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Pharmacotherapy for Adults With Alcohol-Use Disorders in Outpatient Settings

Comparative Effectiveness Reviews, No. 134

Investigators: Daniel E Jonas, MD, MPH, Halle R Amick, MSPH, Cynthia Feltner, MD, MPH, Georgiy Bobashev, PhD, Kathleen Thomas, PhD, Roberta Wines, MPH, Mimi M Kim, PhD, Ellen Shanahan, MA, C Elizabeth Gass, MPH, Cassandra J Rowe, BA, and James C Garbutt, MD.

RTI International–University of North Carolina Evidence-based Practice Center
Rockville (MD): Agency for Healthcare Research and Quality (US); 2014 May.
Report No.: 14-EHC029-EF
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Structured Abstract

Objectives:

To conduct a systematic review and meta-analysis of the efficacy, comparative effectiveness, and harms of medications (both FDA approved and others) for adults with alcohol-use disorders, and to evaluate the evidence from primary care settings.

Data sources:

PubMed®, Cochrane Library, PsycINFO®, CINAHL®, Embase®, U.S. Food and Drug Administration Web site, ClinicalTrials.gov, and World Health Organization International Clinical Trials Registry Platform (January 1, 1970, to October 11, 2013).

Review methods:

Two investigators independently selected, extracted data from, and rated risk of bias of studies. We conducted meta-analyses using random-effects models. We graded strength of evidence (SOE) based on established guidance.

Results:

We included 135 studies. Most patients met criteria for alcohol dependence; mean ages were in the 40s. Studies typically included psychosocial cointerventions; effect sizes reflect the added benefits of medications.For acamprosate and oral naltrexone (50 mg per day), numbers needed to treat (NNTs) to prevent 1 person from returning to any drinking were 12 and 20, respectively (moderate SOE); NNT to prevent 1 person from returning to heavy drinking was 12 for oral naltrexone (50 mg per day) (moderate SOE). Our meta-analyses of four head-to-head trials found no statistically significant difference between the two medications for consumption outcomes (moderate SOE). For injectable naltrexone, meta-analyses found no significant benefit for return to any or heavy drinking, but found a reduction in heavy drinking days (low SOE). Evidence from well-controlled trials does not support efficacy of disulfiram, except possibly for patients with excellent adherence. Among medications used off label, moderate evidence supports the efficacy of nalmefene and topiramate for improving some consumption outcomes, and limited evidence supports the efficacy of valproic acid. Evidence from primary care settings was scant. We found insufficient direct evidence to conclude whether medications for alcohol-use disorders are effective for improving health outcomes.

Compared with placebo, patients treated with acamprosate had a higher risk of anxiety, diarrhea, and vomiting; those treated with naltrexone had a higher risk of dizziness, nausea, and vomiting. In head-to-head studies, the risks of headache and vomiting were slightly higher for naltrexone than for acamprosate. Individual trials of topiramate reported a significantly increased risk of paresthesias, anorexia, difficulty concentrating, dizziness, psychomotor slowing, and other adverse effects.

Our meta-analyses for variation in naltrexone response related to OPRM1 polymorphisms found no statistically significant difference between A-allele homozygotes and those with at least one G allele, but confidence intervals were wide and additional studies are needed.

Conclusions:

Acamprosate and oral naltrexone have the best evidence for improving alcohol consumption outcomes for patients with alcohol-use disorders. Head-to-head trials have not consistently established the superiority of one medication. Thus, other factors may guide medication choices, such as frequency of administration, potential adverse events, coexisting symptoms, and availability of treatments.

Contents

Prepared for: Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services1, Contract No. 290-2012-00008-I. Prepared by: RTI International–University of North Carolina Evidence-based Practice Center, Research Triangle Park, NC

Suggested citation:

Jonas DE, Amick HR, Feltner C, Bobashev G, Thomas K, Wines R, Kim MM, Shanahan E, Gass CE, Rowe CJ, Garbutt JC. Pharmacotherapy for Adults With Alcohol-Use Disorders in Outpatient Settings. Comparative Effectiveness Review No. 134. (Prepared by the RTI International–University of North Carolina Evidence-based Practice Center under Contract No. 290-2012-00008-I.) AHRQ Publication No. 14-EHC029-EF. Rockville, MD: Agency for Healthcare Research and Quality; May 2014. www.effectivehealthcare.ahrq.gov/reports/final.cfm.

This report is based on research conducted by the RTI International–University of North Carolina Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-2012-00008-I). The findings and conclusions in this document are those of the authors, who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ. Therefore, no statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services.

The information in this report is intended to help health care decisionmakers—patients and clinicians, health system leaders, and policymakers, among others—make well informed decisions and thereby improve the quality of health care services. This report is not intended to be a substitute for the application of clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information, i.e., in the context of available resources and circumstances presented by individual patients.

This report may be used, in whole or in part, as the basis for development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products may not be stated or implied.

This report may periodically be assessed for the urgency to update. If an assessment is done, the resulting surveillance report describing the methodology and findings will be found on the Effective Health Care Program Web site at: www.effectivehealthcare.ahrq.gov. Search on the title of the report.

None of the investigators have any affiliations or financial involvement that conflicts with the material presented in this report.

1

540 Gaither Road, Rockville, MD 20850; www​.ahrq.gov

AHRQ (US Agency for Healthcare Research and Quality)

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