Stem Cell Therapy Could Avoid Joint Replacement

By Pat Anson, Editor

An experimental stem cell treatment that grows new cartilage could someday help millions of arthritis patients avoid joint replacement surgery.

Researchers at Washington University School of Medicine in St. Louis and Cytex Therapeutics in Durham, N.C. have developed a 3-D, biodegradable synthetic scaffold that is molded into the precise shape of a patient’s hip joint.

The scaffold, which is covered with cartilage made from the patient’s own stem cells, is designed to be implanted onto the surface of an arthritic hip.

Resurfacing the hip joint with this “living” tissue could ease arthritis pain, and may delay or even eliminate the need for hip replacement surgery, according to researchers.

Joint replacement surgery is usually performed on the elderly to relieve pain from osteoarthritis, a painful and disabling condition caused by a loss of cartilage and the degradation of joints. Over a million hip and knee joint replacement surgeries are performed annually – a number expected to surpass four million by 2030 due to the aging of the U.S. population. 

WASHINGTON UNIVERSITY IMAGE

“We’ve developed a way to resurface an arthritic joint using a patient’s own stem cells to grow new cartilage, combined with gene therapy to release anti-inflammatory molecules to keep arthritis at bay. Our hope is to prevent, or at least delay, a standard metal and plastic prosthetic joint replacement,” said Farshid Guilak, PhD, a professor of orthopedic surgery at Washington University.

After inserting a gene into the newly grown cartilage and activating it with a drug, researchers say the gene will release anti-inflammatory molecules to fight arthritis.

“When there is inflammation, we can give a patient a simple drug, which activates the gene we’ve implanted, to lower inflammation in the joint,” said Guilak. “We can stop giving the drug at any time, which turns off the gene.”

By adding gene therapy to the stem cell and scaffold technique, Guilak and his colleagues believe it will be possible to coax patients’ joints to fend off arthritis, preserve cartilage, and function better for a longer time.

The 3-D scaffold is built using a weaving pattern that gives the device the structure and properties of normal cartilage. It is made with hundreds of biodegradable fiber bundles that are woven together to create a high-performance fabric that functions like normal cartilage.

“The woven implants are strong enough to withstand loads up to 10 times a patient’s body weight, which is typically what our joints must bear when we exercise,” said Franklin Moutos, PhD, vice president of technology development at Cytex.

Scientists have tested the tissue engineering in cell culture, and some customized implants are being tested in laboratory animals. If all goes well, such devices could be ready for testing in humans in three to five years.

Currently, there are about 30 million Americans who have osteoarthritis. That number includes a growing number of younger patients — ages 40 to 65 — who have limited treatment options.  Doctors are often reluctant to perform hip replacement surgery on patients under age 50 because prosthetic joints typically last for less than 20 years. A second surgery to remove a worn prosthetic can destroy bone and put patients at risk for infection and other complications.

“We envision in the future that this population of younger patients may be ideal candidates for this type of biological joint replacement,” said Bradley Estes, PhD, vice president of research and development at Cytex.

The research findings, which are published in the Proceedings of the National Academy of Sciences, are supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the National Institute on Aging, which are both part of the National Institutes of Health (NIH).

New Molecules May Combat Immune System Disease

By Pat Anson, Editor

A team of international researchers may have unlocked an ancient secret in the human immune system that could lead to new treatments for rheumatoid arthritis, multiple sclerosis and inflammatory bowel disease (IBD).

"Innate immunity is so old it goes all the way down to frogs, fish and even insects," says Professor Matt Cooper of the University of Queensland’s Institute of Molecular Bioscience.

Cooper and colleagues at Kings College London and the U. S. National Institutes of Health say the human immune system is basically comprised of two parts: the adaptive immune system, which produces antibodies against infection, and a very ancient pathway, known as the innate immune system.

"It stops us getting infections, but it also drives a lot of inflammatory diseases,” explains Cooper.  "So, in one case it's keeping us alive by stopping the bugs getting us, but if it goes wrong, we start to get diseases like arthritis, multiple sclerosis and IBDs such as colitis.

"Researchers always thought key components of these pathways acted alone, but our teams have discovered they can communicate and work together."

IBD is a chronic and painful inflammation of the gastrointestinal tract. Inflammation affects the entire digestive tract in Crohn’s disease, but only the large intestine in ulcerative colitis.

The study findings, published in the journal Science, may have significant implications for treating millions of people who suffer from inflammatory diseases.

"Inflammation in diseases such as colitis occurs when the immune system is activated inappropriately, and causes symptoms including pain, diarrhea, fever and weight loss," said Cooper. "Current treatments are not always effective, possibly because they are only blocking one of the key pathways and inflammation still occurs through the other pathway."

Researchers have developed two small molecules that each block one pathway.

activated immune cells

"We have tested these molecules and the results show that they both reduce inflammation when administered separately," Cooper said. "This work is still in the early stages but we are hopeful our ongoing research will lead to more effective treatments for the millions of IBD sufferers.

