|
UDCA
(n = 304)
|
Placebo
(n = 300)
|
Adjusted effects estimate
(95% CI), p value
|
Interaction test
|
Bile acid concentration, all women, N |
256 |
247 |
|
|
Bile acid concentration (μmol/L),
geometric mean (SD)
|
22.8 (2.4)
|
19.0 (2.8)
|
GMR 1.17 (1.00 to 1.36)
p = 0.045
|
|
Baseline bile acid conc. <40 μmol/L, N |
196 |
191 |
|
p = 0.647 |
Bile acid concentration (μmol/L),
geometric mean (SD)
|
19.1 (2.3)
|
16.0 (2.6)
|
GMR 1.19 (1.00 to 1.41)
p = 0.047
|
|
Baseline bile acid conc. ≥40 μmol/L, N |
60 |
56 |
|
|
Bile acid concentration (μmol/L),
geometric mean (SD)
|
40.6 (2.2)
|
34.5 (2.9)
|
GMR 1.13 (0.81 to 1.58)
p = 0.466
|
|
Baseline bile acid conc. <100 μmol/L, N |
236 |
233 |
|
p = 0.458 |
Bile acid concentration (μmol/L),
geometric mean (SD)
|
21.3 (2.3)
|
17.8 (2.7)
|
GMR 1.19 (1.02 to 1.39)
p = 0.031
|
|
Baseline bile acid conc. ≥100 μmol/L, N |
20 |
14 |
|
|
Bile acid concentration (μmol/L),
geometric mean (SD)
|
49.6 (2.5)
|
56.8 (3.2)
|
GMR 0.97 (0.48 to 1.96)
p = 0.941
|
|
Itch score, all women, N |
241 |
227 |
|
|
Itch score (mm), mean (SD)
|
49.8 (25.8)
|
56.6 (26.8)
|
MD -5.26 (-9.48 to -1.03)
p = 0.015
|
|
Baseline itch score <60 mm, N |
108 |
90 |
|
p =
0.640 |
Itch score (mm), mean (SD)
|
39.9 (23.9)
|
43.3 (23.6)
|
MD -4.04 (-10.33 to 2.26)
p = 0.211
|
|
Baseline itch score ≥60 mm, N |
133 |
137 |
|
|
Itch score (mm), mean (SD)
|
57.9 (24.6)
|
65.4 (25.1)
|
MD -6.00 (-11.73 to -0.28)
p = 0.041
|
|
Baseline bile acid conc. <40 μmol/L, N |
187 |
178 |
|
p = 0.455 |
Itch score (mm), mean (SD)
|
49.6 (25.6)
|
54.9 (26.5)
|
MD -4.41 (-9.13 to 0.30)
p = 0.067
|
|
Baseline bile acid conc. ≥40 μmol/L, N |
54 |
49 |
|
|
Itch score (mm), mean (SD)
|
50.4 (26.8)
|
62.8 (27.1)
|
MD -8.03 (-17.68 to 1.62)
p = 0.106
|
|
Baseline bile acid conc. <100 μmol/L, N |
226 |
216 |
|
p = 0.753 |
Itch score (mm), mean (SD)
|
49.9 (25.6)
|
56.3 (26.5)
|
MD -5.37 (-9.63 to -1.10)
p = 0.014
|
|
Baseline bile acid conc. ≥100 μmol/L, N |
15 |
11 |
|
|
Itch score (mm), mean (SD)
|
48.7 (29.6)
|
63.1 (31.8)
|
MD -5.77 (-34.12 to 22.57)
p = 0.693
|
|