Drug Shows Promise for Treating Psoriatic Arthritis

By Pat Anson, Editor

An injectable drug used to treat plaque psoriasis may also be effective in treating psoriatic arthritis, according to new research published in the New England Journal of Medicine.

Secukinumab – which is sold by Novartis under the brand name Cosentyx – helped reduce swollen joints in a double-blind Phase III study involving over 600 patients with psoriatic arthritis. Treatment with Cosentyx resulted in rapid and significant improvements in about half of the patients compared to a placebo.

The study was neither large enough or long enough to evaluate side effects associated with long-term use of Cosentyx.

Psoriatic arthritis is a form of arthritis that affects about a third of people who have psoriasis — a condition that features red skin lesions. Joint pain, stiffness and swelling are the main symptoms of psoriatic arthritis, which can affect any part of the body, including the fingertips and spine.  

No cure for psoriatic arthritis exists, so the focus is on controlling symptoms and preventing further damage to joints.

Cosentyx was approved in Europe early this year as a first-line treatment for moderate-to-severe plaque psoriasis. The drug is also approved in the U.S. as a treatment for plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy (light therapy).

Novartis has applied for Cosentyx to be used as a treatment for psoriatic arthritis and ankylosing spondylitis.

Psoriatic arthritis can develop at any time, but it most commonly appears between the ages of 30 and 50, according to the National Psoriasis Foundation. Genes, the immune system and environmental factors all appear to play a role in the onset of the disease. About 10 percent of people inherit one or more of the genes that could eventually lead to psoriasis, but only 2 to 3 percent actually develop the disease.

The Link Between Empathy and Pain

Pat Anson, Editor

The Merriam-Webster dictionary defines the word empathy as “understanding, being aware of, being sensitive to, and vicariously experiencing the feelings, thoughts, and experience of another.”

Or as former President Bill Clinton famously said, “I feel your pain.”

But new research suggests empathy may be a lot more complicated than we think – at least when it comes to feeling the pain of others.

A team of European researchers has found evidence that empathy may be strongly influenced by neurotransmitters in the brain -- and is not just a form of emotional or social bonding.

Their findings suggest that empathy is dependent – not on feeling the pain of others --- but on experiencing pain yourself.

“Empathy is of major importance for everyday social interaction. Recent neuroscientific models suggest that pain empathy relies on the activation of brain areas that are also engaged during the first-hand experience of pain,” wrote psychologist Clauss Lamm of the University of Vienna, lead author of a study published in Proceedings of the National Academy of Sciences.

Lamm and his colleagues recruited 100 participants for an experimental trick with a placebo. They divided the volunteers into two groups and gave one group a pill they thought was a painkiller but was actually a placebo. The second group received no pill at all.

Both groups were given a small electric shock and asked to rate the degree of pain they felt -- and the degree of pain they saw in others who were also shocked.

The group that received the placebo not only reported less pain than the control group, but they also felt there was less pain experienced by others. That placebo-empathy effect was confirmed by MRI’s – which found there was less activity in brain areas of the placebo group that felt less pain and empathy for others.

Researchers tested the placebo-empathy effect in a second study in which they used the drug naltrexone to block opioid receptors in some of the volunteers. Those given naltrexone reported feeling more pain when shocked and felt that others felt more pain as well.

"This result strongly suggests an involvement of the opioid system in placebo-empathy, which is an important step to a more mechanistic understanding of empathy,” said Lamm.

"The present results show that empathy is strongly and directly grounded in our own experiences – even in their bodily and neural underpinnings. This might be one reason why feelings of others can affect us so immediately – as we literally feel these feelings as if we were to experience them ourselves, at least partially. On the other hand, these findings also explain why empathy can go wrong – as we judge the feelings of others based on our own perspective,” explains Lamm.

Lamm and his colleagues are now working on a follow-up study in which they are investigating the effects of opioids on empathy.

Blood Test Identifies Women Prone to Migraine

By Pat Anson, Editor

Researchers may have discovered a new marker for episodic migraine – lipids in the blood that regulate inflammation in the brain.

In a small study involving 88 women, researchers found that total levels of the lipids -- called ceramides or sphingolipids -- were significantly decreased in women with episodic migraine when compared to women without migraine. Episodic migraine is defined as less than 15 headaches per month. The women in this study had an average of 5.6 headache days a month.

"While more research is needed to confirm these initial findings, the possibility of discovering a new biomarker for migraine is exciting," said study author B. Lee Peterlin, DO, with the Johns Hopkins University School of Medicine. The study is published in Neurology,  the medical journal of the American Academy of Neurology.

Ceremides are bioactive lipids that may be involved in other neurological disorders, such as dementia and multiple sclerosis.

Women with migraine had approximately 6,000 nanograms per milliliter of ceramides in their blood; while women without headache had about 10,500 nanograms. Every standard deviation increase in total ceramide levels was associated with over a 92% lower risk of having migraine. Two other types of lipids, called sphingomyelin, were associated with a 2.5 times greater risk of migraine.

The researchers tested their theory by analyzing the blood of a random sample of 14 of the women. They were able to correctly identify those who had migraine and those who did not based on their lipid levels.

"This study is a very important contribution to our understanding of the underpinnings of migraine and may have wide-ranging effects in diagnosing and treating migraine if the results are replicated in further studies," said Karl Ekbom, MD, with the Karolinska Institute in Stockholm, Sweden, who wrote an accompanying editorial.

Ekbom noted there were limitations in the study. Only women were included, chronic migraine was not studiedm and an unusually high number of participants had migraine with aura

Migraine is thought to affect a billion people worldwide and about 36 million adults in the United States, according to the American Migraine Foundation. It affects three times as many women as men. In addition to headache pain and nausea, migraine can also cause vomiting, blurriness or visual disturbances, and sensitivity to light and sound.

