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Cited by 73Substance Abuse Treatment and OutcomesAlcohol Consumption and Health EffectsAlcoholism and Thiamine Deficiency

Baclofen for alcohol use disorder

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Minozzi, Silvia, Saulle, Rosella, Rösner, Susanne·2018·Cochrane Database of Systematic Reviews
DOI 10.1002/14651858.cd012557.pub2PMC PMC6517285
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Abstract

BACKGROUND: Alcohol use disorder (AUD) and alcohol-related impairments belong to the most widespread psychiatric disorders leading to specific psychophysical, affective and cognitive symptoms and consequences for psychosocial well-being and health. Alcohol consumption is increasingly becoming a problem in many developing regions and AUD prevalence is estimated at 4.1% worldwide, with highest prevalence in European countries (7.5%), and the North America (6.0%). Therapeutic approaches, including pharmacotherapy, play an important role in treating patients with AUD. OBJECTIVES: To assess the efficacy and safety of baclofen for treating people with AUD, who are currently drinking, with the aim of achieving and maintaining abstinence or reducing alcohol consumption. SEARCH METHODS: We searched the Cochrane Drugs and Alcohol Specialised Register, CENTRAL, MEDLINE, Embase, two further databases and two clinical trials registries, conference proceedings, and the reference lists of retrieved articles. The date of the most recent search was 30 January 2018. SELECTION CRITERIA: Randomised controlled trials (RCTs) of at least four weeks' treatment duration and 12 weeks' overall study duration comparing baclofen for relapse prevention of AUD with placebo, no treatment or other treatments. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. MAIN RESULTS: We included 12 RCTs (1128 participants). All studies but three recruited fewer than 100 participants. Participants had a diagnosis of alcohol dependence according the Diagnostic and Statistical Manual of Mental Disorders (DSM) IV or the International Classification of Diseases (ICD)-10 criteria who were currently drinking. The mean age of participants was 48 years, and there were more men (69%), than women. All studies compared baclofen to placebo, except for one study that evaluated baclofen versus acamprosate. The included studies considered baclofen at different doses (range 10 mg a day to 150 mg a day). In all but one of the studies, participants in both the baclofen and placebo groups received psychosocial treatment or counselling of various intensity.We judged most of the studies at low risk of selection, performance, detection (subjective outcome), attrition and reporting bias.We did not find any difference between baclofen and placebo for the primary outcomes: relapse-return to any drinking (RR 0.88, 95% CI 0.74 to 1.04; 5 studies, 781 participants, moderate certainty evidence); frequency of use by percentage of days abstinent (MD 0.39, 95% CI -11.51 to 12.29; 6 studies, 465 participants, low certainty evidence) and frequency of use by percentage of heavy drinking days at the end of treatment (MD 0.25, 95% CI -1.25 to 1.76; 3 studies, 186 participants, moderate certainty evidence); number of participants with at least one adverse event (RR 1.04, 95% CI 0.99 to 1.10; 4 studies, 430 participants, high certainty evidence); the dropout rate at the end of treatment (RR 0.98, 95% CI 0.77 to 1.26, 8 studies, 977 participants, high certainty evidence) and dropout due to adverse events (RR 1.11, 95% CI 0.59 to 2.07; 7 studies, 913 participants, high certainty evidence).We found evidence that baclofen increases amount of use (drink per drinking days), (MD 1.55, 95% CI 1.32 to 1.77; 2 studies, 72 participants, low certainty evidence).Among secondary outcomes, there was no difference on craving (MD 1.38, 95% CI -1.28 to 4.03, 5 studies, 469 participants), and anxiety (SMD 0.07, 95% CI -0.14 to 0.28; 5 trials, 509 participants). We found that baclofen increased depression (SMD 0.27, 95% CI 0.05 to 0.48; 3 studies, 387 participants).Concerning the specific adverse events we found that baclofen increased: vertigo (RR 2.16, 95% CI 1.24 to 3.74; 7 studies, 858 participants), somnolence/sedation (RR 1.48, 95%CI 1.11 to 1.96; 8 studies, 946 participants), paraesthesia (RR 4.28, 95% CI 2.11 to 8.67; 4 studies, 593 participants), and muscle spasms/rigidity (RR 1.94, 95%CI 1.08 to 3.48; 3 studies, 551 participants). For all the other adverse events we did not find significant differences between baclofen and placebo.For the comparison baclofen versus acamprosate, we were only able to extract data for one outcome, craving. For this outcome, we found that baclofen increased craving compared with acamprosate (MD 14.62, 95% CI 12.72 to 16.52; 1 study, 49 participants). AUTHORS' CONCLUSIONS: None of the primary or secondary outcomes of the review showed evidence of a difference between baclofen and placebo. The high heterogeneity among primary studies results limits the interpretation of the summary estimate, the identification of moderators and mediators of baclofen's effects on alcohol use remains a challenge for further research. Even though some results from RCTs are promising, current evidence remains uncertain regarding the use of baclofen as a first-line treatment for people with AUDs.

