What makes your fibromyalgia body more wobbly some days than others? According to a study by Nuray Akkaya, M.D., and his research team in Turkey, your quality of sleep the night before plays a major role in how well you navigate movements the next day.* But sleep was not the only factor he found that was related to the potential for balance mishaps in people with fibro.

Akkaya compared the postural stability (e.g., balance) of 48 fibromyalgia patients and 32 healthy controls. The body mass index, which is a relative indicator of excess weight, was the same for both groups. The average age was also the same for each group (around 34 years old), so the participants were quite young. No one was on a sedating medication or a drug that might interfere with postural stability testing.

A balance testing system was used to produce a value for the relative fall risk for each person in the study. The fall risk computed for the fibromyalgia group was double that of the healthy control group.

Subjects stood on a platform that measured the relative pressure exerted by each foot when they were asked to modify their standing position, such as neck turned to the right or eyes closed. A person challenged by these simple changes will have more postural sway, meaning one foot presses down harder on the platform. It sounds easy, but many fibromyalgia patients found these tasks to be difficult.

Obviously, a person’s leg function can help keep a sturdy, upright posture when changing positions. Each participant’s lower-body muscle strength was measured along with their ability to stand on one leg. Questionnaires were used to assess various symptoms, such as pain, fatigue, and overall function.

“Postural performance was worse in the fibromyalgia patients compared to the control subjects and it was related to the severity of fatigue and sleep quality in the last 24 hours,” says Akkaya. “Fall risk was found to be related to lower-body strength and scores for the one-leg stance test.” However, the duration of fibro, rating of pain, overall function, and quality of sleep for the past week (not just the previous night) were NOT related to balance in the fibromyalgia patients.

Although all subjects with vestibular-related symptoms, such as ringing in the ears and dizziness, were excluded from the study, vestibular system abnormalities were still detected in the fibromyalgia group. In addition, the sensory signals from the feet (which inform the brain about your stance) and postural reflexes also might contribute to balance disturbances.

“There is no single mechanism that can account for postural instability in fibromyalgia patients,” says Akkaya. However, he points out that warm water therapy improves muscle strength and balance in fibro patients, which is consistent with his finding that reduced leg strength increased risk of falling. So improving lower body function (perhaps with a walking program) and the quality of sleep (using drug and nondrug approaches) should make you more steady on your feet.

* Akkaya N, et al. Assessment of the relationship between postural stability and sleep quality in patients with fibromyalgia. Clin Rheumatol [epub ahead of print] Nov. 21, 2012.

Animal-assisted therapy is a complementary approach to helping people with a wide range of medical conditions. Pets are often dogs trained to be obedient, calm, and comforting, and visits are typically provided through volunteer services at healthcare settings. Obviously, animals can be stress-relieving, but studies also show they boost the body’s production of pain-fighters and immune system healers.

Dawn Marcus, M.D., the lead author of a study at a Pittsburgh pain clinic, measured  the impact of a brief visit with a therapy-trained dog in fibromyalgia patients. During a 10 to 15 minute period prior to their doctor’s appointment, 84 patients received pet therapy  and another 49 fibro patients just spent the time in the waiting room. A short questionnaire before and after the therapy service or wait time was used to detect symptom differences.

“Overall, pain severity was significantly reduced after a brief therapy dog visit,” states Marcus. In fact, all measures including fatigue, stress level, calmness, and cheerfulness improved, not just pain. Slightly longer visits tended to produce better results in the pet therapy group, while cheerfulness and fatigue became worse as time increased for the waiting room group.

“Clinically meaningful pain relief was reported in 34% of the fibromyalgia patients after the dog visit versus only 4% in the waiting room controls,” says Marcus. “Effects did not appear to be substantially influenced by coexisting mood disorder symptoms.”

Satisfaction with the dog therapy visit was 92%. Also, the effectiveness of the pet intervention did not depend upon whether the patient viewed themselves as a “dog lover” or someone who prefers cats.

