idw – Informationsdienst Wissenschaft
Nachrichten, Termine, Experten
Nachrichten, Termine, Experten
The US Food and Drug Administration (FDA) will in future recognize a relevant reduction in the amount of alcohol consumed by alcohol-dependent people as a treatment goal in approval studies for new therapeutic approaches. Large-scale epidemiological and clinical studies have demonstrated the positive efficacy of reduced alcohol consumption. The scientific data on alcohol consumption reduction was evaluated over more than five years and confirmed by the FDA following an independent re-analysis. Experts hope that this will provide new incentives for therapy studies for the treatment of alcohol addiction.
For many people, alcohol dependence is a chronic, recurring illness. It is extremely difficult to remain abstinent in the long term. Low chances of success in achieving abstinence are one of the main reasons why only around 10 percent of those affected start treatment. At the end of a large US study, for example, the success rate measured in terms of abstinence was around 35 percent, but measured in terms of a defined reduction in the amount drunk was 75 percent. This result was confirmed in further studies. The significantly higher chance of success is important when it comes to deciding on treatment, or also to generate hope among relatives.
Drinking reduction as a paradigm shift
More than fifty years ago, methadone substitution was introduced for heroin addicts. This medical prescription of an addictive substance to reduce health and social damage was an enormously successful paradigm shift in the treatment of addicted patients. For alcohol addicts, however, the requirement of abstinence as the only therapeutic goal has so far stood in the way of a harm-minimizing approach. The FDA's decision is therefore of fundamental importance. It considerably expands the therapeutic options and places a reduction in the amount drunk as an equivalent therapeutic goal alongside abstinence. This takes up earlier approaches of the European Medicines Agency (EMA). A reduction in the amount drunk had already been recognized there, but only as an intermediate (secondary) therapeutic goal.
New active ingredients and more differentiated therapy
The FDA's decision is based on the re-analysis of comprehensive study data compiled by a working group of US experts. Contrary to widespread belief, a significant reduction in the amount drunk is also possible for addicts over several years. Prof. Dr. Karl Mann, Emeritus Chair of Addiction Research at the Central Institute of Mental Health, is a member of the working group. He sees the new development as a great opportunity: "Recognition by the FDA will lead to a significant lowering of the threshold for starting treatment. More people worldwide will find their way into treatment. The entire range of proven socio-, psycho- and pharmacotherapies will be better utilized.
In addition, the improved chances of success should encourage the pharmaceutical industry to conduct new studies, for example to support the reduction of drinking quantities with medication." Mann also emphasizes the concrete benefits of the approach for those affected, their personal environment and society: "The study data show that those affected with reduced consumption report clinically significant improvements in their well-being and performance. The risk of addiction and healthcare costs decrease, while mental health and quality of life improve. As a recognized therapeutic goal alongside abstinence, the drinking reduction approach enables a more differentiated and individualized therapy."
Who is an alcohol addict?
Alcohol dependence is present if at least three of six defined criteria are met: 1. a strong desire to consume alcohol, 2. difficulty in controlling intake (in terms of start, end and quantity), 3. a physical withdrawal syndrome when reducing or stopping, 4. a development of tolerance to the effects, 5. a progressive neglect of other interests in favor of alcohol intake and 6. continued use of alcohol despite evidence of clear harmful consequences, such as liver damage due to excessive drinking. According to the study, around two million people in Germany are addicted to alcohol. Currently, 70 percent of them are men, although women have been catching up considerably in recent years. A further two million or so people do not meet the criteria for addiction, but consume alcohol to an extent that is clearly harmful to their health. Around 70,000 people die every year from the effects of addiction.
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About CIMH
The Central Institute of Mental Health (CIMH) stands for internationally outstanding research and pioneering treatment concepts in psychiatry and psychotherapy, child and adolescent psychiatry, psychosomatics and addiction medicine. The CIMH clinics provide psychiatric care for the population of Mannheim. At the CIMH, mentally ill people of all ages can rely on the most advanced treatments based on international standards of knowledge. Educating people about mental illness, creating understanding for those affected and strengthening prevention is another important part of our work. In psychiatric research, the CIMH is one of the leading institutions in Europe. Since 2021, it has been a site of the German Centre for Mental Health. The CIMH is institutionally linked to the University of Heidelberg through jointly appointed professors from the Mannheim Medical Faculty. The CIMH is a member of the Health + Life Science Alliance Heidelberg Mannheim.
https://force-dsc.my.site.com/ddt/s/ddt-project?ddtprojectid=33 To the documentation of the FDA
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