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 |