Smoking Accelerates Multiple Sclerosis

By Pat Anson, Editor

Smoking is never a good idea for anyone – especially people in chronic pain -- but according to a new study it is particularly bad for multiple sclerosis patients, both before and after diagnosis.

Cigarette smoking is already a known risk factor for developing multiple sclerosis (MS), but in a first of its kind study published in JAMA Neurology, Swedish researchers found that continuing to smoke after diagnosis significantly accelerates progression of the disease.

MS is a chronic and incurable disease which attacks the body’s central nervous system, causing numbness in the limbs, difficulty walking, paralysis, loss of vision, fatigue and pain. Symptoms begin with a series of irregular relapses, and after about 20 years MS worsens into a secondary progressive (SP) stage of the disease.

In a study of over 700 MS patients who continued to smoke after their diagnosis, researchers found that each additional year of smoking accelerated the time to SP conversion by 4.7 percent.  

Looking at it another way, the study found that patients who continued to smoke converted to SP faster (at an average age of 48) than those who quit smoking (at age 56).

“This study demonstrates that smoking after MS diagnosis has a negative impact on the progression of the disease, whereas reduced smoking may improve patient quality of life, with more years before the development of SP disease,” said lead author Jan Hillert, MD, Department of Clinical Neuroscience, Karolinska University Hospital Solna in Stockholm.

“Evidence clearly supports advising patients with MS who smoke to quit. Health care services for patients with MS should be organized to support such a lifestyle change.”

Getting MS patients to quit is important not only for patients, but for society as a whole because of the high cost of treating MS. Disease modifying drugs such as fingolimod and natalizumab, cost about $30,000 per year and are not always effective.

“This study adds to the important research demonstrating that smoking is an important modifiable risk factor in MS. Most importantly, it provides the first evidence, to our knowledge, that quitting smoking appears to delay onset of secondary progressive MS and provide protective benefit,”  said Myla Goldman, MD, of the University of Virginia, and Olaf Stüve, MD, of the University of Texas Southwestern Medical Center in an accompanying editorial in JAMA Neurology.

Previous studies have found that smoking increases your chances of having several types of chronic pain conditions.

A study of over 6,000 Kentucky women found that those who smoked had a greater chance of having fibromyalgia, sciatica, chronic neck pain, chronic back pain and joint pain than non-smokers. Women in the study who smoked daily more than doubled their odds of having chronic pain.

A large study in Norway found that smokers and former smokers were more sensitive to pain than non-smokers. Smokers had the lowest tolerance to pain, while men and women who had never smoked had the highest pain tolerance.

Discovery Could Lead to Earlier RA Treatment

By Pat Anson, Editor

Scientists have discovered a new protein that regulates the severity of tissue damage caused by rheumatoid arthritis, a finding that could help identify RA patients earlier for more aggressive treatment.

The protein – known as C5orf30 – was found in DNA and biopsy samples from the joints of over 1,000 RA patients in the UK and Ireland.

"Our findings provide a genetic marker that could be used to identify those RA patients who require more aggressive treatments or personalized medicine," said Professor Gerry Wilson from the School of Medicine and Medical Science, University College Dublin, who led the research.

"They also point to the possibility that increasing the levels of C5orf30 in the joints might be a novel method of reducing tissue damage caused by RA".

Rheumatoid arthritis is a chronic autoimmune disease in which the body’s own defenses attack joint tissues, causing joint pain, inflammation and bone erosion. About 1.5 million Americans and 1% of adults worldwide suffer from RA.

"These exciting findings will prompt us to further explore the role of this highly conserved protein that we know so little about, and its significance in human health and disease,” said co-author Dr. Munitta Muthana from the Medical School at the University of Sheffield.

The study, funded by Arthritis Ireland and the University of Sheffield, is published in the journal PNAS.

It is estimated that 30% of patients with rheumatoid arthritis are unable to work within 10 years of onset of the disease. It affects more women than men, and often more severely. RA is most common between the ages of 40 and 70, but it can affect people of all ages, including children.

Although there is no cure for RA, new drugs are available to treat the disease and slow joint damage. Self-management of the condition by patients, including exercise, is also known to reduce pain and disability.

One of the biggest problems in treating RA is early diagnosis and treatment, which can reduce the amount of joint damage.  

"Treatments for arthritis have improved enormously over the last number of years. Thirty years ago, rheumatologists' waiting rooms were filled with people in wheelchairs. Today, that is no longer the case. The outlook for a person diagnosed with arthritis in 2015 is much brighter than it used to be,” said John Church, CEO of Arthritis Ireland.

British researchers recently said they were close to developing a blood test that could detect both RA and osteoarthritis in its earliest stages.

Osteoarthritis (OA) is a progressive joint disorder caused by painful inflammation of soft tissue, which leads to thinning of cartilage and joint damage in the knees, hips, fingers and spine.

Researchers at the University of Warwick’s Medical School identified a biomarker linked to both forms of arthritis. Diagnostic blood tests already exist for RA, but the newly identified biomarker could lead to one which can diagnose both RA and osteoarthritis.

“This discovery raises the potential of a blood test that can help diagnose both RA and OA several years before the onset of physical symptoms," said lead researcher Naila Rabbani, PhD.

Rabbani’s research focused on citrullinated proteins (CPs), a biomarker present in the blood of people with early stage rheumatoid arthritis. Patients with RA have antibodies to CPs and the Warwick researchers established for the first time that CPs levels also increase in early-stage OA.

That research is published online in Nature Scientific Reports.

Debate Grows over Spinal Injections

By Pat Anson, Editor

A controversial government funded study critical of epidural steroid injections has been republished in the Annals of Internal Medicine, fueling a growing debate over the effectiveness and safety of spinal injections.

A prominent pain specialist called the study’s publication in a peer-reviewed journal “an insult to thousands of physicians across the world."

