Table 2.
Analysis | No. of Patients | Observed Results |
Adjusted Resultsa |
|||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Baselineb |
Follow-Up |
Within Group |
Between Group |
Follow-Up |
Differencec | 95% CI | Pd | |||||||
Mean | 95% CI | Mean | 95% CI | Difference | Pe | Differencef | Pg | Mean | 95% CI | |||||
BPI worst pain score | ||||||||||||||
Week 6 | −0.33 | .32 | −0.27 | −0.88 to 0.34 | .38 | |||||||||
O3-FAs | 108 | 7.09 | 6.80 to 7.39 | 5.41 | 4.94 to 5.87 | −1.69 | < .001 | 5.38 | 4.77 to 5.99 | |||||
Placebo | 115 | 6.98 | 6.71 to 7.25 | 5.63 | 5.17 to 6.08 | −1.36 | < .001 | 5.65 | 5.04 to 6.26 | |||||
Week 12 | −0.24 | .38 | −0.17 | −0.79 to 0.44 | .58 | |||||||||
O3-FAs | 102 | 7.08 | 6.77 to 7.39 | 5.34 | 4.85 to 5.84 | −1.74 | < .001 | 5.30 | 4.68 to 5.91 | |||||
Placebo | 107 | 6.92 | 6.65 to 7.20 | 5.43 | 4.97 to 5.89 | −1.50 | < .001 | 5.47 | 4.86 to 6.09 | |||||
Week 24 | −0.43 | .52 | −0.36 | −1.08 to 0.38 | .34 | |||||||||
O3-FAs | 94 | 7.06 | 6.75 to 7.38 | 4.83 | 4.28 to 5.38 | −2.23 | < .001 | 4.77 | 4.04 to 5.50 | |||||
Placebo | 98 | 6.88 | 6.59 to 7.16 | 5.07 | 4.53 to 5.61 | −1.81 | < .001 | 5.13 | 4.40 to 5.86 | |||||
BPI pain interference | ||||||||||||||
Week 6 | −0.06 | .82 | −0.05 | −0.57 to 0.47 | .84 | |||||||||
O3-FAs | 108 | 4.14 | 3.73 to 4.55 | 3.22 | 2.74 to 3.69 | −0.92 | < .001 | 3.22 | 2.84 to 3.59 | |||||
Placebo | 115 | 4.13 | 3.72 to 4.54 | 3.27 | 2.82 to 3.72 | −0.86 | < .001 | 3.27 | 2.91 to 3.63 | |||||
Week 12 | 0.10 | .74 | 0.11 | −0.44 to 0.66 | .70 | |||||||||
O3-FAs | 102 | 4.17 | 3.74 to 4.60 | 3.14 | 2.64 to 3.64 | −1.03 | < .001 | 3.12 | 2.73 to 3.51 | |||||
Placebo | 107 | 4.12 | 3.70 to 4.55 | 2.99 | 2.55 to 3.44 | −1.13 | < .001 | 3.01 | 2.63 to 3.40 | |||||
Week 24 | −0.14 | .65 | −0.15 | −0.39 to 0.70 | .58 | |||||||||
O3-FAs | 94 | 4.05 | 3.62 to 4.48 | 2.57 | 2.10 to 3.05 | −1.48 | < .001 | 2.58 | 2.19 to 3.00 | |||||
Placebo | 98 | 4.09 | 3.64 to 4.54 | 2.75 | 2.28 to 3.21 | −1.34 | < .001 | 2.74 | 2.35 to 3.13 | |||||
Global rating of change in joint pain from baselineh | ||||||||||||||
Week 6 | 0.10 | .56 | 0.10 | −0.24 to 0.44 | .57 | |||||||||
O3-FAs | 109 | 0.72 | 0.47 to 0.96 | — | < .001 | 0.72 | 0.47 to 0.96 | |||||||
Placebo | 112 | 0.62 | 0.39 to 0.85 | — | < .001 | 0.62 | 0.38 to 0.86 | |||||||
Week 12 | 0.27 | .16 | 0.26 | −0.10 to 0.63 | .16 | |||||||||
O3-FAs | 98 | 0.76 | 0.47 to 1.04 | — | < .001 | 0.75 | 0.49 to 1.02 | |||||||
Placebo | 104 | 0.49 | 0.25 to 0.73 | — | < .001 | 0.49 | 0.24 to 0.75 | |||||||
Week 24 | 0.08 | .74 | 0.07 | −0.35 to 0.49 | .74 | |||||||||
O3-FAs | 90 | 0.77 | 0.46 to 1.08 | — | < .001 | 0.77 | 0.46 to 1.07 | |||||||
Placebo | 95 | 0.69 | 0.40 to 0.99 | — | < .001 | 0.70 | 0.40 to 0.99 | |||||||
Global rating of change in joint stiffness from baselineh | ||||||||||||||
Week 6 | 0.13 | .43 | 0.13 | −0.20 to 0.46 | .44 | |||||||||
O3-FAs | 109 | 0.59 | 0.35 to 0.82 | — | < .001 | 0.59 | 0.35 to 0.82 | |||||||
Placebo | 114 | 0.46 | 0.23 to 0.69 | — | < .001 | 0.46 | 0.23 to 0.69 | |||||||
Week 12 | 0.27 | .12 | 0.28 | −0.07 to 0.62 | .12 | |||||||||
O3-FAs | 98 | 0.68 | 0.41 to 0.95 | — | < .001 | 0.68 | 0.43 to 0.93 | |||||||
Placebo | 103 | 0.41 | 0.18 to 0.63 | — | < .001 | 0.41 | 0.16 to 0.65 | |||||||
Week 24 | 0.00 | 1.00 | −0.003 | −0.41 to 0.41 | .99 | |||||||||
O3-FAs | 91 | 0.65 | 0.35 to 0.94 | — | < .001 | 0.65 | 0.35 to 0.94 | |||||||
Placebo | 97 | 0.65 | 0.36 to 0.94 | — | < .001 | 0.65 | 0.36 to 0.94 |
Abbreviations: BPI, Brief Pain Inventory; O3-FA, omega-3 fatty acid.
From linear regression adjusting for baseline BPI score and stratification factors.
Among patients with week-6, -12, or -24 BPI worst pain score, respectively.
Difference derived from O3-FAs minus placebo.
Between-group P values.
P value for paired t tests for difference between baseline and week-12 measures within treatment arm.
Difference from change between follow-up and baseline score for O3-FAs minus change between baseline and follow-up for placebo (ie, difference in differences).
P value for unpaired t tests for difference in change measures between treatment arms.
Questionnaire evaluates changes in symptoms since last visit, so no baseline scores were collected.