"It may give other scientists opportunities to develop new drugs against these diseases."

A healthy immune system is activated when the body recognizes invading microbes and alerts immune cells, such as T cells. Disease begins when the immune response spirals out of control and begins attacking healthy tissue.  

Researchers at New York University’s Langone Medical Center are also working on a theory known as the "hygiene hypothesis" that may explain why there is an increase in inflammatory bowel disease worldwide. They believe intestinal parasites and bacteria that humans were long exposed to are beneficial and help balance the immune system.

Sanitary practices have sharply reduced these parasitic and bacterial infections in developed nations, which now have some of the highest rates of Crohn’s and colitis. Researchers believe the immune response to infections triggers the growth of Clostridia, a bacterium known to counter inflammation.

Rheumatoid Arthritis Drug Linked to Overdoses

Pat Anson, Editor

A drug that’s long been used to treat rheumatoid arthritis and other autoimmune diseases has been linked to dozens of deaths in the U.S. and Australia, mainly because patients have taken it daily rather than the recommended weekly dose, according to a new study published in the Medical Journal of Australia.

Methotrexate was originally developed and is still used for chemotherapy because of its ability to stop the growth and spread of tumors. Because it is also effective as an immune system inhibitor, low doses of methotrexate became a front line therapy for rheumatoid arthritis in the 1950’s. It is also used to treat psoriasis, lupus, sarcoidosis, and inflammatory bowel diseases such as Crohn’s.

Researchers say methotrexate is safe when taken once or twice a week, but the drug is so potent that accidental daily dosing can be lethal.

“The unusual dosing schedule of low dose methotrexate is associated with a risk that it will be prescribed, dispensed or administered daily instead of weekly,” said lead author Rose Cairns, PhD, of the NSW Poisons Information Centre in Australia.

“Used appropriately, methotrexate is considered safe and efficacious; accidental daily dosing, however, can potentially be lethal. Higher or more frequent doses can result in gastro-intestinal mucosal ulceration, hepatotoxicity, myelosuppression, sepsis and death.”

In a review of medication errors in Australia from 2004 to 2014, researchers linked methotrexate to 22 deaths, including seven cases in which erroneous daily dosing was documented. One patient took methotrexate for 10 consecutive days. Reasons for the errors included patient misunderstanding and incorrect packaging of the drug by pharmacists.

A similar study of medication errors in the U.S. over a 4 year period identified over 100 methotrexate dosing errors that resulted in 25 deaths. Over a third (37%) of the errors were attributed to the prescriber, 20% to the patient, 19% to pharmacists, and 18% to administration by a health care professional.

The researchers also found a “worrying increase” in the number of medication errors just in the past year.

“It is difficult to explain this increase, but the risk of methotrexate medication error may be increasing as the population ages. Older people may be at increased risk because of a range of problems that includes confusion, memory difficulties, and age-related decline in visual acuity,” said Cairns.

Cairns and her colleagues say more needs to be done by drug makers and health professionals to reduce the risk of methotrexate overdosing, such as clearer labeling, smaller sized packages, and distinctly colored tablets.

"Methotrexate use is likely to continue increasing as Australia's population ages, so that additional measures are needed to prevent these errors," the authors concluded.

Prince Treated for Opioid Overdose Days Before Death

By Pat Anson, Editor

Pop icon Prince suffered from chronic pain and was treated for an opioid overdose just days before his death, according to tabloid reports.

Prince’s body was found Thursday in an elevator at his compound in Minneapolis. A cause of death has not yet been determined.

According to TMZ, Prince was treated at a hospital in Moline, Illinois last Friday when his private jet made an unscheduled landing after a concert in Atlanta. Initial reports were that Prince was treated at the hospital for the flu, but TMZ reported he may have needed emergency treatment for an overdose.

“Multiple sources in Moline tell us, Prince was rushed to a hospital and doctors gave him a ‘save shot’ ... typically administered to counteract the effects of an opiate,” TMZ said.

A “save shot” most likely means an injection of naloxone, a life-saving drug that quickly reverses the effects of an opiate overdoses.

TMZ later updated the story to say that Prince was actually given the injection by paramedics at a local airport and then taken to the hospital.

“Our sources further say doctors advised Prince to stay in the hospital for 24 hours. His people demanded a private room, and when they were told that wasn't possible ... Prince and co. decided to bail. The singer was released 3 hours after arriving and flew home,” TMZ said.

An autopsy was performed on the body of 57-year old entertainer this morning, but preliminary findings and a toxicology analysis could take days or weeks.

"As part of a complete exam, relevant information regarding Mr. Nelson's medical and social history will be gathered," the coroner said in a statement, referring to Prince as Rogers Nelson, his birth name. TMZ said authorities were trying to obtain Prince’s hospital records in Moline.

"We have no reason to believe it was suicide," said Carver County Sheriff Jim Olson, who also refused to address reports that Prince had overdosed last week.

"I'm not able to confirm that at this time at all," Olson said. "There have been so many rumors out that I've read about. I don't know if I can dispel all the rumors that are out there."

