Two Drug Combo Relieves Neuropathy Pain

By Pat Anson, Editor

British researchers say a combination of two widely used drugs – an antidepressant and an opioid – can significantly relieve pain and other symptoms caused by neuropathy.

In a study published in the journal PAIN, researchers at Queens University say combining the painkiller morphine with the antidepressant nortriptyline relieved chronic neuropathic pain in nearly 90 percent of patients – significantly better than when either drug is used alone.

"Morphine and nortriptyline are excellent candidates for pain management because of the extensive research conducted on them, their low cost, and widespread availability all over the world," said Ian Gilron, MD, a professor in Queen's School of Medicine and anesthesiologist at Kingston General Hospital.

"Current neuropathic pain treatments are ineffective or intolerable for many sufferers so this new evidence supporting the morphine-nortriptyline combination is important news for patients."

Nortriptyline, an antidepressant sold under the brand names Aventyl and Pamelor, is already being used to treat pain in the arms and legs caused by multiple sclerosis. Morphine has long been used to treat both acute and chronic pain.

Neuropathic pain is characterized by tingling or burning sensations that develop as result of nerve damage caused by conditions such as shingles, diabetes, amputation, inflammation, and cancer. About 8% of adults worldwide suffer from neuropathy. Many drugs used to treat neuropathic pain, such as Neurontin and Lyrica, often don’t work or have unpleasant side effects.

In the double-blind, randomized study, 52 neuropathy patients were given a choice of trying every one of three treatments: morphine alone, nortriptyline alone, and a combination of the two drugs over six-week treatment periods. Patients were asked to record their pain levels and side effects during each treatment.

The average daily pain before treatment was 5.6, measured using a rating scale from 0-10. Average daily pain dropped to 2.6 when patients received the two drug combination. Patients taking nortriptyline and morphine alone rated their pain at 3.1 and 3.4, respectively.

Researchers said that common side effects for both drugs, which include constipation and dry mouth, did not worsen with the combined treatment.

"It's important to remember that we don't want to completely eliminate patients' ability to sense pain as it's a warning system for us, but we do want to find the right balance of pain relief and drug side effects," said Gilron

Nortriptyline and morphine are currently not available in a combined formulation. According to the Mayo Clinic, using the two drugs together is usually not recommended because they both cause sedation.

Study: One in Five Opioid Prescriptions for Low Back Pain

By Pat Anson, Editor

Doctors continue to prescribe opioids for low back pain, headaches and fibromyalgia – even though some medical guidelines recommend against their use for such common conditions, according to a large new study.

In an analysis of prescriptions filled for 12 million of its members between July 2013 and September 2014, pharmacy benefit manager Prime Therapeutics found that about one in five opioid prescriptions were written to treat low back pain.

"Our analysis found low back pain was the most common diagnosis among all members taking an opioid, even though medical guidelines suggest the risks are likely greater than the benefits for these individuals," said Catherine Starner, PharmD, lead health researcher for Prime Therapeutics.

Over 22% of those receiving long-acting opioids had been diagnosed with low back pain, nearly 5% had headache and about 2% were diagnosed with fibromyalgia.

In a position paper adopted last year, the American Academy of Neurology found there was “no substantial evidence” for long term use of opioids to treat low back pain, fibromyalgia and headache.

“Collectively, the data suggest that opioids do not improve function in low back pain and therefore should be avoided. While I am an advocate of minimizing opioids to every extent possible, I also believe that absolutes can be damaging," said Beth Darnall, PhD, a pain psychologist, clinical associate professor at Stanford University and author of Less Pain, Fewer Pills.

“In select individual cases, opioids may be one part of an effective pain management plan.  Even then, patients should be monitored closely and opioids used at the lowest dose for the shortest amount of time possible.  The opioid studies are based on large samples and there are always outliers; we must find ways of minimizing risks, protecting patients, and still leaving room for the reality that the medications may be effective for a minority of individuals.”

Nearly 9% of Prime Therapeutics’ members were prescribed at least one opioid during the study period. On average, the cost for those taking short-acting opioids was $72 per member, compared to $907 per member taking only long-acting opioids.

The company said a clinical program that assesses the appropriateness of long-acting opioids could help improve safety and reduce costs. A screening program could also identify members with a significant number of opioid claims in a short period, or those with diagnosed conditions that may not benefit from prolonged opioid use.

"Identifying these members and helping them find the most appropriate pain treatment for their condition could help reduce safety concerns," said Starner.

Darnall says an education program would also help – one that includes non-drug treatments.

“To reduce opioid prescriptions, patients must be given access to effective alternatives,” Darnall said in an email to Pain News Network. “Additionally, by providing patients with education regarding the limitations of opioids and associated risks clinicians may engage patients in their own care and motivate them to seek and try alternatives.  Such alternatives include psycho-behavioral interventions, self-management programs, graded exercise programs, rehabilitation approaches, and the like.”

Prime Therapeutics manages pharmacy claims for health insurers, employers, and government programs including Medicare and Medicaid. It is collectively owned by 13 Blue Cross and Blue Shield Plans, subsidiaries or affiliates.

Physical Therapy vs. Surgery for Spinal Stenosis

By Pat Anson, Editor

Physical therapy works just as well as surgery in relieving pain and other symptoms of lumbar spinal stenosis in older patients, according to researchers at the University of Pittsburgh.

