Fibromyalgia

Archive for the ‘Research’ Category

XMRV linked to CFS

Posted by Kelli on October 18th, 2009

Retrovirus Linked to Chronic Fatigue Syndrome, Could Aid in Diagnosis

By Katherine Harmon
October 8, 2009

Recently implicated in some severe prostate cancer patients, the retrovirus XMRV has now been found in many with chronic fatigue – - changing the landscape for diagnosis and possible treatment

OVERTAKING CHRONIC FATIGUE: An electron micrograph shows the XMRV retrovrius in the blood of a patient with cfs.
Source: WHITTENMORE PETERSON INSTITUTE

More so than many illnesses, chronic fatigue syndrome (CFS) frustrates those who suffer from it and those close to them, due to its nebulous assembly of symptoms, along with continued controversies over its etiology, diagnosis, treatment and even its nomenclature. Now, the discovery of a familiar retrovirus in many CFS patients could bring new energy to the field—and fresh hope for more specific medical care.
Chronic fatigue is in part a misnomer. The syndrome often has more to do with immune system abnormalities than pervasive tiredness—although the two can go hand in hand. The symptoms range from exhaustion to muscle pain, giving CFS a reputation among some as a “wastebasket diagnosis”. The slipperiness of the syndrome is in part because “it’s diagnosed based on exclusion,” says Judy Mikovits, director of research at the Whittemore Peterson Institute for Neuro-Immune Disease in Reno, Nev., and co-author of research on the retrovirus findings published online today in Science. Doctors often apply the label if no other explanation can be found for a patient’s symptoms, which may be part of the reason it seems to pop up in everyone from overworked career women to continually sick children.
Roughly 17 million people worldwide are thought to have CFS, but given current diagnosis methods, the true number could be much higher or lower. Having a specific virus to look for would make for much more robust tests and possibly even be a step toward treatment. Mikovits’s team thinks they have found just such a candidate.
The xenotropic murine leukemia virus–related virus (XMRV) has recently been linked to strong cases of prostate cancer. Like CFS, this cancer involves changes in an antiviral enzyme (RNase L). The prostate cancer discovery got Mikovits and her team thinking: Would they find the same retrovirus in people with CFS?
After analyzing biological samples from more than 100 CFS patients for the retrovirus, two thirds of them were found to test positive for the virus—compared with 3.7 percent of 218 healthy volunteers who were screened.
Precisely how this virus is related to chronic fatigue, however, remains a mystery. One of the problems with tracking down CFS is that it may not be a single ailment. “We think that the problem is that CFS is a collection of many, many different diseases even though it has similar symptoms,” says Brigitte Huber, a professor of pathology at Tufts University’s Sackler School of Graduate Biomedical Sciences in Boston. She and others suspect that the retrovirus may be unleashing other underlying conditions and viruses in the body.
“This new retrovirus may be able, through infecting human cells, [to] induce a transcription of an endogenous virus,” says Huber, who has been studying the presence of an ancient retrovirus (HERV-K18) dormant in most people but active in patients with CFS and multiple sclerosis. “We’ve already shown that Epstein-Barr virus can do exactly this.”
Even in their testing for the XMRV retrovirus, Mikovits says, “We could see a human endogenous virus at the same time” as XMRV. “There are a number of old diseases that seem to be rising at an infectious rate,” she says. Although this background noise of various viruses may be difficult to sort though, it brings clues to help researchers find the root cause of CFS. “It’s possible, downstream, that this will all feed into the same mechanism,” Huber says.

*** Note: This post has been modified from the original for space & the excessive unnecessary extra scientific jargon included that was not necessary the express my point in this blog. The original in it’s entirety can be found here: http://www.scientificamerican.com/article.cfm?id=chronic-fatigue-syndrome-retrovirus ***

Posted via email from Kelli’s Posterous

Sodium Oxybate Improves FMS Core Symptoms??

