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Pharmacological therapies for alcohol use disorder reduce hepatic decompensation & mortality in alcohol-related liver disease: A GRADE evaluation through a meta-analysis
*For correspondence: Dr Mohit Varshney, Department of Psychiatry, Institute of Liver and Biliary Sciences, New Delhi 110 070, India e-mail: mohitvarshney.aiims@gmail.com
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Received: ,
Accepted: ,
Abstract
Background & objectives
The role of behavioural therapies for alcohol use disorder (AUD) has been reported in patients with alcohol-related liver disease (ALD); however, that of pharmacological treatments is yet to be established. We conducted a systematic review and meta-analysis to study the use of these pharmacological interventions in ALD for liver-related and patient-important outcomes, including abstinence.
Methods
We conducted a systematic search of four major databases. Title and abstract screening, full-text review, risk of bias assessment, and data extraction were performed independently by two reviewers. Random-effects meta-analysis was used to calculate pooled effect estimates with 95 per cent confidence intervals (CI). The certainty of the evidence was assessed using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) tool and categorised as high, moderate, low, or very low.
Results
Altogether, eleven studies (1 RCT and 10 cohort studies) were included in the systematic review and eight studies in the meta-analyses. Meta-analysis of two cohort studies (44813 participants) showed significantly lower odds of all-cause mortality with the use of AUD pharmacotherapy with acceptable statistical heterogeneity [Odds Ratio (OR) 0.86; 95% CI 0.79–0.93; I2 = 0%]. Meta-analysis of one RCT and three cohort studies (303 participants) for the outcome of abstinence revealed a pooled proportion of 47.5 per cent (95% CI, 42.1–52.9; I2 = 11.7%). The certainty in estimates was very low.
Interpretation & conclusions
The present systematic review and meta-analysis suggest that pharmacological therapies in ALD may reduce overall mortality and the incidence of hepatic decompensation. However, given the very low certainty of evidence, these findings should be interpreted with caution and underscore the need for well-designed trials.
Keywords
Alcohol-related liver disease
patient-important outcomes
pharmacological therapies
Globally, more than half of all cirrhosis-related deaths are attributed to alcohol consumption1. Alcohol-associated liver disease (ALD) is the leading cause of liver-related mortality and the most common reason for liver transplantation. In 2017, alcohol-associated cirrhosis was responsible for nearly 25 per cent of the 1.32 million global deaths due to cirrhosis2.
The 10-yr survival rate for individuals with ALD is 88 per cent among those who maintain abstinence, compared to 73 per cent among those who relapse into alcohol use3. Notably, alcohol cessation remains theonly effective treatment for alcohol-related cirrhosis4. Delivering high-quality care for ALD includes appropriate management of alcohol use disorder (AUD), which is a key quality indicator for optimal treatment5–6.
Disulfiram, acamprosate, and naltrexone are three medications approved by the US Food and Drug Administration (FDA) for the treatment of alcohol use disorder (AUD). These agents have been associated with increased abstinence rates, reduced binge drinking, and lower rates of AUD-related hospitalizations7. Additionally, in patients with AUD, gabapentin and topiramate have been linked to fewer days of heavy drinking, while baclofen has shown potential as a safe option for supporting abstinence8. Addressing AUD through pharmacologic therapies in patients with ALD may help reduce long-term adverse outcomes. However, evidence regarding the effectiveness of these therapies specifically in the ALD population remains limited. Although the management of AUD in ALD consists of multi-faceted approaches, it is important to establish the independent role of pharmacotherapy for AUD, in combination with behavioural therapy, to precisely delineate its role in ALD, and to attribute the effect on outcomes correctly toindividual interventions. The role of behavioural treatments in this regard has been reported9, but that of pharmacological therapies is yet to be established. A systematic summary of the evidence on the use of pharmacological treatments for AUD in ALD is needed to guide the formulation of guidelines and recommendations. Therefore, we conducted a systematic review and meta-analysis to study the use of these pharmacological interventions in ALD for patient-important outcomes such as abstinence and liver-related patient-important outcomes. Further, to study the efficacy and safety of pharmacological therapies for AUD in alcohol related liver disease.