Their two year-year study, published in the Annals of Internal Medicine, is believed to be the first that compares outcomes between surgery and physical therapy (PT) for spinal stenosis, a condition caused by narrowing of the spinal canal that causes pain, numbness and weakness in the lower back.  Decompression surgery to relieve pressure on spinal nerves has become a fast-growing intervention in today's older population.

"Probably the biggest point to put across to physicians, patients and practitioners is: Patients don't exhaust all of their non-surgical options before they consent to surgery. And physical therapy is one of their non-surgical options," said principal investigator Anthony Delitto, PhD, chair of the Department of Physical Therapy, University of Pittsburgh School of Health and Rehabilitation Sciences.

Delitto, a physical therapist, was puzzled why some patients responded well to physical therapy  and others to surgery.

In his study, 169 patients aged 50 and older with spinal stenosis agreed to be randomly assigned to two groups: Those who would have decompression surgery and those who would have two standardized physical therapy sessions each week for six weeks.

In his study, 169 patients aged 50 and older with spinal stenosis agreed to be randomly assigned to two groups: Those who would have decompression surgery and those who would have two standardized physical therapy sessions each week for six weeks.

After both groups were re-examined at intervals of six months, one year and two years, the patient outcomes appeared to be about equal. There were no detectable differences between the groups in how their pain abated and the degree to which function was restored in their backs, buttocks and legs.

"The idea we had was to really test the two approaches head to head," said Delitto. "Both groups improved, and they improved to the same degree. Now, embedded in that, there are patients who did well in surgery, and patients who failed in surgery. There are patients who did well in PT, and there are patients who failed with PT. But when we looked across the board at all of those groups, their success and failure rates were about the same."

The research project also revealed issues surrounding physical therapy and the cost of co-pay – which apparently discourage some patients from continuing their treatment.

"One of the big things that we know held patients back from PT were co-payments," Dr. Delitto added. "Patients were on Medicare, and a lot of them were on fixed incomes. Some of those co-payments had to come out of pocket at $25, $30, $35 per visit. That adds up, and some of the patients just couldn't afford it."

Most patients didn't finish the PT regimen allowed under Medicare and one-third of the patients failed to complete even half of the regimen. About one in six didn't show for a single treatment, though they had agreed to consider physical therapy.

Florida's State of Pain

By Pat Anson, Editor

If you suffer from chronic pain or care for someone who does, a recent half hour special report by WESH-TV in Orlando is “Must See TV” – whether you live in Florida or not.

In many ways Florida was ground-zero in the “War on Drugs,” with a sordid history of pill mills and unscrupulous doctors who dished out prescriptions for painkillers like they were candy.

In 2010, according to the Centers for Disease Control and Prevention, 98 of the top 100 oxycodone dispensing doctors in the country were in Florida and eight Floridians were dying every day from drug overdoses.

The state started cracking down. Law enforcement agencies raided doctors’ offices, shutdown over 100 pill mills, and heavily penalized pharmacies that were dispensing too many opioids.

The crackdown worked and overdoses soon declined, but somewhere along the way – in the view of many chronic pain patients -- the War on Drugs became a War on Patients. 

Florida doctors started dropping pain patients from their practices and pharmacies began turning away longtime customers who had never abused painkillers, forcing many to go on a “pharmacy crawl” in search of someone to fill their prescriptions. Faced with daily unrelenting pain, some patients resorted to suicide.

Much of what happened in Florida is now occurring on a national level, with pain patients being marginalized and viewed as drug addicts by a health care system that has grown fearful and paranoid.

WESH-TV investigative reporter Matt Grant and his producers do a commendable job covering all of this, explaining how legitimate pain patients have become unintended casualties in Florida’s War on Drugs.

You can watch his report below in three installments:

From Russia with Pain

By Pat Anson, Editor

If you’re a pain sufferer who has difficulty getting prescriptions written and filled for opioid pain medication – be glad you don’t live in Russia.

In Russia, even terminally ill cancer patients have trouble getting opioids. And some have committed suicide rather than spend their remaining days in pain.

In February, 11 cancer patients committed suicide in Moscow alone, according to a special report published in Meduza, a web-based Russian media outlet that operates out of Latvia.

“There’s no end to the pain. It won’t stop next morning, or tomorrow, or the day after. It won’t disappear if a tooth is pulled out or if drops of medicine are squeezed into your ear. If you don’t relieve the pain somehow, it eats you up right to the end. It’s absolutely unbearable,” one cancer patient was quoted as saying.

Getting painkillers in Russia is difficult for everyone, whether they have cancer or not. It can take up to three days for adults, according to Meduza, and for children up to 12 days.

Here’s what cancer patients have to do:

First they visit a general practitioner at a clinic, who will assess their pain levels and send them to an oncologist. The oncologist will then write up an assessment and send the patient back to the general practitioner, who will write up a prescription. The head of the clinic must then stamp the prescription, which is only valid for five days.

Clinics typically forward prescriptions to pharmacies at 4 pm – so if a patient doesn’t have a prescription approved by then, they have to wait until the next day.

All of these steps leading to long lines at the clinic, the oncologist and the pharmacy. The final indignity for patients is that they have to return the used containers and packaging from their previous medication to get a new one.

Adding to the stigma is that narcotic painkillers have long been deemed unnecessary in Russia – dating back to Soviet times. Patients who use the drugs are often treated like addicts and doctors who prescribe narcotics are sometimes punished as criminals.

This has led to a thriving black market for painkillers and soaring prices for pain medication that are sold legally. The government is reported to be conducting checks of pharmacies in major cities to protect against price gouging.

