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Fibromyalgia

Medically reviewed by Leigh Ann Anderson, PharmD. Last updated on Apr 21, 2020.

Fibromyalgia is a chronic condition that can lead to widespread pain and tender points in your muscles and fibrous tissues (tendons, ligaments). This can lead to problems with sleep, low mood, and daytime drowsiness, sometimes interfering with work, school or other daily activities. Symptoms can vary from person-to-person and may fluctuate. Fibromyalgia affects 4 million people in the US, particularly women, according to the US Centers for Disease Control and Prevention (CDC). 

A number of different medicines have been studied in fibromyalgia. Lyrica (pregabalin) first became licensed for this use in June 2007. Other treatments, such as Cymbalta (duloxetine) and Savella (milnacipran) are now also approved. Physical exercise, cognitive behavioral therapy (changing your thought patterns), mindfulness and patient education also can play a positive role in treatment.

Inflammation does not typically occur with fibromyalgia, and common NSAID pain relievers such as ibuprofen and naproxen have not been proven effective. Research suggest the nervous system is involved, and medications such as anti-seizure drugs and antidepressants appear to be most helpful.

Table 1: Summary of Fibromyalgia Drug Treatment Options

Treatment Dose or Usage How effective Common side effects

pregabalin (Lyrica) - generic available in US

Note: Efficacy of Lyrica CR has not been established for treatment of fibromyalgia

In anti-seizure class of drugs

Initial dose: 75 mg orally twice a day

Increase dose to 150 mg orally twice a day within 1 week based on efficacy and tolerability; the dose may be further increased to 225 mg orally twice a day, if needed.

Maximum dose: 450 mg per day

A Cochrane review found that pregabalin 300 to 600 mg resulted in a reduction in pain over 12 to 26 weeks for patients with moderate to severe pain. However, the effect was limited and only about 10% over placebo group. Improvements in pain was accompanied by improved quality of life.

The results were similar to other approved fibromyalgia treatments such as milnacipran (Savella) and duloxetine (Cymbalta).

  • dizziness
  • somnolence
  • dry mouth
  • fluid retention in lower legs (edema)
  • blurred vision
  • weight gain
  • difficulty concentrating

Side effects are dose-related.

Schedule V controlled substance and may cause euphoria in some patients (2 to 3%).

duloxetine (Cymbalta) - generic available

In serotonin and norepinephrine reuptake inhibitor (SNRIs) antidepressant class

Initial dose: 30 mg orally once a day for 1 week

Maintenance dose: 30 to 60 mg orally once a day. Doses above 60 mg per day offer no added benefit.

After 3 months, continued treatment should be based on individual patient response.

A Cochrane review looked at six studies of 2249 participants with fibromyalgia. 

Researchers found that duloxetine at 60 mg daily was effective for fibromyalgia over 12 and 28 weeks as well as for painful physical symptoms in depression (low to moderate quality evidence).

The number needed to treat in fibromyalgia was 8 people to achieve a 50% or better response in one person. 

The effect in fibromyalgia may be achieved via a greater improvement in mental symptoms than in physical pain.

  • nausea
  • dry mouth
  • drowsiness
  • constipation
  • decreased appetite
  • headache
  • excessive sweating

Side effects are dose-related.

milnacipran (Savella) - generic not yet available

In serotonin and norepinephrine reuptake inhibitor (SNRIs) antidepressant class

Maintenance dose: 50 mg orally 2 times a day (titrate dose up slowly over one week).

Maximum dose: 100 mg orally 2 times a day (200 mg orally per day)

A Cochrane review analyzed 6 studies of milnacipran in fibromyalgia, with over 4,000 subjects. Participants were treated with milnacipran 100 or 200 mg, or placebo, for 8 to 24 weeks at the target dose.

The overall effect was modest, providing moderate pain relief (30% reduction) in 1 in 10 (10%) more people than did placebo. The authors concluded that while milnacipran gives good pain relief, but only to a minority of patients

  • nausea
  • dizziness
  • constipation
  • headache
  • dry mouth
  • difficulty sleeping
  • hot flush
  • excessive sweating
  • vomiting
  • palpations, heart rate increased
  • high blood pressure
Tricyclic antidepressants (TCAs) - for example, amitriptyline, nortriptyline

Use lower doses for fibromyalgia than for depression.

May be best if given before bedtime to help with sleep and minimize daytime drowsiness.

