| Methods |
Design: three group parallel trial
Purpose: examine the effect of reserpine on the behaviour of chronic mentally ill patients |
| Participants |
Patients: chronic mentally ill men
Baseline comparability: yes |
| Interventions |
Placebo: pill with no reserpine
Untreated: no pill
Experimental: pill with reserpine
(Co‐intervention: yes, no group difference) |
| Outcomes |
Behaviour change
Blood pressure
Weight |
| Notes |
Relevant outcome data not accessible |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
'random numbers table' |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
Low risk |
'The hospital pharmacist alone knew which group received reserpine or placebo' |
| Blinding?
Outcome assessor |
Unclear risk |
NS |
| Incomplete outcome data addressed?
All outcomes |
High risk |
Drop‐out > 15% or NS |
| Free of selective reporting? |
High risk |
Relevant outcome data not accessible |
| Free of other bias? |
Low risk |
|
| Trial size > 49? |
Low risk |
N = 60 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Drop‐out > 15% or NS |