Meduza’s story about the suicides sparked a backlash and a heavy-handed attempt by the government to prevent other websites from reporting on poor access to pain medication. The pretext given for the censorship was a 2012 Russian law that prohibits online content advocating suicide and drug use. Any website violating the law can be blocked by the government.

One site was told to delete copy that simply said: "The wife of the deceased explained that her husband suffered from constant pain because of cancer and often said he was tired of being sick."

Moscow's deputy mayor disputed the notion that the suicides were in any way connected to lack of access to painkillers -- claiming that at least seven of the 11 people who killed themselves were unaware they had cancer.

The deputy head of the Russian Federation Council's constitutional law committee disputed the notion that forcing websites to delete information would prevent more suicides.

"The information about the reasons for suicides by cancer sufferers is socially significant in this case,” Senator Konstantin Dobrynin told the state news agency RIA Novosti. “Covering up such information could lead to even more victims."

The World Health Organization ranks Russia 38th out of 43 European countries in access to painkillers, but the problem isn’t unique to Russia.

According to one recent study, pain medications such as morphine and codeine were not widely available or virtually non-existent in a dozen eastern European countries stretching from Poland to Turkey.

'National Pain Strategy' Report Released

By Pat Anson, Editor

The National Institutes of Health has quietly released a draft copy of its National Pain Strategy, a long awaited report designed to advance pain research, healthcare and education in the U.S.

The report calls chronic pain a “complex disease and a threat to public health” and identifies several areas where physicians and the healthcare system are failing pain sufferers.

“Access to high-quality integrated care based on clinical evidence is hindered by many challenges, including a payment system that does not support optimal care. Pain management often is limited to pharmacological treatment offered by a single primary care practitioner or to procedure-oriented and incentivized specialty care that is not coordinated and not aligned with the best available evidence or expected outcomes,” the report says.

“Even when interdisciplinary care is provided, creating and executing a care plan is often fragmented, with poor communication among clinicians and without consideration of patient preferences. The clinician or team’s choice of therapy may be based on practice experience or on insurance coverage, rather than one informed by a comprehensive pain assessment, clinical evidence or best practices.”

The report only briefly addresses the controversy over the abuse and diversion of opioid painkillers, and how some pain sufferers are being denied pain medication by their doctors and pharmacists.

“The reluctance of many clinicians to prescribe these medications, and patients’ concerns over stigmatization associated with opioids may jeopardize quality pain control in the population. Only a small percentage of practitioners and patients account for the majority of opioid-related risk through abuse of prescribing privileges and inappropriate management of prescriptions,” the report said.

Other key findings of the report:

• People with pain are too often stigmatized in the health care system and in society, which can lead to delayed diagnosis, misdiagnosis, and bias in treatment.
• Significant barriers to pain care exist, especially for populations disproportionately affected by pain.
• Although pain is widespread in the population, research is lacking on the prevalence, impact, and outcomes of most common chronic pain conditions.
• Significant improvements are needed in pain management practices.
• Primary care doctors are not sufficiently trained in pain assessment and treatment.  
• Greater collaboration is needed between primary care doctors and pain specialists.

“I agree that collaboration between primary and pain specialists is helpful in some cases, though I do not believe it is mandatory,” said Celeste Cooper, a retired nurse and patient advocate who reviewed the report.

“To think that a primary physician cannot complete continuing education courses for management of mild to moderate chronic pain is ridiculous. Primary physicians are on the front lines. They will be held accountable for prevention strategies, but they aren’t able to make assessments for treating pain? This seems like tying their hands behind their backs.’

The National Pain Strategy is an outgrowth of the 2011 Institute of Medicine report, “Relieving Pain in America,” which found that 100 million Americans suffer from chronic pain.

One critic of the new report says it lacks vision and will not make pain care better.

 “I think the report reflects that it has been developed by (and for) special interest groups who are not very skilled at planning or project management. This report is ungainly and lacks a real focus -- and so I think people in pain will be wondering what exactly they can expect to be different and better for them,” said patient advocate David Becker in an email to Pain News Network.

“I think it is unethical for special interest groups to assume that any and every individual in pain cannot be cured and should not receive stem cell therapy or other curative/regenerative care. In this regard, it reinforces the received view -- and a self- serving view -- that people in pain should be treated indefinitely by medical care."

While not perfect, Cooper said she was encouraged by the report's recommendations.

"Looking at chronic pain as a public health issue is the right approach in my opinion. It will avail resources that wouldn’t otherwise be accessible. The report is comprehensive, there will be roadblocks in implementing all the suggestions, but hopefully generations to come will benefit. As an educator, I was impressed on seeing short-term to long-term goals. This strategy provides a mechanism for reassessment and revision," Cooper said in an email.

The Interagency Pain Research Coordinating Committee is accepting public comments on the National Pain Strategy until May 20, 2015.

Comments can be emailed to NPSPublicComments@NIH.gov.

When Your Body Betrays You

By Jennifer Martin, Columnist

I remember very vividly the day I first began thinking about how much my body has betrayed me. It wasn’t too long after I got home from spending nearly six weeks in the hospital.  I was recovering from my first j-pouch surgery. 

I was sitting on the couch at my mother and stepfather’s house, feeling depressed, weak and hopeless.  I couldn’t see the light at the end of the tunnel.  These were emotions I had not experienced to this extent before; even after the years of ups and downs I had had living with rheumatoid arthritis and ulcerative colitis.

