Table II.
Effect of LEM vs. placebo on QOL scores during the study course.
| First course | Second course | ||||||
|---|---|---|---|---|---|---|---|
| Scores | Groups | Subject no. | Day 1 | Day 8 | Day 22 | Day 8 | Day 22 |
| FACT-BRM total score | LEM | 21 | 119.5±5.1 | 107.0±4.9 | 112.9±5.5 | 103.9±5.7 | 112.6±4.6 |
| Placebo | 21 | 116.2±4.1 | 100.5±5.9 | 110.4±5.6 | 96.2±5.4a | 107.4±5.9 | |
| FACT-G total score | LEM | 21 | 80.4±3.6 | 71.6±3.4 | 75.6±3.8 | 69.4±4.1 | 74.7±3.2 |
| Placebo | 21 | 77.4±3.5 | 66.6±4.2 | 73.0±4.0 | 63.2±3.7a | 71.1±4.2 | |
| FACT-BRM TOI | LEM | 21 | 81.4±3.7 | 69.4±3.9 | 75.9±4.0 | 67.7±4.1a | 76.0±3.5 |
| Placebo | 21 | 81.6±2.4 | 65.1±4.3b | 74.8±3.8 | 61.8±3.8b | 72.1±4.3 | |
| PWB | LEM | 22 | 23.9 ±0.8 | 18.6±1.3b | 21.8±1.1 | 17.6±1.4b | 20.5±1.0a |
| Placebo | 21 | 24.1±0.9 | 17.0±1.7b | 20.7±1.2a | 15.7±1.3b | 20.0±1.3a | |
| SWB | LEM | 21 | 20.8±1.1 | 20.6±1.3 | 20.5±1.3 | 20.1±1.3 | 19.6±1.3 |
| Placebo | 21 | 19.4±1.6 | 20.2±1.5 | 19.0±1.7 | 19.6±1.5 | 19.0±1.6 | |
| EWB | LEM | 22 | 17.3±1.0 | 17.0±1.1 | 16.5±1.2 | 16.1±1.4 | 16.9±1.1 |
| Placebo | 21 | 15.3±1.1 | 15.2±1.2 | 16.6±0.9 | 14.8±1.1 | 16.3±1.0 | |
| FWB | LEM | 22 | 18.5±1.7 | 15.4±1.5 | 16.8±1.4 | 15.6±1.4 | 17.7±1.4 |
| Placebo | 21 | 18.6±1.4 | 14.2±1.7a | 16.7±1.4 | 13.1±1.1b | 15.8±1.6 | |
| BRMP | LEM | 21 | 22.5±1.0 | 20.4±0.7 | 20.8±0.9 | 18.7±1.1a | 20.8±0.8 |
| Placebo | 21 | 22.1±1.0 | 19.3±1.0a | 21.5±0.8 | 18.8±1.0a | 20.9±1.1 | |
| BRMCE | LEM | 21 | 16.6±1.1 | 15.0±1.2 | 16.5±1.3 | 15.8±1.0 | 17.1±1.0 |
| Placebo | 21 | 16.7±1.0 | 14.6±1.2 | 15.9±1.2 | 14.2±1.3 | 15.4±1.2 | |
Measurement values are shown as mean ± standard error. Variation within each group was assayed by the Kruskal-Wallis test with the Steel test vs. day 1 of the first course.
a
P<0.05
b
P<0.01. LEM, Lentinula edodes mycelia extract; QOL, quality of life; FACT, Functional Assessment of Cancer Therapy; G, general scale; TOI, Trial Outcome Index; PWB, physical well-being; SWB, social/family well-being; EWB, emotional well-being; FWB, functional well-being; BRMP, BRM physical subscale; BRMCE, BRM cognitive/emotional subscale; BRM, biological response modifier.