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. 2015 May 4;33(17):1910–1917. doi: 10.1200/JCO.2014.59.5595

Table 2.

Mean BPI Worst Pain/Stiffness Score, Pain Interference, and Global Rating of Change

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.

a

From linear regression adjusting for baseline BPI score and stratification factors.

b

Among patients with week-6, -12, or -24 BPI worst pain score, respectively.

c

Difference derived from O3-FAs minus placebo.

d

Between-group P values.

e

P value for paired t tests for difference between baseline and week-12 measures within treatment arm.

f

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).

g

P value for unpaired t tests for difference in change measures between treatment arms.

h

Questionnaire evaluates changes in symptoms since last visit, so no baseline scores were collected.