Table 3. Effects of Hemin and Placebo Infusions on Gastroparesis Symptoms and Quality of Life Evaluated Every Two Weeks.
| Scores | Baseline Placebo (n=9) | 8 weeks Placebo (n=7) | Baseline Hemin (n=9) | 8 weeks Hemin (n=9) |
|---|---|---|---|---|
| PAGI-SYM | ||||
| GCSI total score* | 3.3 ± 0.1 | 1.9 ± 0.5 | 3.1 ± 0.3 | 1.4 ± 0.3 |
| Nausea/vomiting subscore* | 3.2 ± 0.4 | 1.3 ± 0.4 | 2.9 ± 0.6 | 1.3 ± 0.4 |
| Fullness/early satiety subscore* | 3.4 ± 0.3 | 2.1 ± 0.5 | 3.8 ± 0.3 | 1.9 ± 0.4 |
| Bloating subscore* | 3.4 ± 0.4 | 2.4 ± 0.7 | 2.6 ± 0.5 | 1.0 ± 0.3 |
| Upper abdominal pain subscore* | 2.8 ± 0.6 | 1.7 ± 0.6 | 3.7 ± 0.4 | 1.4 ± 0.4 |
| Lower abdominal pain subscore* | 1.9 ± 0.4 | 1.4 ± 0.5 | 2.6 ± 0.4 | 1.3 ± 0.4 |
| Heartburn/regurgitation subscore* | 1.8 ± 0.4 | 0.9 ± 0.5 | 2.0 ± 0.4 | 1.0 ± 0.4 |
| FDA NVFP composite subscore* | 3.3 ± 0.2 | 1.7 ± 0.4 | 3.4 ± 0.4 | 1.5 ± 0.4 |
| Dyspepsia Severity Ratings** | ||||
| Fullness | 59.8 ± 10.2 | 43.0 ± 14.3 | 47.9 ± 10.2 | 31.4 ± 9.0 |
| Inability to finish a regular meal | 54.7 ± 10.2 | 36.2 ± 14.5 | 36.6 ± 9.7 | 30.9 ± 10.5 |
| Bloating in upper abdomen | 46.2 ± 14.0 | 51.7 ± 16.8 | 24.0 ± 11.2 | 27.2 ± 7.8 |
| Discomfort in upper abdomen | 44.0 ± 12.6 | 41.9 ±13.3 | 45.8 ± 9.8 | 34.0 ± 9.5 |
| Pain/ache in upper abdomen | 45.1 ± 12.8 | 40.6 ± 13.6 | 37.3 ± 11.5 | 29.3 ± 10.0 |
| Nausea after meals | 52.4 ± 10.8 | 22.1 ± 8.3 | 41.9 ± 11.1 | 36.1 ± 10.5 |
| PAGI-QOL | ||||
| Total score | 1.8 ± 0.3 | 3.1 ± 0.6 | 2.3 ± 0.4 | 3.7 ± 0.4 |
| Daily activities | 1.5 ± 0.4 | 2.9 ± 0.6 | 1.9 ± 0.4 | 3.2 ± 0.5 |
| Diet/food habits | 1.4 ± 0.3 | 3.1 ± 0.5 | 3.1 ± 0.5 | 2.9 ± 0.5 |
Abbreviations: FDA NVFP, US Food and Drug Administration Nausea, Vomiting, Fullness, and Pain; GCSI, Gastroparesis Cardinal Symptom Index; PAGI-QOL, Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life; PAGI-SYM, Patient Assessment of Upper Gastrointestinal Disorders-Symptoms; GCSI, Gastroparesis Cardinal Symptom Index.
Components coded 0 (no symptoms) to 5 (very severe). GCSI total score is the average of 9 components from the nausea/vomiting, fullness/early satiety, and bloating subscores. These individual subscores are averages of 3, 4, and 2 components, respectively. Subscores for upper and lower abdominal pain, heartburn/regurgitation and FDA NVFP composite are averages of 2, 2, 7, and 4 components, respectively.
Components coded on the VAS scale of 0 (no severity) to 100 (worst ever).
Components coded 0 (lowest quality of life) to 5 (highest quality of life). Total score is the sum of all 30 survey components. Subscores for daily activities and diet/food habits are sums of 10 and 7 components, respectively.
Data shown as mean ± SEM.