In a systematic review of 30 placebo controlled trials, researchers found that epidural steroid injections (ESI’s) offer limited or no relief from radiculopathy and spinal stenosis, two conditions that cause low back pain. The study was funded by the Agency for Healthcare Research and Quality (AHRQ) and conducted at the request of the Centers for Medicare and Medicaid Services.

“Epidural corticosteroid injections for radiculopathy were associated with early improvements in some outcomes versus placebo interventions, but effects were small and unsustained, and epidural corticosteroid injections had no clear effects in patients with spinal stenosis,” wrote lead author Roger Chou, MD, a Professor at Oregon Health & Science University (OHSU) School of Medicine and a staff physician in the Internal Medicine Clinic at OHSU.

Epidural injections using analgesics have long been used to relieve pain during childbirth, but spinal injections with steroids are also widely used for back pain. Although the Food and Drug Administration has never approved the use of steroids to treat back pain, several million ESI’s are performed “off label” in the U.S. annually.

The shots have become a common and sometimes lucrative procedure at many hospitals and pain management clinics. Costs vary from a few hundred dollars to over $2,000 per injection.

“Evidence on the effects of using different approaches, corticosteroids, or doses on effectiveness of epidural corticosteroid injections was limited, but indicated no clear effects,” said Chou, who was the principal investigator and author of several other studies published in peer reviewed journals.

“It is a travesty that Chou et al continue to publish these types of manuscripts. It is an insult to thousands of physicians across the world who perform these procedures and millions of patients who have received relief from them,” said Laxmaiah Manchikanti, MD, chairman and CEO of the American Society of Interventional Pain Physicians.

Manchikanti, who is medical director of a pain clinic in Paducah, Kentucky, conducted several of the studies reviewed by Chou and his colleagues.

“Consumers need to understand that the design of their systematic review is flawed and that significant bias exists in the reporting of the results,” Manchikanti wrote in an email to Pain News Network. “It is like eating 2 bananas from different countries and saying both are equally sweet, so neither is sweet. They also are looking for the differences in improvement between both groups rather than how a patient has improved from before the treatment to after the treatment."

Chou’s study also came under fire when it was released by the AHRQ. The Multisociety Pain Workgroup (MPW), a coalition of 14 different societies representing anesthesiologists, surgeons and pain management doctors, sent a lengthy letter to the AHRQ, calling the report's analysis on the effectiveness of ESI's "flawed” and “absurd.”  .

"I don't think its surprising that people who do these injections might disagree or not be happy with the results. Some of the comments seem to demonstrate a poor understanding of how to look at interventions in scientific research," Chou told Pain News Network. "I think people are afraid that they're not going to get paid for doing these types of things. It's not surprising, when people's pocketbooks are threatened, this how they respond."

Chou and his colleagues found the only significant benefit of ESI’s was temporary relief from back pain that usually lasts for only a few days. He attributes much of the pain relief to a placebo effect.

"It's clear that interventions for back pain have a very high placebo effect. We've known that for decades and its been demonstrated over and over again," said Chou.

Manchikanti says most of his patients get pain relief that lasts for several weeks.

“Each patient should be selected individually. They should understand the risks and the off-label nature of these drugs in the epidural space,” he said. “Epidural corticosteroids have been shown to be risky, come with a warning from the FDA, and are an off-label use of these powerful anti-inflammatories.

“For a patient, if they choose to have the procedures done with local anesthetic alone, or with local anesthetic and steroids, they should measure their progress. If they do not improve with the first procedure, they should carefully think about the second procedure; however, there is no reason to have any more than 2 procedures if they do not improve.”

The Choosing Wisely campaign of the ABIM Foundation, which seeks to reduce or eliminate unnecessary medical procedures, also recommends that doctors do not to repeat the injection if a patient shows no sign of improvement.

A number of prominent pain doctors have told Pain News Network the shots are overused, with some patients getting dozens of injections.  

Terri Anderson says repeated shots gave her temporary pain relief from a bulging disc in her back.

“I did receive immediate and short-term benefits over a 3 year time frame. However, I am here to tell you that the injections did not save me from surgery as the disc ultimately failed,” she said.

Anderson now suffers from arachnoiditis, a chronic and painful inflammation of the spinal column that has left her permanently disabled. The Hamilton, Montana woman believes the condition was brought on by too many injections.

“If I had the opportunity to go back in time, I would have stayed away from intervention and lived with the pain I had which was chronic, but it was manageable,” Anderson said.

“The government and professional medical societies have been keeping chemically induced adhesive arachnoiditis hidden from public awareness. Why is that? There is too much profit at stake for hospitals and pain clinics throughout the country. If a physician were to provide their patients with true informed consent (and explain the horrors of arachnoiditis), then no one in their right mind would undergo an epidural steroid injection.”

Researchers Say Back to School Headaches Often Real

By Pat Anson, Editor

With summer nearly over and millions of children heading back to school, many parents will hear a familiar refrain:

“I’ve got a headache. Can I stay home from school?”

While parents may be tempted to think their child dreads going back to school and just wants to prolong summer a little longer, kids now have research to back them up.

In a study of emergency room visits by children, researchers at Nationwide Children’s Hospital in Columbus, Ohio found that pediatric headaches do indeed increase in the fall – often because children are stressed out by abrupt changes in their summer routines, nutrition and sleep patterns.

“When we saw many of our families and patients in clinic, the families would report that their child or teenager’s headaches would increase during the school year,” said lead researcher Ann Pakalnis, MD, a neurologist and Director of the Comprehensive Headache Clinic at Nationwide Children’s Hospital.

“So, we decided to go back and look at emergency department visits for that time period and see if there were more visits here at certain seasonal variations during the year.”

Pakalnis and her colleagues analyzed about 1,300 emergency room visits to the hospital by children from 2010 to 2014. The number of pediatric headaches was stable throughout the year, except for the fall – when headaches in school aged children surged by nearly a third.