Prince reportedly suffered from hip problems for over a decade and needed a double-hip replacement. But as a devout Jehovah’s Witness, he would not have a blood transfusion, which made surgery nearly impossible.

“Prince has suffered for years,” a source told The National Enquirer in January. “It’s harder for him to get around.”

The Enquirer said years of strutting and dancing onstage had taken a toll on Prince’s joints and he may have suffered from severe osteoarthritis. 

“If he ignores the doctor’s advice, his walking will become impaired,” said Dr. Stuart Fischer, who did not treat Prince. “He’ll need a cane or a wheelchair for the rest of his life.”

Prince appeared hobbled and used a cane during the 2013 Grammy Awards, but in the past he has also used canes as a fashion accessory.

Prince was seen leaving a Walgreens pharmacy the night before his death. It was his fourth visit to the pharmacy this week. An employee there said he looked frail, according to TMZ.

Another Reason for Arthritis Patients to Quit Smoking

By Pat Anson, Editor

Rheumatoid arthritis sufferers who quit smoking can significantly reduce their risk of an early death, according to a British study published in the journal Arthritis Care and Research.

University of Manchester researchers studied a database of over 5,600 rheumatoid arthritis (RA) patients that included hospital admissions and death certificates. They found that the risk of death was almost two times higher in RA patients who smoked compared to those who never smoked.

The good news for smokers is that if they quit, the risk of death fell for each year they didn’t smoke. Former smokers have a risk similar to that of RA patients who had never smoked.

"This research provides important evidence that the risk of early death starts to decline in patients who stop smoking, and continues year on year,” said Deborah Symmons, Professor of Rheumatology and Musculoskeletal Epidemiology at The University of Manchester.

“We hope that this research can be used by public health professionals and rheumatologists to help more people quit smoking and reduce premature deaths, particularly for newly diagnosed patients with rheumatoid arthritis."

RA is a chronic autoimmune disease in which the body’s own defenses attack joint tissues, causing swelling, inflammation and bone erosion. Many health experts believe the inflammation triggered by RA in the joints may cause inflammation throughout the body, including the heart’s coronary arteries.

According to the Arthritis Foundation, more than 50 percent of premature deaths in people with rheumatoid arthritis result from cardiovascular disease. The heightened risk of heart disease applies to all forms of arthritis, including osteoarthritis, gout, lupus and psoriatic arthritis.

"Rheumatoid arthritis is a debilitating and painful condition affecting over 400,000 people in the UK, it can begin at any age and is unpredictable - one day you can feel fine and the next day be confined to bed, unable to get up to dress, even go to the toilet unaided,” said Stephen Simpson, Director of Research and Programmes for Arthritis Research UK.

"As a charity, we are committed to preventing, transforming and curing arthritis and musculoskeletal diseases, and this research shows that cutting out smoking is one intervention which can help this condition from developing."

There is already plenty of evidence to show an association between smoking and increased risk of death in the general population, but the habit is especially risky for chronic pain sufferers. Studies have found that smoking increases your chances of having several types of chronic pain conditions, such as degenerative disc disease.

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

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

A recent study in Sweden published in JAMA Neurology found that smoking after a diagnosis of multiple sclerosis significantly accelerates progression of the disease.

Promising Results for New Rheumatoid Arthritis Drug

By Pat Anson, Editor

A new drug being developed by Eli Lilly significantly reduces pain, inflammation and other symptoms of rheumatoid arthritis, according to the findings of an international research team published in the New England Journal of Medicine. Nearly ten percent of the patients taking the drug Baricitinib went into full remission.

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.

Baricitinib inhibits two enzymes, called Janus kinase 1 and 2, which are activated in the inflammatory response to RA.

“This is the first drug to demonstrate meaningful clinical benefit in patients who’ve failed virtually every other commercial drug for rheumatoid arthritis,” said lead author Mark Genovese, MD, a professor of immunology and rheumatology at Stanford University School of Medicine.

Researchers at Stanford and Medical University of Vienna in Austria enrolled 527 RA patients from 24 countries in the Phase 3 clinical study. The patients had been living with the autoimmune disease for 14 years, on average, had moderate to severe symptoms, and had not responded well to previous treatments. Patients were divided into three groups, one with a daily dosage of 2 mg of Baricitinib, one with 4 mg, and a control group given placebos.

After 24 weeks, the patients who received Baricitinib had significant improvements in their symptoms, suffering less pain, joint swelling and other signs of disease activity. The group with the 4 mg dose showed even better results than those with the 2 mg dose, compared to the placebo group.

"With Baricitinib, we will have a drug that works even if the currently employed medications are not sufficiently effective,” said co-author Joseph Smolen, manager of the University Clinic for Internal Medicine III at Medical University of Vienna. “Almost 10 % of the patients went into full remission (a cure-like state) within six months, and almost half of the patients demonstrated significant improvement of in disease activity and physical functioning. All this may constitute a new basis for the treatment of rheumatoid arthritis that could become available in the near future."

