Treatment effects of sustained-release morphine 20 mg/day versus placebo from baseline to days 5–7 or end of treatment in the intention-to-treat population (n=284)
| Morphine 20 mg/day (n=145) | Placebo (n=139) | Morphine versus placebo | ||
| Mean change from baseline (SE) | Mean difference (95% CI) | P value | ||
| Primary endpoint | ||||
| Breathlessness now (VAS) | −5.00 (2.13) | −4.86 (2.07) | −0.15 (−4.59 to 4.29) | 0.95 |
| Secondary endpoints | ||||
| Worst breathlessness, 24 hours (VAS) | −10.51 (2.59) | −5.29 (2.61) | −5.23 (−10.77 to 0.31) | 0.064 |
| Best breathlessness, 24 hours (VAS) | −2.11 (2.14) | 0.80 (2.10) | −2.91 (−7.43 to 1.61) | 0.207 |
| Average breathlessness, 24 hours (VAS) | −4.49 (2.09) | −2.36 (2.06) | −2.13 (−6.64 to 2.38) | 0.355 |
| Breathlessness unpleasantness now (VAS) | −2.16 (2.21) | 0.10 (2.20) | −2.26 (−6.87 to 2.36) | 0.338 |
| Change in participant functional status (AKPS) | −1.15 (0.75) | −0.26 (0.75) | −0.89 (−2.44 to 0.66) | 0.260 |
| Participant health-related quality of life (EORTC-QLQ-C15 PAL) | 1.8 (2.2) | 1.5 (2.2) | 0.35 (−4.41 to 5.11) | 0.88 |
| Appetite loss (EORTC-QLQ-C15 PAL) | 3.0 (3.2) | 0.5 (3.2) | 2.46 (−4.22 to 9.14) | 0.47 |
| Constipation (EORTC-QLQ-C15 PAL) | 15.8 (3.8) | 2.3 (3.8) | 13.47 (5.31 to 21.62) | 0.001 |
| Dyspnoea (EORTC-QLQ-C15 PAL) | −7.0 (2.9) | −5.9 (2.8) | −1.08 (−7.14 to 4.98) | 0.73 |
| Emotional functioning (EORTC-QLQ-C15 PAL) | −0.8 (2.3) | 2.2 (2.3) | −3.08 (−7.97 to 1.81) | 0.215 |
| Fatigue (EORTC-QLQ-C15 PAL) | 6.1 (2.9) | −4.8 (2.9) | 10.92 (4.78 to 17.06) | <0.001 |
| Nausea/vomiting (EORTC-QLQ-C15 PAL) | 6.1 (2.6) | −1.4 (2.6) | 7.51 (1.98 to 13.04) | 0.008 |
| Pain (EORTC-QLQ-C15 PAL) | −1.1 (2.4) | 0.02 (2.4) | −1.12 (−6.28 to 4.05). | 0.67 |
| Physical functioning (EORTC-QLQ-C15 PAL) | −5.0 (2.3) | −0.6 (2.4) | −4.42 (−9.43 to 0.59) | 0.083 |
| Insomnia (EORTC-QLQ-C15 PAL) | −6.1 (3.5) | −8.4 (3.4) | 2.27 (−5.10 to 9.64) | 0.54 |
| Carers quality of life (CQOLC) | −1.4 (2.3) | −2.4 (3.2) | 0.94 (−7.70 to 9.58) | 0.82 |
| Blinded treatment preference | ||||
| I have been less breathless during the past week | 64/132 (48.5%) | 66/134 (49.3%) | N/A | N/A |
| This medication would benefit me enough to be on it long term | 55/128 (43.0%) | 62/131 (47.3%) | N/A | N/A |
AKPS, Australia-modified Karnofsky Performance Status; CQOLC, Carer Quality of Life Index—Cancer; VAS, 100 mm visual analogue scale.