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  • In a meta-analysis comparing baclofen to placebo and acamprosate on relapse rates, frequency of alcohol use, and frequency of heavy drinking days, there were no significant differences between baclofen and placebo, and adverse events and dropout did not differ significantly.

    “In a meta-analysis comparing the effectiveness of baclofen to placebo and acamprosate on relapse rates, frequency of alcohol use, and frequency of heavy drinking days, there were no significant differences between baclofen and placebo. Similarly, the number of participants experiencing at least one adverse event, the dropout rate and dropout due to adverse events did not differ significantly.”

    From A Narrative Review of Current and Emerging Trends in the Treatment of Alcohol Use Disorder (2024) · cites this paper as [57]

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  • The use of baclofen as a first-line treatment for AUDs remains uncertain due to lack of conclusive evidence and heterogeneity among studies.

    “Overall, the review suggests that the use of baclofen as a first-line treatment for AUDs remains uncertain due to the lack of conclusive evidence and heterogeneity among studies [57].”

    From A Narrative Review of Current and Emerging Trends in the Treatment of Alcohol Use Disorder (2024) · cites this paper as [57]

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  1. [1]1. Cochrane Library Trusted evidence. Informed decisions. Better health. Cochrane Database of Systematic Reviews summary of findings tables. Journal of Clinical Epidemiology 2011;64:383-94.
  2. [23]23. Lefebvre C, Manheimer E, Glanville J. Chapter 6: Searching for studies. In: Higgins JP, Green S, editor(s). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011). The Cochrane Collaboration, 2011. Available from handbook.cochrane.org.

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Authors
Minozzi, S., Saulle, R., & Rösner, S.
Affiliations
  • Lazio Regional Health Service; Department of Epidemiology; Via Cristoforo Colombo, 112 Rome Italy 00154
  • Forel Klinik (CH)
ORCID
Venue
Cochrane Database of Systematic Reviews
Publisher
Wiley
Published
2018-11-26
Volume
2018
Issue
11
Pages
CD012557-CD012557
ISSN
  • 1361-6137 (ISSN-L)
  • 1465-1858
DOI
10.1002/14651858.cd012557.pub2
PMC
PMC6517285
OpenAlex
W2588747705
Semantic Scholar
27b1339cc08b7792a89eef2a3e7fc25982f514e0
Cited by
73
References
104
Citations by year
2025: 2 · 2024: 8 · 2023: 14 · 2022: 11 · 2021: 13 · 2020: 12 · 2019: 12 · 2018: 1
FWCI
1.36
Type
journal article
Language
en
Update notices
new_version (2023-01-13)
Open access
Locations
  • Cochrane Database of Systematic Reviews (publishedVersion)
  • Europe PMC (PubMed Central) (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Epidemiology › Substance Abuse Treatment and Outcomes
  • Health Sciences › Medicine › Pathology and Forensic Medicine › Alcohol Consumption and Health Effects
  • Health Sciences › Medicine › Neurology › Alcoholism and Thiamine Deficiency
Keywords
baclofen, alcoholism, relapse prevention, alcohol abstinence, acamprosate, pharmacotherapy, treatment efficacy and safety, psychosocial interventions, alcohol consumption reduction, placebo comparison, dose comparison, adverse events, tolerability, alcohol-related cancer, alcohol-related accidents
MeSH terms
Acamprosate, Alcohol Deterrents, Alcohol Drinking, Alcoholism, Baclofen, Depression, Female, Humans, Male, Middle Aged, Patient Dropouts, Recurrence, Randomized Controlled Trials as Topic, GABA-B Receptor Agonists, Craving

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