Grote 2009.
Methods | Randomised, placebo‐controlled trial | |
Participants | 60 adult men and women meeting all 4 RLS diagnostic criteria who had IRLS scores >= 10 and s‐ferritin < 45 ng/mL, recruited from three separate hospitals (Sweden) | |
Interventions | Intervention: 200 mg iron sucrose IV (10 mL of 20 mg/mL iron (III) as iron (III)‐hydroxide sucrose complex) given 5 times over 3 weeks Placebo: sodium chloride given with same timing as intervention |
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Outcomes | IRLS (baseline (BL), week 3, week 7, week 11, month 5, month 8, month 12, with difference at week 11 set as primary outcome), ferritin, ESS | |
Notes | Funded by pharmaceutical company | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Minimisation method |
Allocation concealment (selection bias) | Low risk | Central randomisation |
Blinding (performance bias and detection bias) All outcomes | Low risk | Non‐transparent infusion bags and disposables used to obscure treatment condition |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Intention‐to‐treat analysis with last observation carried forward |
Selective reporting (reporting bias) | Unclear risk | Study protocol registered but registration date appears to be after study completion |
Other bias | Low risk | No other risks identified |