"We see a lot of headaches in young boys, from five to nine years of age, and in boys they tend to get better in later adolescence,” said Pakalnis, who is also a professor of Clinical Pediatrics and Neurology at The Ohio State University College of Medicine. “In teenage girls, migraines oftentimes make their first presentation around the time of puberty and unfortunately tend to persist into adulthood.”

The two types of headaches seen most often by physicians are tension headaches and migraines. About 20 percent of all pediatric patients 11 years and older suffer from migraine, which are often associated with nausea and vomiting, as well as sensitivity to light, sound and smell. Tension headaches tend to feel more like a painful tightening around the head.

The increase in fall headaches may be attributed to a number of factors, including academic and social stress, schedule changes and an increase in extracurricular activity. Other common headache triggers include lack of sleep, too much caffeine, lack of exercise and too much time on a computer or mobile device.

Researchers say headaches can often be prevented, just by getting three meals a day, drinking enough liquids, and getting adequate sleep.

“Your brain is like your cell phone,” said Howard Jacobs, MD, a headache specialist at Nationwide Children’s. “If you don’t plug your cell phone in, it doesn’t have energy, it doesn’t work well. If you don’t plug your brain in by providing energy, it doesn’t work well and that causes headaches.”

If headaches persist or get worse, Jacobs says a doctor should be seen.

“A sudden, severe headache or a change in the headache sensation from previous, what we call ‘first or worst’ headaches should be evaluated,” said Jacobs. “Another good rule of thumb is that if the headaches are interfering with a child’s normal routine, then it is time to get them evaluated, so therapy can be instituted to return your child’s life to normal.”

Nationwide Children’s Hospital produced this video about the headache study:

Findings from Nationwide Children's Hospital physicians demonstrate that headaches increase in fall in children, a trend that may be due to back-to-school changes in stress, routines and sleep.

For tension headaches, doctors say over-the-counter pain relievers such as acetaminophen, ibuprofen or naproxen can be helpful, but they can make headaches worse if taken too often.

Until recently, treatment options have been limited for children with migraine.

In May, the U.S. Food and Drug Administration approved Treximet for pediatric migraine patients 12 years of age and older. Treximet is the first approved prescription drug for migraine to contain both sumatriptan and naproxen. Sumatriptan is a triptan that works in the brain by reducing vascular inflammation. Treximet was approved by the FDA for use by adults in 2008.

In June, the FDA also approved Zomig nasal spray for the treatment of migraine in pediatric patients 12 and older. Zomig provides pain relief in as little as 15 minutes, with most patients obtaining some relief in about two hours. Zomig was approved for use by adults in 2003.

New Stimulator Delivers Back Pain Relief

By Pat Anson, Editor

A new type of spinal cord stimulator (SCS) provides significantly more relief from chronic back and leg pain than traditional SCS therapy, according to the results of a new study published in the journal Anesthesiology.

The Senza spinal cord stimulator, which recently won approval from the U.S. Food and Drug Administration, uses high frequency pulses of 10,000 Hz to mask a patient’s perception of pain. Traditional SCS therapies use frequencies of 40 to 60 Hz.

"This is the first long-term study to compare the safety and effectiveness of high frequency and traditional SCS therapy for back and leg pain," said lead author Leonardo Kapural, MD, professor of anesthesiology at Wake Forest University School of Medicine and clinical director at the Carolinas Pain Institute.

"Chronic back and leg pain have long been considered difficult to treat and current pain relief options such as opioids have limited effectiveness and commonly known side effects. Given the prevalence of chronic pain, high frequency SCS is an exciting advance for our patients."

image courtesy of nevro

In a study of 171 patients with implanted SCS devices, 85 percent of those with back pain and 83 percent with leg pain using the Senza HF10 stimulator had a 50% reduction in pain or greater after three months.

Only about half the patients implanted with a traditional SCS device (44% with back pain and 56% with leg pain) experienced that kind of pain relief.

None of the patients in the HF10 therapy group experienced paresthesia – a tingling or buzzing sensation often felt with lower frequency stimulators. They were also more likely to be “very satisfied” with their pain relief (55% versus 32%).

Lower back pain affects about a quarter of the world’s adult population and is the leading cause of disability. Back pain is usually treated with physical therapy or pain relievers.

For chronic back pain, spinal cord stimulators are often the treatment of last resort because the devices have to be surgically placed near the spine and connected to batteries implanted under the skin. The devices send electrical impulses into the spine to mask pain.

The Senza SCS system is made by Nevro (NYSE: NVRO), a medical device company based in Menlo Park, California. Senza has been available in Europe and Australia for the last five years. In May, Senza won approval from the FDA for use in the United States.

MarketsandMarkets, a market research firm based in Dallas, estimates the global market for spinal cord stimulators and other neuromodulation devices could reach $6.8 billion by 2017.

Can Alcohol Help Treat Chronic Pain?

By Pat Anson, Editor

Treating chronic pain with a glass of wine or beer may not sound like a good idea, but an intriguing new study in the U.K. found that alcohol consumption is associated with lower levels of disability in pain patients.

Researchers at the University of Aberdeen in Scotland surveyed over 2,200 people with fibromyalgia and other chronic widespread pain conditions about their alcohol consumption. About a quarter of the respondents were teetotalers, the rest drank rarely, moderately or heavily – the latter consuming as much as 21 to 35 “units” of alcohol a week.

A “unit” was defined as 10 ounces of beer, a small glass of wine or a single beverage with hard liquor – meaning the heaviest drinkers averaged three to five drinks a day.

Drinkers overall reported less disability than people who never drank alcohol, but it was the heaviest drinkers who reported the least disability. They were 67% less likely to experience disability than the teetotalers.

“As well as an association between alcohol consumption and lower levels of disability in pain patients, we also found that the population prevalence of chronic pain was lower in drinkers than in non-drinkers. It’s clear that non-drinkers are more likely to have pain, and more likely to be disabled by it if they have it, compared to drinkers,” said Marcus Beasley, study coordinator at the University of Aberdeen.

