Chronic Fatigue Patients ‘Disrespected and Rejected’

By Pat Anson, Editor

An independent panel convened by the National Institutes of Health is calling for major changes in the way the healthcare system treats people suffering from chronic fatigue – a complex and poorly understood disorder that affects an estimated one million Americans, most of them women.

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is characterized by extreme fatigue, chronic pain, impaired memory, insomnia, and other symptoms that do not improve with rest.  Many of the symptoms overlap with other diseases and disorders -- including fibromyalgia, depression, and inflammation – making a correct diagnosis even more difficult.

There is also a stigma often associated with chronic fatigue.

“Both society and the medical profession have contributed to ME/CFS patients feeling disrespected and rejected. They are often treated with skepticism, uncertainty, and apprehension and labeled as deconditioned or having a primary psychological disorder,” the panel states in its final report.

“ME/CFS patients often make extraordinary efforts at extreme personal and physical costs to find a physician who will correctly diagnose and treat their symptoms while others are treated inappropriately causing additional harm.”

Although the economic burden of chronic fatigue is estimated at between $2 billion and $7 billion annually, the panel said there has been “minimal progress” in improving the state of science for ME/CFS over the last 20 years. There are no pathogens linked to chronic fatigue, no diagnostic tests and no known cures.

"We need to learn more about the cellular and molecular mechanisms of this disease and how immunologic, neurologic, and other factors contribute to ME/CFS," said Carmen Green, MD, the panel’s chair and professor of anesthesiology, obstetrics and gynecology, and health management and policy at the University of Michigan Schools of Medicine and Public Health.

"We need to fund more studies that can be easily reproduced, and we must gain a better understanding of how ME/CFS affects people and their families in terms that are clinically meaningful to them. In addition, we need to have a greater understanding of the impact of ME/CFS across the life span, especially in underserved and vulnerable populations."

What little research that has been done has focused on Caucasian, middle-aged women.  The panel said new studies need to include children, minorities, men, patients living in rural areas, and those who are homebound.

To address these knowledge gaps, the panel is calling for more research and opportunities for new investigators to study ME/CFS. It also called for the creation of a repository of biological samples from chronic fatigue patients (e.g., serum, whole blood, RNA, DNA) to support new studies.

In addition, the panel recommended new educational training courses to help health care providers diagnose and treat ME/CFS.

"ME/CFS exists, and despite the absence of a clear definition, an estimated one million Americans are affected by it," said Green. "In order to develop primary prevention strategies and effective drug treatments, there needs to be a clear understanding of its causes and the populations it affects."

Much of the information gathered by the panel came during a public workshop and public comment period in December of last year. The five member panel, which included Penney Cowan of the American Chronic Pain Association, operated as an independent commission. Its final report is not a policy statement of the NIH or the federal government, and there are no guarantees its recommendations will be funded or acted upon.

Value of Arthroscopic Knee Surgery ‘Inconsequential’

By Pat Anson, Editor

Arthroscopic knee surgery on older adults has become a routine procedure in North America and Europe – with over 850,000 arthroscopies performed every year to relieve knee pain in the UK and the United States alone.

But a new study published in the The BMJ questions the evidence behind the procedure and calls the benefit of knee surgery “inconsequential.” The article is part of The BMJ's “Too Much Medicine” campaign, which highlights the waste of resources and potential harm caused by unnecessary medical care.

“The small inconsequential benefit seen from interventions that include arthroscopy for the degenerative knee is limited in time and absent at one to two years after surgery,” the report says. “Taken together, these findings do not support the practice of arthroscopic surgery for middle aged or older patients with knee pain with or without signs of osteoarthritis.”

Knee arthroscopies are a type of “keyhole” surgery in which the surgeon makes a small incision in the knee and inserts a tiny camera and instruments to diagnose and repair damaged ligaments or torn meniscus. Many specialists are convinced of the benefits of the surgery.

But when researchers in Denmark and Sweden reviewed 18 studies on arthroscopic knee surgery, they found that half were of poor quality or lacked a placebo control. The other nine studies found that the surgery provided pain relief for up to six months, but without any significant benefit in physical function.

Risks associated with arthroscopic knee surgery, although rare, include deep vein thrombosis (DVT), infection, pulmonary embolism, and death.

"It is difficult to support or justify a procedure with the potential for serious harm, even if it is rare, when that procedure offers patients no more benefit than placebo," argues Professor Andy Carr from Oxford University’s Institute of Musculoskeletal Sciences in an accompanying editorial.

With rates of knee surgery at their current level, Carr says thousands of lives could be saved and DVTs prevented each year if the procedure was discontinued or diminished.

“We may be close to a tipping point where the weight of evidence against arthroscopic knee surgery for pain is enough to overcome concerns about the quality of the studies, confirmation bias, and vested interests. When that point is reached, we should anticipate a swift reversal of established practice,” Carr wrote.

The BMJ study is not the first to question the value of arthroscopic knee surgery.  A 2014 report by a German health organization found the procedure provides no benefit to patients with osteoarthritis, and does not relieve pain any better than physical therapy or over-the-counter pain medications.

