Efficacy of tandospirone in patients with irritable bowel syndrome-diarrhea and anxiety

Table 1 Demographic and baseline characteristics of the study participants with irritable bowel syndrome-diarrhea n (%)

Characteristic	Arm A (n = 100)	Arm B (n = 100)
Age (yr)
mean ± SD	46.6 ± 12.9	44.7 ± 12.8
Range	20-65	19-64
Female gender	35 (42.7)	43 (48.9)
Anxiety
mean ± SD	21.8 ± 5.2	20.9 ± 4.7
Range	14-24	14-24
Abdominal pain and diarrhea score
mean ± SD	8.3 ± 2.0	8.0 ± 2.1
Range	4-12	4-14

Table 2 Response rates in the subjects with irritable bowel syndrome-diarrhea for abdominal pain and diarrhea n (%)

	Arm	n	CR	PR	SR	NR	Response rate
Abdominal pain
Per protocol	A	82	22 (26.8)	21 (25.6)	27 (32.9)	12 (14.6)	43 (52.4)a
	B	88	14 (15.9)	15 (17.0)	28 (31.8)	31 (35.2)	29 (33.0)
Intention-to-treat	A	100	22 (22)	21 (21)	27 (27)	30 (30)	43 (43)a
	B	100	14 (14)	15 (15)	28 (28)	43 (43)	29 (29)
Diarrhea
Per protocol	A	82	25 (30.5)	25 (30.5)	23 (28)	9 (11)	50 (61.0)b
	B	88	13 (14.8)	21 (23.9)	30 (34.1)	24 (27.3)	34 (38.6)
Intention-to-treat	A	100	25 (25)	25 (25)	23 (23)	27 (27)	50 (50)a
	B	100	13 (13)	21 (21)	30 (30)	36 (36)	34 (34)
Abdominal pain plus diarrhea
Per protocol	A	82	24 (29.3)	28 (34.1)	21 (25.6)	9 (11)	52 (63.4)b
	B	88	11 (12.5)	26 (29.5)	15 (17.0)	36 (40.9)	37 (42.0)
Intention-to-treat	A	100	24 (24)	28 (28)	21 (21)	27 (27)	52 (52)a
	B	100	11 (11)	26 (26)	15 (15)	48 (48)	37 (37)

^aP < 0.05,

^bP < 0.01 vs arm B. CR: Complete response; NR: Non-response; PR: Partial response; SR: Slight response.

Table 3 Response rates in the subjects with irritable bowel syndrome-diarrhea for anxiety n (%)

Anxiety	Arm	n	CR	PR	SR	NR	Response rate
Per protocol	A	82	16 (19.5)	45 (54.9)	17 (20.7)	4 (4.9)	61 (74.4)b
	B	88	4 (4.5)	17 (19.3)	25 (28.4)	42 (47.7)	21 (23.9)
Intention-to-treat	A	100	16 (16)	45 (45)	17 (17)	22 (22)	61 (61)b
	B	100	4 (4)	17 (17)	25 (25)	54 (54)	21 (21)

^bP < 0.01, arm A vs arm B. CR: Complete response; NR: Non-response; PR: Partial response; SR: Slight response.