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. 2014 Jul 21;111(29-30):493–502. doi: 10.3238/arztebl.2014.0493

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.