Posted by Kelli on June 15th, 2009

Data Suggests Sodium Oxybate Significantly Improves Pain and the Core Symptoms of Fibromyalgia

06/15/2009

PALO ALTO, Calif., June 15, 2009 — Jazz Pharmaceuticals’ (Nasdaq: JAZZ) sodium oxybate (JZP-6) demonstrated statistically significant and clinically meaningful improvement in pain and the core symptoms associated with fibromyalgia, according to Phase III data presented last week at the 2009 Associated Professional Sleep Societies meeting in Seattle, WA. These data have not been evaluated by the FDA or other regulatory authorities for use of sodium oxybate in the treatment of fibromyalgia.

Widespread chronic pain is the hallmark of fibromyalgia, but the vast majority of patients are also affected by a broader constellation of symptoms, including fatigue, sleep disturbances, cognitive dysfunction, and impaired physical function.

“The data showed that sodium oxybate improves the key symptoms of fibromyalgia: pain, fatigue, and sleep disturbances,” said Dr. Todd Swick, one of the study’s investigators and Medical Director of the Houston Sleep Center and Assistant Clinical Professor of Neurology at the University of Texas-Houston School of Medicine. “Millions of people are diagnosed with fibromyalgia and there is a continuing unmet need for therapies that address the constellation of symptoms that can have a significant impact on patients’ quality of life.”

The 14-week randomized, double-blind, placebo-controlled study included 548 adult patients with fibromyalgia randomized to one of three treatment arms: sodium oxybate 4.5 g/night, sodium oxybate 6 g/night or placebo. The primary outcome measure was the proportion of patients who achieved at least 30% reduction in pain from baseline to endpoint based on the Pain Visual Analog Scale (VAS).

At three months, 54.2% (p<0.001) of patients treated with sodium oxybate 4.5 g/night and 58.5% (p<0.001) of patients treated with sodium oxybate 6 g/night showed significantly greater reduction in pain as measured by at least a 30% improvement in baseline pain VAS score, compared with 35.2% of patients taking placebo using Last Observation Carried Forward analysis.

Additional Data Highlights

– Patients treated with sodium oxybate 4.5 g/night and 6g/night showed significant reductions in fatigue as early as Week 1 after dosing compared with placebo as measured by the Fatigue VAS (p<0.001). These differences were maintained throughout the 14 weeks of the study (p less than or equal to 0.009).

-- Patients taking sodium oxybate 4.5 g/night and 6g/night showed significant improvement in sleep patterns compared to placebo as measured by the Jenkins Sleep Scale (p<0.001).

-- Statistically significant improvements in mean scores on the Fibromyalgia Impact Questionnaire, a measure of daily function, and on Patient Global Impression of Change were seen in patients receiving sodium oxybate compared to placebo.

-- Sodium oxybate was generally well tolerated, with the majority of adverse events reported being mild to moderate in nature. Adverse events were similar to those seen in previous sodium oxybate experience.

-- In this study, the most common adverse events, with incidence greater than or equal to 5% and at least twice the rate of placebo, were headache, nausea, dizziness, vomiting, diarrhea, anxiety, and sinusitis.

Additional details on the data presented at the 2009 APSS can be found at http://www.journalsleep.org/PDF/AbstractBook2009.pdf (abstract 0984, p.354).

Development Plans

Jazz Pharmaceuticals has completed its second Phase III clinical trial of JZP-6 and expects to announce top-line results from this study around mid-2009. Assuming positive results for the second study, the company anticipates submitting a New Drug Application for sodium oxybate for the treatment of fibromyalgia to the U.S. Food and Drug Administration by the end of 2009. UCB anticipates filing in the EU shortly after. UCB has the exclusive marketing and distribution rights to sodium oxybate for fibromyalgia in Europe and some other countries outside North America and will manage registrations accordingly.

About Sodium Oxybate

Sodium oxybate is the sodium salt form of gamma-hydroxybutyrate, an endogenous neurotransmitter and metabolite of GABA. While the precise mechanism of action is unknown, the effects may be mediated in part through interaction with GABA(B) and GHB receptors. Sodium oxybate is the active ingredient in XYREM(R), approved by the FDA for the treatment of excessive daytime sleepiness (EDS) and cataplexy (the sudden loss of muscle tone) in adult patients with narcolepsy. The American Academy of Sleep Medicine recommends sodium oxybate as a standard of care for the U.S. Food and Drug Administration-approved indications. It is also approved by the European Medical Evaluation Agency (EMEA) for the treatment of narcolepsy with cataplexy in adult patients. Most commonly reported adverse drug reactions in narcolepsy patients are dizziness, nausea and headaches. Sodium oxybate has the potential to induce respiratory depression and neuropsychiatric events. Sodium oxybate has not been evaluated by regulators for the treatment of fibromyalgia and is not approved for this use. Additional safety information for Xyrem, including black box warnings, can be found in the full prescribing information at http://www.xyrem.com/prescribing-information.php.

