Cymbalta provides pain relief for Fibromyalgia?

UPDATE: Shortly after publishing this post, I received the following comment from an Anonymous reader:

Please talk to some women taht have tried this drug before you take it. A friend of mine's mother was prescribed this drug because she had migranes. She told me that this drug made her feel crazy and want to kill herself. It has psycological effects for some women, so please talk to some people on this drug before you use it also look further into possible side effects.

Thanks for the comment. I have heard similar adverse reactions from someone who tried Prozac: she knew of the downside, that it could make one feel violent or suicidal, but did not recognise the downside when it happened to her and she wanted to kill her much loved dog because it was being overactive and getting on her nerves.

Please note, any treatments that are mentioned in this blog are only filed here for my own reference. This is not a regular blog, I never check the visitor stats. Most of the time I forget anyone visits here and I always get a shock when someone comments. Then I cringe when I realise other people actually read some of this stuff. I do not recommend anything except resting, not even exercise.

By the way, I have made slight progress since my six week rest regime. Did not want to mention details yet as it is early days. The change is miniscule but major to me but I am not yet clear if there has been an actual improvement or whether its just a case of my managing better to live within my baseline. Can't tell the difference yet, until I try a few other things.

This is the first time I have some sort of control over the pain, and am bathing in the light of not experiencing so much pain. It is such a change not to feel so ghastly 100% of time. Eyes are clearer, wider and I can see out of them better for most of the day, and for longer. Concentration lasts longer. Adverse reaction to stress doesn't last more than a several days. Sore throat doesn't come on so quickly and joints and muscles don't flare up so quickly, and when they do, the pain starts subsiding within days. I can tell this through my blogging.

Also, before I forget I have organised a few major projects over the past three months and completed one major one (a new fire) started in January when the old one broke down. New lino has been laid in the kitchen and the guest bedroom has been transformed - all that's missing is the new carpet (next year) and a few details to do with electrics and a vanity mirror and shelf. After the lino was installed I could barely walk for three days. Pain was so great in right shin, I had to hop around on left foot and use a stick for walking. Thought of a broom handle under my arm but it hurts to lift my arms. Thankfully, that malady has disappeared. I've still not been beyond my gate since March 2003. I wear socks indoors, and only wear slip ons to go to the post box or back gate. Maybe the arch in my right foot is going more flat, and I strained the leg while walking around more than usual when lino was being laid - plus the old carpet tape that was stuck to the floor kept sticking to the bottom of my socks which meant pulling my leg up each time to get free. That's all I can think it was. I did too much walking too soon. All the usual symptoms flared within a few days and took me all week to reach the point I was two weeks prior. So, I am taking all increments slowly which is why I am not rushing out the door and down to the beach - yet. I have a feeling I might be able to get 50 yards to the beach and back without it setting me back for weeks and months after. The trouble I have is not in sustained walking, it's being vertical for longer than ten minutes. Still can't sit up longer than 5-10 minutes without the body feeling like its crashing and collapsing inside. Which is why I still cannot get out in a wheelchair. Can't sit up for long enough without feeling ghastly ill and brain seizing up like meningitis.

Over the past two months I have managed to sit outside, on a low foot stool (chairs are more difficult) leaning against the wall. Used a timer. Increased it from 5 - 10 minutes over 2 months. Sunlight hurt my eyes, like it does when you have flu. You know how you don't feel like sunbathing or facing the breezy outdoors when you are suffering the height of flu? Well, that is how I feel every day, without exception. All days are bad, some days are just worse than others. But lately the worse days have been less. The worse days used to be nearly all the time.

A friend is coming to stay for a weekend at the end of September. I am planning another six week rest regime after that. Takes a lot of planning and organising and getting six weeks of food and groceries in place.

P.S.

In a previous post here, where I logged the start of my rest regime, I received this comment from Richard, again - probably because of the way the Blogger commenting system is set up - logged as Anonymous:

"Anonymous said...
Hey I hope you stick at it with the rest periods, I looked a this site completely accidentally I used to have M.E. and reading this brought back memories of a hard time, even though i was quite young! I know it seems like a stupid, annoying and completely exasperating idea, to sleep or rest even when you don't want to, but it worked for me. I really hope you keep at it, also the pet thing really helped, cats rule for companioship. Kind Regards. Richard."

