Growing Number of Seniors Discovering Medical Benefits of Cannabis

By Pat Anson, PNN Editor

A new survey shows that medical marijuana is increasingly being used by California seniors to treat pain, insomnia, depression and other conditions associated with old age. Many began using cannabis for the first time as older adults.

Researchers at the University of California at San Diego surveyed 568 seniors at a geriatric clinic in southern California. All were at least 65 years of age, and most were older than 75.

Fifteen percent of the seniors said they have used cannabis products within the past three years, with the method of consumption evenly split between lotions (35%), tinctures (35%) and smoking (30%). Over three‐quarters reported cannabis “somewhat” or “extremely” helpful in managing their symptoms, with few adverse effects.

Although medical marijuana has been legal in California since 1996, sixty-one percent of respondents said they used cannabis for the first time as older adults. Recreational use in California was legalized in 2016.

“Most older adults in the sample initiated cannabis use after the age of 60 years and used it primarily for medical purposes to treat pain, sleep disturbance, anxiety, and/or depression. Cannabis use by older adults is likely to increase due to medical need, favorable legalization, and attitudes,” researchers reported in the Journal of the American Geriatric Society.

Over half of respondents (53%) reported using cannabis on a daily or weekly basis. The majority (78%) used cannabis for medical purposes only, with the most common conditions being pain/arthritis (73%), sleep disturbance (29%), anxiety (24%), and depression (17%).

“It is not surprising that a rising percentage of seniors consider cannabis to be a viable therapeutic option in their later years. Many seniors struggle with pain, anxiety, restless sleep, and other conditions for which cannabis products may help mitigate,” said Paul Armentano, Deputy Director of NORML, a marijuana advocacy group.

“Moreover, many seniors are well aware of the litany of serious adverse side-effects associated with available prescription drugs, like opioids or sleep aids, and they perceive medical cannabis to be a practical and potentially safer alternative.”

Most respondents said their family and friends knew of their cannabis use, but less than half (41%) reported their healthcare provider was aware.

Previous studies have found that cannabis is growing in popularity among older adults, primarily due to changes in public attitudes.

Nationwide survey findings recently published in the Annals of Internal Medicine found that about 5% of adults aged 55 and older said they'd used marijuana or hashish in the previous month. Use was almost twice as high among men, with 6.7% reporting cannabis use compared to 3.5% of women.

Although interest in medical marijuana is growing, there is limited research in the U.S. on its effectiveness in treating pain and other symptoms, especially among seniors.

A large study in Israeli found medical marijuana can significantly reduce chronic pain in elderly patients without adverse effects. Many patients were also able stop or reduce their use of opioid medication.    

Nearly 60 percent who originally reported "bad" or "very bad" quality of life said their lives had improved to "good" or "very good." And over 70 percent reported moderate to significant improvement in their symptoms. About one in four Israeli adults use cannabis, one of the highest rates in the world.

What I Learned About Meditation and Acceptance

By Mia Maysack, PNN Columnist

Recently I was asked how I've managed to deal with agonizing pain every day for over 20 years. The answer is far from simple, as it has been an extraordinarily long road that I'll continue to travel for the rest of my life.  

After over a decade of attempting mainstream remedies such as pills, injections, procedures and other therapies, I reached a point of hopelessness that led to contemplating the possibility of giving up. I had become tired and sick of being sick and tired. 

I still am! 

At the beginning of my holistic journey, I felt as though all my options were exhausted. Enough already with the corporate approach to medicine, along with being treated as either a drug seeker or experimental lab rat. 

To be clear, I'm tremendously grateful for all the avenues I've been able to travel, as well as the providers who did what they could to help me along the way. I am even thankful for the doctor who initially misdiagnosed my ear infection as “swimmer’s ear” -- even though it almost cost my life and led to a permanent state of discomfort. 

I wouldn't be who I am without those experiences, nor would I now be in this position to assist others in the treacherous journey that is chronic illness. 

Acknowledging grief, as real a symptom as the hurt itself, was a first step for me. I had to come to terms with knowing what I experienced was not a personal punishment, and also develop a relationship or coexistence with it that was mandatory for my survival.  

After growing in affirmation of those truths, I was then able to wrap my mind around acceptance. That didn't mean I liked the situation and I still don't! My illness doesn't define who I am as a person or where I'm able to go from here -- based on the things that I can control.  

This would be about the time some of you may question the merit of what I'm speaking about. So let me take this moment to break it down.  

Is an altered state of mind going to address or correct all my problems?  No.

Am I suggesting the idea that "positivity" cures?  Also no.  

I am reminded of a medical professional who endured a traumatic spinal injury and was told they'd never walk again. This began a four month long meditative process for this individual, who envisioned having surgery to the point of feeling its physical effects. Needless to say, they are not only walking again, but still practicing medicine.

Of course, there are things that cannot be "fixed." But shifting gears in how we think about a problem cultivates space for an opportunity to no longer dwell on what we're unable to change. Instead, we can invest and focus on what we can change.  

Dwelling isn't the same as grieving, so give yourself permission for having thoughts of "screw this!"  

Exploring new territory is what it means to be human. When we decide our experiences are opportunities for evolution, there's always a chance of merging onto an “on-ramp” that leads to personal growth and acceptance. 

That's another benefit of meditation that I encourage you to study for yourselves. When our bodily systems are more relaxed and we're breathing adequately, there's often improvement in how we’re feeling. Each moment consists of evolution because things are always changing, 

It took a while, but I've come to embody that same sort of energy. There's a lot throughout the world I can’t do very much about. But there are small things I can handle with great love, which includes coexisting with the different aspects of my life. Compassionate nurturing is a monumental and radical task, but it's vital and necessary.  

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

Weather App Provides Personalized Pain Forecast

By Pat Anson, PNN Editor

Like many people who live with arthritis, Dave Richtor noticed that cold and wet weather made his joints ache more than usual.

“I’ve always just been stiffer and slower on grey days,” says Richtor, who lives in the seaside city of Brighton, south of London. “I’m in bed for ten hours a day. When I’m waking up and stiff, there’s obviously been in the night a temperature change.

“My grandma used to know when a storm was coming 20 minutes before it happened. She’d say, ‘Oh, a storm is coming. I’m getting a headache.’”

Feeling “under the weather” is more than just family folklore. Richtor was intrigued by a recent University of Manchester study called Cloudy With a Chance of Pain, which analyzed data from over 10,000 UK residents who recorded their daily pain levels on a smartphone app. The GPS location of their phones was then compared to local weather conditions.

