Muscle Relaxants Ineffective for Low Back Pain and Fibromyalgia

By Pat Anson

Muscle relaxants are increasingly prescribed “off label” as an alternative to opioid medication, but according to a new analysis they are no more effective than a placebo in treating fibromyalgia and low back pain. They may be beneficial, however, for patients suffering from muscle cramps, neck pain and trigeminal neuralgia.

Researchers reviewed 44 studies involving nearly 2,500 patients who were prescribed a muscle relaxant for various pain conditions. Nine skeletal muscle relaxants (SMRs) were assessed, drugs that were initially developed and then approved by the FDA as anti-spasticity and anti-spasmodic medications:

• Carisoprodol (Soma)

• Baclofen

• Tizanidine

• Cyclobenzaprine

• Eperisone

• Quinine

• Orphenadrine

• Chlormezanone

• Methocarbamol

Despite a lack of evidence on their effectiveness beyond 3 weeks, prescribing of SMRs doubled between 2005 and 2016, with office visits for refills of SMR prescriptions tripling over the same period, indicating they were increasingly being used long-term and off-label. According to a 2021 study, over a third of patients prescribed SMRs did not have a musculoskeletal disorder, a sign of “unnecessary or inappropriate use.”

Researchers involved in the current study, published in JAMA Network Open, reached a similar conclusion that muscle relaxants are overprescribed.

“Despite increasing prevalence and increasing risks of their use, our systematic review suggests only limited evidence of efficacy for long-term use of SMRs for a small subset of pain syndromes,” wrote lead author Benjamin Oldfield, MD, an Assistant Clinical Professor of Internal Medicine at Yale School of Medicine.

“Evidence for effectiveness was strongest for SMRs used for muscle spasms, painful cramps, and neck pain; in studies of SMRs for fibromyalgia, low back pain, headaches, and other syndromes, some showed small benefits and some did not, and on balance studies did not suggest a benefit.”

Oldfield and his colleagues say physicians should consider deprescribing SMRs to pain patients who have been using them long-term without apparent benefit.   

Adverse side effects from SMRs include sedation, somnolence, dizziness and dry mouth. The FDA also warns against taking the drugs with opioids, which could raise the risk of respiratory depression and overdose.

SMRs also increase the risk of falls, fractures, and vehicle crashes. Because of those risks, muscle relaxants should be avoided altogether in elderly patients, according to the American Geriatrics Society.

Can a Smartphone App Relieve Fibromyalgia Symptoms?

By Pat Anson

It was a little over a year ago that the FDA authorized the marketing of the first smartphone app designed specifically to treat fibromyalgia. The Stanza app uses a form of cognitive behavioral therapy (CBT) to help patients improve their quality of life by lessening the pain, anxiety, fatigue and depression that often come with fibromyalgia.

New findings from a placebo-controlled Phase 3 study, recently published in the The Lancet, helped demonstrate Stanza’s potential benefits.  

“This novel, non-drug therapy, available using a smartphone, makes management of fibromyalgia more accessible and convenient. This offers new hope for people with fibromyalgia, who have continued to experience unmet treatment needs,” says lead investigator Lesley Arnold, MD, an Associate Professor of Psychiatry at the University of Cincinnati College of Medicine.

Arnold and her colleagues enrolled 275 fibromyalgia patients in a 12-week trial, with half randomly assigned to receive Stanza treatment and the other half serving as a control group. Participants were allowed to continue taking medications and any other therapies they were using before the study.

Fibromyalgia is a difficult condition to diagnose and treat, because it comes with a wide array of symptoms such as widespread body pain, headaches, fatigue, insomnia, brain fog and mood disorders. The FDA has approved only three medications for fibromyalgia -- duloxetine (Cymbalta), milnacipran (Savella), and pregabalin (Lyrica) – but many patients consider the drugs ineffective or have too many side effects.

Stanza uses a form of CBT called Acceptance and Commitment Therapy (ACT) to teach patients psychological skills to help lessen the impact of fibromyalgia on their lives. A daily 15–20-minute session includes ACT lessons on deep breathing, mindfulness and other self-management skills.   

The effectiveness of Stanza was measured by the patients themselves, through a self-assessment test known as Patient Global Impression in Change (PGIC), in which participants described changes in their overall well-being.  

After 12 weeks, over 70% of participants in the Stanza group had improvements in their PGIC score, compared to 22% in the control group. Stanza participants also had more significant improvement in their pain intensity, physical function, fatigue, sleep and depression. No adverse events were observed either group.

It’s important to note the research was funded by Swing Therapeutics, the maker of Stanza, which calls it largest study ever conducted of a medical device for fibromyalgia.

“Fibromyalgia options are typically limited to a handful of pharmacological interventions that have limited efficacy and that can come with difficult-to-manage side effects,” says Mike Rosenbluth, CEO of Swing. “This publication validates Stanza as a guideline-directed non-drug approach that many patients previously couldn’t access due to few available trained clinicians, geographic limitations and cost.

Stanza is intended for use five to seven days per week, for a standard treatment period of 12 weeks. After that, Stanza can be used as needed. Previous studies have found that improvements in fibromyalgia symptoms can last up to 12 months after Stanza therapy.

Although it’s a self-guided app, Stanza requires a prescription and the supervision of a medical professional trained in its use.  Currently, Stanza clinicians are only available in the states of Illinois, Michigan, Missouri, Nevada, Ohio, Pennsylvania, Tennessee and Texas.  Medicare Part B and some private insurers cover Stanza treatment.  

Study Finds Low-Dose Naltrexone Works No Better than Placebo

By Pat Anson, PNN Editor

In recent years, low-dose naltrexone (LDN) has grown in popularity as a treatment for fibromyalgia and other chronic pain conditions. Although naltrexone is only FDA-approved for the treatment of substance use disorders, a growing number of patients and providers say low doses of naltrexone prescribed off-label can be effective in relieving pain.

A new study by Danish researchers is casting doubt on the some of those claims, finding that LDN works no better than a placebo in reducing pain for women with fibromyalgia. In their double-blind, placebo-controlled study, 99 adult women with fibromyalgia were randomly assigned to receive either an LDN pill or an identical-looking placebo daily for 12 weeks.

The study findings, recently published The Lancet Rheumatology, found a minor improvement in pain intensity for the LDN group, with a similar pain reduction in the placebo group. There were no serious adverse events in either group.

“This study did not show that treatment with low-dose naltrexone was superior to placebo in relieving pain. Our results indicate that low-dose naltrexone might improve memory problems associated with fibromyalgia, and we suggest that future trials investigate this further,” wrote lead author Karin Due Bruun, MD, a researcher in the Pain Center at Odense University Hospital in Denmark.

