Weak evidence on nalmefene creates dilemmas for clinicians and poses questions for regulators and researchers

摘要: Background and aims Nalmefene has been approved in Europe for the treatment of alcohol dependence subsequently recommended by UK National Institute Health Care Excellence (NICE). This study examines critically evidence base underpinning both decisions issues arising. Methods Published studies nalmefene were identified through a systematic search, with documents from European Medicines Agency, NICE appraisal public clinical trial registries also examined to identify methodological issues. Results Efficacy data used support licensing suffer risk bias due lack specification priori outcome measures sensitivity analyses, use post-hoc sample refinement inappropriate comparators. Despite this, efficacy reducing consumption those is, at best, modest, uncertain significance individual patients. The relevance existing routine primary care practice is doubtful. Conclusions Problems registration, design, analysis reporting trials did not prevent it being licensed treating dependence. creates dilemmas clinicians commissioning organisations where heavily promoted, poses wider questions about effectiveness medicines regulation system how develop base.