ArticleBMC medicine2016
Evaluation in alcohol use disorders - insights from the nalmefene experience.
Article in BMC medicine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.
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
10 citing papers in PubMed, 1 synthesis or guideline pooled it.
- The evidence base for psychotropic drugs approved by the European Medicines Agency: a meta-assessment of all European Public Assessment Reports.Epidemiology and psychiatric sciences · 2020Pooled it
- Long-term safety and efficacy of nalmefene in Japanese patients with alcohol dependence.Psychiatry and clinical neurosciences · 2020Trial
- Histamine H3 Receptor as a target for alcohol use disorder: challenging the predictability of animal models for clinical translation in drug development.Translational psychiatry · 2026Article
- Medications for the Treatment of Alcohol Dependence-Current State of Knowledge and Future Perspectives from a Public Health Perspective.International journal of environmental research and public health · 2023Review
- Article
- [Pharmacotherapy of alcohol withdrawal: update and new developments].Der Nervenarzt · 2021Review
- Response to 'Nalmefene in alcohol-dependent patients with a high drinking risk: A limited efficacy in reducing alcohol consumption'.Psychiatry and clinical neurosciences · 2020Article
- Vibration of effects from diverse inclusion/exclusion criteria and analytical choices: 9216 different ways to perform an indirect comparison meta-analysis.BMC medicine · 2019Article
- From gene networks to drugs: systems pharmacology approaches for AUD.Psychopharmacology · 2018Review
- Practical outpatient pharmacotherapy for alcohol use disorder.Drugs in context · 2018Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Nalmefene was the first treatment approved by the European Medicines Agency for reducing alcohol consumption in adult patients with alcohol dependence. It is often presented as a paradigm shift in therapeutics, but major issues limit the interpretation of the evidence supporting its use. The randomised trials submitted provided no evidence of harm reduction, the differences on consumption outcomes were of questionable clinical relevance, the target population was defined a posteriori and the drug was compared to a placebo although naltrexone was already used off-label. No post-approval randomised study is currently designed to clearly address these issues. In addition, nalmefene trials have been uncritically cited, even in guidelines. This experience reveals weaknesses in drug evaluations in alcohol dependence, which call for changes. We propose to dispense with alcohol consumption as a surrogate outcome, to consider comparative effectiveness issues, and to recommend randomised post-approval studies in case of controversial approval.
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.