalgia patients or were their parents, offspring or siblings.

"We used a range of techniques, including Artificial Intelligence, to confirm that the changes we saw in the microbiomes of fibromyalgia patients were not caused by factors such as diet, medication, physical activity, age, and so on, which are known to affect the microbiome," says Minerbi.

Researchers say it's not clear whether the changes in gut bacteria seen in fibromyalgia patients are simply markers of the disease or whether they play a role in causing it. Because fibromyalgia involves a cluster of symptoms, the next step will be to investigate whether there are similar changes in the gut microbiome of patients with other types of chronic pain, such as back pain, headaches and neuropathic pain.

“This is the first evidence, at least in humans, that the microbiome could have an effect on diffuse pain, and we really need new ways to look at chronic pain." said senior author Yoram Shir, MD, Director of the Alan Edwards Pain Management Unit

If their findings are confirmed, researchers think their discovery could speed up the process of diagnosing fibromyalgia.

"By using machine learning, our computer was able to make a diagnosis of fibromyalgia, based only on the composition of the microbiome, with an accuracy of 87 per cent. As we build on this first discovery with more research, we hope to improve upon this accuracy, potentially creating a step-change in diagnosis," says Emmanuel Gonzalez, PhD, Canadian Center for Computational Genomics and the Department of Human Genetics at McGill University.

Several previous studies have suggested an association between diet and fibromyalgia. Donna Gregory Burch says her fibromyalgia symptoms improved when she went on a gluten-free diet. Studies show that consuming food additives such as monosodium glutamate (MSG) can worsen symptoms, while foods rich in Vitamin D can help reduce joint and muscle pain.

Gabapentinoids Raise Risk of Suicide and Overdose in Younger People

By Pat Anson, PNN Editor

Gabapentinoids – a class of nerve medication widely prescribed to treat chronic pain – increase the risk of suicide, overdose, traffic accidents and head or body injuries in younger people, according to a large new study published in The British Medical Journal.

Sales of the two main gabapentinoids, pregabalin (Lyrica) and gabapentin (Neurontin), have tripled in recent years in the United States, where they are often promoted in prescribing guidelines as safer alternatives to opioids.

A team of researchers followed nearly 192,000 people enrolled in the Swedish Prescribed Drug Register who filled prescriptions for gabapentinoids on at least two consecutive occasions from 2006 to 2013. That information was compared to data in the Swedish Patient Register, which collects information on hospital admissions and outpatient care, as well as the Swedish Cause of Death Register.

Over the study period, researchers found that patients taking gabapentinoids had higher rates of suicide or suicidal behavior (5.2%), unintentional overdose (8.9%), traffic accidents (6.3%) and head or body injuries (36.7%) than the general population.

The risks were strongest for people who were prescribed 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.

Researchers believe the drugs may have more impact on younger people because they have faster metabolisms, which could lead to withdrawal problems that affect their impulsivity and emotions.

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“Overall, gabapentinoids seem to be safe for a range of outcomes in older people. However, the increased risks found in adolescents and young adults prescribed gabapentinoids, particularly for suicidal behaviour and unintentional overdoses, warrant further research,” said lead author Seena Fazel, MD, of the University of Oxford in England.

“If our findings are triangulated with other forms of evidence, clinical guidelines may need review regarding prescriptions for young people, and those with substance use disorders. Further restrictions for off-label prescription may need consideration.”

Pregabalin is approved by the FDA to treat diabetic nerve pain, fibromyalgia, post-herpetic neuralgia caused by shingles and spinal cord injuries; while gabapentin is approved for epilepsy and post-herpetic neuralgia. Both drugs are also widely prescribed off-label to treat back pain, depression, migraine and other chronic conditions.

Gabapentinoids are increasingly being used recreationally by addicts who have found the medications enhance the effects of heroin and other opioids. The drugs were recently classified as controlled substances in the UK.

Gabapentin is not currently scheduled as a controlled substance by the DEA, while Lyrica is classified as a Schedule V controlled substance, meaning it has low potential for addiction and abuse.  

A recent clinical review found little evidence the drugs should be used off-label to treat pain and that prescribing guidelines often exaggerate their effectiveness. The CDC’s controversial opioid guideline, for example, calls gabapentin and pregabalin “first-line drugs” for neuropathic pain.

“Despite documentation that these drugs were promoted improperly for off-label treatment of pain, the recent rapid increase in prescribing of gabapentinoids suggests a persisting sense among clinicians that gabapentinoids are highly effective pain medications,” wrote Christopher Goodman, MD, and Allan Brett, MD, of the University of South Carolina School of Medicine.

