Table 1.
Baseline and Descriptive Characteristics
| Group | Gas Defense (n = 30) |
Placebo (n = 31) |
|---|---|---|
| Site | ||
| Dominican Republic | 27 (90%) | 27 (87%) |
| Miami, FL | 3 (10%) | 4 (4%) |
| Age, Years | 34.8 ± 12.5 | 38.2 ± 12.6 |
| Gender | ||
| Female | 16 (53%) | 17 (55%) |
| Male | 14 (47%) | 14 (45%) |
| Ethnicity | ||
| Hispanic | 27 (90%) | 28 (90%) |
| Non-Hispanic | 3 (10%) | 3 (10%) |
| Race | ||
| Black/AA | 8 (27%) | 7 (23%) |
| Caucasian | 9 (30%) | 9 (29%) |
| Other | 12 (43%) | 15 (48%) |
| Height, cm | 164.2 ± 8.6 | 165.8 ± 9.8 |
| Weight, kg | 71.4 ± 14.1 | 79.2 ± 19.3 |
| Status | ||
| Completed Protocol | 30 (100%) | 30 (97%) |
| Early Termination | 0 (0%) | 1 (3%) |
| Heart Rate, beats/minute | 69.9 ± 12.1 | 70.7 ± 10.3 |
| Systolic Blood Pressure, mm Hg | 121.2 ± 17.0 | 122.2 ± 10.9 |
| Diastolic Blood Pressure, mm Hg | 75.1 ± 9.0 | 76.0 ± 7.2 |
| GSRS - Abdominal Pain Subscore | 3.17 ± 1.85 | 3.14 ± 1.48 |
| GSRS - Abdominal Distension Subscore | 3.38 ± 2.13 | 4.14 ± 1.43 |
| GSRS - Increased Flatus Subscore | 3.86 ± 1.92 | 4.07 ± 1.53 |
| GSRS - Total GI Symptom Score | 40.8 ± 19.8 | 39.4 ± 12.1 |
| SODA - Bloating Subscore | 2.52 ± 1.48 | 2.93 ± 1.25 |
| SODA - Gas Subscore | 3.28 ± 0.96 | 3.28 ± 0.84 |
| SODA - Non-pain Symptoms Score | 16.83 ± 3.35 | 17.00 ± 2.09 |
| SODA - Satisfaction Score | 8.3 ± 3.4 | 9.2 ± 3.5 |
| SF-36v2 - Physical Component Summary | 49.9 ± 8.5 | 49.0 ± 9.9 |
| SF-36v2 - Mental Component Summary | 51.3 ± 10.1 | 51.3 ± 9.9 |
Values are expressed as mean ± standard deviation.