Table A1.
Mean M-SACRAH, WOMAC, and FACT-ES Scores at 6, 12, and 24 Weeks
| Analysis | No. of Patients | Observed Results |
Adjusted Results* |
||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline† |
Follow-Up |
Difference‡ | Follow-Up |
Difference‡ | 95% CI | P | |||||
| Mean | 95% CI | Mean | 95% CI | Mean | 95% CI | ||||||
| M-SACRAH | |||||||||||
| Week 6 | −3.5 | −1.77 | −6.16 to 2.63 | .43 | |||||||
| O3-FAs | 107 | 35.6 | 31.1 to 40.1 | 28.7 | 24.4 to 33.0 | 29.6 | 25.2 to 34.0 | ||||
| Placebo | 115 | 38.3 | 34.4 to 42.3 | 32.2 | 28.3 to 36.2 | 31.4 | 27.0 to 35.8 | ||||
| Week 12 | −0.6 | 0.72 | −4.17 to 5.60 | .77 | |||||||
| O3-FAs | 100 | 34.9 | 30.3 to 39.6 | 28.1 | 23.2 to 33.0 | 28.8 | 23.9 to 33.7 | ||||
| Placebo | 107 | 37.3 | 33.2 to 41.4 | 28.7 | 24.9 to 32.6 | 28.1 | 23.2 to 33.0 | ||||
| Week 24 | −2.3 | −0.99 | −6.32 to 4.34 | .72 | |||||||
| O3-FAs | 92 | 35.2 | 30.4 to 39.9 | 24.2 | 19.3 to 29.1 | 24.8 | 19.5 to 30.2 | ||||
| Placebo | 97 | 37.8 | 33.4 to 42.2 | 26.5 | 22.4 to 30.5 | 25.8 | 20.5 to 31.2 | ||||
| WOMAC | |||||||||||
| Week 6 | −0.4 | −1.19 | −5.74 to 3.37 | .61 | |||||||
| O3-FAs | 108 | 49.1 | 45.2 to 53.0 | 38.2 | 33.7 to 42.8 | 37.8 | 33.2 to 42.3 | ||||
| Placebo | 115 | 47.9 | 43.9 to 51.9 | 38.6 | 34.2 to 42.9 | 39.0 | 34.4 to 43.5 | ||||
| Week 12 | −0.7 | −2.13 | −7.30 to 3.04 | .42 | |||||||
| O3-FAs | 100 | 49.5 | 45.4 to 53.6 | 35.3 | 30.4 to 40.2 | 34.5 | 29.4 to 39.7 | ||||
| Placebo | 107 | 47.4 | 43.3 to 51.6 | 36.0 | 31.6 to 40.4 | 36.7 | 31.5 to 41.8 | ||||
| Week 24 | −1.3 | −2.41 | −8.13 to 3.31 | .41 | |||||||
| O3-FAs | 93 | 49.0 | 44.7 to 53.3 | 31.4 | 26.4 to 36.4 | 30.8 | 25.1 to 36.6 | ||||
| Placebo | 97 | 47.3 | 43.0 to 51.6 | 32.7 | 28.1 to 37.4 | 33.2 | 27.5 to 39.0 | ||||
| FACT-ES | |||||||||||
| Week 6 | −1.1 | 1.37 | −1.47 to 4.21 | .35 | |||||||
| O3-FAs | 108 | 87.4 | 84.2 to 90.5 | 92.5 | 89.2 to 95.8 | 93.8 | 91.0 to 96.7 | ||||
| Placebo | 115 | 90.6 | 87.6 to 93.7 | 93.6 | 90.7 to 96.6 | 92.4 | 89.6 to 95.3 | ||||
| Week 12 | −0.2 | 2.14 | −1.16 to 5.44 | .21 | |||||||
| O3-FAs | 100 | 87.8 | 84.5 to 91.1 | 93.8 | 90.4 to 97.2 | 95.0 | 91.7 to 98.3 | ||||
| Placebo | 107 | 90.9 | 87.8 to 94.0 | 94.0 | 90.7 to 97.2 | 92.8 | 89.5 to 96.1 | ||||
| Week 24 | −0.3 | 1.44 | −2.07 to 4.95 | .42 | |||||||
| O3-FAs | 93 | 88.4 | 84.9 to 91.8 | 96.9 | 93.3 to 100.4 | 97.8 | 94.3 to 101.3 | ||||
| Placebo | 97 | 90.8 | 87.4 to 94.3 | 97.2 | 93.8 to 100.6 | 96.3 | 92.8 to 99.8 | ||||
| Analgesic use§ | |||||||||||
| Week 6 | −0.13 | −0.09 | −0.81 to 0.63 | .80 | |||||||
| O3-FAs | 68 | 5.49 | 4.79 to 6.18 | 4.82 | 4.13 to 5.52 | 4.84 | 4.30 to 5.38 | ||||
| Placebo | 82 | 5.54 | 4.78 to 6.30 | 4.95 | 4.14 to 5.77 | 4.93 | 4.44 to 5.43 | ||||
| Week 12 | −0.42 | −0.53 | −1.39 to 0.33 | .23 | |||||||
| O3-FAs | 64 | 5.70 | 5.00 to 6.40 | 4.84 | 4.08 to 5.60 | 4.79 | 4.16 to 5.41 | ||||
| Placebo | 69 | 5.55 | 4.78 to 6.32 | 5.26 | 4.43 to 6.10 | 5.31 | 4.71 to 5.92 | ||||
| Week 24 | −0.004 | 0.10 | −0.83 to 1.03 | .84 | |||||||
| O3-FAs | 62 | 4.52 | 4.68 to 6.16 | 4.92 | 4.12 to 5.72 | 4.97 | 4.30 to 5.65 | ||||
| Placebo | 65 | 5.65 | 4.84 to 6.45 | 4.92 | 4.21 to 5.63 | 4.87 | 4.21 to 5.53 | ||||
Abbreviations: BPI, Brief Pain Inventory; FACT-ES, Functional Assessment of Cancer Therapy–Endocrine Symptoms; M-SACRAH, Modified Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands; O3-FA, omega-3 fatty acid; WOMAC, Western Ontario and McMaster Universities Osteoarthritis Index.
From linear regression adjusting for baseline BPI score and stratification factors (osteoarthritis, prior taxane exposure).
Among patients with week-6, -12, or -24 worst pain scores, respectively.
Difference derived from O3-FAs minus placebo. (for M-SACRAH and WOMAC).
Frequency of analgesic use, where 1 = ≤ one pill per week, 2 = two to three pills per week, 3 = four to six pills per week, 4 = one pill/ per day, and 5 = ≥ one pill per day. Value is sum of frequencies of use of acetaminophen, ibuprofen, other nonsteroidal anti-inflammatory drugs, narcotics, other pain medication, and aspirin. At each time point, < 5% of participants took narcotics.