| Methods |
Design: five group parallel trial
Purpose: examine the effect of different drugs, in addition to a supportive treatment program, on cessation of smoking |
| Participants |
Patients: male smokers wanting to quit
Baseline comparability: yes (prognostic variables) |
| Interventions |
Placebo: tablet with no drug
Untreated: no tablet
Experimental: tablet with lobeline, dextroamphetamine or imipramine
Untreated: no tablet
(Co‐intervention: supportive treatment program, mostly group sessions) |
| Outcomes |
Number of abstinent smokers (cessation or reduction to < 10% of baseline value) |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
NS |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
Low risk |
'... administering five drug conditions in a random and double‐blind fashion...' |
| Blinding?
Outcome assessor |
Unclear risk |
Not relevant as patient reported outcome |
| Incomplete outcome data addressed?
All outcomes |
High risk |
Drop‐out > 15% or NS |
| 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 = 54 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Drop‐out > 15% or NS |
