| Methods |
Design: 2 x 2 factorial design
Purpose: examine the effect of strict control and placebo on relapse rate of abstinent alcoholics |
| Participants |
Patients: woman in‐patients attending an alcoholism clinic
Baseline comparability: yes |
| Interventions |
Placebo: injections with saline
Untreated: no injections
Experimental:
‐strict external control of alcohol abstinence
‐no strict external control of alcohol abstinence
(Co‐intervention: stay at a clinic with unspecified 'complex and extensive treatment program', e.g. in a few cases patients received 'liver preparation') |
| Outcomes |
Number of abstinent drinkers |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Blinding?
Treatment provider |
High risk |
Not described as double‐blind (placebo/experimental) |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
Drop‐out < 15% |
| 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 = 70 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Allocation not clearly concealed |