Materials & Methods
The study was conducted at Centre for Community Medicine, All India Institute of Medical Sciences, New Delhi and department of Psychiatry, Institute of Liver and Biliary Sciences, New Delhi.
Methods and study period
This review adhered to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and the Meta-analysis of Observational Studies in Epidemiology (MOOSE) guidelines10,11. The protocol for this systematic review was registered on PROSPERO (registration no. CRD42021279482). The study was conducted between December 2023 to May 2024.
Inclusion criteria
We included adult patients with alcohol-related liver disease (ALD) at any stage, including alcoholic fatty liver, alcoholic steatohepatitis, liver fibrosis, cirrhosis, or alcoholic hepatitis. The interventions of interest were any of the following pharmacological agents: naltrexone, baclofen, acamprosate, gabapentin, or topiramate. The comparator was management without the use of these drugs. Outcomes for efficacy included recovery in liver disease, mortality, abstinence, drinking days, craving, heavy drinking, hepatic decompensation, and clinical recovery. Outcomes for safety included liver-related adverse events. We included randomised controlled trials, cohort studies, and case series.
Data sources and searches
First stage: We searched for systematic reviews of randomised controlled trials. Wesearched the following databases: Medline, Embase, Cochrane Database of Systematic Reviews and Epistomonikos. In cases where datawere duplicated or reported across multiple studies, the most recent or the most comprehensive publication was included in the analysis. The reference lists of retrieved articles and relevant reviews were screened to identify other potentially eligible studies. We did not impose any language restrictions.
We had initially planned to search the TRIP database. However, during the conduct of the review, we substituted this with the Epistemonikos database to enhance the yield from grey literature and non-indexed studies. The search strategy implemented in CENTRAL and MEDLINE is provided in supplementary material 1.
Selection of studies
Two reviewers (MP, MV) independently screened titles and abstracts. Full-text articles were retrieved for studies deemed potentially eligible by either reviewer, and final eligibility was determined through full-text review. Data extraction and risk of bias assessment were also conducted independently by both reviewers. Any disagreements at any stage were resolved through discussion. In case of conflicts, a third reviewer was referred to, and the decision of the third reviewer was considered binding.
Data extraction
From each included study, we extracted information on the first author’s last name, year of publication, study design, setting, and inclusion criteria, sample size, participant characteristics, baseline disease severity, therapeutic dose, duration, and timing of intervention, as well as reported outcomes.
Risk of Bias assessment
Risk of bias was assessed using the Cochrane Risk of Bias tool for RCTs and the Newcastle Ottawa Scale for Cohort studies12,13.
Data synthesis and statistical analysis
We conducted meta-analyses using a random-effects model and calculated pooled odds ratios with 95 per cent confidence intervals employing the Generic Inverse Variance method. Wherever available, adjusted effect estimates were used for data synthesis. We assessed heterogeneity using visual inspection of forest plot and the I2 statistic. We carried out statistical analyses using softwares Review Manager 5.3 and OpenMeta Analyst.
GRADE (Grading of Recommendations Assessment, Development and Evaluation)
We applied the GRADE approach to assess the certainty of evidence for each outcome, categorising it as high, moderate, low, or very low. The assessment considered domains including risk of bias, imprecision, inconsistency, indirectness, and publication bias, following detailed GRADE guidance. Findings were summarised in evidence profile14.
Results
Study selection
The electronic database search yielded 546 records. After removing duplicates, 524 unique titles and abstracts were screened. Of these, 508 were excluded based on title and abstract review, and 16 full-text articles were assessed for eligibility. Of these, four were excluded - two had duplicate data, two had an inappropriate population. The list of excluded studies is reported in supplementary material 2. Eleven studies were included in the systematic review, and eight in the meta-analyses (Fig. 1)15–24.