Another large study in Australia also questions the value of arthroscopic knee surgery, finding there was no significant benefit for osteoarthritis patients.

The American Medical Society for Sports Medicine (AMSSM) lists arthroscopic knee surgery as one of five procedures that are not always necessary in the Choosing Wisely campaign. The AMSSM advises physicians to avoid recommending knee arthroscopy as a treatment for patients with degenerative meniscal tears.

Depending on insurance, hospital charges and the surgeon, arthroscopic knee surgery costs about $4,000.

Aleve & Other Pain Relievers Reduce Fertility in Women

By Pat Anson, Editor

Health experts have warned for years about the side effects of over-the-counter pain relievers – everything from liver failure to heart disease to hearing loss.

Now researchers are saying that Aleve and some other non-steroidal anti-inflammatory drugs (NSAIDs) reduce the fertility of women so significantly they could potentially be used as an emergency form of contraception.

The results of a small study presented at the European League Against Rheumatism Annual Congress show that three NSAIDs --  naproxen, diclofenac, and etoricoxib -- inhibited ovulation in women after just a few days of treatment.

Naproxen, diclofenac, and etoricoxib are the active ingredients in several brand name drugs sold around the world, including Aleve, Voltaren, and Arcoxia, respectively. Etoricoxib is not approved for use in the United States.

Thirty nine Iraqi women of childbearing age who suffered from back pain took part in the study; receiving diclofenac (100mg once daily), naproxen (500mg twice daily), etoricoxib (90mg once daily), or a placebo.

Treatment was given for 10 days from day 10 of the onset of their menstrual cycle, with their progesterone levels and follicle diameter analyzed via blood sample and sonography.

“After just ten days of treatment we saw a significant decrease in progesterone, a hormone essential for ovulation, across all treatment groups, as well as functional cysts in one third of patients,” said study investigator Professor Sami Salman, Department of Rheumatology, University of Baghdad.

“These findings show that even short-term use of these popular, over-the-counter drugs could have a significant impact on a woman's ability to have children. This needs to be better communicated to patients with rheumatic diseases, who may take these drugs on a regular basis with little awareness of the impact.”

Of the women receiving NSAIDs, only 6.3% taking diclofenac, 25% taking naproxen, and 27.3% taking etoricoxib ovulated, compared with 100% of the control group that was not taking a pain reliever.

The dominant follicle remained unruptured in 75% of the women taking diclofenac, 25% taking naproxen and 33% of the patients receiving etoricoxib. Rupturing of the dominant follicle and the subsequent release of an oocyte (unfertilized egg), is essential for ovulation to occur.

“These findings highlight the harmful effects NSAIDs may have on fertility, and could open the door for research into a new emergency contraception with a more favorable safety profile than those currently in use,” said Salman.

NSAIDs are among the most common pain relief medicines in the world. Every day more than 30 million Americans use them to relieve pain, lower fever and reduce inflammation.

How Chronic Pain Changes Mood and Motivation

By Pat Anson, Editor

Researchers in California have found the first biological evidence that chronic pain alters regions in the brain that regulate mood and motivation -- raising the risk of depression, anxiety and substance abuse.

In animal studies at UCLA and UC Irvine, researchers found that brain inflammation in rodents that was caused by chronic nerve pain led to accelerated growth and activation of immune cells called microglia. Those cells trigger chemical signals within the brain that restrict the release of dopamine, a neurotransmitter that helps control the brain's reward and pleasure centers.

"For over 20 years, scientists have been trying to unlock the mechanisms at work that connect opioid use, pain relief, depression and addiction," said Catherine Cahill, associate professor of anesthesiology & perioperative care at UCI, Christopher Evans of UCLA's Brain Research Institute. "Our findings represent a paradigm shift which has broad implications that are not restricted to the problem of pain and may translate to other disorders."

The study also revealed why opioid drugs such as morphine and cocaine may lose their effectiveness as animals transition from acute pain to chronic pain. Cahill and her colleagues learned that opioids fail to stimulate a dopamine response in mice and rats, resulting in impaired reward-motivated behavior.

Treating the rodents with a long-acting antibiotic called minocycline inhibited microglial activation, and restored dopamine release and reward-motivated behavior. That finding suggests that a similar approach could be used in treating chronic pain in humans.

"Our findings demonstrate that a peripheral nerve injury causes activated microglia within reward circuitry that result in disruption of dopaminergic signaling and reward behavior. These results have broad implications that are not restricted to the problem of pain, but are also relevant to affective disorders associated with disruption of reward circuitry," the study found.

The results of the five-year study appear online in the Journal of Neuroscience.

Cahill and her research team are now trying to establish that pain-derived changes in human brain circuitry can account for mood disorders.

"We have a drug compound that has the potential to normalize reward-like behavior," she said, "and subsequent clinical research could then employ imaging studies to identify how the same disruption in reward circuitry found in rodents occurs in chronic pain patients."

