Efficacy of mosapride citrate with polyethylene glycol solution for colonoscopy preparation

Table 1 Baseline characteristics

Variable	Overall		Excluding patients with severe constipation		P value
	A (mosapride)	B (placebo)	C (mosapride)	D (placebo)	A vs B	C vs D
No. of patients	124	125	108	120
Age (yr, mean ± SD)	67.3 ± 8.6	67.8 ± 10.1	67.3 ± 8.5	67.5 ± 10.2	NS	NS
< 60	21	21	18	21	NS	NS
60-69	42	44	37	42
≥ 70	61	60	53	57
Male	69	83	64	80	NS	NS
Female	55	42	44	40
Body mass index (kg/m2, mean ± SD)	22.5 ± 2.9	22.6 ± 2.7	22.7 ± 2.9	22.7 ± 2.6	NS	NS
Bowel movements per week
< 2	16	5	0	0	< 0.05	NS
≥ 2	108	120	108	120
Previous colonoscopy
None (first time)	38	27	32	26	NS	NS
≥ 2	86	98	76	94

P value by the χ² test. NS: Not significant.

Table 2 Results of the preparation and endoscopic findings

Variable	Overall		Excluding patients with severe constipation		P value
	A (mosapride)	B (placebo)	C (mosapride)	D (placebo)	A vs B	C vs D
No. of patients	124	125	108	120
Time to first defecation (min, mean ± SD)	55.4 ± 27.3	71.2 ± 28.6	52.9 ± 26.2	70.4 ± 28.9	< 0.001	< 0.001
Frequency of defecation (times, median, quartile)	8.3 (4-18)	8.6 (4-18)	8.3 (4-18)	8.0 (4-18)	NS	NS
Time of bowel preparation (min, mean ± SD)	185.1 ± 63.8	198.0 ± 76.5	178.6 ± 58.2	198.0 ± 76.6	0.11	< 0.05
Elapsed time from last fluid intake to colonoscopy (min, mean ± SD)	154.6 ± 48.9	154.1 ± 48.2	157.1 ± 63.2	155.5 ± 62.1	NS	NS
Cecal intubation rate, n (%)	119 (96.0)	124 (99.2)	108 (100)	120 (100)	NS	NS
Insertion time1 (min, median, quartiles)	7.8 (2-55)	8.5 (2-38)	7.4 (2-55)	8.5 (2-38)	NS	NS
Feel of peristalsis, n (%)	20 (16.1)	22 (17.6)	14 (13.0)	22 (18.3)	NS	NS
Amount of irrigation fluid
None	67	65	57	62	NS	NS
< 50 mL	40	47	33	46
50-100 mL	15	11	12	11
> 100 mL	2	1	2	1
Endoscopic findings
Cancer	5	5	3	5
Polyps	70	82	61	79	NS	NS
Diverticulosis	32	39	29	38

P value by the Mann-Whitney U test.

¹Insertion time was based on patients in whom the cecal portion of the colon examined. NS: Not significant.

Table 3 Efficacy of overall colon-cleansing

Variable	Right colon		Left colon and rectum		P value
	Mosapride	Placebo	Mosapride	Placebo	Right	Left
No. of patients	119	125	124	125
Overall score
Excellent	39	24	48	33	< 0.05	< 0.05
Good	34	38	37	39	NS	NS
Fair	18	21	12	10	NS	NS
Poor	3	3	2	4	NS	NS
Inadequate	25	39	25	39	0.07	0.06
Optimal ratings, n (%)	91 (76.5)	83 (66.4)	97 (78.2)	82 (65.6)	0.08	< 0.05

P value by the χ² test. NS: Not significant.

Table 4 Results of colon-cleansing efficacy excluding patients with severe constipation

Variable	Right colon		Left colon and rectum		P value
	Mosapride	Placebo	Mosapride	Placebo	Right	Left
No. of patients	104	120	108	120
Overall score
Excellent	37	24	46	33	< 0.01	< 0.05
Good	31	37	33	38	NS	NS
Fair	16	20	10	9	NS	NS
Poor	2	3	1	4	NS	NS
Inadequate	18	36	18	36	< 0.05	< 0.05
Optimal ratings, n (%)	84 (80.8)	81 (67.5)	89 (82.4)	80 (66.7)	< 0.05	< 0.01

P value by the χ² test. NS: Not significant.

Table 5 Results of patient questionnaire n (%)

Variable	Overall		Excluding patients with severe constipation		P value
	A (mosapride)	B (placebo)	C (mosapride)	D (placebo)	A vs B	C vs D
No. of patients	124	125	108	120
Compliance > 80%	120 (96.8)	119 (95.2)	105 (97.2)	114 (95.0)	NS	NS
100% intake	112 (90.3)	115 (92.0)	97 (89.8)	110 (91.7)	NS	NS
Any symptom
Nausea	5 (4.0)	6 (4.8)	3 (2.7)	4 (3.3)	NS	NS
Vomiting	0	1 (0.8)	0	0	NS	NS
Distension	40 (32.3)	31 (24.8)	31 (28.7)	28 (23.3)	NS	NS
Abdominal pain	4 (3.2)	2 (1.6)	3 (2.8)	2 (1.7)	NS	NS
Circulatory reactions	0	0	0	0	NS	NS
Willingness to repeat the same regimen	77/115 (66.9)	82/112 (73.2)	67/100 (67.0)	79/108 (73.1)	NS	NS
How easy/difficult to take preparation compared with previous one (easy/invariable/difficult)	34/42/10	24/67/7	32/37/8	23/66/5	< 0.05	< 0.05

P value by the χ² test. NS: Not significant.