Earley 2009.
Methods | Randomised, placebo‐controlled trial | |
Participants | 18 adult men and women with RLS and PLMS > 15/hr, enrolled from a single medical centre (USA) | |
Interventions | Intervention: iron sucrose, given as a 500 mL infusion (containing 500 mg iron sucrose) over 10 hours, then another 500 mL over 12 hours the following day Placebo: sodium chloride, given in the same infusion volume and with the same dosing schedule |
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Outcomes | IRLS (a secondary outcome), PLMS/hr by second night PSG, ferritin, global rating scale (7‐point scale of symptom severity completed by the participant), sleep diary, periodic limb movements during wake on the suggested immobilisation test, change in cerebrospinal fluid ferritin levels, change in MRI iron index in substantia nigra | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomised 2:1 but does not specify method of sequence generation |
Allocation concealment (selection bias) | Low risk | Randomisation performed by pharmacy |
Blinding (performance bias and detection bias) All outcomes | Low risk | Nurse and one investigator (CJE) knew treatment status at times but were not outcome assessors. IV solution and tubing wrapped with black opaque plastic to conceal solution |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All subjects who received interventions were analysed |
Selective reporting (reporting bias) | Unclear risk | No study protocol available |
Other bias | Low risk | No other risks identified; prior review rated high risk of bias for early stopping based on stopping rule, but this has been removed per current Cochrane guidance |