Den Boer 1990.
Methods | Study design: Randomised controlled trial | |
Participants |
Diagnosis: DSM‐III‐R Method of diagnosis: not stated Age: for fluvoxamine M = 37, for ritanserin M = 35, for placebo M = 37 Sex: the female to male ratio was almost 3 to 1 in all groups Location: the Netherlands; setting: outpatients Co‐morbidities: patients with a primary diagnosis other than panic disorder were excluded Rescue medication: none |
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Interventions |
Participants were randomly assigned to either: (1) fluvoxamine arm Duration: 8 weeks Treatment Protocol: fixed dosage = 150 mg (2) ritanserin arm Duration: 8 weeks Treatment Protocol: fixed dosage = 20 mg (3) placebo arm Duration: 8 weeks Total number of randomised patients = 60. The number of patients randomised for each arm is not provided. |
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Outcomes |
Time points for assessment: baseline, weekly Outcomes: 1. SCL‐90 2. Hamilton Rating Scale for Anxiety (HAMA) 3. State‐Trait Anxiety Inventory (STAI) 4. Fear Questionnaire (FQ) 5. panic inventory |
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Notes |
Date of study: not stated Funding source: not stated Declarations of interest among the primary researchers: not stated. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "randomised". |
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 | Data are reported in graphs (HAMA, FQ); other data only partially reported. |
Other bias | Unclear risk | Sponsorship bias cannot be ruled out. |