Treatment of Fibromyalgia
Begin with Exercise as First-Line Therapy
Start immediately with a graduated aerobic exercise program—this is the only intervention with "strong-for" recommendation and Level Ia, Grade A evidence for improving pain, function, and quality of life in fibromyalgia. 1, 2
Exercise Prescription Algorithm
Week 0–2: Initiate low-impact aerobic activity (walking, swimming, or cycling) at 10–15 minutes per session, 2–3 times weekly, keeping intensity low enough to avoid symptom flare-ups. 1
Week 3–6: Progress duration to 20–30 minutes per session, 3–5 times weekly, gradually increasing intensity based on tolerance. 1, 2
Week 7 onward: Target 30–60 minutes of aerobic exercise 5 days weekly, and add progressive resistance/strengthening training 2–3 times weekly once aerobic tolerance is established. 1, 2
Heated pool therapy (with or without concurrent exercise) provides additional benefit with Level IIa, Grade B evidence and may improve exercise tolerance, particularly for patients with mobility limitations; effective protocols involve 25–90 minute sessions, 2–3 times weekly. 1
Additional Non-Pharmacological Interventions
Cognitive behavioral therapy (CBT) is recommended (Level Ia, Grade A) particularly for patients with comorbid depression, anxiety, or maladaptive coping strategies; it produces modest reductions in pain (effect size ≈ –0.29) and disability (effect size ≈ –0.30) with durable long-term benefits. 1, 2
Manual acupuncture is recommended (Level Ia, Grade A) for pain reduction and quality-of-life improvement; treatment courses typically span 8–13 weeks with twice-weekly sessions for the first 4 weeks, each involving 20–30 minutes of needle retention with manual stimulation. 1, 2
Meditative movement therapies (tai chi, yoga, qigong) improve sleep (effect size –0.61) and fatigue (effect size –0.66) with Level Ia, Grade A evidence; recommended dose is 12–24 hours total over 8–12 weeks (≈1–2 hours per week). 1, 2
Mindfulness-based stress reduction programs are recommended as adjunctive therapy. 1, 2
Reserve Pharmacotherapy for Severe Pain or Sleep Disturbance
Initiate pharmacologic treatment only after 4–6 weeks of optimized exercise and non-pharmacological interventions have failed to produce adequate improvement, or when severe pain or sleep disturbance is present at baseline. 1
First-Line Medication Options (Choose ONE)
Duloxetine 30 mg daily for 1 week, then increase to 60 mg daily is the preferred first-line option for patients with pain plus comorbid depression or anxiety (Level Ia, Grade A); do not exceed 60 mg/day because doses of 120 mg provide no additional benefit and are associated with higher rates of adverse events. 1, 3
- Approximately 50% of patients achieve at least 30% pain reduction with duloxetine 60 mg daily. 1
Pregabalin 75 mg twice daily, titrated to 150 mg twice daily (300 mg/day total) over 1 week is recommended for patients with predominant pain without mood symptoms (Level Ia, Grade A); the target dose range is 300–450 mg/day, and doses above 450 mg/day do not improve efficacy but increase dose-dependent adverse reactions. 1, 4
- Patients receiving pregabalin are 38% more likely to achieve at least 30% pain reduction compared with placebo (Risk Ratio = 1.38; 95% CI 1.25–1.51). 1
- Pregabalin requires dose adjustment in patients with creatinine clearance <60 mL/min. 1, 4
Amitriptyline 10 mg at bedtime, increased by 10 mg weekly to target 25–50 mg nightly (maximum 75 mg/day) is recommended for patients with prominent sleep disturbance (Level Ia, Grade A); the number needed to treat for 50% pain relief is 4.1. 1, 2
- Amitriptyline produces a moderate analgesic effect (effect size –0.40) and modest improvements in sleep (effect size 0.47) and fatigue (effect size 0.48). 1
- In patients ≥65 years, start at 10 mg and titrate slowly due to anticholinergic effects (falls, confusion, constipation, urinary retention). 1, 5
Milnacipran 12.5 mg once daily on day 1, then 12.5 mg twice daily on days 2–3, then 25 mg twice daily on days 4–7, then increase to target dose of 50 mg twice daily (100 mg/day total) or 100 mg twice daily (200 mg/day total) is an alternative SNRI option (Level Ia, Grade A); doses of 200 mg/day do not confer additional benefit over 100 mg/day. 1, 6
Second-Line Option When First-Line Fails
If pain reduction is <30% after 4–6 weeks at target dose of the initial first-line agent, switch to an alternative first-line medication from a different drug class. 1
If partial response (30–50% pain reduction) is observed, consider adding a second agent from a different class. 1
Tramadol is recommended (Level Ib, Grade A) for patients whose pain remains uncontrolled after adequate trials of duloxetine, pregabalin, or amitriptyline; it demonstrates a moderate effect size of 0.657 for pain reduction but should be used with caution given opioid-related risks. 1
Medications to Avoid—Never Prescribe
Strong opioids (morphine, oxycodone, hydrocodone) are not recommended under any circumstances because they lack demonstrated efficacy and are associated with significant harm, including risk of dependence and adverse systemic effects (Level Ia, Grade A). 1, 2, 5
Systemic corticosteroids have no role in fibromyalgia treatment and lack efficacy (Level Ia, Grade A). 1, 2, 5
NSAIDs (ibuprofen, naproxen) have no proven benefit over placebo when used as monotherapy because fibromyalgia is not an inflammatory condition; a weak recommendation against their use is supported by unanimous expert agreement. 1, 2
Monitoring and Reassessment
Evaluate treatment response every 4–8 weeks using standardized pain scores (0–10 scale), functional status assessments, and patient global impression of change (PGIC). 1, 2
Most treatments show modest effect sizes (standardized mean differences ≈ 0.3–0.8); expect 30–50% pain reduction rather than complete resolution. 1
Multicomponent therapy (combining exercise, CBT, and medication) may provide greater benefit than any single intervention. 1, 2
Long-term management requires ongoing exercise maintenance and periodic reassessment of medication need. 2
Critical Pitfalls to Avoid
Never initiate pharmacotherapy before establishing an aerobic exercise program; exercise is the sole "strong-for" recommendation and must be the foundation of care. 1
Never exceed duloxetine 60 mg/day or pregabalin 450 mg/day; higher doses increase adverse events without added benefit. 1, 3, 4
Do not combine gabapentin with pregabalin or duloxetine; gabapentin and pregabalin bind to identical targets with the same mechanism, making this combination pharmacologically redundant. 1
Do not discontinue any medication abruptly; taper gradually over 2–4 weeks to minimize withdrawal symptoms (dizziness, headache, nausea, paresthesia, irritability). 3
Avoid relying solely on pharmacological therapy without implementing exercise and behavioral approaches. 1