Wang 2009.
Methods | Randomised, placebo‐controlled | |
Participants | 18 adult men and women with RLS who had ferritin 15‐75 ng/mL and IRLS scores >= 11 | |
Interventions | Intervention: ferrous sulfate 325 mg bid in non‐descript capsules Placebo: lactose, appearance‐matched Study drug continued for 12 weeks |
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Outcomes | IRLS (BL, 6 weeks, 12 weeks), ferritin (BL, 6 weeks, 12 weeks), single question on change in quality of life at 12 weeks (improved, same, worsened), compliance at 6 and 12 weeks (by manual pill count) | |
Notes | Authors raise issue of iron causing stool discolouration and therefore inadvertent unblinding, although this is speculative | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Used randomly generated sequenced number programme |
Allocation concealment (selection bias) | Low risk | Independent investigative pharmacist performed randomisation and kept randomisation code in locked cabinet |
Blinding (performance bias and detection bias) All outcomes | Low risk | Matched capsules of placebo and iron; investigators and participants blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants who were randomised completed the study |
Selective reporting (reporting bias) | Unclear risk | No study protocol available |
Other bias | Low risk | No other risks identified |
BL: baseline CGI‐I: Clinical Global Impression of Improvement ESRD: end‐stage renal disease ESS: Epworth Sleepiness Scale FSS: fatigue severity scale IRLS: International RLS Study Group severity scale IRLSSG: International Restless Legs Syndrome Study Group IV: intravenous MOS: medical outcomes of sleep MRI: magnetic resonance imaging PGI‐C: Patient Global Impression of Change
PLMS: periodic limb movements of sleep PSG: polysomnography PSQI: Pittsburgh Sleep Quality Index RLS: restless legs syndrome RLS‐QoL: RLS quality of life scale SF‐36: Short‐form‐36 VAS: visual analogue scale