Table 1.
Demographics: Baseline clinical and demographic characteristics of participants in placebo, individual treatment, and combined treatment groups.
| Placebo -
Education Only (N=35) |
Loperamide - Education Only (N=71) |
Placebo - Exercise plus Bio feedback (N=69) |
Loperamide - Exercise plus Biofeedback (N=72) |
||
|---|---|---|---|---|---|
| Endpoint | Category | Baseline Characteristic |
Baseline Characteristic |
Baseline Characteristic |
Baseline Characteristic |
| Age, mean (SD) [min, max], y | 62.5 (10.5) [40.2, 83.3] | 62.5 (10.7) [38.1, 83.3] | 65.5 (10.3) [39.7, 93.4] | 63.6 (12.4) [27.5, 87.6] | |
| Race, No. (%) | American Indian/Alaskan Native | 2 (5.7) | 0 (0.0) | 1 (1.4) | 0 (0.0) |
| Black/African American | 6 (17.1) | 10 (14.1) | 10 (13.9) | 9 (13.0) | |
| More than one race | 0 (0.0) | 0 (0.0) | 4 (5.6) | 1 (1.4) | |
| Other | 2 (5.7) | 2 (2.8) | 1 (1.4) | 2 (2.9) | |
| White | 25 (71.4) | 59 (83.1) | 56 (77.8) | 57 (82.6) | |
| Ethnicity, No. (%) | Hispanic/Latina | 2 (5.7) | 7 (9.9) | 7 (9.7) | 7 (10.1) |
| Not Hispanic/Not Latina | 32 (91.4) | 63 (88.7) | 64 (88.9) | 61 (88.4) | |
| Unknown/Not Reported | 1 (2.9) | 1 (1.4) | 1 (1.4) | 1 (1.4) | |
| Prior accidental bowel leakage surgery, No(%) | 0 (0.0) | 4 (5.6) | 3 (4.2) | 5 (7.2) | |
| Prior rectal or anal surgery, No. (%) | 7 (20.6) | 6 (8.6) | 12 (17.1) | 8 (11.6) | |
| BMI, mean (SD) [min, max] | 30.5 (9.0) [20.2, 62.1] | 31.0 (6.7) [20.2, 48.5] | 29.9 (6.7) [19.5, 55.0] | 28.8 (6.6) [17.1, 43.2] | |
| Dietary Fiber Score, mean (SD) [min, max] | 15.1 (7.3) [2.0, 33.0] | 15.3 (6.3) [4.0, 31.0] | 16.5 (6.4) [4.0, 41.0] | 16.1 (5.8) [5.0, 29.0] | |
| Daily fiber intake, mean (SD) [min, max] | 14.6 (5.4) [4.9, 27.8] | 14.7 (4.7) [6.4, 26.3] | 15.6 (4.7) [6.4, 33.7] | 15.3 (4.3) [7.1,24.9] | |
| Bristol Stool Index, No. (%) | Type 2. Sausage shaped but lumpy | 6 (17.1) | 6 (8.5) | 16 (22.2) | 5 (7.2) |
| Type 3. Like a sausage or snake but with cracks on | 2 (5.7) | 14 (19.7) | 9 (12.5) | 10 (14.5) | |
| Type 4. Like a sausage or snake, smooth and soft | 14 (40.0) | 24 (33.8) | 20 (27.8) | 25 (36.2) | |
| Type 5. Soft blobs with clear cut edges | 5 (14.3) | 13 (18.3) | 12 (16.7) | 15 (21.7) | |
| Type 6. Fluffy pieces with ragged edges, a mushy s | 8 (22.9) | 14 (19.7) | 15 (20.8) | 14 (20.3) | |
| Rome III IBS Clinical Status, No. (%) | 5 (14.3) | 14 (19.7) | 14 (19.4) | 15 (21.7) | |
| PAC-SYM Scores, mean (SD) [min, max] | Stool Score | 1.1 (0.8) [0.0, 2.6] | 1.2 (0.8) [0.0, 2.8] | 0.9 (0.9) [0.0, 3.8] | 1.1 (0.8) [0.0, 2.8] |
| Rectal Score | 0.8 (0.8) [0.0, 2.7] | 0.7 (0.7) [0.0, 2.7] | 0.9 (0.7) [0.0, 3.3] | 0.7 (0.7) [0.0, 2.3] | |
| Abdominal Score | 1.0 (1.1) [0.0, 3.5] | 1.1 (0.9) [0.0, 3.3] | 1.1 (0.8) [0.0, 3.4] | 0.9 (0.8) [0.0, 3.0] | |
| Global Score | 1.0 (0.7) [0.0, 2.7] | 1.1 (0.7) [0.0, 2.6] | 0.7 (0.8) [0.0, 3.0] | 0.9 (0.6) [0.0, 2.5] | |