“Guidelines and review articles have contributed to this perception by often uncritical extrapolation from FDA-approved indications to off-label use.”

Fibromyalgia Stole My Life, Kratom Gave It Back

By Mary Ann Dunkel, Guest Columnist

Fibromyalgia stole my life more than 28 years ago. I have severe chronic pain and fatigue that limits my activities of daily living. Unless you have experienced unrelenting severe pain 24 hours a day, you cannot know the horror of it.

I have been prescribed more pharmaceuticals than I can remember and suffered damaging side effects from them. I've participated in psychotherapy, aqua therapy, multiple pain management programs, acupuncture and hypnosis. None of these modalities brought me relief and for quite some time I was bedridden and dependent on family for care.

My doctors have prescribed me morphine, fentanyl, oxycodone, tramadol and other medications to control the pain. None of them worked for very long and I could see these prescriptions were going to lead to addiction. Often, I weaned myself off them and suffered through terrible withdrawal because the small amount of relief they gave was not worth the risk of addiction or overdose death. Bottom line is these narcotics were not effective in treating my chronic pain.

There were times when I thought about taking my life because I just couldn't get a break from the pain and didn't think I could take it any longer.

Then a friend introduced me to kratom. She had been consuming it for more than 10 years without side effects or becoming addicted to it. I started my own journey consuming kratom.

Kratom is not a drug. It is a dietary supplement. It does not heal any disease, but it has certainly improved my quality of life. I am having pain free days and my energy level is greatly improved. Kratom has restored my ability to have a normal life and I can enjoy all sorts of activities that make my life rich and full.

Kratom does not make me high, nor do I experience side effects. I am now clear minded without the sedation caused by narcotics. And I am devastated that the FDA is working to ban the only thing that has helped me in the past 28 years.

MARY ANN DUNKEL

MARY ANN DUNKEL

I am sick to death of reporters parroting the lies from the FDA and CDC. I implore you. The studies they have done are full of inaccuracies and half-truths. Independent studies of the autopsies in the so called kratom deaths have shown the victims had multiple medications in their systems. They also included a death caused by gunshot.

Eight leading scientists have studied kratom and found it to be safe. It has been used for hundreds of years without problem. It is not an opioid; it is related to the coffee plant. It does attach to the same receptors in the brain as opioids, but so do many other substances such as chocolate and milk.

I would suggest to you that the FDA wants it banned because it is cutting into Big Pharma's financial bottom line. People are finding the help they need without costly and deadly pharmaceuticals. I fear that if kratom is banned this country will see an epidemic of self-inflicted deaths by people who have no hope. Kratom would become a black market substance due to overreach by the government to protect the monies they get from pharmaceutical lobbies.

Please investigate these facts and do the right thing. Do a story on the positives of kratom.

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Do you have a story you want to share on PNN? Send it to: editor@painnewsnetwork.org.

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.

‘Radical Shift’ Predicted in Fibromyalgia Diagnosis and Treatment  

By Pat Anson, PNN Editor

New research has uncovered a previously unknown connection between fibromyalgia and the early stages of diabetes, which could dramatically change the way the chronic pain condition is diagnosed and treated.

In a small study of 23 fibromyalgia patients and two control groups, researchers at The University of Texas Medical Branch at Galveston (UTMB) were able to separate patients with fibromyalgia (FM) from healthy individuals using a common blood test for insulin resistance, or pre-diabetes. They then treated the fibromyalgia patients with a medication targeting insulin resistance (IR), which dramatically reduced their pain levels.

“Although preliminary, these findings suggest a pathogenetic relationship between FM and IR,  which may lead to a radical paradigm shift in the management of this disorder,” researchers reported in the online journal PlosOne.

Fibromyalgia is a poorly understood disorder that causes widespread body pain, fatigue, insomnia, headaches and mood swings. The cause is unknown, the symptoms are difficult to treat and there is no universally accepted way to diagnose it.

"Earlier studies discovered that insulin resistance causes dysfunction within the brain's small blood vessels. Since this issue is also present in fibromyalgia, we investigated whether insulin resistance is the missing link in this disorder," said Miguel Pappolla, MD, a professor of neurology at UTMB.

Pappolla and his colleagues found that patients with fibromyalgia can be identified by their hemoglobin A1c levels, a protein in red blood cells that reflects blood sugar levels. A1c tests are widely used to diagnose type 2 diabetes and pre-diabetes, and are routinely used in diabetes management.

