ReviewAddiction (Abingdon, England)2016
Weak evidence on nalmefene creates dilemmas for clinicians and poses questions for regulators and researchers.
Review in Addiction (Abingdon, England), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
13 citing papers in PubMed, 42 citations in OpenAlex.
- Nalmefene in alcohol-dependent patients with a high drinking risk: Randomized controlled trial.Psychiatry and clinical neurosciences · 2019Trial
- Who Receives Nalmefene and How Does It Work in the Real World? A Single-Arm, Phase IV Study of Nalmefene in Alcohol Dependent Outpatients: Baseline and 1-Month Results.Clinical drug investigation · 2018Trial
- Nalmefene and naltrexone reduce alcohol intake via selective efficacy in subpopulations distinguished by behavioral and blood-based biomarkers.Communications medicine · 2026Article
- A critical scientific evaluation of a purportedly negative data report - response to Seneviratne et al. 2022.Frontiers in psychiatry · 2023Article
- Alcohol Use Disorder: Neurobiology and Therapeutics.Biomedicines · 2022Review
- Neuroimmune and Mu-Opioid Receptor Alterations in the Mesocorticolimbic System in a Sex-Dependent Inflammatory Pain-Induced Alcohol Relapse-Like Rat Model.Frontiers in immunology · 2021Article
- Pharmacotherapies and personalized medicine for alcohol use disorder: a review.Pharmacogenomics · 2020Review
- Drinking Levels and Profiles of Alcohol Addicted Rats Predict Response to Nalmefene.Frontiers in pharmacology · 2019Article
- Nalmefene Phase IV Study: A Seeding Flying in the Face of Evidence?Clinical drug investigation · 2018Article
- Binge Drinking: Current Diagnostic and Therapeutic Issues.CNS drugs · 2017Article
- Comment on: "Safety and Tolerability of Pharmacological Treatment of Alcohol Dependence: Comprehensive Review of Evidence".Drug safety · 2016Article
- Article
- Weak evidence on nalmefene creates dilemmas for clinicians and poses questions for regulators and researchers.Addiction (Abingdon, England) · 2016Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 6 institutions in 1 country.
Funding
Abstract
BACKGROUND AND
aimsNalmefene has been approved in Europe for the treatment of alcohol dependence and subsequently recommended by the UK National Institute for Health and Care Excellence (NICE). This study examines critically the evidence base underpinning both decisions and the issues arising.
methodsPublished studies of nalmefene were identified through a systematic search, with documents from the European Medicines Agency, the NICE appraisal and public clinical trial registries also examined to identify methodological issues.
resultsEfficacy data used to support the licensing of nalmefene suffer from risk of bias due to lack of specification of a priori outcome measures and sensitivity analyses, use of post-hoc sample refinement and the use of inappropriate comparators. Despite this, evidence for the efficacy of nalmefene in reducing alcohol consumption in those with alcohol dependence is, at best, modest, and of uncertain significance to individual patients. The relevance of existing trial data to routine primary care practice is doubtful.
conclusionsProblems with the registration, design, analysis and reporting of clinical trials of nalmefene did not prevent it being licensed and recommended for treating alcohol dependence. This creates dilemmas for primary care clinicians and commissioning organisations where nalmefene has been heavily promoted, and poses wider questions about the effectiveness of the medicines regulation system and how to develop the alcohol treatment evidence base.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.