Healthcare providers may struggle with recommending alternative care to fibromyalgia patients due to limited studies on a therapy’s benefits, as well as cost and availability constraints. Although these latter two issues are not a barrier for doctors who wish to provide pet therapy for patients in their waiting room, this study offers a starting basis for such a practice.

Of course, you don’t have to wait for your physician to offer you a slice of pet therapy to receive the potential benefits from it. If you don’t already have a pet, contact your local Humane Society, animal organization, or veterinarian clinic to find out about programs in your area. You may also volunteer for a while to determine what type of animal best suits you and your pocketbook.

For those of you who have a pet or two, please comment about pros or the cons of owning various types of animals. Also, if you have a photogenic pet or one that has lots of character, please copy a picture with a comment to our Facebook page album at www.facebook.com/FibroNetwork. Animals can be hilarious, so don’t hesitate to give other fibromyalgia patients a chuckle.

* Marcus DA, et al. Impact of Animal-Assisted Therapy for Outpatients with Fibromyalgia. Pain Medicine [epub ahead of print] Nov.21, 2012.

The evaluated patients were referred by Melbourne physicians to a local rheumatology clinic between March 2008 and September 2010. No one was pre-selected based on symptoms or treatments because the study goal was to look at factors in a community sample of people with fibromyalgia.

Out of 150 patients, 63% met the strict tender point criteria (i.e., they had at least 11 of the 18 specified tender points), while the remaining study participants were diagnosed with fibro based on symptoms. The latter method is common practice by many physicians who recognize the widespread pain of fibromyalgia and its associated symptoms. Both approaches are described in our website section on diagnosis.

As expected, patients meeting the tender point criteria had higher ratings for pain, fatigue and trouble sleeping, as well as a greater number of associated conditions. Among all 150 patients the average number of associated conditions was five. The two most common were chronic headaches and irritable bowel syndrome, as shown below.

“A higher number of associated conditions in this group of patients was correlated with a longer duration of symptoms, worse pain, and a higher illness impact,” states Guymer. Why more associated conditions were found in patients with a longer illness duration was not addressed.

Study participants’ average age was 47 and duration of fibro was 10 years. Guymer found that the younger a patient’s age, the more serious they rated their fatigue. She suggests that may be because “younger people expect to have higher than usual energy levels in keeping with their peers.” This implies older patients are more apt to attribute fatigue to aging, which could be a false assumption.

What about the use of various treatments and their rated benefits? At the time of the study, low-dose tricyclic antidepressants (such as amitriptyline), Cymbalta, and Lyrica were available in Australia, although not specifically approved for treating fibromyalgia. Guymer’s research report emphasizes that these three medications have “evidence of significant benefit in the management of fibromyalgia.” But as it turned out, these meds did not live up to expectations.

Only 35% of the patients were taking the medications Guymer described as “evidence-based.” Perhaps the low usage of these meds was due to their poor performance. The only benefit obtained from them was a slight improvement in physical function, but they did not reduce the key symptoms of pain, fatigue, or disrupted sleep.

Psychological approaches to pain management had been tried by 30% of the 150 fibro patients, but did not produce improvements. “Complementary or alternative therapies were being used regularly at least once a month for the past three months by almost half of the patients,” says Guymer. Examples included naturopathy, osteopathy, physical therapy, massage, acupuncture, chiropractic treatment, and movement therapies such as tai chi. These treatments provided a significant decrease in anxiety.

Patients engaged in regular aerobic exercise at least 20 minutes twice per week (44%) had reduced illness impact scores, better physical function, and less fatigue, anxiety and depression. Whereas patients who were less likely to exercise had a greater number of other associated conditions and higher scores for pain, fatigue, and sleep disruption. It’s difficult to know whether those who exercised were just more able to do so.

Staying fit is an important goal for maintaining overall health and function for anyone, with fibro or not. Surprisingly, milder movement therapies, such as tai chi and yoga, were not considered forms of exercise in this study despite reports showing they help fibromyalgia patients maintain function.