Researchers say pre-diabetics with slightly elevated A1c levels carry a higher risk of developing widespread body pain, a hallmark of fibromyalgia and other chronic pain conditions.

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"Considering the extensive research on fibromyalgia, we were puzzled that prior studies had overlooked this simple connection," said Pappolla. "The main reason for this oversight is that about half of fibromyalgia patients have A1c values currently considered within the normal range.

“However, this is the first study to analyze these levels normalized for the person's age, as optimal A1c levels do vary throughout life. Adjustment for the patients' age was critical in highlighting the differences between patients and control subjects."

After identifying the fibromyalgia patients with elevated A1c levels, researchers treated them with metformin, an oral medication that manages insulin resistance by restoring normal blood sugar levels. The patients showed dramatic reductions in their pain levels, with half (8 of 16 patients) having a complete resolution of pain.

“Our data provides preliminary evidence suggesting that IR may be a pathological substratum in FM and sets the stage for future studies to confirm these initial observations. If confirmed, our findings may translate not only into a radical paradigm shift for the management of FM but may also save billions of dollars to healthcare systems around the world,” researchers reported.

Why I’m Fed Up with the Healthcare System

By Nyesha Brooks, Guest Columnist

I'm so fed up with the healthcare system. I was diagnosed a year ago with a chronic invisible illness known as fibromyalgia. I also have depression and anxiety. I was relieved to finally have a name for what I was going through.

My journey with this illness has been pure hell. I live with chronic pain every day of my life. I had to resign from my employment of 8 years because I could not bear the pain any longer.

Suicide is a BIG concern when people have fibromyalgia. I had to reach out to the crisis hotline due to feeling like nobody understood. The pain is so unbearable, constant fatigue, numbness in your body parts, and crippling back pain at times. You also get brain fog that can cause memory loss and mood swings. It’s all isolating.

While there is no cure for fibromyalgia, doctors say it’s not fatal. But if you live your life in pain every day, it will cause all kinds of health problems that can lead to death.

My issue with the doctors today is they don't listen anymore and they stereotype everyone as opioid abusers. I’ve never done drugs or abused medications in my life. Even when I'm in severe pain, I still take only what is prescribed for me. It's almost like they want you to go home and suffer.

The problem with fibromyalgia is there's no detection or extensive research on it. There’s not a lot of information out there. To the naked eye I look fine and healthy. However, that’s not my reality. I have nerve damage. When I'm home I wear something very comfortable and I'm in bed most of my day. We are very sensitive to loud sounds and light. I listen to a lot of relaxing sounds on Youtube such as the rain falling.

NYESHA BROOKS

NYESHA BROOKS

I have big help from my family that assist me throughout the day because I have limitations. I take all kinds of medications that I keep in a bag. The medication doesn't work at all. It just makes you very drowsy and increases the pain that you’re already in. Due to the opioid epidemic, we're restricted from getting the right medications.

I’ve been to the ER so many times because I get flare ups that can last all day or weeks. I'm on high blood pressure medicine due to being in severe pain. I'm telling you I don’t wish this on my worst enemy.

I have been fighting for my social security disability for a year now. I was rejected the first time and now I’m waiting on my appeal decision. It’s very upsetting because I'm a mother and I just want to take care my children.

Plan B is not even an option for me because I can't handle a day-to-day job. One task burns me out or takes me hours to do. My therapist says because I'm always stressing, I'm not going to be here to see my benefits. Today my doctor looked at me and suggested because of my age I should go back to the work world. I'm fed up. My doctor bases my reality on his research. How is research more accurate than my truth?

I met so many fibro warriors from a support group on Instagram and we all have similar stories with the healthcare system. I need help getting this awareness out because fibromyalgia matters and is real. The doctors need to take our illnesses seriously and listen. One rejection can cost a person their life. We need love, support and understanding.

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Nyesha Brooks lives in South Philadelphia.

Do you have a story you want to share on PNN? Send it to: editor@painnewsnetwork.org.

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.

1 in 5 Multiple Sclerosis Patients Misdiagnosed

By Pat Anson, PNN Editor

Nearly one in five patients who are told they have multiple sclerosis are misdiagnosed with the autoimmune disease, according to a new study of patients referred to two MS treatment centers in Los Angeles. The patients spent an average of four years being treated for MS before receiving a correct diagnosis.