Another advantage of Baricitinib is that it can be taken orally once a day and does not have to be administered intravenously or through injections, unlike other RA medications. Some patients in the study had side effects, such as mild upper respiratory infections and shingles.

About 1.5 million Americans and 1% of adults worldwide have rheumatoid arthritis. About three of every four people with the disease are women.

New injectable biologic drugs often work in controlling RA initially, but lose their effectiveness over time or have unacceptable side effects. They are also notoriously expensive, with some of the newer drugs costing $20,000 annually.

According to a recent study, RA patients enrolled in Medicare Part D plans paid an average out-of-pocket cost of $835 a month for a biologic in 2013. Costs varied widely depending on the drug – from $269 a month for the biologic infliximab to $2,993 a month for anakinra.

The Baricitinib trial was sponsored by Eli Lilly, which has filed for approval of the drug with the U.S. Food and Drug Administration. Three other Lilly-sponsored studies have shown  Baricitinib was effective in newly diagnosed patients, and in head-to-head competition with the RA medications adalimumab and methotrexate. Baricitinib is also being studied in trials for atopic dermatitis and systemic lupus erythematosus.

Vitamin D Ineffective for Knee Osteoarthritis

By Pat Anson, Editor

Recent studies have suggested that Vitamin D supplements may help reduce pain from fibromyalgia, arthritis and other chronic conditions.

But the “sunshine vitamin” did not relieve pain or stop cartilage loss in patients with knee osteoarthritis, according to new research published in JAMA.

Osteoarthritis is a joint disorder that leads to thinning of cartilage and progressive joint damage. Knee osteoarthritis (OA) is very common and affects over 250 million people worldwide. Nearly 40 percent of Americans over the age of 45 have some degree of knee OA.

Over 400 people with knee OA and low serum levels of Vitamin D participated in the placebo controlled study in Australia and Tasmania. They were divided into two groups; with one receiving Vitamin D supplements and the other a placebo.

Over the course of the two-year study, knee pain, stiffness and physical function were measured with the WOMAC pain scale and MRI scans were used to monitor cartilage volume, defects and bone marrow lesions.  

While the supplements did increase Vitamin D blood levels, they did not reduce knee pain. MRI’s also showed no significant differences in cartilage between the two groups.

“Vitamin D supplementation, when compared with placebo, did not result in significant differences in change in MRI-measured tibial cartilage volume or change in WOMAC knee pain score over 2 years. These findings do not support the use of vitamin D supplementation for preventing tibial cartilage loss or improving WOMAC knee pain among patients with knee osteoarthritis,” said lead author Changhai Ding, MD, of the University of Tasmania.

Vitamin D helps control levels of calcium and phosphate in the body and is essential for the formation of strong bones and teeth. Vitamin D also modulates cell growth, improves neuromuscular and immune function, and reduces inflammation

Vitamin D deficiency – a condition known as hypovitaminosis D -- is caused by poor nutritional intake of Vitamin D, inadequate sunlight or conditions that limit Vitamin D absorption. The most severe type of hypovitaminosis D causes general body pain, especially in the shoulder, rib cage, lumbar and pelvic regions.

Researchers at National Taiwan University Hospital recently found a “positive crude association” between fibromyalgia and hypovitaminosis D.  According to the Vitamin D Council, low levels of Vitamin D could be the result of fibromyalgia, rather than the cause of the disease.

Sources of Vitamin D include oily fish and eggs, but it can be difficult to get enough through diet alone. Ultraviolet rays in sunlight are the principal source of Vitamin D for most people.

Miss Understood: How Arthritis Has Changed Me

By: Arlene Grau, Columnist

I've been noticing several changes in myself since turning 30 this past August, most of which are physical and have more to do with my lupus and rheumatoid arthritis (RA). I've never been the type of person who cares about her looks or what people think about me. However, when I began noticing large nodules forming on my fingers and persistent swelling around my wrists and knuckles I became more self-conscious.

It became especially embarrassing one day when I went to share how I had noticed certain nodules getting bigger and a friend said, "Wow that looks gross." I guess in a way I expected her to be more sympathetic about my situation, but some people may never understand.

I have some fingers that I can hardly bend and others that remain stiff for hours. Most of my fingers have become swollen and tender to the touch. I'd say my hands have suffered the most due to my RA and it makes life that much more difficult.

Just a few weeks ago I woke up unable to walk, so I ended up in the hospital. After having x-rays and an MRI, they ended up finding a labral tear and severe arthritis damage in my right hip, hence the reason why I couldn't walk.

I saw an orthopedic surgeon who said I can either have surgery now to repair it or get a cortisone injection to see if it helps temporarily, but based on the amount of damage my hip has I'm going to need a hip replacement in a few years. That news hit me like a ton of bricks.

ARLENE GRAU

I'm only thirty years old and I already have to mentally prepare myself for a future hip replacement? Not because I fell or because I broke it, but because my arthritis is so advanced that it ate away at my hip. It's a lot to take it. I feel like every time I've gotten tests done, whether its blood work or an MRI, they always find something that I don't want to hear about.