Critics Question Oxygen Therapy for Fibromyalgia

By Pat Anson, Editor

Some experts are challenging the findings of a new clinical study that found that hyperbaric oxygen therapy (HBOT) could be used to treat -- and possibly even cure -- fibromyalgia.

Israeli researchers gave HBOT therapy to dozens of women suffering from fibromyalgia and found there was a significant improvement in their pain and other symptoms. The women were put in pressurized air chambers and breathed pure oxygen for 90 minutes, five times a week for two months.

Researchers say brain scans of the women before and after HBOT proved their theory that additional oxygen alters brain pathology and "repairs" parts of the brain overly sensitized by chronic pain. 

"Brain pathology? This is speculation being presented as established knowledge," said John Quintner, MD, an Australian rheumatologist who maintains that fibromyalgia is not a disease, but a "symptom cluster" that could have many different causes.

tHE INTERIOR OF A HYPERBARIC CHAMBER. COURTESY OF Sagol Center for Hyperbaric Medicine and Research

Fibromyalgia is a poorly understood disorder that is characterized by deep tissue pain, headaches, fatigue, depression and insomnia. The cause is unknown.

"This clinical trial is using a methodology that is predicated upon fibromyalgia being a distinct medical condition," said Quintner, telling Pain News Network that the study proved little, but was "good news for those who manufacture portable HBOT units." 

Researchers at the Sagol Center for Hyperbaric Medicine and Research at the Assaf Harofeh Medical Center and Tel Aviv University were studying the use of HBOT on stroke and concussion patients when they realized that oxygen therapy might also change the neural activity of patients with fibromyalgia.

"Patients who had fibromyalgia in addition to their post-concussion symptoms had complete resolution of the symptoms," said Shai Efrati, MD,  lead author of the study that is published online in PLoS ONE. 

Efrati said some patients will require follow-up sessions of HBOT and some won't need to.

"We have learned, for example, that when fibromyalgia is triggered by traumatic brain injury, we can expect complete resolution without any need for further treatment. However, when the trigger is attributed to other causes, such as fever-related diseases, patients will probably need periodic maintenance therapy."

HBOT puts more oxygen into the bloodstream, which delivers it to the brain. Efrati's earlier studies found that HBOT induces neuroplasticity, which leads to repair of chronically impaired brain functions. Most of the women who participated in the new study had fibromyalgia that the researchers believe was triggered by brain trauma.

DR. SHAI EFRATI

"Symptoms in about 70 percent of the women who took part have to do with the interpretation of pain in their brains," said Eshel Ben-Jacob, a study co-author who is an adjunct professor of biosciences at Rice University. "They're the ones who showed the most improvement with hyperbaric oxygen treatment. We found significant changes in their brain activity.

"Most people have never heard of fibromyalgia. And many who have, including some medical doctors, don't admit that this is a real disorder. I learned from my MD friends that this is not the only case in which disorders that target mainly women raise skepticism in the medical community as to whether they're real or not."

HBOT Claims Called "Crazy" 

One of those skeptics is Fred Wolfe, MD, a prominent fibromyalgia researcher who says the Israeli study lacks proper controls used in most clinical studies -- such as patients being "blinded" to whether they are receiving treatment or a placebo.  

"The fibromyalgia study world is filed with positive studies based on unacceptable controls," said Wolfe. "While I don't know enough about this treatment to be sure, I would tend to think the symptomatic improvement could be based on control and blinding problems. It is possible that the demonstrated effect on the brain of oxygen is separate from the effect of symptoms." 

Wolfe is particularly troubled by a recommendation at the end of the study that fibromyalgia patients should undergo HBOT therapy now, "rather than wait until future studies are completed.”  

"I could only characterize (that) as crazy. Crazy because of the money it would cost and crazy because it posits fibromyalgia as brain disease. FM is not a disease and there is a difference between mechanism and causes. One needs some replication before jumping in," said Wolfe in an email to Pain News Network. 

Many fibromyalgia patients are ready to jump in, based on the comments from readers to our first report about the Israeli study.

"Where do you find studies like this to volunteer? I would so do this," wrote one fibromyalgia sufferer.

"I would so try this. I often feel like I'm not getting enough oxygen," said another.

"Sign me up, please," a woman wrote.

"Is this available in Tucson or Phoenix, Arizona?" asked another woman.

Many fibromyalgia sufferers are desperate for any kind of treatment that would provide relief, much less a cure. In the Israeli study, several patients either drastically reduced or eliminated their use of pain medications.

"The results are of significant importance since, unlike the current treatments offered for fibromyalgia patients, HBOT is not aiming for just symptomatic improvement," said Efrati. "HBOT is aiming for the actual cause -- the brain pathology responsible for the syndrome. It means that brain repair, including even neuronal regeneration, is possible even for chronic, long-lasting pain syndromes, and we can and should aim for that in any future treatment development."

John Quintner is not convinced.

"I have thought long and hard about this issue and have come to the conclusion that we have been dealing with a 'symptom cluster' rather than with a syndrome," he said. "According to my understanding, fibromyalgia is best explained as an  'idiom of human distress' and, as such, is outside the purview of the biomedical model." 

