What is the efficacy of Low-Dose Naltrexone (LDN) for the treatment of fibromyalgia?

From the Guidelines

Low-dose naltrexone (LDN) is a viable treatment option for fibromyalgia patients, with a recommended dose of 1.5 mg at bedtime, gradually increasing by 1.5 mg every two weeks to a maximum dose of 4.5 mg, as it has been shown to decrease pain and improve satisfaction with life in patients with fibromyalgia 1.

Key Considerations

• LDN works by modulating the immune system and reducing inflammation, rather than directly affecting pain pathways, which may help reduce pain, improve sleep, decrease fatigue, and enhance cognitive function.
• The treatment should be started with a low dose of 1.5 mg and gradually increased to minimize side effects, which are generally mild and include vivid dreams, headaches, and initial sleep disturbances.
• LDN is typically well-tolerated and does not cause the dependency issues associated with opioids, making it a suitable option for patients who have not responded to other treatments.

Treatment 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, and associated features such as depression, fatigue, and sleep disturbance 1.
• Non-pharmacological therapies, such as aerobic and strengthening exercise, cognitive behavioral therapies, and multicomponent therapies, should be considered as initial management options.
• Pharmacological management, including amitriptyline, duloxetine, milnacipran, tramadol, and pregabalin, may be used in conjunction with non-pharmacological therapies to achieve optimal treatment outcomes.

Patient-Specific Considerations

• The treatment approach should be individualized based on patient needs, preferences, and comorbidities, and patients should be involved in shared decision-making with their healthcare provider.
• Patients should continue other effective treatments while trying LDN, and the treatment should be monitored regularly to assess effectiveness and adjust the dose as needed.

From the Research

Efficacy of Low-Dose Naltrexone (LDN) in Fibromyalgia

• LDN has been studied as a potential treatment for fibromyalgia, with some studies suggesting its effectiveness in reducing pain and symptom severity 2, 3, 4.
• A systematic review and meta-analysis found that LDN was superior to placebo in alleviating pain in fibromyalgia patients, but not in raising mechanical pain threshold 3.
• Another systematic review and meta-analysis found that LDN marginally reduced pain and symptom severity from baseline, but these effects were not superior to placebo 5.
• A qualitative analysis of clinical trials involving LDN for the treatment of fibromyalgia found that LDN was effective in the symptomatic management of fibromyalgia, with no severe adverse events reported 4.

Safety of Low-Dose Naltrexone (LDN) in Fibromyalgia

• The majority of studies found that LDN was well-tolerated and safe for use in fibromyalgia patients, with no serious adverse events reported 2, 3, 4.
• One study found that the incidence of vivid dreams was significantly higher in the treatment group compared to placebo 3.
• Another study found that LDN was associated with a higher incidence of headache, but this was not statistically significant 3.

Comparison to Other Treatments

• Duloxetine and pregabalin are two FDA-approved treatments for fibromyalgia, but they may have limitations in terms of efficacy and safety 6.
• A study found that duloxetine and pregabalin had response rates of 33% and 32%, respectively, and were associated with adverse events such as nausea, fatigue, dizziness, and somnolence 6.
• LDN may be considered as an alternative or adjunctive treatment option for fibromyalgia patients who do not respond to or tolerate traditional treatments 2, 3, 4.