Methods |
Design: three group parallel trial
Purpose: examine the effect of disulfiram and placebo implants on alcoholism |
Participants |
Patients: alcoholics
Baseline comparability: NS |
Interventions |
Placebo: implants without disulfiram
Untreated: no implants
Experimental: implants with disulfiram
(Co‐intervention: NS) |
Outcomes |
Number of abstinent drinkers
Mean time to first alcoholic consumption |
Notes |
Patients were randomised to placebo and no treatment in a 4:1 ratio |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Blinding?
Treatment provider |
Low risk |
'Assignment to the disulfiram and placebo conditions was double‐blind' |
Blinding?
Outcome assessor |
Unclear risk |
Not relevant as patient reported outcome |
Incomplete outcome data addressed?
All outcomes |
High risk |
|
Free of selective reporting? |
Unclear risk |
No protocol available |
Free of other bias? |
Low risk |
|
No signs of variance inequality or skewness? |
Unclear risk |
Not relevant (binary outcome) |
Trial size > 49? |
Low risk |
N = 50 |
Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
|