The study found a modest association between weather and pain, with people more likely to feel muscle aches and joint pain on days with low barometric pressure – and the wet and windy weather that usually comes with it.

The study not only gave credibility to a link between weather and pain, it gave Richtor an idea. Why not create an app that gives users a personalized pain forecast? Many apps track the weather and some keep track of pain levels, but there were no apps that married the two.  

“I’ve done extensive research into it, and can’t see those two things matching up,” Richtor told PNN. “Most people I know in this field have been like, ‘Why hasn’t anyone done this before?’”

That’s the inspiration behind Weather Flare, a free health app designed to help people with chronic pain anticipate changes in the weather and their pain levels. Users create a personal profile of their conditions, medications and symptoms, which are then compared to weather conditions provided by AccuWeather. The app “learns” from user input and develops a customized forecast to help people prepare for changes in their symptoms. 

Richtor is currently holding a Crowdfunding campaign to raise money for further upgrades to the Weather Flare app.

Weather Flare is not just for pain sufferers. Richtor says people with asthma, allergies and other health conditions can benefit from knowing about weather conditions such as air quality and pollen counts.

He’s also working with a professor at the University of Sussex to develop a database to warn of drug interactions caused by the weather. For example, people with psoriasis who take methotrexate can be sensitive to prolonged sunlight.

“We’re incredibly excited to have the University of Sussex onboard to assist us with further developments for our app, making Weather Flare even more supportive for sufferers,” says Richtor. “The positive thing about me just having this crazy idea in my head, is that I can help other people manage their own conditions. If it just makes 1% of difference to someone’s day, then I’ve achieved what I set out to do.” 

The app is still in beta stage – meaning the developers are still working out some technical issues. When I downloaded the app, it was unable to recognize my location despite repeated attempts.

Weather Flare is not just for people in the UK. Because AccuWeather provides forecasts and weather conditions around the world, it can be used anywhere. To download the app, click here.

Study Finds ‘Evidence Lacking’ for Most Fibromyalgia Treatments

By Pat Anson, PNN Editor

A new analysis has found little evidence to support the long-term use of any medication or therapy to treat fibromyalgia, a poorly understood disorder characterized by widespread body pain, fatigue, poor sleep and depression.

An international team of researchers from Brazil and Australia reviewed 224 clinical trials of fibromyalgia treatments and found many of them small and of poor quality. High quality evidence was found for cognitive behavioral therapy (CBT), anti-depressants, and central nervous system (CNS) depressants as short and medium-term treatments for fibromyalgia. No treatment was found to be effective long term.

“In this systematic review, the effectiveness of most therapies for fibromyalgia was not supported. Strong evidence supported only cognitive behavioral therapy for pain, as well as antidepressants and central nervous system depressants for pain and quality of life, but these associations were small,” wrote lead author Vinícius Cunha Oliveira, PhD, an adjunct professor at Federal University of the Valleys of Jequitinhonha and Mucuri in Brazil.

“Some therapies may be associated with small reductions in pain and improvements in quality of life in people with fibromyalgia; however, current evidence is lacking for most therapies.”

The study findings, published in JAMA Internal Medicine, reflect what many fibromyalgia sufferers already know; many treatments are ineffective in improving their symptoms.

The Food and Drug Administration has approved only three drugs for fibromyalgia; the antidepressants duloxetine (Cymbalta) and milnacipran (Savella), and the anti-seizure medication pregabalin (Lyrica). All three drugs were originally developed for other medical conditions and are being repurposed as treatments for fibromyalgia.

A large 2014 survey of fibromyalgia patients by the National Pain Foundation found that most people who tried the three FDA-approved drugs did not feel they were effective.

Exercise, acupuncture, massage, electrotherapy, myofascial release, and several other non-pharmaceutical treatments are also commonly recommended for fibromyalgia pain. Researchers found only “moderate” evidence to support their short-term use. High quality evidence was only found for CBT, a form of meditation in which a therapist works with a patient to reduce unhelpful thinking and behavior.

“Clinicians should be aware that current evidence for most of the available therapies for the management of fibromyalgia is limited to small trials of low methodological quality,” researchers concluded. “Clinicians and patients should choose therapies by considering other important outcomes in addition to those presented in this review, such as adverse effects, out-of-pocket costs, and patient preferences.”

The National Institutes of Health estimates about 5 million Americans have fibromyalgia. Most people diagnosed with fibromyalgia are women, although men and children also can be affected.

Walmart Sues Feds Over Prescribing Regulations

By Pat Anson, PNN Editor

In an unusual move, Walmart has filed a lawsuit against the Department of Justice and Drug Enforcement Administration, asking a federal court to clarify the “roles and legal responsibilities of pharmacists and pharmacies” in filling opioid prescriptions.

“We are bringing this lawsuit because there is no federal law requiring pharmacists to interfere in the doctor-patient relationship to the degree DOJ is demanding, and in fact expert federal and state health agencies routinely say it is not allowed and potentially harmful to patients with legitimate medical needs,” the company said in a statement.

Walmart and other pharmacy chains are defendants in multiple class action lawsuits alleging the companies helped fuel the opioid crisis by dispensing opioids irresponsibly. They have also been fined tens of millions of dollars by the DEA for lax controls on opioid prescriptions. According to ProPublica, federal prosecutors in Texas even sought criminal charges against Walmart, but were overruled by top officials at the Department of Justice.

Walmart is the largest retailer in the world and operates over 5,000 in-store pharmacies in the United States. The company said it filed suit against the DOJ and DEA because it was caught “between a rock and a hard place” over opioid prescribing.    

“Unfortunately, certain DOJ officials have long seemed more focused on chasing headlines than fixing the crisis. They are now threatening a completely unjustified lawsuit against Walmart, claiming in hindsight pharmacists should have refused to fill otherwise valid opioid prescriptions that were written by the very doctors that the federal government still approves to write prescriptions,” Walmart said.

“At the same time that DOJ is threatening to sue Walmart for not going even further in second-guessing doctors, state health regulators are threatening Walmart and our pharmacists for going too far and interfering in the doctor-patient relationship. Doctors and patients also bring lawsuits when their opioid prescriptions are not filled.”

‘Corresponding Responsibility’

Under current law, pharmacists have a “corresponding responsibility” when filling prescriptions – a legal right to refuse to fill prescriptions they consider unusual or improper. Most pharmacists will call the prescribing doctor to double-check before turning away a patient, but Walmart and other pharmacies have gone even further by blacklisting doctors deemed to have questionable prescribing practices.  

