Appendix F. Table 10aSelf-rated quality of sleep for alpha-2-delta ligands trials: Medical Outcomes Scale- Sleep Problems Index II or Pittsburgh Sleep Quality Index

Study/Duration (wks)Treatment/controlInstrumentBaseline Score (±SD)*Mean change from baseline (±SD)*SMD [95%CI] or P-value between placebo
Lee, 201118Gabapentin enacarbil 600 mg (n=115)MOS-sleep adequacy30.5
(24.08)
29.1
(29.91)
0.0003

<0.0001
Gabapentin enacarbil 1200 mg (n=111)34.7
(24.86)
27.7
(29.1)
Placebo (n=96)34.8
(24.62)
13.6
(24.59)
Allen, 201138
(6)
Pregabalin (300 mg ** n=24)MOS-SPI-II,NR−22.3 (19.1)−0.29 [−0.29 to 0.86]
Placebo (n=23)9-itemNR−16.8 (18.2)
Garcia- Borreguero, 201022
(12)
Pregabalin (n=30)MOS-sleep adequacyNRNRNR, P=0.001
Placebo (n=23)NRNR
Kushida, 200923
(12)
Gabapentin enacarbil (XP13515)(n=112)MOS-sleep
adequacy
NR27.7 (29.9)0.50 [0.23 to 0.76]
Placebo (n=108)NR13.4 (27.4)
Gabapentin enacarbil (XP13515)(n=112)PSQINRNRNR, “all PSQ outcomes significantly improved with XP13515 at week 12”
Placebo (n=108)NRNR
Garcia- Borreguero, 200224
(6 × 2)
Gabapentin (n=22)PSQI9.7 (all patients)6.4 (1.9) ††P<0.001
Placebo (n=22)9.4 (1.9) ††

Medical Outcomes Scale- Sleep Problems Index II; PSQI = Pittsburgh Sleep Quality Index; SD = standard deviation; SMD = standardized mean difference

*

If provided.

**

Fixed dose study (range 50–400 mg), 300 mg dose used for analysis.

Crossover trial, two 6 week treatment periods

††

Scores at end of treatment

If provided.

Fixed dose study (range 50–400 mg), 300 mg dose used for analysis.

Crossover trial, two 6 week treatment periods

Scores at end of treatment

From: Appendix F, Outcomes Tables

Cover of Treatment for Restless Legs Syndrome
Treatment for Restless Legs Syndrome [Internet].
Comparative Effectiveness Reviews, No. 86.
Wilt TJ, MacDonald R, Ouellette J, et al.

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