Exercise and certain medications (tricyclic antidepressants, Cymbalta and Lyrica) are all touted to improve the pain of fibromyalgia, yet this study failed to substantiate these claims. Guymer and her colleagues did not point this out in the article, but the data was clear about lack of pain relief. One could only guess this omission is somehow related to the consultation fees received by the authors from the makers of Cymbalta and Lyrica (Eli Lilly and Pfizer).

* Guymer EK, et al. Clinical characteristics of 150 consecutive fibromyalgia patients attending an Australian public hospital clinic. Int J Rheumatic Dis 15:348-57, 2012.

Do you like Lyrica, Cymbalta or Savella? Have any of these meds cured you? Or has cognitive behavioral therapy been the answer for your fibromyalgia symptoms? According to the FibroCollaborative, a program funded by Pfizer and made up of 25 physicians, these would be your only options.¹ This is what they promote as the roadmap to success, but actually, it is the roadmap to doom for all fibromyalgia patients.

You may have initially viewed the FDA-approval of Lyrica as a milestone, but chances are you did not know what was brewing behind the scenes. Soon after the FDA-approval of the three drugs, new criteria for fibromyalgia appeared in print in early 2010.^2,3,4 They don’t require a doctor to examine or talk to you; identifying your illness has been reduced to filling out a 2-page form. The criteria were disguised as an easier way for primary care providers to diagnose fibromyalgia, but more than likely, it expands the diagnosis to anyone who has muscle pain and trouble sleeping.

This new way to sell more drugs (even though each one only works in one out of 8 to 15 patients) can be credited with one of the big chiefs of the FibroCollaborative, Daniel J. Clauw, M.D., of the University of Michigan in Ann Arbor.⁵ Clauw is the author of many research papers, but lately, the majority have just been about pushing certain drugs. He and his Pfizer-affiliated colleagues want all primary care doctors to know there are three drugs for treating fibro: Lyrica, Cymbalta, and Savella. Although many medicines are available to treat you, few others are mentioned.

While everyone thinks of researchers as working on the patient’s behalf, when it comes to the 25 members working on Pfizer’s behalf, it is hard to believe that your interests will trump profits. But don’t think this money-making plan was solely cooked up by Clauw. He shares the podium with:

Lesley M. Arnold, M.D., of the University of Cincinnati,
Bill H. McCarberg, M.D., of Kaiser Permanente,
L. Jean Dunegan M.D., JD, of Brighton, MI,
and Dennis C. Turk, Ph.D., of the University of Washington.

What’s more, there are another 20 members who dance to Pfizer’s tune that deserve acknowledgment as well:

Kenneth Barrow, PA–C, MHS – Wilmington, NC
*Lucinda Bateman, M.D. – Salt Lake City, UT
Larry Culpepper M.D., MPH, – Boston University
Cassandra Curtis, M.D. – Greenfield, IN
Yvonne D’Arcy, M.S., CRNP – Johns Hopkins
Kevin B. Gebke, M.D. – Indiana University
*Robert Gerwin, M.D. – Bethesda, MD
*Don L. Goldenberg, M.D. – Newton-Wellesley Hospital
James I. Hudson, M.D., ScD – McLean Hospital
Rakesh Jain, M.D., MPH – Lake Jackson, TX
Arnold L. Katz, M.D. – Overland Park Medical Center, KS
Andrew G. Kowal, M.D. – Burlington, MA
*Charles Lapp, M.D. – Charlotte, NC
*Michael McNett, M.D. – Chicago, IL
*Philip J. Mease, M.D. – Seattle, WA
Danielle Petersel, M.D. – Pfizer, NY
*I. Jon Russell, M.D., PhD – San Antonio, TX
Stephen M. Stahl, M.D., PhD – San Diego, CA
*Roland Staud, M.D. – Gainesville, FL
Alvin F. Well, M.D., PhD – Oak Creek, WI

Those with an asterisk used to advocate for fibromyalgia patients (along with Clauw), but how can anyone view their actions with integrity given their alliance with a drug initiative that only promotes three medications for treating fibro? If you need something to help you fall asleep at night, you best get hip with Lapp’s behavior modification program.

