Weak evidence for prescribed alcohol drug, say scientists

June 6, 2016
Weak evidence for prescribed alcohol drug, say scientists
Credit: University of Stirling

A drug being used to treat alcohol problems in the UK was licensed for use despite insufficient evidence to prove its effectiveness, new research led by the University of Stirling has found.

The drug nalmefene, marketed as Selincro, was approved in Europe in February 2013 and was subsequently recommended by the UK National Institute for Health and Care Excellence (NICE).

Yet a team of scientists have 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.

Outlined in the journal Addiction, a group of experts analysed the published studies of nalmefene that formed the basis for the licensing and NICE decision. They concluded that 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 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 is currently licensed to be used in conjunction with psychosocial support to reduce alcohol consumption in patients diagnosed with , with consistently high consumption levels, but who do not experience physical withdrawal symptoms when they stop drinking.

Explore further: Meta-analysis finds evidence for nalmefene in the treatment of alcohol dependence is weak

Related Stories

Nalmefene for alcohol dependence: Added benefit not proven

December 4, 2014

Nalmefene (trade name Selincro) has been approved since February 2013 for people with alcohol dependence who currently drink a lot of alcohol, but who do not have physical withdrawal symptoms and who do not require immediate ...

Recommended for you

Drug against alcoholism works, researchers claim

March 17, 2017

French researchers provided fresh evidence Friday to support claims that a drug touted as a miracle cure for alcoholism, and prescribed for this purpose in France, actually works.

Should parents give their children alcohol?

March 10, 2017

Children and teens who are given alcohol by their parents are twice as likely to be drinking full serves of alcohol by age 15 or 16, but are much less likely to binge drink, a UNSW study shows.

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.