Table 3.
Changes in modified KMI scores from baseline according to category.
| Domain | MENOLACTO® (n = 32) | Placebo (n = 35) | p * | p ** | p † |
|---|---|---|---|---|---|
| Hot flashes | |||||
| Baseline | 8.13 ± 3.44 | 9.03 ± 2.63 | |||
| Week 6 | 4.38 ± 2.56 | 5.83 ± 3.80 | 0.5376 | 0.2576 | 0.1004 |
| Week 12 | 2.50 ± 2.44 | 5.14 ± 3.15 | 0.0526 | 0.0512 | 0.0018 |
| Paresthesia | |||||
| Baseline | 3.75 ± 1.88 | 3.37 ± 1.66 | |||
| Week 6 | 1.25 ± 1.50 | 2.63 ± 2.04 | 0.0002 | 0.0002 | <0.0001 |
| Week 12 | 1.38 ± 1.64 | 2.17 ± 1.90 | 0.0333 | 0.0356 | 0.0320 |
| Insomnia | |||||
| Baseline | 3.94 ± 1.79 | 4.29 ± 1.82 | |||
| Week 6 | 2.19 ± 1.93 | 3.37 ± 2.10 | 0.0515 | 0.0418 | 0.0238 |
| Week 12 | 1.94 ± 1.93 | 2.91 ± 1.90 | 0.1841 | 0.1300 | 0.1614 |
| Nervousness | |||||
| Baseline | 4.00 ± 1.61 | 3.71 ± 2.12 | |||
| Week 6 | 1.81 ± 1.64 | 3.03 ± 2.08 | 0.0026 | 0.0025 | 0.0014 |
| Week 12 | 1.13 ± 1.24 | 2.34 ± 1.91 | 0.0041 | 0.0038 | 0.0026 |
| Melancholia | |||||
| Baseline | 2.00 ± 0.84 | 1.97 ± 0.86 | |||
| Week 6 | 0.91 ± 0.69 | 1.60 ± 0.95 | 0.0024 | 0.0053 | 0.0004 |
| Week 12 | 0.63 ± 0.66 | 1.26 ± 0.95 | 0.0107 | 0.0131 | 0.0056 |
| Vertigo | |||||
| Baseline | 1.38 ± 0.87 | 1.54 ± 0.82 | |||
| Week 6 | 0.63 ± 0.66 | 1.20 ± 0.99 | 0.0568 | 0.0591 | 0.0157 |
| Week 12 | 0.56 ± 0.72 | 1.03 ± 0.86 | 0.2806 | 0.2126 | 0.0689 |
| Fatigue | |||||
| Baseline | 2.31 ± 0.74 | 2.54 ± 0.70 | |||
| Week 6 | 1.13 ± 0.87 | 1.97 ± 1.01 | 0.0105 | 0.0151 | 0.0016 |
| Week 12 | 1.00 ± 0.72 | 1.83 ± 0.92 | 0.0059 | 0.0104 | 0.0028 |
| Arthralgia, Myalgia | |||||
| Baseline | 2.13 ± 0.71 | 1.91 ± 0.89 | |||
| Week 6 | 1.16 ± 0.77 | 1.49 ± 0.92 | 0.0138 | 0.0112 | 0.0115 |
| Week 12 | 0.91 ± 0.73 | 1.40 ± 1.03 | 0.0020 | 0.0039 | 0.0033 |
| Headache | |||||
| Baseline | 1.72 ± 0.81 | 1.63 ± 1.03 | |||
| Week 6 | 0.75 ± 0.84 | 1.31 ± 1.02 | 0.0064 | 0.0089 | 0.0080 |
| Week 12 | 0.47 ± 0.67 | 1.09 ± 0.85 | 0.0034 | 0.0047 | 0.0028 |
| Heart palpitation | |||||
| Baseline | 1.81 ± 0.82 | 1.80 ± 0.93 | |||
| Week 6 | 0.63 ± 0.66 | 1.34 ± 1.06 | 0.0009 | 0.0007 | 0.0005 |
| Week 12 | 0.38 ± 0.55 | 0.94 ± 0.97 | 0.0180 | 0.0107 | 0.0132 |
| Formication | |||||
| Baseline | 1.59 ± 0.80 | 1.40 ± 0.98 | |||
| Week 6 | 0.47 ± 0.67 | 1.14 ± 0.91 | <0.0001 | <0.0001 | <0.0001 |
| Week 12 | 0.38 ± 0.55 | 0.94 ± 0.84 | 0.0019 | 0.0015 | 0.0014 |
| Dryness of vagina | |||||
| Baseline | 2.28 ± 0.89 | 2.17 ± 1.01 | |||
| Week 6 | 1.25 ± 0.80 | 1.97 ± 0.95 | 0.0029 | 0.0045 | 0.0003 |
| Week 12 | 0.94 ± 0.91 | 1.83 ± 0.92 | 0.0006 | 0.0007 | 0.0003 |
Values are presented as the mean ± SD. * Comparison between groups (changes from baseline); two-sample t-test. ** Comparison between groups (changes from baseline); Wilcoxon rank-sum test. † Comparison between groups (changes from baseline); ANCOVA adjusted for baseline and age.