Methods | Allocation: random, no further details. Blindness: single (rater-blinded). Duration: 16 weeks (8 weeks observed). Design: parallel. Location: multicentre. Country: not reported. |
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Participants | Diagnosis: (DSM-IV) schizophrenia, PANSS total score of 70 or more, PANSS positive subscore of 4 or more on at least 2 items. N=75. Age: 18-65 years. Sex: not reported. History: duration ill not reported, age at onset not reported. Setting: inpatient. |
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Interventions |
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Outcomes | Leaving the study early: any reason. Mental State: BPRS hostility cluster score. Adverse effects: EPS (BAS, SAS), weight gain. Unable to use- Mental State - PANSS total score, PANSS positive subscore, PANSS negative subscore (no usable data) |
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Notes | ||
Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Adequate sequence generation? | Unclear risk | Random, no further details. |
Allocation concealment? | Unclear risk | No further details. |
Blinding? Objective outcomes |
Low risk | Objective outcomes such as laboratory measures or death are unlikely to have been much affected by problems of blinding |
Blinding? Subjective outcomes |
Unclear risk | Single, rater-blind. Whether blinding was successful has not been examined, but the compounds differ quite substantially in side-effects. This can be a problem for blinding |
Incomplete outcome data addressed? All outcomes |
Unclear risk | The attrition rate was moderate (18. 6%). The last-observation-carried-forward method was used to account for people leaving the study early. It assumes that a participant who discontinued the study would not have had a change of his condition if he had remained in the study. This assumption can obviously be wrong. It is unclear whether this led to bias |
Free of selective reporting? | High risk | Efficacy data (PANSS) were only presented as per cent change, without indications of standard deviations, standard errors, p-values or ranges. Only interim data after half the patients had been recruited have been presented |
Free of other bias? | High risk | The study was sponsored by the manufacturer of quetiapine. |