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. 2016 Sep 12;2016(9):CD011567. doi: 10.1002/14651858.CD011567.pub2

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
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
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)
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
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.