Table 2.
Primary endpoints: Changes in the functional and symptom scales of EORTO-QLQ-C30 in the intent-to-treat population.
| THL-P (n = 28) | Placebo (n = 11) | P-value | |
|---|---|---|---|
| Change from baseline | |||
| EORTO-QLQ-C30 | |||
| GHS/QOL | 41.7 (29.2, 50.0)† | −33.3 (−33.3, 0)† | <0.001* |
| Functional scales | |||
| Physical | 13.3 (3.3, 26.7)† | 0 (−13.3, 13.3) | 0.014* |
| Role | 0 (0, 41.7)† | 0 (−16.7, 0) | 0.018* |
| Emotional | 8.3 (0, 25.0)† | 0 (−33.3, 8.3) | 0.024* |
| Cognitive | 16.7 (0, 16.7)† | 0 (−33.3, 0) | <0.001* |
| Social | 0 (0, 33.3)† | 0 (−33.3, 33.3) | 0.379 |
| Symptom scales | |||
| Fatigue | −22.2 (−33.3, −11.1) † | 0 (−11.1, 22.2) | <0.005* |
| Nausea and vomiting | 0 (0, 0) | 0 (0, 16.7) | 0.656 |
| Pain | 0 (−25.0, 16.7) | 0 (0, 16.7) | 0.124 |
| Single items | |||
| Dyspnoea | 0 (−33.3, 0) | 0 (0, 0) | 0.528 |
| Insomnia | 0 (0, 16.7) | 0 (0, 33.3) | 0.569 |
| Appetite loss | 0 (0, 0) | 0 (0, 0) | 0.633 |
| Constipation | 0 (−16.7, 0) | 0 (0, 0) | 0.770 |
| Diarrhoea | 0 (0, 33.3) | 0 (0, 33.3) | 0.866 |
| Financial difficulties | 0 (0, 0) | 0 (0, 0) | 0.747 |
THL-P: Tien-Hsien liquid practical; EORTO-QLQ-C30: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30.
*P < 0.05 versus placebo (Mann-Whitney U test). † P < 0.05 versus baseline (Wilcoxon signed ranks test). Values are presented as median (interquartile).