Table 1.
Baseline characteristics and overview of the included studies
| Study | Follow-up (weeks) | ITT population (n)
|
Race | Age (years) (mean ± SD)
|
Sex (female%)
|
Baseline IRLS score (mean ± SD)
|
PPX administration | Scale of self-rated sleep quality | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PPX | PBO | PPX | PBO | PPX | PBO | PPX | PBO | |||||
| Winkelman et al8 | 12 | 254 | 85 | White (97.3%) | 51.4 ± 12.7 | 51.5 ± 14.0 | 61.8 | 63.5 | 23.4 ± 5.1 | 23.5 ± 5.2 | Starting dose = 0.125 mg/day forced titrated up to 0.25, 0.5, 0.75 mg/day 3 weeks after | VAS |
| Partinen et al9 | 3 | 86 | 21 | White | 56.9 ± 10.8 | 53.3 ± 11.1 | 72.1 | 81 | 22.7 ± 4.1 | 22.9 ± 4.2 | Fixed dose: 0.125, 0.25, 0.5, 0.75 mg/day | SSQ* |
| Oertel et al10 | 6 | 224 | 144 | White (98.8%) | 55.4 ± 11.6 | 55.8 ± 10.9 | 64.3 | 68.4 | 24.7 ± 5.2 | 24.9 ± 5. 4 | Starting dose = 0.125 mg/day Stepwise increased to optimum dose: 0.25, 0.5, 0.75 mg/day | VAS |
| Ferini-Strambi et al11 | 12 | 182 | 182 | White (99.5%) | 56.3 ± 12.4 | 56.9 ± 13.0 | 72.5 | 63.6** | 24.2 ± 5.2 | 24.6 ± 5.7 | As above | MOS |
| Inoue et al12 | 6 | 20 | 21 | Asian | 48.7 ± 16.1 | 62.3 ± 11.9 | 55 | 47.6 | 23.4 ± 6.4 | 25.1 ± 5.8 | As above | PSQI |
| Ma et al13 | 6 | 195 | 92 | Asian | 56.46 ± 11.88 | 56.86 ± 11.89 | 60.5** | 80.6** | Not available | Not available | As above | RLS-6* |
Notes:
*
Data from these two studies cannot be combined for meta-analysis because it is not feasible to merge the scores of diverse items
**
calculation was based on safety population.
Abbreviations: IRLS, International Resdess Leg Syndrome Study Group Rating Scale; ITT, intent-to-treat; MOS, medical outcome study; PBO, placebo; PPX, Pramipexole; PSQI, Pittsburgh Sleep Quality Index; RLS, restless leg syndrome; RLS-6, a six item scale to assess the severity of RLS symptoms; SD, standard deviation; SSQ, subjective sleep quality; VAS, visual analog scale.