As with many other medically unexplained syndromes, there is no universally accepted treatment or cure for fibromyalgia, and treatment typically consists of symptom management. Developments in the understanding of the pathophysiology of the disorder have led to improvements in treatment, which include prescription medication, behavioral intervention, exercise, and alternative and complementary medicine. Indeed, integrated treatment plans that incorporate medication, patient education, aerobic exercise and cognitive-behavioral therapy have been shown to be effective in alleviating pain and other fibromyalgia-related symptoms. In 2005, the American Pain Society produced comprehensive guidelines for patient evaluation and management. More recently, the European League Against Rheumatism (EULAR) issued updated treatment guidelines.
Cognitive behavioural therapy (CBT) and related psychological/behavioral therapies are evidence-based treatments which have been shown to be moderately effective in randomized controlled trials. The greatest benefit occurs when CBT is used along with exercise.
A meta-analysis of 1,119 subjects found "strong evidence that multicomponent treatment has beneficial short-term effects on key symptoms of FMS." A 2010 systematic review of 14 studies reported that CBT improves self-efficacy or coping with pain and reduces the number of physician visits at post-treatment, but has no significant effect on pain, fatigue, sleep or health related quality of life at post-treatment or followup. Depressed mood was also improved but this could not be distinguished from some risks of bias. A multidisciplinary approach, often including CBT is sometimes considered to be the "gold standard" of treatment for chronic pain syndromes such as fibromyalgia.
There are three medications that have been approved by the FDA for treatment of fibromyalgia. Pregabalin was approved in June 2007, duloxetine was approved in June 2008, and milnacipran was approved in January 2009. Pregabalin and duloxetine have been shown to reduce pain in a substantial number of patients with fibromyalgia, but there were others who did not benefit. Placebo-controlled trials involving a total of over 2000 patients have shown milnacipran to be significantly more effective than placebo in treating both pain and the broader syndrome of fibromyalgia.
A 2009 meta-analysis in the Journal of the American Medical Association concluded that antidepressants were "associated with improvements in pain, depression, fatigue, sleep disturbances, and health-related quality of life in patients with FMS." The authors also stated that the goal of antidepressants in fibromyalgia should be "possible symptom reduction", and if used long term, their effects should be evaluated against side effects. Tricyclic antidepressants were the most effective against pain, fatigue, and sleep problems, but have many side effects due to interaction with adrenergic, cholinergic or histaminergic receptors, and sodium channels. Selective serotonin reuptake inhibitors (SSRIs) and Serotonin-norepinephrine reuptake inhibitors (SNRIs) had lower side effects.
Tramadol, a centrally acting analgesic with atypical opioid and antidepressant-like activity, is moderately effective in treating fibromyalgia pain. Long-term effectiveness and tolerability are unknown. Tramadol combined with paracetamol provides fast, lasting relief that is more effective than either drug alone. This combination therapy has demonstrated efficacy, safety and tolerability for up to two years without the development of tolerance, in the treatment of chronic pain. It is as effective as codeine plus paracetamol but produces less sleepiness and constipation, and it is free of the toxic effects associated with non-steroidal anti-inflammatories.
The anti-convulsant drugs gabapentin (Neurontin) and pregabalin (Lyrica) have been tested in fibromyalgia. Gabapentin is approved for use in treatment of neuropathic pain but not in fibromyalgia. Pregabalin – originally labeled for the treatment of nerve pain suffered by diabetics – has been cleared by the US Food and Drug Administration for the treatment of fibromyalgia. A randomized controlled trial of pregabalin at a dose of 450 mg/day found that 6 patients is the number needed to treat (NNT) for one patient to have a 50% reduction in fibromyalgia-related pain. A Cochrane Database analysis of pregabalin use in chronic pain concluded that "A minority of patients will have substantial benefit with pregabalin, and more will have moderate benefit. Many will have no or trivial benefit, or will discontinue because of adverse events." A meta-analysis of four trials of pregabalin in fibromyalgia found that, for patients who did respond to pregabalin, there was a reduction in their time off work of greater than 1 day per week.