MS is a chronic disease that attacks the body’s central nervous system, causing pain, numbness, difficulty walking, paralysis, loss of vision, and fatigue. The symptoms are similar to those of several other chronic conditions – including neuropathy, migraine and fibromyalgia – which often leads to a misdiagnosis.

Researchers at the Cedars-Sinai Multiple Sclerosis and Neuroimmunology Center analyzed the cases of 241 patients who had been diagnosed by other physicians and then referred to the Cedars-Sinai or UCLA MS clinics.

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Their findings, published in the journal Multiple Sclerosis and Related Disorders, indicate that 43 of the 241 patients (18%) with a previous diagnosis of MS did not meet the criteria for the disease.

"The diagnosis of MS is tricky. Both the symptoms and MRI testing results can look like other conditions, such as stroke, migraines and vitamin B12 deficiency," said lead author Marwa Kaisey, MD. "You have to rule out any other diagnoses, and it's not a perfect science."

The most common correct diagnoses was migraine (16%), radiologically isolated syndrome (RIS) (9%), spondylopathy (7%), and neuropathy (7%). RIS is a condition in which patients do not experience symptoms of MS even though their imaging tests look similar to those of MS patients.

The misdiagnosed patients received approximately 110 patient-years of unnecessary MS disease modifying drugs. Nearly half received medications that carry a known risk of developing progressive multifocal leukoencephalopathy, a potentially fatal brain infection.

"I've seen patients suffering side effects from the medication they were taking for a disease they didn't have," Kaisey said. "Meanwhile, they weren't getting treatment for what they did have. The cost to the patient is huge — medically, psychologically, financially."

The cost of disease modifying medications for an MS patient in the U.S. exceeds $50,000 a year. Investigators estimated that the unnecessary treatments identified in this study alone cost almost $10 million. 

Researchers hope the results of the study will lead to new biomarkers and improved imaging techniques to help prevent future MS misdiagnoses.

A similar study in 2016 also found that MS patients were often misdiagnosed. One third of the patients were misdiagnosed for a decade or longer, most took unnecessary and potentially harmful medication to treat a disease they didn't have, and some even participated in clinical trials for experimental MS therapies. About a third suffered from morbid thoughts of death.

Men Needed for Fibromyalgia Vaccine Study

By Pat Anson, PNN Editor

The start of a potentially groundbreaking study of a vaccine to treat fibromyalgia has been delayed because not enough men have volunteered to participate.

Massachusetts General Hospital and EpicGenetics – a Los Angeles-based  biomedical company  – received FDA approval last year to enroll 300 fibromyalgia patients in a placebo controlled Phase 2 study to see if the bacillus Calmette-Guérin (BCG) vaccine can be an effective treatment for fibromyalgia. Volunteers must first test positive for fibromyalgia after taking a diagnostic blood test developed by EpicGenetics.  

Half the volunteers will receive injections of the BCG vaccine every 12 months, while the other half will receive placebo injections. The 3-year study was initially projected to begin January first, but has yet to get underway.

“One of the problems we’re having is that the vast majority of the people who have taken the blood test are women aged 50 and above,” said Bruce Gillis, MD, the CEO and founder of EpicGenetics. “We really need more diversity. So we are pushing hard to find more men and more younger people to test.

“We’re still hoping to start this year. But we’re hoping for more diversity in the patients.”

Fibromyalgia is a poorly understood disorder that causes widespread body pain, fatigue, insomnia, headaches and mood swings. The cause is unknown, there is no cure and the symptoms are difficult to manage. Between 75 and 90 percent of the people who have fibromyalgia are women.

The BCG vaccine has been used for over 80 years to prevent tuberculosis and meningitis in children. Gillis believes the same vaccine can be used in adults to stimulate the immune system and reverse symptoms of fibromyalgia.

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“When BCG has been administered in other chronic illnesses, it has triggered the immune system’s stem cells to change their behavior. And in our case, we believe that should allow for the production of healthier peripheral blood mono-nuclear cells -- the white blood cells that we find to be impacted in fibromyalgia,” Gillis told PNN.

“The expectation is that when the patient receives the BCG there is a stimulus to change stem cells and white blood cell production to produce healthier cells.  And as a consequence, their fibromyalgia should be reversible.”

EpicGenetics’ FM/a blood test for fibromyalgia was first introduced in 2012 and is now covered by Medicare and most insurance companies. The cash cost for patients without insurance is $1,080. If the BCG vaccine proves effective, Gillis says the vaccine will be provided at no cost to patients who test positive for fibromyalgia.

Anyone interested in participating in the study at Massachusetts General Hospital should send an email to fmtest@epicgtx.com.