The Danish study is notable, because placebo-controlled, double-blind studies are considered the gold standard in medical research. Until now, much of the evidence about LDN has been anecdotal or low quality.

In a 2020 review of nearly 800 LDN studies, another research team could find only eight that were high quality enough to meet their criteria for evaluation. Nevertheless, they found that LDN “provides an alternative in medical management of chronic pain disorders.”

A 2019 review by British researchers also found that LDN is safe to use, but recommended that more clinical studies be conducted.

How naltrexone works is not exactly clear. LDN supporters believe the drug modulates the immune system, reduces inflammation and stimulates the production of endorphins, the body's natural painkiller.

In 50mg doses, naltrexone blocks opioid receptors in the brain and decreases the desire to take opiates or alcohol. But in smaller doses of 5mg or less, patients have found LDN to be an effective pain reliever. PNN columnists have shared their positive experiences using LDN to treat everything from interstitial cystitis to Ehlers-Danlos syndrome to fibromyalgia.  

A woman with fibromyalgia tried all sorts of FDA-approved medications to relieve her leg pain, brain fog and depression. None worked, until she tried LDN.   

“After about seven days, my pain lessened,” said Janice Hollander. “[LDN] has completely changed my life. I don’t know that I would be here today if it wasn’t for it. I don’t think I could go for another year in the misery I was in.” 

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

Patients interested in trying LDN often encounter doctors who won’t prescribe it off-label. The LDN Research Trust includes a list of LDN-friendly doctors and pharmacies on its website.

My Story: How I Was Medically Gaslighted

By Preslee Marshall, Guest Columnist

I remember the first time I experienced what felt like an electric shock sensation. It was a sudden zap out of nowhere, and I wasn’t sure what to make of it. 

It started happening about once a month, then turned into once every two weeks. Before I knew it, this painful experience was happening several times a day with no apparent explanation. 

Recognizing that the pain I was feeling wasn’t normal, I went to a walk-in clinic to get answers. 

I went over my symptoms with a doctor and was told, “It’s probably just fibromyalgia. Do Tai Chi, it should help with that.”  

Confused, I asked the doctor to spell out what fibromyalgia was, as I hadn’t heard of it before. The way it was brushed off with “do Tai Chi,” I figured it couldn’t be too serious. 

Finding information online about fibromyalgia didn’t take much time or effort. This chronic disorder causes pain and tenderness throughout the body, fatigue and trouble sleeping. One thing that stood out to me was how some people with fibromyalgia wind up on disability.  

On the one hand, I could see the seriousness of fibromyalgia and how it can change people's lives. But on the other hand, I’m told to “do Tai Chi” with no official diagnosis or test.

What if the doctor was wrong? 

PRESLEE MARSHALL

I decided to contact another medical professional about my symptoms and to get testing done to rule out other possible conditions. I called my family doctor (sweet lady, but her office is too far from me) and told her what was happening. She brought up a few ideas on what she thinks could be the problem, such as multiple sclerosis or fibromyalgia, and sent in a referral for me to see a neurologist, which was a 6-month wait.  

As my pain worsened, I knew I couldn’t wait six months, so I called the walk-in clinic again and said that if it was fibromyalgia, then I should be sent for testing to determine that. I begged for an MRI test to rule out other illnesses, which I thought would help tremendously. I knew I needed to get referred as soon as possible if I wanted answers. 

The clinic assured me that the neurologist would send me for those tests anyway, and that there was no point in doing it now. In my heart, I knew that it wouldn’t be that easy. It took some convincing, but the clinic finally agreed to send the referral for an MRI.  

‘Get Your Nails Done’ 

After a long wait, it was finally time to see the neurologist, who I thought would solve my problems. I was wrong.  

The first question I was asked was if I had anxiety. After answering yes, I could tell that he was sold on that being the problem.  I’ve struggled with social anxiety for as long as I remember. I knew that this was not the case and said that to him.  

“It’s all in your head,” he said at the end of the appointment. “If you get your nails done, you’ll feel better.”  

I was shocked and devastated. I walked into the lobby, went straight to the bathroom, and cried. I knew the pain was real, but felt hopeless, wiping away my tears to head home.  

That same month, just to prove to myself that I didn’t imagine my symptoms, I got a manicure, pedicure, massage and facial. And I still felt awful! I needed to prove to the doctor that he was wrong. I had my upcoming MRI to look forward to. 

The day came and I got the MRI. The imaging test ruled out multiple sclerosis as a possibility, as well as other conditions. I brought those results back to my family doctor, who referred me to a rheumatologist.  

After seeing the MRI results, asking me a few questions, and giving me a pressure point test, the rheumatologist diagnosed me with fibromyalgia. At that point, it had been over a year and a half since I started noticing the symptoms. I felt grateful to finally have a diagnosis. 

Word of the Year 

After such a long ordeal and less-than-ideal treatment by medical professionals, I’m on a mission to raise awareness about medical gaslighting. 

Merriam-Webster, the oldest dictionary publisher in the United States, recently picked "gaslighting" as its word of the year. There are different forms of gaslighting, which Merriam-Webster defines this way: 

“Psychological manipulation of a person… that causes the victim to question the validity of their own thoughts, perception of reality, or memories and typically leads to confusion, loss of confidence and self-esteem, uncertainty of one's emotional or mental stability, and a dependency on the perpetrator.” 

Medical gaslighting is when a healthcare provider makes a patient feel as though their perception of their own symptoms is false. A common phrase being, “It’s all in your head.” 

In my case, it was “do Tai Chi” and “get your nails done.”  

After suffering for well over a year and having medical professionals dismiss my symptoms, I realized that it was up to me to get myself properly diagnosed. 

I’d like to remind others who are struggling not to give up. It can feel like an impossible never-ending situation, but there are people in the medical field who will listen. 

Preslee Marshall, 25, is from Winnipeg, Manitoba. When she’s not busy managing her business, Preslee is traveling the world and unlocking new opportunities for her future. 

Do you have a “My Story” to share? Pain News Network invites other readers to share their experiences about living with pain and treating it. Send your stories to editor@painnewsnetwork.org.

Fibromyalgia: Often Ignored and Poorly Treated

By Victoria Reed, PNN Columnist

Up until about 10 years ago, I had never heard of fibromyalgia. But during a routine medical visit, my doctor recognized symptoms that I described as possibly being signs of fibromyalgia. After an in-depth exam and other testing, a diagnosis of fibromyalgia was made.