Experimental RA Vaccine Shows Promise

By Pat Anson, Editor

Australian researchers have developed an experimental vaccine for rheumatoid arthritis (RA)  that could prevent the disease from developing in high-risk patients who have a genetic predisposition for RA.

In a small Phase I clinical study, researchers say the "Rheumavax" vaccine was safe and effective in suppressing the immune system response that triggers RA -- a chronic autoimmune disease in which the body’s own defenses attack joint tissues, causing swelling, inflammation and bone erosion. About 1% of adults worldwide suffer from RA.

"Current therapies only treat the symptoms and slow the progression of the disease,” said Professor Ranjeny Thomas of the University of Queensland Diamantina Institute. “We have designed a vaccine-style treatment or ‘immunotherapy’ specifically for individuals carrying high-risk rheumatoid arthritis genes and specific rheumatoid arthritis antibodies, called anti-CCP."

CCP antibodies are present in about 60% to 70% of people with RA and can be detected years before symptoms appear.

The personalized Rheumavax vaccine is made by taking a sample of each patient's blood and extracting an immune system cell called dendritic cells. Those cells are then challenged with a foreign peptide and an immune system modulator to create a vaccine that is then injected back into the patient.

Researchers say Rheumavax "teaches" the patient’s immune system to ignore a naturally occurring peptide that triggers the production of CCP antibodies that cause inflammation. In the study, 18 patients received a single injection of Rheumavax and one month later showed no signs of inflammation or RA disease flares.

“At this stage, the technique would not be ideal for widespread treatment or prevention of rheumatoid arthritis because it’s costly and time-consuming," said Thomas. “However, the promising results of this trial lay the foundations for the development of a more cost-effective, clinically-practical vaccine technology that could deliver similar outcomes for patients." 

"This research is such an exciting advancement for arthritis sufferers.  To know that someday in the future, hopefully the near future, there may be a treatment that actually treats the cause, not just the symptoms of rheumatoid arthritis, makes me very hopeful," said  Jennifer Martin, a rheumatoid arthritis sufferer and columnist for Pain News Network.  

"I often worry that my son could have inherited this awful illness from me and that one day he will begin to show symptoms.  To think that there may be a treatment that is effective very early on, or even before symptoms arise if they are able to detect the gene is very reassuring."

Professor Thomas says if Rheumavax proves successful treating RA, it could also be applied to other autoimmune diseases, such as Type 1 diabetes.  The study is published in the journal Science Translational Medicine. 

Until the late 1990s, one in three RA patients were permanently disabled within five years of disease onset. Although there are no cures for RA, in recent years there has been significant improvement in treatment, with disease control now possible for many patients who receive biologic drugs.

Poor Sleep Makes Osteoarthritis Worse

By Pat Anson, Editor

A new study is adding to the growing body of evidence linking poor sleep habits to chronic pain.

Researchers at Johns Hopkins University School of Medicine say patients with knee osteoarthritis (OA) who slept poorly had greater central sensitization -- which amplifies the amount of pain they feel. They are also more likely to catastrophize -- a clinical term meaning they were consumed by thoughts about pain.

Osteoarthritis is a joint disorder that leads to thinning of cartilage and progressive joint damage. Nearly 40 percent of Americans over the age of 45 have some degree of knee OA.

"Our study is the largest and most comprehensive examination of the relationship between sleep disturbance, catastrophizing and central sensitization in knee OA," said lead author Claudia Campbell, PhD, from the Department of Psychiatry & Behavioral Sciences at Johns Hopkins University School of Medicine. The study is published in Arthritis Care & Research.

The study included 208 participants who were categorized into four groups: OA patients with insomnia, OA patients with normal sleep habits, healthy controls with insomnia, and healthy controls without pain and normal sleep habits. Most of the participants were female.

Results showed that patients with knee OA and insomnia had the greatest degree of central pain sensitization compared to the controls. Researchers also found that patients with poor sleep and high catastrophizing scores reported higher levels of central sensitization -- which was associated with increased  pain.

"While no causal processes may be determined from this study, our data suggest that those with low sleep efficiency and higher catastrophizing have the greatest central sensitization. Understanding the intricate relationship between sleep, central sensitization, and catastrophizing has important clinical implications for treating those with chronic pain conditions such as knee OA," said Campbell.

A recent study in Norway found that getting a good night’s sleep plays a key role in determining how bad your pain levels are doing the day.  Those who had trouble sleeping at least once a week had a 52% lower pain tolerance. The study, which was published in the journal PAIN,  is the first to link insomnia and impaired sleep to reduced pain tolerance in a large, general population sample.  

A previous study in Norway found that women who have trouble sleeping are at greater risk of developing fibromyalgia.

Study Links Painkillers to Homicides

By Pat Anson, Editor

You can add the term “homicidal” to the list of stigmas faced by chronic pain patients.

A new study in the journal World Psychiatry has found that certain drugs that affect the central nervous system – particularly opioid painkillers – significantly increase the risk of committing murder.

