Table 5.

Change in irritable bowel syndrome-related quality of life and level of anxiety and depression (Hospital Anxiety and Depression Score)

Treatment		Baseline		Week 12	Change from baseline	Within-group comparison	Comparison with placebo	Comparison with low- and high-dose
	n	mean ± SD	n	mean ± SD	mean ± SD	P value	P value	P value
IBS-QoL
Placebo	121	66.4 ± 17.5	118	73.2 ± 19.0	7.0 ± 12.3	< 0.001	NA	0.412
Low-dose	124	63.9 ± 19.0	110	71.6 ± 19.3	7.4 ± 12.3	< 0.001	0.812	NA
High-dose	122	68.2 ± 16.5	113	76.5 ± 15.8	8.5 ± 8.8	< 0.001	0.238	NA
HADS total score
Placebo	119	9.2 ± 5.6	110	8.6 ± 6.6	-0.4 ± 4.3	0.302	NA	0.134
Low-dose	122	10.1 ± 5.7	109	9.2 ± 6.0	-1.0 ± 4.4	0.034	0.435	NA
High-dose	118	9.7 ± 5.5	109	8.2 ± 5.8	-1.5 ± 3.9	< 0.001	0.071	NA
HADS-Anxiety
Placebo	121	5.9 ± 3.5	114	5.3 ± 3.6	-0.4 ± 2.6	0.036	NA	0.246
Low-dose	122	6.1 ± 3.3	109	5.5 ± 3.1	-0.6 ± 2.7	0.011	0.726	NA
High-dose	119	6.2 ± 3.3	109	5.0 ± 3.1	-1.0 ± 2.2	< 0.001	0.099	NA
HADS-Depression
Placebo	119	3.4 ± 2.9	111	3.4 ± 3.6	0.0 ± 2.3	0.906	NA	0.162
Low-dose	124	4.0 ± 3.0	109	3.7 ± 3.4	-0.3 ± 2.2	0.258	0.376	NA
High-dose	119	3.5 ± 2.9	110	3.2 ± 3.1	-0.4 ± 2.4	0.041	0.125	NA

HADS: Hospital anxiety and depression score; IBS-QoL: Irritable bowel syndrome quality of life.