Perhaps it is good news that Lapp’s behavior program is free on his website. Of course, once you have given all of your contact details on the website, who is to say they won’t get passed along to Pfizer?

While talented physicians and researchers have placed their loyalty to the drug company, rather than remaining independent-minded scientists, the question is: why? There had to be a draw to the drug company’s scheme. Money? Power? Or maybe a little of both? Regardless of the reasons, it appears that treating patients is no longer their primary interest.

These days, one may automatically assume patient organizations are working in collaboration with the drug companies. It can be a sneaky way of connecting you to Pfizer’s initiative, to collect info about you as a fibro consumer in order to improve their marketing strategies. Is that really what you want as a patient, to be viewed as marketing income from the organizations you trust to have your back?

Take for example, the National Fibromyalgia Association (NFA), who even in the midst of legal troubles keeps sending out emails to patients to collect more data on you. They have a disconnected phone number and an address that is nothing more than a box. Now the National Fibromyalgia and Chronic Pain Association (NFMCPA) out of Utah has taken over the patient-related reins of the NFA. They promote the FibroCollaborative on their website, so perhaps they sit at the same table with the NFA, the American Chronic Pain Association, and others to help Pfizer’s bottom line.

This is not the case for the Fibromyalgia Network (or the American Fibromyalgia Syndrome Association). There is a price to pay for not being a puppet on Pfizer’s or anyone else’s string. Although the Network makes lots of info available for free, we have to charge for our publications. That’s the price you pay for objectivity.

1. Arnold LM, Clauw DJ, et al. Mayo Clin Proc 87:488-96, 2012.
2. Wolfe F, Clauw DJ, et al. Arthritis Care Res 62:600-10, 2010.
3. Wolfe F, Clauw DJ, et al. J Rheumatol 38:1113-22, 2011.
4. Arnold LM, Clauw DJ, et al. Mayo Clin Proc 86:457-64, 2011.
5. Clauw DJ, et al. Mayo Clinic Proc 86:907-11, 2011.

The overall impact of fibromyalgia symptoms were measured using validated tools in a recent investigation headed up by Virginia Aparicio, Ph.D., and her research team in Spain.¹  Health status, physical function, overall well-being, work missed, work difficulty, pain, fatigue, morning tiredness, stiffness, anxiety, and depression were assessed. From these measurements, Aparicio was able to decipher how each gender is impacted by fibromyalgia.

Differing from most other fibro studies, this one contained a larger sample of 20 male and 79 female patients age-matched with similar characteristics. Using multiple procedures to match the men and women according to height, weight, and body mass index, Aparicio and her team aimed to take a closer look at the differences between the male and female quality of life and set of symptoms. So which faired better?

Perhaps neither. Women with fibromyalgia were found to have less vitality/more fatigue than men. This finding could imply that strength and energy are more dwindled in women, whose metabolic processes can be more demanding. Otherwise, it could mean fibromyalgia symptoms affect the female body in a different way than males.

On the other hand, fibromyalgia created more physical impairments in the men compared to the group of women. The overall impact of the condition was also harder on the men. This coincides with an earlier study conducted by Isabel Ruiz-Perez, M.D., also of Spain, who found, “Men with fibromyalgia had a worse perception of their health” and “more impact of the disease.”²

But the primary symptom of fibromyalgia is pain, although fatigue and physical function are certainly important. “Nevertheless,” says Aparicio, “concerning pain perception, gender differences appear to be low or nonexistent.”

So the question of whether men or women are more impacted by fibromyalgia remains to be determined. The female patients in Aparicio’s study displayed greater fatigue and morning tiredness. Yet it’s not as simple to interpret the study by saying men with fibro are more affected functionally, and women with fibro are more drained of energy. Each person is different, and summing up how one handles such a complex disease is not likely to be that simple.

