Cohn 1986a.
Methods | 1. Randomized 2. Double blind 3. 2 paralle groups: ‐Buspirone 10‐60mg/d ‐Cloraepate 15‐90mg/d 4. Duration: 4 weeks with 4‐7 single‐blind washout 5. Analysis: end point data using ANOVA; subgroup of axous patients accompanied by depression with HAM‐D of 18 or more also analyzed |
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Participants | 1. Diagnosis: GAD (DSM‐III) 2. N=293 3. Age (mean for all patients): 38.3 Sex: 83% females Setting: outpatients History: exluded women who were pregnant or not using reliable means of contraception, any significant renal, liver, or cardiovascular disease, significant findings on physical examination, electrocardiography, or clinical laboratory evaluation or manifestations of psychosis, borderline states, severe behavioral disorder, organic mental disorders, or serious psychosomatic disorders, patients who had received any central nervous system‐active medication within seven days or any neuroleptic agent, antidepressant, or investigational drug witin four weeks of the study |
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Interventions | 1. Buspirone (N = 218) 2. Clorazepate (N = 75) |
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Outcomes | 1. dropout rates 2. HAM‐A 3. HAM‐D 4. Physician's Questionnaire 5. Lipman‐Rickels Symptom Checklist (SCL‐56) 6. Profile of Mood States (POMS) 7. Sleep Evaluation Questionnaire |
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Notes | (a) Means and SD not avaliable on HAM‐A | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |