Efficacy and Safety of the Two Ayurveda Drug Regimens in Uterine Fibroids: A Randomized Single-Blind Clinical Trial

Table 4

The secondary efficacy endpoints changes in the 12^th week and 24^th week.

Variable	Arm I (n = 35)	Arm II (n = 37)	Arm III (n = 30)	value
PBAC score MD (% change)	1.02 (44.31)	−10.97 (−33.73)	−2.90 (−14.44)
PBAC at 12^th week
≥100 (menorrhagia)	01 (02.9)	04 (10.8)	02 (06.7)	0.410
99–02 (normal flow)	34 (97.1)	33 (89.2)	28 (93.3)
<02 (amenorrhea)	00 (0.0)	00 (0.0)	00 (0.0)
UFS-QOL-symptom severity^α
Baseline (mean ± SD)	33.21 (15.91)	32.26 (16.52)	30.72 (14.21)	0.815
12^th week (mean ± SD)	25.71 (16.45)	22.63 (12.74)	34.16 (14.77)	0.006
value (baseline to 12^th week)	0.001	0.001	0.006
24^th week mean difference from 12^th week (MD ± SD)	0.00 (2.00)	0.00 (0.00)	—
value (12^th–24^th week)	1.00	0.05	—
UFS-QOL-HRQL^α^α
Baseline (mean ± SD)	51.45 (16.98)	58.57 (17.48)	59.13 (15.51)	0.112
12^th week (mean ± SD)	57.73 (17.37)	64.63 (17.63)	55.35 (16.47)	0.081
value (baseline to 12^th week)	0.005	0.035	0.010
24^th week (mean ± SD)	57.53 (17.14)	64.60 (17.14)	—
value (12^th–24^th week)	0.160	0.786	—

Arm I and Arm II, experimental groups; Arm III, control group; PBAC, pictorial blood loss assessment chart; score value ≥ 100, menorrhagia; 99–02, normal flow; <02, amenorrhea; HRQL, health-related quality of life; UFS-QOL, Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire; SD, standard deviation; MD, mean difference. Significant level of , based on the chi-square test (between groups). Significant level of , based on ANOVA (between groups). Significant level of , based on the paired t-test (before and after within groups). ^αScore range from 0 to 100, a higher score indicates greater symptom severity; ^ααscore range from 0 to 100, higher scores indicate better HRQL.