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Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

Myalgic encephalomyelitis/chronic fatigue syndrome is a complex, debilitating disease of unknown etiology. The prevalence varies widely. A systemic review and meta-analysis by Lim et al. estimates an overall prevalence of 0.89% according to the most commonly used CDC-1994 case definition criteria.49 The peak age of onset is between 20 and 45 years, with a female to male ratio of 3:1.50 Although the primary symptom is post-exertional fatigue, various neurologic, cardiovascular, respiratory, and gastrointestinal manifestations are commonly present. Currently, there are no known effective medical treatments, and diagnosis is primarily though the exclusion of other conditions. No controlled clinical trials of LDN use in this patient population have been reported in the literature. Case studies, retrospective chart reviews, and anecdotal reports have been published.

Bolton et al.51 published three case reports of LDN administration for the treatment of chronic fatigue syndrome. The first case report is a 63-year-old female who developed profound weakness, fatigue, general malaise, light and sound sensitivity, repeated dizziness causing collapse, persistent anxiety, and widespread pain, all of which occurred after the development of viral meningitis. Pertinent history also includes an episode of gastroenteritis with subsequent multiple food intolerances. Multiple medications were tried with no improvement. In 2010, the patient was started on 1.5 mg of LDN daily, and the dose was increased slowly over the course of 2 years. Slight energy improvements and reduced intolerances to food were noticed at a dose of 4.5 mg/day, however, the dose was reduced to 3 mg due to headaches. The LDN dose was again slowly increased, and this patient has been maintained on 6 mg BID for the past 7 years at the time of publication. This patient reports a normal quality of life with symptoms such as poor sleep and excessive pain absent. Intellectual and cognitive functioning have returned. Energy levels were still noted to be reduced slightly during events such as infections, prolonged overexertion or excessive mental effort, with some reductions delayed up to 48 hours.

The second case report is of a 59-year-old female who was started on LDN 0.25 mg/day (at age 54) for a 25-year history of profound fatigue and weakness, flu-like symptoms, post-exertional malaise, cognitive impairment, nausea, widespread pain, and sleep disturbance. Possible precipitating factors that may have led to her diagnosis of ME/CFS include possible viral infection, early pregnancy, and exposure to ticks within 6 months of symptom onset. A very low dose of naltrexone was started due to known immune hypersensitivity (urticarial). Improved sleep and lower pain levels were noticed at a dose of 1 mg/day, approximately 6 months after LDN initiation. Pain and sleep issues continued, but at a lower level. Her functional level did not improve, and symptoms of post-exertional neuroimmune exhaustion, periodic muscle weakness, orthostatic intolerance, symptomatic sinus tachycardia, urticarial rashes, and susceptibility to bacterial infections are still present. This patient considered LDN to be beneficial long term, and she also takes ivabradine and certirizine to control these symptoms.

The third case report is a 39-year-old male who initiated LDN 1 mg/day (at age 37) for chronic fatigue syndrome that was diagnosed by his pediatrician during childhood. Pertinent medical history during childhood includes a head injury, glandular fever, severe tonsillitis, nasal polyps, sinusitis, and seasonal allergic rhinitis. The LDN dose was gradually increased to 4.5 mg/day. Improved sleep pattern and fewer colds, which are no longer associated with an energy dip or subsequent depression, were reported. Functional level improved from being mild/moderately limited on a daily basis (60-70% on functional activity scale) to mild limitations (80-90% on functional activity scale).

Polo et al.52 investigated LDN in 218 ME/CFS patients through a retrospective chart review at a private sleep and breathing clinic. Typical ME/CFS patients at the clinic had been sick for several years and had undergone extensive tests at primary and secondary healthcare levels to rule out other diseases. The severity of symptoms ranged from mild to very severe. Patients were directed to start LDN 1.5 mg every morning for 1 week, followed by a dose increase to 3 mg (1.5 mg twice daily). The daily dose was allowed to be increased to 4.5 mg after 6 weeks on LDN therapy. Treatment was discontinued if no treatment effect was observed within the first 6 months. Treatment response and adverse effects were recorded during visits or upon renewal of prescription and were based on spontaneous reporting, without any structured questionnaire or rating scales. The magnitude of response was scored on a scale of 0-6 based on the number of symptom modalities for which any improvement was reported. Adverse effects were calculated with a similar scoring system. A large proportion of patients (73.9%) reported some degree of alleviation of ME/CFS symptoms after the initiation of LDN therapy, and approximately half of the patients experienced a response in at least two different ME/CFS symptoms. Improvement in vigilance/alertness was reported in 51.4% of patients, physical performance improvement in 23.9%, and cognitive dysfunction diminished in 21.1%. Adverse events were reported in 54.2% of patients, and 7.3% of patients discontinued treatment due to an adverse event. Most adverse symptoms were mild and temporary, with the most common being insomnia (15.3%) and nausea (15.3%). Adverse symptoms were more common than expected during the initial phase of treatment, including a wide spectrum of autonomic symptoms typically observed in ME/CFS. Study authors noted that an initial aggravation of symptoms followed by rapid alleviation suggests a possibility that LDN targets underlying nervous system dysfunction. While this retrospective study provides some preliminary information on the effectiveness and safety of LDN for ME/CFS, additional prospective, controlled clinical trials are needed.

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