Gastroenterol Res

Gastroenterology Research, ISSN 1918-2805 print, 1918-2813 online, Open Access

Article copyright, the authors; Journal compilation copyright, Gastroenterol Res and Elmer Press Inc

Journal website http://www.gastrores.org

Original Article

Volume 3, Number 5, October 2010, pages 185-190

Does Timing of Colon Procedures Affect Outcomes in D-IBS Trials?

Figure 1. Average daily stool consistency score, frequency and pain score by group during the first 7 days of treatment. Abbreviations: BM, bowel movement.

**Table 1.** Summary of Baseline Characteristics for IBS-D Patients Taking Placebo
Characteristic	Group 1 (n = 28)	Group 2 (n = 24)
Age (year), mean (sd)	46.9 (14.9)	49.7 (14.1)
Race (% white), n (%)	27 (96%)	22 (91%)
Gender (% female), n (%)	19 (68%)	18 (75%)
Height (cm), mean (sd)	167.7 (8.2)	166.0 (9.0)
Weight (kg), mean (sd)	76.2 (13.6)	77.9 (16.2)
Years since onset of IBS symptoms, mean (sd)	13.9 (12.7)	13.2 (14.9)
Years since IBS diagnosis, mean (sd)	2.3 (2.4)	4.2 (9.0)
Full colonoscopy (instead of sigmoidoscopy), n (%)	25 (89%)	23 (96%)
Days between colon procedure and first dose of placebo, mean (sd)	4.9 (2.2) Range: 1 - 3	506 (329) Range: 35 - 1160

Table 1. Summary of Baseline Characteristics for IBS-D Patients Taking Placebo

Characteristic

Group 1 (n = 28)

Group 2 (n = 24)

Age (year), mean (sd)

46.9 (14.9)

49.7 (14.1)

Race (% white), n (%)

27 (96%)

22 (91%)

Gender (% female), n (%)

19 (68%)

18 (75%)

Height (cm), mean (sd)

167.7 (8.2)

166.0 (9.0)

Weight (kg), mean (sd)

76.2 (13.6)

77.9 (16.2)

Years since onset of IBS symptoms, mean (sd)

13.9 (12.7)

13.2 (14.9)

Years since IBS diagnosis, mean (sd)

2.3 (2.4)

4.2 (9.0)

Full colonoscopy (instead of sigmoidoscopy), n (%)

25 (89%)

23 (96%)

Days between colon procedure and first dose of placebo, mean (sd)

4.9 (2.2) Range: 1 - 3

506 (329) Range: 35 - 1160

**Table 2.** Summary of Symptoms During Screening Period
Symptom	Group 1 (n = 28) Mean (sd)	Group 2 (n = 24 ) Mean (sd)	P Value
Pain score	2.07 (0.39)	2.12 (0.46)	0.327
Number of bowel movements	3.15 (1.25)	3.95 (2.33)	0.100
Consistency	5.07 (0.85)	5.28 (1.00)	0.371
Percentage of screening days with urgency	80.6 (22.7)	80.8 (19.9)	> 0.999

Table 2. Summary of Symptoms During Screening Period

Symptom

Group 1 (n = 28) Mean (sd)

Group 2 (n = 24 ) Mean (sd)

P Value

Pain score

2.07 (0.39)

2.12 (0.46)

0.327

Number of bowel movements

3.15 (1.25)

3.95 (2.33)

0.100

Consistency

5.07 (0.85)

5.28 (1.00)

0.371

Percentage of screening days with urgency

80.6 (22.7)

80.8 (19.9)

