Two completely different medications are the topic of treatment this month for people with fibromyalgia (FM). Naltrexone is an old drug that has been around for 30 years and Savella is the newest drug specifically approved for the treatment of FM. The two medications operate by completely different mechanisms and both may be beneficial. While naltrexone is more affordable, Savella has more research studies to back its effectiveness for relieving FM pain.

If you are baffled by perfuse sweating that you know is not due to menopause, dry eyes and mouth, dizziness, constipation, loss of sex drive, irregular heart patterns and other symptoms that are not pain-related, find out how common these symptoms are in people with FM. Not only are many patients unaware of these symptoms, but the general public barely understands the facts about fibro. With May 12 Fibromyalgia Awareness Day less than two weeks away, we have a new poster for you to display that is designed to improve public knowledge about FM ... both now and in the months to come.

In this eNews Alert:

• Naltrexone Offers Novel Approach to Pain Relief
• More Than Just Pain
• Sleep Disruption & Cardiac Arrhythmias
• Savella: New Drug to Treat Fibro Available May 4
• Pfizer’s Fibro Put Down
• New Awareness Poster
• New Support Groups

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Naltrexone Offers Novel Approach to Pain Relief

Preliminary research has given an old drug a possible boost on a new use. In a small trial using a low dose of naltrexone, six of ten fibromyalgia patients reported a 30 percent reduction in pain. One woman in the study felt so much better that she went back to work. Researchers at Stanford University are currently expanding the study to test more patients with the medication. The American Fibromyalgia Syndrome Association (AFSA) funded the study.

Read about this preliminary research in the Latest News section of our website.

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The widespread pain of fibromyalgia is just one of the many symptoms that you have to put up with everyday. In fact, other symptoms may be what drives you to see the doctor, such as excessive sweating, dry eyes and mouth, constipation, dizziness, nausea, muscle weakness, unrefreshing sleep, and loss of sex drive. These symptoms and more are produced by abnormal function of the autonomic nervous system that controls all of your organs and can be documented by a simple 73-item questionnaire called the Composite Autonomic Symptoms Scale (COMPASS).

If the dysfunction of the autonomic nervous system is responsible for your many non-painful symptoms, then the COMPASS scores for people with fibromyalgia (FM) should be significantly elevated over that of healthy control subjects. But, higher scores do not just reflect a widespread pain condition because Manuel Martinez-Lavin, M.D., of Mexico City, also compared the scores of FM patients with people who had rheumatoid arthritis (an inflammatory joint disease).*

Thirty women with FM, 30 with rheumatoid arthritis (RA), and 30 healthy control subjects completed the COMPASS questionnaire. In addition, the FM study participants completed the Fibromyalgia Impact Questionnaire (FIQ). The FIQ is a validated measure of how functionally impacted a person is with FM. Martinez-Lavin wanted to see how well the scores on the two questionnaires correlated with one another.

First, the COMPASS scores for the FM group were more than twice that of the RA group, while the scores for the RA group were double that of the healthy controls. Second, the higher the COMPASS score for a person with FM, the greater their FIQ score (the more their FM impacted them). These two findings indicate that FM patients have non-pain symptoms related to different problems of autonomic system function. It also shows that the symptoms caused by the autonomic malfunctions are an integral part of the FM.

Martinez-Lavin pointed out responses from FM patients to specific COMPASS questions that you may find very interesting:

• 57 percent felt they did not derive any restorative benefit from sleep, while 30 percent found sleep to provide some slight restorative value
• 59 percent are constipated all of the time while 21 percent frequently experience this symptom (implying that movement through the GI tract is slowed down)
• Compared to five years ago, 30 percent said they sweat much more than they used to, and another 37 percent said that their body sweating had increased somewhat. For those of you who experience hot flashes but you know it is not menopause, this could offer an explanation for the uncontrollable drenching that you get during the day and night.
• 63 percent said that their eyes felt excessively dry
• 63 percent said that their mouth felt excessively dry
• 57 percent felt dizzy or faint when standing up from sitting position (17 percent said this happens almost all of the time while 40 percent indicated it occurred frequently)
• 27 percent said they had a complete absence of sexual desire while 33 percent said it was greatly reduced
• Close to 60 percent said they feel “full” quicker than they use to (implying that it is taking longer for the stomach to empty)

If any of the above symptoms have been bugging you and your doctors have run tests to exclude other medical conditions as the cause of these symptoms, take comfort in knowing that you are not alone.

