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