Ogrendik 2011.
Methods | Design: randomised, placebo‐controlled, parallel‐group trial | |
Participants |
Number assigned: 100 adults (macrolide n = 50, placebo n = 50) Age in years (mean ± SD): macrolide: 49 ± 7, placebo: 45 ± 8 Setting: secondary care |
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Interventions |
Indication: rheumatoid arthritis Type of macrolide: roxithromycin Route: per oral Dose per day: 300 mg Duration of treatment: 6 months Total treatment dose: 54,000 mg |
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Outcomes |
Adverse events stated as an outcome in trial registration/protocol/paper: unclear Adverse events ascertainment: participant asked Adverse events: data reported Antimicrobial resistance: not reported Death: reported that no deaths occurred |
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Funding sources | None stated. | |
Notes | Concomitant medication: yes | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Central computer‐generated randomisation |
Allocation concealment (selection bias) | Low risk | Central allocation |
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 | Low dropout, most discontinued because of lack of efficacy of treatments |
Selective reporting (reporting bias) | Low risk | Unclear if adverse events were stated as an outcome. Standardised ascertainment, only most frequently reported adverse events reported (5% cut‐off). |
Other bias | Low risk | None were identified. |