Bandelow 2004.
Methods | Study design: Randomised controlled trial | |
Participants |
Diagnosis: DSM‐IV and ICD‐10 diagnosis of panic disorder with or without agoraphobia Method of diagnosis: Not stated Age: for sertraline, M = 39.6 (SD = 11.7); for paroxetine, M = 38.1 (SD = 11.7) Sex: for sertraline, 60% women, 40% men; for paroxetine 66% women, 34% men Location: 5 centres in Denmark, 22 centres in Germany, 2 centres in the Netherlands, 2 centres in Switzerland, 2 centres in Turkey; setting: outpatients Co‐morbidities: patients with clinically significant and unstable medical illness, bipolar disorder, schizophrenic disorder, delusional disorder, epilepsy, major depressive disorder (MDD), obsessive‐compulsive disorder (OCD), social phobia, history of alcoholism or drug abuse were excluded Rescue medication: chloral hydrate, zolpidem or zopiclone allowed if necessary to treat severe insomnia, less than 3 times per week |
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Interventions | Participants were randomly assigned to either: (1) sertraline arm (n = 112) Duration: 12 weeks Treatment Protocol: flexible dosage; range = 25 ‐ 150 mg, M = 84.5, SD = 39.1 (2) paroxetine arm (n = 113) Duration: 12 weeks Treatment Protocol: flexible dosage; range = 10 ‐ 60 mg, M = 48.1, SD = 11.2 |
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Outcomes |
Time points for assessment: baseline, week 1, 2, 4, 6, 8, 12 and 15 Outcomes: 1. Panic and Agoraphobia Scale (PAS) 2. agoraphobia/avoidance behaviour 3. anticipatory anxiety 4. disability 5. health worries 6. Clinical Global Impression‐Severity of Illness (CGI‐S) 7. Clinical Global Impression‐Improvement (CGI‐I) 8. Hamilton Rating Scale for Anxiety (HAMA) 9. Montgomery–Åsberg Depression Rating Scale (MADRS) 10. Sertraline Quality of Life Battery 11. Digit Symbol Substitution Task 12. Digit Span 13. Patient Global Impression (PGI) |
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Notes |
Date of study: data were collected from January 2000 to June 2001 Funding source: Funded by Pfizer Inc, New York Declarations of interest among the primary researchers: Dr Bandelow has received grant/research support from GlaxoSmithKline |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "they were randomly assigned". No further details. |
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 details. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "double blind". No further details. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | "[...] a secondary analysis was performed on the ITT population, which consisted of all patients who were randomly assigned to study drug and for whom at least one post baseline PAS assessment was available" |
Selective reporting (reporting bias) | Low risk | All outcomes were reported. |
Other bias | High risk | Sponsored by Pfizer; the role of the funder in planning, conducting and writing the study is not discussed. |