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The latest news on fibromyalgia syndrome-chronic fatigue syndrome/myalgic encephalopathy (FMS/ME) is posted below in support of Fibromyalgia Network's mission to educate patients and the media with ad-free reporting.
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- FDA Approves Second Drug to Treat Fibromyalgia - June 27, 2008
- Are You Becoming Cold-Sensitive? - May 30, 2008
- Diagnosing FM Saves Money - March 27, 2008
- Novel Way to Aid Sleep, Relieve Anxiety in Fibromyalgia - Feb. 26, 2008
FDA Approves Second Drug to Treat Fibromyalgia
Posted: June 27, 2008
The U.S. Food and Drug Administration (FDA) approved Cymbalta (duloxetine) on June 16 for treating fibromyalgia. Cymbalta is the first serotonin-norepinephrine reuptake inhibitor (SNRI) that has been proven to reduce pain in fibromyalgia patients. This is the second FDA-approved medication to treat the disease, while the first was Lyrica (pregabalin) in June 2007.
The Fibromyalgia Network has been reporting on the progress of Cymbalta through clinical trials since the spring of 2004.
SNRI drugs, such as Cymbalta, are thought to relieve pain by increasing the availability of serotonin and norepinephrine (NE) in the central nervous system. These two neurotransmitters help filter out pain signals in the spinal cord so that fewer make it up to the brain. When serotonin and NE are released at the nerve endings, SNRIs latch onto these two neurotransmitters and carry them back across the nerve junction so that both can be reused to fight pain. In a way, SNRIs "recycle" the two neurotransmitters that are low in many patients with fibromyalgia.
In the most recent double-blind, randomized, phase III clinical trial of 520 men and women with fibromyalgia, researchers compared Cymbalta at 20 mg, 60 mg, and 120 mg doses taken once daily for six months versus placebo. People taking the two higher doses (but not 20 mg/day) reported pain reduction after the first week. After three and six months, patients taking either 60 or 120 mg daily reported a significant reduction in pain compared to patients taking the placebo. Aside from measures of pain, the two higher doses of Cymbalta also reduced mental fatigue, which might possibly relate to improvements in mental clarity.
Cymbalta was shown to be equally effective in men and women with and without mood disorders. Even people over 65 years of age reaped similar improvements in pain as those in the younger age groups.
Nausea, dry mouth, constipation, and sleepiness were the most common side effects of the medication. The side effects increased at the higher dose. Weight gain or blood pressure elevations may occur in a subgroup of patients taking Cymbalta.
Details on overcoming side effects, monitoring blood pressure and making adjustments for daytime sleepiness were reported in the January 2008 issue of the Fibromyalgia Network Journal. "The key message is to not give up too soon: try different doses and try taking it at different times during the day. Patients usually find the right approach for them," said Lesley Arnold, M.D. of the University of Cincinnati College of Medicine, in Ohio, and lead investigator for the clinical trials on Cymbalta.
Cymbalta has already been FDA-approved to treat diabetic peripheral neuropathic pain (DPNP), major depressive disorder, and generalized anxiety disorder, all in adults older than 18 years of age.
The FDA also added important warnings and precautions to the Cymbalta prescription information including who should not take this medication.
The July 2008 edition of the Fibromyalgia Network Journal outlines the progress of six additional medications that are currently being tested for the treatment of fibromyalgia.
Are You Becoming Cold-Sensitive?
Posted: May 30, 2008
As people get older, they often relocate to places with a warmer climate. In fact, purchasing a retirement home in a sunny location (such as southern Arizona or Florida) to live in during the winter months is fairly common for those who can afford it. This quest for humans to escape cold weather during their retirement years may have a physiological basis according to Robert Yezierski, Ph.D., and his team at the University of Florida, who looked at the sensitivity to heat and cold stimuli as rats age.
Many chronic, painful conditions tend to increase with age, such as rheumatoid arthritis, diabetes, cancer, and fibromyalgia. "Important to understanding these conditions is the question of how advancing age changes the processing and ultimately the perception of pain," comments Yezierski in his study presented at the May 2008 American Pain Society (APS) meeting.
Rats of varying ages were injected in the hind paws with a substance that causes a temporary state of inflamation and discomfort. Next they were evaluated for changes in thermal sensitivity as a function of advancing age using four different age groups: 8 months, 16 months, 24 months and 32 months. In rat time, 8-10 months of age is considered mature, while 37 months is considered "very old." The rats were tested to determine their relative degree of thermal preference and the speed at which they escaped cold and hot environments (50 degrees F and 112 degrees F).
Yezierski found that the older the rat, the greater their preference to heat (i.e., aversion to cold), implying an increased cold sensitivity as animals age. He also found that the speed at which the 32-month old rats escaped from the cold and hot environments was faster than for any of the other age groups. In fact, the 8- and 16-month old rats were not bothered by exposure to the hot/cold climates.