While Aparicio’s study is still early research on gender differences in fibromyalgia, this study is of growing importance as doctors struggle to treat and monitor both male and female patients. Treatment plans require individual approaches. Men may need to work to aid their physical function, while women may need more focus on reducing the symptom of fatigue. It’s certainly research deserving of more attention.

1. Aparicio V, et al.  Am J Men’s Health [epub ahead of print] Apr 11, 2012.
2. Ruiz-Perez I, et al.  Rev Clin Esp 207:433-9, 2007.

If you are a man with fibro, there is a terrific site just for you: www.menwithfibro.com.

People can grasp how back pain interferes with one’s ability to put on their shoes, bending for household chores, or yard maintenance tasks. Even the difficulties of sitting in a chair or standing for prolonged periods of time with a sore back might be something the average person can relate to.

At any given time, roughly 72% of fibromyalgia patients have objective evidence of painful muscular knots in their low back region.¹ This means most people with fibro have low back pain with the added discomfort of their widespread symptoms. On the flip side, a recent study found 28% of women with chronic low back pain also met the criteria for fibromyalgia.²

The purpose of the above study was to examine the impact fibromyalgia had on people already burdened with chronic low back pain, compared to those who only had the back pain. By itself, low back pain produced serious consequences for the 130 people in the study. Many objective findings such as handgrip strength, walking speed, and work disability were combined with validated questionnaires to assess the impact of the chronic painful conditions.

As to be expected, chronic low back pain seriously affected patients in the study regardless of whether they also had the widespread symptoms of fibromyalgia. However, patients with both pain conditions were clearly more burdened. So if the people in your life (partner, friend or coworker) understand how back pain interferes with function, this study might help explain why your fibro symptoms further limit your abilities.

“The back pain plus fibromyalgia group showed significantly more severe impairments in body functions, more severe activity limitations, and participation restrictions,” writes the lead author Lena Nordeman, Ph.D., RPT. She adds, “Less social support and lower healthy-related quality of life” was also found in the patients with both conditions compared to those with low back pain.

More specifically, the reduced speed of walking and handgrip strength in the fibro group was nearly the same as that reported for healthy people 15 years older. Many patients with fibromyalgia state they feel much older than they really are, and the measurements from this study offer confirmation. However, it is not just a state of mind, as neither patient group (low back or fibro) met the criteria for clinical depression or anxiety.

Physical function and vitality were both significantly lowered in the fibromyalgia group versus the low back pain group. This likely reflects the more systemic and fatiguing effects of the widespread symptoms of fibro versus the more regional back pain syndrome.

If anyone questions your limitations, you might start by asking if they have ever had a severe back ache because most people have. Then explain how fibromyalgia further impacts your function on a daily basis.

1. Ge HY, et al. Arthritis Res Ther 13(2):R48, Mar 22, 2011.
2. Nordeman L, et al. Clin J Pain 28:65-72, 2012.

An effective treatment for sleep can be challenging to find, particularly one that does not leave you feeling hung over in the morning. Medications may help by sedating you, but after you wake up, their effects may persist. Rather than a therapy that works by sedation, it would be better to find a treatment that actually improves the quality and restorative nature of your sleep. Of course, long-term safety is also a concern because the sleep disorder of fibromyalgia is most often persistent and chronic.

A research team in Italy tested a more natural route to treating insomnia.* Using only melatonin, zinc, and magnesium supplements, they enrolled a group of residents in a long-term care facility for the study.

Each of the three supplements selected are substances the body needs and uses every day. While there are no set quantities for melatonin use, science knows this naturally produced hormone in the brain is closely associated with sleep-wake cycles and diminishes in quantity as we age. Zinc and magnesium are both trace minerals that are needed by the body to make melatonin. In addition, zinc may improve mood, and magnesium is relaxing and calming. Combined, all three of these elements seem to strengthen each other’s properties and should lead to better quality of sleep.

