מתוך medicontext.co.il
NEW YORK (Reuters Health) – Despite approval by the US Food and Drug Administration, naltrexone does not seem to be effective in treating men with chronic, severe alcohol dependence, according to a report appearing in the December 13th issue of The New England Journal of Medicine.
The journal released the findings early after premature media coverage.
Dr. John H. Krystal, from Yale University in New Haven, Connecticut, and colleagues assessed the outcomes of 627 men with chronic, severe alcohol dependence who were randomized to receive naltrexone, placebo, or naltrexone followed by placebo for 12 months. All of the men were offered counseling and were encouraged to attend Alcoholics Anonymous meetings.
Analysis at 13 weeks revealed that naltrexone-treated patients did not have a longer relapse-free interval than patients who received placebo. At 52 weeks, the groups did not differ in terms of the percentage of days on which drinking occurred or the numbers of drinks per day.
The findings indicate that naltrexone combined with psychosocial therapy is not an effective treatment for alcohol dependence, the authors state. However, it is possible that naltrexone in combination with other medications or psychosocial interventions may be useful in the treatment of alcoholism.
In an accompanying editorial, Dr. Richard K. Fuller and Dr. Enoch Gordis, from the National Institute on Alcohol Abuse and Alcoholism in Bethesda, Maryland, comment that "if additional studies find that naltrexone works, it will be important to identify which patients are likely to benefit and which are not."
The two physicians note that "if no benefit is found, such results coupled with the results of [the current study] would weigh against the use of naltrexone as an adjunctive treatment for alcoholism."
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