Freeman 1986.
| Study characteristics | ||
| Methods | RCT design: 2‐arm parallel‐group trial Total N randomised: 107 Length of follow‐up: no follow‐up Analysis: per‐protocol (60 of 107 participants completed the trial) |
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| Participants | Location: USA Number of study centres and setting: patients from 1 hospital CAD criteria: patients undergoing CABG (assessment method and time to randomisation not specified) Depression criteria: a score of 13 or greater on the Center for Epidemiological Studies ‐ Depression Scale (CES‐D) or a score of 36 or greater on the Spielberger State Anxiety Inventory (SSAI), or both; presence of clinically significant anxiety or depression was confirmed by a semistructured psychiatric interview Other entry criteria: under 65 years of age Exclusion criteria: females of childbearing potential, patients with a history of sensitivity to benzodiazepines, patients with prior or existing evidence of substance abuse, antisocial personality, psychosis, significant uncontrolled systemic disease, cerebral infarction, dementia, or insufficient English Treatment N: 32 (sex and age distribution unclear) Control N: 28 (sex and age distribution unclear) Comparability of groups: treatment group had significantly higher anxiety scores at baseline; no further information regarding group comparability |
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| Interventions | Treatment: alprazolam (tablets, 2.5 mg/d at bedtime, maximum dose 4.5 mg/d) Control: placebo Duration of treatment: 1 month |
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| Outcomes | Review outcomes: depression symptoms (CES‐D score, also Zung Self‐Rating Depression Scale) Other outcomes: anxiety symptoms (SSAI, Zung Self‐Rating Anxiety Scale), Global Impression Scale, structured psychiatric semistructured interviews (signs and symptoms of psychosis, cognitive dysfunction, depression, anxiety, and somatisation) |
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| Funding | Upjohn Company | |
| Notes | Mixed study sample (participants with depression and/or anxiety) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Comment: No details reported |
| Allocation concealment (selection bias) | Unclear risk | Comment: No details reported |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: No details reported |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: No details reported |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Comment: Only 60 of 107 patients completed the trial Comment: 22 early drop‐outs in the alprazolam group (with noncompleters being less distressed than completers preoperatively) Comment: 25 early drop‐outs in the placebo group (with noncompleters being more distressed than completers preoperatively) |
| Selective reporting (reporting bias) | Unclear risk | Comment: No protocol or design paper available Comment: psychiatric semistructured interviews were performed at all assessment time points (signs and symptoms of psychosis, cognitive dysfunction, depression, anxiety, and somatization) but were not reported |
| Other bias | Unclear risk | Comment: unclear if selection bias present. 60% of 459 patients met entrance criteria and 23% were included. "The remainder were excluded from entering the drug trial by semistructured interview or were rendered ineligible because of surgical complications or withdrawal of consent." (p. 39) Comment: possible baseline imbalance. Treatment group significantly higher anxiety scores at baseline; no further information regarding comparability of groups |