* Solano C, et al. J Clin Rheumatol 15(4):2009 [Epub ahead of print].

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Many researchers have shown that people with fibromyalgia (FM) have an autonomic nervous system with a hyperactive sympathetic branch and an underactive parasympathetic branch. The sympathetic system is geared to respond to stress, but who needs this system to be on full throttle when one is sleeping? The parasympathetic system is designed to aid with sleep and digestion, but obviously it’s not doing an adequate job because sleep is severely disturbed and digestion is slowed (see results in section above).

Ordinarily, the sympathetic system is dominant during the day and the parasympathetic system is dominant during the night period. Although previous studies have shown sympathetic dominance, a research team from Turkey was interested in measuring the day-to-night fluctuations in the autonomic system and whether patients were more prone to cardiac arrhythmias.* In general, a cardiac arrhythmia is an alteration in the heartbeat caused by abnormal neurological impulses traveling to the heart muscle. The heart, as with all other organs, is controlled by the autonomic nervous system.

Fifty FM patients and age-matched healthy controls were studied with a small 24-hour heart monitor to evaluate the autonomic nervous system function during the day and night. Subjects were also put through a number of tests to assess how their autonomic and cardiovascular systems responded to abruptly laying down to standing up (and vice versa).

FM patients were clearly different from the healthy control group in many ways. The nighttime sympathetic activity for the FM group was just as active as it was during the day and the parasympathetic system never did step up to the plate, activity wise. This means that during the night when you are trying to sleep, the stress response branch of your sympathetic system is revved up for action. Naturally, this situation is not at all conducive for sleep and could explain your nighttime troubles. An active sympathetic system is not going to allow you to easily drift off into deep sleep and will likely limit your ability to stay asleep, particularly the deep stages that restore your body.

When FM patients went from standing to laying down, or vice versa, the difference in autonomic function between the patients and healthy control subjects was more exaggerated than the findings between night and day. After laying down, the sympathetic system continued to be dominant. Upon standing, the sympathetic activity in the FM group did not change because it was already operating at maximum capacity and was unable to respond to the stress challenge of standing up. This may help explain why so many FM patients in the above COMPASS study stated that they felt dizzy or faint when they stood up because this activity requires the sympathetic system to quickly activate the heart to pump more blood to the head. In FM patients, the sympathetic system is maxed out and cannot respond to even simple challenges such as going from a reclined to standing position.

If the autonomic nervous system that controls the heart is not functioning properly in FM patients, could this impact their odds of cardiac arrhythmias? The Turkish team found that the answer to this question was “yes” —but only by a small factor. Although more studies are warranted to determine how the abnormalities seen in the autonomic nervous system might contribute to increased incidence of irregular heart patterns, or cardiac arrhythmias, the research team concluded that FM patients should be closely followed for arrhythmias.

Before you overreact, please keep in mind that arrhythmias do occur in healthy people and may not be serious in nature (do not rush to your doctor to ask for a cardiac workup). Also, the majority of the arrhythmias were detected during the nighttime, so standard daytime EKG tests that are often used to evaluate heart function may not pick up arrhythmias. However, if you do notice a lot of irregular heartbeats, particularly skipping of a beat, you may require a 24-hour holter monitor or a device called an event monitor to pick the cardiac irregularities. Keep in mind that cardiac workups can be extremely costly and may not lead anywhere in terms of treatment.

The best way to use the findings from this study is to better understand your symptoms, such as your difficulty sleeping (review the suggestions offered in the April 2009 Fibromyalgia Network Journal for how to turn off the chatter in your brain during the night). Also try to eliminate as much stress from your life as possible. Stress does not cause FM, but nonetheless, your body does not respond properly to stress. And keep in mind, future research on the role of the autonomic nervous system in FM is bound to bring forth more answers about the many symptoms that bug you.

* Dogru MT, et al. Anadolu Kardiyol Derg 9(2):110-7, 2009.

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After a couple of delays, Savella, the latest Food and Drug Administration (FDA)-approved drug to treat fibromyalgia, should be available for most pharmacies to order by May 4. Makers of the medication said Savella was shipped to wholesalers on April 17, and that it would take one to two weeks to distribute the product to the stores. Even if a store doesn't have Savella on the shelf it can generally get it that day or within 24 hours.