All of this and people still tell me that I don't look sick, they question my illness, or the severity of it. They question why I no longer work or what I do all day. They assume I must be having a wonderful time while my kids are at school. All assumptions because they either enjoy gossiping or they don't want to bother sitting down and getting the facts from me.

At a glance I may look like any other person. But up close you can see that I'm not your average mom or housewife.

My diseases have caused so much to my body. I have so many battle wounds and stories. Some untold, some I've cried about, and some I'm proud I've overcome.

My diseases have changed me. I'm not the same person I was when I was first diagnosed and I don't just mean that in the physical sense. In some ways I'm stronger because I've overcome so much and I'm going to continue fighting. But I also feel like I've aged and I'm tired of all the changes it's brought upon me.

They say change is good, but I don't think they were referring to the type of changes caused by autoimmune diseases.

Arlene Grau lives in southern California with her family. Arlene suffers from rheumatoid arthritis, fibromyalgia, lupus, migraine, vasculitis, and Sjogren’s disease.

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.

Arthroscopic Knee Surgery Not Cost-Effective

By Pat Anson, Editor

Another study is raising doubts about the value of arthroscopic knee surgery, a procedure that is routinely used to treat osteoarthritis and other chronic knee problems. Researchers at Western University in Canada say the surgery provides no additional benefit compared to physical therapy, exercise and medication.

Over 250 million people worldwide suffer from knee osteoarthritis (OA), which causes thinning of cartilage and progressive joint damage. Nearly 40 percent of Americans over the age of 45 have some degree of knee OA.

Investigators at Western’s Bone and Joint Institute analyzed the cost-effectiveness of arthroscopic  surgery, 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.

Over 850,000 arthroscopies are performed every year to relieve knee pain in the UK and the United States alone.

"We previously showed in a randomized clinical trial that arthroscopy for knee osteoarthritis provided no benefit over optimized non-operative care. Despite that finding, and subsequent similar studies, the surgery is still commonly performed," says Trevor Birmingham, the Canada Research Chair in Musculoskeletal Rehabilitation at Western's Faculty of Health Sciences. "That's why we felt it was important to do the accompanying cost-effectiveness analysis."

The two-year study, published in the journal BMJ Open, found that arthroscopic knee surgery is “not an economically attractive treatment option” compared to non-operative treatments such as physical therapy, exercise and medication. Depending on insurance, hospital charges and the surgeon, arthroscopic surgeries cost about $4,000.

“Patients who received non-operative therapies showed similar improvements in pain, function, and quality of life compared to those who also received surgery, at a significantly lower cost,” says lead author Jacquelyn Marsh, a Post-Doctoral Fellow in Health Economics at Western University.

While most people do feel better after knee arthroscopy, randomized clinical trials found that patients improve to a similar extent when they receive non-operative treatments or ‘sham’ surgery, where the patient receives anesthesia but doesn’t actually receive the surgical treatment.

“When that body of evidence is coupled with the present economic analysis, one has to question whether health care funds would be better spent elsewhere,” said Birmingham.

A 2014 report by a German health organization also found arthroscopic  surgery does not relieve pain any better than physical therapy or over-the-counter pain medications.

Another study published last year in the The BMJ called the benefit of knee surgery “inconsequential.” Researchers in Denmark and Sweden reviewed 9 studies on arthroscopic knee surgeries and found that the surgery provided pain relief for up to six months, but without any significant benefit in physical function. Risks from the surgery are rare, but include deep vein thrombosis, 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," wrote Professor Andy Carr from Oxford University’s Institute of Musculoskeletal Sciences in an accompanying editorial.

Carr said thousands of lives could be saved if the surgery was discontinued or performed less often.

Supplements Help Relieve Pain of Osteoarthritis

By Pat Anson, Editor

Two natural dietary supplements are effective at relieving pain and stiffness caused by osteoarthritis, without the side effects caused by non-steroidal anti-inflammatory drugs (NSAIDs), according to two new research studies.

One study found that a combination of glucosamine and chondroitin was effective in treating knee osteoarthritis (OA), while the other study examined an herbal treatment used for thousands of years in Chinese medicine to treat joint pain.

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

The first study was a meta-analysis (a study of studies) involving over 16,000 patients with knee OA. Published in the journal Scientific Reports, it is the first study of its kind to compare glucosamine, chondroitin, and the two in combination, against the NSAID celecoxib or a placebo in the treatment of knee OA.

Researchers found that the combination of glucosamine and chondroitin was associated with significant improvement in pain relief and functional enhancement, compared to placebo, without the high rate of gastrointestinal side effects in patients who received celecoxib.

There was "no significant difference" in pain relief between celecoxib and the glucosamine/chondroitin combination.