Fibromyalgia is a complex disorder which causes widespread musculoskeletal pain, fatigue, sleep and memory issues. Symptoms can begin after a traumatic injury, surgery or infection. It sometimes takes many years to receive a diagnosis, and there is currently no cure.

People like me with autoimmune disorders, such as rheumatoid arthritis or lupus, often suffer from fibromyalgia. It is more common in women than men. The disorder can be accompanied by headaches, irritable bowel syndrome, anxiety and depression. Many fibromyalgia patients also complain of “fibro fog,” which impairs the ability to focus, pay attention and concentrate on mental tasks.

Fibromyalgia seems to run in families. I have multiple family members with the condition, spanning at least three generations. My mother had symptoms of fibromyalgia, but unfortunately never received a diagnosis.

Many experts agree that the key mechanism behind fibromyalgia is central sensitization, which causes the brain and spinal cord to become hypersensitive to pain signals. Pain will be amplified and linger well beyond the initial injury. The hypersensitivity can also affect other senses, leading to discomfort with strong scents or chemicals, bright lights and sounds. Being in loud, crowded spaces can create an overwhelming experience for fibromyalgia sufferers. 

Unfortunately, fibromyalgia is still a somewhat controversial diagnosis, because it is not yet fully understood and its symptoms can overlap with many other conditions. Some people even say that it’s a “garbage can” diagnosis that’s only given when no other one can be made. Many old school doctors believe that fibromyalgia is not a real condition, which is why it can often take years to receive a proper diagnosis.

However, recent research has discovered that there are differences in the brains of fibromyalgia patients. One important discovery is that of neuro-inflammation, which, simply put, is inflammation in certain regions of the brain. This research, documented by PET scans, does confirm inflammatory mechanisms in the brains of fibromyalgia patients and is a major step forward in trying to understand and treat it. It also helps to validate the existence of the condition itself.  

People with fibromyalgia are sometimes not taken seriously by their own doctors and denied appropriate pain management. Many are also denied disability payments as well. I know from experience that the condition can be terribly painful, with deep muscle aches and sore tender spots all over the body.

I have not had success with any of the traditionally prescribed drugs, such as Lyrica (pregabalin), an anticonvulsant that’s also used to treat nerve pain and seizures. While I’ve had some success with a high-quality CBD oil and various CBD creams, it is my prescribed pain medication, in combination with acetaminophen, that gives me the most pain relief.

Unfortunately, some fibromyalgia patients encounter roadblocks in finding a physician who is willing to prescribe pain medication if the only condition they have is fibromyalgia. This definitely needs to change! Fibromyalgia patients are worthy of treatment whether they have other pain conditions or not. The current anti-opioid climate continues to cause patients to suffer needlessly.

If you feel that you may be suffering from fibromyalgia, don’t be afraid to push, push and push for a diagnosis! If your doctor is not willing to help you, look for another doctor and don’t stop until you find one that takes your symptoms seriously. Research all you can on the condition and learn what you can do to help yourself.

Even though it might be difficult to exercise due to the fatigue that fibromyalgia causes, start by adding a little walking to your daily routine, even if it’s just 5 or 10 minutes. Exercise is good for your overall health and well-being, and it can help improve your mood. Being completely sedentary will only make things worse.

Regular massage is sometimes prescribed as well. If you can’t afford a professional massage, you can get a prescription for a therapeutic/medical massage, which will be a little cheaper. You can also purchase one of those self-massage sticks that can be found at sporting goods stores. I have found these things to be helpful to manage my symptoms.

I also suggest joining an online support group. There are many, many people suffering from fibromyalgia, and in these groups you can connect with people around the world, make some new friends, and learn about treatments that work for others.

Living with fibromyalgia is not easy, but it doesn’t have to be a hopeless situation either. If more doctors would take the condition seriously, make a timely diagnosis and provide appropriate treatment, perhaps there would be less suffering for those of us with fibromyalgia.

Victoria Reed lives in northeast Ohio. She suffers from endometriosis, fibromyalgia, degenerative disc disease and rheumatoid arthritis. 

No One Deserves to Suffer from Chronic Pain

By Victoria Reed, PNN Columnist

Recently I had a conversation with a family member who suffers from chronic pain. He said that he “deserves” the pain, because it resulted from certain actions and choices he made as a young person. He went on to say that my chronic pain isn’t “fair” because I did nothing to cause it.

I was astonished that he would actually feel that way. Does anyone really deserve to live a life with chronic pain? Surely, not!

He’s right in saying that I did not do anything to cause my pain. I just happen to have genetics that contribute to the development of certain illnesses, particularly the autoimmune kind. This runs strongly in my family. My sisters have multiple autoimmune illnesses, including rheumatoid arthritis (RA), lupus, type 1 diabetes and fibromyalgia. My mother suffered from untreated fibromyalgia as well. In addition, my daughter has been diagnosed with fibromyalgia.

Obviously, none of us did anything to cause our illnesses, nor the pain that comes from having them.

While this particular family member may have made some questionable choices as a teen that caused injuries and persistent pain well into adulthood, he doesn’t deserve chronic pain. It’s not uncommon for teen boys to engage in risky behavior, and I’ve told him that his pain is no less important and no more deserved than mine. 

While there can be many, many causes of chronic pain, compassion must be given to each and every patient, regardless of the cause. Life happens! Whether it’s the result of a genetic-based illness, an automobile crash or some other accident or injury, no one deserves to live in pain. Even if the incident that caused your pain was due to your own negligence or carelessness, it is still valid pain, and treatment is as justified as it is for any illness.   

RA Drug Shortage Continues 

On the flip side, I have been experiencing continued difficulty getting my RA medication. Actemra (tocilizumab) is a biologic drug that was created specifically to treat RA, and the IV form has been my mainstay treatment for many years. However, there is still a worldwide shortage of Actemra because it’s been repurposed to treat covid patients. According to a statement by Genentech, the drug’s manufacturer, there will most likely be continued shortages throughout the pandemic.  

At one point during the summer of 2021, Genentech reported a “temporary stockout” of Actemra IV in the U.S. because so much of it was being used for covid patients. During that time, I was forced to switch to a different form of treatment. But even after switching to a subcutaneous self-injection, whenever I attempted to refill my prescription, my pharmacy informed me that the medication is “long-term out of stock.”  

This formulation was not approved by the FDA’s Emergency Use Authorization to treat covid, but it appears that it is indeed being used for that purpose and is frequently unavailable to RA patients. To say that this is frustrating would be an understatement!  

While covid is no doubt a serious illness, untreated RA with its systemic inflammation is also very serious. This runaway inflammation can, and often does, do damage to the heart, lungs and eyes. Untreated and poorly treated RA is also associated with a 10 to 15 year decrease in life expectancy.   

