Table 2.

Patient-reported outcomes before randomization among study participants

CharacteristicAll (N=97)FemalesMalesP Value
Gastrointestinal symptoms rating scale, total score, mean±SD1.38±0.431.41±0.451.30±0.390.3
 Reflux1.48±0.991.54±1.041.31±0.830.3
 Abdominal pain1.46±0.611.51±0.661.31±0.440.14
 Indigestion1.47±0.561.53±0.591.33±0.450.13
 Diarrhea1.20±0.441.20±0.441.20±0.450.9
 Constipation1.28±0.551.26±0.521.35±0.640.5
SF-36 mental composite score, mean±SD52.4±8.4651.9±8.7753.7±7.630.4
SF-36 physical composite score, mean±SD52.7±6.4252.5±6.4753.0±6.390.7
HALT pain questionnaire, n (%)
 Since diagnosis of PKD, ever experienced nagging or chronic pain in the back55 (57)43 (61)12 (44)0.13
 Since diagnosis of PKD, ever experienced nagging or chronic pain in the back radiating into buttocks/hips/legs32 (33)28 (40)4 (15)0.02
 Since diagnosis of PKD, ever experienced nagging or chronic pain in the abdomen38 (39)28 (40)10 (37)0.8
Back pain within prior 3 mo, n (%)0.2
 Never26 (27)17 (24)9 (33)
 Rarely18 (19)14 (20)4 (15)
 Sometimes24 (25)15 (21)9 (33)
 Often11 (11)11 (16)0 (0)
 Usually12 (12)8 (11)4 (15)
 Always6 (6)5 (7)1 (4)
Pain radiating to buttocks/hips/legs within prior 3 mo, n (%)0.8
 Never66 (68)45 (64)21 (78)
 Rarely12 (12)10 (14)2 (7)
 Sometimes12 (12)9 (13)3 (11)
 Often4 (4)3 (4)1 (4)
 Usually3 (3)3 (4)0 (0)
 Always0 (0)0 (0)0 (0)
Abdominal pain within 3 mo, n (%)0.9
 Never49 (51)35 (50)14 (52)
 Rarely11 (11)8 (11)3 (11)
 Sometimes27 (28)20 (29)7 (26)
 Often2 (2)2 (3)0 (0)
 Usually7 (7)4 (6)3 (11)
 Always1 (1)1 (1)0 (0)
  • Continuous variables reported as mean±SD and tested between females/males using t tests. Categoric variables reported as n (%) and tested between groups using chi-squared tests or Fischer exact tests. SF-36, Short Form-36; PKD, polycystic kidney disease.