Low dose naltrexone (LDN) may be on its way to becoming a new therapeutic agent for multiple sclerosis. Evidence for its efficacy in attenuating multiple sclerosis symptoms is scarce, but results of a phase 3 clinical trial, “A Randomized Placebo-Controlled, Crossover-Design Study of the Effects of Low Dose Naltrexone,” suggest that LDN enhances the mental health quality of life of patients with multiple sclerosis.
The trial, initiated in 2007 by a group led by Bruce Cree, MD, PhD, at the University of California, San Francisco, sought to evaluate changes in quality of life for multiple sclerosis patients following treatment with 4.5 mg naltrexone (LDN). Eighty patients were enrolled in the trial, and treatment was administered nightly for eight weeks. Of primary interest was a difference in mean score of the multiple sclerosis quality of life inventory (MSQLI54) between LDN-treated and placebo-treated patients.
According to results published in 2010 in the journal Annals of Neurology, at the end of the trial, sixty patients had completed treatment. Ten patients withdrew before the end of the first trial period, but none withdrew due to a multiple sclerosis-LDN adverse event. In fact, one patient withdrew early due to a perceived benefit of treatment. Results from the other ten patients were not available due to database management errors and incomplete quality of life surveys.
Although the diminished number of patients reduced the trial’s statistical power, a significant improvement in mental health quality of life was identified. There was a 3.3-point improvement on the Mental Component Summary score of the Short Form-36 General Health Survey, a 6-point improvement on the Mental Health Inventory, a 1.6-point improvement on the Pain Effects Scale, and a 2.4-point improvement on the Perceived Deficits Questionnaire.
Low-dose naltrexone is thought to affect immune function by increasing the level of endorphins in the body up to 100-300%. In addition, LDN may reduce microglial activity in the brain and reduce the amount of inflammation in the central nervous system. It is inexpensive and is given as a capsule once a day at bedtime. Virtually no serious side effects are associated with LDN–only a common complaint of disrupted sleep that rarely persists past one week of treatment. Yet before LDN can be indicated for use in multiple sclerosis patients, more studies must be conducted to evaluate its continued safety and efficacy.
LDN continues to make headlines in biotech and healthcare, not only for multiple sclerosis, but also for other diseases. Recently, IBD News Today reported on how low dose naltrexone may alleviate Crohn’s Disease symptoms, while biopharmaceutical company TNI BioTech Inc. recently announced its first shipment of Lodonal, an LDN immunotherapeutic, to The Republic of Panama and The Republic of Malawi for the treatment of cancers.