Freeman 1986.
| 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 patients completed the trial) |
|
| Participants | Location: USA Number of study centres and setting: Patients from 1 hospital CAD diagnosis: Patients undergoing Coronary Artery Bypass Surgery (CABG) (assessment method and time to randomisation not specified) Depression diagnosis: A score of 13 or greater on the Center for Epidemiological Studies ‐ Depression Scale (CES‐D) and/or a score of 36 or greater on the Spielberger State Anxiety Inventory (SSAI); 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 for 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 significantly higher anxiety scores at baseline; no further information regarding comparability of groups |
|
| Interventions | Treatment: Alprazolam (tablets, 2.5mg/d at bedtime, maximum dose 4.5mg/d) Control: Placebo Duration of treatment: 1 month |
|
| Outcomes | Review outcomes: CES‐D score, Zung Self‐Rating Depression Scale (Zung SDS) score Other Outcomes: SSAI score, Zung Self‐Rating Anxiety Scale (Zung SAS), Physician's Global Impression Scale, signs and symptoms of psychosis, cognitive dysfunction, depression, anxiety, and somatization (psychiatric semistructured interviews) |
|
| Funding | Upjohn Company | |
| Notes | Mixed study sample (patients 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 (performance bias and 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 dropouts in the alprazolam group (with noncompleters being less distressed than completers preoperatively) Comment: 25 early dropouts in the placebo group (with noncompleters being more distressed than completers preoperatively) |
| Selective reporting (reporting bias) | High risk | Comment: No protocol or design paper available Comment: Signs and symptoms of psychosis, cognitive dysfunction, depression, anxiety, and somatization (psychiatric semistructured interviews) assessed but not reported |
| Other bias | High risk | Comment: Possible selection bias: 60% of 459 patients met entrance criteria, but only 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 Comment: Conflicting interests: Funding through Upjohn Company |