Forty-three men and women with insomnia were carefully selected to participate. Since they were elderly, the researchers were meticulous in screening out people with dementia, depression, other sleep disorders, or those on any medication that might alter sleep.

Researchers administered a series of commonly used questionnaires for assessing sleep. In addition, everyone wore armband sensors that measured how much they slept and moved during the day and night. The greater the activity picked up by the sensors during the night, the more the disturbed sleep. The questionnaires were given before and after the eight-week study, while the armbands were worn for 72 hours before the study and the last two weeks of the week study.

Twenty-two participants were given 5 mg of melatonin, 225 mg of magnesium, and 11 mg of zinc in a pear sauce each night before bed for eight weeks. The dose of the magnesium and zinc is just shy of the standard recommended daily allowance as established by the U.S. Department of Agriculture.

The other 21 participants were part of the control group that received only the pear sauce. None of the participants knew whether they were in the test group or the placebo control group.

Patients in the test group reported a 45% improvement in their sleep quality, compared to the control group. In addition, benefits were reported in not only quality of sleep, but also mood, ease in getting to sleep, morning alertness, and overall feeling better during the day. The sensor on the armband also measured significant improvements in total sleep time and daytime movement. In contrast, control group members reported no differences in sleep or health at all. Overall, side effects were minimal and none of the participants in either group dropped out of the study.

“These study findings are of great relevance from a clinical point of view,” says Mariangela Rondanelli, Ph.D., of the University of Pavia, Italy, the study’s lead researcher. “The concept of quality of life is defined as perceived global achievement and satisfaction within a number of key domains, with special emphasis on well-being.” Rondanelli notes that a larger study will need to be done before more conclusions can be drawn.

While it may seem expected that melatonin could help with sleep, the other benefits may not be as clear, she says. “It is possible that better nighttime sleep quality made participants more alert during the day. Furthermore, improved mood and well-being may have positively influenced the subjective evaluation of daytime sleepiness in the participants.”

More information on supplements and health is reported in the article, “Covering the Bases on Nutrition,” that appears in the April 2011 issue of the Fibromyalgia Network Journal. A feature article “Setting the Clock Straight on Melatonin” is offered as a free bonus to those receiving the Journal. Join the Fibromyalgia Network to stay abreast with the latest in research, treatments, and coping tips.”

* Rondanelli M, et al. JAGS 59:82-90, 2011.

Blomqvist and colleagues decided to put estrogen to the test. It’s commonly assumed that estrogen replacement helps with the pain processing system in the body to reduce fibromyalgia discomfort. Yet this is just a theory endorsed by many in the medical community without any concrete proof.

Half of the 49 to 60-year-old women in Blomqvist’s study were treated for eight weeks with an estrogen patch (delivering 17 beta-estradiol, the natural form of this hormone), and the other half were treated with a placebo, look-alike patch. Numerous measures of pain sensory levels were taken before the trial, after the eight-week trial period, and 20 weeks after the end of the trial. These tests were selected because people with fibromyalgia have an amplified sensory system in which the pain volume in the central nervous system is abnormally high. This means that light touch or slight changes in temperature are more readily perceived as painful.

If estrogen replacement therapy actually reduced fibromyalgia pain, it should decrease the pain volume, and this will be picked up by the many different tests that were done on all of the trial subjects. For example, the amount of pressure applied before the subjects detected it as painful should increase in the estrogen group. In addition, the length of time that subjects could immerse their hand in icy-cold water before it became uncomfortable should increase.

“Our data show that estrogen treatment does not alleviate pain in post-menopausal women with fibromyalgia,” Blomqvist says. In other words, none of the pain sensory tests were improved by the estrogen.