That’s what happened to a nurse practitioner at an Arizona pain clinic, who received a letter from Walmart in 2018 saying it would no longer fill her prescriptions – even though there was no indication any of her patients had been harmed by opioids.

“In reviewing your controlled substance prescribing patterns and other factors, we have determined that we will no longer be able to continue filling your controlled substance prescriptions,” the letter states.

“It was very humiliating. I was upset about it,” said nurse practitioner Carolyn Eastin. “We’ve already had patients who can’t get prescriptions there.”

A former Walmart pharmacist told PNN the company closely monitors opioid prescriptions and the doctors who write them.

“They had assembled prescription numbers for every doctor who had filled prescriptions at my store. They knew the exact number of medications ordered and sold down to the tablet. They knew what drugs the doctors wrote for and what percentage of the total each drug they wrote for," the pharmacist explained.

In its statement, Walmart said its pharmacists “refused to fill hundreds of thousands of opioid prescriptions they thought could be problematic” and had “blocked thousands of questionable doctors from having their opioid prescriptions filled.” The company also said it frequently assisted law enforcement agencies in “bringing bad doctors to justice.”

Caught in the middle of this are pain patients with legitimate prescriptions that are not getting filled. In August, two patients filed class action complaints against Walgreens, Costco and CVS alleging they were discriminated against by the pharmacies.

As PNN has reported, Sen. Elizabeth Warren (D-MA) and other members of Congress are urging the DEA to update a regulation that would allow pharmacists to only partially fill an opioid prescription. Patients would have to return a second time to get the rest of their medication.

The Devil Effect on Patients with Pain

By Dr. Lynn Webster, PNN Columnist

Society's response to pain management has shifted over the years. While pain treatment today often generates controversy, in the past it was viewed differently.

During the U.S. Civil War, a wounded soldier who was in agony was often given enough chloroform “to render him insensible to pain." Afterwards, soldiers may not have recalled the pain they felt, even if they remembered having surgery. We were concerned enough for our soldiers to ease their suffering with the most effective medication that was available.

At other periods in our history, society worried more about the risks of treating pain than the debilitating and sometimes lethal effects of the pain itself. At times, we even questioned whether pain was real and whether people were just inventing symptoms to receive attention or drugs.

People with pain have often been stigmatized. They have been expected to just tough it out, and those who couldn't were accused of being weak.

The Pendulum Swings Toward Empathy

In the 1990s, most people dying of cancer experienced excruciating pain, despite the fact that doctors had the means to help them. Opioids could ease their suffering. And a consensus began to grow in the medical profession that prescribing opioids for cancer-related pain was the right thing to do. Soon after, doctors began prescribing opioids for non-cancer pain, such as arthritis. The number of prescriptions increased.

Treating pain with opioids became acceptable -- even expected -- when the alternative was to let people suffer. It seemed reasonable at the time. There was little evidence then that opioids would cause serious harm if people used the pain medication as directed.

We always acknowledged that a subset of the patient population was at risk for abuse or addiction. Pain doctors like me did the best we could for patients with the research that was available to us at the time. Perhaps, in some cases, we would do things differently now.

Casting Blame for the Opioid Crisis

Ultimately, “overprescribing” was recognized as one of the contributors to America’s drug crisis. Looking back, it is easy to cast blame. We now have better information about the risks of using opioids. But there were few effective tools at the time to control pain, so prescribing opioids seemed like a valid alternative to letting patients suffer unnecessarily.

As more opioids were prescribed, there was a corresponding increase in all drug overdoses. That set off alarms, even though the causes of overdoses are myriad and complicated, and there is no simple correlation between rising opioid prescriptions and increased overdose deaths.

Societal attitudes began to shift again in the first decade of the 21st century. Families who lost loved ones to overdoses were looking for someone to blame. There were public and private demands to hold someone accountable for their deaths. The initial target was the pharmaceutical industry.

This wasn't anything new. The American public has more hostility toward Big Pharma than any other industry. A 2019 Gallop poll found that the public felt more distrust of Big Pharma than they did of the federal government!

The news media covered the tragedies of teenagers and young adults who were dying from overdoses. Often, those deaths involved opioids. The media also covered stories of families torn apart by addiction. Then the media's narrative shifted to allegations of deceit, greed and cover-ups by the pharmaceutical industry.

At first, they focused on Purdue Pharma. The company was making billions of dollars from OxyContin, and they were accused of irresponsibly promoting its use. The federal government filed a lawsuit against Purdue Pharma and this week announced a $8.3 billion settlement with the company.  

I recall the initial complaints about OxyContin were unrelated to the increased number of opioid related overdoses. Instead, Workers Compensation groups were complaining about the skyrocketing cost of the drug. In the late 1990’s, I recall hearing the medical director of Utah’s workers’ compensation program speak to the local pain society. He angrily insisted that the cost of OxyContin was exploding and must be stopped.

A new "Opium War" had begun. But this time, it was not between the Chinese and British. Instead, it involved health insurers and opioid manufacturers.

Chasing a Pot of Gold

The need to blame someone for the overdoses and make them pay for the harm opioids caused accelerated. Opioid manufacturers and physicians were in the cross-hairs of policymakers and law enforcement agencies.

Opioid distributors and patient advocacy groups were also accused of contributing to the drug crisis. It was alleged that distributors knowingly and irresponsibly supplied communities with large amounts of pills that far exceeded the amount needed for medical purposes. Advocacy groups were accused of being front organizations for opioid manufacturers. Whether or not distributors were irresponsible depends on one’s perspective, but the accusation about patient organizations was often baseless and malicious.

Of course, the bandwagon of accusers grew as the potential pot of gold increased. Lawsuits filed by states, cities and counties could result in a golden egg if they could convince a sympathetic jury or judge that they had been wronged. The sympathies of the public turned more and more against the drugs used in pain treatment.

The Devil Effect Harms Us All

Greed and the harm it causes is a well-known story. However, what is not as well appreciated is how it leads to a cognitive bias called the "devil effect" -- in which one bad quality creates the impression that there must be only negative qualities associated with a person or entity.

The belief that Big Pharma is inherently bad makes it difficult to appreciate the good things (such as vaccines and cures) that come from the industry, and to separate it from the bad things. Today, when doctors consult with or accept any funding from the industry, particularly the companies that make opioids, it is often referred to as “being in bed with the devil.”

Society’s belief that Big Pharma is inherently evil helps explain why people in pain are struggling. The truth is, Big Pharma is not intrinsically bad -- although there are some bad actors in the industry -- and drugs used to manage pain are essential partners in healing when used appropriately.

