Hu 2013.
Study characteristics | ||
Methods |
Study design: Randomized controlled trial Study grouping: Parallel group How were participants recruited: Hospital Type of RCT: Prospective, randomized, 12‐week, open‐label,flexible‐dose, parallel‐group study |
|
Participants |
Baseline characteristics Paliperidone ER
olanzapine
Overall
Inclusion criteria: Inpatients, aged 18 to 45 years, fulfilled diagnostic criteria for schizophrenia, body mass index (BMI) 18 to 30 kg/m2, and they must either not have received any antipsychotic treatments in the past or they must not have been taking an antipsychotic medication for at least 3 months were included Exclusion criteria: Treatment with paliperidone, olanzapine, clozapine, or antidepressant within 1 month; current treatment with insulin or oral antidiabetic agents, or a prior diagnosis of diabetes or hyperlipidaemia; current substance abuse; a current medical condition that may affect glucose/lipid metabolism; and pregnancy Pretreatment: The groups did not differ significantly on any characteristic (p>0.05). |
|
Interventions |
Intervention characteristics Paliperidone ER
Olanzapine
|
|
Outcomes |
Fasting glucose
BMI
Waist circumference
Drop‐out
|
|
Identification |
Sponsorship source: This work is partly supported by a grant fromShanghai Commission of Science and Technology (No. 10440710200). Country: China Setting: Hospital (First Affiliated Hospital, College of Medicine, Zhejiang University, and Kangci Hospital of Jiaxing.) Comments: ‐ Authors name: Shaohua Hu, Mingrong Yao Institution: Department of Mental Health, First Affiliated Hospital, Zhejiang University School of Medicine, Email: xuyi61@yahoo.com.cn Address: Department of Mental Health, First Affiliated Hospital,Zhejiang University School of Medicine, Hangzhou 310003, China |
|
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "List of random sequence assignments for each drug was drawn up by a computer at the beginning of the study". "80 participants were randomly assigned to treatment sequentially, with an equal probability of receiving paliperidone ER or olanzapine, 40 participants in each group. " |
Allocation concealment (selection bias) | Unclear risk | No information. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "a prospective, randomized, 12‐week, open‐label, flexible‐dose, parallel‐group study". Judgement's comment: No blinding was done. Measures of blood glucose less likely to be influenced than measure of waist circumference. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No blinding was done. Measures of blood glucose less likely to be influenced than measure of waist circumference and drop‐outs. |
Incomplete outcome data (attrition bias) All outcomes | High risk | 7/40 patients in paliperidone group and 17/40 in olanzapine group discontinued treatment. Outcomes only reported for patients who completed treatment (as treated analysis). Some drop‐outs were due to adverse effects (more in olanzapine arm) or poor response. It is likely that adverse effects of olanzapine are underestimated. |
Selective reporting (reporting bias) | Unclear risk | Protocol not referenced. |
Other sources of bias | Unclear risk | Quote: "we were unable to perform an intent‐to‐treat analyses because all patients who dropped out failed to complete 4 weeks of treatment, and therefore the missing data could not be addressed appropriately using the Last Observation Carried Forward (LOCF)". Judgement's comment: Only baseline characteristics for those who completed the study are reported. No reporting of conflicts of interest. |