The Swedish and Finnish researchers behind the study wanted to know if there was any scientific basis for the claim that anti-depressants and other psychotropic drugs can cause violent behavior. It’s an issue that was debated after massacres committed by young people in schools and other public places in Finland and around the world.

"It has been repeatedly claimed that it was the anti-depressants used by the persons who committed these massacres that triggered their violent behavior. It is possible that the massive publicity around the subject has already affected drug prescription practices," said lead author Jari Tiihonen of the Karolinska Institute in Sweden.

In one of the first studies of its kind, researchers analyzed a database of 959 people convicted of homicide in Finland between 2003 and 2011 to see what medications they were taking before their crimes.  

They found that anti-psychotic medication was not associated with a significantly increased risk of homicide, and there was only a slightly elevated risk for most people taking anti-depressants and benzodiazepines – drugs used to treat anxiety and insomnia.

But the study did find, rather surprisingly, that there was a significantly higher risk of committing a homicide associated with opioid pain medications like oxycodone and tramadol (93% higher) and anti-inflammatory pain relievers such as acetaminophen (206% higher).

The risk was even more elevated for young people. For someone under the age of 26, there was a 223% greater chance of them killing someone if they were taking opioids. Young people taking benzodiazepines had a 95% greater risk.

"Benzodiazepines can weaken impulse control, and earlier research has found that painkillers affect emotional processing. Caution in prescribing benzodiazepines and strong painkillers to people with a history of substance abuse is advisable," Tiihonen concluded.

Although alcohol and other intoxicants were also involved in a majority of the homicides, the researchers said their use did not explain the differences between the drug groups.

In 2007, an 18-year old Finnish high school student named Pekka-Eric Auvinen fatally shot eight people at his school before taking his own life. He had been taking anti-depressants for a year prior to the massacre.

The Citizens Commission on Human Rights UK has a list of several other massacres around the world linked to the use of anti-depressants. Opioids are not mentioned in any of the examples.

New Software Helps Doctors See Kids' Pain Levels

By Pat Anson, Editor

Accurately assessing pain levels in a patient is difficult because pain is so subjective. No one really knows how much pain a patient is in – except the patient.

It gets even harder when the patient is a young child who can’t verbally express their feelings the same way an adult can. For decades doctors have relied on low-tech diagnostic tools like the Wong Baker Pain Scale – a series of sad and smiling faces the child chooses from to help the doctor understand how much pain they are in.

Thankfully, that era may be coming to an end with the development of a high-tech approach at the University of California, San Diego School of Medicine.

Researchers there have demonstrated the validity of new software that measures pediatric pain by recognizing facial patterns in each patient. Their study is published online in the journal Pediatrics.

“The current methods by which we analyze pain in kids are suboptimal,” said senior author Jeannie Huang, MD, a professor in the UC San Diego School of Medicine Department of Pediatrics and a gastroenterologist at Rady Children's Hospital-San Diego.

COURTESY UC SAN DIEGO SCHOOL OF MEDICINE

“In this study, we developed and tested a new instrument, which allowed us to automatically assess pain in children in a clinical setting. We believe this technology, which enables continuous pain monitoring, can lead to better and more timely pain management.”

The researchers used the software to analyze pain-related facial expressions from video taken of 50 youths, ages five to 18 years old, who had laparoscopic appendectomies.

Researchers filmed the patients during three different post-surgery visits: within 24 hours of their appendectomy; one calendar day after the first visit and at a follow-up visit two to four weeks after surgery. Facial video recordings and self-reported pain ratings by each patient, along with pain ratings by parents and nurses were collected.

“The software demonstrated good-to-excellent accuracy in assessing pain conditions,” said Huang. “Overall, this technology performed equivalent to parents and better than nurses. It also showed strong correlations with patient self-reported pain ratings.”

Huang says the software also did not demonstrate bias in pain assessment by ethnicity, race, gender, or age – an important consideration given how subjective current pain scales can be.

Because the software operates in real-time, doctors can be alerted to pain when it occurs instead of during scheduled assessments. The technology could also advocate for children when their parents are not around to notify medical staff about their child's pain level.

Huang said the software needs further study with more children and other types of pain in a clinical setting.

“It still needs to be determined whether such a tool can be easily integrated into clinical workflow and thus add benefit to current clinical pain assessment methods and ultimately treatment paradigms,” she said.

Huang says controlling pain is important, not only for the child's comfort, but also for their recovery since studies have shown that under-treatment of pain is associated with poor surgical outcomes.

Can Oxygen Therapy Treat Fibromyalgia?

By Pat Anson, Editor

Hyperbaric oxygen therapy – also known as HBOT – has been used for decades to treat infections, severe burns, carbon monoxide poisoning, even scuba divers recovering from decompression sickness.

Patients undergoing HBOT are put in a pressurized room or tube. The higher air pressure allows lungs to gather more oxygen than they would normally – helping the body to heal faster.