It’s understandable why doctors are currently experimenting with older, established medications to treat covid.  Fortunately, researchers have discovered that some of these older medications have been helpful and do decrease the severity of the virus. However, existing users of any particular medication shouldn’t lose access or have their necessary prescriptions significantly delayed. RA patients are no less important than covid patients.  

Chronic illness is a common problem that affects millions of people worldwide. But depending on where you live and what your condition is, you may not receive the same level of treatment and may not be taken as seriously as you’d like. No longstanding pain should be ignored, as untreated and under-treated pain will undoubtedly lead to other problems, such as depression, anxiety and even suicide. The risk of suicide also increases when patients are forced to taper off of opioids.  

The one thing that we all have in common is that we are human beings, and no matter what the chronic pain condition is, everyone deserves to be treated humanely and compassionately, just as any animal in pain would be. Nobody ever “deserves” to suffer. 

Victoria Reed lives in Cleveland, Ohio. She suffers from endometriosis, fibromyalgia, degenerative disc disease and rheumatoid arthritis. 

A Third of Long Haulers Have ‘FibroCOVID’

By Pat Anson, PNN Editor

Nearly a third of patients with long-haul covid have symptoms strikingly similar to fibromyalgia, according to a new study by Italian researchers who say being male and obese are strong risk factors for developing “FibroCOVID.”  

“In the light of the overwhelming numbers of the SARS-CoV-2 pandemic, it is reasonable to forecast that rheumatologists will face up with a sharp rise of cases of a new entity that we defined (as) ‘FibroCOVID’ to underline potential peculiarities and differences,” wrote lead author Francesco Ursini, MD, an Associate Professor of Rheumatology at the University of Bologna.

The study findings, published online in RMD Open: Rheumatic & Musculoskeletal Diseases, are based on a survey of over 600 patients with post-acute COVID-19 – also known as "long COVID."

Nearly 31% of the long-haulers had musculoskeletal pain, fatigue, cognitive impairment and sleep disturbances – classic symptoms of fibromyalgia, as defined by the American College of Rheumatology.

Unlike traditional fibromyalgia, which primarily affects women, a higher percentage of men (43%) had symptoms of FibroCOVID. They were also more likely to be obese, have high blood pressure, and a severe COVID-19 infection.

“Globally, respondents with FM (fibromyalgia) exhibited features suggestive of a more serious form of COVID-19, including a higher rate of hospitalisation and more frequent treatment with supplemental oxygen,” Ursini and his colleagues reported. “Taken together, our data suggest a speculative mechanism in which obesity and male gender synergistically affect the severity of COVID-19 that, in turn, may rebound on the risk of developing post-COVID-19 FM syndrome and determine its severity.”

The long-term effects of a COVID-19 infection are currently unknown. While some patients have minor symptoms and recover quickly, about a third will develop long COVID and have symptoms that persist for several months after the initial infection.  

Previous studies of long-haul covid have also found similarities with autoimmune conditions such as lupus and myalgic encephalomyelitis, also known as chronic fatigue syndrome (ME/CFS).  

Vaccines Cut Risk of Long Covid

Being fully vaccinated against COVID-19 cuts the risk of developing long covid in half, according to a new UK study. Researchers at King’s College London looked at health data from a mobile app used by millions of people in the UK and found that those who received two doses of the Moderna, Pfizer or AstraZeneca vaccines had significantly lower risk of a “breakthrough” infection that turns into long covid.

“We found that the odds of having symptoms for 28 days or more after post-vaccination infection were approximately halved by having two vaccine doses. This result suggests that the risk of long COVID is reduced in individuals who have received double vaccination, when additionally considering the already documented reduced risk of infection overall,” researchers reported in the journal The Lancet Infectious Diseases.

“Almost all individual symptoms of COVID-19 were less common in vaccinated versus unvaccinated participants, and more people in the vaccinated than in the unvaccinated groups were completely asymptomatic.”

Fully vaccinated.people aged 60 or older were more likely to have no symptoms of a breakthrough infection, according to researchers.

Fibromyalgia Patients Needed for Online Therapy Study

By Pat Anson, PNN Editor

A digital therapeutics company is looking for volunteers to participate in a clinical trial to see if smartphone-based therapy can improve symptoms of fibromyalgia.

Swing Therapeutics recently announced that its acceptance and commitment therapy program (ACT), a form of cognitive behavioral therapy (CBT), has received Breakthrough Device Designation from the Food and Drug Administration. CBT is a form of psychotherapy, in which patients are encouraged to reduce unhelpful thinking and behavior.

“Currently, most people living with chronic pain conditions like fibromyalgia are offered medications and some suggestions for modifying their lifestyle. Behavioral therapies have evidence supporting their effectiveness for pain management, but are not widely available or easily accessed by the average individual,” said David Williams, PhD, Associate Director of Chronic Pain and Fatigue Research Center at the University of Michigan, who is an advisor to Swing Therapeutics.

The company says a pilot study of its online therapy program has shown promise in managing fibromyalgia, a poorly understood disorder characterized by widespread body pain, fatigue, poor sleep and depression. The self-guided daily program includes interactive lessons and exercises designed to help fibromyalgia sufferers understand, accept and manage their symptoms. The core program lasts 12 weeks, followed by a maintenance phase for extended use.

Swing is looking for 500 participants in the U.S. who are at least 22 years of age and have a diagnosis of fibromyalgia. The digital therapy program can be conducted at home, with no in-person medical visits or medications required.  Participants will receive compensation after completing surveys at the end of the 12-week program. Click here to learn more about the study.

“Our team is committed to creating valuable digital therapies and demonstrating strong clinical evidence to support their use. The results of our initial studies are encouraging, and with the support of the FDA, we look forward to optimizing the product as we advance through our pivotal trial,” said Mike Rosenbluth, PhD, founder and CEO of Swing Therapeutics.

The FDA has approved only three drugs to treat fibromyalgia: the antidepressants duloxetine (Cymbalta) and milnacipran (Savella), and the anti-seizure medication pregabalin (Lyrica). Many patients say the drugs are ineffective and have side effects. A recent analysis found little evidence to support the long-term use of any medication or therapy to treat fibromyalgia.

Can Psychedelics Be Used to Treat Fibromyalgia?

By Pat Anson, PNN Editor

A startup pharmaceutical company has announced plans for a clinical trial to see if a psychedelic compound may be useful in treating fibromyalgia.