I remember my mom telling me, “You need to work through these feelings of depression.  We need to get you out of the house.  Staying inside all day isn’t going to help.  Let’s go to the harbor so you can at least sit outside and be around people.”

My husband told me, “You need to fight.  I can’t fight for you if you are going to give up.”

My stepdad said to me, “You are strong.  I know you can get through this.  We are all here for you.”

While I appreciated all of these sentiments, all I wanted to do was scream at them, “You have no idea what I need!  I am not strong!  I don’t want to do this anymore!” 

And I wanted to scream at my body, “How could you do this to me? Why are you doing this to me?” 

I had never felt so lost and confused.  And I had never felt so betrayed by my own body, which at the time struck me as odd, seeing as I had been living with chronic illness and pain my whole life.

What I eventually learned from that horrible day was that my family was right.  The only way you can begin to resolve these feelings of body betrayal is to do something about it;  to learn to cope with your chronic pain or chronic illness, even if you don’t want to. 

Trust me, the last thing I wanted to do that day was to go out in public looking as sick as I did and feeling like I was about to collapse.  I had no idea how I was even supposed to make it from the car to the nearest bench to sit down.  But I did, and while I’m not going to claim that it fixed everything, it did help my mood somewhat. 

At that time I was angry at my husband because I felt like he was putting a lot of pressure on me.  I felt like in order to fight I had to put on a happy face all of the time and that I was not allowed to experience my pain or sorrow in front of him.  

After giving what he said some thought however, I realized what he meant.  He didn’t mean that I was never allowed to feel sorry for myself and he didn’t mean that I was never allowed to complain or cry. 

What he meant was that I was the only one who had control over how I dealt with my situation and the upcoming struggles I was still to have.  I could either  give in and give up or I could find a way to work through what I was going through.  He couldn’t do that for me.

I remember wanting to tell my stepdad that I felt the complete opposite of strong.  I also remember feeling guilty for the support my family was giving me.  I felt like a burden and I didn’t want them to give up so much just for me.  It didn’t feel fair and it didn’t feel right that just because I was going through something so terrible they had to go through it with me. 

Looking back on my experience, I realize how lucky I was and still am to have that kind of support.  It is so important for those experiencing chronic pain or chronic illness to have a support system, whether it is one friend, a support group or a whole clan of people.

I have learned that all you can do in those moments when you feel your body has betrayed you is do what you can.  We don’t have control over the chronicity of our conditions.  However, as much as it doesn’t seem like it at times, we do have control over how we choose to approach our condition. 

We can learn to cope by:

• participating in enjoyable activities when we feel well
• advocating for our health
• taking our medications
• getting help when we feel depressed or anxious
• exercising when we have the energy and aren’t in too much pain
• making sure we aren’t isolating ourselves from friends and family
• resting when we do not feel well
• focusing on the positive things in our lives
• learning to manage the guilt we may feel

We can give in to all of the negative thoughts, or we can learn how to combat negative thinking.

We can let our pain or illness define us or we can learn how not to let that happen.

We can give in and give up, or we can fight. 

Jennifer Martin, PsyD, is a licensed psychologist in Newport Beach, California who suffers from rheumatoid arthritis and ulcerative colitis. In her blog “Your Color Looks Good” Jennifer writes about the psychological aspects of dealing with chronic pain and illness. 

Jennifer is a professional member of the Crohn’s and Colitis Foundation of America and has a Facebook page dedicated to providing support and information to people with Crohn’s, Colitis and Digestive Diseases, as well as other types of chronic pain.

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

FDA Issues Guidance on Abuse Deterrent Opioids

By Pat Anson, Editor

The U.S. Food and Drug Administration has released its long-awaited guidance on abuse-deterrent opioids, beating a Congressional deadline and a potential loss of $20 million in funding.

The document “Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling” explains the FDA’s current thinking about abuse-deterrent properties and recommends to drug makers how clinical studies should be conducted to evaluate their effectiveness.

Abuse deterrent formulas are intended to make it harder for drug abusers to crush or liquefy a narcotic painkiller for snorting or injecting. But the evidence is mixed that they actually work.

“It should be noted that these technologies have not yet proven successful at deterring the most common form of abuse — swallowing a number of intact capsules or tablets to achieve a feeling of euphoria. Moreover, the fact that a product has abuse -deterrent properties does not mean that there is no risk of abuse.  It means, rather, that the risk of abuse is lower than it would be without such properties. Because opioid products must in the end be able to deliver the opioid to the patient, there may always be some abuse of these products,” the FDA said in its report.

The agency has been under pressure from Congress to move faster in developing guidelines for abuse deterrence. An appropriations bill passed late last year would have moved $20 million in funding from the FDA’s Commissioner’s office if the guidance wasn’t released by June 30.

“The science of abuse-deterrent medication is rapidly evolving, and the FDA is eager to engage with manufacturers to help make these medications available to patients who need them,” said FDA Commissioner Margaret Hamburg, MD. “We feel this is a key part of combating opioid abuse. We have to work hard with industry to support the development of new formulations that are difficult to abuse but are effective and available when needed.”

So far only four opioids have been approved with abuse-deterrent formulas, OxyContin, Embeda, Targiniq and Hysingla. The latter was recently introduced by Purdue Pharma as the only “pure” hydrocodone extended release product with abuse-deterrence.

