Allen 2011.
Methods | Randomised, placebo‐controlled trial | |
Participants | 46 adult men and women with at least moderately severe RLS (IRLS >= 15), RLS symptoms at least five nights per week, and at least 15 PLMS/hour, enrolled from multiple sites | |
Interventions | Intervention: ferric carboxymaltose 500 mg in 100 mL normal saline, infused over 15 minutes, on days 0 and 5 Placebo: 100 mL normal saline with same dosing schedule |
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Outcomes | IRLS, RLS‐QoL, CGI‐I, PGI‐C, MOS scale, FSS, PLMS measured by actigraphy, ferritin | |
Notes | Funded by pharmaceutical company | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Study randomised, but method of sequence generation not specified |
Allocation concealment (selection bias) | Low risk | Central allocation using interactive voice recognition system |
Blinding (performance bias and detection bias) All outcomes | Low risk | Study nurse not blinded and interacted with participants, but was not an outcome assessor. IV bag and tubing concealed for study drug administration |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Three dropouts were not included in final analysis, all three from placebo group, all withdrew before receiving full dose of placebo (i.e. after 0 or 1 doses), none reported side effects |
Selective reporting (reporting bias) | Unclear risk | Study protocol available but clinicaltrials.gov reports the protocol was first received 2/23/11, after the study was completed |
Other bias | Low risk | No other risks identified |