fibromyalgia
FIBROMYALGIA

Fibromyalgia is a clinical syndrome wherein the patient experiences generalized pain and fatigue that cannot be explained by the presence of any other disorder.
It is often considered to be psychosomatic or psychogenic in nature.
It is found in approximately 2% of the population and the prevalence increases with age, most common in women 20-55 year of age

Principles of Therapy

Goals of Treatment

  • To reduce symptoms
  • To improve the physical & mental health of patients as well as their quality of life
  • To reduce the need for medicine
  • To enhance independence

Principles of Treatment

  • Treatment should be individualized based on the severity of pain, presence of other symptoms or comorbidities & the degree of functional impairment
  • Use a multidisciplinary approach & offer individually-tailored strategies that include both pharmacological & non-pharmacological therapies in the management of FM
  • Medications should be started at very low doses & gradually increased to reach the final dose that is set by the patient, based on efficacy & side effects

Combination Therapy

  • Patients w/ FM experience multiple symptoms that may benefit from several different drugs that have different mechanisms of action & may preferentially benefit 1 symptom domain over another
  • To ensure safe combination, it is important to know the potential drug-drug interactions
  • Combination therapy is best introduced sequentially so that patient can gain a sense of effectiveness of 1 drug & adjust to adverse effects that may be more prominent initially & then diminish or resolve before introducing a 2nd drug

Outcome measures

  • A comprehensive assessment of symptom severity (eg pain, fatigue, sleep quality, anxiety, depression), physical function, & psychosocial status is the key status & outcome variables in FM
  • Eg visual analog scales (VAS) for pain, fibromyalgia impact questionnaire (FIQ) that measures physical function, work status, depression, anxiety, pain, fatigue & well being during the preceding wk

Pharmacotherapy

Anticonvulsants

  • It is an analog of the neurotransmitter GABA; it binds to the alpha2-delta subunit resulting in modulation of Ca channels & reduction in the release of several neurotransmitters, including glutamate, norepinephrine, serotonin, dopamine & substance P
  • Recommended to be started with the lowest possible dose

Gabapentin

  • Clinically effective in the treatment of FM
  • Studies show great reductions in level & response to pain, sleep improvement, & overall impact of FM after treatment

Pregabalin

  • Approved for the treatment of patients w/ FM
  • Considered an alternative to Amitriptyline in patients w/ more sleeping problems
  • Based on meta-analysis, Pregabalin was found to be superior than placebo & Milnacipran in providing pain relief
  • Provides significant improvements in fatigue & health-related quality of life

Cyclobenzaprine

  • Has a strong evidence for medication efficacy in the treatment of FM
  • Alternative medication to Amitriptyline
  • Officially classified as a centrally-acting skeletal muscle relaxant but shares similar structural properties w/ TCAs
    • It acts on the brain stem, decreasing the tonic-somatic motor activities
  • Relaxes tense muscles leading to pain relief & facilitates sleep

NSAIDs

  • There is no evidence of their effectiveness when used alone in the treatment of FM
  • May be used as adjuncts for analgesia when combined w/ TCA

Opioids

  • Strong opioids are generally not recommended
  • Should only be considered for moderate to severe pain unresponsive to conventional treatment and only after all other pharmacological & non-pharmacological therapies have been exhausted

Pramipexole

  • It is a nonergot-derivative dopamine receptor agonist
  • Pramipexole provides greater improvement in the mean pain score after 14 wk of study; however, higher doses were used than many patients can tolerate
    • Hence, further study is needed to evaluate the efficacy & safety of Pramipexole
    • Its use may be limited in patients refractory to multiple approved or better established medications

Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs)

  • These agents have greater neuroreceptor selectivity; considered more potent & are better tolerated than older TCA

Duloxetine

  • Approved for the treatment of FM
  • Highly selective inhibitor of serotonin (5-HT) reuptake
  • Significantly reduces pain severity & improves global assessments
    • Majority of its impact on pain was a direct effect
  • Also improves mental fatigue but not general fatigue
  • Based on meta-analysis, Duloxetine was found to be superior than placebo & Milnacipran in providing pain relief
  • Based on a pivotal study, it was shown that Duloxetine neither helped nor hindered sleep quality
  • Best tolerated in the morning

Milnacipran

  • Approved for the treatment of FM
  • It has mild N-methyl-D-aspartate inhibitor properties
  • Reduces pain & improves global status & physical function in patients w/ FM
  • May be used as an initial therapy in patients who have exhaustion
  • Similar to Duloxetine, Milnacipran does not interfere w/ sleep nor does it help w/ sleep

Selective Serotonin Reuptake Inhibitors (SSRIs)

  • Considered to have less impact in alleviating pain of FM than TCA or the newer SNRI, although they may be helpful for clinical domains like fatigue or mood disorder

Fluoxetine

  • There is moderate evidence of the efficacy in the treatment of FM
  • Based on a flexible placebo-controlled dose study, Fluoxetine demonstrated improvement on FIQ score as well as subscores for pain, fatigue & depression

Tramadol

  • Inhibits reuptake of norepinephrine & serotonin, & enhances serotonin release
    • It alters perception & response to pain by binding to mu-opiate receptors in the CNS
  • Provides effective pain relief either alone or in combination w/ Paracetamol
  • Based on a large randomized controlled trial, VAS for pain was decreased, pain relief was improved & pain threshold was reduced after treatment w/ Tramadol
  • Should be used w/ caution due to possibility of typical opiate withdrawal symptoms after discontinuation & the risk of abuse & dependence

