What are the treatment options for Fibromyalgia (Fibromyalgia syndrome)?

From the Guidelines

Fibromyalgia treatment should prioritize a multidisciplinary approach, combining non-pharmacological and pharmacological therapies tailored to the patient's needs, with a focus on improving health-related quality of life. The most recent and highest quality study, published in 2017 1, recommends a graduated approach to management, starting with non-pharmacological therapies such as aerobic and strengthening exercise, cognitive behavioral therapies, and multicomponent therapies.

Non-Pharmacological Management

Key non-pharmacological interventions include:

• Aerobic and strengthening exercise, which has a strong recommendation for improving symptoms 1
• Cognitive behavioral therapies, which have a weak recommendation but are still considered beneficial 1
• Multicomponent therapies, which also have a weak recommendation but can be effective for some patients 1
• Meditative movement therapies, such as qigong, yoga, or tai chi, and mindfulness-based stress reduction, which can help reduce symptom flares 1

Pharmacological Management

Pharmacological options, as recommended by the 2017 study 1, include:

• Amitriptyline at low dose, with a weak recommendation for improving pain and sleep disturbances
• Duloxetine or milnacipran, which have a weak recommendation for reducing pain and improving function
• Pregabalin, which has a weak recommendation for reducing pain
• Tramadol, which has a weak recommendation for managing pain, but should be used with caution due to its potential for dependence and side effects

Lifestyle Changes

In addition to these therapies, lifestyle changes such as maintaining consistent sleep habits, practicing stress reduction techniques, and using heat therapy can provide temporary relief and improve overall symptoms. Regular moderate exercise, starting with short sessions and gradually increasing as tolerated, is also crucial for managing fibromyalgia symptoms.

By prioritizing a multidisciplinary approach and tailoring treatment to the individual patient's needs, healthcare providers can help improve health-related quality of life and reduce the morbidity and mortality associated with fibromyalgia, as emphasized by the 2017 study 1.

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 Patients were enrolled with a minimum mean baseline pain score of greater than or equal to 4 on an 11-point numeric pain rating scale and a score of greater than or equal to 40 mm on the 100 mm pain visual analog scale (VAS).

Study F2: This randomized withdrawal study compared pregabalin with placebo. Patients were titrated during a 6-week open-label dose optimization phase to a total daily dose of 300 mg, 450 mg, or 600 mg Patients were considered to be responders if they had both: 1) at least a 50% reduction in pain (VAS) and, 2) rated their overall improvement on the PGIC as "much improved" or "very much improved. "

For various degrees of improvement in pain from baseline to study endpoint, Figures 3 and 4 show the fraction of patients achieving that degree of improvement in Studies DPNP-1 and DPNP-2, respectively.

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 (a history of widespread pain for 3 months, and pain present at 11 or more of the 18 specific tender point sites).

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

Fibromyalgia treatment options include:

• Pregabalin (PO): Studies F1 and F2 demonstrated a reduction in pain by visual analog scale and improvement based on patient global assessment and Fibromyalgia Impact Questionnaire.
• Duloxetine (PO): Studies FM-1 and FM-2 demonstrated statistically significant improvement in endpoint mean pain scores from baseline and increased the proportion of patients with at least a 50% reduction in pain score from baseline. Key points:
• Pregabalin and duloxetine are effective treatments for fibromyalgia.
• Both medications demonstrated a reduction in pain and improvement in patient global assessment and Fibromyalgia Impact Questionnaire.
• The optimal dosage for pregabalin is 450 mg daily, while for duloxetine it is 60 mg daily. 2 3

From the Research

Fibromyalgia Treatment Options

• Fibromyalgia is a chronic widespread pain condition that affects millions of people worldwide, with current pharmacotherapies often being ineffective and poorly tolerated 4.
• Combination pharmacotherapy has been studied as a potential treatment option, with some studies finding evidence that it can reduce pain compared to monotherapy 4.
• Pregabalin, an α2-δ agonist, is approved for the treatment of fibromyalgia in several countries and has been shown to be efficacious in reducing pain, improving sleep quality, and patient status 5.
• A network meta-analysis comparing the efficacy of amitriptyline, duloxetine, and pregabalin for treating fibromyalgia found that pregabalin 450 mg was superior to duloxetine 30 mg and pregabalin 150 mg for reducing pain intensity by 30% 6.
• Cognitive behavioural therapies (CBTs) have also been shown to be effective in reducing key symptoms of fibromyalgia, including pain, negative mood, disability, and fatigue 7.
• The efficacy and safety of pregabalin have been compared in different dosing schedules, with one study finding no significant difference between twice daily and once nightly dosing 8.

Pharmacotherapy

• Combination pharmacotherapy may be a viable treatment option for fibromyalgia, with some studies finding evidence of reduced pain compared to monotherapy 4.
• Pregabalin has been shown to be efficacious in reducing pain, improving sleep quality, and patient status, with a safety and tolerability profile consistent across all studies 5.
• Amitriptyline, duloxetine, and pregabalin have been compared in a network meta-analysis, with pregabalin 450 mg found to be superior to duloxetine 30 mg and pregabalin 150 mg for reducing pain intensity by 30% 6.

Non-Pharmacological Therapies

• CBTs have been shown to be effective in reducing key symptoms of fibromyalgia, including pain, negative mood, disability, and fatigue 7.
• CBTs have been found to be superior to controls, including waiting list, treatment as usual, attention controls, and active non-pharmacological therapies, in reducing symptoms and disability 7.