"This comprehensive analysis provides us with a wealth of historical data supporting the safety and efficacy of glucosamine and chondroitin in the management of joint health. It is consistent with recent findings suggesting that the efficacy of this combination is comparable to celecoxib in terms of relieving pain and improving function," said lead author Chao Zeng, MD, of the Department of Orthopaedics at Xiangya Hospital at Central South University in Changsha, China.

"This is important news for patients requiring long-term treatment, as the potential side-effect associated with profiles of NSAIDs such as celecoxib warrant consideration of alternative treatment options that are safe and effective."

Glucosamine and chondroitin are both found in healthy cartilage, which acts as a cushion between the bones in a joint. In dietary supplements, glucosamine can be harvested from shells and shellfish or made synthetically. Chondroitin can also be made in a lab, or manufactured from cartilage found in cows, pigs, sharks and other animals.

Chondroitin and glucosamine are popular in supplements used to treat joint pain, but according to the Arthritis Foundation, “most studies assessing their effectiveness show modest to no improvement compared with placebo in either pain relief or joint damage.” The American Academy of Orthopaedic Surgeons also recommends against their use.

The second, smaller study examined the effectiveness of Arthrem, a dietary supplement made in New Zealand that contains an herbal extract from the plant Artemisia annua (Qinghaosu), which has been used in Chinese medicine for more than 2,000 years.

Forty-two people with osteoarthritis of the knee or hip were enrolled in the randomized, controlled study, which was published in the journal Clinical Rheumatology. Researchers say patients who took an Arthrem capsule twice a day for 12 weeks had a significant reduction in pain and stiffness and an increase in their physical function.

"The published results show that the natural product, Arthrem, has potential as an anti-inflammatory/analgesic in osteoarthritis," said Dr. Sheena Hunt, study co-author and principal scientist for Promisia Integrative, the company that makes Arthrem and conducted the study.

"Particularly positive results were observed in a subset of patients with mild to moderate osteoarthritis. In this subgroup, the average magnitude of pain after 12 weeks of taking Arthrem was less than half of the value at the start of the study. Arthrem at this dose was also well tolerated with no treatment-related side effects."

Arthrem recently became available in the United States. Those who qualify can sign up for a free, no obligation, two month trial online at www.Arthrem.com.

Compared to pharmaceuticals, the U.S. Food and Drug Administration loosely regulates the $35 billion dietary supplement industry and many manufacturers' claims about their products are unverified.  The agency recently announced plans to tighten enforcement of the industry by creating a dietary supplement office.

The World Health Organization estimates that about 10% of men and 18% of women over age 60 have osteoarthritis.

New Blood Test Predicts Early Rheumatoid Arthritis Risk

By Pat Anson, Editor

British researchers are developing a new blood test that could predict the likelihood of developing rheumatoid arthritis (RA) up to 16 years before the onset of symptoms. Such a test would substantially increase the early detection of RA and make treatment more effective.

Rheumatoid arthritis is a chronic autoimmune disease in which the body’s own defenses attack joint tissues, causing pain, inflammation and bone erosion.

Researchers at the Kennedy Institute of Rheumatology at Oxford University developed a blood test that looks for antibodies in a protein called citrullinated tenascin-C (cTNC), which is often found in high levels in the joints of people with RA.  

In a study of over 2,000 patients, the blood test diagnosed RA in about 50% of cases. The test also had a very low rate of false positives.

"What is particularly exciting is that when we looked at samples taken from people before their arthritis began, we could see these antibodies to cTNC up to 16 years before the disease occurred – on average the antibodies could be found seven years before the disease appeared,” said Professor Kim Midwood of the Kennedy Institute.

"This discovery therefore gives us an additional test that can be used to increase the accuracy of the CCP assay and that can predict rheumatoid arthritis, enabling us to monitor people and spot the disease early. This early detection is key because early treatment is more effective."

Early RA treatment focuses on suppressing the immune system to reduce inflammation and slow progression of the disease.

"Early diagnosis is key, with research showing that there's often a narrow window of opportunity following the onset of symptoms for effective diagnosis and control of disease through treatment. Furthermore, current tests for rheumatoid arthritis are limited in their ability to diagnose disease in different patients,” said Stephen Simpson, director of research at Arthritis Research UK, which funded the study.

"This could have great potential to help patients with rheumatoid arthritis get the right treatment early to keep this painful and debilitating condition under control."

A similar diagnostic blood test for RA is already on the market in the United States, Canada, Europe, Japan and Australia. The JOINTstat test looks for another protein called 14-3-3η. A recent study of 149 RA patients in Japan found that serum 14-3-3η levels can predict disease severity and clinical outcomes. Drugs that reduce 14--3-3η levels can delay the onset and severity of RA, and increase the chances of remission.

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

New Skin Patch Delivers Pain Relief with Ibuprofen

By Pat Anson, Editor

There are many different types of skin patches already on the market to treat pain --- containing everything from lidocaine to capsaicin to powerful opioids like fentanyl. Now British researchers say they’re a step closer to developing the first transdermal patch containing ibuprofen.

