From the Guidelines
Treatment for severe fibromyalgia should involve a multifaceted approach combining medications, physical therapy, and lifestyle modifications, with a focus on improving health-related quality of life and balancing benefit and risk of treatment, as recommended by the EULAR revised recommendations for the management of fibromyalgia 1, 2.
Medication Management
For medication management, options include:
- Amitriptyline (at low dose) with a strong recommendation for 100% of patients 2
- Duloxetine or milnacipran with a strong recommendation for 100% of patients 2
- Pregabalin with a strong recommendation for 94% of patients 2
- Tramadol with a weak recommendation for 100% of patients 2
- Cyclobenzaprine with a weak recommendation for 75% of patients 2
Non-Pharmacological Management
Non-pharmacological management should include:
- Aerobic and strengthening exercise with a strong recommendation for 100% of patients 2
- Cognitive behavioral therapies with a weak recommendation for 100% of patients 2
- Multicomponent therapies with a weak recommendation for 93% of patients 2
- Defined physical therapies, such as acupuncture or hydrotherapy, with a weak recommendation for 93% of patients 2
- Meditative movement therapies, such as qigong, yoga, or tai chi, and mindfulness-based stress reduction with a weak recommendation for 71-73% of patients 2
Lifestyle Modifications
Lifestyle modifications are crucial and include:
- Maintaining regular sleep schedules (7-9 hours nightly)
- Practicing stress reduction techniques like meditation for 15-20 minutes daily
- Moderate exercise starting with 5-10 minutes daily and gradually increasing
- Identifying and avoiding personal triggers
This comprehensive approach addresses both the physical symptoms and neurological pain processing abnormalities characteristic of fibromyalgia, which involves central sensitization and dysregulation of pain pathways in the central nervous system. Key aspects of management should be tailored according to pain intensity, function, associated features, fatigue, sleep disturbance, and patient preferences and comorbidities, with a focus on shared decision-making with the patient 2.
From the FDA Drug Label
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) 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 Severe Fibromyalgia:
- Milnacipran: Studies show that milnacipran hydrochloride is effective in managing fibromyalgia, with a larger proportion of patients experiencing a reduction in pain from baseline of at least 30% and rating themselves as much improved or very much improved 3.
- Duloxetine: Duloxetine delayed-release capsules are also effective in managing fibromyalgia, with treatment resulting in statistically significant improvement in endpoint mean pain scores from baseline and an increased proportion of patients with at least a 50% reduction in pain score from baseline 4. Key Points:
- Both milnacipran and duloxetine are effective in managing fibromyalgia.
- The degree of pain reduction may be greater in patients with comorbid major depressive disorder (MDD).
- Higher dosages of duloxetine (120 mg) did not confer greater benefit than lower dosages (60 mg) and were associated with more adverse reactions and premature discontinuations of treatment.
From the Research
Treatment Options for Severe Fibromyalgia
- Fibromyalgia is a complex condition that requires multimodal treatment, including pharmacological and non-pharmacological therapies 5.
- Several drugs are available to manage the symptoms of fibromyalgia, but none can control all symptoms, and multicomponent therapy is often necessary 5.
- The American Food and Drug Administration (FDA) has approved duloxetine, milnacipran, and pregabalin for the treatment of fibromyalgia, while the European Medicines Agency (EMEA) has not approved any drugs for this condition 5.
Pharmacological Interventions
- A network meta-analysis of 102 trials found that serotonin-norepinephrine reuptake inhibitors (SNRIs) and pregabalin had statistically significant benefits compared to placebo, but the benefits were small and not clinically relevant 6.
- Duloxetine, pregabalin, and milnacipran have been shown to improve pain management, quality of life, and sleep quality in fibromyalgia patients, with duloxetine being the most effective treatment 7.
- Amitriptyline, duloxetine, gabapentin, and pregabalin are commonly used to treat fibromyalgia, but patients often discontinue treatment due to side effects or lack of efficacy 8.
Non-Pharmacological Interventions
- A Delphi consensus exercise recommended aerobic exercise, education, sleep hygiene, and cognitive behavioral therapy as core treatments for all fibromyalgia symptoms 9.
- Mind-body exercises, such as mindfulness, were recommended as core interventions for pain, fatigue, and sleep problems, and as adjunctive treatments for other symptoms 9.
- Multicomponent therapy, including non-pharmacological interventions, has been shown to have small to moderate benefits over placebo in medium-sized trials 6.