Table 1.
Patient Demographics and Baseline Characteristics
| Parametera | Duloxetine n=177 |
Placebo n=176 |
Total n=353 |
|---|---|---|---|
| Age, years | 65.5 (8.0) | 66.4 (8.4) | 65.9 (8.2) |
| Male, n (%) | 35 (19.8) | 44 (25.0) | 79 (22.4) |
| Duration of OA, years | 4.0 (4.2) | 4.5 (4.3) | 4.2 (4.2) |
| BPI average pain score | 5.0 (1.0) | 5.1 (1.0) | 5.0 (1.0) |
| SF-36 score | |||
| SF361: Physical Functioning | 57.6 (19.1) | 55.9 (18.2) | 56.8 (18.7) |
| SF362: Role-Physicalb | 71.2 (23.7) | 73.5 (20.0) | 72.3 (21.9) |
| SF363: Bodily Pain | 45.9 (12.9) | 45.1 (12.9) | 45.5 (12.9) |
| SF364: General Health | 62.7 (16.0) | 64.0 (16.3) | 63.4 (16.1) |
| SF365: Vitality | 66.3 (18.1) | 65.4 (16.8) | 65.9 (17.4) |
| SF366: Social Functioning | 84.7 (19.3) | 85.8 (18.9) | 85.2 (19.1) |
| SF367: Role-Emotionalc | 80.8 (23.5) | 85.8 (17.4) | 83.3 (20.8) |
| SF368: Mental Health | 79.0 (17.0) | 78.4 (14.8) | 78.7 (15.9) |
| WOMACd total score | 32.67 (13.18) | 32.70 (13.71) | 32.68 (13.43) |
| WOMAC pain subscale score | 7.46 (2.66) | 7.55 (2.74) | 7.50 (2.70) |
| PAIN1W: Walking on a flat surface | 1.41 (0.74) | 1.45 (0.70) | 1.43 (0.72) |
| PAIN2W: Going up or down stairs | 2.28 (0.71) | 2.28 (0.79) | 2.28 (0.75) |
| PAIN3W: At night while in bed (pain that disturbs your sleep) | 0.98 (0.85) | 0.97 (0.80) | 0.98 (0.83) |
| PAIN4W: While sitting or lying down | 1.62 (0.83) | 1.72 (0.89) | 1.67 (0.86) |
| PAIN5W: While standing | 1.16 (0.74) | 1.12 (0.86) | 1.14 (0.80) |
| WOMAC stiffness subscale score | 3.01 (1.49) | 3.02 (1.55) | 3.01 (1.52) |
| STIFF6W: On first waking up in the morning | 1.39 (0.91) | 1.41 (0.90) | 1.40 (0.91) |
| STIFF7W: After sitting or lying down or while resting later in the day | 1.62 (0.80) | 1.60 (0.87) | 1.61 (0.84) |
| WOMAC physical function subscale score | 22.20 (10.21) | 22.14 (10.51) | 22.17 (10.35) |
| PFTN8W: Difficulty going down stairs | 2.11 (0.89) | 2.09 (0.85) | 2.10 (0.87) |
| PFTN9W: Difficulty going up stairs | 1.73 (0.82) | 1.68 (0.86) | 1.71 (0.83) |
| PFTN10W: Difficulty getting up from a sitting position | 1.90 (0.94) | 1.92 (0.94) | 1.91 (0.94) |
| PFTN11W: Difficulty while standing | 1.03 (0.77) | 1.05 (0.82) | 1.04 (0.79) |
| PFTN12W: Difficulty bending to the floor | 1.53 (0.85) | 1.52 (0.89) | 1.52 (0.87) |
| PFTN13W: Difficulty walking on a flat surface | 1.18 (0.81) | 1.11 (0.77) | 1.14 (0.79) |
| PFTN14W: Difficulty getting in or out of a car, or getting on or off a bus | 1.35 (0.84) | 1.38 (0.89) | 1.36 (0.87) |
| PFTN15W: Difficulty while going shopping | 1.17 (0.83) | 1.19 (0.78) | 1.18 (0.80) |
| PFTN16W: Difficulty putting on socks or panty hose or stockings | 1.11 (0.84) | 1.16 (0.85) | 1.14 (0.84) |
| PFTN17W: Difficulty getting out of bed | 1.14 (0.88) | 1.17 (0.84) | 1.16 (0.86) |
| PFTN18W: Difficulty taking off socks or panty hose or stockings | 1.11 (0.85) | 1.09 (0.85) | 1.10 (0.85) |
| PFTN19W: Difficulty while lying in bed | 0.66 (0.74) | 0.72 (0.74) | 0.69 (0.74) |
| PFTN20W: Difficulty getting in or out of the bathtub | 1.06 (0.86) | 0.98 (0.81) | 1.02 (0.84) |
| PFTN21W: Difficulty while sitting | 1.64 (1.09) | 1.63 (1.04) | 1.63 (1.07) |
| PFTN22W: Difficulty getting on or off the toilet | 0.91 (0.84) | 0.88 (0.89) | 0.89 (0.86) |
| PFTN23W: Difficulty doing heavy household chores | 1.80 (0.87) | 1.81 (0.93) | 1.80 (0.90) |
| PFTN24W: Difficulty doing light household chores | 0.79 (0.68) | 0.77 (0.73) | 0.78 (0.71) |
Notes: aExcept where otherwise indicated, data are mean (standard deviation). bRole limitations because of physical problems. cRole limitations because of emotional problems. dWOMAC scale items from Bellamy N, Buchanan WW, Goldsmith CH, et al. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988;15(12):1833–1840. Copyright © 1996 Nicholas Bellamy. All Rights Reserved.28
Abbreviations: BPI, Brief Pain Inventory; OA, osteoarthritis; SF-36, 36-item Short Form Survey; WOMAC, Western Ontario and McMaster Universities Osteoarthritis Index.