Table 3.
Study duration | Study |
|||||||||
---|---|---|---|---|---|---|---|---|---|---|
Goldstein et al36 |
Wernicki et al38 |
Raskin et al37 |
||||||||
12 weeks | 12 weeks | 12 weeks | ||||||||
Demographics | ||||||||||
Percentage female | 38.5 | 38.9 | 53.4 | |||||||
Mean age (years) | 60.1 | 60.7 | 58.8 | |||||||
Treatment group | DLX 20 mg | DLX 60 mg | DLX 120 mg | PBO | DLX 60 mg | DLX 120 mg | PBO | DLX 60 mg | DLX 120 mg | PBO |
n | 115 | 114 | 113 | 115 | 114 | 112 | 108 | 116 | 116 | 116 |
Outcome measure (change from baseline ± SE) | ||||||||||
24-hour average pain | −2.36 (0.21) | −2.89 (0.22) | −3.24 (0.23) | −1.91 (0.22) | −2.72 (0.22)* | −2.84 (0.23)* | −1.39 (0.23) | −2.50 (0.18)* | −2.47 (0.18)* | −1.60 (0.18) |
24-hour worst pain | −2.78 (0.23) | −3.31 (0.24)* | −3.72 (0.24)* | −2.09(0.24) | −3.21 (0.25)* | −3.39 (0.26)* | −1.94 (0.25) | −2.97 (0.20)* | −2.84 (0.20)* | −2.03 (0.20) |
Brief pain inventory | ||||||||||
Average pain | −2.25 (0.21) | −2.81 (0.21)* | −3.07 (0.22)* | −2.04 (0.21) | −2.66 (0.23)* | −3.05 (0.24)* | −1.48 (0.23) | −2.65 (0.19)* | −2.62 (0.19)* | −1.82 (0.19) |
Worst pain | – | – | – | – | −3.33 (0.27)* | −3.50 (0.28)* | −1.98 (0.28) | −3.00 (0.22) | −3.09 (0.22)* | −2.20 (0.22) |
Least pain | – | – | – | – | −1.88 (0.22)* | −2.30 (0.22)* | −0.86 (0.22) | −1.98 (0.18)* | −1.86 (0.18)* | −1.17 (0.18) |
CGI -S | −1.28 (0.11)* | −1.42 (0.12)* | −1.7 (0.12)* | −0.83 (0.12) | −1.37 (0.11)* | −1.47 (0.12)* | −0.98 (0.12) | −1.42 (0.09)* | −1.40 (0.10)* | −0.93 (0.09) |
PGI -I | 2.68 (0.12) | 2.21 (0.12)* | 2.24 (0.12)* | 2.91 (0.12) | 2.61 (1.44)* | 2.40 (1.29)* | 3.17 (1.44) | 2.50 (0.10)* | 2.54 (0.10)* | 3.04 (0.10) |
Note: Results were statistically significant (P < 0.05) versus placebo.
Abbreviations: DLX, duloxetine; PBO, placebo; FIQ, Fibromyalgia Impact Questionnaire; CGI-I, Clinical Global Impressions of Severity; PGI-I, Patient’s Global Impressions of Improvement; SE, standard error.