Research Article
Randomized, Double-Blind, Placebo-Controlled Study of Modified Erzhi Granules in the Treatment of Menopause-Related Vulvovaginal Atrophy
Table 6
Modified Kupperman Index.
| | groups | baseline | 4 weeks | 8 weeks | 12 weeks | 4 weeks after drug withdrawal | p1 | p2 | p3 | p4 |
| modified KI | treatment group | 22.64±6.38 | 19.23±6.16 | 17.72±6.17 | 17.38±5.67 | 19.18±5.84 | <0.001 | <0.001 | <0.001 | <0.001 | placebo group | 23.61±6.56 | 23.47±7.17 | 22.75±6.18 | 23.19±6.05 | 23.25±5.66 | 0.219 | 0.136 | 0.571 | 0.978 | p | 0.531 | 0.054 | 0.002 | <0.001 | 0.007 | | | | |
| sweating, hot flushes | treatment group | 4.31±3.23 | 2.77±2.92 | 2.26±3.02 | 2.15±3.02 | 2.87±2.89 | <0.001 | <0.001 | <0.001 | 0.001 | placebo group | 4.56±3.19 | 4.56±3.19 | 4.44±3.28 | 4.44±3.28 | 4.56±3.19 | 1.000 | 0.317 | 0.317 | 1.000 | p | 0.796 | 0.036 | 0.007 | 0.004 | 0.053 | | | | |
| paresthesia | treatment group | 1.69±1.42 | 1.59±1.39 | 1.59±1.39 | 1.38±1.39 | 1.59±1.39 | 0.317 | 0.317 | 0.058 | 0.480 | placebo group | 2.39±1.64 | 2.17±1.61 | 2.11±1.72 | 2.39±1.71 | 2.33±1.69 | 0.102 | 0.059 | 0.705 | 0.527 | p | 0.060 | 0.058 | 0.110 | 0.004 | 0.026 | | | | |
| insomnia | treatment group | 2.46±1.55 | 1.85±1.33 | 1.69±1.34 | 1.69±1.26 | 1.95±1.41 | 0.001 | 0.001 | 0.001 | 0.022 | placebo group | 2.61±1.57 | 2.72±1.45 | 2.33±1.62 | 2.22±1.64 | 2.33±1.55 | 0.157 | 0.157 | 0.109 | 0.285 | p | 0.849 | 0.012 | 0.042 | 0.047 | 0.126 | | | | |
| nervousness | treatment group | 2.92±1.29 | 2.77±1.35 | 2.77±1.35 | 2.72±1.34 | 3.03±1.37 | 0.083 | 0.059 | 0.096 | 1.000 | placebo group | 2.89±1.69 | 2.72±1.80 | 2.61±1.71 | 2.72±1.80 | 2.67±1.59 | 0.180 | 0.257 | 0.480 | 0.317 | p | 0.817 | 0.409 | 0.542 | 0.554 | 0.322 | | | | |
| melancholia | treatment group | 1.00±0.76 | 1.05±0.82 | 1.05±0.82 | 1.05±0.82 | 1.08±0.80 | 1.000 | 1.000 | 1.000 | 0.564 | placebo group | 0.86±0.83 | 0.86±0.73 | 0.89±0.72 | 0.91±0.78 | 0.94±0.77 | 0.157 | 0.083 | 0.157 | 0.059 | p | 0.390 | 0.347 | 0.440 | 0.539 | 0.551 | | | | |
| vertigo | treatment group | 0.82±0.76 | 0.83±0.81 | 0.75±0.74 | 0.85±0.83 | 0.88±0.72 | 1.000 | 0.317 | 0.527 | 0.257 | placebo group | 0.89±0.62 | 0.91±0.61 | 0.89±0.63 | 0.94±0.59 | 1.06±0.59 | 1.000 | 0.655 | 0.705 | 0.059 | p | 0.589 | 0.419 | 0.329 | 0.406 | 0.227 | | | | |
| fatigue | treatment group | 1.62±0.49 | 1.18±0.55 | 1.05±0.55 | 1.00±0.60 | 1.08±0.62 | <0.001 | <0.001 | <0.001 | <0.001 | placebo group | 1.58±0.73 | 1.57±0.74 | 1.6±0.74 | 1.6±0.74 | 1.57±0.74 | 1.000 | 0.564 | 0.564 | 1.000 | p | 0.629 | 0.017 | 0.001 | <0.001 | 0.005 | | | | |
| arthralgia, myalgia | treatment group | 0.79±0.83 | 0.73±0.75 | 0.53±0.64 | 0.50±0.60 | 0.53±0.64 | 0.317 | 0.004 | 0.002 | 0.004 | placebo group | 0.86±0.76 | 0.86±0.73 | 0.91±0.70 | 0.91±0.70 | 0.91±0.74 | 0.317 | 0.564 | 0.655 | 0.655 | p | 0.654 | 0.413 | 0.014 | 0.009 | 0.020 | | | | |
| headache | treatment group | 0.90±0.88 | 0.90±0.81 | 0.90±0.78 | 0.95±0.78 | 1.00±0.82 | 1.000 | 1.000 | 0.564 | 0.356 | placebo group | 1.03±0.81 | 1.03±0.82 | 1.03±0.75 | 1.03±0.75 | 0.97±0.79 | 1.000 | 1.000 | 1.000 | 0.480 | p | 0.529 | 0.567 | 0.500 | 0.710 | 0.817 | | | | |
| heart palpitation | treatment group | 0.72±0.76 | 0.80±0.82 | 0.65±0.74 | 0.65±0.70 | 0.73±0.68 | 0.257 | 0.257 | 0.366 | 1.000 | placebo group | 0.67±0.59 | 0.66±0.59 | 0.60±0.60 | 0.63±0.60 | 0.60±0.55 | 1.000 | 0.527 | 0.739 | 0.527 | p | 0.971 | 0.654 | 0.962 | 0.943 | 0.503 | | | | |
| formication | treatment group | 0.28±0.46 | 0.35±0.62 | 0.25±0.44 | 0.28±0.45 | 0.28±0.45 | 0.317 | 0.317 | 1.000 | 1.000 | placebo group | 0.28±0.45 | 0.29±0.46 | 0.29±0.46 | 0.26±0.44 | 0.20±0.41 | 1.000 | 1.000 | 0.317 | 0.18 | p | 0.967 | 0.840 | 0.729 | 0.862 | 0.451 | | | | |
| sexual complaints | treatment group | 3.64±1.29 | 3.69±1.17 | 3.54±1.17 | 3.54±1.17 | 3.54±1.17 | 0.564 | 0.317 | 0.414 | 0.527 | placebo group | 3.89±1.43 | 3.83±1.46 | 3.94±1.39 | 4.00±1.35 | 4.00±1.35 | 0.317 | 0.564 | 0.157 | 0.157 | p | 0.257 | 0.709 | 0.174 | 0.109 | 0.109 | | | | |
| urinary tract infection | treatment group | 1.49±1.70 | 0.97±1.58 | 0.72±1.41 | 0.67±1.40 | 0.67±1.40 | 0.004 | <0.001 | <0.001 | <0.001 | placebo group | 1.11±1.30 | 1.06±1.31 | 1.11±1.30 | 1.11±1.30 | 1.11±1.30 | 0.317 | 1.000 | 1.000 | 0.317 | p | 0.410 | 0.802 | 0.185 | 0.122 | 0.088 | | | | |
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