Does alcohol act as an analgesic and simply dull pain sensations? Or does it treat and help prevent chronic pain? The researchers are cautious about drawing any conclusions.

“This study has demonstrated strong associations between level of alcohol consumption and CWP (chronic widespread pain). However the available evidence does not allow us to conclude that the association is causal. The strength of the associations means that specific studies to examine this potential relationship are warranted,” wrote Professor Gary Macfarlane, lead author of the study published in the journal Arthritis Care & Research.

“The design of this study cannot tell us whether drinking causes people to have less problems with pain, or if people who have pain make the choice not to drink. In any case people that drink are very different on a wide range of health measures than those that do not drink,” said Beasley.

“For primary care practitioners these findings mean that the fact a patient does not drink could be considered a potential marker for having other health problems, including with chronic pain. Otherwise, the advice that practitioners give to patients should remain the same – drink less if possible, and if consuming alcohol then do so within recommended safe limits.”

Previous research has linked moderate alcohol consumption with a lower risk of heart disease, stroke and diabetes. But drinking too much alcohol can lead to a variety of serious health problems.

How much is too much?

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

The UK study isn’t the first to find an association between alcohol and a reduced risk of chronic pain. A large study conducted in Sweden, published in the British Medical Journal, found that women who had more than three drinks a week had about half the risk of developing rheumatoid arthritis than non-drinkers.

Another study, published in Arthritis Research & Therapy, found that low and moderate drinkers suffering from fibromyalgia had less pain, less fatigue and missed fewer days of work than non-drinkers.

Marijuana Effective for Diabetic Neuropathy Pain

By Pat Anson, Editor

New research shows that inhaled medical marijuana can significantly reduce pain from diabetic neuropathy within minutes of treatment.

The study, published in The Journal of Pain, also found there was a dose dependent reduction in pain depending on the strength of marijuana used.

Researchers at the University of California San Diego followed 16 patients with diabetic peripheral neuropathy (DPN) in a double-blind study as they were exposed to low, medium and high doses of tetrahydrocannabinol (THC), the psychoactive compound in marijuana that makes people “high.”

Patients used a Volcano vaporizer to inhale marijuana with 1%, 4% and 7% THC, as well as a placebo. A vaporizer was used because it is less harmful than smoking and delivers THC into the bloodstream rapidly.

“We hypothesized that inhaled cannabis would result in a dose-dependent reduction in spontaneous and evoked pain with a concomitant effect on cognitive function,” said lead author Mark Wallace, MD, professor of anesthesiology, University of California San Diego School of Medicine. 

Results showed that the highest dose of THC reduced pain by nearly 70%, with the analgesic effect starting within minutes of inhaling and reaching its peak about an hour after treatment. The analgesic effect of the low and medium doses of THC was slightly lower.

All of the patients experienced either euphoria or somnolence, regardless of the dose, with modest effects on attention, memory and impairment.

“These findings along with previous studies suggest that cannabis might have analgesic benefit in neuropathic pain syndromes, including treatment-refractory DPN,” said Wallace.

Nearly 26 million people in the United States have diabetes and about half have some form of neuropathy, according to the American Diabetes Association.  Diabetic peripheral neuropathy causes nerves to send out abnormal signals. Patients feel burning, tingling or prickling sensations in their toes, feet, legs, hands and arms.

There are only two drugs approved by the Food and Drug Administration to treat DPN -- Cymbalta and Lyrica – and many patients say they don’t work or have unpleasant side effects.

Marijuana Helps Heal Broken Bones

Meanwhile, researchers in Israel have discovered that a compound in marijuana can help heal fractures and rebuild bones.

In an animal study published in the Journal of Bone and Mineral Research, researchers at Tel Aviv University reported that cannabinoid cannabidiol (CBD) – a non-psychoactive ingredient in marijuana – significantly enhanced the healing process in rats with broken legs.

Earlier studies by the same research team found that cannabinoid receptors in the human body stimulate bone formation and inhibit bone loss. The findings suggest that cannabinoid based drugs could be used to treat osteoporosis and other bone-related diseases.

"The clinical potential of cannabinoid-related compounds is simply undeniable at this point," said Dr. Yankel Gabet of the Bone Research Laboratory at the Department of Anatomy and Anthropology at Tel Aviv University.

The researchers injected one group of rats with CBD alone and another with a combination of CBD and THC. They found that CBD by itself provided the most therapeutic benefit.

"We found that CBD alone makes bones stronger during healing, enhancing the maturation of the collagenous matrix, which provides the basis for new mineralization of bone tissue," said Gabet.

"Other studies have also shown CBD to be a safe agent, which leads us to believe we should continue this line of study in clinical trials to assess its usefulness in improving human fracture healing.”

Most Pain Patients Use Alternative Therapy (Video)

By Pat Anson, Editor

A large new study of chronic pain patients found that over half were using chiropractic care or acupuncture for pain relief, but many didn’t discuss their use of alternative therapy with their primary care providers.

Researchers surveyed over 6,000 patients in Oregon and Washington State who were Kaiser Permanente members and had three or more outpatient visits for chronic pain in 18 months.

The study, published in the American Journal of Managed Care, found that 58 percent of the patients had used chiropractic care, acupuncture, or both.

Over a third (35%) of the pain patients who had acupuncture never told their doctor, while 42% who had chiropractic care didn't talk to their providers about it. Almost all of the patients said they would be happy to share this information if their doctor had asked.

"Our study confirms that most of our patients with chronic pain are seeking complementary treatments to supplement the care we provide in the primary care setting," said Charles Elder, MD, lead author of the study and affiliate investigator at the Kaiser Permanente Center for Health Research. "The problem is that too often, doctors don't ask about this treatment, and patients don't volunteer the information.

"We want our patients to get better, so we need to ask them about the alternative and complementary approaches they are using. If we know what's working and what's not working, we can do a better job advising patients, and we may be able to recommend an approach they haven't tried,” said Elder, who is the lead physician for Kaiser Permanente's complementary and alternative medicine program.

