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. 2019 Jan 18;2019(1):CD011825. doi: 10.1002/14651858.CD011825.pub2

Peterson 1996.

Methods Design: randomised, placebo‐controlled, 4‐armed trial
Participants Number assigned: 89 adults and elderly (macrolide n = 55, placebo n = 34)
Age in years (mean (range)): macrolide: 51.7 (26 to 77), placebo: 48.4 (22 to 76)
Setting: secondary care
Interventions Indication: duodenal ulcer
Type of macrolide: clarithromycin
Route: per oral
Dose per day: 1500 mg
Duration of treatment: 14 days
Total treatment dose: 21,000 mg
Outcomes Adverse events stated as an outcome in trial registration/protocol/paper: yes
Adverse events ascertainment: physical + clinical examination (lab tests)
Adverse events: data reported
Antimicrobial resistance: not reported
Death: not reported
Funding sources Study supported by Glaxo Wellcome Inc.
Notes Concomitant medication: yes
Note: this is a 4‐armed randomised controlled trial (placebo, clarithromycin, ranitidine bismuth citrate, ranitidine bismuth citrate + clarithromycin). Importantly, the participants in both the macrolide and the placebo group received a placebo at some time to ensure blinding in all groups.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Sequence generation not described.
Allocation concealment (selection bias) Unclear risk Allocation not described.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Identical‐appearing placebo
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Participants and clinicians blinded.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Dropouts due to adverse events reported.
Selective reporting (reporting bias) Low risk Adverse events stated as an outcome, standardised ascertainment, and adverse events reported.
Other bias Unclear risk Participants were assigned in a 2:1 ratio.