The selective serotonin and norepinephrine dual reuptake inhibitor was approved for the management of fibromyalgia on Jan. 14, 2009. The medication was on hold for a few weeks while the makers submitted a cosmetic formulation change to the FDA, which now has been approved.

During clinical trials, the Fibromyalgia Network has been referring to Savella as its study name "milnacipran" in Fibromyalgia Network Journal articles since 2004. Details about the medication, its side effects, and who may or may not be good candidates for the drug, can be read in the Latest News Archives section of our website.

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Even if Lyrica has not been helpful for controlling your symptoms, the many widely publicized TV commercials sponsored by the drug’s manufacturer, Pfizer, have certainly improved awareness of your medical condition. Some advertisements have been better than others, but some Members feel the latest TV ad starts off as a put down to fibromyalgia (FM) patients everywhere. It shows a woman with a tray full of food at a family gathering making the following statements:

“My fibromyalgia muscle pain is real. But I am not the type of person to just lie down and quit, not with all these people counting on me. I walked right in and asked my doctor about Lyrica.”

It’s doubtful that Pfizer intended to imply that “other” fibromyalgia patients are the type who just “lie down and quit,” but this is how the commercial is being perceived, and it couldn’t be further from the truth. The 2008 Fibromyalgia Network survey on employment issues clearly showed that patients are doing everything possible to hang onto their jobs and careers. You are definitely all fighters and you don’t take anything laying down!

As a survivor, let Pfizer know a few key factors about living with fibromyalgia that you would like their next commercial to portray. The company has a website that invites FM patients to share their stories. Click on this link to the Lyrica website and identify yourself as a fibromyalgia patient representative and consumer, and then briefly point out what you would like for them to convey in their next commercial (in other words, state how you would like a person with fibromyalgia to appear). Are there certain strengths that you would like the patient in the commercial to portray? Also, are there specific symptoms of fibromyalgia that you would like to see emphasized? Please give this some thought and take the time to offer useful advice and constructive suggestions. Without your input, Pfizer could very well botch another commercial!

If you have not seen the TV ad above, you can view it online. Of course, viewer discretion advised!

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The Fibromyalgia Network is offering a new 18-by-24 inch, full-color poster to help you spread fibromyalgia awareness any time throughout the year. The new poster can be hung at health fairs, library booths, May 12 Awareness events, support group meetings, or various gatherings to remind everyone that "Fibromyalgia — It's REAL."

Most people looking at the colorful photo will wonder: Why is the woman colorless? That's when their curiosity leads them to read, "You don't look sick and no one can see your pain, it's easy to feel invisible ..." The poster is designed to convey a "picture" of your life with fibromyalgia without forcing the public to read about your illness.

Free bookmarks are included with each order of posters.

• 1 poster and 10 bookmarks: $6
• 5 posters and 25 bookmarks: $10

The poster compliments our other Fibromyalgia Awareness items including our popular purple silicone wristbands; the 8-inch car magnets; 1.5-inch colorfully decorated pins; and the amazing 5.5-by-8.5 inch, removable static-charged decals that adhere to virtually any smooth surface including windows, doors, and walls without any sticky residue.

These items are designed to spread awareness with practically no effort or energy on your part while getting the public to think about how difficult it must be to live with fibromyalgia.

Fibromyalgia Awareness can be easy and fun, too. See all of our Awareness items at www.fmnetnews.com/awareness. To order Awareness items with a credit card call us toll-free at (800) 853-2929, or go to our website.

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Fibromyalgia Network wishes to welcome 11 fibromyalgia/chronic fatigue syndrome support groups that we have added to our referral list this month. For a copy of our complete, current listings, send us a self-addressed, stamped envelope requesting the state referral sheet of your choice.

For additional support group information, call our toll-free line at (800) 853-2929 or e-mail groups@fmnetnews.com. We know it can be difficult to get a new group off the ground and we wish to promote those just starting so all Members in the area can benefit. If you e-mail or call us for information about a support group in your area, please specify your location in terms of the nearest major metropolitan city.

If you have been searching for a nearby support group, check our list of new groups to see if one has formed in your city. This link to new groups is temporarily available for Members of the Fibromyalgia Network only.

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Wishing you improved fibromyalgia awareness throughout the month of May,

Kristin Thorson & the Staff of FM Network

Fibromyalgia Network ... Helping Patients Since 1988

PO Box 31750 | Tucson, AZ 85751-1750 | (800) 853-2929 | www.fmnetnews.com 

Copyright © 1988-2009 Fibromyalgia Network
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