Table 3.

Concentrations [geometric mean (95% confidence intervals)] and percentage changes from cycle 1 (baseline) to cycle 5 in serum estrogens, serum SHBG, and urinary estrogen metabolites in the early follicular, late follicular, and mid-luteal phases of the menstrual cycle, by study arm

Early follicular
Late follicular
Mid-luteal
Cycle 1, mean (95% CI)Cycle 5, mean (95% CI)% ChangeCycle 1, mean (95% CI)Cycle 5, mean (95% CI)% ChangeCycle 1, mean (95% CI)Cycle 5, mean (95% CI)% Change
Serum
Estrone (pg/mL)
    Botanical (n = 13)52 (46-59)49 (41-58)−5.7799 (73-134)86 (63-118)−13.1
    Diet (n = 10)47 (38-58)56 (42-75)19.1587 (61-123)79 (59-105)−9.20
    Placebo (n = 12)47 (41-55)52 (37-73)10.6492 (74-115)74 (55-99)−19.6
Estrone-sulfate (ng/mL)
    Botanical (n = 13)1.25 (1.08-1.45)1.10 (0.94-1.28)−12.0*1.89 (1.46-2.45)1.65 (1.24-2.20)−12.7
    Diet (n = 10)1.27 (1.15-1.42)1.36 (1.09-1.69)7.092.05 (1.58-2.66)1.97 (1.53-2.53)−3.90
    Placebo (n = 12)1.36 (1.15-1.62)1.46 (1.17-1.81)7.352.22 (1.77-2.79)1.80 (1.41-2.31)−18.9
Total estradiol (pg/mL)
    Botanical (n = 12)53 (43-64)57 (47-70)7.55142 (93-216)149 (100-223)4.93154 (120-197)166 (140-195)7.79
    Diet (n = 9)43 (33-55)58 (46-73)34.88127 (75-216)113 (78-163)−11.0138 (99-193)159 (121-209)15.22
    Placebo (n = 12)47 (36-63)57 (34-95)21.28143 (111-185)103 (65-164)−28.0141 (112-176)136 (112-166)−3.55
Free estradiol (pg/mL)
    Botanical (n = 13)1.1 (0.9-1.3)1.1 (0.9-1.4)0.003.3 (2.2-4.9)3.1 (2.2-4.5)−6.062.9 (2.3-3.7)3.2 (2.6-3.8)10.34
    Diet (n = 9)1.0 (0.8-1.3)1.3 (1.1-1.6)30.003.0 (1.8-5.2)2.6 (1.8-3.7)−13.33.1 (2.2-4.3)3.6 (2.7-4.9)16.13
    Placebo (n = 12)1.1 (0.8-1.5)1.3 (0.8-2.0)18.183.4 (2.6-4.4)2.4 (1.6-3.5)−29.43.3 (2.6-4.2)3.0 (2.5-3.7)−9.09
SHBG (nmol/L)
    Botanical (n = 13)72 (56-92)72 (55-95)0.0066 (51-86)72 (56-94)9.0975 (54-104)78 (61-101)4.00
    Diet (n = 9)49 (38-62)56 (42-74)14.2947 (37-61)52 (39-69)10.6458 (46-73)53 (39-70)−8.62
    Placebo (n = 12)48 (35-66)52 (39-69)8.3346 (33-63)50 (36-69)8.7049 (36-65)54 (40-74)10.20
Urine
2-Hydroxyestrone (ng/mg Cr)
    Botanical (n = 14)24.2 (17.7-33.0)23.1 (17.5-30.6)−4.55
    Diet (n = 10)20.8 (13.1-33.0)20.4 (11.1-37.2)−1.92
    Placebo (n = 13)16.2 (6.7-39.1)12.9 (7.7-21.9)−20.4
16α-Hydroxyestrone (ng/mg Cr)
    Botanical (n = 14)12.9 (11.0-15.2)11.5 (9.2-14.3)−10.9
    Diet (n = 10)12.0 (8.6-16.7)13.1 (8.8-19.6)9.17
    Placebo (n = 13)12.3 (5.1-29.4)10.5 (7.7-14.4)−14.6
2α-Hydroxyestrone/16α-hydroxyestrone ratio
    Botanical (n = 14)1.9 (1.5-2.4)2.0 (1.7-2.5)5.26
    Diet (n = 10)1.7 (1.3-2.4)1.6 (0.9-2.7)−5.88
    Placebo (n = 13)1.3 (0.9-2.0)1.2 (0.9-1.7)−7.69
  • NOTE: All P values >0.10 unless otherwise indicated. Comparing change between cycles 1 and 5 in botanical or diet arms versus change in placebo using paired t tests with unequal variances.

    Abbreviation: 95% CI, 95% confidence interval.

  • * P = 0.083 when compared with placebo.

  • Baseline SHBG significantly higher in botanical arm versus placebo arm (P = 0.01).