Our tendency toward black or white blanket perceptions -- and our choice to not learn about the complexities that would allow for a more balanced approach in our reasoning -- has consequences for every aspect of society. When it comes to pain management, the devil effect has yielded the terrible unintended cost of suffering by innocent people.

The pendulum eventually may swing back toward empathy for people who are suffering, but not until more people recognize the influence the devil effect has on society's attitudes towards Big Pharma, opioids and people in pain.

Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. He is author of the award-winning book The Painful Truth, and co-producer of the documentary It Hurts Until You Die. Opinions expressed here are those of the author alone and do not reflect the views or policy of PRA Health Sciences. You can find Lynn on Twitter: @LynnRWebsterMD. 

An Aspirin a Day May Keep COVID at Bay

By Pat Anson, PNN Editor

Ever since the start of the pandemic, there has been a lively and sometimes heated debate over anti-viral medications like hydroxychloroquine and remdesivir – and whether they can treat or even prevent COVID-19 infections.  

It turns out one of the most effective drugs is a simple and inexpensive pain reliever that most people already have in their medicine cabinets: aspirin.

A new study by researchers at the University of Maryland School of Medicine found that hospitalized COVID-19 patients who took a daily low-dose aspirin had significantly lower risk of complications and death. Aspirin takers were less likely to be placed in an intensive care unit (ICU) or be hooked up to a mechanical ventilator, and they were much more likely to make it out of the hospital alive.

"This is a critical finding that needs to be confirmed through a randomized clinical trial," said study leader Jonathan Chow, MD, Assistant Professor of Anesthesiology at UMSOM. "If our finding is confirmed, it would make aspirin the first widely available, over-the-counter medication to reduce mortality in COVID-19 patients."

Chow and his colleagues say their study, published in the journal Anesthesia and Analgesia, provides "cautious optimism" that a daily low-dose aspirin (usually 81 milligrams) can help prevent severe COVID-19 complications.

Millions of older adults already take aspirin daily to lower their risk of heart attack or stroke.

If our finding is confirmed, it would make aspirin the first widely available, over-the-counter medication to reduce mortality in COVID-19 patients.
— Dr. Jonathan Chow

Researchers analyzed the medical records of 412 COVID-19 patients, aged 55 on average, who were hospitalized at the University of Maryland Medical Center in Baltimore and three other hospitals on the East Coast. About a quarter of the patients were taking a daily low-dose aspirin before they were admitted or right after admission to manage their cardiovascular disease.

Researchers found aspirin reduced the risk of being put on a ventilator by 44 percent, lowered the risk of being put in ICU by 43 percent, and reduced the risk of dying in the hospital by 47 percent.  Patients who took aspirin daily also had less risk of adverse events such as major bleeding.

COVID-19 infections increase the risk of blood clots that can form in the heart, lungs, blood vessels and other organs. Complications from blood clots can lead to heart attacks, strokes, organ failure and death.

"We believe that the blood thinning effects of aspirin provides benefits for COVID-19 patients by preventing microclot formation," said co-author Michael Mazzeffi, MD, Associate Professor of Anesthesiology at UMSOM. "Patients diagnosed with COVID-19 may want to consider taking a daily aspirin as long as they check with their doctor first."

Doctors often recommend a daily “baby” aspirin for patients who have cardiovascular disease. They caution, however, that aspirin can increase the risk of bleeding when taken in combination with other medications like steroids or blood thinners.

"While confirmatory studies are needed to prove that aspirin use leads to better outcomes in COVID-19, the evidence thus far suggests that patients may want to discuss with their doctor whether it is safe for them to take aspirin to manage potentially prevent serious complications," said E. Albert Reece, MD, Dean of the University of Maryland School of Medicine.

Researchers from Wake Forest School of Medicine, George Washington University School of Medicine, Northeast Georgia Health System, and Walter Reed National Military Medical Center also participated in the study.

Fentanyl and Heroin Use Rise During Pandemic

By Pat Anson, PNN Editor

The use of illicit fentanyl and heroin rose dramatically during the first two months of the COVID-19 pandemic, according to a large new study by Quest Diagnostics. Misuse of hydrocodone, morphine and some other opioid medications also increased.

The study adds to growing signs that Americans are turning to potent illicit drugs to cope with the stress and economic disruption caused by the pandemic.

“It’s the social isolation, the depression, the anxiety, stress, job loss, the loss of health insurance and the election. All these things that add stress to our lives are driving people to increase use of alcohol at home and, in the case of this study, drug misuse,” said co-author Harvey Kaufman, MD, Senior Medical Director for Quest Diagnostics. 

Kaufman and his colleagues analyzed data from over 872,000 urine drug tests, comparing samples taken before the pandemic to those taken from March 15 to May 14, 2020. The urine samples came largely from people undergoing substance abuse treatment or were prescribed opioids and other controlled substances, and are not representative of the population at large.

Interestingly, while the rate of drug misuse remained largely the same before and during the pandemic – about 49 percent – there were notable shifts in the type of drugs being misused.

Drug positivity rates increased by 44% for heroin and 35% for non-prescribed fentanyl, a synthetic opioid that is 50 to 100 times more potent than morphine. Positivity rates for non-prescribed opiate medication (hydrocodone, hydromorphone, codeine and morphine) rose by 10 percent. There were no significant changes in the misuse of oxycodone and tramadol. 

Fentanyl was frequently found in urine samples that tested positive for amphetamines (89%), benzodiazepines (48%), cocaine (34%), and opiates (39%). The abuse of multiple substances in combination with fentanyl has been a growing problem for years, but Quest researchers were surprised by how much it has accelerated.

“It’s shocking that something could move that quickly. It’s been well underway for half a dozen years, but the pandemic supercharged it,” Kaufman told PNN.

Gabapentin Misuse

One surprising detail in the Quest study is that the nerve drug gabapentin (Neurontin) is being misused more often than any other prescription drug. Non-prescribed gabapentin was found in nearly 11% of urine samples — second only to marijuana — in the first two months of the pandemic. While that’s down from pre-pandemic levels, it adds to a growing body of evidence that gabapentin is being overprescribed and abused.

POSITIVITY RATES FOR NON-PRESCRIBED DRUGS (MARCH-MAY 2020)

SOURCE: QUEST DIAGNOSTICS

Gabapentin was originally developed as an anti-convulsant, but it has been repurposed to treat chronic pain and is often prescribed off-label as an alternative to opioids. When taken as prescribed, there is little potential for gabapentin to be misused. However, when taken with muscle relaxants, opioids or anxiety medications, gabapentin can produce a feeling of euphoria or high.

