Table 1.

Patient demographics and disease status at baseline for all randomized patients

Demographics of All Randomized Patients	Placebo BID (N = 208)	Lubiprostone 24 mcg BID (N = 210)	P value*
Mean ± SD age, y	50.3 ± 12.0	50.5 ± 9.7	0.975
Sex, N (%)			0.541
Women	137 (65.9)	132 (62.9)
Men	71 (34.1)	78 (37.1)
Race, N (%)†			0.821
White	164 (79.2)	160 (76.2)
Black or African American	36 (17.4)	42 (20.0)
Asian	4 (1.9)	3 (1.4)
American Indian or Alaska Native	2 (1.0)	2 (1.0)
Other	1 (0.5)	3 (1.4)
Disease status, mean ± SD
Number of SBMs per week‡	1.5 ± 1.0	1.4 ± 1.1	0.793
Consistency of SBMs§∥	3.0 ± 0.8	3.0 ± 0.9	0.555
Constipation severity¶,#	2.3 ± 0.8	2.3 ± 0.8	0.951
Straining associated with SBMs§,#	2.6 ± 0.8	2.7 ± 0.9	0.431
Abdominal discomfort¶,#	2.1 ± 0.7	2.1 ± 0.7	0.980
Abdominal bloating¶,#	2.2 ± 0.8	2.2 ± 0.8	0.879
Bowel habit regularity‡,**	4.7 ± 1.6	4.5 ± 1.7	0.382
Modified Functional Living Index-Emesis¶,††	46.0 ± 13.0	46.4 ± 12.7	0.734
Brief Pain Inventory short form – Pain Severity‡‡,§§	4.4 ± 3.0	5.0 ± 2.8	0.106
Morphine equivalents,∥∥ mg/d	237 ± 451	265 ± 407	0.012
Rescue medication usage,¶ %	15.4 ± 19.0	13.9 ± 18.6	0.550

BID = twice daily; SBM = spontaneous bowel movement.

^*P values for continuous variables are from a van Elteren test stratified by pooled site; P values for categorical variables are from Fisher's exact test.

^†Placebo, N = 207; lubiprostone, N = 210.

^‡Placebo, N = 204; lubiprostone, N = 209.

^§Placebo, N = 187; lubiprostone, N = 176.

^∥5-point scale: 0 = very loose; 1 = loose; 2 = normal; 3 = hard; 4 = very hard.

^¶Placebo, N = 205; lubiprostone, N = 209.

^#5-point scale: 0 = absent; 1 = mild; 2 = moderate; 3 = severe; 4 = very severe.

^**7-point scale: 1 = very regular; 7 = very irregular.

^††Subscale: 9–63.

^‡‡Placebo, N = 189; lubiprostone, N = 191.

^§§Scale: 0–10.

^∥∥Placebo, N = 204; lubiprostone, N = 208.