About Fibromyalgia

Fibromyalgia, a chronic condition characterized by widespread pain, affects 0.5% – 5% of adults worldwide. Fibromyalgia is believed to be a central nervous system condition, resulting from neurological changes in how the brain perceives and responds to pain. In addition to pain, the main symptoms are fatigue, disturbed sleep and morning stiffness. The exact causes of fibromyalgia are unknown. It may be triggered by physical trauma, emotional stress, chronic pain or infection. Genetics, neurochemicals that affect pain modulation, neurohormones and sleep physiology abnormalities are thought to play a role. Research also has suggested a relationship between sleep and pain. Fibromyalgia patients experience a high prevalence of sleep problems, including a reduction in non-restorative or deep sleep.

About Jazz Pharmaceuticals, Inc.

Jazz Pharmaceuticals is a specialty pharmaceutical company that identifies, develops and commercializes innovative treatments for important, underserved markets in neurology and psychiatry. For further information see http://www.JazzPharmaceuticals.com.

Jazz Pharmaceuticals “Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995

This press release contains forward-looking statements related to the development of Jazz Pharmaceuticals’ sodium oxybate (JZP-6) product candidate for the treatment of fibromyalgia, including the timing of results from the second Phase III pivotal clinical trial and the submission of a New Drug Application to the FDA. These forward-looking statements are based on the company’s current expectations and inherently involve significant risks and uncertainties. Jazz Pharmaceuticals’ actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to the outcomes of the company’s second Phase III clinical study of sodium oxybate for the treatment of fibromyalgia and the timing of the announcement of clinical results, and risks that a New Drug Application may not be submitted, or may be delayed, and that sodium oxybate for the treatment of fibromyalgia may not be approved for marketing by regulatory authorities. These and other risk factors are discussed under “Risk Factors” in the Quarterly Report on Form 10-Q for the quarter ended March 31, 2009 filed by Jazz Pharmaceuticals with the Securities and Exchange Commission on May 7, 2009. Jazz Pharmaceuticals undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations.

Study of Sodium Oxybate in Patients With FMS

Posted by Kelli on June 15th, 2009

Jazz Pharmaceuticals to Present Data From First Phase III Study of Sodium Oxybate in Patients With Fibromyalgia

06/09/2009

PALO ALTO, Calif., June 9 — Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) announced today that data from the company’s first Phase III clinical trial of sodium oxybate (JZP-6) for the treatment of fibromyalgia will be presented this week during the Associated Professional Sleep Societies (APSS) 2009 Annual Meeting in Seattle, Washington and also during the European League Against Rheumatism (EULAR) Congress in Copenhagen, Denmark.

Following are the details on each of these data presentations.

– At APSS on June 10, 2009, Dr. Todd Swick will be presenting a poster entitled “Impaired Sleep and Daytime Functioning at Baseline in Subjects with Fibromyalgia: a 14-week Randomized, Double-blind, Placebo-controlled Trial of Sodium Oxybate” in the 10:15 am-12:15 pm poster session.

– At APSS on June 11, 2009 at 9:00 am in Ballroom 6E, Dr. Swick will also deliver an oral presentation entitled “Sodium Oxybate Improves Pain, Fatigue, and Sleep in Fibromyalgia: Results from a 14-week Randomized, Double-blind, Placebo-controlled Study.”

– At EULAR on June 12, 2009, in Room C2 from 5:30-7:00 pm, Dr. I. Jon Russell will be presenting “Sodium Oxybate in the Treatment of Fibromyalgia” at a UCB-sponsored Symposium entitled: “Fibromyalgia: How Much More than Pain?” The symposium will be chaired by Dr. Ernest Choy and also features Dr. Gilles Lavigne and Dr. Michael Spaeth as speakers.