Purdue’s reformulated version of OxyContin was the first opioid to have abuse deterrence. It was introduced in 2010, at a time when the painkiller was widely being abused.

A recent study by researchers at Washington University’s School of Medicine in St. Louis found that over a quarter of drug abusers entering treatment facilities admitted they still abused OxyContin. About a third of the abusers said they had found a way to inhale or inject it. The rest took the painkiller orally.

One unintended consequence of reformulating OxyContin is that 70% of the drug abusers who stopped using it and who switched to other narcotics started using heroin.

"The newer formulations are less attractive to abusers, but the reality is -- and our data demonstrate this quite clearly -- it's naïve to think that by making an abuse-deterrent pill we can eliminate drug abuse. There are people who will continue to use, no matter what the drug makers do, and until we focus more on why people use these drugs, we won't be able to solve this problem,” said senior investigator Theodore J. Cicero, PhD, a professor of neuropharmacology in psychiatry.

Some patients believe the reformulated version of OxyContin is less effective as a pain reliever and causes gastrointestinal problems because it is harder to digest.

The FDA said it would take “a flexible, adaptive approach” to the future evaluation and labeling of abuse-deterrent products.

“Development of abuse-deterrent products is a priority for the FDA, and we hope this guidance will lead to more approved drugs with meaningful abuse-deterrent properties,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research.

“While abuse-deterrent formulations do not make an opioid impossible to abuse and cannot wholly prevent overdose and death, they are an important part of the effort to reduce opioid misuse and abuse.”

Over 16,500 deaths in the U.S. were linked to opioids in 2010. According to the National Institutes of Health, only about 5% of patients taking opioids as directed for a year end up with an addiction problem.

Acetaminophen Ineffective for Back Pain

By Pat Anson, Editor

The world’s most widely used over-the-counter pain reliever is ineffective in treating low back pain and provides little benefit to people with osteoarthritis, according to a new study published in the British Medical Journal.

In a systematic review of a dozen research reports (a study of studies), Australian researchers also questioned many of the conventional treatments for back pain and other musculoskeletal conditions.

Acetaminophen -- also known as paracetamol – is the active ingredient in Tylenol, Excedrin, and hundreds of other pain medications. It is often recommended by doctors worldwide for back pain and osteoarthritis.

"Clinicians should carefully weigh benefits and harms when making treatment decisions. Paracetamol is not efficacious and potentially harmful. In this context we cannot justify its continued use for these prevalent diseases,” said Professor David Hunter of the University of Sydney.

The researchers found “high quality” evidence showing that patients taking acetaminophen are at greater risk of liver toxicity and nearly four times more likely to have abnormal results from liver function tests.

"World-wide, paracetamol is the most widely used over-the counter medicine for musculoskeletal conditions so it is important to reconsider treatment recommendations given this new evidence," said lead author, Gustavo Machado of The George Institute and the University of Sydney.

Low back pain is the leading cause of disability worldwide, and osteoarthritis of the hip or knee is the 11th highest contributor to global disability.

"This latest research, the most comprehensive systematic review of its kind, reaffirms this with an even larger, global patient base, and has for the first time also established that the effects of paracetamol for knee and hip osteoarthritis are too small to be of clinical importance." said senior author Manuela Ferreira of the George Institute for Global Health and the University of Sydney.

"We urgently need to take stock of the evidence for common musculoskeletal conditions, a largely under-recognized health priority, and make sure people are receiving appropriate care."

Treatments known to be effective for low back pain include counseling, physical therapy, exercise and psychological therapies such as cognitive behavioral therapy.

Aerobic exercise, strengthening exercise, weight management and anti-inflammatory medicines have been shown to provide benefit for patients with lower limb osteoarthritis.

A recent study published in The Lancet found that acetaminophen had no effect on pain, disability, function, sleep quality, or quality of life for people with low back pain.

Over 50 million people in the U.S. use acetaminophen each week to treat pain and fever. The pain reliever has long been associated with liver injury and allergic reactions such as skin rash. In the U.S. over 50,000 emergency room visits each year are caused by acetaminophen, including 25,000 hospitalizations and 450 deaths.

Study Claims 10% of Pain Patients Addicted to Opioids

By Pat Anson, Editor

Estimating rates of opioid abuse and addiction has never been easy. Dozens of different studies have come to startling different conclusions, and there is even disagreement over the definition of abuse and addiction.

Now a professor at the University of New Mexico is weighing in on the subject -- and his conclusions are likely to stir even more debate.

In a systematic review of 38 research reports (a study of studies) published in the journal PAIN, lead author Kevin Vowles and his colleagues estimate that up to 30 percent of the opioids prescribed for pain are misused and that about 10 percent of pain patients are addicted to them.

They also question whether opioids should be prescribed at all for chronic pain.

“It is not clear whether the risks of opioid use outweigh the potential for benefit. The efficacy of opioids and their suitability for the long-term management of chronic pain still remain very much in question and while this uncertainty in effectiveness is well established, it stands in somewhat stark contrast to the clinical reality of chronic pain treatment, where rates of prescriptions have skyrocketed such that opioids are now among the most frequently prescribed medications,” wrote Vowles.

“We are not certain whether the benefits derived from opioids, which are rather unclear based on the extant literature, compensate for this additional burden to patients and health care systems.”

The researchers noted there was extremely wide variation in the rates of opioid misuse and addiction in the studies they analyzed. Rates of “problematic use” ranged from less than 1% all the way up to 81%.