A likely factor in the decline in gabapentin misuse during the pandemic is a drop in physician visits. Fewer visits mean fewer prescriptions, and gabapentin may have become less available for diversion.

Just as stay-at-home orders forced many patients to cancel or postpone healthcare appointments, it also led a significant decline in drug testing. Orders for lab tests by Quest dropped by as much as 70% in the first few weeks of the pandemic. They have since rebounded, but are still well below pre-pandemic levels.

“COVID-19 interrupted non-essential patient care, but it hasn’t stopped drug misuse,” co-author Jeffrey Gudin, MD, Senior Medical Advisor to Quest, said in a statement. “Given the psychological, social, and financial impacts of the COVID-19 crisis, more efforts are needed to ensure that patients are taking medications as prescribed. While the nation focuses on the pandemic, we must not lose sight of the ongoing drug misuse epidemic, which continues to kill upwards of 70,000 Americans each year.” 

After briefly declining in 2018, drug overdoses began rising again in 2019. According to one preliminary study, drug overdoses are up about 17 percent so far this year.

FDA Designates First Virtual Reality Device for Chronic Pain

By Pat Anson, PNN Editor

AppliedVR, a Los Angeles-based virtual reality company, has announced that its EaseVRx headset has received Breakthrough Device Designation from the Food and Drug Administration for treating fibromyalgia and chronic intractable low back pain.

EaseVRx is the first virtual reality (VR) device to get a Breakthrough Designation from the FDA for treating a chronic pain condition. The designation speeds up the development and review of new medical devices that treat life-threatening or irreversibly debilitating diseases or conditions. It could also speed up insurance coverage of VR therapy for chronic pain.

“AppliedVR is the most evidence-backed VR platform on the market, and today’s FDA designation demonstrates that health experts across the spectrum recognize the therapeutic potential of VR as a viable treatment for pain,” Matthew Stoudt, CEO and co-founder of AppliedVR, said in a statement.

“Now, with the COVID-19 pandemic severely disrupting Americans’ ability to get in-person care safely, we’re looking forward to getting EaseVRx into the hands of people suffering from pain. Providers believe in it, patients want it, and payers are coming around to it.” 

VNR+.jpg

AppliedVR funded a recent clinical trial that showed VR therapy can be self-administered at home to treat chronic pain. Patients living with fibromyalgia or chronic lower back pain were given VR headsets and instructed to watch at least one virtual reality program daily for 21 days.

The programs immerse users in a “virtual” environment where they can swim with dolphins, play games or enjoy beautiful scenery. The goal is to help patients learn how to manage their pain and other symptoms by distracting them and making their pain seem less important

At the end of the study, 84 percent of the patients reported they were satisfied with VR therapy. Their pain intensity was reduced an average of 30 percent. Physical activity, mood, sleep and stress levels also improved.

“Virtual reality is a promising skills-based behavioral medicine that has been shown to have high patient engagement and satisfaction,” said Beth Darnall, PhD, AppliedVR’s chief science advisor. “However, chronic pain patients to date have had very limited access to it, so we’re excited to continue working with the FDA to develop our platform and get it into the market faster.”

PNN columnist Madora Pennington, who lives with chronic pain from Ehlers-Danlos Syndrome, recently reviewed one of AppliedVR’s headsets. She said watching VR programs helped calm and relax her.

“The benefits of VR therapy continued for me after the sessions ended. When pain or panic about pain began to set in, I found it drifts away rather than latching onto me like it used to,” Madora wrote. “After a couple weeks of VR, during a visit to physical therapist, I noticed I was no longer afraid of her touching my neck and back, and actually enjoyed it.”

AppliedVR’s technology is being used in hundreds of hospitals, but is not expected to be available for home use until next year. The company is working with Geisinger Health and Cleveland Clinic on two studies to see if VR therapy can be used as an opioid-sparing tool for acute and chronic pain.

VR for Phantom Limb Pain

Virtual reality technology received another boost this week when the Department of Defense awarded Chicago-based Coapt a $2.3 million grant to develop virtual reality therapies for phantom limb pain. Wounded veterans and amputees who have lost arms or legs often suffer from nerve pain and other sensations from their missing limbs.

"Phantom limb pain is a serious and persistent challenge for many upper and lower-limb amputees, and new, technology-based therapies have incredible promise," Blair Lock, co-founder and CEO of Coapt, said in a statement. "Preliminary work has shown that VR-based, actuated therapy can manage pain more effectively and have lasting effects. This grant will allow us to further study this therapy and bring to market a solution for those suffering from phantom limb pain in a way that also happens to be engaging."

Coapt has previously developed a VR-based therapy to help upper-limb amputees improve control of their prostheses. The technology also shows promise as a treatment for phantom limb pain. Coapt will use the grant money to further study the effectiveness of VR therapy and create a commercially viable product for both civilians and veterans with upper and lower-limb amputations.

Migraine and Arthritis Patients Report More Pain During Pandemic

By Pat Anson, PNN Editor

Two new surveys are opening a window into how migraine and arthritis patients are managing their pain and getting treatment during the coronavirus pandemic. Many remain fearful about visiting a provider and want insurers to make access to medication easier.

The first survey, conducted by the Headache & Migraine Policy Forum, found a significant increase in stress and migraine attacks in over 1,000 U.S. migraine patients who were surveyed over the summer.

Asked how COVID-19 had impacted their health and treatment, over two-thirds (69%) of patients said they were experiencing an increase in monthly migraines. Eight out of ten (84%) said they felt more stress managing their disease (84%) and over half (57%) said their overall health had worsened.

“Treating a debilitating condition like migraine disease during a global pandemic can increase stress for patients, many of whom already struggle with day-to-day activities. Added stress can mean more frequent attacks, resulting in more visits to see a health care provider or even costly ER visits,” the Policy Forum said.

But while the frequency of migraine attacks increased, many patients were reluctant about seeing a provider and potentially exposing themselves to COVID-19. Six out of ten (61%) said they were afraid to seek care at a doctor’s office or hospital, and 74% were hesitant to visit an emergency room when having an acute migraine attack.

Some insurers have relaxed rules about prior authorization and step therapy to make access to medication easier during the pandemic. But most migraine patients say their own insurers need to be more flexible.

  • 72% had difficulty managing their migraine because they couldn’t get a longer supply of medication

  • 73% said insurers did not allow them to get more medication per pharmacy fill

  • 70% said insurers did not reduce barriers like prior authorization

  • 76% said insurers did not stop requiring step therapy

While migraine patients were often unhappy with their insurers, most were delighted with telehealth. The vast majority (83%) said they hoped their providers continued using telehealth after the pandemic ends.

