Table 3Individual Outcomes and Strength of Evidence in Placebo-Controlled Studies of Alpha-2-Delta Ligands

Outcome for Treatment vs. Placebo, Strength of EvidenceRLS Treatment That Was Compared With PlaceboNumber of TrialsnSummary Statistics [95% CI] for Comparisons of RLS Treatment vs. PlaceboAbsolute Effect per 100 Patients [95% CI]
Increase in IRLS Rating Scale responders (>50% score reduction) Image clinrestlesslegfu1.jpgGabapentin enacarbil1321RR 1.54 [1.18 to 2.01]21 more per 100 [7 to 40 more]
Pregabalin2182RR 2.03 [1.33 to 3.11]34 more per 100 [11 to 69 more]
Increase in Clinical Global Impressions Scale responders (much or very much improved) Image clinrestlesslegfu1.jpgGabapentin enacarbil2431RR 1.80 [1.51 to 2.14]33 more per 100 [21 to 48 more]
Pregabalin144RR 1.14 [0.80 to 1.64]9 more per 100 [12 fewer to 40 more]
Improvement in RLS quality of life Image clinrestlesslegfu3.jpgGabapentin enacarbil1538SMD 0.42 [0.16 to 0.69]Not reported
Pregabalin1124SMD −0.05 [−0.65 to 0.55]Not reported
Improvement in patient self-rated sleep using the MOS-SPI-II Scale Image clinrestlesslegfu1.jpgGabapentin enacarbil2431SMD 0.53 [0.33 to 0.72]Not reported
Increase in number of patients with >1 adverse event Image clinrestlesslegfu2.jpgGabapentin enacarbil3738RR 1.09 [1.00 to 1.19]Not reported
Pregabalin2195RR 1.67 [0.74 to 3.80]Not reported

See the legend under Table 2.

From: Treatment for Restless Legs Syndrome

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Comparative Effectiveness Review Summary Guides for Clinicians [Internet].

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