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

GSK‐29060/1.

Methods Study design: Randomised controlled trial
Participants Diagnosis: Panic disorder according to the DSM ‐ III criteria
Method of diagnosis: Structured Clinical Interview (SCID) for DSM ‐ III
Age: for paroxetine, M = 39.1 (SD = 11.1); for alprazolam, M = 39.5 (SD = 12.5)
Sex: for paroxetine, 49 women, 28 men; for alprazolam 48 women, 28 men
Location: USA; setting: outpatients
Co‐morbidities: patients with Axis I disorders other than panic disorder, current major depression (unless panic disorder dominated the clinical picture and preceded affective symptoms chronologically), any severe or uncontrolled medical condition were excluded
Rescue medication: Not stated
Interventions Participants were randomly assigned to either:
(1) paroxetine arm (n = 77)
Duration: 10 weeks
Treatment Protocol: flexible dosage; range = 10 ‐ 60 mg, M and SD not provided
(2) alprazolam arm (n = 77)
Duration: 10 weeks
Treatment Protocol: flexible dosage; range = 1 ‐ 6 mg, M and SD not provided
(3) placebo arm (n = 72)
Duration: 10 weeks
Outcomes Time points for assessment: baseline, endpoint (10 weeks)
Outcomes:
1. % of patients having zero panic attacks
2. mean change from baseline in the number of panic attacks
3. % of participants with a > 50% reduction from baseline in the number of full panic attacks
4. Clinical Global Impression Severity of Illness Score (CGI‐S)
5. number of full and limited panic attacks
6. intensity of panic attacks
7. anticipatory anxiety
8. Marks Sheehan Phobia Scale
9. Clinical Global Impression Improvement Score (CGI‐I)
10. Hamilton Rating Scale for Anxiety (HAMA)
11. Montgomery–Åsberg Depression Rating Scale (MADRS)
12. Sheehan Disability Scale (SDS)
13. Social Adjustment Self‐Report Questionnaire
Notes Date of study: November 1992 to April 1994
Funding source: GSK
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: "randomized".
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 Quote: "All subjects in the ITT population (which included all subjects who received any double blind medication) for whom at least one valid post efficacy evaluation was available were included in the ITT efficacy analysis. All subjects randomized were included in the safety analysis".
Selective reporting (reporting bias) Low risk All outcomes were reported.
Other bias High risk Sponsored by GSK; the role of the funder in planning, conducting and writing the study is not discussed.