- PRISMA flow diagram for study selection.
Study characteristics and estimates reported
The mean age of the cohort ranged from 16 to 58 yr. Disease severity at baseline was recorded in all studies. The therapies used were Naltrexone (three studies), Baclofen (seven studies), Acamprosate (four studies), Gabapentin (two studies), and Topiramate (two studies). The outcomes assessed were abstinence, hepatic decompensation, hepatic side effects, mortality, hospital visits, and discontinuation rate (Supplementary Table I).
Risk of bias assessment
The risk of bias assessments for reported outcomes from one RCT and ten observational studies are summarised in supplementary tables II and III. For the RCT23, the method of randomisation, allocation concealment, blinding and incomplete outcome data were assessed to have low risk of bias. For cohort studies15–22,the high risk of bias for all outcomes was observed for co-interventions being similar and for assessment of prognostic factors, where four studies were assessed as having a high risk of bias. (Supplementary Tables II and III).
Pooled odds ratios for the effect of AUD therapy on outcomes
Meta-analysis of two cohort studies (44813 participants) showed significantly lower odds of all-cause mortality with the use of AUD pharmacotherapy with OR 0.86; 95% CI 0.79–0.93; I2= 0% (Fig. 2).
- Meta-analysis for the effect of AUD therapy on all-cause mortality in ALD patients.
A meta-analysis of three cohort studies (94,887 participants) revealed significantly lower odds of hepatic decompensation over 6–12 months with the use of AUD pharmacotherapy, accompanied by high statistical heterogeneity (OR 0.61; 95% CI 0.41–0.89; I2 = 92% Fig. 3).
- Meta-analysis for the effect of AUD therapy on hepatic decompensation in ALD patients.
Meta-analysis of one RCT and three cohort studies (303 participants) for the outcome of abstinence revealed a pooled proportion of 47.5 per cent (95% CI 42.1 – 52.9; I2=11.7% Fig. 4). The limited number of studies precluded assessment of publication bias and exploration of heterogeneity by subgroup analysis.
- Meta-analysis for the pooled proportion of patients that achieved alcohol abstinence with AUD therapy.
GRADE
The overall certainty in estimates was very low for both outcomes: all-cause mortality and hepatic decompensation. The evidence from observational studies was rated down for inconsistency for the outcome ‘hepatic decompensation’, while noting that the higher I-squared value was due to differences in magnitude from large studies, rather than direction of effect. The evidence for the outcome ‘all-cause mortality’ was rated down for risk of bias due to high risk of bias from one study23 (Table).
| Certainty assessment | Summary of findings | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Participants (studies) follow up | Risk of bias | Inconsistency | Indirectness | Imprecision | Publicationbias | Overall certainty of evidence | Control event rate (%) | Relative effect(95% CI) | Anticipated absolute effects | ||
| With no AUD drugs | Risk with no AUD drugs | Risk difference with AUD drugs | |||||||||
| Hepatic decompensation | |||||||||||
| 94.887 (3 Not observa- serious tional studies) | Not serious | serious* | Not serious | Not serious | None | ⊕○○○Very low | 3267/28282 (11.6) | OR 0.61 (0.41 to 0.89) | 116 per 1,000 | 42 fewer per 1,000 (from 65 fewer to 11 fewer) | |
| All-cause mortality | |||||||||||
| 44813 (2 observational studies) | Serious | Not serious | Not serious | Not serious | None | ⊕○○○Very low | 435/886 (50.2) | OR 0.86 (0.79 to 0.93) | 38 fewer per 1,000 (from 59 fewer to 18 fewer) | ||
Cl, confidence interval: OR. odds ratio. *I2=84%, but all estimates from these studies pointed in the same direction. Source: Ref 31
Discussion
The present systematic review and meta-analysis suggests that pharmacological therapies in ALD may reduce mortality and the incidence of hepatic decompensation and may help in achieving a high level of abstinence; thereby improving liver disease outcomes in the short and long term. The evidence comes from mostly cohort studies, and overall, very few studies have adequately addressed the effect of AUD therapies on long term patient-important outcomes. Meta-analysis of three cohort studies revealed a statistically significant and precise reduction by about 40 per cent in risk of hepatic decompensation in ALD over 6 to 12 months.
