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Pilot trial of Low Dose Naltrexone and quality of life in MS

Title
Pilot trial of Low Dose Naltrexone and quality of life in MS
Publication Type
Journal Article
Research Type
Human
Reported as
Clinical Trial
Date
February 01, 2010
Authors
Bruce A.C. Cree, Elena Kornyeyeva, Douglas S. Goodin
Institution
University of California San Francisco
Link
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.