Jazz Pharmaceuticals has completed a second Phase III pivotal clinical trial of JZP-6 and expects to announce top-line results from that study in mid-2009. Assuming positive results in the second study, the company anticipates submitting a New Drug Application for sodium oxybate for the treatment of fibromyalgia to the U.S. Food and Drug Administration by the end of 2009.

About Sodium Oxybate

Sodium oxybate is the sodium salt form of gamma-hydroxybutyrate, an endogenous neurotransmitter and metabolite of GABA. While the precise mechanism of action is unknown, the effects may be mediated in part through interaction with GABA(B) and GHB receptors. Sodium oxybate is the active ingredient in XYREM(R), approved by the FDA for the treatment of excessive daytime sleepiness and cataplexy (the sudden loss of muscle tone) in adult patients with narcolepsy. The American Academy of Sleep Medicine recommends sodium oxybate as a standard of care for the U.S. Food and Drug Administration-approved indications. It is also approved by the European Medical Evaluation Agency for the treatment of narcolepsy with cataplexy in adult patients. Most commonly reported adverse drug reactions in narcolepsy patients are dizziness, nausea and headaches. Sodium oxybate has the potential to induce respiratory depression and neuropsychiatric events. Sodium oxybate has not been evaluated by regulators for the treatment of fibromyalgia and is not approved for this use.

About Fibromyalgia

About Jazz Pharmaceuticals, Inc.

Jazz Pharmaceuticals “Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995

(C) 2009 Jazz Pharmaceuticals, Inc.
SOURCE Jazz Pharmaceuticals, Inc.
CONTACT: Willie Quinn, Executive Director, Corporate Development of Jazz Pharmaceuticals, Inc.,
+1-650-496-2800, investorinfo@jazzpharmaceuticals.com
Web Site: http://www.jazzpharmaceuticals.com

Adjust Your Anger Management Style

Posted by Kelli on May 30th, 2009

Adjust Your Anger Management Style—Reduce Your Pain
By Dr. John Fry

Researchers published some very interesting findings this April in the European Journal of Pain regarding how much pain you feel when you’re dealing with angry feelings. The authors conclude:

“Our study suggests that anger and a general tendency to inhibit anger predicts heightened pain in the everyday life of female patients with fibromyalgia. Psychological intervention could focus on healthy anger expression to try to mitigate the symptoms of fibromyalgia.”

Previous research has shown that inhibiting anger increases pain in other pain conditions, as well. It turns out that when you suppress anger, you’re actually more aware of it and are angrier inside. This internal churning then creates more pain for those with fibromyalgia.

Does that mean that blasting away will reduce pain? Not really. It’s not a good solution, because then relationships often deteriorate. Research on marriage has shown that if there is a harsh start-up to a conversation, 90 percent of the time that conversation will fail to resolve the issue. Couples who say five times more positives than negatives to each other have almost no chance of divorce, while couples with only twice as many positives as negatives in their interaction have a fairly high probability of divorce. So blasting away clearly hurts relationships. This increases the possibility of anxiety and/or depression, and we know from previous research that both of those states are predictors of more pain in the future. Then what’s a man or woman with fibromyalgia to do?

By handling your anger better, neither blasting away nor by ‘eating it,’ you actually can decrease your fibromyalgia pain

Below are five practical tips that I have found to be helpful gleaned from over 30 years of private practice as a psychologist in Orange County, California, as well as from giving over a dozen seminars on anger management:

