Zhang 2014.
Study characteristics | ||
Methods |
Study design: Randomized controlled trial Study grouping: Parallel group How were participants recruited: From patients receiving treatment at hospital in 2012‐2014. Type of RCT: Randomized trial |
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Participants |
Baseline characteristics Olanzapine
Quetiapine
Aripriprazole
Overall
Inclusion criteria: Based on the inclusion criteria, eligible participants: (a) met the diagnostic criteria for schizophrenia based on the 3rd edition of the Chinese Classification of Mental Disorders (CCMD‐3); (b) has a total score of >60 on the Positive and Negative Syndrome Scale (PANSS); (c) had never been treated with antipsychotic medication; (d) had a duration of illness ≤ 5 years; (e) were 17 to 60 years of age; (f) had normal functioning heart, liver, and kidneys; and (g) provided written informed consent (or the guardian provided written informed consent) to participate in the study. Exclusion criteria: Individuals were excluded if they: (a) had a mental disorder induced by endocrine dysfunction (e.g., thyroid dysfunction); (b) were pregnant or breast feeding; (c) has a history of alcohol or drug dependence; or (d) took medications that could influence metabolism including glucocorticoids, diuretics, or contraceptives. Pretreatment: There were no statistically differences between groups with respect to gender, proportion of inpatients, age, duration of illness, or severity of illness (measured by the PANSS score). 47 inpatients had a higher PANSS baseline score than the 103 outpatients, as expected but no statistically significant difference between baseline PANSS scores of inpatients across the three treatment groups or across the outpatients of the three groups. |
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Interventions |
Intervention characteristics Olanzapine
Quetiapine
Aripriprazole
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Outcomes |
Fasting blood glucose
Cholesterol
Drop‐outs
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Identification |
Sponsorship source: The study was not funded by any agency Country: China Setting: Zhangilagang Kangle Hospital Comments: Authors name: Shufen Zhang Institution: Kangle Hospital Email: zxcscompany@163.com Address: Kangle Hospital, Zhangilagang City, Jiangsu Province, China |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Those enrolled were randomly assigned a study group by using a random number table. |
Allocation concealment (selection bias) | Unclear risk | No information on allocation concealment |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No information on how participants were blinded |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | The study mentions that the assessors for clinical assessment were blinded to patients' treatment status. There is no mention of blinding of assessors of biochemical outcomes but these are more objective and these outcome measurements are not likely to be influenced by lack of blinding |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Judgement comment: The study did not include data of participants that dropped out in the baseline characteristics. There is also no mention of intention‐to‐treat analysis. Each group started with either 55 or 54 in the group after random allocation and in both baseline and after 8‐week follow up, N = 50 for each of the three groups. Drop‐out was 5 in each of the three treatment groups with similar reasons for dropping out. |
Selective reporting (reporting bias) | Unclear risk | Judgement comment: Prespecified outcomes mentioned in the Methods section are addressed in the study. There is no reference to protocol in the study. |
Other sources of bias | Unclear risk | Judgement comment: The study was not funded by any agency. During the study, benzodiazepines and anticholinergics were used if considered necessary by clinicians. |