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. Author manuscript; available in PMC: 2014 Jun 25.
Published in final edited form as: Cochrane Database Syst Rev. 2012 May 16;5:CD007834. doi: 10.1002/14651858.CD007834.pub2

Sloand 2004.

Methods randomized, placebo-controlled trial
Participants 25 adult men and women with ESRD (on either hemodialysis or peritoneal dialysis) who also had RLS by IRLSSG criteria, recruited from the dialysis units of a single medical center (USA)
Interventions Active: IV iron dextran given as: 30 mg test dose over 3 min, followed by 970 mg (in 485 mL volume) over 3 hrs if no reaction to the test dose Placebo: NaCl given in the same volume & and with the same timing as the intervention group
Outcomes ferritin, Hct, GI side effects, U of R severity score (10 pt scale where 0=none, 10=bad) at 0, 1, 2, 4 wks
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk method of randomization not specified
Allocation concealment (selection bias) Low risk
Blinding (performance bias and detection bias)
All outcomes
Low risk
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk two placebo patients dropped out after infusion, but Figure 1 reports data on all 14 placebo patients
Selective reporting (reporting bias) Unclear risk no study protocol available
Other bias Unclear risk baseline imbalance of 2 points in RLS severity score; there was also a broader range of scores in the treated group; imbalance in duration of dialysis