Tricyclic Antidepressants (TCAs)

  • Considered as initial therapy in patients w/ FM
  • Have the strongest evidence for medication efficacy in the treatment of FM, particularly Amitriptyline
  • Recommended as nighttime medication
  • Use is limited by a lack of uniform effectiveness & relatively high frequency of side effects
    • Efficacy of the drugs may decrease over time in some patients

Amitriptyline

  • Has a strong evidence for medication efficacy in the treatment of FM
  • Blocks neuronal reuptake of noradrenaline & serotonin thus increasing synaptic concentration of serotonin &/or norepinephrine in the CNS
  • Indirect comparison in meta-analyses demonstrated greater efficacy of Amitriptyline in the treatment of FM than for SSRIs, SNRIs

Tropisetron

  • A potent selective & competitive antagonist of 5HT3 receptors
  • Reduces pain & improves function in FM
  • Has analgesic effect based on small trials of FM patients in a bell-shaped curve dose effect

Combination Therapies

SNRI plus Anticonvulsant

  • Significant pain reduction & global improvement w/ the addition of Milnacipran in patients w/ suboptimal response to Pregabalin

SSRI plus TCA

  • Combination of Fluoxetine & Amitriptyline was noted to have better outcome measures compared to either drug alone
    • Same results were noted in the combination of Fluoxetine & Cyclobenzaprine over a 12-wk period

Other Agents

  • Moclobemide & Pirlindole may reduce pain & often improve function
  • Painful areas in muscle may respond to local inj of local anesthetics; corticosteroids are never indicated
  • Corticosteroids are useful only as management for coexisting inflammatory processes
  • Cannabinoids (eg Nabilone, Dronabinol) may be considered for FM patients who are greatly affected by lack or disturbance of sleep

Non-Pharmacological Therapy

Exercise

  • Recommended as the first intervention among the treatment strategies for FM patients
  • Goal is to make a gradual move toward functional independence & fitness
  • All modes of exercise can be modified based on the severity of FM & presence of comorbidities
  • Stress the importance of slow & gradual progression to avoid patients from experiencing pain exacerbation due to exercise which will trigger discontinuation of the exercise program
  • Based on systematic review of controlled trials, low impact aerobic exercise was found to have beneficial effects on aerobic performance, pain & pressure thresholds over tender point sites in those subjects who received aerobic exercise training
  • Studies have shown that aerobic exercise in warm pools seems to be as beneficial as land-based aerobic exercise, w/ additional benefits in mood & sleep duration
  • The type & intensity of exercise program should be individualized
    • Optimal cardiovascular fitness training requires a minimum of 30 min of aerobic exercise 2-3x/wk
  • There is an increasing evidence for the beneficial effects of strength training
    • Strength training 2x/wk is encouraged
  • Advise patients to avoid pain by stretching to the point of resistance, not to the point of pain. This is esp for patients w/ joint hypermobility
  • Based on recent reviews on flexibility training (eg yoga, pilates, T’ai Chi), the results showed improvement in pain, function and quality of life but adherence to the program is recommended
  • Qigong & T’ai Chi offer some promise of efficacy but more rigorous assessment is needed for these to be considered an evidence-based treatment for FM
  • Effective exercise can be done individually or in a group
    • Type of exercise is largely determined by patient preference & access to group classes & warm-water pools; pool exercise classes should not be confused w/ swimming

Psychological & Behavioral Therapies

  • There is good evidence to support the beneficial effect of psychological therapies, particularly cognitive behavioral therapy (CBT)
  • The goal of CBT is to increase self-management, which includes moving patients toward more adaptive beliefs regarding their ability to control FM symptoms, resulting in increased functioning
  • Based on a meta-analysis, a number of psychological measures provided a statistically significant, but small to medium effect on short- & long-term pain reduction in patients w/ FM
    • All psychological methods were comparably effective in decreasing depression & pain severity
    • It was concluded that patients w/ FM should be treated w/ combination methods that include psychological interventions as a major component, such as high-dose CBT w/ relaxation/biofeedback
  • Other methods that may be helpful include educational interventions, relaxation training, activity pacing, guided imagery, written emotional disclosure, distraction strategies

Physical Therapy & Modalities

  • There is moderate evidence that support the efficacy of acupuncture
  • Diffuse & regional pain is improved by strategies like sauna, hot baths & showers, hot mud, & massage; however, excessive dependence on these physical modalities may confound patient’s efforts to attain self-efficacy for pain control
  • Trigger-point inj, chiropractic manipulation & myofascial release may be well accepted by patients but these modalities have questionable efficacy

Transcranial Direct Current Stimulation

  • Makes use of weak DC current for 20 min into the brain via electrodes placed on the cranium in order to modify brain activity
  • Daily use improves pain & physical function in patients w/ FM

Repetitive Transcranial Magnetic Stimulation

  • Applies magnetic waves to the cranium
  • Daily use for 30 min improves sleep efficiency, reduced arousals and improvement in symptoms

Complex Neural Pulse Stimulation

  • Makes use of lower power magnetic pulse applied to the cranium through a headset that is used by the patient everyday for 40 min
  • Preliminary studies indicate improvement in the chronic pain associated w/ FM

Other Therapies

  • There has been mixed or limited evidence for efficacy of hypnotherapy, mineral springs or salt baths (balneotherapy)
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