Yes, We Can Treat Alcoholism Effectively
Abstract & Commentary
By Joseph E. Scherger, MD, MPH, Clinical Professor, University of California, San Diego. Dr. Scherger reports no financial relationships to this field of study.
Synopsis: The medical management of alcohol dependence is highly effective if done intensively. In a large randomized controlled trial, best outcomes occurred with frequent contact with a primary care provider, naltrexone, with or without a combined behavioral intervention. A recently approved medication, acamprosate, did not provide additional benefit.
Source: Anton RF, et al. Combined pharmacotherapies and behavioral interventions for alcohol dependence: the COMBINE study: a randomized controlled trial. JAMA. 2006;295:2003-2017.
About 8 million Americans have alcohol dependence by current diagnostic criteria. Alcohol dependence is a leading preventable cause of morbidity and mortality, and is a major contributor to health care costs. Most persons with alcohol dependence are not recognized or treated by primary care physicians.
The COMBINE Study Research Group, based at the Center for Drug and Alcohol Programs, Medical University of South Carolina, conducted a multicenter randomized controlled trial of almost 1400 recently alcohol-abstinent volunteers. There were 8 treatment groups and a control group which received behavioral intervention without medical management or medications. In order to understand these findings, and be successful in practice, a description of the interventions is important.
All the patients met the diagnostic criteria for primary alcohol dependence and the average age was 44. At randomization all patients were abstinent from 4 to 21 days. The treatment period was 16 weeks and the patients were followed for one year after treatment. Four of the treatment groups received medical management and medication (naltrexone, acamprosate or both) or placebo, but no combined behavioral intervention (CBI). Four of the treatment groups received medical management, CBI, and medication or placebo. The control group received CBI alone.
Medical management consisted of 9 primary care visits over the 16-week period. The initial visit was 45 minutes and covered the diagnosis of alcohol dependence, the negative consequences of drinking, a recommendation for abstinence, education about medications and a medication adherence plan in collaboration with the patient. Attendance at support groups such as Alcoholics Anonymous (AA) was encouraged. The 8 subsequent visits (2 weeks apart) averaged 20 minutes and covered a review of the patient's drinking behavior, overall functioning, medication adherence and adverse effects. Patients who resumed drinking were given advice and encouraged to attend support groups.
Combined behavioral intervention was delivered by licensed behavioral specialists with expertise in alcoholism treatment. Up to twenty 50-minute sessions were available covering cognitive behavioral therapy, 12-step facilitation, motivational interviewing, and support system involvement. Flexibility was permitted in the number of sessions and selection of modules based on the patient's needs and interest. A motivational interviewing style was used throughout.
Patients had to return for their biweekly primary care visits to receive medication. All naltrexone, acamprosate, and placebo pills were identical in appearance, and all groups took the same number of pills each day. Naltrexone was given as 25 mg days 1 to 4, 50 mg days 5 to 7, and 100 mg days 8 to 112. Acamprosate was given as two 500 mg tablets 3 times per day. These higher than usual doses were chosen based on evidence that they were more effective and provided better coverage for missed doses. Both medications were well tolerated.
Before treatment, the patients averaged 1 in 4 days of abstinence (25%). All 9 groups averaged two thirds or 67% or more abstinent days. The best results were seen with medical management plus naltrexone (80% abstinent days), medical management plus CBI (79%) and medical management, CBI and naltrexone (77%). The control group receiving CBI alone had 67% abstinent days. Acamprosate offered no additional benefit during this trial. The treatment differences persisted over the 1-year follow-up period.
Commentary
The efficacy of this medical management trial in treating alcohol dependence is impressive. The use of a primary care setting should motivate internists and other primary care physicians to treat more of these patients. Similar to other conditions requiring behavioral and lifestyle change (smoking and obesity), a multimodal intervention is required with intensive follow-up. While such a treatment approach is expensive, and reimbursement is always challenging for a condition such as alcohol dependence, this primary care approach is much less expensive than inpatient or residential treatment programs.
This study was funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA). The lead investigators have received funding by the pharmaceutical manufacturers of the medications. There were some surprises in the findings. The lack of additional benefit of acamprosate does not fit with other trials which have shown efficacy in maintenance of abstinence from alcohol.1 It may be that the intensive medical management and CBI masked the benefit of the medication that might be seen with less intensive approaches. CBI did not provide as much added benefit as might be expected, but the intensive medical management with referral to AA or other support groups was comparable and may have masked the benefit of behavioral intervention. Busier primary care physicians may need to rely more on behavioral therapists.
The big lesson here for primary care physicians is that excellent outcomes may be achieved in treating alcohol dependence using a medical model combining frequent visits and medications, especially naltrexone.
Reference
1. Mason BJ. Treatment of alcohol-dependent outpatients with acamprosate: a clinical review. J Clin Psychiatry. 2001;62 Suppl 20:42-48.
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