The majority of the patients in the study (71 percent) were women, and the mean age was 61. Most suffered from back pain, joint pain, arthritis, neck and muscle pain, or headache.

The study was funded by a grant from the National Center for Complementary and Integrative Health.

A video report on the study that was produced by Kaiser Permanente can be seen here:

One-hundred million Americans suffer from chronic pain every year, and many of them turn to alternative therapies for relief. In fact, a new study shows that more than half of patients with chronic pain enrolled in a managed care setting use chiropractic care or acupuncture.

How Does Your Surgeon Rate?

By Pat Anson, Editor

Before the Internet age, finding a good doctor usually depended on word-of-mouth referrals and recommendations -- or just sheer luck.

Now there are over a dozen online resources to help patients find physicians in all sorts of medical specialties, from oncology and neurology to podiatry and psychology.

The latest is Surgeon Scorecard, a searchable database put together by the non-profit ProPublica, that estimates complication rates for nearly 17,000 doctors who perform one of eight elective surgeries, including neck and lumbar spinal fusions, as well as hip and knee replacements.

The database – which uses government records collected from Medicare patients – can be searched by location, hospital or surgeon to learn how they performed during these “routine” procedures -- and whether they had complications such as infections, blood clots, internal bleeding or worse.

“It’s long overdue,” Dr. Charles Mick, a former president of the North American Spine Society told ProPublica. “Hopefully, it will be a step toward a culture where transparency and open discussion of mistakes, complications and errors will be the norm and not something that’s hidden.”

ProPublica found that even the best hospitals had surgeons with higher than average complication rates – and that selecting the right doctor could be a matter of life or death. Over 200,000 hospital patients die every year from preventable errors and complications.

Overall, complication rates are low for most surgeons – just 2 to 4 percent depending on the procedure – but a small share of doctors (11%) are responsible for about 25% of the complications. Hundreds of surgeons have complication rates double and triple the national average.

One such doctor is Constantine Toumbis, a surgeon at Citrus Memorial Hospital in Inverness, Florida. The “Surgeon Scorecard” shows that at least 27 of Toumbis’ patients have either died or suffered serious complications after surgery.

One patient died just days after a spinal fusion -- even though Toumbis had written in her records that the operation went well, according to ProPublica. An autopsy proved otherwise, when the medical examiner found bone fragments in the patient’s neck and signs of an extensive hemorrhage.

Toumbis and Citrus Memorial both declined to comment to ProPublica about the case.

Patient Resources

In addition to the "Surgeon Scorecard," several other searchable databases can be found in the “Patient Resources” section of this website that can help you find a good doctor, healthcare facility or the right treatment.

Vitals can help you locate a doctor with a specific specialty anywhere in the United States, along with patient reviews of that physician.

RateMDs has patient reviews of over a million doctors and healthcare facilities, including some outside the United States.

Healthgrades uses an extensive database and patient reviews to rate doctors based on their experience, complication rates and patient satisfaction.

The Centers for Medicare and Medicaid Services has a database that reveals if your doctor received money from a drug maker or medical device company for consulting, travel expenses, meals, research and promotional services.

Iodine has been called the "Yelp of Medicine." It uses patient reviews to rate the quality, efficacy and side-effects of prescription drugs, including opioid painkillers.

Healthcare Bluebook helps consumers save money on medical expenses -- everything from drugs to surgery to x-rays -- by giving them access to a nationwide database that estimates a "fair price" for whatever they're paying for.

Is Cinnamon a Safer Pain Reliever?

By Pat Anson, Editor

A new warning from the U.S. Food and Drug Administration about the risk of serious side effects from non-steroidal anti-inflammatory drugs (NSAIDs) may have you thinking about finding safer, more natural pain relievers.

The idea isn’t new by any means – about 2,400 years ago the Greek physician Hippocrates was writing about the use of willow bark to ease aches and pains. Other natural remedies used for centuries to relieve pain and reduce inflammation include St. John’s Wort, ginger, ginseng, turmeric, and cinnamon.

Cinnamon, in fact, was recently found to be nearly as effective as the NSAID ibuprofen in relieving pain from menstrual cramps (dysmenorrhea).

The results of a small double-blind clinical trial, published in the Journal of Clinical and Diagnostic Research, evaluated the effects of cinnamon, ibuprofen and a placebo in 114 Iranian female college students. The women were broken up into groups of three; and given either 420 mg of Cinnamon Zeylanicum, 400 mg of ibuprofen or a starch placebo during the first 72 hours of their menstrual cycle.

Eight hours after treatment, researchers found that pain severity in the cinnamon group was significantly less than those who took a placebo, while pain severity in the ibuprofen group was less than those who took cinnamon.

Although ibuprofen was found to be the more effective pain reliever, the researchers believe cinnamon may be a better treatment for menstrual cramps because it doesn’t have the side effects of ibuprofen.

“The research results suggest that, Cinnamon as compared significantly reduces the severity and duration of pain during menstruation, but this effect is less compared to that of Ibuprofen. Due to the lack of adverse events in this study, Cinnamon can be used as a safe and non-pharmacological treatment for primary dysmenorrheal pain in young girls,” the researchers reported.

Iranian researchers have also found that thyme oil and lavender oil were effective in treating menstruation cramps, according to GreenMedInfo.

Last week, the FDA warned that "everyone may be at risk" from using NSAIDs – and ordered drug makers to strengthen warning labels about the risk of a fatal heart attack or stroke.

The warning applies to Advil, Tylenol, Motrin and other popular pain relievers sold over-the-counter, as well as all prescriptions drugs containing ibuprofen and acetaminophen. Many multi-symptom cold and flu products, such as NyQuil and DayQuil, also contain NSAIDs.

The agency said studies have shown the risk of serious side effects can occur in the first few weeks of using NSAIDs and could increase the longer people use the drugs. The revised warning does not apply to aspirin.

