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

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
  • Sex(N, % female, % male): female 12 (36%), male 21 (64%)

  • Age (mean, SD): 25.24 (SD 8.49) years

  • Number of participants: 33 patients (completed the entire 12‐week treatment protocol

  • Ethnicity: Han Chinese (100%)


olanzapine
  • Sex (N, % female, % male): female 6 (26%), male 17 (74%)

  • Age (mean, SD): 28.65 (SD 7.14) years

  • Number of participants: 23 patients (completed the entire 12‐week treatment protocol

  • Ethnicity: Han Chinese (100%)


Overall
  • Sex (N, % female, % male): female 18 (32%), male 38 (68%)

  • Age: not reported

  • Number of participants: 56

  • Ethnicity: Han Chinese (100%)


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
  • Class of drug: Antipsychotic

  • Dose: Variable; aiming for 6 mg/day (mean 7.55, SD 2.27 mg/day)

  • Frequency: Daily

  • Duration: 12 weeks

  • Who delivered the intervention? Not reported

  • Type of intervention: Pharmacological


Olanzapine
  • Class of drug: Antipsychotic

  • Dose: Variable, aiming for 15 mg/day (mean 15.87, SD 3.34 mg/day)

  • Frequency: Daily

  • Duration: 12 week

  • Who delivered the intervention? Not reported

  • Type of intervention: Pharmacological

Outcomes Fasting glucose
  • Outcome type: Continuous

  • Reporting: Fully reported

  • Unit of measure: mmol/l

  • Direction: Lower is better

  • Data value: Endpoint


BMI
  • Outcome type: Continuous

  • Unit of measure: kg/m2

  • Direction: Lower is better

  • Data value: Endpoint


Waist circumference
  • Outcome type: Continuous

  • Reporting: Fully reported

  • Unit of measure: cm

  • Direction: Lower is better

  • Data value: Endpoint


Drop‐out
  • Outcome type: Dichotomous

  • Reporting: Fully reported

  • Direction: Lower is better

  • Data value: Endpoint

  • Notes: drop‐outs reported but baseline sample is excluding drop outs

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.