Promising new research out of Israel suggests that HBOT can also be used to treat fibromyalgia patients by causing neuroplasticity – a “re-wiring” of the brain that can change neural activity in areas overly sensitized by chronic pain. The study has been published in the journal PLoS ONE.

“This study provides evidence that HBOT can improve quality of life and well-being of many FMS (fibromyalgia) patients. It shows for the first time that HBOT can induce neuroplasticity and significantly rectify brain activity in pain related areas of FMS patients,” wrote lead author Shai Afrati, MD, of the Institute of Hyperbaric Medicine, Assaf Harofeh Medical Center.

file photo of a woman getting hyperbaric oxygen therapy

Fibromyalgia is a poorly understood disorder that is characterized by deep tissue pain, headaches, fatigue, depression and insomnia. The cause is unknown and there is no cure.

Afrati, who has also studied oxygen therapy on stroke and concussion victims, enrolled 60 female fibromyalgia patients in his latest study. For five days each week they were given 90 minutes of HBOT with oxygen enriched air.

“It is plausible that increasing oxygen concentration by HBOT can change the brain metabolism and glial function to rectify the FMS-associated brain abnormal activity. It has already been demonstrated that exposure to hyperbaric oxygen induces significant anti-inflammatory effect in different conditions and pathologies,” said Afrati.

After two months, brain imaging showed the women had significant changes in neural activity, and they reported less pain and fewer tender points. Several said that they had either reduced or stopped taking pain medication.

However, not everyone could handle being placed in a pressurized air chamber. Five women dropped out of the study, complaining of dizziness, claustrophobia and an inability to adjust to the air pressure.

But Afrati is encouraged by the results.  

“Follow-up studies are needed in order to investigate the durability of the HBOT effects on FMS. It might be that some patients will need more HBOT sessions,” he wrote. “Since there is currently no solution for FMS patients, and since HBOT is obviously leading to significant improvement, it seems reasonable to let FMS patients benefit from HBOT, if possible, now rather than wait until future studies are completed.”

New Arthritis Treatment Could Slow Joint Damage

By Pat Anson, Editor

Researchers in California are working on a novel method for the treatment of rheumatoid arthritis that could open the door to a new class of medications that prevent joint damage.

Rheumatoid arthritis (RA) is a chronic autoimmune disease in which the body’s own defenses attack joint tissues, causing pain, inflammation and bone erosion. Most RA treatments focus on suppressing the immune system to reduce inflammation and slow progression of the disease.

"Unfortunately, for around 40 percent of patients, immune-targeted therapies are not sufficient to bring them into full remission," said Nunzio Bottini, MD, an associate professor at the La Jolla Institute for Allergy and Immunology and associate professor of Medicine at the University of California, San Diego.

"If we could add a drug that acts on a different target without increasing immune suppression it could be very valuable."

Bottini and his colleagues are focusing on specialized cells called fibroblast-like synoviocytes (FLS) that line the inside of joints, providing lubrication and repairing joint injuries. In RA patients, the cells invade surrounding cartilage and secrete enzymes that break down the rubbery tissue that cushions the bone. They also trigger bone destruction.

"Even if your inflammation is completely under control with the help of current therapies -- and they are excellent -- the damage to the skeletal structure is not necessarily arrested in the long term because synoviocytes continue to cause damage," explains Bottini. "And although synoviocytes are considered the main effectors of cartilage damage in rheumatoid arthritis there's no therapy directed against them."

FLS cells rely on phosphates to transmit signals. When researchers screened tissue samples from rheumatoid arthritis patients for the expression of phosphatases, they discovered that an enzyme called RPTPσ -- short for receptor protein tyrosine phosphatase sigma -- is highly expressed on the surface of their FLS cells. RPTPσ weakens the ability of synoviocytes to aggressively invade the joint's cartilage.

"RPTPσ acts like an inhibitory signal that is pre-coded on the surface of these cells," says postdoctoral researcher Karen Doody, PhD, first author of the study published in Science Translational Medicine.

“Being able to activate RPTPσ's activity gives us a specific tool with which to adjust the migration and aggressiveness of synoviocytes in rheumatoid arthritis," said Doody, who hopes to develop drugs that make the cells less invasive and lose their ability to attach to cartilage.

"The ultimate goal is to use biologics that target synoviocytes in combination with treatments that suppress the immune system, such as methotrexate or anti-TNF, to address all three aspects of rheumatoid arthritis: swollen joints as a result of inflammation, cartilage damage and bone damage."

About 1.5 million Americans and 1% of adults worldwide suffer from RA.

'Robust Response' to National Pain Strategy

By Pat Anson, Editor

Public reaction to the National Pain Strategy has been “very robust” according to the co-chair of the government committee that released a draft version of the report in early April.

Today marks the deadline for public comments on the 72-page report, a long awaited study that calls chronic pain a threat to public health, and identifies several areas where physicians and the healthcare system are failing pain sufferers.

“I think it’s safe to say that there was a very robust response,” said Linda Porter, PhD, co-chair of the National Institutes of Health’s Interagency Pain Research Coordinating Committee (IPRCC).