> 0.999

**Table 3.** Summary of Symptom Changesa From Baseline During 12-week Treatment Period
Symptom	Week	Group 1 (n = 28)	Group 2 (n = 24)	P Valueb
^aValues shown are group mean changes from the screening period in unadjusted symptom scores.
^bP value from test of group difference at each week from repeated measures model adjusted for baseline value.
Mean change from baseline in pain score	1	-0.528	-0.544	0.966
	2	-0.703	-0.619	0.968
	3	-0.767	-0.805	0.488
	4	-0.644	-0.767	0.150
	5	-0.789	-0.639	0.860
	6	-0.895	-0.571	0.662
	7	-0.948	-0.872	0.506
	8	-0.845	-0.881	0.361
	9	-0.923	-0.916	0.431
	10	-1.055	-0.834	0.901
	11	-0.991	-0.909	0.659
	12	-0.948	-0.874	0.973
Mean change from baseline in number of bowel movements	1	-0.084	-0.428	0.379
	2	-0.192	-0.650	0.299
	3	-0.138	-0.583	0.187
	4	-0.264	-0.751	0.122
	5	-0.309	-0.280	0.765
	6	-0.338	-0.390	0.686
	7	-0.161	-1.072	0.014
	8	-0.308	-0.517	0.628
	9	-0.078	-0.686	0.127
	10	-0.114	-0.450	0.403
	11	-0.294	-0.641	0.290
	12	-0.276	-0.111	0.577
Mean change from baseline in consistency	1	-0.118	-0.492	0.173
	2	-0.400	-0.254	0.377
	3	-0.370	-0.539	0.507
	4	-0.142	-0.506	0.086
	5	-0.284	-0.149	0.833
	6	-0.422	-0.444	0.487
	7	-0.278	-0.710	0.047
	8	-0.139	-0.607	0.049
	9	-0.178	-0.772	0.010
	10	-0.558	-0.573	0.706
	11	-0.301	-0.476	0.238
	12	-0.474	-0.305	0.661
Mean change from baseline in percentage of days with urgency	1	-0.102	-0.126	0.8194
	2	-0.147	-0.174	0.6878
	3	-0.150	-0.250	0.6348
	4	-0.199	-0.227	0.6007
	5	-0.166	-0.176	0.8077
	6	-0.211	-0.198	0.8531
	7	-0.162	-0.266	0.0571
	8	-0.129	-0.299	0.1459
	9	-0.226	-0.321	0.2236
	10	-0.254	-0.303	0.3325
	11	-0.263	-0.289	0.8031
	12	-0.210	-0.318	0.1737

Table 3. Summary of Symptom Changesa From Baseline During 12-week Treatment Period

Symptom

Week

Group 1 (n = 28)

Group 2 (n = 24)

P Valueb

^aValues shown are group mean changes from the screening period in unadjusted symptom scores.

^bP value from test of group difference at each week from repeated measures model adjusted for baseline value.

Mean change from baseline in pain score

-0.528

-0.544

0.966

-0.703

-0.619

0.968

-0.767

-0.805

0.488

-0.644

-0.767

0.150

-0.789

-0.639

0.860

-0.895

-0.571

0.662

-0.948

-0.872

0.506

-0.845

-0.881

0.361

-0.923

-0.916

0.431

-1.055

-0.834

0.901

-0.991

-0.909

0.659

-0.948

-0.874

0.973

Mean change from baseline in number of bowel movements

-0.084

-0.428

0.379

-0.192

-0.650

0.299

-0.138

-0.583

0.187

-0.264

-0.751

0.122

-0.309

-0.280

0.765

-0.338

-0.390

0.686

-0.161

-1.072

0.014

-0.308

-0.517

0.628

-0.078

-0.686

0.127

-0.114

-0.450

0.403

-0.294

-0.641

0.290

-0.276

-0.111

0.577

Mean change from baseline in consistency

-0.118

-0.492

0.173

-0.400

-0.254

0.377

-0.370

-0.539

0.507

-0.142

-0.506

0.086

-0.284

-0.149

0.833

-0.422

-0.444

0.487

-0.278

-0.710

0.047

-0.139

-0.607

0.049

-0.178

-0.772

0.010

-0.558

-0.573

0.706

-0.301

-0.476

0.238

-0.474

-0.305

0.661

Mean change from baseline in percentage of days with urgency

-0.102

-0.126

0.8194

-0.147

-0.174

0.6878

-0.150

-0.250

0.6348

-0.199

-0.227

0.6007

-0.166

-0.176

0.8077

-0.211

-0.198

0.8531

-0.162

-0.266

0.0571

-0.129

-0.299

0.1459

-0.226

-0.321

0.2236

-0.254

-0.303

0.3325

-0.263

-0.289

0.8031

-0.210

-0.318

0.1737