Research Article

Randomized, Double-Blind, Placebo-Controlled Study of Modified Erzhi Granules in the Treatment of Menopause-Related Vulvovaginal Atrophy

Table 1

Baseline parameters in the two groups.

treatment groupplacebo groupp

demographic
 n3936
 Age, years59.67±3.4758.53±4.530.338
 Body mass index, kg/m24.23±3.4524.59±3.510.726
 age of menopause, years49.43±3.9349.44±4.250.061
 Menopause time, years10.24±5.379.09±5.960.241
 Course of disease, years1.56±0.881.21±1.210.979

vaginal health score9.87±2.3310.44±2.350.245
 elasticity2.18±0.562.25±0.550.585
 moisture2.00±0.762.08±0.730.700
 pH1.92±0.661.89±0.710.810
 mucosa1.95±0.892.14±0.720.330
 discharge1.82±0.682.08±0.730.127

Vaginitis score4.50±1.574.58±1.570.925
 pain0.87±0.520.94±0.630.619
 painful sexual intercourse1.18±0.731.26±0.810.673
 itching1.38±0.751.19±0.580.276
 burning1.18±0.681.06±0.710.472

vaginal maturation index
 percentage of superficial cells0.67±1.181.06±1.240.079
 percentage of basal cells55.23±10.3253.53±9.950.494

female sexual function index12.78±8.5512.26±8.390.738
 desire2.38±0.762.40±0.980.841
 arousal1.65±1.661.48±1.550.710
 lubrication1.92±1.941.80±1.900.844
 orgasm1.81±1.821.58±1.620.527
 satisfaction2.79±0.893.01±1.010.212
 pain2.24±2.152.00±1.970.431

modified Kupperman Index22.64±6.3823.61±6.560.531
 Sweating, hot flushes1.08±0.811.14±0.800.796
 Paresthesia0.85±0.711.19±0.820.060
 Insomnia1.23±0.781.31±0.790.849
 Nervousness1.46±0.641.44±0.840.817
 Melancholia1.00±0.760.86±0.830.390
 Vertigo0.82±0.760.89±0.620.589
 Fatigue1.62±0.491.58±0.730.629
 Arthralgia, myalgia0.79±0.830.86±0.760.654
 Headache0.90±0.881.03±0.810.529
 Heart palpitation0.72±0.760.67±0.590.971
 Formication0.28±0.460.28±0.450.967
 Sexual complaints1.82±0.641.94±0.710.257
 Urinary tract infection0.74±0.850.56±0.650.410