Trenkwalder 2017.
Methods | Randomised, placebo‐controlled trial | |
Participants | 110 participants with at least moderately severe RLS (IRLS >= 15) and serum ferritin less than 75 ng/mL (or serum ferritin 75‐300 ng/mL and transferrin saturation < 20%) | |
Interventions | Intervention: intravenous ferric carboxymaltose, 1000 mg infusion over 15 minutes Control: placebo with matched infusion rate |
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Outcomes | IRLS, CGI‐severity, PGI‐C, RLS‐6 quality of life scale, MOS sleep | |
Notes | Funded by pharmaceutical company | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomised by statistician |
Allocation concealment (selection bias) | Low risk | Central allocation |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Nurse administering treatment was not blinded but did not assess outcomes. Unclear how treatment was concealed during IV administration |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Relatively high dropout rate (21%), but for similar reasons and used last observation carried forward |
Selective reporting (reporting bias) | Low risk | Protocol registered on EudraCT prior to start of enrolment; protocol consistent with reported outcomes |
Other bias | Low risk | No other risks identified |