Arman 2008.
Study characteristics | ||
Methods | Randomisation: randomised, no other details
Blinding: double‐blind Duration: 12‐weeks Country: Iran |
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Participants | Diagnosis: schizophrenia or schizoaffective disorder N = 49 Age: 10.09 years (< 20 years) Sex: male and female Setting: inpatients History: < 20 years of age, taking risperidone (2‐6 mg/d according to their responses to treatment), creatinine level < 1.4 mg/dL, normal liver function test Excluded: treatment with antipsychotic earlier, current substance abuse or significant medical illness, untreated hypertension, history of intolerance to metformin, receiving weight loss agents, glaucoma, heart disease, abnormal ECG, asthma, combination of antipsychotics, or treatment with anti‐migraine agents containing serotonin agonists |
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Interventions |
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Outcomes |
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Notes | 61.4% study completers | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "After completing baseline assessments, the subjects were randomly assigned to metformin and placebo." Pg 1131 Comment: randomisation methods are unavailable |
Allocation concealment (selection bias) | High risk | Comment: information is unavailable. Combined with the lack of details about randomisation and complete absence of information about allocation concealment, the risk of bias is quite high. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "...Identical appearing placebo pills..." Pg 1131 Comment 1: the study indicates the presence of identical placebo pills, however, it is unclear which personnel were blinded in the study. Comment 2: various adverse effects were reported in the treatment group, which may have broken blinding. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Information is unavailable |
Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: "17 were excluded due to incomplete use of drugs or side‐effects of the drugs. 2 of these patients have experienced diarrhoea at the second week. 3 patients had nausea and vomiting in metformin group, which were excluded from study too." Pg 1132 Comment: excluded participants were not included in the analysis, hence only ~62% of the study population was analysed. |
Selective reporting (reporting bias) | Unclear risk | Study protocol is unavailable |
Other bias | Low risk | No obvious bias |