What is the recommended treatment for fibromyalgia?

Treatment for Fibromyalgia

Begin immediately with aerobic and strengthening exercise as your primary intervention, then add duloxetine 60 mg daily, pregabalin 300–450 mg/day, or amitriptyline 25–50 mg nightly if exercise alone provides insufficient relief after 4–6 weeks. 1

First-Line: Non-Pharmacological Interventions (Start Here)

Exercise Program (Strongest Evidence: Level Ia, Grade A)

• Start with low-intensity aerobic exercise: 10–15 minutes of walking, swimming, or cycling, 2–3 sessions per week 1
• Progress gradually over 4–6 weeks to 20–30 minutes, 3–5 sessions weekly, then advance to 30–60 minutes, 5 days weekly over 8 weeks 1, 2
• Add progressive resistance training targeting major muscle groups 2–3 times weekly once aerobic tolerance is established 1, 2
• Tailor intensity to baseline fitness to avoid symptom flare-ups; increase duration before intensity 1

Heated Pool Therapy (Level IIa, Grade B)

• Hydrotherapy sessions of 25–90 minutes, 2–3 times weekly for 5–24 weeks provide consistent symptom relief 1
• Particularly helpful for patients with mobility limitations or as an adjunct to land-based exercise 2

Cognitive Behavioral Therapy (Level Ia, Grade A)

• Prioritize CBT for patients with comorbid depression, anxiety, or maladaptive coping strategies 1, 3
• Produces modest but durable reductions in pain (effect size ≈ −0.29) and disability (effect size ≈ −0.30) 1

Meditative Movement Therapies (Level Ia, Grade A)

• Qigong, yoga, or tai chi: 12–24 total hours over 8–12 weeks (≈1–2 hours per week) 1
• Improves sleep (effect size ≈ −0.61) and fatigue (effect size ≈ −0.66) 1

Acupuncture (Level Ia, Grade A)

• Manual acupuncture (not electro-acupuncture): twice-weekly sessions for minimum 8 weeks, with 20–30 minutes needle retention and manual stimulation 1
• Significantly improves quality of life immediately after treatment and at 3-month follow-up 1

Second-Line: Pharmacological Management (Add at 4–6 Weeks if Needed)

First-Line Medications (All Level Ia, Grade A)

Duloxetine (Preferred for Comorbid Depression)

• Start 30 mg once daily for 1 week, then increase to 60 mg once daily 1, 3, 4
• Do NOT exceed 60 mg/day—doses of 120 mg provide no additional benefit and increase adverse events 1, 4
• Approximately 50% of patients achieve ≥30% pain reduction 1
• Also treats comorbid depression and anxiety 1, 3

Pregabalin (Preferred for Prominent Sleep Disturbance)

• Start 75 mg twice daily, increase to 150 mg twice daily within 1 week 1, 3, 5
• Target dose 300–450 mg/day in divided doses 1, 5
• Do NOT exceed 450 mg/day—higher doses offer no additional benefit but increase dose-dependent adverse reactions 1, 5
• 38% more likely to achieve ≥30% pain reduction versus placebo (RR 1.38; 95% CI 1.25–1.51) 1
• Adjust dose for renal impairment (CrCl <60 mL/min) 1, 5

Amitriptyline (Preferred for Sleep Disturbance, Caution in Elderly)

• Start 10 mg at bedtime, increase by 10 mg weekly to target 25–50 mg nightly 1, 3, 2
• Number needed to treat for 50% pain relief is 4.1 1
• Moderate analgesic effect (SMD −0.40) and improves sleep (SMD 0.47) and fatigue (SMD 0.48) 1
• Avoid in patients ≥65 years due to anticholinergic effects (falls, confusion, constipation, urinary retention) 1, 2
• Therapeutic effects emerge over 3–7 weeks 3

Milnacipran (Alternative SNRI)

• Start with dose escalation over 1 week to minimize side effects, target 100–200 mg/day in divided doses 1, 6
• Similar efficacy to duloxetine for pain reduction (RR 1.38; 95% CI 1.25–1.51) 1
• Dropout rates due to side effects approximately double compared to placebo 1