One study -- a review of 25 research reports – left the barn door wide open by broadly estimating the “prevalence of problematic opioid use behavior” at 0% to 50% of pain patients.

“The vagueness inherent in these definitions, areas of overlap among them, and their sometimes interchangeable use have made it difficult to determine exact rates and types of problematic opioid use,” conceded Vowles.

Exactly what constitutes opioid misuse is also debatable.

Vowles defined misuse as “opioid use contrary to the directed or prescribed pattern of use, regardless of the presence or absence of harm or adverse effects.” Such a definition means a patient who has stopped using a prescribed opioid – even if they no longer have pain – is misusing the medication.

(Several years ago this writer was sent home from the hospital after surgery with a two week supply of Vicodin. Fortunately, the surgery was successful and the pain subsided after a few days. A half empty bottle of Vicodin sat unused in my medicine cabinet for years before I had sense enough to throw it out. Under Vowles’ definition, I had “misused” the Vicodin.)

Studies by some of the nation’s largest drug screening companies consistently show that many Americans don’t take the drugs that are prescribed for them. A large study by Quest Diagnostics found that 60% of Americans failed to take a medication as prescribed by their physicians and that 42% had no drugs in their system. Should they be included in estimates of misuse?

Rates of addiction in the studies analyzed by Vowles also varied greatly – from 0.7% of pain patients up to 34.1%.

An adjusted analysis by Vowles estimated the average rate of addiction at 8% to 12% -- a figure nearly double the estimate of the National Institutes of Health (NIH). According to the NIH, only about 5% of patients taking opioids as directed for a year end up with an addiction problem.

“Misuse, abuse and addiction mean different things to different researchers,” said Lynn Webster, MD, past president of the American Academy of Pain Medicine and vice president of scientific affairs at PRA Health Sciences.

“We must keep in mind that behaviors determine the diagnoses of misuse, abuse and addiction and these behaviors are subjective interpretations. Subjective interpretations are influenced by one's biases and perspective.  Misuse to one researcher can be addiction to another. Unfortunately there has not been a standard interpretation of behaviors and I doubt there ever will be due to personal beliefs about opioids and addiction.”  

While Webster doesn’t take issue with the design of the study – he does dispute the overall conclusion that the risks of opioid abuse outweigh the benefits.  

“It is undoubtedly true that some people should not be prescribed opioids.  But even using their reported averages for abuse and addiction, a majority of people do not abuse or become addicted and therefore shouldn't necessarily be denied treatment particularly if there is no other option,” Webster wrote in an email to Pain News Network. 

Ironically, only one study analyzed by Vowles even looked at the recreational abuse of opioids – perhaps the biggest contributor to the so-called “epidemic” of prescription drug abuse in the U.S.  That study estimated the rate of abuse by pain patients at just 8% -- far below their estimated rates of misuse.

Vowles admits there are several limitations to his study.

“The most obvious is the degree of variability within this literature. In spite of our attempts to minimize the impact of this variability, the range of misuse and addiction was incredibly broad,” he wrote.

“These sources of variability will likely continue to cloud our ability to make precise estimates. There is clearly room here for a series of carefully controlled studies where sources of variability are held constant, or as constant as possible, to more clearly illuminate prevalence rates of problematic opioid use in individuals with chronic pain.”

Knee Osteoarthritis Raises Risk of Early Death

By Pat Anson, Editor

Osteoarthritis is painful no matter where it occurs – in the hip, fingers, elbow or other joints. But osteoarthritis of the knee seems to be particularly troublesome for middle-aged women. 

British researchers say knee osteoarthritis significantly raises the risk of cardiovascular disease and can even lead to early death.

In a study of early mortality in middle-aged women with osteoarthritis, researchers looked at data collected by the Chingford Study, which followed the health over 1,000 British middle-aged women for over two decades.

They found that osteoarthritis of the knee was strongly associated with early overall death and cardiovascular mortality. Women with knee pain and radiographic osteoarthritis had almost two times greater risk of early death and over three-times increased risk of dying from a cardiovascular event, when compared with women without knee pain or osteoarthritis. 

No link was found between hand osteoarthritis and a higher risk of mortality. 

“These findings suggest that any self-reported knee pain in osteoarthritis, as opposed to hand pain, seems to be a crucial factor leading to early cardiovascular mortality and is likely to be linked with decreased mobility. Radiographic osteoarthritis without pain is not affecting long-term mortality. More research is needed to understand how people adapt to knee pain, and how this leads to cardiovascular impairment,” said lead author Stefan Kluzek, PhD, of the Arthritis Research UK Centre of Excellence for Sport, Exercise and Osteoarthritis at the University of Oxford.

Researchers did not examine the reasons for the higher death rate, but an earlier look at data from the Chingford study found that women with knee OA were more likely to have hypertension, raised blood glucose, and moderately raised serum cholesterol.

Osteoarthritis is a joint disorder that leads to thinning of cartilage and progressive joint damage. Knee osteoarthritis is quite common and affects over 250 million people worldwide. Nearly 40 percent of Americans over the age of 45 have some degree of knee OA, and those numbers are expected to grow as the population ages.

A Pained Life: Depression is Allowed

By Carol Levy, Columnist

"You're depressed."

Friends say it. Family may say it. Sometimes doctors say it.

Well, duh. We live with pain for much of the day or all day long. It is hard not to be depressed!

Our lives have been changed in ways we never could have imagined. Pain is the boundary by which we live. Can I do this, go there, be with people, or work?

