Sloand 2004.
Methods | Randomised, placebo‐controlled trial | |
Participants | 25 adult men and women with ESRD (on either haemodialysis or peritoneal dialysis) who also had RLS by IRLSSG criteria, recruited from the dialysis units of a single medical centre (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: sodium chloride given in the same volume and with the same timing as the intervention group |
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Outcomes | ferritin, hematocrit, gastrointestinal side effects, University of Rochester severity score (10‐point scale, where 0 = none, 10 = bad) at 0, 1, 2, 4 weeks | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method of randomisation not specified |
Allocation concealment (selection bias) | Low risk | Randomisation appears to have been performed by pharmacy |
Blinding (performance bias and detection bias) All outcomes | Low risk | Medication and tubing covered with opaque sleeve to conceal treatment condition |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Two placebo participants dropped out after infusion; Figure 1 reports data on all 14 placebo participants although use of last observation carried forward not explicitly stated |
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 |