Searching for Medical Marijuana’s ‘Therapeutic Window’

Dr. Mark Ware is one of the world’s leading experts on medical marijuana. Ware is an associate professor in Family Medicine and Anesthesia at McGill University in Montreal and director of clinical research at the Alan Edwards Pain Management Unit at McGill University Health Centre. He practices pain medicine at Montreal General Hospital.

Although medical marijuana is legal throughout Canada, and in 23 U.S. states and the District of Columbia, mainstream medicine still frowns upon its use. Research into the therapeutic benefits of cannabis -- particularly for pain management -- has also been limited.

Pain News Network editor Pat Anson recently spoke with Ware at the annual meeting of the American Pain Society. The interview has been edited for content and clarity.

DR. MARK WARE.

Anson: You’ve called medical marijuana an “incredible social experiment.” What do you mean by that? 

Ware: I think what we’re seeing is the lid coming off something that’s been going on for a long time. I think people have been self-experimenting with marijuana for years and years. People have been growing it in their basements and backyards. So there’s been a social experiment with cannabis since the 1960’s in the Western world.

I think the medical aspect of it has kind of followed through with that, because as you get thousands of people using cannabis, eventually somebody with an illness is going to stumble upon it. Lester Grinspoon (a marijuana researcher) reported on this in 1971. So that’s how long we’ve known or suspected the potential medical properties. The fact that the drug has been illegal has suppressed the possibility of there being much in the way of good quality research. So the experiment has been going on underground, out of sight and out of the public eye.

What we’re seeing now is that suddenly we’re able to talk about it. We’re able to look at this seriously. And we’re beginning to realize how much was already going on. So I think it’s an experiment that’s been going on for a long time and we’re beginning to put some parameters around it now, which allow us to track it more carefully. And hopefully it can yield some important results that can help inform the patient and the physician about what to do with this.

Anson: Some doctors have told me they don’t think marijuana will ever go mainstream until big companies like Pfizer and Purdue Pharma start backing marijuana research and doing clinical studies. Would you agree with that?

Ware: I don’t know if I would agree with that. That’s true for new pharmaceutical drugs. If you’re developing a molecule from the lab up, you need Big Pharma to come along and take that and move it to the point where they can do the big clinical trials.

With an herbal medicine, I think you almost don’t want to look at the pharmaceutical model for drug development. It’s more like how we regulate natural health products in Canada. We want good quality cultivation techniques, we want good quality processing, and we want to know what it is that we’re giving to patients.

I think fundamentally what we have to figure out is what we want to know about this drug. What is it that we need to know and how do we go about getting that information?

I think if we wait for Big Pharma to come along it’s going to be a long wait.  They would have been on this long ago if they thought this was important.

It’s a plant based medicine that’s already in our society at some level and we need to recognize the reality that mainstream doesn’t mean mainstream prescription availability. It’s going to mean mainstream figuring out how to put cannabis in a safe place in our society.

Anson: Medical marijuana is so widely available today, it’s like we’re already past the clinical trial phase.

Ware:  Exactly.  And to go back and do the Phase III study now, it’s expensive and would take hundreds of millions of dollars. And that requires knowing whether you’re going to get your money back. Companies invest that money when they know they’ve got a patent and they can make money back on the drug in the ten years after it’s launched. It’s much harder to see that happening with an herbal material like cannabis.

Why invest the money? It’s already available. You can already buy it at the dispensary. So now the question is how do we improve that process? How do we improve the quality of the product? How do we label them so people know what’s in them? How do we provide information to the patients that are buying them? What they should be looking for and what they should be careful about?

And how do we inform the physicians and health professionals who should be managing that whole process or at least informing it? What kinds of patients should be avoiding this? This isn’t for young kids. This isn’t for women who are pregnant. Some of this is obvious, but some of it needs to be specified and mandated.

I don’t think there’s strong enough evidence to start using cannabis in younger people. I think that the risks of cannabis on the developing brain in teenagers is significant enough that, unless there is a very real reason like a younger person with a severe intractable illness, this is a drug that should be held for the 25 and older crowd.

I would caution people who have unstable heart problems against using cannabis. It does increase your heart rate, can open up your blood vessels, and that could precipitate some heart problems.

Anson: What are the pain conditions that you think medical marijuana can be beneficial for?

Ware: I think for sure it’s more likely effective for chronic pain than acute pain. It’s never been reported for acute pain syndromes, but it has been reported for chronic pain.  There are clinical trials now that bear out that chronic neuropathic pain is one of the relieved conditions that it seems to respond to. We’ve seen reports for spinal cord injury, fibromyalgia, and PTSD (post-traumatic stress disorder). Cannabinoids appear to have some signals in some of these conditions.

And then you go beyond that to abdominal pain with Crohn’s disease, diabetic neuropathy, and so on. The list of conditions where it looks like it may work is as long as your arm.  There are individual case reports of cannabis being used on a huge range of conditions.

Anson: What is the most effective delivery system? Everyone thinks of smoking, but there are plenty of other ways to ingest marijuana.

Ware: There are. And I think the key thing is the difference between inhaling and taking it by mouth. The inhaled route is a very quick onset, has a very rapid effect on the patient, and then a fairly quick half-life; whereas the oral route takes much longer to absorb and takes a longer time for the patient to feel the effects. But then it lasts a lot longer. 

courtesy drug policy alliance

So it’s almost like a short acting versus a long acting medication. I don’t think there’s any way of saying one is more effective than the other. I think they’re effective in different ways.

If I was vomiting because of chemotherapy, I’d want something I could inhale to control the vomiting quickly. But if I’m not able to sleep because of my chronic pain, I want something that would be longer lasting so I could sleep through the night.  I don’t want to wake up three hours later and have to do it again. So I think we just have to figure out how to use the different administrative techniques for different clinical conditions.