Pain is often the arbiter. I want to do something, but the pain tells me I can't.

How depressing. How sad.

Does that then mean we are psychiatrically ill? Does it mean that the pain is, as many of us have been told, "All in your head?"

I won't deny that for some patients the pain is psychosomatic or has a large psychological and emotional component. But for most of us the diagnosis is firm, the pain real and physical.

Interestingly and sadly however, MedicineNet.com and many other sources include this in their definition and description of what causes depression: “Chronic pain that does not respond to treatment.”

And yet when you click the link for "chronic pain" they do not refer to it being psychosomatic or having psychosomatic causes.

How many of us continue with treatments, procedures, and surgeries despite a lack of benefit? Does that automatically translate into psychogenic origin?

The questions arise. Did depression cause my pain? Would my illness not have appeared if I wasn’t depressed? Is that answerable? Would an answer matter?

What I do know is that depression carries with it not only a feeling of persistent sadness, but feelings of hopelessness and helplessness.

And how can we not feel hopeless, and helpless, when at one time or another most of us hear these kinds of statements from our doctors:

"There is no cure. You’ll have to learn to live with it.”

“I don't have an answer for why you have the pain you do.”

“There is nothing left to try.”

I remember being upset the first time I was prescribed an antidepressant. My doctor had to reassure me, "No, Carol. These drugs can work on the pain. I am not giving it to you because I doubt your pain is real."

Whether we have depression arising from pain or depression causing our pain to appear, it is worth trying to deal with it, through counseling and maybe medication too.

I often hear people with chronic pain ask if their shortness of breath, weakness, insomnia, etc. could be related to the fibromyalgia, back pain, neuropathy or whatever condition they suffer from.  It is easy to think that all our physical changes and complaints come from our diagnosed illnesses. It is harder to see past what we know we have.

I think the same is true for depression. Even if we get relief from pain, the depression may still be there.

It is incumbent on doctors -- and us -- to accept that a psychological issue and diagnosis may exist separate and distinct from our chronic pain.

It is important that our psychological state be seen as equally important, worthy, and possibly separate from our chronic pain. And we need to allow ourselves the acceptance of a dual diagnosis, even if it is a psychological one.

Carol Jay Levy has lived with trigeminal neuralgia, a chronic facial pain disorder, for over 30 years. She is the author of “A Pained Life, A Chronic Pain Journey.” 

Carol is the moderator of the Facebook support group “Women in Pain Awareness.” Her blog “The Pained Life” can be found here.

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

Racial Disparities Found in Joint Replacement Surgery

By Pat Anson, Editor

Black, Hispanic and Medicaid patients are significantly more likely to be readmitted to the hospital after total joint replacement (TJR) surgery, while women are less likely to suffer complications, according to new studies presented at the annual meeting of the American Academy of Orthopaedic Surgeons in Las Vegas.

In one study, researchers analyzed race and ethnic data on nearly 53,000 patients admitted to Connecticut hospitals for TJR from 2008 to 2012. The average patient was 67 years of age, white, female and covered by Medicare.

Patients who were African-American were 62% more likely to be readmitted to the hospital within 30 days of TJR. Hispanic patients were 50% more likely and Medicaid patients were 40% more likely to be readmitted than patients with private insurance.

"Our study shows that black patients who undergo total knee replacement may have poorer outcomes," said lead study author and orthopedic surgeon Courtland Lewis, MD. "After controlling for two key variables implicated in race and ethnic disparities in hospital readmission -- preoperative comorbidities and type of insurance coverage -- black patients still have a 35 percent higher likelihood of all-cause, 30-day readmission compared to white patients.”

Lewis said the disparity with white patients may be due to black patients having less access to primary care and less communication with health care providers.

Racial disparities in health care have long been documented, including that black patients utilize hip and total knee replacement at rates nearly 40 percent less than white patients, despite having higher rates of osteoarthritis—a leading cause of joint deterioration. Total hip and knee replacements are common surgical treatments for late-stage arthritis.

The overall 30-day readmission rate for patients in the study was about 5 percent. The most common reasons for readmission were postoperative infection, inflammatory reaction due to a joint prosthesis, hematoma complications, and dislocation of a prosthetic joint.

A second study looked at nearly 60,000 knee and hip replacements at a hospital in Ontario, Canada. Researchers found that men were 15% likely than women to return to the emergency department within 30 days of TJR surgery – even though women who had the surgery were older and more likely to be frail. Over half the patients in the study were women.

The findings contradict the theory that TJR is underutilized in female patients because they have worse outcomes then men.

"Despite the fact that women have a higher prevalence of advanced hip and knee arthritis, prior research indicates that North American women with arthritis are less likely to receive joint replacement than men," said lead study author Bheeshma Ravi, MD, an orthopaedic surgery resident at the University of Toronto. "One possible explanation is that women are less often offered or accept surgery because their risk of serious complications following surgery is greater than that of men.

"In this study, we found that while overall rates of serious complications were low for both groups, they were lower for women than for men for both hip and knee replacement, particularly the latter" said Dr. Ravi. "Thus, the previously documented sex difference utilization of TJR cannot be explained by differential risks of complications following surgery." 

Men in the study were found to be up 70 percent more likely to have a heart attack within three months of TJR surgery and 70 percent more likely to have an infection or require revision surgery within two years of a total knee replacement.

