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. Author manuscript; available in PMC: 2014 Sep 19.
Published in final edited form as: Cochrane Database Syst Rev. 2011 Jan 19;(1):CD006626. doi: 10.1002/14651858.CD006626.pub2
Methods Allocation: random, no further details.
Blindness: double, no further details.
Duration: 28 weeks.
Design: parallel.
Location: multicentre.
Setting: in- and outpatient.
Participants Diagnosis: (DSM-IV) schizophrenia (n = 277), schizophreniform disorder or schizoaffective disorder, BPRS score of 42 or more.
N = 339.
Sex: 220 M, 119 F.
Age: 18-65 years (mean = 36.21 years).
History: duration ill not reported, age at onset mean = 23.7 years
Interventions
  1. Olanzapine: flexible dose. Allowed dose range: 10-20 mg/day. Mean dose: 17.2 mg/day. N = 172.

  2. Risperidone: flexible dose. Allowed dose range: 4-12 mg/day. Mean dose: 7.2 mg/day. N = 167

Outcomes Leaving the study early: any reason, adverse events, inefficacy.
Mental State: PANSS total score, BPRS total score, PANSS positive subscore, PANSS negative subscore, SANS total score.
Quality of life: QLS total score.
Adverse effects: open interviews, cardiac effects (ECG), death (any reason, suicide attempt), EPS (akathisia, akinesia, dyskinesia, dystonia, extrapyramidal symptoms, parkinsonism, tremor, use of antiparkinson medication), Prolactin associated side effects (abnormal ejaculation, abnormally high prolactin value, amenorrhea, decreased libido, galactorrhea, gynaecomastia, impotence), sedation, backache, blurred vision, breathing difficulties, early wakening, nightmares, seizures, weight gain, laboratory (glucose, white blood cell count)
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?
subjective outcomes
Unclear risk Double, no further details. Whether blinding was successful has not been examined, but the compounds differ quite substantially in side effects. This can be a problem for blinding
Blinding?
objective outcomes
Low risk Objective outcomes such as laboratory measures or death are unlikely to have been much affected by problems of blinding
Incomplete outcome data addressed?
All outcomes
High risk The overall attrition was high 47.5 %. The LOCF 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
Free of selective reporting? High risk Adverse effects were only reported in the case of a significant difference between groups. Important side effects may have been missed by this procedure
Free of other bias? High risk The study was sponsored by the manufacturer of olanzapine.