From the Guidelines
Fibromyalgia treatment should involve a multifaceted approach, prioritizing non-pharmacological therapies such as aerobic and strengthening exercise, cognitive behavioral therapies, and multicomponent therapies, as recommended by the most recent and highest quality study 1.
Key Components of Treatment
- Non-pharmacological management:
- Pharmacological management:
Importance of Comprehensive Approach
The management of fibromyalgia should aim at improving health-related quality of life, balancing benefit and risk of treatment, and often requires a multidisciplinary approach with a combination of non-pharmacological and pharmacological treatment modalities tailored according to pain intensity, function, associated features, and patient preferences and comorbidities 1.
Recent Recommendations
The most recent study 1 provides updated recommendations for the management of fibromyalgia, emphasizing the importance of a comprehensive assessment of pain, function, and psychosocial context, and recognizing fibromyalgia as a complex and heterogeneous condition.
Comparison with Previous Studies
Previous studies, such as 1 and 1, also emphasize the importance of a multifaceted approach to treating fibromyalgia, but the most recent study 1 provides the strongest and most up-to-date evidence for the recommended treatments.
From the FDA Drug Label
Studies F1 and F2 enrolled patients with a diagnosis of fibromyalgia using the American College of Rheumatology (ACR) criteria (history of widespread pain for 3 months, and pain present at 11 or more of the 18 specific tender point sites). The studies showed a reduction in pain by visual analog scale In addition, improvement was demonstrated based on a patient global assessment (PGIC), and on the Fibromyalgia Impact Questionnaire (FIQ).
Study F1: This 14-week study compared pregabalin total daily doses of 300 mg, 450 mg and 600 mg with placebo
Study F2: This randomized withdrawal study compared pregabalin with placebo.
The efficacy of duloxetine delayed-release capsules for the management of fibromyalgia in adults was established in two randomized, double-blind, placebo-controlled, fixed-dose trials in adult patients meeting the American College of Rheumatology criteria for fibromyalgia
Treatment for Fibromyalgia:
- Pregabalin: The studies showed a reduction in pain by visual analog scale. Improvement was demonstrated based on a patient global assessment (PGIC), and on the Fibromyalgia Impact Questionnaire (FIQ) 2.
- Duloxetine: Treatment with duloxetine delayed-release capsules 60 mg or 120 mg daily statistically significantly improved the endpoint mean pain scores from baseline and increased the proportion of patients with at least a 50% reduction in pain score from baseline 3.
From the Research
Treatment Options for Fibromyalgia
- The treatment of fibromyalgia often involves a combination of pharmacological and non-pharmacological interventions 4
- Medications such as duloxetine, milnacipran, pregabalin, and amitriptyline have been shown to have consistent benefits for a range of symptoms in fibromyalgia patients 5, 6, 7, 4
- A study comparing the efficacy of duloxetine, pregabalin, and milnacipran found that duloxetine was the most effective treatment, improving pain, quality of life, and sleep quality 5
- Another study found that combining pregabalin and duloxetine improved multiple clinical outcomes compared to monotherapy 6
- A network meta-analysis comparing the efficacy of amitriptyline, duloxetine, and pregabalin found that pregabalin 450mg was the best performing option for reducing pain intensity by 30%, and amitriptyline 25mg was the best performing option for reducing pain intensity by 50% 7
Medication Use Patterns
- A large population-based cohort study found that patients diagnosed with fibromyalgia who newly started amitriptyline, duloxetine, gabapentin, or pregabalin had similar clinical characteristics and medication use patterns, including high rates of comorbidities and concomitant medication use 8
- The study also found that only one-fifth of patients continued treatment for ≥1 year, and the dose of the medication was not increased in most patients during the follow-up period 8