“I feel  like we really got the word out widely and the comments are coming in from a very broad range of the community, ranging from the professional societies, individual patients, coalitions of patients that have come together, and patient advocacy. So yes, I’m comfortable with it. We’ve gotten a good range of comments from a really broad set of folks.”

Some pain patients and advocates have complained that the IPRCC was dominated by academic researchers, physicians and government bureaucrats – and not enough input was sought from pain sufferers during the drafting of the National Pain Strategy (NPS).

“The NPS is essentially an underpowered, unrealistic, and undemocratic occupational strategy of some pain experts and professionalized lay experts, who were chosen because of their ideology and rank in certain organizations and government,” wrote patient advocate David Becker in his public comment on the NPS.

“There is no evidence that a survey or needs assessment of what Americans want from pain care was done or considered by the NPS and the NPS fails to make a case for their ‘evidence based, high quality, interdisciplinary, integrated multimodal biopsychosocial model’ as being what people in pain actually want out of pain care -- and especially those Americans in pain who will be forced to live with a plan they had no say in developing.”

Porter said she could not release the number of comments that have come in during the public comment period, but she was satisfied patients had a voice in drafting the National Pain Strategy.

“We felt very strongly that their voice had to be heard,” Porter told Pain News Network. “We had patients and patient advocates on every single one of the work groups, on the oversight panel, and on the IPRCC. There was actually a large group of patient advocates and we made sure that each of the working groups had at least a voice on it and some of them had several.”

A list of members on the IPRCC’s oversight committee can be found here. Two of the panel’s 14 members are pain sufferers and/or patient advocates. The rest are longtime experts in the field of pain management, including several who helped write the 2011 Institute of Medicine report, “Relieving Pain in America,” which estimated that 100 million Americans suffer from chronic pain.

Implementing the Plan

One member of the oversight committee said he found it “really exciting in terms of changing the culture of pain,” but admitted there were “minor things” about the NPS that bothered him.

“There is nothing in it about pediatric pain. There’s not as much emphasis on research as we would always like, particularly basic science is left out of it,” said Greg Terman, MD, an anesthesiologist and professor at the University of Washington who is president of the American Pain Society.

“The general problem that I had as a member of the oversight committee is how are we going to implement any of the recommendations? And the answer is I don’t think anyone knows yet, it’s not even final. But I am optimistic.”

The NPS calls for significant improvement in pain management practices, including better education in pain care for physicians, more collaboration between primary care physicians and pain specialists, broader insurance coverage of pain treatments, and more research. But nowhere in the report is the cost for any of the recommendations even discussed.

“That was not our responsibility nor did we have the ability to estimate what these would cost,” says Linda Porter. “It was really out of our scope and we were not asked to do that. It will certainly come up in the planning stage.”

Porter said cost estimates will be handled by the federal Department of Health and Human Services, which is still in the “discussion and planning stage” of deciding which recommendations to implement first. She expects a plan to be announced in late summer or early fall of this year.

“Things move slowly in government I hear,” says Terman. “It’s there, at least in writing, what needs to be done from our expert opinion. Having it gathered all in one area has never been done before and maybe if we can’t make it happen in the next year, maybe in a few more years. If it’s still sitting there waiting to be implemented, sadly there will still be patients waiting to be helped.”

Older Men Less Likely to Be Screened for Osteoporosis

By Pat Anson, Editor

Elderly men are far less likely to be screened for osteoporosis or to take preventive measures against the bone-thinning disease than women, according to the results of a new study.

"We were surprised at how big a difference we found between men and women regarding osteoporosis," said Irina Dashkova, MD, lead author of the study, which is being presented at The American Geriatrics Society's annual meeting in Washington, DC. "In our environment, you just get this perception that osteoporosis is a women's problem. This has to be changed, and the sooner the better.

More than 10 million Americans suffer from osteoporosis, which raises their risk for serious bone fractures.  About 2 million are men -- and another 8 to 13 million men have low bone mineral density, a precursor to osteoporosis. Previous studies have found that 13% of white men over the age og 50 will experience at least one osteoporosis-related fracture during their lifetime.

“We know from research that when men suffer fractures, their mortality is higher than in women and that severe medical consequences and loss of independence are much more prevalent in men,” said Dashkova.

The risk of death after sustaining a hip fracture is twice as high in men compared to women, and loss of independence is also more common in males. Some medical conditions and drugs that can raise the risk of osteoporosis are male-specific, such as prostate cancer drugs that affect the production of testosterone.

Dashkova and her colleagues at North Shore-LIJ Health System surveyed 146 older men and women in New York and Florida and found “stunning” gender differences in attitudes and beliefs about osteoporosis:

• Women were far more likely to report a family history of osteoporosis (nearly 91% compared to 9%)
• Most women would accept osteoporosis screening, while less than 25% of men would
• Women were 4 times more likely to take preventive measures against osteoporosis, such as taking calcium and vitamin D supplements

Part of the problem may be that healthcare providers aren't encouraging men to undergo screening as often as they should.

