Fw: Important new article in ls of Neurology ###

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Fwiw: Important new article in ls of Neurology ###

http://www3.interscience.wiley.com/journal/123289912/abstract

ls of Neurology

Volume 9999 Issue 999A, Page NA

Published Online: 19 Feb 2010

Copyright © 2009 American Neurological Association

Research Article

Pilot trial of low dose naltrexone and quality of life in MS

Bruce A.C. Cree *, Elena Kornyeyeva, S. Goodin

Multiple Sclerosis Center at Univ. of Calif. in San Francisco

350 Parnassus Ave., Suite 908, San Francisco, CA 94117

email: Bruce A.C. Cree (bruce.cree@...)

*Correspondence to Bruce A.C. Cree, Multiple Sclerosis Center at UCSF, 350 Parnassus Ave., Suite 908, San Francisco, CA 94117

Abstract

Objective:

To evaluate the efficacy of 4.5 mg nightly naltrexone on the quality of life of multiple sclerosis patients.

Methods:

This single center, double-masked, placebo-controlled, crossover studied evaluated the efficacy of eight weeks of treatment with 4.5 mg nightly naltrexone (Low dose naltrexone or LDN) on self reported quality of life of MS patients.

Results:

80 subjects with clinically definite multiple sclerosis were enrolled and 60 subjects completed the trial. 10 withdrew before completing the first trial period: 8 for personal reasons, 1 for a non-MS related adverse event and 1 for perceived benefit. Database management errors occurred in 4 other subjects and quality of life surveys were incomplete in 6 subjects for unknown reasons. The high rate of subject dropout and data management errors substantially reduced the trial's statistical power. LDN was well tolerated and serious adverse events did not occur. LDN was associated with significant improvement on the following mental health quality of life measures: a 3.3 point improvement on the Mental Component Summary score of the SF-36 (P=.04), a 6 point improvement on the Mental Health Inventory (P<.01), a 1.6 point improvement on the Pain Effects Scale (P=.04) and a 2.4 point improvement on the Perceived Deficits Questionnaire (P=.05).

Interpretation:

LDN significantly improved mental health quality of life indices. Further studies with LDN in MS are warranted.

Ann Neurol 2010.

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Received: 2 July 2009; Revised: 8 January 2010; Accepted: 10 February 2010