1. Choose assertive over aggressive or passive ways of expressing your anger.
You’re not left with the two bad choices of aggressively blasting away or letting your anger eat you up inside. Many people aren’t clear about the difference between aggressive and assertive, and so they choose the passive approach. Pressure and irritability grow, and then they blast away. Afterwards, guilt takes over and they drop back into a passive role until the pressure builds again. Not a fulfilling cycle, is it?
Sometimes people choose the “passive aggressive” option and use sneaky aggression. This includes trying to make someone else feel guilty without appearing to be angry at them. An example would be saying within earshot of an unsupportive spouse, “People who don’t cut us fibromyalgia patients some slack are insensitive and uncaring.” This tactic just tends to make others pull away from us, though.
The assertive option has the best chance of resolving the issue, reducing your anger, and hence reducing your pain. Here’s a great way to understand the differences between aggressive, assertive, and passive. When you are aggressive, you are only expressing your own needs: “You are being a jerk because you don’t understand my pain.” When you are passive, you are only looking at the other person’s needs: “I’d better not bother him with my concerns. It will only rock the boat.” When you are assertive, you are speaking up for your own needs while still taking into account the needs of the other, taking into account both people’s needs:“I know you’ve been really preoccupied with work, and it must be hard to hear about my pain, but it makes me feel closer to you if you listen to how my day went. I’ll try not to belabor it.” When first learning to be a more assertive person, it helps to think of a way to say something where the first clause in your sentence addresses your listener’s needs, and the second clause expresses your needs.

2. Understand that anger is usually a secondary emotion.
Anger is almost always preceded by one of four emotions—impatience, frustration, fear, or—most commonly in relationships—hurt. It helps to ask yourself the question, “If I couldn’t feel angry, what feeling would I be left with?” Then try to express your feelings at that level. Many times it makes your feelings a lot clearer to the other person, and usually they have an easier time hearing you and responding with less defensiveness.

3. Look at your “self-talk” and clean up the distortions that make you angrier.
A situation, however difficult, does not automatically translate into your mood. Its how you interpret the situation, what you tell yourself about it, that in the final analysis determines mood. If you throw a pity party for yourself, you view other people as horrible for picking on you, a poor defenseless creature. Then you get angrier. If you exaggerate the other’s offense, using words like “always” or “never” instead of “usually” or “rarely,” you make the other out to be a much worse person, which fuels your anger further. If you assume the worst about other’s intentions, you miss the positives they are trying to express by telling yourself they don’t really mean it.
Any time you are angry, ask questions of your angry conclusions: “Are there other ways to interpret her behavior? Even though this hurt my feelings, has he been nice to me in the past? He did that once—does that mean he always will do it?” You may still be angry, but usually less so—and this gives you a chance to see the issue more in tune with reality, rather than as an exaggeration of reality.

4. Look at the needs behind the other’s position or behaviour.
Most issues between people are not like a pie where, if I get 70 percent of my needs met, you will only get 30 percent of yours met. There are win-win solutions (and lose-lose solutions)! Instead of arguing your position and fighting the other’s position, look at your needs and theirs to see if there is another option that meets more of both sets of needs.
One way to increase the chances of understanding the other’s needs is simply to ask and then try to paraphrase their response back to them. It is easier to do this if you realize that understanding is not the same as agreement. You can understand without necessarily agreeing. If the other person feels understood, though not agreed with, there is usually less fuel to their fire. This increases the chances of a resolution, or at least of an accommodation where the rough edges get worn off of the disagreement so it is more tolerable to both of you.

5. Learn how to forgive, especially when the other has apologized.
My favourite quote on forgiveness comes from the late Lew Smedes, who was a professor at Fuller Theological Seminary: “When you forgive someone, the person you most take off the hook is yourself!” Forgiveness, particularly when the other is trying to do better, releases you most of all.
It helps me to forgive another if I ask myself these questions—“Have I ever done something like that to another?” and “Do I need forgiveness for things that I have done?” While forgiveness is at the core of religious faith, it is also key to good relationships.
Another helpful way of looking at forgiveness is as giving up the right to hurt back. Revenge is really not sweet, because we have lowered ourselves to what we condemn in others!

In summary, by handling your anger better, neither blasting away nor by “eating it,” you actually can decrease your fibromyalgia pain. Try practicing these five tips for a week and see if you don’t feel better. I’m rooting for you!

Dr. John Fry is a psychologist in private practice in Newport Beach, California. He works with men, women, adolescents, children, and marriages. One of his specialties is working with fibromyalgia patients. His wife has fibromyalgia and he sits on the National Fibromyalgia Association’s Board of Directors. To learn more, go to http://www.drjohnfry.com/.