California-based Tryp Therapeutics is partnering with scientists at the Chronic Pain & Fatigue Research Center at University of Michigan Medical School for the Phase 2a study, which would be the first to evaluate the effictiveness of psilocybin – the psychoactive compound in “magic mushrooms” -- in treating fibromyalgia.

"We are thrilled to collaborate with such forward-looking clinicians and scientists to develop additional treatment options for fibromyalgia," Jim Gilligan, PhD, Tryp’s President and Chief Science Officer said in a statement.

"The Chronic Pain & Fatigue Research Center at the University of Michigan brings incomparable experience with evaluating treatments for fibromyalgia and other chronic pain indications, and there is nothing more important to our collective team than creating therapies that will address the daily distress of these patients."

The study will evaluate the safety and efficacy of TRYP-8802, an oral formulation of synthetic psilocybin developed by Tryp. The treatment, which will also include psychotherapy, is designed to target pain through neuroplasticity, which alters and reorganizes neural networks in the brain.

Fibromyalgia is a poorly understood disorder characterized by widespread body pain, fatigue, poor sleep, anxiety and depression. Standard treatments for fibromyalgia, such as non-steroidal anti-inflammatory drugs (NSAIDs) and gabapentinoids (Lyrica, Neurontin), often prove to be ineffective or have unwelcome side effects.

"Existing treatment options for fibromyalgia are often ineffective and show significant side effects," said Daniel Clauw, MD, Director of the Chronic Pain & Fatigue Research Center.

Tryp plans to submit an Investigational New Drug application to the FDA for the Phase 2 trial in September. Phase 2 studies typically involve a few hundred people with a disease or condition, and are designed to test the safety and efficacy of a treatment.  A much larger Phase 3 study is usually required before the FDA will even consider approval.

Interest in using psychedelics to treat medical conditions has been growing in recent years, primarily as a way to treat depression, anxiety and other mental health issues. Preliminary research suggests that microdoses of LSD, psilocybin and other psychedelics may also be effective in treating pain.

Another pharmaceutical startup – Mind Medicine (MindMed) – recently announced plans to  investigate LSD as a treatment for cluster headache and an unnamed “common, often debilitating, chronic pain syndrome.”

Tryp Therapeutics is focused on developing psilocybin-based compounds for the treatment of diseases with unmet medical needs. The company recently announced a partnership with the University of Michigan to study synthetic psilocybin as a treatment for neuropsychiatric disorders. Tryp is also working with the University of Florida to investigate psilocybin as a treatment for eating disorders.

LSD, psilocybin and other psychedelics are classified as Schedule I controlled substances, meaning they have a high potential for abuse and currently have no accepted medical use in the United States.

Fibromyalgia Patients Substituting CBD for Pain Medication

By Pat Anson, PNN Editor

With opioid medication increasingly harder to obtain, many people with chronic pain are turning to cannabis-based products for pain relief.  A new survey of fibromyalgia patients suggests that cannabidiol (CBD) works well not only as an alternative to opioids, but for many other pain medications.

Researchers at Michigan Medicine surveyed 878 people with fibromyalgia who were currently using a CBD product and found that 72% of them had substituted CBD for a conventional pain medication.

Over half (59%) reduced or stopped taking non-steroidal anti-inflammatory drugs (NSAIDs), while 53% used CBD as a substitute for opioids, gabapentinoids (35%) or benzodiazepines (23%), an anti-anxiety medication that was once commonly prescribed for pain.

"I was not expecting that level of substitution," said Kevin Boehnke, PhD, a research investigator in the Department of Anesthesiology and the Chronic Pain and Fatigue Research Center at Michigan Medicine.

Fibromyalgia is a poorly understood disorder characterized by widespread body pain, fatigue, poor sleep, anxiety and depression. Standard treatments for fibromyalgia such as gabapentinoids often prove to be ineffective or have unwelcome side effects.

"Fibromyalgia is not easy to treat, often involving several medications with significant side effects and modest benefits," said Boehnke. "Further, many alternative therapies, like acupuncture and massage, are not covered by insurance."

CBD is one of the chemical compounds found in cannabis, but it doesn’t have the same intoxicating effect as tetrahydrocannabinol (THC), the psychoactive ingredient in marijuana.  Some cannabis products contain a combination of THC and CBD, while others just have CBD.

Survey participants who used CBD products containing THC were more likely to report symptom relief and to use them as substitutes for pain medication. This suggests that THC may enhance the therapeutic benefits of CBD.

A recent Israeli study found that people with fibromyalgia who took daily doses of cannabis oil rich in THC had significantly less pain and fatigue.

Another recent study in Israel found that cannabis products – both with and without THC – reduced pain and depression in fibromyalgia patients. Like the findings of the Michigan study, about one out of five patients either stopped taking or reduced their use of opioids and benzodiazepines.

"People are using CBD, substituting it for medication and doing so saying it’s less harmful and more effective,” said Boehnke. “If people can find the same relief without THC's side effects, CBD may represent a useful as a harm reduction strategy."

The Michigan Medicine study was recently published in The Journal of Pain.

The Trouble With Pain Treatment Guidelines

By Donna Gregory Burch

I'm trying to figure out why certain medical organizations think they know more about treating my chronic pain than my actual doctors. It seems every single one of these groups shares the same opinion: Opioids are bad. Antidepressants, exercise and meditation are good.

That's the takeaway from new treatment guidelines for fibromyalgia and other forms of “chronic primary pain” released by the European Pain Federation and the UK’s National Institute for Health and Care Excellence (NICE). Both sets of recommendations are on trend with the opioid prescribing guideline adopted by the U.S. Centers for Disease Control and Prevention (CDC) in 2016.

The European Pain Federation recommends against using opioids to treat fibromyalgia, low back pain, irritable bowel syndrome and other forms of chronic primary pain for which there is no known cause. Opioids can be used for certain types of “secondary” pain caused by surgery, trauma, disease or nerve damage, according to the federation, but only when other treatments such as exercise, meditation and non-opioid medications have failed.

The NICE guidelines are even stricter, advising physicians not to prescribe any kind of painkiller to those with fibromyalgia, chronic headache, chronic musculoskeletal pain and other chronic primary conditions. That includes non-opioid painkillers like paracetamol (acetaminophen), non-steroidal anti-inflammatory drugs (NSAIDs), gabapentinoids (gabapentin, pregabalin), corticosteroids (prednisone, prednisolone) and benzodiazepines (Valium, Xanax).

As someone who lives with fibromyalgia, chronic lower back pain and chronic daily headaches, I thank God that I don't live across the pond, as they say. Frankly, I'd probably throw myself off a bridge if my doctors adhered to either of these guidelines.