Researchers have found that good-quality studies for amitriptyline are lacking, even though it has been a first-line treatment for fibromyalgia for many years.

Authors concluded that amitriptyline probably does provide good levels of pain relief for some people with fibromyalgia, possibly 1 in 4 (25%). Side effects can be common. Amitriptyline will probably not work for most patients.

  • dry mouth
  • fluid retention
  • weight gain
  • constipation
  • drowsiness
  • difficulty concentrating

Side effects are dose-related.

cyclobenzaprine (Fexmid)

Oral: Initially, 5 to 10 mg once daily before bedtime (immediate release).

Titrate up to 10 to 40 mg daily in 1 to 3 divided doses if needed. 

A review of 5 studies involving 312 patients found that 85% of patients reported side effects and over one-third discontinued the studies.

However, small improvements were primarily seen in sleep but not pain at 12 weeks but were similar to placebo effect. The authors found evidence for cyclobenzaprine use in fibromyalgia to be weak.

Guidelines suggest it may be effective for mild to moderate symptoms, particularly with sleep disturbance.

Cyclobenzaprine will not have an effect on depression.

  • drowsiness
  • dry mouth
  • constipation
  • dizziness,
  • nausea,
  • heartburn

Is fibromyalgia real?

Because the symptoms can be vague and there's no obvious cause, doctors and patients can sometimes wonder if it is a real illness; however, evidence suggest that the symptoms are not just "all in your head." 

  • Brain imaging studies have shown a difference in the way the brain processes pain messages.
  • Substance P, a chemical in the body that increases awareness of pain, is increased in the spinal fluid in people with fibromyalgia.
  • Serotonin, a chemical in the brain that affects mood, sleep, and appetite is usually low in fibromyalgia.

How is fibromyalgia diagnosed?

Despite ongoing research, the best way to diagnosis of fibromyalgia is not fully known. No specific tests, such as labs or x-rays, can diagnose this condition. Your doctor will primarily diagnose your condition based on your history, symptoms, and a physical exam. Blood tests or x-rays may be ordered to rule out other conditions such as lupus, hypothyroidism, osteoarthritis or rheumatoid arthritis.

  • The American College of Rheumatology (ACR) previously used criteria to evaluate widespread tenderness and pain at pressure points (11 of 18 points), but this is no longer required for diagnosis. However, symptoms are usually present for at least 3 months.
  • The severity of pain is often taken into account. Symptoms of fatigue (waking unrefreshed), thinking and memory ability, headache and digestive issues may be considered.
  • Evaluation of mood disorders, such as depression or anxiety, may be suggested. These can often occur in conjunction with fibromyalgia. A review of your sleep history may be conducted to rule out restless leg syndrome or sleep apnea.

Symptoms of fibromyalgia

Common symptoms include:

  • widespread pain - muscle and soft tissue pain, often at specific tender points such as the neck, chest, elbows, knees, base of scull, buttocks area.
  • difficulties sleeping or waking from sleep in the morning feeling tired
  • daytime fatigue - occurs in more than 90% of people; closely related to chronic fatigue syndrome (CFS).
  • cognitive difficulties (inability to focus, memory problems, difficulty concentrating – often referred to as “fibro fog”)
  • stiffness

People with fibromyalgia may also experience:

  • depression
  • anxiety
  • irritable bladder
  • irritable bowel syndrome (IBS), with constipation, diarrhea or both
  • tingling, burning or other sensations on the skin
  • restless legs
  • sleep apnea
  • difficulty concentrating and memory difficulties
  • headaches, including migraines
  • cold intolerance
  • temporomandibular joint (TMJ) syndrome (pain in the jaw joints and muscles that control movement)
  • muscle weakness

Treatment

There is no cure for fibromyalgia and while symptoms can be controlled, they may not go away completely. Your pain may fluctuate over time. Most people who have fibromyalgia do have some level of improvement with treatment.

The condition does not lead to a further disease of joints or muscles, and is not life-threatening, although quality of life can be greatly impacted. Several modes of treatment, typically used together, appear to be most helpful and includes medication, exercise, and methods to improve sleep and mood.

Medications

A number of medicines and remedies have been researched for fibromyalgia, but usually benefits are small. Several approved drug treatments are now available for fibromyalgia, but results can vary between patients. Doctors may prescribe older medicines for fibromyalgia that not FDA approved for this use (called "off-label"). These medications may have been used for many years, with success in some patients, for fibromyalgia symptoms (see Table 1).

