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Press Release Date: January 7, 1999
Two relatively new medications, naltrexone and acamprosate, show promise for the treatment of patients with alcohol dependence, according to a new report on the effectiveness of medications used to treat alcoholism, developed by the North Carolina-based Research Triangle Institute (RTI) and the University of North Carolina (UNC) at Chapel Hill on behalf of the Agency for Health Care Policy and Research (AHCPR). The medications appear to reduce the urge to drink, decrease the frequency with which a person drinks and, in some studies, improve abstinence. Naltrexone has been in use in the United States for the treatment of alcoholism only since 1994. Acamprosate is widely used in Europe and has been granted investigational drug status within this country by the Food and Drug Administration, and clinical trials are also currently underway.
The study's conclusions are based on a systematic review of the best available evidence from published research. The Pharmacotherapy for Alcohol Dependence is the third in a series of evidence reports and technology assessments sponsored by AHCPR to provide public- and private-sector organizations with comprehensive, science-based information on common, costly conditions and health care technologies. RTI-UNC is one of 12 AHCPR Evidence-based Practice Centers (EPCs) in the United States and Canada under contract to review all the relevant literature on designated topics related to prevention, diagnosis, treatment, and management of common diseases and clinical conditions. The reports will also address, where appropriate, use of alternative or complementary therapies and specific medical procedures or health care technologies.
"The release of this third evidence report represents AHCPR's continued commitment to building the much-needed evidence base for medical practice," said AHCPR Administrator, John M. Eisenberg, M.D. "We are very pleased that our partners have pledged to use this evidence report on alcohol dependence and forthcoming EPC reports to improve the quality of health care services."
Alcohol dependence or alcoholism is a chronic and progressive disorder that afflicts approximately 9.6 percent of men and 3.2 percent of women in the U.S. over their lifetimes. Alcoholism can develop starting in adolescence and continuing into older age groups. Those at highest risk are men and women between 18 to 29 years of age.
The impact of alcohol dependence is greatly underestimated. About 100,000 Americans die each year from alcohol-related diseases such as cirrhosis of the liver, esophageal or stomach cancer, and from traumatic deaths such as overdose, suicide, homicide, and traffic accidents.
Alcohol dependence also has a high financial toll. It costs the economy an estimated $166 billion annually mostly due to health effects, lost productivity, and treatment of alcohol-related diseases.
Naltrexone and acamprosate attempt to treat the primary symptoms of alcohol dependence. They diminish the frequency of drinking, enhance abstinence, and minimize relapse. "This evidence report will provide practitioners with the most up-to-date information on the efficacy of current and widely used treatments for alcohol dependence," according to Suzanne West, Ph.D., Senior Research Epidemiologist and leader of the RTI-UNC research team. "However, the evidence also indicates that these new medications will not eliminate the problem of alcohol dependence. Many individuals continued to drink even while taking the medications."
An examination and review of the available literature on medications that have been or are now used to treat alcoholism, typically in conjunction with some type of psychosocial intervention, found the following:
- Naltrexone is thought to work in the central nervous system to block the part of the brain reward pathway that is activated by alcohol. It reduces the pleasurable or emotional response to drinking, leads to lower relapse rates, and diminishes drinking frequency.
- Acamprosate decreases the number of drinking days and may increase the number of people who give up drinking altogether.
- Disulfiram, in use for nearly half a century, acts as a psychological deterrent to alcohol intake by producing unpleasant symptoms when alcohol is consumed. In most controlled studies disulfiram had minimal impact. Disulfiram administered under supervised conditions may prove beneficial, but this has not been well studied.
- Serotonergic agents such as fluoxetine and buspirone are also used in treating depression and anxiety. However, the limited evidence that exists does not prove that they benefit patients who are only alcohol dependent.
- Lithium, which is also used to treat bipolar disorders, is not useful for treating patients who have alcohol dependence without other psychiatric conditions such as depression or anxiety.
"Whether a medication works varies within the population affected," said James C. Garbutt, M.D., Associate Professor of Psychiatry at UNC-CH and scientific director for the project. "No one medication can be singled out as the best for all situations or even as being effective for all patients with alcoholism. We hope these findings will help clinicians to treat this disorder."
The report suggests that future research address the effectiveness of long-term maintenance of patients on those medications proven to work alone, the effectiveness of combinations of medications, and the optimal combinations of drug and psychosocial therapies. Because many of the individuals in the studies returned to drinking while on medication, another suggested area of research is on the development of new therapies for treating alcohol dependence that are even more beneficial than those reviewed in this evidence report.
AHCPR will partner with several key health agencies with established alcohol research and treatment networks, such as the National Institute on Alcohol Abuse and Alcoholism (NIAAA) and the Substance Abuse and Mental Health Services
Administration (SAMHSA), to disseminate the evidence report. NIAAA funded many of the alcohol studies cited in the report. SAMHSA recently published a treatment improvement protocol for clinicians on the use of naltrexone. AHCPR also plans to disseminate the report to a broad array of health care-related organizations and other interested groups in the United States and Canada.
RTI-UNC consulted on the alcohol dependence evidence report with the American Society of Addiction Medicine, which recommended the topic. The EPC reviewed studies published from 1966 through 1997 in English, French, or German; on adults 18 years or older with alcohol dependence; with sample sizes of 10 or more subjects, and with a control group for comparison. The evidence report was peer reviewed by experts involved in clinical practice or research, professional associations that specialize in alcoholism treatment, and quality-of-care organizations.
Select to access the online summary of The Pharmacotherapy for Alcohol Dependence (AHCPR 99-E003). Print copies are available from the AHCPR Publications Clearinghouse (P.O. Box 8547, Silver Spring, MD 20907 (telephone within the U.S.: 1-800-358-9295 and 703-437-2078 from outside the United States).
The full report will be posted online in late January 1999 on the National Library of Medicine's HSTAT database. Also in late January 1999, printed copies will become available from the AHCPR Publications Clearinghouse.
Forthcoming AHCPR evidence reports and technology assessments examine evaluation of abnormal cervical cytology, depression treatment with new drugs, diagnosis, treatment of attention deficit and hyperactivity disorder, treatment of acute sinusitis, testosterone suppression treatment for prostatic cancer, and other topics. Recently assigned topics include management of acute chronic obstructive pulmonary disease, management of cancer pain, criteria for weaning from mechanical ventilation, management of pre-term labor, and management of chronic hypertension during pregnancy (select to access press release).
Previous EPC evidence reports released examined sleep apnea and traumatic brain injury.
Note to Editors: For further details about the study, including the respective roles of Research Triangle Institute and the University of North Carolina at Chapel Hill, contact: Reid Maness, Communications Director, Research Triangle Institute, (919) 541-7044 (firstname.lastname@example.org).
For additional information, contact AHCPR Public Affairs: Harriett Bennett, (301) 427-1861 (HBennett@ahrq.gov); Karen Migdail, (301) 427-1855 (KMigdail@ahrq.gov).