Researchers at the University of Warwick have formed a company called Medherent to produce and patent an adhesive patch that can deliver a high dose of ibuprofen through the skin for as long as 12 hours to treat conditions such as back pain, arthritis and neuralgia.

Their patch differs from others already on the market because the medication is embedded into the polymer matrix that sticks the patch to the patient’s skin. The embedding technology allows the patch to contain 5 to 10 times the amount of analgesic currently used in medical patches.

"Many commercial patches surprisingly don't contain any pain relief agents at all, they simply soothe the body by a warming effect,” says University of Warwick research chemist Professor David Haddleton.

image courtesy of medherent

“Our technology now means that we can for the first time produce patches that contain effective doses of active ingredients such as ibuprofen for which no patches currently exist. Also, we can improve the drug loading and stickiness of patches containing other active ingredients to improve patient comfort and outcome."

The researchers are now testing other analgesics to see if they too can be embedded into the polymers. So far they’ve had good results with methyl salicylate – a wintergreen-scented chemical used in some topical liniments and gels.

“We believe that many other over the counter and prescription drugs can exploit our technology and we are seeking opportunities to test a much wider range of drugs and treatments within our patch," says Haddleton.

In an email to Pain News Network, Medherent’s CEO said the technology is compatible with a wide range of drugs, including opioids. The company is currently seeking partners to help develop the patches.

"Our first products will be over-the-counter pain relief patches and through partnering we would expect to have the first of those products on the market in around 2 years,” said Nigel Davis. “In addition to our pain relief products, our technology also works with drugs in many other therapeutic areas. We can see considerable opportunities in working with pharmaceutical companies to develop innovative products using our next generation transdermal drug-delivery platform."

Adding opioids to the mix is tricky business, because some opioid patches already on the market are being abused. According to CBCNews, transdermal patches containing fentanyl are blamed for over 600 deaths in Canada. Addicts have learned they can cut up fentanyl patches to smoke or ingest them  

Asked if Medherent’s patch technology would prevent similar abuse, Davis said, “We hope so but need to do more work on that before we make claims of that sort. “

Decision on Opioid Implant Nears

Meanwhile, Titan Pharmaceuticals (NASDAQ: TTNP) has announced that the Food and Drug Administration has scheduled a meeting with the company next month to discuss its new drug application for Probuphine, an implant containing buprenorphine, a weak acting opioid used to treat addiction.

Ironically, some addicts have learned they can get high by abusing buprenorphine and it is prized as a street drug that can ease withdrawal pains from heroin. Buprenorphine, which is more widely known under the brand name Suboxone, is currently only available in pills and oral films.

The Probuphine implant would be difficult to abuse. About the size of a matchstick, it is designed to be inserted subcutaneously under the skin of the upper arm, where it can release steady doses of buprenorphine for as long as six months.

Titan and its partner, Braeburn Pharmaceuticals, believe the implant technology could someday be used to deliver other medications, including opioids for pain relief.

image courtesy of titan pharmaceuticals

Probuphine’s path to the marketplace hasn’t been a smooth one. Braeburn and Titan were stunned in 2013 when the FDA denied approval of the implant and asked for a new clinical study of Probuphine’s effectiveness. Since then, the companies have conducted a study showing that the implant was more effective than buprenorphine tablets in treating addiction. The companies are hoping for FDA approval in 2016.

Tommie Copper Tarnished By Fed Charges

By Pat Anson, Editor

Some of the shine has come off athletic apparel company Tommie Copper, Inc.

The company has agreed to pay $1.35 million to settle federal charges that it deceptively advertised its copper-infused compression clothing would relieve pain and inflammation caused by arthritis, fibromyalgia and other chronic diseases.

Tommie Copper’s settlement with the Federal Trade Commission also requires the company and founder Thomas Kallish to have “competent and reliable” scientific evidence before making any future claims about pain relief, disease treatment, or the health benefits of their products.

Tommie Cooper advertised its copper-infused garments in infomercials, brochures, social media, and print media such as Arthritis Today magazine. The ads claimed the clothing alleviated pain caused by multiple sclerosis, arthritis, and fibromyalgia; and could provide pain relief comparable to or better than drugs or surgery.

Some of the infomercials feature talk show host Montel Williams, who suffers from multiple sclerosis, declaring, “Tommie Copper truly is pain relief without a pill.”

 “It’s tempting to believe that wearing certain clothing will eliminate severe pain, but Tommie Copper didn’t have science to back its claims,” said Jessica Rich, Director of the FTC’s Bureau of Consumer Protection. “If you see an ad for a product that promises to replace the need for drugs or surgery, talk to a healthcare professional before you spend your money.”

The company’s website now only claims its products “can be worn all day to provide relief from everyday aches and pains.” The clothing, including sleeves, braces, shirts and socks, range in price from $29.95 to $69.50.

The proposed federal court order imposes an $86.8 million judgment against Tommie Copper, which will be suspended upon payment of $1.35 million by the company within seven days . The company neither admitted or denied any of the allegations in the settlement.