“COVID has introduced a host of new challenges for people living with migraine disease. Telemedicine clearly provides an important link to care, but patients are looking for insurance providers to do more to facilitate care, including cutting red tape and ending delay tactics,” Lindsay Videnieks, Executive Director of the Headache & Migraine Policy Forum said in a statement.

Arthritis Patients Want New Treatments

The second survey of nearly 2,000 adults suffering from osteoarthritis had similar findings. Over a third of respondents (37%) told the Arthritis Foundation that they had missed or cancelled a doctor’s appointment due to fear of COVID-19 infection. Only 15% said their osteoarthritis is well managed.

Osteoarthritis (OA) is a joint disorder that leads to thinning of cartilage and progressive joint damage. No disease-modifying drugs are currently available to treat OA, and over the counter pain relievers have only mild to moderate effects on OA pain.

"Pain is debilitating. My back and hip pain are so bad that I have trouble getting out of bed," said one survey respondent. "Each step is excruciating, and I wonder how much longer I can deal with the pain."

"You spend a lot of time & effort trying not to think about it because what you focus on magnifies," another patient wrote. "You hate pain scales because how do you rate something that is always there? Oftentimes it's not the pain's intensity but rather the duration."

Nearly two-thirds (65%) of patients said they use non-steroidal anti-inflammatory drugs (NSAIDs) or topical medication to manage their pain, 29% use physical therapy or massage, and another 29% said total joint replacement helped.

The primary change OA patients want is for insurers to increase coverage of new arthritis treatments, though more than half said they were only interested in a new treatment for pain if it didn't also increase their joint damage.

The Arthritis Foundation recently joined with 30 other healthcare organizations in asking the Food and Drug Administration and National Institutes of Health to make the development and availability of pain treatments a higher priority within the agencies.

Reduced Drinking Can Improve Pain Symptoms

By Pat Anson, PNN Editor

It’s no secret that alcohol consumption has risen sharply during the coronavirus pandemic, as more people are drinking to cope with anxiety, loneliness, stress and boredom. According to recent research published in JAMA Network Open, alcohol sales rose 54% in the first weeks of the pandemic, and there was a significant increase in heavy drinking among women.

Excessive alcohol use may worsen mental and physical health problems, and it is particularly problematic for people with chronic pain, who are often prescribed medications that shouldn’t be taken with alcohol.

Another reason to reduce drinking is that it could improve your pain symptoms, according to a recent study of U.S. military veterans published in Alcoholism: Clinical and Experimental Research. The study followed about 7,000 veterans who took annual surveys between 2003 and 2015 that included questions about their mental health and alcohol and substance use.

Researchers identified about 1,500 veterans who reported heavy drinking in at least one survey, and then compared those who reduced their alcohol consumption to those who did not.

The veterans who reduced their drinking were more likely to have improved pain symptoms two years later, and had higher odds of stopping smoking, cannabis, or cocaine use. There was no noticeable improvement in their depression and anxiety.

“We found some evidence for improvement of pain interference symptoms and substance use after reducing drinking among US veterans with unhealthy alcohol use, but confidence intervals were wide,” wrote lead researcher Ellen Caniglia, an epidemiologist in the NYU School of Medicine in New York City.

Caniglia and her colleagues noted that the timing of alcohol reduction relative to improvement in pain and other conditions was often unknown, so it cannot be concluded that less drinking caused the improvement or vice versa.

The veterans included in the study were not representative of the overall population; nearly half had moderate to severe chronic pain, more than half had anxiety, a third had depression, and half were HIV-positive. More than two-thirds were tobacco smokers, a third reported cannabis use, and another third reported cocaine use.

That said, researchers say their findings support efforts to reduce drinking in veterans with unhealthy alcohol use, and suggest that reduced drinking is unlikely to worsen pain symptoms or increase the abuse of other substances.

Some previous studies have found that moderate alcohol consumption may actually improve pain symptoms. A 2015 survey of over 2,200 people with fibromyalgia and other chronic pain conditions found that drinkers reported significantly less disability than teetotalers.

And a 2017 analysis published in the Journal of Pain found “robust evidence” that a few drinks can produce a “moderate to large reduction in pain intensity.”

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

Great Progress Being Made in Treating Arachnoiditis

By Dr. Forest Tennant, PNN Columnist

About 5 years ago, most medical practitioners had either never heard of Adhesive Arachnoiditis (AA) or thought it was a spider bite. Today, almost all practitioners in the modern world have heard of AA. Many now understand it and some even treat it. A few are trying some innovative new approaches.

AA is a chronic inflammation that starts inside the spinal canal that can lead to severe suffering, neurologic impairments and a shortened lifespan. Once inflammation starts, it apparently never, or rarely, goes totally away.  

Treatment and prevention in recent years have greatly reduced the occurrence of some serious neurologic impairments and autoimmune complications of AA. The most obvious decrease in new cases reviewed by the Tennant Foundation are those of upper and lower extremity paraparesis (partial paralysis) and total paralysis, which are rapidly disappearing.

Urinary and bladder impairments that require catheterization are also hardly seen. And the autoimmune manifestations of arthritis, thyroid deficiency and carpal tunnel are disappearing.

Why the improvement? Awareness, thanks to patients, social media and advocates who have educated the medical profession about AA. Fewer epidurals, early treatment and emergency measures have all helped. The development of protocols for prevention, emergency intervention and on-going treatment have been essential.

Major Remaining Problems

Persons with AA are still having difficulty, in some communities, finding medical practitioners who are comfortable and willing to treat AA. The major complication is the development of constant pain and the intractable pain syndrome.

The key to preventing AA and stopping its progression is early treatment. Our research has clearly shown that AA is almost always preceded by one of 3 intraspinal canal inflammatory conditions:

  1. Protruding, degenerated intravertebral discs.

  2. Cauda equina inflammation.

  3. Arachnoid inflammation (i.e. plain arachnoiditis) due to collagen disorders or needle injury.

Some intraspinal canal inflammatory disorders always precede AA. These disorders should be aggressively treated to prevent AA.

Select Corticosteroids Essential for AA

We believe all persons with typical AA symptoms and documentation of the disease on an MRI must take one of two corticosteroids (CS): methylprednisolone or dexamethasone for the spinal canal inflammation and pain of AA.

Currently there is no other medication agent that consistently and predictably suppresses intraspinal canal inflammation and reduces pain. Do not expect to halt progression or have much recovery if you do not consistently take a CS.

