Pollack 2007b.
Methods | Study design: Randomised controlled trial | |
Participants |
Diagnosis: DSM‐IV panic disorder with or without agoraphobia Method of diagnosis: Mini‐International Neuropsychiatric Interview Age: for venlafaxine 75 mg, M = 36.2, SD = 10.7; for venlafaxine 150 mg, M = 37.7, SD = 11.5, for paroxetine M = 37.6, SD = 10.5 Sex: for venlafaxine 75 mg, females = 66%, males = 34%; for venlafaxine 150 mg, females = 70%, males = 30%; for paroxetine females = 64%, males = 36% Location: Europe; setting: outpatients Co‐morbidities: patients with other predominant Axis I or II disorders and important medical conditions were excluded Rescue medication: zaleplon or zolpidem permitted up to 3 times per week for the first 2 weeks of randomised treatment |
|
Interventions |
Participants were randomly assigned to either: (1) venlafaxine 75 mg arm (n = 166) Duration: 12 weeks Treatment Protocol: fixed dosage = 75 mg/day (2) venlafaxine 150 mg arm (n = 168) Duration: 12 weeks Treatment Protocol: fixed dosage = 150 mg/day (3) paroxetine arm (n = 166) Duration: 12 weeks Treatment Protocol: fixed dosage = 40 mg/day (4) placebo arm (n = 163) Duration: 12 weeks |
|
Outcomes |
Time points for assessment: baseline, weeks 1, 2, 3, 4, 6, 8, 10, 12 Outcomes: 1. frequency of panic attacks from the Panic and Anticipatory Anxiety Scale 2. patients free of panic attacks at endpoint 3. Panic Disorder Severity Scale (PDSS) 4. PDSS: anticipatory anxiety 5. Phobia Scale 6. Hamilton Rating Scale for Anxiety (HAMA) 7. Sheehan Disability Scale (SDS) 8. Quality of Life Enjoyment and Satisfaction Questionnaire 9. Clinical Global Impression Improvement Score (CGI‐I) |
|
Notes |
Date of study: not stated Funding source: sponsored by Wyeth Research Declarations of interest among the primary researchers: members of advisory boards, and research support received by many pharmaceutical companies, including AstraZeneca, GlaxoSmithKline, Eli Lilly, Pfizer, Roche, Wyeth; some authors' affiliations refer to Wyeth. |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "randomized". |
Allocation concealment (selection bias) | Unclear risk | No information provided. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "Study medication was provided as identical appearing capsules and was to be taken once daily with food". |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Study medication was provided as identical appearing capsules and was to be taken once daily with food". |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Quote: "statystical analysis on the primary and secondary outcome measures were performed for an ITT population of patients who had at least one post randomisation visit on therapy using LOCF values". |
Selective reporting (reporting bias) | Low risk | All outcomes were reported. |
Other bias | High risk | Sponsored by Wyeth; the role of the funder in planning, conducting and writing the study is not discussed. |