Reding 1986.
Study characteristics | ||
Methods | Study design: parallel design Number of arms: 2 Experimental arm: trazodone‐HCl (serotonin modulator) Control arm: matched placebo |
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Participants | Geographical location: USA
Setting: inpatient Stroke criteria: all subtypes Method of stroke diagnosis: via clinical signs and CT (100%) Time since stroke: on average 45 +/‐ 5 days (treatment group) and 48 +/‐ 13 days (control group) prior to randomisation Inclusion criteria: not reported Exclusion criteria: 1) myocardial infarction within previous month; 2) antiarrhythmic medication Total number randomised in this study: 27 Number randomised to treatment group: unclear Number randomised to control group: unclear Total number included in final analysis: 5 Number included in treatment group for final analysis: 3 (66% men, mean age 67 years, SE 6) Number included in control group for final analysis: 2 (50% men, mean age 73 years, SE 16) |
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Interventions | Treatment: trazodone‐HCl (serotonin modulator) 50 mg daily; dose escalation every 3 days to target dose of 200 mg
Control: matched placebo
Treatment duration: treatment continued for 32 +/‐ 6 days (treatment group) and 24 +/‐ 4 days (control group) Follow‐up: not reported |
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Outcomes | Primary outcomes
Secondary outcomes
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Patients were assigned to either treatment or placebo groups according to a table of random numbers." pp. 763 |
Allocation concealment (selection bias) | Unclear risk | Comments: method of allocation concealment not reported |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "Trazodone hydrochloride (50 mg) or placebo in an identical capsule was administered orally by the nursing staff ..." pp. 763 |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "... attending physician, unaware of treatment group assignment, noted signs or symptoms possibly due to trazodone ..." pp. 764 |
Incomplete outcome data (attrition bias) All outcomes | High risk | Comments: only 5/27 patients completed the study at target dose. The study was discontinued due to perceived side effects in both groups. The analysis is presented in subgroups with only numbers of improved not total numbers analysed |
Selective reporting (reporting bias) | Unclear risk | Comments: no trial protocol available to compare with the publication |
Other bias | Low risk | Comments: there was no statistically significant difference between the treatment and control group in baseline demographic characteristics |