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Experience Project.
Posted: Mon May 12, 2008 10:50 am Post subject: Ameircan Academy of Neurology Meeting
Two groups reported on the use of low dose naltrexone (LDN). Naltrexone is an opioid antagonist that has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of addictions to opioids and alcohol. At significantly lower doses, it has been prescribed as a treatment for a variety of diseases. Dr. Gianvito Martino (San Raffaele Hospital, Milan, Italy) and colleagues administered 5 mg of LDN to 40 people with primary-progressive MS for 6 months, evaluating its safety and effects on spasticity, pain and fatigue. Five patients dropped out. Significant improvements were shown in fatigue and depression. Transient increases in liver enzymes, urinary tract infections, mild agitation and sleep disturbance were the most common adverse events. (Abstract #P01.149, funded by the Italian Federation of Multiple Sclerosis)
Dr. Bruce Cree (University of California, San Francisco) and colleagues reported that eight weeks of treatment with LDN significantly improved quality of life (specifically, mental health, pain, and self-reported cognitive function) in 60 people with MS as measured by the MS Quality of Life Inventory. No impact was observed on physical quality of life (such as fatigue, bowel and bladder control, sexual satisfaction, and visual function). Vivid dreaming was reported during the first week of treatment by some patients, but no other adverse effects were reported. (Abstract #P02.151) Patient advocates with MS have funded Dr. Cree to conduct a larger, controlled study that will involve 80 people with MS.
Here's an abstract about the Italian study paulmur posted on, but this one is from the just completed European Neurological Society meeting.
A pilot trial of low-dose naltrexone in primary progressive multiple sclerosis
M. Gironi, F. Martinelli Boneschi, P. Sacerdote, C. Solaro, R. Cavarretta, L. Moiola, M. Zaffaroni, V. Pilato, M. Cursi, M. Radaelli, S. Bucello, V. Martinelli, R. Nemni, G. Comi, G. Martino on behalf of the Italian Federation of Multiple Sclerosis
Introduction: Naltrexone is an orally semi synthetic opiate antagonist licensed, in a 50 mg dose, for the treatment of alcohol and heroin addiction, while at lower doses it is supposed to exert an agonistic activity triggering a prolonged up regulation of beta-endorphins (BE), an endogenous opioid with immunomodulatory functions. A symptomatic effect on spasticity, pain and fatigue of low dose naltrexone (LDN) in Multiple Sclerosis (MS) has been reported in anecdotic observations.
Methods: A six-month pilot multicentre open-label trial with LDN (5 mg/die) has been carried out in 40 patients (pts) affected by primary progressive (PP)MS. Safety and efficacy of LDN on spasticity, pain, fatigue and depression were the major outcome measures of the study. Clinical and biochemical evaluations were serially performed at follow-up visits. BE levels in peripheral blood mononuclear cells (PBMC), as well as allelic variants of the gene coding for the mu opioid receptors (OPRM1) and its mRNA levels were also measured. Validated scales of measures (Ashworth, Visual Analogue Scale, Beck, Fatigue Severity Scale and SF36) were used for testing spasticity, pain, depression, fatigue and quality of life.
Results: Five drop-outs and two unrelated serious adverse events occurred during the study. Transitory haematological abnormalities (increase of liver enzymes), urinary tract infections, mild agitation and sleep disturbance were the commonest adverse events. The PBMC BE levels increased in all patients since the 3rd month of therapy and were still raised 1 month after the end of therapy discontinuation at a statistically significant levels. No change was found for mRNA levels of OPRM1and no correlation between allelic variants and clinical responsiveness. According to pre-defined criteria of responsiveness for spasticity, fatigue, pain or depression, more than half of patients reported an improvement in at least one of these secondary outcomes. As regards quality of life, there was a general trend of improvement between final and baseline evaluation. Only 3 patients experienced EDSS clinical progression of the disease during the study.
Conclusion: Our findings support a safe profile for LDN in PPMS, further studies should be considered in order to explore the potential efficacy of the drug in MS patients.
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