Table 3. Estimated values (Mean and 95% confidence interval) for differences between the mistletoe treatment and control groups of patients with locally advanced or metastatic pancreatic cancer with respect to mean differences from the baseline in EORTC-QLQ-C30 scale variables and relative body weight.
EORTC scale | Mixed model | |||
---|---|---|---|---|
Mean[95% CI] | p-value for treatment without interaction | p-valuefor treatment with interaction | p-value for interaction “visit × treatment” | |
Global quality of health | 26.1 [22.7; 29.6] |
< 0.001 | < 0.001 | < 0.001 |
Role functioning | 17.8 [11.9; 23.6] |
< 0.001 | < 0.001 | < 0.001 |
Social functioning | 11.4 [4.72;18.16] |
0.004 | < 0.001 | 0.506 |
Cognitive functioning | 18.7 [11.8; 25.6] |
< 0.001 | < 0.001 | 0.016 |
Physical functioning | 22.3 [17.6; 27.1] |
< 0.001 | < 0.001 | < 0.001 |
Emotional functioning | 19.5 [13.6; 25.4] |
< 0.001 | < 0.001 | 0.045 |
Pain | –23.0 [–29.0; –17.0] |
< 0.001 | < 0.001 | < 0.001 |
Fatigue | –30.6 [–36.1; –25.0] |
< 0.001 | < 0.001 | < 0.001 |
Appetite loss | –43.9 [–51.0; –36;7] |
< 0.001 | < 0.001 | 0.031 |
Financial problems | –15.6 [–23.1; –8.2] |
< 0.001 | < 0.001 | 0.626 |
Insomnia | –37.2 [–45.8; –28.6] |
< 0.001 | < 0.001 | < 0.001 |
Nausea/vomiting | –10.9 [–16.0; –5.9] |
< 0.001 | < 0.001 | < 0.001 |
Diarrhea | –4.5 [–7.3; –1.7] |
0.005 | < 0.001 | 0.028 |
Constipation | –1.3 [–2.8; 0.1] |
0.140 | 0.026 | 0.121 |
Shortness of breath | –0.8 [–2.5; 0.8] |
0.320 | 0.339 | 0.040 |
Body weight[% change relative to baseline] | 8.56 [7.0; 10.0] |
< 0.001 | < 0.001 | < 0.001 |
The function scales are arranged in increasing order of baseline values, and the symptom scales in decreasing order. The main analysis is the mixed model, without any interaction between trial treatment and visits; sensitivity analyses are the mixed model with interaction, stratified by the timepoint of the last regular follow-up visit. For each individual analysis, the p-values of the quality-of-life scales were adjusted for multiple testing with the Bonferroni-Holm correction.
EORTC QLQ-C30, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30; CI, confidence interval.