Table 6.
Effect of treatment groups on quality of life score
| Visit | Chitosan (mean ± SD) [range] |
Placebo (mean ± SD) [range] |
P value |
|---|---|---|---|
| PCS Score | |||
| Day 0 (n = 58, 31) | 40.99 ± 6.51 [22.80 − 56.90] | 41.26 ± 5.78 [33.10 − 57.70] | 0.869 |
| Day 90 (n = 59, 31) | 51.32 ± 7.23*@ [32.10 − 61.80] | 43.19 ± 7.50[31.20 − 56.40] | < 0.0001 |
| Change from baseline (PCS Score) | |||
| Day 90 (n = 59, 31) | 10.58 ± 8.07@ [-27.70 – 8.50] | 1.93 ± 5.69 [−17.60 – 6.30] | < 0.0001 |
| MCS score | |||
| Day 0 (n = 58, 31) | 48.34 ± 6.77 [27.20 − 60.50] | 46.16 ± 7.77 [17.70 − 61.90] | 0.173 |
| Day 90 (n = 59, 31) | 49.10 ± 7.08 [33.20 − 61.60] | 47.45 ± 6.60 [27.90 − 62.40] | 0.283 |
| Change from baseline (MCS Score) | |||
| Day 90 (n = 59, 31) | 0.98 ± 6.73 [-20.80 − 16.70] | 1.28 ± 8.81 [-34.30 − 10.60] | 0.4755 |
Values are expressed as Mean ± Standard deviation (SD). * = statistically significant as compared to baseline. @ - statistically significant as compared to placebo at day 90. N = Number of subjects in each treatment group