Richard, thankis for the kind comment - if you ever happen upon this site again, please let me know your web or email address. Thanks.

Lulu in Wales



Fellow ME sufferer S, at A Life in Wales blog, is facing difficult times. Lulu is one of her two cats. The photo was taken from S's blog. Thinking of you S. God bless. Things will turn out for the best, you mark my words. [I think you are a bit too isolated where you are anyway] I'll email soon.
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CYMBALTA

Recently, SB of Abide blog says her doctor said he might have something that could help her Fibromyalgia.

Encouraged by the research and his own patients' experience he has put SB on a Cymbalta trial.

A reader at Abide commented about using Cymbalta, saying it gave her more energy, and someone she knew went from wheelchair to walking because of Cymbalta.

SB helpfully pointed out an article on Cymbalta published by Medical News Today October 19, 2004. Here is a copy:

The antidepressant Cymbalta (duloxetine HCl; pronounced sim-BAWL'-tuh), a dual-reuptake inhibitor of serotonin and norepinephrine, 60 mg once or twice daily, significantly reduced pain in more than half of women treated for fibromyalgia, with and without major depression, according to 12-week data presented this week at the annual meeting of the American College of Rheumatology.

These data are being presented one month after another study, in which Cymbalta also significantly reduced pain in women with fibromyalgia versus placebo, was published in Arthritis and Rheumatism.

"The results in these study patients were very striking in the degree of reduction of pain, which is the primary symptom of fibromyalgia. In addition, Cymbalta significantly improved these patients' quality of life and overall functioning, as measured by quality of life and disability scales," said Lesley M. Arnold, M.D., University of Cincinnati College of Medicine, Cincinnati, Ohio, who presented the study. "For many, the pain of fibromyalgia makes them so sensitive to being touched that even a hug from a loved-one can be intolerable."

In the study, Cymbalta's effect on pain was independent of any effect on mood, and there was no significant difference in response rates between patients in the study with and without major depression.

Fibromyalgia is a chronic disorder that causes widespread pain and tenderness in the muscles and soft tissue of nearly 6 million Americans, predominantly women.1 According to the National Fibromyalgia Association, patients often experience a deep muscular aching, throbbing, twitching, stabbing and shooting pain that "knows no boundaries, migrating to all parts of the body and varying in intensity." Neurological complaints, such as numbness, tingling and burning, are often present and add to the discomfort of the patient.

While the cause of fibromyalgia remains unknown, it has been linked to abnormalities in the brain's neurotransmitters, serotonin and norepinephrine, the same neurotransmitters believed to play a role in major depressive disorder, diabetic peripheral neuropathic pain and stress urinary incontinence.1

There is no approved treatment for fibromyalgia. Cymbalta, a balanced and potent serotonin and norepinephrine reuptake inhibitor, is proven to help treat the emotional and painful physical symptoms of depression. It also is the only approved treatment for management of pain caused by diabetic peripheral neuropathy, a type of nerve damage. Cymbalta is not approved for the treatment of fibromyalgia.

Study Findings

More than half of patients treated with 60 mg of Cymbalta, once or twice daily, responded to treatment after 12 weeks, compared with one-third of those taking a sugar pill.

Patients treated with 60 mg of Cymbalta, once or twice daily, were significantly more likely to experience a sustained treatment response than those treated with a sugar pill (44 percent, 43 percent and 19 percent, respectively).

Patients treated with 60 mg of Cymbalta, once or twice daily, had functional improvements on the Sheehan Disability Scale which measures disability at work, in family life and in social life, that were significantly greater than those of patients taking a sugar pill.

Cymbalta 60 mg once or twice daily directly reduced pain (75.7 and 87.5 percent, respectively) more than the indirect effect attributed to improvement in depressive symptoms (24.4 percent and 12.5 percent, respectively).

Cymbalta 60 mg twice a day also relieved the pain associated with tender points often associated with fibromyalgia.

Treatment-emergent adverse events were more common in patients treated with Cymbalta 60 mg once or twice daily, than in those treated with a sugar pill (79.2 percent). Events were typically mild to moderate in severity.

Patients taking Cymbalta 60 mg once or twice daily were more likely to discontinue because of side effects than those taking placebo (21.2 percent, 23.3 percent and 11.7 percent respectively).