“We need patients from age 18 to 80 plus. And we need more men. I don’t think I’ll ever get an equivalent number of men as I will women, but I need more than just a handful of men,” says Gillis.

Study: Alcohol Relieves Fibromyalgia Pain

By Pat Anson, PNN Editor

Another study is adding to a growing body of evidence that alcohol is an effective – yet risky – way to treat chronic pain.

Researchers at the University of Michigan surveyed over 2,500 patients being treated at a university pain clinic about their drinking habits, pain severity and physical function. Participants were also assessed for signs of depression and anxiety. About a third of the patients were diagnosed with fibromyalgia (FM), a poorly understood disorder characterized by widespread body pain, fatigue, insomnia, headaches and mood swings.

Researchers, who recently published their study in the journal Pain Medicine, found that patients who were moderate drinkers had less pain and other symptoms than those who did not drink alcohol.

“Female and male chronic pain patients who drink no more than 7 and 14 alcoholic drinks per week, respectively, reported significantly lower FM symptoms, pain severity, pain-related interference in activities, depression, anxiety and catastrophizing, and higher physical function,” said lead author Ryan Scott, MPH, of UM’s Chronic Pain and Fatigue Research Center.

“These findings suggest that chronic pain patients with a lesser degree of pain centralization may benefit most from low-risk, moderate alcohol consumption.”

According to the Mayo Clinic, moderate alcohol consumption for healthy adults means up to one drink a day for women of all ages and men older than age 65, and up to two drinks a day for men age 65 and younger.

Of the study participants, over half reported use of opioid medication, which carries serious risks when combined with alcohol. Perhaps for that reason, participants in the UM study drank less alcohol than the general population.

“People with chronic pain may drink less due to the stigma and because they are being told not to drink while on pain medication,” says Scott.

Moderate drinkers with chronic pain were more likely to be white, have an advanced degree and were less likely to use opioids. They reported less pain, lower anxiety and depression, and higher physical function.

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Researchers found that fibromyalgia patients who drank moderately reported decreased pain severity and depression, but alcohol had no effect on how widespread their pain was or other symptoms such as cramps, headache, fatigue, poor sleep and cognitive dysfunction.

Scott believes alcohol may stimulate the production of gamma-aminobutyric acid (GABA), a neurotransmitter in the central nervous system that reduces nerve activity. Alcohol and drugs such as gabapentin (Neurontin) that act on GABA typically have relaxing effects.

“Alcohol increases gamma-aminobutyric acid in the brain, which is why we could be seeing some of the psychiatric effects. Even though alcohol helped some fibromyalgia patients, it didn’t have the same level of effect,” said Scott. “You probably need much more GABA to block pain signals and that may be why we’re not seeing as high an effect in these patients.”

Over a dozen previous studies have also found that alcohol is an effective pain reliever. In a 2017 review published in the Journal of Pain, British researchers found “robust evidence” that alcohol acts as an analgesic.

“It could be a stepping stone to increased quality of life, leading to more social interactions,” says Scott. “Fibromyalgia patients in particular have a lot of psychological trauma, anxiety and catastrophizing, and allowing for the occasional drink might increase social habits and overall health.”

Ambroxol: A Potential New Treatment for Chronic Pain

By A Rahman Ford, PNN Columnist

Researchers say a drug long used in cough syrup and cold medicines shows potential for treating some types of neuropathic pain.

A small study recently published in the journal Headache found that topical administration of ambroxol in a cream could significantly decrease pain in patients with trigeminal neuralgia, a chronic facial condition that can make even routine tasks such as brushing one’s teeth excruciatingly painful. 

In their review of the medical records of five trigeminal neuralgia patients, German researchers reported that all five patients experienced pain reduction with ambroxol 20% cream being applied within 30 minutes of a pain flare, with pain relief lasting from 4 to 6 hours.  In one case, pain was eliminated completely in one week.  

The results were similar to those of previous German studies and were so significant that researchers recommended that ambroxol “should be investigated further as a matter of urgency.”

Similarly, a recent study in the journal Pain Management found that application of topical ambroxol reduced spontaneous pain in several patients with complex regional pain syndrome (CRPS), a little understood nerve condition that causes chronic pain after a significant injury or surgery.  Notably, ambroxol therapy improved several other neuropathy-related conditions in CRPS patients, including edema, allodynia, hyperalgesia, skin reddening, motor dysfunction and skin temperature.

