Saddichha 2008.
Study characteristics | ||
Methods |
Study design: Randomized controlled trial Study grouping: Parallel group How were participants recruited: All consecutive inpatients diagnosed with first episode schizophrenia Type of RCT: Randomized, double‐blind, controlled prospective study |
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Participants |
Baseline characteristics Risperidone
haloperidol
olanzapine
control
Overall
Inclusion criteria: Consenting inpatients. Diagnosed with DSM IV schizophrenia. Controls ‐ consecutively seen accompanying persons of patients attending the institute Exclusion criteria: Patients with other psychiatric comorbidity or history of severe physical illness. Alcohol and substance abuse or dependence. History of pre‐existing diabetes or hypertension or family history of hypertension or DM. Pretreatment: There were no significant differences between the groups in age, gender and fasting blood sugar (FBS).However, a significant difference in 2 hour post‐prandial blood sugar (PPBS) was noted between the control group and the treatment group, which persisted only for males |
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Interventions |
Intervention characteristics Risperidone
Haloperidol
Olanzapine
Control
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Outcomes |
Fasting blood sugar
Diabetes ‐ ADA criteria
Diabetes ‐ WHO criteria (FBS)
Drop‐outs
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Identification |
Sponsorship source: Not mentioned Country: India Setting: Central Institute of Psychiatry, Ranchi, India which is a referral psychiatric institute Comments: ‐ Authors name: S Saddichha Institution: National Tobacco Control Programme, WHO India, Bhubaneshwar Email: saddichha@gmail.com Address: 790, Govind Prasad, Mahabir Nagar Road 2, Cuttack Road, Bhubaneswar 751012, India. |
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Notes | Dr Sharad Philip on 11/08/2019 05:47 Population Details not given in the text of the article or tables about O, R and H groups. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Quote: "All consecutive patients with a DSM‐IV diagnosis of schizophrenia, in the Central Institute of Psychiatry, Ranchi, India". "Patients included in the study were randomized to receive risperidone, olanzapine or haloperidol. " Judgement comment: no sequence generation was reported. It appears randomizations may have taken place between antipsychotics but not vs control arm. |
Allocation concealment (selection bias) | Unclear risk | Judgement comment: not mentioned. Decision of O vs R vs H was in routine care. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Judgement comment: the study was double blind, however, no detailed information on how they were blinded. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "All assessments were performed by a single investigator blind to the diagnosis and medication prescribed and all investigations were carried out in the same laboratory." |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Drop‐outs unclear. |
Selective reporting (reporting bias) | Unclear risk | No reference to protocol. |
Other sources of bias | Low risk | No other sources of bias identified. |