If you are shaking your head at the results of this trial, Blomqvist states, “The present study did not monitor potential beneficial effects of estrogen treatment on symptoms of fibromyalgia not directly related to pain.” He adds that sleep, hot flashes (vasomotor symptoms), anxiety, mood, or general quality of life may be eased by estrogen replacement. In fact, our June 30, 2010 Latest News describes two trials showing that estrogen supplementation reduces sleep disruption and next-day fatigue in peri- and post-menopausal women. However, neither of these studies involved fibromyalgia patients, so they did not evaluate estrogen’s impact on pain.

“Any beneficial effects of estrogen on fibromyalgia are likely not related to reduction of pain,” writes Blomqvist. But he adds that additional studies looking at estrogen’s effect on other fibromyalgia symptoms may still be of interest.

If you are a woman with fibromyalgia on estrogen replacement therapy, make sure you understand why. If the reason is because you were hoping the hormone would reduce your pain, talk to your doctor because you may want to see how you do without the hormone. However, if you are taking estrogen because of hot flashes, sleep disruption (and the resulting daytime fatigue it can cause), anxiety, or mood, this study does not refute the hormone’s role in easing these symptoms. Due to the potential risks of long-term use, such as breast cancer and cardiovascular problems, research reports that help clarify the most likely benefits of estrogen are always valuable.

* Stening KD, et al. Rheumatology [Epub ahead of print] November 14, 2010.

The lead authors Shyh-Ching Lo, Ph.D., at the FDA and Harvey Alter, Ph.D., at the NIH, are two highly acclaimed virologists. In addition, Harvard’s CFS expert Anthony Komaroff, M.D., provided the majority of the patient blood samples and his track record for being thorough leaves no question that the samples used for the study represent the modern-day person with CFS. However, even with a skilled team, replication of these findings on a larger scale are urgently needed.

Last year a U.S. team reported that 68% of CFS patients had DNA evidence of a xenotropic MLV-related virus (XMRV).² They also reported XMRV was present in 2.7% of healthy blood donors. After the initial news of the XMRV, four other studies failed to find it in blood samples from CFS patients. So what exactly does this latest published finding mean?

Both XMRV and MLV are retroviruses that originate from mice (e.g., murine in their name means “from mouse”). Xenotropic means the virus has evolved to the point where it can no longer go back to infect mice and must reside in humans. The most recently detected virus appears capable of infecting both mice and humans, meaning it is polytropic (infecting more than one species) rather than xenotropic.

The ability of the MLV-related virus to live inside mice and humans means that the gene sequences controlling how it infects a host would have to differ from that found in the XMRV. As it turns out, Lo and Alter report that the section regulating how each virus infects a host does differ between the MLV-related virus and XMRV. So these are different–but related–viruses with genetic material that overlaps by 97%.

In the mid-1990s, it was hypothesized that CFS was caused by mycoplasmal infections (mycoplasma are literally miniature bacteria that might have easily escaped detection by standard lab tests). The 37 CFS blood samples from this study were frozen and used for the recent study by Lo and Alter.

Twenty-five of the patients were diagnosed by Komaroff and the remaining 12 from nearby physicians in private practice. Of the 25 CFS patients diagnosed by Komaroff, 24 (96 percent) tested positive for the MLV-related virus. In addition, he located eight of his 25 subjects whose blood was donated 15 years ago to get fresh blood earlier this year to analyze for the presence of the virus.

Seven of the eight “fresh blood” samples from the CFS patients tested positive for the MLV-related virus. However, they showed significant variation from the gene sequences detected from the blood drawn 15 years earlier. This is what would be expected from a retrovirus because they continue to evolve over time. If Lo and Alter had falsely identified a contaminant instead of a retrovirus, its gene structure would have remained the same. In fact, three closely related structures of the MLV-related virus were actually found in the CFS patients, which also reinforces the concept that this is a retroviral and not some other type of viral infection.