Although this study was done in rats, not humans, it lends support to the common phenomena expressed by retirement-aged people who can no longer stand the cold and also tend to develop an aversion to extremely hot climates.
Diagnosing Fibromyalgia Saves Money
Posted: March 27, 2008
There are two opposing views about the economic impact of diagnosing people with fibromyalgia. One school of thought, often touted by the very people who cling to the notion that fibromyalgia is not real, says that the mere labeling of a person with fibromyalgia leads to "illness behavior" and an increase in health care costs. According to the other school of thought, making the diagnosis should reduce the number of health care visits and associated medical costs. "If the latter hypothesis is confirmed," write the authors of a recent economic study, "providers might then be legitimately concerned not only with the costs of diagnosing fibromyalgia but also with the cost of not diagnosing fibromyalgia."*
The study, conducted in Great Britain, looked at the medical costs per year of patients not diagnosed with fibromyalgia and compared it to their costs per year after they were diagnosed. In a way, patients served as their own control because it looked at each person’s change in medical expenditures before and after the fibromyalgia diagnosis.
Information about the cost of four categories was obtained: 1) diagnostic tests, 2) medications, 3) referrals to specialists, and 4) visits to the general practitioner (similar to the primary care provider in the United States). Between the years 1998 and 2003, 2,260 new diagnoses of fibromyalgia were recorded. The average age of the patients was 49 years, and 81 percent of the cases were women.
Following diagnosis, study results demonstrated substantial reductions in health care costs. In fact, the overall cost savings per patient, per year was $265. Looking at how this breaks down into the various health resource categories, the savings were as follows: $96 on tests, $89 on medications, $62 on referrals to specialists, and $18 on visits to general practitioners. Understandably, the cost savings would be less for doctor visits because fibromyalgia is a chronic condition and patients still need to regularly see a physician for their fibromyalgia-related health care.
While $265 per patient per year may not sound like a lot of savings, keep in mind the high prevalence rate of fibromyalgia (3-5 percent of the general population). In the United States, if just 10 percent of people with fibromyalgia were currently undiagnosed, the added medical burden would be $2 million per year using the cost valued from the Great Britain study. However, medical costs are considered to be much higher in the United States, so the cost burden of not diagnosing people with fibromyalgia would be substantially more.
The January 14th front page article in the New York Times called into question whether the diagnosis of fibromyalgia was real. The report also stated that diagnosing fibromyalgia placed a financial burden on the health care system. Clearly, these statements were merely opinions that were deceptively promoted as fact. This research paper provides the scientific proof that diagnosing people with fibromyalgia not only reduces unnecessary suffering, but it saves on health care costs too.
* Annemans L, et al. Arthritis Rheum 58(3):895-902, 2008.
Novel Way to Aid Sleep, Relieve Anxiety in Fibromyalgia
Posted: February 26, 2008
Kim Jones, Ph.D., F.N.P., and the team at Oregon Health & Sciences University in Portland, have shown that growth hormone secretion from the brain's hypothalamus-pituitary system is substantially low in one-third of fibromyalgia patients. Growth hormone is needed in the body for repairing muscle tissues, and inadequate amounts of this hormone could lead to tiny tears in the muscles that eventually generate pain. In fact, a trial to use growth hormone to treat fibromyalgia showed benefit, but this injectable medicine is rarely prescribed because it is costly and not covered by insurance.
The Oregon team tried two relatively inexpensive methods to boost growth hormone production in 165 patients with fibromyalgia during a six-month period.* One method was for patients to take pyridostigmine (PYD), a drug that is used to increase acetylcholine but it also enhances growth hormone secretion. The patients in the PYD group took 60 mg of this medication three times a day (after a dosing up period). The other method was for patients to join a group-exercise program designed for fibromyalgia, because in healthy people exercise is touted as beneficially increasing growth hormone secretion. People in the exercise group met for one hour three times a week.
As it turned out, neither PYD or exercise increased growth hormone secretion in the fibromyalgia patients during the six-month trial. However, PYD was found to significantly improve the patient’s rating of sleep and anxiety.
The authors said they were intrigued by the improvements in sleep and speculate that the PYD may be working to improve the activity in the parasympathetic branch of the autonomic nervous system. The parasympathetic branch is the body's "rest and digest" control system. It transmits signals mostly through the use of acetylcholine, which is increased by PYD. Many studies have linked reduced parasympathetic activity to sleep disturbances, so taking PYD could be a novel way to improve your sleep.
Only two of the 106 patients assigned to take PYD dropped out of the study because of drug side effects, so in general, PYD is fairly well tolerated. The side effects of PYD include abdominal pain, diarrhea (helpful if you are constipated), and muscle cramping or twitching. PYD is a prescription medication that has been around a long time, is inexpensive, and available as a generic.
* Jones KD, et al. Arthritis & Rheum 58(2):612-22, 2008.
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