The present study suggests disengagement from a ‘liver-centric’ management of ALD to one that incorporates a multidisciplinary approach. Pharmacotherapy for AUD in these patients remains underutilised, and as highlighted here, deserves more attention in both clinical practice and research. Various reasons mentioned in the literature have been a lack of referral for AUD management, unwillingness of patients due to a lack of understanding, lack of infrastructure for AUD treatment in liver hospitals; lack of insurance coverage for AUD treatment; and apprehension of treating doctors regarding side effects of pharmacotherapy25.It may also be worth investigating further the barriers to effective pharmacotherapy for AUD in ALD, and methods to mitigate these barriers.
In view of the paucity of trial data for this question, it is recommended that clinical trials attempt to detect a signal for patient-important outcomes such as mortality, decompensation and quality of life in ALD patients.
This is the first systematic review to address the issue of the effect of pharmacotherapy for AUD in ALD. In a narrative review the potential role of Baclofen in the subset of patients with high severity of AUD and advanced liver disease was underlined26. The authors concluded that Baclofen may be safe and effective in this patient population. Furthermore, the role of Baclofen in achieving alcohol abstinence in patients listed for transplant is another potential area to be explored. In another review, authors highlighted the lack of formal trials to test the efficacy of pharmacotherapies in patients of AUD and ALD, and mentioned Baclofen as a promising agent in this regard27. In a systematic review, authors reported the effects of simultaneous management of AUD and liver Disease28. They reported that compared to the standard of care, odds for decompensation with AUD intervention and 30-day readmission were lower by 44 per cent and 59 per cent, which was the finding from one study only.
The present study includes more cohort studies with an aim to explore the role of pharmacotherapy for AUD in ALD patients, which needs to be established independent of that in combination with behavioural therapy, so that reduction in adverse outcomes can be attributed to it. While treatment of AUD is multi-faceted, studying the effect of multiple and diverse interventions together, such as the case with pharmacotherapy and behavioural therapy, precludes the possibility of establishing individual effects, magnitude of effects and effect modification. While safety data are limited, hepatic decompensation is not an absolute contraindication to pharmacotherapy for AUD. Baclofen, in particular, is considered safe in advanced liver disease due to its renal excretion and minimal hepatic metabolism.
Another therapy, with interesting effects worth exploring further, is faecal microbiota transplantation (FMT). In a randomised clinical trial, and an observational Indian study, patients with alcohol-associated hepatitis (AAH) were treated with either FMT or standard of care (SoC) using corticosteroids29,30. The randomised clinical trial demonstrated that the FMT group experienced significantly fewer incidences of ascites, hepatic encephalopathy, infections, and hospitalisations compared to the SoC group. Additionally, the FMT group had lower rates of relapse to alcohol use and longer times to relapse. At the three-year follow up, the survival rate was higher in the FMT group, with notable gut microbiota changes, including increased abundance of beneficial bacteria like Bifidobacterium. Conversely, the SoC group showed higher mortality rates due to sepsis and less favourable gut microbiota profiles. The study concluded that FMT not only improved clinical outcomes and survival but also promoted beneficial changes in gut microbiota, highlighting its potential as a superior treatment modality for severe AAH compared to corticosteroids. However, the data from this study was not amenable to being included in the meta-analysis due to its unique design and specific outcomes.