Dopamine agonists (e.g. pramipexole (Mirapex) and ropinirole (ReQuip)) resulted in some improvement in a minority of patients, but numerous side effects, including the onset of impulse control disorders like compulsive gambling and shopping, have led to concern about this approach.
Cyclobenzaprine is a muscle relaxant medication used to relieve skeletal muscle spasms and associated pain in acute musculoskeletal conditions. It is the most well-studied drug for this application, and it also has been used off-label for fibromyalgia treatment. Clinical trials with very low doses of cyclobenzaprine have demonstrated efficacy in fibromyalgia.
Tizanidine is a centrally acting α-2 adrenergic agonist used as a muscle relaxant. It is used to treat the spasms, cramping, and tightness of muscles caused by medical problems such as multiple sclerosis, spastic diplegia, back pain, or certain other injuries to the spine or central nervous system. It is also prescribed off-label for some symptoms of fibromyalgia.
According to a 2004 review of fibromyalgia treatment studies, opioids (other than tramadol) have not had randomized controlled trials, and "should be considered only after all other medicinal and nonmedicinal therapies have been exhausted." An analysis of insurance claims by 52,000 fibromyalgia patients showed that 40% had received opioids in any given year (predominantly short-acting agents). As of 2010, there is insufficient evidence to recommend the routine use of opioids in fibromyalgia, and are not recommended as they can worsen mood, such as depression in fibromyalgia, have abuse and dependence potential as well as have a significant adverse effect profile. Long-term use of opioids may worsen pain in some people. Additionally opioids are not recommended as there are other treatments for which an evidence base of effectiveness and efficacy exists. Despite there being insufficient evidence of benefit, people are still commonly prescribed opioids for fibromyalgia.
Investigational medications include cannabinoids and the 5-HT3 receptor antagonist tropisetron. A controlled study of guaifenesin failed to demonstrate any benefits from this treatment. Quercetin, a flavanoid and pharmacologically active natural compound, which acts as an anti-inflammatory and has mast cell inhibitory properties may be effective in the treatment of fibromyalgia. Preliminary research on naltrexone at very low dosage has been found to be effective in reducing fibromyalgia symptoms by more than 30 percent in one small pilot study of 10 women. Naltrexone, an opioid antagonist also acts at very low dosage, to inhibit microglia cells thereby reducing proinflammatory cytokines and neurotoxic superoxides.
Exercise improves fitness and sleep and may reduce pain and fatigue in some people with fibromyalgia. In particular, there is strong evidence that cardiovascular exercise is effective for some patients. Long-term aquatic-based exercise has been proven beneficial as it combines cardiovascular exercise with resistance training. However, due to the cold sensitivities of people with fibromyalgia syndrome, aquatic therapy must take place in a warm pool. Not only that, but the air temperature outside of the pool must also be heated to prevent fibromyalgia patients from getting chills and aches when out of the water. This involves a specialised pool facility, which makes this therapy more expensive and less accessible than regular swimming exercise.
Tai chi was studied in a small, single blinded randomized controlled trial, resulting in a relative benefit ratio of 2.0 on the Fibromyalgia Impact Questionnaire and a relative benefit increase of 100.0%. In populations similar to those in this study which had a rate of benefit as measured by the Fibromyalgia Impact Questionnaire of 40% without treatment, the number needed to treat is 2.
In the majority of the literature on therapy options for fibromyalgia, an overwhelming number of studies echo the same sentiment: that the optimal intervention for fibromyalgia would include a treatment package, consisting of appropriate medications in combination with non-pharmacological treatments including physical exercise and cognitive behaviour therapy. Although the majority of fibromyalgia treatment reviews recommend this multi-treatment approach, very few actually study the interactive benefits of combining the therapy options, with many stating that ‘more research needs to be done.’ By adding parts of each of the three therapy options (drug therapy, exercise, and cognitive-behavioural therapy), fibromyalgia patients and clinicians have the ability to create individualised treatment packages that suit the patient’s particular needs. Because not everyone with fibromyalgia experiences the same co-morbidities and secondary symptoms, it’s important to have treatment options that are adaptive and personalized, not a ‘one size fits all’ treatment.
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