Most medications with a positive effect in fibromyalgia are related to antidepressants or anti-seizure medications and have an effect in the central nervous system (brain and spinal cord). Most manufacturer studies have seen a high placebo response rate, meaning the treatment may only be slightly better than using a sugar pill.

Common medications used in the treatment of fibromyalgia include:

  • pregabalin (Lyrica)
  • tricyclic antidepressants such as amitriptyline
  • gabapentin (Neurontin)
  • duloxetine (Cymbalta)
  • milnacipran (Savella)
  • antidepressant selective serotonin reuptake inhibitors

Anti-inflammatory drugs such as NSAIDs (e.g. ibuprofen, naproxen) typically are not effective for fibromyalgia, as muscle inflammation does not play a role in pain. Guidelines do not recommend the use of opioids and corticosteroids based on lack of efficacy and high risk of side effects.

Acetaminophen (Tylenol) may provide short-term relief and can be combined with other therapies.

Some patients may report relief with cannabis products, including cannabidiol (CDB); however, high quality studies are not available to fully support this use.

Non-pharmacologic treatments

Other non-pharmacologic treatments can be effective for fibromyalgia and may have an added effect when combined with medication. However, not all non-pharmacologic are proven through rigorous studies.

  • exercise and/or strength training
  • cognitive behavioral therapy
  • patient education to set realistic expectations
  • acupuncture 
  • hypnosis
  • tai chi and yoga
  • biofeedback
  • relaxation techniques

Physical Exercise

Studies show that many people with fibromyalgia have clear improvements from exercise and muscle strengthening. Aerobic exercise such as biking, walking, and swimming improve muscle strength and overall fitness. Muscle strengthening can lower pain and tender points.

Always check with your doctor before starting on an exercise program. It is usually best to start slowly and increase activity over time, especially if you have not recently exercised regularly. You may want to initially start a program with a physical therapist. Try to eventually exercise for 30 minutes a day three times a week.

Cognitive behavioral therapy

Cognitive behavioral therapy (CBT) is a program to help you control your thoughts about your pain and how to manage it more effectively. It helps in dealing with stress and negative emotions that can make fibromyalgia worse. A psychotherapist has sessions for individual patients. This therapy can help pain, depression, tiredness and function in people with fibromyalgia.

More Resources

Sources

  1. Fibromyalgia. US Centers for Disease Control and Prevention (CDC). October 2017.
  2. Macfarlane GJ, Kronisch C, Dean LE, et al. EULAR revised recommendations for the management of fibromyalgia. Annals of the Rheumatic Diseases 2017;76:318-328.
  3. Opioid use: Opioid Use in Fibromyalgia: A Cautionary Tale., Goldenberg DL, Clauw DJ, Palmer RE, Clair AG, Mayo Clin Proc. 2016;91(5):640. Epub 2016 Mar 11.
  4. Moore RA, Derry S, Aldington D, et al. Amitriptyline for fibromyalgia in adults. Cochrane Database of Systematic Reviews 2015, Issue 7. Art. No.: CD011824. DOI: 10.1002/14651858.CD011824 
  5. Donnelly L, Moran J, Foley M. Pregabalin (Lyrica) for Acute Fibromyalgia Pain. Am Fam Physician. 2018;97(9): PMID: 29763265
  6. Derry S, Cording M, Wiffen PJ, et al. Pregabalin for pain in fibromyalgia in adults. Cochrane Database Syst Rev. 2016;(9):CD011790
  7. Lyrical Product Label. Pfizer. New York, NY. April 2020.
  8. Lunn MPT, Hughes  RAC, Wiffen  PJ. Duloxetine for treating painful neuropathy, chronic pain or fibromyalgia. Cochrane Database of Systematic Reviews 2014, Issue 1. Art. No.: CD007115. DOI: 10.1002/14651858.CD007115.pub3
  9. American College of Rheumatology (ACR). Fibromyalgia. https://www.rheumatology.org/
  10. Cording M, Derry S, Phillips T, et al. Milnacipran for pain in fibromyalgia in adults. Cochrane Database of Systematic Reviews 2015, Issue 10. Art. No.: CD008244. DOI: 10.1002/14651858.CD008244.pub3

Further information

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