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. 2022 Oct 3;2022(10):CD013337. doi: 10.1002/14651858.CD013337.pub2

Arman 2008.

Study characteristics
Methods Randomisation: randomised, no other details
Blinding: double‐blind
Duration: 12‐weeks
Country: Iran
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
Interventions
  1. Metformin (1000 mg/d; started as 500 mg tablet for week 1, with an increase to 500 mg tablets twice a day) in combination with risperidone (2‐6 mg/d); N = 16

  2. Placebo (once/d during week 1, with an increase to twice/d after week 1) in combination with risperidone (2‐6 mg/d); N = 16

Outcomes Able to use:
  1. Primary outcome

    1. Weight measures

      1. Weight

      2. BMI


Unable to use:
  1. Secondary outcome

    1. Physiological: laboratory measures

      1. Fasting blood glucose (data not available)

      2. Complete blood count (data not available)

      3. Creatinine (data not available)

      4. Prolactin level (data not available)

      5. Liver function tests (data not available)

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