And no, I'm not being overdramatic. I'm sure I speak for many of the readers here at Pain News Network and my own website, Fed Up With Fatigue, when I express alarm over how authoritarian and inhumane these guidelines aimed at chronic pain patients are becoming.

Of course, things aren't much better on U.S. soil. Physicians here are still running scared due to the CDC's opioid guideline. It's becoming increasingly difficult to find doctors who will prescribe opioids or even accept a patient who is already on opioids. It matters little if the patient has been using them responsibly for years or even decades.

A ‘Little Bit of Life’ Gone

A couple of weeks ago, one of my readers shared that she used to be able to work and manage her home when her opioid dosage was at a certain level. But then the CDC decided to stick its nose into her personal health journey by recommending that general practitioners should not prescribe opioids to patients with fibromyalgia.

Her doctor saw those recommendations and cut her dosage. Now, she's basically homebound. The little bit of life that she had as a chronic pain patient is no longer.

How is this fair? Or humane?

It isn't.

And why is she being punished because a small number of opioid users were irresponsible and became addicted? That is not the fault of the millions of opioid users who do use them responsibly!

It's easy for “experts” and regulators to condemn opioids when they're not the ones in pain. And it's a slap in the face to have them tell me I should take ibuprofen for a migraine, or worse yet, to go take a walk.

Obviously, they haven't experienced the headaches that I have - one of which was so bad that I curled up in a ball on the sofa and whispered to my husband through tears, "I just want to die."

And yes, it really was that bad! To suggest that doing some deep breathing or talking with a counselor is going to help that level of pain is completely asinine.

Opioids and Fibromyalgia

But I think what pisses me off the most is that these government agencies and medical organizations constantly say over and over and over again that opioids don't work for fibromyalgia. There's no way they actually took the time to review the existing research, because if they had they would know that statement is based on opinion, not fact.

The truth is very few research trials have actually studied if opioids are an effective treatment for fibromyalgia. In 2016, I took a deep dive into the research on using opioids for fibromyalgia and was stunned by just how little data there really is.

In 2011 and 2013, there were a couple of large studies at McGill University in Montreal, Canada, involving around 300 fibromyalgia patients who were being treated with opioids. The researchers concluded "opioid-treated patients were more symptomatic and were more likely to be unemployed and to be receiving disability benefits."

The inference from that statement is that somehow the opioids increased the patients' symptoms when there's no way to know for sure if that's what really happened. It's entirely possible those patients were on opioids because their symptoms were more severe, which would also explain why those particular patients were more likely to be unemployed and on disability.

You'd think these researchers would remember a simple principle that many of us learned in college: Correlation doesn't equal causation.

Then, there have been at least three studies (2000, 2003 and 2011) that looked at the effectiveness of tramadol, a weaker synthetic opioid, at reducing fibromyalgia pain. All of these studies confirmed tramadol improved fibro-related pain.

A small Swedish study from 1995 found intravenous morphine did not improve fibromyalgia pain, and a 2003 study from the University of Cincinnati College of Medicine concluded opioids were not effective.

I might have missed a small trial here and there, but that's basically the gist of the research that has studied the use of opioids for fibromyalgia. Little has changed since I reviewed the research five years ago. There still haven't been any large trials testing the efficacy of opioids in fibro patients.

So looking at the scant research that's available, how can the people who develop these treatment guidelines honestly say opioids don't work for fibromyalgia patients? They can't.

As the saying goes, "absence of evidence is not evidence of absence." In other words, you can't say opioids don't work when you've never even taken the time to study whether opioids help fibromyalgia pain or not.

And it is disingenuous to suggest otherwise.

Donna Gregory Burch was diagnosed with fibromyalgia in 2014 after several years of unexplained pain, fatigue and other symptoms. She was later diagnosed with chronic Lyme disease. Donna covers news, treatments, research and practical tips for living better with fibromyalgia and Lyme on her blog, FedUpWithFatigue.com. You can also find her on Facebook, Twitter and Pinterest. Donna is an award-winning journalist whose work has appeared online and in newspapers and magazines throughout Virginia, Delaware and Pennsylvania.

New European Guideline Says Opioids ‘Do Not Work’ for Many Types of Chronic Pain

By Pat Anson, PNN Editor

Calling opioid medication a “two edged sword,” the European Pain Federation (EFIC) has released new guidelines that strongly recommend against using opioids to treat fibromyalgia, low back pain, migraine, irritable bowel syndrome and other types of chronic non-cancer pain.

“The new recommendations advise that opioids should not be prescribed for people with chronic primary pain as they do not work for these patients,” the EFIC said in a statement.

However, the guideline states that low doses of opioids may be suitable for treating “secondary pain syndromes” caused by surgery, trauma, disease or nerve damage, but only after exercise, meditation and other non-pharmacological therapies are tried first.

“Opioids should neither be embraced as a cure‐all nor shunned as universally dangerous and inappropriate for chronic noncancer pain. They should only be used for some selected chronic noncancer pain syndromes if established non‐pharmacological and pharmacological treatment options have failed,” the guideline states. “In this context alone, opioid therapy can be a useful tool in achieving and maintaining an optimal level of pain control in some patients.”

Opioid pain relievers are not as widely used in Europe as they are in the United States or Canada. The EFIC said it was trying to “allay concerns over an opioid crisis” developing in Europe, as it has in North America.       

“As the leading pain science organisation in Europe, it is crucial that EFIC sets the agenda on issues such as opioids, where there are growing societal concerns. These recommendations clarify what role opioids should play in chronic pain management,” EFIC President Brona Fullen said in a statement.

The guideline’s lead author, Professor Winfried Häuser, said he and his colleagues tried to strike a middle ground on the use of opioids.

“The debate on opioid-prescribing for chronic non-cancer pain has become polarized: opioids are either seen as a dangerous risk for all patients, leading to addiction and deaths, or they are promoted as most potent pain killers for any type of pain,” said Häuser, who is an internal medicine specialist in Germany.

“Opioids are still important in the management of chronic non-cancer pain – but only in some selected chronic pain syndromes and only if established non-pharmacological and non-opioids analgesics have failed or are not tolerated.”

PROP Consulted for European Guideline

The guideline was developed by a 17-member task force composed of European experts in pain management, including 9 delegates selected by EFIC’s board “who advocate and who are critical with the use of opioids.” Only one delegate from Pain Alliance Europe represented patients.

The recommendations developed by the task force were reviewed by five outside experts, including Drs. Jane Ballantyne and Mark Sullivan, who belong to Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group in the U.S.  Ballantyne is PROP’s President, while Sullivan is a PROP board member. Several changes suggested by the outside experts were adopted.

