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. 2010 Jan 20;2010(1):CD003974. doi: 10.1002/14651858.CD003974.pub3

Sibilio 1957.

Methods Design: three group parallel trial 
 Purpose: examine the effect of promazine on the behaviour of chronic schizophrenics
Participants Patients: woman chronic schizophrenic in‐patients 
 Baseline comparability: yes
Interventions Placebo: capsule with no promazine 
 Untreated: no capsule 
 Experimental: capsule with promazine 
 (Co‐intervention: no)
Outcomes Behaviour change on Gardner Behavior Chart
Notes Relevant outcome data not accessible
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 'The double‐blind technique was employed throughout the study'
Blinding? 
 Outcome assessor Low risk 'Those attendants who rated the patients' behavioral adjustment did not dispense medication and were unaware of the experimental group to which a patient was assigned'
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 = 62
Clearly concealed allocation + trial size > 49 + drop‐out max 15% High risk Allocation not clearly concealed