Depression and Obesity Raise Risk of Low Back Pain

By Pat Anson, Editor

Depression, obesity, smoking, and alcohol use significantly raise the risk of having low back pain, according to a large new study presented at the annual meeting of the American Academy of Orthopaedic Surgeons.

“The results were pretty surprising to us. We kind of expected to find a significant difference but not to that extent,” said lead study author and orthopedic surgeon Scott Shemory, MD.

Shemory and his colleagues at Summa Health and the Crystal Clinic Orthopedic Center in Akron, Ohio reviewed the health records of over 26 million patients from 13 health care systems in the U.S. Of those 26 million patients, 1.2 million were diagnosed with lower back pain.

Researchers then analyzed the records to see if the patients with low back pain had any of the four modifiable risk factors: obesity, depressive disorders, alcohol and tobacco use.

• 19.3% of low back pain patients were depressed
• 16.75% were obese with a body mass index (BMI) over 30
• 16.53% were nicotine dependent.
• 14.66% abused alcohol

The study did not address the “chicken and egg question” of which came first. Do depression and obesity cause low back pain, or does low back pain lead to depression, obesity and other risk factors?

“With our study there was no way to determine the cause and the effect or which came first because there was so much overlap,” Shemory told Pain News Network.

“Especially with alcohol abuse and depressive disorders. Anybody who’s got low back pain for years and years, I don’t think it would be surprising that they would have a higher chance of depression or alcohol abuse.”

Regardless of which came first, Shemory says patients should take steps to improve their health by eliminating risk factors that they can control.

“If a patient has any of these risk factors and has low back pain that doesn’t have a neurogenic cause, like a pinched nerve or something like that, I would be counseling them on trying to control these risk factors, not just for their general health but their back pain and livelihood as well,” he said.

According to the National Instituteof Neurological Disorders and Stroke, about 80 percent of adults experience low back pain at some point in their lives. It is the most common cause of job-related disability and a leading contributor to missed work days. One large survey found that over a quarter of adults reported having low back pain during the past 3 months.

Accepting Chronic Pain: Is it Necessary?

By Jennifer Martin, Columnist

A patient of mine told me the other day, “I don’t think I will ever be able to accept my chronic pain. It has completely changed my life.” 

I think this is something that most people with chronic pain contend with at some point in time; wanting to hold onto hope that their diagnosis isn’t chronic or not wanting to come to the realization that they will have to live with the pain forever.

When most people hear the word “acceptance” they equate it with the notion that they should feel that it’s okay or it’s alright to have a chronic condition.  Many people don’t ever feel okay about having to live with pain or an illness for the rest of their lives. It is not something that is easy to get used to and it’s not fair.

• Accepting chronic pain does not mean giving into it and it doesn’t mean that you stop looking for treatment.
• Accepting chronic pain does not mean accepting a lifetime of suffering.
• Accepting chronic pain does not mean you are never allowed to feel angry or sad.
• Accepting chronic pain does not mean that you have to give up hope for the future.

When I use the word “acceptance,” I mean accepting the reality of your situation and recognizing that this new reality could be permanent. Those of us with chronic conditions may never like this reality and it may never be okay, but eventually it is necessary to accept it and learn to live life with it. It is the new norm with which we must learn to live.

Acceptance also involves making adaptations and alterations to our lives.  We must find new things that bring us joy and we must have hope for the future.

• Accepting chronic pain means learning to live again.
• Accepting chronic pain means advocating for ourselves and our health so that we can be as healthy as possible.
• Accepting chronic pain means learning our limits and learning to cope with feelings of guilt when we have to say “no.”
• Accepting chronic pain means being able to look at your diagnosis as something you have, not who you are.  Your condition does not define you.
• Accepting chronic pain means re-evaluating your role as a husband/wife, mother/father, etc. as well as your life’s goals -- and figuring out how you can maintain these roles and attain your goals with your chronic condition.

For many of us, learning to accept our chronic condition isn’t easy.  It is a learning process with a lot of ups and downs.  It is something we may resist and something we may think impossible.  It is difficult to accept something that has completely changed our lives and possibly the direction we thought our life was going to take.

Why is it necessary to accept your chronic condition?

Once you are diagnosed with a chronic condition, it will be always be with you.  The sooner you are able to begin the process of acceptance, the sooner you will be able to learn exactly how to live with it.  It is also how you will learn to cope.

Accepting chronic pain means learning to live life in a different way than before your diagnosis.  It means learning to pace your activities, educating yourself, taking your medications, advocating for yourself, and surrounding yourself with support.  It also means accepting that some aspects of your condition are out of your control. 

Chronic pain can be unpredictable.  There may be days when you feel in control of your pain and you are able to accomplish everything you would like to.  There may also be days when your pain is unbearable, you feel angry about your situation, and all you can do is rest.  Accepting your chronic pain means adjusting and adapting to the ways in which your life is different now that you may be living with this kind of unpredictability.

Your life may never go back to what it was prior to your chronic pain.  But that doesn’t mean you can’t live a happy, successful, hopeful life with pain.  Learning to accept your chronic pain can help you get there.

Jennifer Martin, PsyD, is a licensed psychologist in Newport Beach, California who suffers from rheumatoid arthritis and ulcerative colitis. In her blog “Your Color Looks Good” Jennifer writes about the psychological aspects of dealing with chronic pain and illness. 

Jennifer is a professional member of the Crohn’s and Colitis Foundation of America and has a Facebook page dedicated to providing support and information to people with Crohn’s, Colitis and Digestive Diseases, as well as other types of chronic pain.

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