Coincidentally, Ballantyne, Sullivan and three other PROP board members were involved in the drafting of the opioid guideline released in 2016 by the U.S. Centers for Disease Control and Prevention. That controversial guideline is now being rewritten by the CDC after voluminous complaints from patients and doctors that the recommendations led to forced tapering, withdrawal, uncontrolled pain and suicides.

Sullivan and two other PROP board members were also involved in drafting Canada’s 2017 opioid guideline, which was modeled after the CDC’s and provoked similar complaints from Canadian pain patients.

90 MME Recommended Limit

The CDC and Canadian opioid guidelines appear to have been used as resources by the EFIC task force, which adopted many of the same recommendations, even while acknowledging the low quality of evidence used to support them.   

One recommendation is straight out of the CDC guideline, advising European doctors to “start low and go slow.” Prescribers are urged to start patients on low doses of 50 morphine milligram equivalents (MME) or less a day and to avoid increasing the dosage above 90 MME/day.

One significant difference with the North American guidelines is that the EFIC recommends that opioids not be prescribed for fibromyalgia, migraines and other chronic “primary pain” conditions for which there is no known cause – suggesting those disorders have an emotional or psychological element that will lead to opioid abuse.

“Prescription of high doses of opioids to patients with primary pain syndromes might have been a factor driving the opioid crisis in North America,” the EFIC guideline warns.

“This was further compounded by patient characteristics that included physical and psychological trauma, social disadvantage and hopelessness that served as a trigger for reports of pain intensity prompting prescriptions of more opioids.”

Secondary pain conditions for which opioids “can be considered“ include multiple sclerosis, stroke, restless leg syndrome, Parkinson’s disease, rheumatoid arthritis, phantom limb pain, non-diabetic neuropathy, spinal cord injuries and Complex Regional Pain Syndrome (CRPS). 

Unlike the North American guidelines, the EFIC acknowledges that there are physical and genetic differences between patients. Some patients who are rapid metabolizers “might require higher dosages of opioids than the ones recommended by the guidelines.“

EFIC GRAPHIC

The EFIC also warns that its guideline should not be used to justify abruptly tapering or discontinuing opioids for anyone already prescribed at higher dosages. The recommendations are also not intended for the management of short-term acute pain, sickle cell disease or end-of-life care.

Living With Chronic Pain and Finding Happiness During a Pandemic

By Victoria Reed, Guest Columnist

These are trying times. For those of us struggling with chronic pain, we know what it means to be tough. We battle our own bodies, doctors and even unsympathetic family members every day. We know what it’s like to struggle and make sacrifices -- because that’s what we have to do to survive.

With the arrival of Covid-19, it has added another layer to our already complex lives. But how do we learn to live with this virus and find happiness in the face of overwhelming adversity? I don’t have all the answers, but I do know what’s working for me and what brings me joy. 

I have lived with chronic pain for all of my adult life. My first problem began during my teens, when I developed persistent, unexplained pelvic pain. After many doctor visits and three exploratory surgeries, a sympathetic and kind OB/GYN reproductive endocrinologist finally gave me the answer: endometriosis.

Receiving treatment for endometriosis, which included hormone therapy and surgery to remove adhesions, didn’t take all of the pain away, but it did restore my fertility and allow me to eventually have babies.

Then, during my mid 20’s, my back suddenly went out. I had had no falls, accidents or injuries that I could recall. That would set the stage for another type of pain to take over my life, which there really was no cure for. I got a diagnosis of degenerative disc disease at age 27.

I managed the pain with physical therapy to tighten my core muscles, regular use of ice and heat, rest and pain medication. I also had a caudal nerve block. But by age 32, I began having new symptoms of joint swelling in random joints. Back to the doctor I went!

During that visit with a rheumatologist, I had requested to be tested for rheumatoid arthritis (RA) because my twin sister had recently received that diagnosis. Sure enough, blood tests confirmed that I did indeed have antibodies specific to RA. For those of you who have RA, you know that it is.a.beast.

VICTORIA REED

Over time, beating back RA became like a full-time job; take this medication, take that medication, inject this, apply that. Eventually, after trials of several expensive biologic medications and DMARD’s (disease-modifying antirheumatic drugs), we found one that worked. I get it by IV infusion about once a month at the Cleveland Clinic.

Biologics suppress the immune system to help bring down the inflammation that damages the joints, heart and lungs. RA also causes chronic, debilitating fatigue. It’s like you haven’t slept in a month and got run over by a truck, not like the tiredness you feel when you only had a few hours of sleep the night before.

Then a year or two later, during a routine visit with my rheumatologist, she listened to me as I described being sore all over. After a thorough exam, I received the diagnosis of fibromyalgia, another chronic and painful condition.

Here we go again! When will it stop? Some people might just want to give up, but I had three kids to raise, and it was important for me to fight for my health for them. My 18-year marriage had become a casualty and giving up was not an option!

With the diagnosis of fibromyalgia, I had to adapt to the reality that I was never going to be free of pain and fatigue. They had become my constant companions. I managed, and my kids grew up watching my struggle. They are now 16, 19 and 21 and are happy, well-adjusted individuals, but they’ve had to watch me deal with pain their entire lives. 

Since it was obvious that my body hated me, why would it stop assaulting and insulting me? Guess what? It did not. I have since been diagnosed with FOUR more autoimmune and related disorders: Hashimoto’s thyroiditis (thyroid attack), Sjogren’s syndrome (mucous membrane attack), Raynaud’s phenomenon (small artery abnormality) and the loveliest of all: LADA (Latent Autoimmune Diabetes of Adulthood), a form of Type 1 diabetes that is primarily treated with insulin.

Fast forward to 2020. Covid-19 arrives? No problem! I’m used to challenges. I’m used to pills, needles, pain and fatigue. Wearing a mask is the least of my worries, as I’ve been fighting to stay alive and healthy for all of my adult life and a few of my teenage years.

These days, I make time to do the things that please me, such as riding my 2-wheel Italian scooter, gardening, camping and traveling. I even learned how to ride a motorcycle at age 50! I do not dwell on my pain.

Living in northeast Ohio limits year-round sunshine, but when it is warm and sunny outside, that’s where you’ll always find me! Peace comes when I am at one with nature. Happiness is a state of mind. We can choose to be miserable or we can choose to be happy, and despite my health challenges, I am grateful and thankful for the blessings that I do have.

So, to all of you pain warriors, hang in there! Look for and hold onto the positive. Surround yourself with positive people. Cut out those friends and family that are negative energy (I did). Make time to do things you enjoy. It’s not easy, but it is possible to find peace and happiness in the face of overwhelming adversity.

