Skip to main content
. 2019 Jan 18;2019(1):CD011825. doi: 10.1002/14651858.CD011825.pub2

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
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
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
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.