Due to the ever evolving nature of retroviruses, you may wonder how these infectious agents can be found and identified with a shred of confidence. Virologists use a number of probes that can detect short gene sequences believed to be specific for identifying various parts of the viral structure. The entire gene sequences of a retrovirus do not change, so if the multiple probes can detect enough matches, even an evolved retrovirus can be found. An analogy might be fingerprint analysis in which only seven points provides a match.

What does this all mean? Even Lo and Alter were quick to point out that while they found strong evidence of the MLV-related virus, they did not actually culture the agent. This would offer definitive proof that the retrovirus resides in CFS patients. Also, until much larger studies are done, the authors state that their 86.5% prevalence of the virus may not apply to CFS patients in the general population.

“Even if subsequent studies confirm an association between MLV-like viruses and CFS, that will not establish a causal role for these viruses in the pathogenesis of this illness,” write the authors. “For example, such a high frequency of infections with MLV-related viruses in patients with CFS could reflect an increased susceptibility to viral infections due to an underlying CFS-related immune dysfunction, rather than a primary role for these viruses in the pathogenesis of CFS.”

Whether the retrovirus is the cause of CFS or an opportunistic agent that takes advantage of people with a compromised immune system, this report by Lo and Alter is bound to draw more attention and research dollars to investigate the CFS-viral link. Given the high overlap between CFS and fibromyalgia, people with this latter diagnosis should also stay tuned for future studies on this retroviral connection as well.

1. Lo SC, et al. PNAS [Epub ahead of print] August 23, 2010.
2. Lombardi VC, et al. Science 326:585-589, 2009.

The researchers wondered if a significant change in pain intensity could predict whether a person also reaped improvements in sleep, mood, quality of life, and physical function. Pain intensity is a simple measure because it is just the difference in pain scores after eight weeks on Lyrica compared to each patient’s pain score before starting the drug. But how much does the pain intensity have to improve in order for the drug to be considered a successful therapy? To answer this question, the researchers divided the clinical trial information obtained on 2,757 fibromyalgia participants into the following five groups:

• Substantial benefit – greater than 50 percent reduction in pain intensity
• Moderate benefit – between 30 and 50 percent reduction
• Minimal benefit – between 15 and 30 percent reduction
• Marginal benefit – between 0 and 15 percent reduction
• Worse – pain intensity was made worse by the drug

Out of the 2,757 participants, 689 of them received a placebo (sugar pill) and the remainder received Lyrica at various doses (150 mg to 600 mg per day), with the average dose being around 450 mg/day. One third of the patients (899) withdrew before the trials ended and were not included in the analysis for determining how the reduction in pain intensity might predict a favorable response. This left 1,858 patients included in the analysis, and the number of patients fitting into each of the five groups were:

• 510 patient – Substantial benefit
• 390 patients – Moderate benefit
• 304 patients – Minimal benefit
• 366 patients – Marginal benefit
• 288 patients – Worsening of symptoms during trial

Oddly, the study authors did not indicate which of the above patients were taking Lyrica and which were taking the placebo. The same holds true for the 899 patients who withdrew before the end of the trial—Was it due to drug side effects or because they were taking the placebo? This information could possibly have been withheld since the data was provided by Pfizer, the manufacturer of Lyrica. Putting these questions aside, the study authors were able to use reduction in pain intensity as a predictor of who responded to Lyrica.

Fibromyalgia patients who achieved a substantial or moderate benefit based on pain intensity scores were the ones who showed significant improvements in all other symptom measures. In addition, lost time from work was significantly reduced for patients in these two categories (substantial or moderate benefit).

“Pain intensity reduction is a simple and effective predictor of those patients who should continue treatment, and those who should discontinue and try an alternative therapy,” write the study authors. “In our sample in fibromyalgia, this means that two-thirds would have to seek another treatment.”

Too often, patients stay on a drug for months hoping it will eventually improve their symptoms. This study shows that if your pain intensity does not improve by at least 30 percent within two months, it’s time to talk to your doctor about trying something else.

* Moore RA, et al. PAIN March 25 [Epub ahead of print] 2010.