Let’s hope that Covid-19 will someday be a thing of the past. But if not, we’ll be alright. 

Victoria Reed lives in Cleveland, Ohio.

PNN invites other readers to share their stories with us. Send them to editor@painnewsnetwork.org.

Pilot Study Finds Green Light Therapy Improves Fibromyalgia Symptoms

By Pat Anson, PNN Editor

Fibromyalgia patients exposed to green light therapy had significant improvements in their pain, sleep and quality of life, according to a new pilot study published in the journal Pain Medicine.

The small clinical trial by researchers at the University of Arizona is the first to explore the benefits of green light in treating fibromyalgia symptoms. Previous studies have focused on green light therapy as a treatment for migraine headaches. Green light is believed to have a calming effect on the brain and causes less eye strain.  

Twenty-one adult patients with fibromyalgia being treated at the university’s chronic pain clinic were enrolled in the study. They were exposed to green light-emitting diodes (GLED) for one to two hours daily for 10 weeks. While undergoing treatment, patients were asked to avoid all other sources of light, including computers, smartphones and television, but encouraged to engage in other activities such as reading and listening to music, and to avoid falling asleep.

“To our knowledge, this one-way crossover design efficacy-study clinical trial is the first description of a successful implementation of GLED exposure as a therapy to manage fibromyalgia pain without any reported side effects. The patients enrolled in this study reported significant reduction in their overall average pain intensity, frequency, and duration after GLED treatment,” wrote lead author Mohab Ibrahim, MD, an associate professor in the Departments of Anesthesiology and Pharmacology at UArizona College of Medicine-Tucson. 

In addition to less pain, patients also reported better mood and sleep, and improvements in their ability to work, exercise and perform chores. Eleven patients said they also reduced their use of pain medication, including opioids, while being exposed to green light.    

“GLED may be a safe and affordable method to manage fibromyalgia. We did not observe side effects in animal studies or in reports from our patients. The observed safety and efficacy, coupled with the simplicity of this method, merit further investigation and the design of a randomized clinical trial to fully investigate the role of GLED for fibromyalgia and possibly other chronic pain conditions,” researchers concluded. 

Fibromyalgia is a poorly understood disorder characterized by widespread body pain, fatigue, poor sleep and depression. Many patients report conventional treatments for fibromyalgia are ineffective or have unwelcome side effects. 

In an email to PNN, Ibrahim said he was conducting two more studies on the use of green light to treat other pain conditions, but was not ready to release his findings. He recently reported the results of a small study of green light as a preventative therapy for migraine. 

“Should anyone use green light products? The risk is low, but I still suggest people speak with their physicians first before attempting any therapy,” Ibrahim said.    

Light Sensitivity 

Although more research is needed to fully understand how green light therapy works, some commercial products are available to the public without a prescription.

One is a portable green light lamp made by Allay, a company founded by Harvard Medical School Professor Rami Burstein, PhD, who was the first researcher to discover that different colors in the light spectrum can affect light sensitivity – known as photophobia – among migraine sufferers.

Burstein learned that blue light (the light emitted by TVs and computer screens) can trigger migraines, while a narrow band of green light at low intensity can reduce the severity of migraine attacks.

“Green light has a calming effect because it reduces electrical activity (in the brain),” Burstein told PNN. “It is the only color of light that is associated with positive emotion and reducing anxiety. All other colors of light increase anxiety, irritability, being afraid, being scared, being angry, a whole host of negative emotions.”

Burstein and his partners asked lighting experts to design an affordable green light lamp that people can use at home. Initial estimates ran in the thousands of dollars, but they have since managed to reduce the cost to $150.

ALLAY IMAGE

“It is safe. It’s not invasive. It is inexpensive,” Burstein says. “Try it. Give it a month or two. If it doesn’t work, you can return it for free. No questions asked.”

Allay began selling the lamps in January with a money back guarantee. Of the 3,000 lamps sold so far, Burstein says less than 4 percent of customers have asked for their money back. He expects an updated version of the lamp to be available by the end of the year for less than $100.

Burstein says the lamp eliminates photophobia in nearly all migraine patients. He recommends that migraine sufferers use the Allay lamp one to two hours every day to reduce the frequency and severity of headaches.

Study Shows Cannabis Oil Improves Fibromyalgia Symptoms

By Pat Anson, PNN Editor

A small placebo-controlled trial shows that daily doses of cannabis oil rich in THC (tetrahydrocannabinol) significantly improves pain, fatigue and quality of life in people with fibromyalgia.

The study findings, recently published in the journal Pain Medicine, involved 17 women with fibromyalgia living in Florianopolis, Brazil. Participants were given drops of cannabis oil or a placebo for eight weeks, starting with an initial dose of one drop a day orally and then titrating to an average of 3-4 drops a day.

The cannabis oil used in the study contained 1.22 mg of THC and 0.02 mg of CBD (cannabidiol) per drop. THC is the psychoactive ingredient in marijuana.

The women self-reported their symptoms on a questionnaire every 10 days. Few changes were noted in the placebo group, but the women receiving cannabis oil reported significant improvement on a wide range of symptoms, including pain, depression, anxiety and fatigue. They were also more likely to “feel good” and not miss work compared to the placebo group.

“To our knowledge, this is the first randomized controlled trial to demonstrate the benefit of cannabis oil -- a THC-rich whole plant extract -- on symptoms and on quality of life of people with fibromyalgia,” researchers said. “During the intervention, the impact of the intervention on quality of life in the cannabis group participants was evident, resulting in reports of well-being and more energy for activities of daily living. Pain attacks were also reduced, albeit subjectively, in frequency and intensity.”

The researchers concluded that cannabinoids can be a low-cost and well-tolerated therapy for fibromyalgia patients, and recommended that it be included as an herbal medicine option in Brazil’s public health system.

“The demonstration of safety and efficacy in this gold-standard model is significant. Millions of Americans suffer with FM (fibromyalgia) – a condition that tends to be poorly controlled by standard medicines. These clinical findings indicate that for many of these patients, plant-derived cannabis preparations may be a safe and effective alternative,” said Paul Armentano, Deputy Director of NORML, a pro-marijuana advocacy group.

A major weakness of the Brazilian study is its small size. Participants also continued to self-medicate with analgesics and anti-inflammatory medications during the study, which could have affected the findings.

A larger 2019 study in Israel also found that cannabis reduces pain and improves quality of life for fibromyalgia patients. The cannabis used in that study was ingested by tincture, oil or vaporizer.