The so-called “healing power” and pain relieving power of copper can be traced back thousands of years. But a 2013 study by British researchers found that copper does nothing to alleviate the pain, swelling, or disease progression of rheumatoid arthritis. The study, published in PLOS ONE, found that copper bracelets worn by 70 patients provide no more meaningful therapeutic effect than a placebo.

Hospitals Accountable for Joint Replacement Surgeries

By Pat Anson, Editor

Hospitals will be held accountable for the cost and quality of care given to Medicare patients who undergo hip and knee replacement surgery under a pilot program by the Center for Medicare and Medicaid Services (CMS).

Hip and knee replacements are the most common inpatient surgery for Medicare beneficiaries. In 2014, there were more than 400,000 such procedures, costing Medicare more than $7 billion for hospitalizations alone. Post-surgery complications such as pain and infection often lead to hospital readmissions and extended recovery periods.

Under the Comprehensive Care for Joint Replacement (CJR) model, the hospital where the surgery takes place will be accountable for all services from the time of the surgery through 90 days after hospital discharge. This “bundling” of payments for hospitals, physicians, physical therapists and other health providers is meant to encourage them to work together to deliver more effective and efficient care.

Depending on the hospital’s quality and cost performance, the hospital will either earn a financial reward or be required to refund Medicare for a portion of the cost.

The quality and cost of care for hip and knee replacement surgeries can vary greatly. Currently the average Medicare expenditure for surgery, hospitalization, and recovery ranges from $16,500 to $33,000 across geographic areas. The rate of complications from infections or implant failures can be more than three times higher at some facilities than others.

“Incentives to coordinate the whole episode of care – from surgery to recovery – are not strong enough, and a patient’s health may suffer as a result,” CMS said in a statement. “When approaching care without seeing the big picture, there is a risk of missing crucial information or not coordinating across different care settings. This approach leads to more complications after surgery, higher readmission rates, protracted rehabilitative care, and variable costs. These are not the health outcomes patients want.”

The CJR model is being tested in 67 metropolitan areas throughout the country, and nearly all hospitals in those areas are required to participate. Patients will still be able to choose their doctor, hospital, nursing facility, home health service, and other providers. A list of all 67 areas can be found here.

The aging of the U.S. population is causing a surge in hip and knee replacement surgeries. Over a million joint replacement surgeries are currently performed annually – a number expected to surpass four million by 2030. 

Joint replacement surgery is generally conducted on the elderly to relieve pain from osteoarthritis, a painful and disabling condition caused by a loss of cartilage and the degradation of joints. Twenty-seven million Americans suffer from osteoarthritis.

Recent studies have questioned whether many of the surgeries are appropriate. A five year study of 175 knee replacement patients by the National Institutes of Health found that over a third of the surgeries were inappropriate, according to researchers who found that many patients had pain and other symptoms that were too mild to justify having their knees replaced.  Less than half (44%) of the knee replacement surgeries were classified as appropriate, with 22% rated inconclusive and 34% deemed inappropriate.

Miss Understood: Vibrant Trial

(Editor’s note:  Several weeks ago we were contacted by a sales representative for Neurovative Technologies, a Canadian manufacturer of medical devices that use vibration to relieve chronic pain. These “Vibrant” devices sell for about $300 each and, we were told, “have been able to decrease pain and stiffness and increase range of motion in 95% of our OA, RA and Fibromyalgia patients.” The company was invited and agreed to provide a Vibrant device for back pain at no cost to PNN columnist Arlene Grau for a test run. Arlene suffers from fibromylagia and rheumatoid arthritis.)

By Arlene Grau, Columnist

There are many people who suffer the same pain day in and day out with little to no relief from medication, acupuncture, medical devices, etc. My pain begins in my back and spreads throughout my body. Recently, I was asked to give a drug free and non-invasive device called Vibrant a try to see if it helped with some of the pain I was suffering from. I received the device that is designed for back pain management.

During my time using the device, which was about two weeks, I have found that there is no change in my pain level or relief for my back pain.

The device is recommended for use in 16 minute sessions.  It can be used as many times as you'd like during the day, however it is not recommended that anyone use it for an extended period of time all at once.

It is extremely easy to use. You just push the “on” button and it does all the work. It also comes with a charger and backpack for storing or carrying, which I thought was pretty neat.

The Vibrant device reminded me of a massage chair, but I kept wanting to raise the level of intensity and couldn't because it doesn't come with that feature.

It did however help relieve minor aches and pains related to everyday life. My husband even tried it and said that he found it to be relaxing.

I also have a TENS unit which was prescribed by my pain management doctor and I feel like I get a lot more relief from that than the Vibrant device. As far as being able to target my pain and getting deep down into the problem areas, I feel like the Vibrant device fell short.

It's possible that it's meant for smaller aches and pains, but as far as rheumatoid arthritis and fibromyalgia patients go, there really are no minor pains related to our diseases.

Arlene Grau lives in southern California. She suffers from rheumatoid arthritis, fibromyalgia, lupus, migraine, vasculitis, and Sjogren’s disease.

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.