Van Vliet 1996.
Methods | Study design: Randomised controlled trial | |
Participants |
Diagnosis: DSM‐III‐R panic disorder with or without agoraphobia Method of diagnosis: open interview Age: M = 35, SD = 7.46 Sex: 26 women, 6 men Location: the Netherlands; setting: outpatients Co‐morbidities: patients with another anxiety disorder, major affective disorders or psychotic disorder, alcohol or drug abuse and medical problems were excluded Rescue medication: oxazepam maximum 30 mg daily |
|
Interventions |
Participants were randomly assigned to either: (1) brofaromine arm (n = 15) Duration: 12 weeks Treatment Protocol: fixed dosage 150 mg (2) fluvoxamine arm (n = 15) Duration: 12 weeks Treatment Protocol: fixed dosage 150 mg |
|
Outcomes |
Time points for assessment: weekly Outcomes: 1. Hamilton Rating Scale for Anxiety (HAMA) 2. Montgomery–Åsberg Depression Rating Scale (MADRS) 3. Fear Questionnaire 4. number of panic attacks 5. Hamilton Rating Scale for Depression (HAM‐D) 6. SCL‐90 |
|
Notes |
Date of study: not stated Funding source: not stated Declarations of interest among the primary researchers: not stated. |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "randomly". |
Allocation concealment (selection bias) | Unclear risk | No information provided. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "double blind". No further information provided. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "double blind". No further information provided. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No information provided about management of incomplete outcome data. |
Selective reporting (reporting bias) | High risk | Continuous outcomes are reported incompletely (number of evaluated patients is not reported), so that they cannot be entered in a meta‐analysis; Fear Questionnaire data for agoraphobia are only reported in graphs. |
Other bias | Unclear risk | Sponsorship bias cannot be ruled out. |