Table 1.
Summary of 4 Randomized, Double-Blind, Placebo-Controlled Studies of Duloxetine for the Treatment of Fibromyalgia
Study | Treatment Duration | Dose | Duloxetine (n) | Placebo (n) | Primary Efficacy Measures |
118 | 12 wk | 60 mg bid | 104 | 103 | FIQ total score |
FIQ pain score | |||||
219 | 12 wk | 60 mg qd | 118 | 120 | BPI 24-h average pain score |
60 mg bid | 116 | ||||
320 | 28 wk | 20 mg qd | 79 | 144 | BPI 24-h average pain score |
60 mg qd | 150 | PGI-I score | |||
120 mg qd | 147 | ||||
421 | 28 wk | 60/120 mg qd | 162 | 168 | BPI 24-h average pain score |
PGI-I score |
Abbreviations: bid = twice daily, BPI = Brief Pain Inventory FIQ = Fibromyalgia Impact Questionnaire, PGI-I = Patient Global Impressions-Improvement scale, qd = once daily.