Dexamethasone and methylprednisolone are the preferred CS’s because they cross the blood brain barrier, enter spinal fluid and act on glial cells. Prednisone and hydrocortisone are not as consistently effective as dexamethasone and methylprednisolone, which should be taken in low doses.

  1. Maintenance-low dose of dexamethasone (.5 to .75mg) or methylprednisolone (Medrol) 2 to 4 mg on 2 to 5 days a week. Skip days between dosages. An alternative is a weekly or bi-monthly injection of methylprednisolone or dexamethasone. Injections are usually the answer to corticoid sensitivity or gastric upset.

  2. For flares, a 6-Day Medrol Dose Pak or an injection of methylprednisolone or dexamethasone, preferably mixed with a standard dose of injectable ketorolac.

The fear of corticosteroids comes from daily use of high doses, not from low, intermittent dosages. Some persons with severe asthma and rheumatoid arthritis must take a corticosteroid for years and don’t experience serious side effects.

Forest Tennant, MD, MPH, DrPH, is retired from clinical practice but continues his groundbreaking research on the treatment of intractable pain and arachnoiditis. This column is adapted from bulletins recently issued by the Arachnoiditis Research and Education Project of the Tennant Foundation. Readers interested in subscribing to Dr. Tennant’s bulletins should send an email to tennantfoundation92@gmail.com.

Dr. Tennant and the Tennant Foundation have given financial support to Pain News Network and are currently sponsoring PNN’s Patient Resources section.  


Can Herd Immunity End the Pandemic?

By Roger Chriss, PNN Columnist

The latest round in the ongoing public health debate over the pandemic pits two online petitions against each other: the "Great Barrington Declaration" versus the “John Snow Memorandum.” The former focuses on natural herd immunity, while the latter emphasizes controlling community spread through lockdowns, masks and other public health measures.

The Barrington Declaration has garnered support from the Trump administration because it calls for schools and businesses to reopen, and for life to return to normal for “those who are not vulnerable” to the virus.

“The most compassionate approach that balances the risks and benefits of reaching herd immunity, is to allow those who are at minimal risk of death to live their lives normally to build up immunity to the virus through natural infection, while better protecting those who are at highest risk. We call this Focused Protection,” the Declaration states.

The John Snow Memorandum, named for the famed British physician who halted the 1854 London cholera outbreak, states that "Any pandemic management strategy relying upon immunity from natural infections for COVID-19 is flawed. Uncontrolled transmission in younger people risks significant morbidity and mortality across the whole population."

The Declaration’s Fundamental Flaws

The Declaration claims that “all populations will eventually reach herd immunity – i.e. the point at which the rate of new infections is stable – and that this can be assisted by (but is not dependent upon) a vaccine.”

But we do not know this. Many diseases, from malaria to Ebola, continue to rip through populations without reaching herd immunity. It is entirely possible that Covid-19 will reach a similarly perilous “equilibrium,” becoming endemic until the arrival of a vaccine. At this point we don’t know enough about the coronavirus SARS-CoV-2 to make any strong claims that herd immunity will “eventually” happen.

Moreover, the “Focused Protection” championed in the declaration assumes that we have adequate testing, contact tracing and isolating to protect the vulnerable, though at present the U.S. does not. It further assumes that Covid-19 doesn’t have a significant disease burden, even though there is mounting evidence that the disease can cause considerable and long-lasting harm in otherwise healthy adults and children.

The Declaration assumes that durable immunity to the virus results from infection. But there are a handful of documented cases where reinfection has occurred, such as a 25-year old Nevada man who became seriously ill during his second bout with Covid-19.  It’s not clear how “durable” immunity is.

As Yale immunologist Akiko Iwasaki explains in a recent commentary in The Lancet, “reinfection cases tell us that we cannot rely on immunity acquired by natural infection to confer herd immunity; not only is this strategy lethal for many but also it is not effective."

The experiences of Arizona, Florida and Texas over the summer show that “Focused Protection” doesn’t work in the real world. All three states were hit hard during the summer surge, with hundreds of thousands of cases and tens of thousands of deaths. As we head into the fall, we’re now seeing a surge of new cases in the upper Midwest.

The Memorandum’s Practical Challenge

The John Snow Memorandum states that “controlling community spread of COVID-19 is the best way to protect our societies and economies until safe and effective vaccines and therapeutics arrive within the coming months.”

This is credible, given the experiences of Germany, New Zealand, South Korea and other nations that managed to control virus spread and minimize death and disease through a mixture of public health measures. They created national plans for testing, tracing and isolating, and with consistent public health messaging that minimized socioeconomic disruption. Lockdowns were not always necessary, either. Japan avoided a national lockdown, instead controlling spread with strong public health measures.

The United States, by contrast, has failed to do these things. We are not generally good at public health, as the worsening opioid overdose crisis has clearly shown. The failures in the overdose crisis were arguably prologue for the uncoordinated and undisciplined approach the U.S. has taken to the pandemic.

The Memorandum’s recommendations are laudable, but they will be hard to implement, even though current projections suggest over 170,000 more deaths and millions of new cases of Covid-19 in the coming months.

The U.S. needs to ask itself two questions. First, how did we get to a point where the Great Barrington Declaration even sounds like a good idea? Second, what can we do to find a better way forward, as suggested by the John Snow Memorandum, to avoid additional deaths and disease? Winter is coming and the coronavirus will have the run of the country unless we step up to stop it.

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research. 

Are You Living in the Matrix?

By Dr. Lynn Webster, PNN Columnist

A recent Netflix documentary, "The Social Dilemma," illustrates how social media networks are selling each of us as commodities to advertisers. Tristan Harris, a former Google employee, points out that platforms such as Reddit, Facebook, Twitter and Instagram make money by allowing advertisers to target members who are interested in their products or services.

That means anyone who uses "free" social media are not just consumers. We are the products being sold.

We’re allowing our brains to be manipulated by sophisticated marketing and artificial intelligence (AI) designed to change our behavior. Each time we “like” something or stay on a web page for more than a second, we provide technology companies with additional knowledge about who we are and what makes us tick. Each click helps AI become better at manipulating us, deciding what we see and what we don’t.

Because the things that fill one person's newsfeed may never make their way into another’s, social media networks shape our version of reality while they polarize society. Unfortunately, “fake news” is sometimes more profitable to advertisers than real news. We have segued from living in the Information Age to subsisting in the Disinformation Age. This is especially frightening when we see how much influence conspiracy theories have in our culture today.  

