From the Guidelines
Clinical guidelines for fibromyalgia treatment recommend a multimodal approach combining non-pharmacological and pharmacological interventions, with a focus on improving health-related quality of life and balancing benefit and risk of treatment. The most recent and highest quality study, 1, provides evidence-based recommendations for the management of fibromyalgia, emphasizing the importance of a comprehensive assessment of pain, function, and psychosocial context.
Non-Pharmacological Management
Non-pharmacological therapies are recommended as the initial management approach, with:
- Aerobic and strengthening exercise showing strong evidence (Ia) and a high strength of recommendation (100%) 1
- Cognitive behavioral therapies, multicomponent therapies, and defined physical therapies (such as acupuncture or hydrotherapy) also showing strong evidence (Ia) and a high strength of recommendation (93-100%) 1
- Meditative movement therapies (qigong, yoga, tai chi) and mindfulness-based stress reduction showing moderate evidence (Ia) and a moderate strength of recommendation (71-73%) 1
Pharmacological Management
Pharmacological therapies are recommended as part of a multimodal approach, with:
- Amitriptyline (at low dose), duloxetine, and milnacipran showing strong evidence (Ia) and a high strength of recommendation (100%) 1
- Pregabalin showing strong evidence (Ia) and a high strength of recommendation (94%) 1
- Tramadol and cyclobenzaprine showing moderate evidence (Ib) and a moderate strength of recommendation (75-100%) 1
Treatment Approach
A multimodal approach, combining non-pharmacological and pharmacological interventions, is recommended to improve health-related quality of life and balance benefit and risk of treatment. This approach should be individualized, taking into account patient preferences, comorbidities, and associated features such as depression, fatigue, and sleep disturbance. The most recent study, 1, provides the highest quality evidence for guiding treatment decisions, and its recommendations should be prioritized in clinical practice.
From the FDA Drug Label
The efficacy of pregabalin for management of fibromyalgia was established in one 14-week, double-blind, placebo-controlled, multicenter study (F1) and one six-month, randomized withdrawal study (F2) 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 The results are summarized in Figure 9 and Table 14. For various levels of improvement in pain intensity from baseline to study endpoint, Figure 9 shows the fraction of patients achieving that level of improvement. Table 14 Patient Global Response in Fibromyalgia Study F1 Patient Global Impression of Change Treatment Group (mg/day) % Any Improvement 95% CI PGB = Pregabalin Placebo 47.6 (40.0,55.2) PGB 300 68.1 (60.9,75.3) PGB 450 77.8 (71.5,84.0) PGB 600 66.1 (59.1,73. 1) The efficacy of milnacipran hydrochloride for the management of fibromyalgia was established in two double-blind, placebo-controlled, multicenter studies in adult patients (18 to 74 years of age) A larger proportion of patients treated with milnacipran hydrochloride than with placebo experienced a simultaneous reduction in pain from baseline of at least 30% (VAS) and also rated themselves as much improved or very much improved based on the patient global assessment (PGIC)
The clinical guidelines for treating fibromyalgia include the use of pregabalin and milnacipran.
- Pregabalin has been shown to be effective in reducing pain and improving patient global assessment and Fibromyalgia Impact Questionnaire (FIQ) scores, with the following efficacy rates:
- 300 mg/day: 68.1% of patients experienced any improvement
- 450 mg/day: 77.8% of patients experienced any improvement
- 600 mg/day: 66.1% of patients experienced any improvement
- Milnacipran has also been shown to be effective in reducing pain and improving patient global assessment, with a larger proportion of patients experiencing a simultaneous reduction in pain from baseline of at least 30% (VAS) and rating themselves as much improved or very much improved based on the PGIC, compared to placebo 2 3. Key points:
- Pregabalin and milnacipran are effective treatments for fibromyalgia
- The efficacy of these treatments varies by dose and individual patient response
- Patient global assessment and FIQ scores are important measures of treatment efficacy in fibromyalgia.
From the Research
Clinical Guidelines for Treating Fibromyalgia
The clinical guidelines for treating fibromyalgia involve a multidisciplinary approach that incorporates nonpharmacologic therapies and medications to address problematic symptoms 4, 5. This approach is most effective in improving pain and function.
Nonpharmacologic Therapies
Nonpharmacologic therapies that can improve pain and function in patients with fibromyalgia include:
Pharmacologic Therapies
Pharmacologic therapies that are potentially effective for fibromyalgia include:
- Duloxetine
- Milnacipran
- Pregabalin
- Amitriptyline 4 Nonsteroidal anti-inflammatory drugs and opioids have not demonstrated benefits for fibromyalgia and have significant limitations 4.
Efficacy Rates of Each Treatment Group
The efficacy rates of each treatment group vary:
- A study comparing a pregabalin-duloxetine combination to each monotherapy found that the combination was more effective in reducing daily pain and improving global pain relief, Fibromyalgia Impact Questionnaire scores, SF-36 scores, and Medical Outcomes Study Sleep Scale scores 7.
- Multidisciplinary treatment programs that include a combination of nonpharmacologic and pharmacologic therapies have been shown to be effective in alleviating fibromyalgic symptoms 5, 8, 6.
- The efficacy of multidisciplinary treatment programs can vary depending on the degree of integration of the included disciplines, with more complex harmonization of different perspectives obtained through teamwork strategies potentially leading to better outcomes 8.