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 |
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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 |
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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 |
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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. |
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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. |