Earley 2009.
Methods | Randomized, controlled trial | |
Participants | 18 adult men and women with RLS and PLMS >= 15/hr, enrolled from a single medical center (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: NaCl, given in the same infusion volume & with the same dosing schedule | |
Outcomes | IRLS (a secondary outcome), PLMS/hr by 2nd night PSG, ferritin, global rating scale (7 pt scale of symptom severity completed by the patient), sleep diary, PLMW on SIT, change in CSF ferritin, 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 | randomized 2:1 but doesn't specify method of sequence generation |
Allocation concealment (selection bias) | Low risk | |
Blinding (performance bias and
detection bias) All outcomes |
Unclear risk | Nurse & MD knew treatment status; they were not the outcome assessors but did interact with some subjects |
Incomplete outcome data (attrition
bias) All outcomes |
Low risk | |
Selective reporting (reporting bias) | Unclear risk | no study protocol available |
Other bias | High risk | Stopped early due to data-dependent process (i.e., a stopping rule) |