Table 4.
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TREATMENT | NUMBER OF PATIENTS | STUDY DESIGN | DOSE, DURATION | RESULTS | SIDE EFFECTS |
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Intravenous (IV) iron dextran [58] | 25 Iron dextran: 11 Placebo: 14 |
Double blind- placebo controlled | Iron dextran: 1000 mg Study duration: 4 weeks. IRLS intensity scores were assessed weekly |
At weeks 1 and 2 post-injection, patients in the Iron treated group showed significant reduction of IRLS scores (P = 0.01 and P = 0.03). At week 4, though still lower than placebo, the difference was not statistically significant | No difference in adverse effects between the two groups |
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Intravenous iron sucrose [59] | 30 IV Iron Sucrose: 16 Placebo: 16 |
Randomized, placebo-controlled | Iron sucrose: 100 mg, three times/week for a total of 1000 mg. Study duration: 3 weeks | After two weeks, IRLS scores (compared to baseline) were significantly reduced compared to placebo group (P = 0.000). Improvement of IRLS score in the iron group continued for 4–24 weeks. | No adverse effects |
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Intravenous iron sucrose [60] | 18 Iron sucrose:11 Placebo:7 |
Double blind- placebo controlled | 500 mg of Iron sucrose was administered IV in two successive days for a total of 1000 mg Study duration: 4 weeks Primary outcome for RLS symptom improvement was global rating scale (GRS) |
The trial was aborted half- way into the study since despite some improvement in GRS (at two weeks), authors predicted lack of robust response at the end of the study | Edema in either hands or feet (36%). Nausea or vomiting (36%). Hypotension (18%). dizziness (18%). abdominal pain (9%). All noted during infusion only. |
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GRS: Global rating Scale.