Cho 2016.
Methods | Randomised, placebo‐controlled trial | |
Participants | 64 adult men and women with at least moderately severe RLS (IRLS >= 15) and symptoms at least 5 nights/week, enrolled from a single centre (Republic of Korea) | |
Interventions | Intervention: 1000 mg of ferric carboxymaltose, given intravenously in 100 mL normal saline over 15 minutes, as a single dose Placebo: 100 mL normal saline over 15 minutes, as a single dose |
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Outcomes | IRLS, VAS of symptom severity, PSQI, RLS‐QoL, SF‐36, ferritin | |
Notes | Funded by pharmaceutical company | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer random number generator |
Allocation concealment (selection bias) | Unclear risk | May have used an open random allocation scheduled, i.e. "random number sequence" |
Blinding (performance bias and detection bias) All outcomes | Low risk | Nurse who administered intervention was unblinded but did not assess outcomes. IV bottles and lines were covered with foil to prevent identification of FCM versus placebo |
Incomplete outcome data (attrition bias) All outcomes | Low risk | One participant dropped out prior to receiving medications (not analysed). Two participants dropped out after receiving only one dose (included in safety set but not efficacy analyses). Three dropouts from ferric carboxymaltose and one from placebo group, all because of RLS severity. Included in analyses using last observation carried forward |
Selective reporting (reporting bias) | Unclear risk | No mention of protocol registration |
Other bias | Low risk | No other risks identified |