Lin 2008.
| Methods | Randomized clinical trial, single‐site, open trial, parallel groups Study duration: 1 week from baseline assessment Location: Taiwan |
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| Participants |
Total: 30 patients Setting: hospice and palliative care centre at a large general and teaching hospital Mean age years (SD): olanzapine 61 years (16.50); haloperidol 68 years (12.14) Gender no. (% female): olanzapine 7 (44%); haloperidol 10 (71%) Diagnosis (%): 100% cancer Delirium severity: baseline delirium severity was assessed by the Delirium Rating Scale (Chinese version). DRS (Chinese) scores could range from 10 to 33 with higher scores indicating greater severity. Mean and standard deviations scores were: 17.56 (SD = 5.18) in the olanzapine group and 16.50 (SD = 4.70) in the haloperidol group Performance status: not assessed. Inclusion criteria: patients with advanced cancer requiring hospice and palliative care; diagnosis of delirium as per the DSM‐IV Exclusion criteria: past history of psychiatric disorders; coma, inability to swallow oral medication, treatment with neuroleptic agents within 4 weeks prior to the enrolment |
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| Interventions |
Intervention: olanzapine starting dose 5 mg per day ‒ oral. n = 16 Comparison: haloperidol starting dose 5 mg per day ‒ oral. n = 14 If the participant's condition did not improve doses were titrated up to a maximum daily dose of 15 mg olanzapine or 15 mg haloperidol. Midazolam by intramuscular injection was available when rescue medication was required Timing of treatment: commenced at 6 p.m. on day 1 with doses administered every 24 hours Treatment duration: 1 week |
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| Outcomes |
Outcomes (primary and secondary outcomes undifferentiated):
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| Notes | No information on funding or conflicts of interest provided | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "If the patients needed to have antipsychotic, they were separated randomly to an olanzapine group or a haloperidol group" Comment: no information provided on how participants were randomised |
| Allocation concealment (selection bias) | Unclear risk | No information provided |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Incomplete blinding ‒ assessor was blinded to the treatment received by each participant but participants were unblinded. However, participant unblinding is unlikely to have an effect on the outcome |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "The assessor was blind to what kind of antipsychotic the patients received when she assessed the following DRS‐C and CGI‐S and the side effect of both groups cross time periods" |
| Incomplete outcome data (attrition bias) All outcomes | High risk | High rates of dropout. 11/16 (67%) dropped out in the olanzapine group and 7/14 (50%) dropped out in the haloperidol group. No reasons given and no information provided on handling of missing data. Low number of participants completed study |
| Selective reporting (reporting bias) | Unclear risk | Protocol not available. Insufficient information to judge selective reporting bias |
| Sample size | High risk | Fewer than 50 participants per arm |
DRS: Delirium Rating Scale DSM‐III‐R: Diagnostic and Statistical Manual of Mental Disorders III (revision) DSM‐IV: Diagnostic and Statistical Manual of Mental Disorders III (revision) IQR: Interquartile range mg: milligram mg/d: milligrams per day ml: millilitre MMSE: Mini‐Mental State Examination n: Sample size QT interval: measurement made on an electrocardiogram used to assess some of the electrical properties of the heart. It is calculated as the time from the start of the Q wave to the end of the T wave and approximates to the time taken from when the cardiac ventricles start to contract to when they finish relaxing. SD: standard deviation