The most common side effects for patients taking Cymbalta (occurring in at least 5 percent of patients and at twice the rate for those receiving placebo) were nausea, dry mouth, constipation, diarrhea, decreased appetite, nasopharyngitis, increased sweating and anorexia. In addition, for patients taking Cymbalta 60 mg twice daily, sleepiness and feeling jittery were common side effects.

Methodology

In a 12-week, double blind study, patients were randomized to receive Cymbalta 60 mg once (n=118) or twice daily (n=116), or placebo (n=120). The primary outcome measure was Brief Pain Inventory (BPI) 24-hour average pain severity score (score range: 0 [no pain] -10 [pain as bad as you can imagine]). Response to treatment was defined as a 30 percent reduction in the BPI 24-hour average pain score. Secondary outcome measures included remaining BPI pain and interference scores, Fibromyalgia Impact Questionnaire (FIQ), the tender point pain threshold and tender point number, Clinical Global Impression of Severity (CGI-Severity), Patient Global Impression of Improvement (PGI-Improvement), and the 17-item Hamilton Rating Scale for Depression.

About Cymbalta

Cymbalta is indicated for the treatment of major depression and the management of diabetic peripheral neuropathic pain, both in adults. As Cymbalta has not been studied in children, Lilly discourages its use in those under 18.

Cymbalta should not be confused with Symbyax™ (pronounced SIMM-bee-ax), a medicine for bipolar depression also marketed by Lilly. Symbyax is a combination of olanzapine, the active ingredient in Zyprexa®, and fluoxetine, the active ingredient in Prozac®. Symbyax is available in capsules of 6 mg/25 mg (olanzapine/fluoxetine), 12 mg/25 mg, 6 mg/50 mg and 12 mg/50 mg. Cymbalta is available in 20 mg, 30 mg and 60 mg capsules.

Important Safety Information

Patients being treated with antidepressants should be observed closely for clinical worsening of depressive symptoms and suicidality. Patients and their families should watch for these as well as for anxiety, agitation, panic, difficulty sleeping, irritability, hostility, aggressiveness, impulsivity, restlessness, or overexcitement and hyperactivity. Call the doctor if any of these are severe or occur suddenly. Be especially observant when starting any antidepressant therapy and whenever there is a change in dose.

Prescription Cymbalta is not for everyone. People who are allergic to duloxetine hydrochloride or the other ingredients in Cymbalta should not take it. If you have recently taken a type of antidepressant called a monoamine oxidase inhibitor (MAOI), are taking thioridazine or have uncontrolled narrow-angle glaucoma, you should not take Cymbalta. Talk with your doctor before taking Cymbalta if you have serious liver or kidney problems, glaucoma or consume large quantities of alcohol. Women who are pregnant should talk with their doctor before taking Cymbalta. Nursing while taking Cymbalta is not recommended.

In the fibromyalgia study of Cymbalta, the most common side effects were nausea, dry mouth, constipation, decreased appetite and anorexia. In clinical studies of Cymbalta for depression, the most common side effects were nausea, dry mouth, constipation, decreased appetite, fatigue, sleepiness, and increased sweating. Cymbalta is also approved for the management of neuropathic pain associated with diabetic peripheral neuropathy. In clinical studies of Cymbalta in these patients, the most common side effects were nausea, sleepiness, dizziness, constipation, dry mouth, increased sweating, decreased appetite, and muscle weakness. In all clinical trials, most people were not bothered enough by side effects to stop taking Cymbalta. Your doctor may periodically check your blood pressure. Don't stop taking Cymbalta without talking to your doctor.

For full patient information, visit http://www.Cymbalta.com.

About Lilly

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs. Additional information about Lilly is available at http://www.lilly.com.

This press release contains forward-looking statements about the potential of Cymbalta for the treatment of fibromyalgia and reflects Lilly's current beliefs. However, as with any pharmaceutical product under development, there are substantial risks and uncertainties in the process of development and regulatory review. There is no guarantee that the company will apply for or receive regulatory approval for this indication. There is also no guarantee that the product with be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's filings with the United States Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.

1. American College of Rheumatology. Fibromyalgia Fact Sheet. Available at: http://www.rheumatology.org/public/factsheets/fibromya.asp. Accessed October 4, 2004.