The observational Indian study further supported these findings, revealing that patients with severe alcohol-associated hepatitis (SAH) who underwent FMT had significantly better clinical outcomes compared to those receiving standard care. The FMT group showed lower incidences of ascites, hepatic encephalopathy, infections, and hospitalisations, along with lower alcohol relapse rates and longer time to relapse. The three-year survival rate was higher in the FMT group, which also exhibited beneficial changes in gut microbiota. These studies collectively suggest that FMT offers a promising alternative to corticosteroids for treating severe AAH, though their data could not be included in the meta-analysis.
The present systematic review has several notable strengths. Three major databases were searched using a sensitive search strategy. Screening, data extraction, and risk of bias assessment were carried out independently by two reviewers to minimise error and subjectivity. The certainty of evidence for each outcome was evaluated using the GRADE framework, allowing for careful consideration of key methodological domains such as imprecision, inconsistency, and risk of bias. We used adjusted effect estimates from observational studies, where available, to reduce the potential impact of confounding. These adjusted odds ratios were pooled using the generic inverse variance method, which allows incorporation of multivariable-adjusted data. As most studies reported adjusted odds ratios rather than risk ratios, and given that adjusted RRs were rarely available, reporting pooled ORs was methodologically appropriate. Using RRs would have required relying on unadjusted raw data, potentially introducing greater bias. To our knowledge, this is the first systematic review to address the efficacy of AUD pharmacotherapy on liver-related patient important outcomes.
The included studies had inconsistencies in the outcome reported, in patient characteristics and methods for outcome assessment. There was lack of consistency in reporting of outcome events, which made most studies unamenable to being included in the meta-analysis. Heterogeneity observed with the overall analysis was high. Limited number of studies precluded possibility of conducting subgroup and sensitivity analyses to explore the heterogeneity. In further consideration of our analysis, we observed that although the I-squared (I2) statistic was high, the heterogeneity in terms of direction of effect was not serious. Importantly, all estimates from these studies pointed in the same direction, indicating consistent findings across studies. This situation highlights a drawback of the I2 statistic, which can sometimes overstate the extent of heterogeneity in the presence of large, precise studies. GRADE guidance on addressing inconsistency provides a relevant discussion on this topic, noting that high I2 values in the context of narrow CIs and consistent effect directions should be interpreted with caution31. While the inclusion of observational studies was necessary due to the scarcity of RCTs evaluating pharmacotherapy in ALD, it introduces inherent challenges such as risk of bias, potential confounding, and variability in study conduct and reporting. We addressed this by using the GRADE framework to rate the certainty of evidence separately for each outcome, explicitly considering study design, risk of bias, inconsistency, and indirectness. Nevertheless, the possibility of residual confounding and systematic bias remains, and the findings should be interpreted in this context. Wherever reported, we used adjusted effect estimates from multivariable models to reduce the influence of confounding. However, the included studies varied in the covariates used for adjustment, and several potential confounders such as disease severity, access to care, and behavioural interventions were not consistently accounted for. The included studies enrolled patients across a broad spectrum of alcohol-related liver disease, ranging from alcoholic fatty liver and steatohepatitis to advanced cirrhosis and decompensated disease. While this reflects real-world clinical practice, it introduces clinical heterogeneity that may influence treatment response and outcome trajectories. Several included studies enrolled insured patient populations, which may limit generalizability and introduce selection bias. In addition, most studies lacked pre-registered protocols, raising the possibility of selective outcome reporting.
The present systematic review and meta-analysis suggest that pharmacotherapy for AUD may reduce the risk of adverse patient-important outcomes like hepatic decompensation. These findings must be confirmed by adequately powered cohort studies, and randomizedcontrolled trials yielding experimental evidence of reduced mortality and other patient important outcomes in ALD with pharmacotherapy for AUD.
Financial support & sponsorship
None.
Conflicts of Interest
None.
Use of Artificial Intelligence (AI)-Assisted Technology for manuscript preparation
The authors confirm that there was no use of AI-assisted technology for assisting in the writing of the manuscript and no images were manipulated using AI.
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