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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: 8 weeks.
Design: parallel.
Location: multicentre.
Participants Diagnosis: (DSM-IV) schizophrenia (n = 149) or schizoaffective disorder (n = 26), PANSS between 50 and 120.
N = 176.
Sex: 62 M, 113 F (of intent-to-treat population).
Age: 60 years or more (mean olanzapine = 71.4 years, mean risperidone = 70.9 years) (of intent-to-treat population).
History: duration ill mean = 36.5 years, age at onset mean olanzapine = 33.4 years, mean risperidone = 36.0 years (of intent-to-treat population).
Setting: in- and outpatient.
Interventions
  1. Olanzapine: flexible dose. Allowed dose range: 5-20 mg/day. Mean dose: 11.1 mg/day. N = 89.

  2. Risperidone: flexible dose. Allowed dose range: 1-3 mg/day. Mean dose: 1.9 mg/day. N = 87

Outcomes Leaving the study early: any reason, adverse events, inefficacy.
Global State: CGI.
Mental State: PANSS total score, PANSS positive subscore, PANSS negative subscore.
Adverse effects: open interviews, cardiac effects (ECG), death (natural causes, suicide) EPS (akinesia, dystonia, extrapyramidal symptoms, parkinsonism, tremor, use of antiparkinson medication, ESRS), sedation, seizures, weight change, laboratory (cholesterol, glucose, prolactin)
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
Unclear risk Number of participants leaving the study early was moderate (23.9%). 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. It is unclear whether this led to bias
Free of selective reporting? High risk Only those adverse events that occurred in at least 10% of the participants were reported. This procedure can miss rare, but important adverse events
Free of other bias? High risk The study was sponsored by the manufacturer of risperidone. The mean age of included subjects was about 71 years. Probably due to this reason the upper dose range limit of risperidone was rather low (3mg/day), compared to that of olanzapine (20mg/day)