Source=http://www.fmaware.org/site/News2?page=NewsArticle&id=8929

What do I do?

Posted by Kelli on May 30th, 2009

For my fibromyalgia, I currently take the following Medications/supplements

Multi-vitamin – Naturapathy Dr does not recommend Centrum or most pharmacy brand multi’s
Calcium & Magnesium with vitamin D – Calcium cuz Women with Endo are more susceptible to Osteoporosis. Mg & D to help absorb the Calcium. The Magnesium also to help with muscle spasms & charlie horses. I have found that it has helped.
Fish oils – Generic fish oils, minimum 1000mg a day .. Well, I try to. Naturapathy Dr recommended 1000mg-3000mg daily of the EPA+DHA to help with mental acuity. I’m still waiting for the fog to lift, but I’m not usually getting enough to impact because I fog up & forget.. Lovely catch 22 there.
B complex to help with stress and ensure that I get enough B’s. No, I don’t take a stress formula. Just a normal B complex.. either 50mg or 100mg
Codeine Contin for maintenance pain.
Tylenol #3 for breakthru pain
Oxy codone for severe breakthru pain
Flexeril (Cyclobenzaprine) as a muscle relaxer. I find it better than anything OTC..
Probiotics to help regulate my digestive track – it works, ‘cept when I have an IBS flare or food sensitivity
NSAID, but it’s for my Endometriosis, so I don’t really know if it does impact my FMS or not.

For my fibromyalgia, I currently participate in the following exercise:

Aquafit, really carefully – I’m just getting back into exercise, so I am trying to get to the gentle classes. My local YMCA gym has a class or arthritics and for osteoporosis. Aquafit is a good choice because of the buoyancy of the water, it doesn’t impact my knees, and it’s a gentle eardio
Seriously, right now that’s it. I need access to a hot tub to do further exercise to keep my body warm.

For my fibromyalgia, I intend to return to the following exercises:

Yoga with the hot tub – Yoga provides gentle stretching while working on core strength and balance. The hot tub helps to keep muscles relaxed afterward.
Keeping up with Aquafit – see above
Walking the track to music with the hot tub – I got into walking when my nieces were born, walking with my sister. After I joined the Y and my nephew was born, I would take him in his stroller to walk him around the track. He’s too old now, but I have found it enjoyable with my MP3 player (or CD player back then). I sometimes dance a little bit and my pace changes with the music I’m listening to. It’s hard to overexert myself. The hot tub helps to keep muscles relaxed afterward.

A benefit from the exercise is that I tend to be tired out afterward and relaxed. This makes evening workouts idea in that I go home, go straight to bed and will sleep well, with a decent amount of healing rest. This improves me, physically, emotionally and mentally for the next day.

For my fibromyalgia. my spiritual side is limited. I don’t go to church often, however I do find solace in my home church’s sanctuary. I’ve moved away from my home church and have yet to try out the sanctuary here. I also find the same ’state of grace’ from music, especially my churchy music

For my fibromyalgia, because of my physical limitation, I am limited socially. Most of my social interaction is via the internet on Twitter, Facebook, Email, etc.. The alternative to that in real life is with my SO and his friends. Most of my friends no longer talk to me, or are too far away for more than email. The classes as the Y present a new socialization source, which I hope to be helpful. With the improvement of my health I would like to return to scouting in some sort of part-time or limited capacity.

For my fibromyalgia and my cognitive abilities, I am starting this blog. It will help keep me thinking and requires research. It also provides a creative outlet. I also enjoy doing word searches and have, on recommendation on my therapist, started to colour and have other crafts options available to me.

For my fibromyalgia and an emotional aspect, I have a councilor and have beep placed on anti-depressants. While my time with her is limited I do find that I feel better asfter I speak with her. Additionally I have the support with my SO. While sometimes he can not understand and becomes frustrated, I know he only has best intentions where I am concerned.

How do I cope? Not well. Other than the limited exercise mentioned above, the odd screaming match and the rarer still church visit, I have no real outlets.. Which sucks. Before I got sick, my outlets for frustration and anger and stress were physical. With the fibro, I have lost that. Any suggestions are welcome

by NodeThirtyThree + FreeCSSTemplates