An Old Drug with a New Purpose

With a pharmacological history that can be traced back to Indian ayurvedic medicine, ambroxol was initially approved in 1978 as a medication to break down mucus and make it easier to eliminate by coughing.  It is generally administered in tablet or syrup form. 

Ambroxol is also used to treat a sore throat associated with pharyngitis, thus its potential role as a potent local anesthetic.  The drug’s anesthetic properties stem from its ability to block sodium and calcium channels that transmit pain signals.

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Although the idea that ambroxol can treat a sore throat is widely accepted, its application to other forms of pain is more recent.  

Previous studies using animal models of neuropathic pain have been promising.  In a 2005 study, researchers effectively reduced – and in some cases eliminated – chronic neuropathic and inflammatory pain in rats. Indian researchers also found ambroxol effective in treating neuropathic pain in rats, attributing its success to its antioxidative and anti-inflammatory properties.  Unfortunately, human studies are few at this point.

Ambroxol and Fibromyalgia

A 2017 Clinical Rheumatology study showed that ambroxol can play a key role in treating chronic pain associated with fibromyalgia.  As reported by Fibromyalgia News Today, researchers from Mexico added ambroxol to the treatment regimens of 25 fibromyalgia patients, three times a day for one month.  At the end of the study, pain scores decreased significantly and there was also noticeable improvement in sleep disturbances, stiffness and autonomic nervous system dysfunction.  No major adverse events were reported. 

Another 2017 study supported these findings, with the authors concluding that “fibromyalgia treatment with ambroxol should be systematically investigated” because the drug “is the only treatment option used thus far that has the potential to address not just individual but all of the aforementioned aspects of pain.”

Although data on its effectiveness in humans are limited, ambroxol shows great potential in treating painful conditions for which there are currently few safe and effective options.  It is particularly attractive because it has few significant side effects, is not addictive and can be administered topically in some instances.

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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. He earned his PhD at the University of Pennsylvania.

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

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It 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.

Study Finds Naltrexone Has No Serious Side Effects

By Pat Anson, PNN Editor

A generic drug increasingly used off-label to treat fibromyalgia and other chronic pain conditions is safe to use and more clinical studies are needed on its potential uses, according to British researchers.

Naltrexone is primarily used to treat alcoholism and opioid addiction, but many patients have discovered that low doses of naltrexone (LDN) are effective in relieving pain and other symptoms.

Many doctors won’t prescribe naltrexone, often citing liver toxicity as a reason. But when researchers at The University of Manchester reviewed 89 placebo-controlled studies of naltrexone involving over 11,000 patients, they found no evidence of any serious side effects.

"Though naltrexone is licensed for the treatment of alcohol addiction, it remains underutilized,” says lead author Monica Bolton, PhD, who reported her findings in the journal BMC Medicine. "And that has devastating consequences for individuals, health and social services in the UK and around the world.

"It is cost effective and could reduce deaths."

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“Our review also shows that fears over side-effects are unfounded," said co-author Alex Hodkinson, Phd. "Like all drugs for alcohol addiction, the chaotic nature of being an addict means this drug is simply not prescribed as much as it should be,”

Naltrexone does cause minor side effects in some patients, such as nausea and dizziness, and because it is an opioid antagonist the drug should not be taken with opioid medication.

The fact that naltrexone is generic and inexpensive is one reason the drug is not more widely prescribed. There is little incentive for pharmaceutical companies to market naltrexone or to conduct expensive clinical trials to prove its effectiveness in treating pain.

"As it is safe, cheap and long out of patent, naltrexone would seem an excellent candidate for repurposing for a whole range of conditions,” says Bolton. "That is why it is imperative to find ways to fund clinical trials to test if it might one day be possible to license it.

"The problem is, it is extremely difficult to repurpose existing drugs - and naltrexone is just one example of many wasted opportunities to treat people and save the NHS money."

Of the 89 naltrexone trials included in the Manchester University study, only 3 dealt with chronic pain conditions.

Anecdotal evidence suggests that at very low doses of 5 mg or less, naltrexone may be able to treat a range of immune-modulated conditions including Crohn's disease, HIV, multiple sclerosis, fibromyalgia and Chronic Fatigue Syndrome (ME/CFS).

In a PNN guest column, Marelle Reid shared her experience using LDN to treat Interstitial Cystitis, while Janice Hollander said LDN “completely changed my life” when she started taking it for fibromyalgia.

Patients interested in trying LDN often encounter doctors who refuse to prescribe it. The LDN Research Trust includes a list of LDN-friendly doctors and pharmacies on its website.