'Critical questions' over drug used to treat alcohol abuse
Research suggests there is insufficient evidence about the effectiveness of nalmefene.
The effectiveness of a drug being used to treat alcohol problems in the UK has been questioned.
Stirling University has led new study into nalmefene, which researchers say was licensed for use despite insufficient evidence to prove its effectiveness.
Marketed as Selincro, which was approved in continental Europe in February 2013, the drug was subsequently recommended by the UK National Institute for Health and Care Excellence (NICE).
A team of scientists has found problems with the way clinical trials were conducted and analysed, making it impossible to know how much the drug actually helps to reduce drinking in patients dependent on alcohol.
The group of experts analysed the published studies of nalmefene that formed the basis for the licensing and NICE decision.
Writing in the journal Addiction, they concluded evidence of its effectiveness was weak and any possible effect on patients was small at around a one drink per day reduction on average.
In the trials, side-effects were generally more common in patients taking nalmefene, who were also more likely to drop out of the trials.
The research also found nalmefene is more expensive than similar drugs on the market and that no comparison with these alternatives was made.
Dr Niamh Fitzgerald, a pharmacist and lecturer in alcohol studies at the university's institute for social marketing, led the study.
She said: "It's vitally important that we know that prescribed drugs are effective in treating the intended problem.
"In this case, we found problems with the registration, design, analysis and reporting of these clinical trials which did not prevent the drug being licensed or recommended for use.
"We believe this creates a difficulty for doctors trying to treat alcohol dependence and throws up critical questions for regulators around why a drug was licensed without a bank of high quality, reliable evidence."
The drug is currently licensed to be used in conjunction with psychosocial support to reduce alcohol consumption in patients diagnosed with alcohol dependence, with consistently high alcohol consumption levels but who do not experience physical withdrawal symptoms when they stop drinking.