Anson: Most of our readers are pain patients and when this subject comes up many of them say, “I’ve never tried marijuana. I’m curious about it and I’d like to try it, but I’m worried about getting high.” Can they get pain relief without getting high?

Ware: We’ve done studies where we kept the doses very, very small -- to the point where people have read the protocols and said you’re not giving these patients enough to feel the effect. And in fact, what happens is patients are still able to find analgesic benefit and avoid that euphoric or psychoactive effect.

That’s important for most patients. They want to be able to use a drug or any kind or a therapy that doesn’t impair them from doing the things that they need to do. They need to drive. They need to work. They need to hang out with their families. They need to do their sports and their activities. And this is part of pain management generally. We want people to be living as full and as active a life as possible. We don’t want them collapsing on the couch all day long.

So can we find that window, what we call that therapeutic window, that dose where you get the benefit but you don’t get the sedative or psychoactive effect? And I think we can. I think for patients who are considering this approach, they really have to learn to be very patient and use very, very small doses. Try very small amounts first and allow your body to feel what the drug is doing to you. And if nothing happens, that’s okay. You’ve started with a low enough dose that you felt nothing. You gradually work your way up.

The interesting thing about cannabis is that there are two ways of thinking about dose. One is the amount of the drug itself, the number of grams, joints or pipes, if you will. The other is the THC level of the cannabis itself.

courtesy drug policy alliance

If patients have access to material where the THC level has been standardized or has been measured, they should be trying to use THC cannabis that is as low as possible, because the likelihood of having a psychoactive reaction to a high THC cannabis is much higher.

If it’s high in THC, it doesn’t take much to get that effect, where if they use very low THC levels, less than 10 percent THC, and they use a small quantity of the material, then potentially they can find that therapeutic window that can be effective.

Anson: What about taking marijuana with opioids? Can you do that?

Ware: You can. There’s no medical reason why you shouldn’t. I think the key thing for patients who are doing that, and again I emphasize with the knowledge and support of their physician, is that they can reduce the doses of other medications which may not be helping as much.

Cannabis use can be seen in terms of improving patients in two ways. One is in reducing the medications that they’re already taking, which may have side effects. And the other is in improving their functioning state so that they’re doing more. This is where I think the responsibility lies with the patient to prove to the doctor that this drug is helping. And you do that by reducing your other medications with the doctor’s support, by increasing your functioning and by showing that you’re doing things that you weren’t doing before. That is what doctors want to see.

There appears to be evidence, at least in animal studies, that opioids and cannabinoid drugs work synergistically. So if you take the two separately and you take the two combined, you get a greater effect with the combination than if you took either of the others by themselves.

This synergism, we’ve seen it in patients who started using cannabis successfully and they were able to reduce their other medications. In some cases they find that the dose of opioids they were taking, they can lower it and get a similar effect with much lower doses. With others, they don’t need the opioids any longer and they can taper off it and stop completely. 

Anson: One fear of using medical marijuana is that it could make you more prone to abusing other substances.

Ware: I think patient selection is very important when you’re considering as a physician whether to authorize or prescribe cannabis, because cannabis is a drug with a known risk of abuse and dependence by itself. There are people who struggle with their marijuana use and withdrawal when they try to get off it. Physicians need to be sure they’re not making things worse for a patient that has a dependency disorder by authorizing cannabis.

Screening for dependence means looking for abuse of other substances, such as alcohol. If you’ve done that carefully, prescribing cannabis to a patient who doesn’t have that addiction risk appears to be fairly safe.

Medical cannabis should be used as an option only when all the conventional therapies have failed; when all of the other approaches to pain management, and I’m not just talking about pharmacology, but when all of the non-pharmacological approaches have all been considered and tried. Cannabis is not at the point where it can be thrown in as a first line agent for a patient struggling with pain management.

Anson: Thank you, Dr. Ware.

Childhood Trauma Linked to Adult Migraine

By Pat Anson, Editor

Children who witness domestic violence between their parents are significantly more likely to experience migraine headaches as adults, according to a large new study published in the journal Headache.

Researchers at the University of Toronto examined a nationally representative sample of over 12,000 women and 10,000 men who participated in the 2012 Canadian Community Health Survey-Mental Health. About 6.5% of the men and 14.2% of the women experienced migraine, which is consistent with prior research.

Participants were asked if they had experienced three types of childhood trauma: physical abuse, sexual abuse or if they witnessed parental domestic violence.

"We found the more types of violence the individual had been exposed to during their childhood, the greater the odds of migraine. For those who reported all three types of adversities -- parental domestic violence, childhood physical and sexual abuse -- the odds of migraine were a little over three times higher for men and just under three times higher for women" said Sarah Brennenstuhl, PhD, first author of the study.

Researchers said the most surprising finding was the link between migraines and parental domestic violence. Even after accounting for variables such as age, race, and socioeconomic status, men and women who had witnessed parental domestic violence had 52% and 64% higher odds of migraine compared to those who did not see their parents fighting.

"The cross-sectional design of our study does not allow us to determine if the association between early adversities and migraines is causative, but our findings do underline the importance of future prospective studies investigating the long-term physical health of children exposed to parental domestic violence,” said co-author Esme Fuller-Thomson, professor and Sandra Rotman Endowed Chair at University of Toronto's Factor-Inwentash Faculty of Social Work.

Previous research by Fuller-Thomson has found that depression and thoughts of suicide are more likely among individuals with migraine.

The risk of depression and suicide ideation is about twice as high for those who experience migraine. Individuals with migraine who are under the age of 30 had six times the odds of depression compared to migraineurs aged 65 and over.

Migraine is thought to affect a billion people and about 36 million adults in the United States, according to the American Migraine Foundation. It affects three times as many women as men. In addition to headache pain and nausea, migraine can also cause vomiting, blurriness or visual disturbances, and sensitivity to light and sound. About half of people living with migraine are undiagnosed.

The month of June is Migraine Awareness Month.