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. 2021 Feb 16;2021(2):CD013281. doi: 10.1002/14651858.CD013281.pub2

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
Participants Baseline characteristics
Olanzapine
  • Sex (N, % female, % male): female 16 (32%), male 34 (68%)

  • Age (mean, SD): 41.2 (SD 13.3) years

  • Number of participants: 50


Quetiapine
  • Sex (N, % female, % male): female 17 (34%), male 33 (66%)

  • Age (mean, SD): 40.2 (SD 12.0) years

  • Number of participants: 5


Aripriprazole
  • Sex (N, % female, % male): female 19 (38%), male 31 (62%)

  • Age (mean, SD): 41.7 (SD 13.7) years

  • Number of participants: 50


Overall
  • Sex (N, % female, % male): female 52 (35%), male 98 (65%)

  • Age (mean, SD): 17 to 60 years

  • Number of participants: 150


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.
Interventions Intervention characteristics
Olanzapine
  • Class of drug: Atypical antipsychotics

  • Dose: max 20 mg

  • Frequency: Daily

  • Duration: 8 weeks

  • Who delivered the intervention? Not reported

  • Type of intervention: Pharmacological


Quetiapine
  • Class of drug: antipsychotic

  • Dose: max 750 mg

  • Frequency: Daily

  • Duration: 8 weeks

  • Who delivered the intervention? Not reported

  • Type of intervention: Pharmacological


Aripriprazole
  • Class of drug: Atypical antipsychotics

  • Dose: max 20 mg

  • Frequency: Daily

  • Duration: 8 weeks

  • Who delivered the intervention? Not reported

  • Type of intervention: Pharmacological

Outcomes Fasting blood glucose
  • Outcome type: Continuous

  • Reporting: Fully reported

  • Unit of measure: mmol/l

  • Direction: Lower is better

  • Data value: Endpoint


Cholesterol
  • Outcome type: Continuous

  • Reporting: Fully reported

  • Unit of measure: mmol/l

  • Direction: Lower is better

  • Data value: Endpoint


Drop‐outs
  • Outcome type: Dichotomous

  • Reporting: Fully reported

  • Direction: Lower is better

  • Data value: Endpoint

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
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.