I have been trying to find the trial results of Campral which the FDA licences for alcoholism and I found these:
They show that Campral was licensed for alcoholism on the basis that in three trials it showed a "greater" percentage of subjects not drinking and one trial which showed no difference over placebo.
A randomized, double-blind, placebo-controlle... [Bipolar Disord. 2012] - PubMed - NCBI This study showed Campral having no benefit.
Campral Now Available for Alcoholism Treatment
"FDA approval of Campral is based primarily on the Agency's review of short and long-term efficacy and safety data from double-blind, placebo-controlled trials. In three of the trials, which lasted from 90 days to 360 days, Campral plus psychosocial therapy proved superior to placebo plus psychosocial therapy in maintaining abstinence, as indicated by a greater percentage of subjects being assessed as continuously abstinent throughout treatment.
In a fourth study, the Campral-treated group failed to show a difference on the primary efficacy endpoint, cumulative abstinence duration. In this trial, patients were not required to be abstinent prior to randomization as required in the positive studies."
What this shows is that there doesn't need to be a very significant positive benefit for a drug to be approved for alcoholism treatment. The three trials which showed greater sobriety during the trials were of people who were already abstaining when they started the trial.
They show that Campral was licensed for alcoholism on the basis that in three trials it showed a "greater" percentage of subjects not drinking and one trial which showed no difference over placebo.
A randomized, double-blind, placebo-controlle... [Bipolar Disord. 2012] - PubMed - NCBI This study showed Campral having no benefit.
Campral Now Available for Alcoholism Treatment
"FDA approval of Campral is based primarily on the Agency's review of short and long-term efficacy and safety data from double-blind, placebo-controlled trials. In three of the trials, which lasted from 90 days to 360 days, Campral plus psychosocial therapy proved superior to placebo plus psychosocial therapy in maintaining abstinence, as indicated by a greater percentage of subjects being assessed as continuously abstinent throughout treatment.
In a fourth study, the Campral-treated group failed to show a difference on the primary efficacy endpoint, cumulative abstinence duration. In this trial, patients were not required to be abstinent prior to randomization as required in the positive studies."
What this shows is that there doesn't need to be a very significant positive benefit for a drug to be approved for alcoholism treatment. The three trials which showed greater sobriety during the trials were of people who were already abstaining when they started the trial.