According to the documentary, we have essentially isolated ourselves in a bubble of technology. Loneliness and depression are rampant in our society, and people interact less in the real world than they do online. When others "like" our posts, we get a hormonal rush of chemicals -- and when it dissipates, we crave another hit. The need for approval and belonging keeps us clicking.

As "The Social Dilemma" asks, "How do you wake up from the matrix when you don't know you are in the matrix?"

People with Pain Live in the Matrix, Too

The online audience for messages has become fragmented for people with different views. This limits the reach of any particular message to those who share the same beliefs or problems. That puts people living with pain who reach out to others through social media at a disadvantage they may not even understand.

The documentary makes the point that the only industry besides social media that uses the term “users” is the illicit drug world. People living with pain or addiction are vulnerable to the same dopamine rush that keeps us clicking to receive affirmation from others who share our experiences.

People in pain desperately want to be heard by people who can help them. But, because of AI, only those who already tend to be supportive of people in pain are likely to see their posts.

The very nature of chronic pain and addiction narrows people’s worlds. So does social media. It has a compounding effect. As a society, we need to understand that our world becomes narrower with each click.

Think of those you unfriend or the people who block you on social media. They are the ones you need to hear from, because they are people who have different views from yours. It may feel comfortable to stay within your own lane, but that won't help if your goal is to understood the world and help change it for the better.   

Bursting Your Information Bubble

There are general principles we can all use to sort the truth from the lies on the internet. One is to recognize that if you have a strong emotional response to an online message, you may have become the successful target of manipulation. Take a deep breath and tell yourself the manipulators found a way to trigger your dopamine release. Remember that the message you saw may be only partially true -- or not true at all.

Before you share a post or believe it yourself, verify the source. Check out the veracity of the story on Snopes or some other fact checker. Seek out sources other than those that appear in your timeline or on your news feed. Instead of trusting your search engine, proactively log onto news sites with opposing viewpoints.

If the stories you find feature quotes, go to the original source and see if the message was taken out of context. The greater your emotional reaction to the message, the greater the chances are that it is inaccurate, misleading information.

“The Social Dilemma” website offers a toolkit to “realign your relationship with technology” and explore these issues -- including what social media is doing to our democracy -- more deeply.

We can't ban the internet. We wouldn't want to, even if we could. There are obvious benefits to digital communication, and we can't put the genie back into the bottle.

However, if we don’t want to be trapped in a dystopia where humanity is controlled by a manipulated reality, we have to realize that "free" online services are anything but that. The cost is the truth. When we sacrifice a balanced view of the world because of our desire to belong, we risk locking ourselves in the matrix. 

Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. He is author of the award-winning book The Painful Truth, and co-producer of the documentary It Hurts Until You Die. Opinions expressed here are those of the author alone and do not reflect the views or policy of PRA Health Sciences. You can find Lynn on Twitter: @LynnRWebsterMD. 

Study Finds Most Drugs Ineffective for Neuropathic Pain

By Pat Anson, PNN Editor

A first of its kind study that compared four medications widely used to treat neuropathy found that all four were usually ineffective in treating pain and many patients stopped taking them due to side effects.    

Over 20 million people in the U.S. suffer from neuropathic pain, a tingling, burning or stinging sensation in the hands and feet caused by nerve damage. Neuropathy is often caused by diabetes, chemotherapy or trauma, but in about 25% of cases the cause is unknown and classified as cryptogenic sensory polyneuropathy (CSPN).

There is little guidance for physicians and patients on what drugs to take for CSPN, so researchers at the University of Missouri School of Medicine conducted a “real world” study in which 402 patients with CSPN took one of the four neuropathy medications.

The four drugs studied were nortriptyline (Aventyl), a tricyclic antidepressant; duloxetine (Cymbalta), a serotonin-norepinephrine reuptake inhibitor (SNRI) antidepressant; pregabalin (Lyrica), an anti-seizure drug; and mexiletine (Mexitil), an anti-arrhythmic medication used to treat irregular heartbeats.

Nortriptyline, duloxetine and pregabalin are approved by the FDA for treating neuropathy, while mexiletine is used off-label. None of the drugs were originally developed to treat neuropathic pain.

"As the first study of its kind, we compared these four drugs in a real-life setting to provide physicians with a body of evidence to support the effective management of peripheral neuropathy and to support the need for newer and more effective drugs for neuropathic pain," said lead researcher Richard Barohn, MD, executive vice chancellor for health affairs at the University of Missouri.

After 12 weeks of use, any drug that reduced pain for a patient by at least a 50% was considered effective, a recognized industry standard to define therapy success.. Researchers also kept track of patients who stopped taking a drug and dropped out of the study due to adverse effects.

The study findings, published in JAMA Neurology, can best be described as underwhelming. Patients were far more likely to stop taking a drug than they were to stay on a medication that was helping them.    

Of the four drugs, only nortriptyline was an effective pain reliever for at least 25% of patients. It also had the second-lowest drop-out rate (38%), giving it the highest level of overall utility. Duloxetine had the second-highest efficacy rate (23%) and the lowest drop-out rate (37%).

Pregbalin had the lowest efficacy rate (15%) and the second highest drop-out rate (42%), while mexiletine had the highest drop-out rate (58%) and an efficacy rate of 20 percent.

EFFICACY RATE OF NEUROPATHY DRUGS

SOURCE: JAMA NEUROLOGY

"There was no clearly superior performing drug in the study," Barohn said. "However, of the four medications, nortriptyline and duloxetine performed better when efficacy and dropouts were both considered. Therefore, we recommend that either nortriptyline or duloxetine be considered before the other medications we tested."

While nortriptyline had the highest efficacy rate, it also had the highest rate of adverse events, with over half of patients (56%) reporting side effects such as dry mouth, drowsiness, fatigue and bloating.  

Previous studies have found that duloxetine and pregabalin had higher efficacy rates for neuropathic pain, but Barohn and his colleagues say their research more accurately reflects what patients experience in real life and what physicians encounter in their practice.

“Our findings could affect how these 4 drugs are used by all physicians who treat patients with neuropathy. Findings support duloxetine and nortriptyline as better-performing drug choices in this population with neuropathic pain, suggesting that they should be prescribed before pregabalin or mexiletine are considered. However, this study also supports a finding that all 4 drugs helped improve pain in at least some patients, so each could be tried if others failed,” they concluded.     

There are several other drugs used to treat neuropathy, including gabapentin, venlafaxine and sodium channel inhibitors. Barohn says additional comparative studies should be performed on those drugs. His goal is to build effectiveness data on nearly a dozen drugs for CSPN.