Asadollahi 2018.
Study characteristics | ||
Methods | RCT Study type: interventional (clinical trial) Allocation: randomised Intervention model: parallel assignment Masking: double (participant, outcomes assessor) Primary purpose: treatment |
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Participants | 90 participants Country: Iran Setting: inpatient At randomisation number allocated: N = 90: citalopram (n = 30); fluoxetine (n = 30); placebo (n = 30) % male: citalopram (60%) fluoxetine (50%); placebo (56.6%) Age: mean age: citalopram = 61.7 ± 9.6; fluoxetine = 60.2 ± 8.52; placebo = 58.7 ± 8.56 Inclusion criteria
Exclusion criteria
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Interventions | Participants were randomly allocated to 1 of 3 groups: Group A received 20 mg orally of fluoxetine daily, Group B received 20 mg orally of citalopram daily, and Group C received a placebo orally. The duration of the therapy was 90 days. In addition to the medications, all of the participants received physiotherapy | |
Outcomes | FMMS | |
Funding source | No financial support received | |
Notes | IRCT20141116019971N3. Recruitment January 2015 to January 2016. Authors declared no conflicts of interest | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "A computer‐generated schedule was used by investigators to assign the patients into one of three groups by block randomization: Group A—20mg P.O. daily of citalopram, Group B—20mg P.O. daily of fluoxetine, and Group C—a placebo (microcrystalline cellulose)." |
Allocation concealment (selection bias) | Low risk | Computer‐generated schedule confirmed with authors |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "All of the drugs for each group of subjects were over‐encapsulated by a pharmacist." |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Three evaluators were used in our study, namely, neurology residents who were blind to the interventions." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 5/90 discontinued medication due to moving away‐but this would not have introduced because the reasons for missing data are unlikely to be related to the true outcome (Quote: "The main reason for participants leaving the study was noncompliance in terms of taking their drugs regularly (10 subjects stopped taking the treatment but completed their follow‐up), while five participants intentionally failed to attend follow‐up after two months because they were resident in other cities distant from the location of the study.") |
Selective reporting (reporting bias) | Low risk | There was just one outcome measure planned (see reference on Iranian clinical trials register) and this was reported |
Other bias | Low risk | The study appears to be free of other sources of bias |