Second-Line Medication (When First-Line Fails)

Tramadol (Level Ib, Grade A)

• Reserve for patients whose pain remains uncontrolled after adequate trials of duloxetine, pregabalin, or amitriptyline 1, 3
• Moderate effect size of 0.657 for pain reduction 1
• Use with caution given opioid-related risks 1, 3

Alternative Options (Weaker Evidence)

Cyclobenzaprine (Level Ia, Grade A)

• Can be considered for pain management 1

Gabapentin (Off-Label, Limited Evidence)

• Alternative to pregabalin with similar mechanism of action 1, 3
• 49% of patients achieve ≥30% pain reduction versus 31% with placebo 3
• Requires careful titration due to nonlinear pharmacokinetics 1
• Adjust dose for renal impairment 1

Treatment Algorithm

1. Week 0: Begin patient education about central sensitization + start low-intensity aerobic exercise program 1, 3

2. Weeks 1–4: Gradually increase exercise duration and intensity; add heated pool therapy or CBT based on individual needs 1

3. Week 4–6 Assessment: If pain reduction <30%, add first-line medication:

   • Duloxetine 60 mg daily (if comorbid depression/anxiety) 1, 3
   • Pregabalin 300–450 mg/day (if prominent sleep disturbance) 1, 3
   • Amitriptyline 25–50 mg nightly (if age <65 and sleep disturbance) 1, 3

4. Week 8–12 Assessment: If partial response (30–50% pain reduction), consider adding second agent from different class 1

5. If First-Line Fails: Switch to alternative first-line agent from different drug class 1

6. If All First-Line Agents Fail: Add tramadol with careful monitoring 1, 3

7. Ongoing: Reassess every 4–8 weeks using pain scores, functional status, and patient global impression of change 1, 2

Medications to AVOID (Level Ia, Grade A)

• Strong opioids (morphine, oxycodone, hydrocodone): Lack demonstrated benefit and carry significant harm, particularly in elderly patients 1, 3, 2, 7, 8
• Corticosteroids: No efficacy demonstrated for fibromyalgia 1, 3, 2, 7, 8
• NSAIDs as monotherapy: No proven benefit over placebo 1, 8

Special Populations

Elderly Patients (≥65 Years)

• Avoid amitriptyline due to anticholinergic burden (falls, confusion, constipation, urinary retention) 1, 2
• Prefer duloxetine or pregabalin as first-line options 2
• Check creatinine clearance before prescribing pregabalin due to age-related decline in renal function 2
• Start all medications at lower doses and titrate slowly 2

Renal Impairment

• Pregabalin requires dose adjustment for CrCl <60 mL/min 1, 5
• Duloxetine: Avoid in severe renal impairment (GFR <30 mL/min) 4

Hepatic Impairment

• Duloxetine: Avoid in chronic liver disease or cirrhosis 4

Critical Pitfalls to Avoid

• Never exceed duloxetine 60 mg/day or pregabalin 450 mg/day—higher doses do not increase efficacy and only raise adverse events 1, 4, 5
• Do not prescribe strong opioids or corticosteroids under any circumstances 1, 3, 2
• Avoid NSAIDs as sole therapy—they are ineffective for fibromyalgia pain 1
• Do not rely solely on pharmacological therapy without implementing exercise and behavioral approaches 1
• Do not discontinue medications abruptly—taper gradually over 2–4 weeks to prevent withdrawal symptoms 3, 4
• Do not combine gabapentin with pregabalin—they bind identical targets with the same mechanism, making this pharmacologically redundant 1
• Do not use massage or chiropractic manipulation as primary therapy—passive modalities should not replace active exercise 1

Evidence Quality Summary

• Effect sizes for most treatments are modest (small to moderate, SMD ≈ 0.3–0.8) 1
• Multicomponent therapy (combining exercise, CBT, and medication) may provide greater benefit than any single intervention 1, 2
• Exercise has the strongest evidence (Level Ia, Grade A) for improving pain, function, and quality of life 1, 2, 7, 9
• Pharmacological treatments are second-line and should be added only when non-pharmacological interventions provide insufficient relief 1, 3, 8