"Our survey clearly establishes that physicians are just not thinking of screening men. It's only when older men fall and break their hip that someone thinks maybe we should do something to prevent them breaking the other hip," said Gisele Wolf-Klein, MD, director of geriatric education for the North Shore-LIJ Health System. "Not only is society in general unaware of the problem of osteoporosis in men, men are not seeking screening and diagnosis.

"The average age in my practice is in the 90s, and our patients are to be congratulated because clearly they're doing something right. But we have a duty to make sure those later years are as happy and productive as can be and not spent in a wheelchair."

UK Research Could Lead to Blood Test for Fibromyalgia

By Pat Anson, Editor

British researchers have launched a genetic study of fibromyalgia patients that they hope could lead to a new blood test to diagnose the disease.

Fibromyalgia is a poorly understood disorder characterized by deep tissue pain, fatigue, headaches, depression and insomnia. It is notoriously difficult to diagnose and treat, and some doctors refuse to recognize it as a disease.

Scientists at King’s College London will study tissue samples and measurements taken from volunteers enrolled in Twins UK, a comprehensive study on the effects of genes, aging, disease and the environment on over 12,000 identical and non-identical twins.

Four hundreds twins are enrolled in the fibromyalgia study. In each set of twins, one twin suffers from chronic widespread pain, while the other does not. Tissue samples from both twins will be compared to try to identify biomarkers in their DNA associated with chronic pain.

"Our research will help patients in two ways. First it'll contribute to our understanding of how fibromyalgia – and other chronic pain syndromes such as irritable bowel syndrome – develop, and point to pain pathways which we may not have suspected,” said lead researcher Dr. Frances Williams.

"Secondly, we hope it'll lead to identification of a biomarker which we could work into a blood test."

Fibromyalgia is believed to have genetic influences, but researchers say there are many complicated steps between the genes that may contribute to fibromyalgia and the condition itself.

The study will focus on identifying markers in DNA that are associated with the “switching” on or off certain genes. DNA switching is important to health, as it prevents inappropriate processes from occurring in the body when they should not. Identifying those markers could then lead to a blood test.

“As well as enabling the condition to be diagnosed more effectively, it could help to ‘stratify’ patients into groups depending on disease severity, which will help in clinical trials of potential new treatments. It might even help us predict how the condition will progress,” said Williams.

A bioresearch company based in Santa Monica, California is already marketing a blood test that it claims is 99% accurate in diagnosing fibromyalgia.

EpicGenetics introduced the blood test in 2013, calling it the first definitive test for fibromyalgia.

The FM test looks for protein molecules in the blood called chemokines and cytokines, which are produced by white blood cells. Fibromyalgia patients have fewer chemokines and cytokines in their blood, according to the company, and have weaker immune systems than normal patients.

The blood test costs several hundred dollars and results are available in about a week. Critics have said the test is unreliable and the same molecules can be found in people with other disorders, such as rheumatoid arthritis.

Researchers Develop New Painkiller from Lidocaine

By Pat Anson, Editor

A fast acting pain reliever widely used to treat everything from itching to dental pain could be developed into a new medication that offers longer lasting pain relief.

"Because of its versatility and effectiveness at quickly numbing pain in targeted areas, lidocaine has been the gold standard in local anesthetics for more than 50 years," said George Kracke, PhD, an associate professor of anesthesiology and perioperative medicine at the University of Missouri (MU) School of Medicine.

"While lidocaine is effective as a short-term painkiller, its effects wear off quickly. We developed a new compound that can quickly provide longer lasting relief. This type of painkiller could be beneficial in treating sports injuries or in joint replacement procedures."

Lidocaine is used as an injectable pain reliever for minor surgical or dental procedures, and as an over-the-counter ointment or spray to relieve itching, burning and pain from shingles, sunburns, and insect bites.

The new compound -- called boronicaine -- could potentially serve many of those same functions as an injectable or topical painkiller.  

MU researchers synthesized boronicaine as a derivative of lidocaine by changing its chemical structure. They found that boronicaine provided pain relief that lasted five times longer than lidocaine. In pre-clinical, early stage studies, boronicaine provided about 25 minutes of relief, compared to about five minutes of pain relief with lidocaine.

"Although some conditions may warrant the use of a short-lasting painkiller, in many cases a longer lasting anesthetic is a better option," said Kracke, who is lead author of a study published in the chemistry journal ChemMedChem . "Having a longer lasting anesthetic reduces the dosage or number of doses needed, limiting the potential for adverse side effects."

Other types of short term analgesics provide longer pain relief than lidocaine, but they also have side effects they can cause heart toxicity and gastrointestinal problems. Preliminary findings show no toxicity in single-dose studies of boronicaine, though more studies are needed.

"Boronicaine could have distinct advantages over existing painkilling medications," said M. Frederick Hawthorne, PhD, director of MU's International Institute of Nano and Molecular Medicine and a pioneer in the field of boron chemistry. "We're conducting more research into the side effects of the compound, but in time it could very well become a useful material to use as an anesthetic."