Table 1:
Baseline characteristics by functional dyspepsia (FD) and gastroparesis
| Gastric Emptying Test Status* | |||
|---|---|---|---|
| FD | Gastroparesis | ||
|
|
|||
| Baseline characteristic | Mean (SD) or No. (Percent) (N=224) | Mean (SD) or No. (Percent) (N=720) | P * |
| Demographics/lifestyle: | |||
| Sex: female | 199 (89%) | 603 (84%) | .06 |
| Race: White | 200 (89%) | 640 (89%) | |
| Ethnicity: Hispanic | 22 (10%) | 83 (12%) | .48 |
| Age at baseline (yrs) | 42.8 (13.9) | 43.0 (13.5) | .80 |
| Age at baseline (> 50 yrs) | 64 (29%) | 208 (29%) | .93 |
| Smoked (ever regularly) | 71 (32%) | 225 (31%) | .90 |
| Education: College degree or higher | 79 (35%) | 235 (33%) | .47 |
| Income (≥ $50,000) | 119 (53%) | 357 (50%) | .33 |
| Symptom severity (Global and PAGI-SYM‡): | |||
| Global symptom severity (Investigator-rated): | |||
| Mild | 37 (17%) | 117 (16%) | .04 |
| Moderate | 150 (67%) | 423 (59%) | |
| Gastric failure | 37 (17%) | 175 (24%) | |
| Predominant symptom on presentation: ‡ | |||
| Nausea | 88 (39%) | 225 (31%) | .16 |
| Vomiting | 41 (18%) | 158 (22%) | |
| Abdominal pain | 40 (18%) | 140 (19%) | |
| Any other symptom | 55 (25%) | 197 (27%) | |
| GCSI total score | 3.0 (0.9) | 2.9 (1.1) | .49 |
| Nausea/vomiting subscale | 2.2 (1.3) | 2.4 (1.4) | .11 |
| Post-prandial fullness subscale | 3.6 (1.0) | 3.4 (1.2) | .004 |
| Bloating subscale | 3.2 (1.6) | 3.1 (1.6) | .43 |
| Abdominal pain moderate/severe‡ | 148 (67%) | 472 (66%) | .80 |
| Upper abdominal pain subscale | 3.0 (1.4) | 3.1 (1.5) | .92 |
| Upper abdominal pain severity score | 2.9 (1.5) | 3.0 (1.7) | .91 |
| Upper abdominal discomfort score | 3.1 (1.4) | 3.2 (1.6) | .93 |
| GERD subscale | 1.9 (1.3) | 2.0 (1.4) | .29 |
| Gastric Emptying Scintigraphy (GES): | |||
| % Retention at 2-hours | 33.0 (14.6) | 65.0 (18.0) | n/a |
| % Retention at 4-hours | 4.3 (3.0) | 32.2 (22.0) | n/a |
| Delayed emptying at 2-hours | 0 (0%) | 455 (63%) | n/a |
| Delayed emptying at 4-hours‡ | 0 (0%) | 673 (94%) | n/a |
| Clinical factors: | |||
| Etiology: | .008 | ||
| Idiopathic | 170 (76%) | 472 (66%) | |
| Diabetes Type 1 | 22 (10%) | 125 (17%) | |
| Diabetes Type 2 | 32 (14%) | 123 (17%) | |
| Body Mass Index (BMI): | |||
| Overweight or obese (BMI >25) | 117 (52%) | 406 (56%) | .27 |
| Mean BMI (kg/m2) | 27.9 (8.7) | 27.4 (7.5) | .35 |
| Duration of symptoms at enrollment (years) | 6.1 (7.4) | 5.5 (6.8) | .28 |
| Acute onset of symptoms | 92 (41%) | 326 (45%) | .27 |
| Initial infectious prodrome | 45 (20%) | 135 (19%) | .66 |
| Inflammation‡ | 86 (38%) | 333 (46%) | .04 |
| CRP (mg/dL) | 1.0 (1.8) | 1.9 (6.3) | .02 |
| ESR (mm/hr) | 15.8 (15.6) | 19.7 (20.0) | .007 |
| HbAlc (%) | 6.0 (1.4) | 6.4 (1.8) | .01 |
| Treatment (current use at baseline): | |||
| Narcotics use | 78 (35%) | 278 (39%) | .31 |
| Proton pump inhibitors | 150 (67%) | 541 (75%) | .02 |
| Prokinetics | 66 (29%) | 329 (46%) | <.001 |
| Antiemetics | 138 (62%) | 451 (63%) | .81 |
| Antidepressants | 116 (52%) | 347 (48%) | .35 |
| Anxiolytics | 45 (20%) | 163 (23%) | .42 |
| Pain modulators | 55 (25%) | 182 (25%) | .83 |
| On total parental nutrition (TPN) | 7 (3%) | 52 (7%) | .03 |
| Gastric electric stimulation device implantation | 17 (8%) | 44 (6%) | .43 |
| Psychological & QOL | |||
| Beck Depression Inventory (BDI) score | 18.3 (11.5) | 18.5 (11.3) | .83 |
| Moderate to severe depression (BDI>20)‡ | 91 (41%) | 296 (41%) | .90 |
| State-Trait Anxiety Inventory (STAI): | |||
| State Anxiety score | 43.4 (13.4) | 44.2 (13.7) | .44 |
| Severe state anxiety (≥ 50)‡ | 73 (33%) | 252 (35%) | .51 |
| Trait Anxiety score | 43.0 (12.9) | 43.7 (12.6) | .47 |
| Severe trait anxiety (≥ 50)‡ | 69 (31%) | 237 (33%) | .56 |
| Quality of Life total score | 2.6 (1.1) | 2.6 (1.1) | .98 |
| PAGI-QOL‡ ≥ 3 | 80 (36%) | 265 (37%) | .85 |
| Overall Health Survey‡ (SF-36 v2) | |||
| Physical health component subscore | 33.8 (11.0) | 33.2 (10.6) | .53 |
| Mental health component subscore | 40.3 (12.2) | 38.9 (13.0) | .15 |
GpR and GpR2 patients with either idiopathic or diabetic etiology without rapid gastric emptying are included. 37 patients with normal emptying and symptoms of gastroparesis were excluded due to not being classified as Functional Dyspepsia (FD) by Rome III criteria (Total N=944).
Functional Dyspepsia (FD) defined as percent retention from a Gastric Emptying Test (GET) being ≤ 60% at 2-hours and ≤ 10% at 4-hours and meeting the criteria for FD using Rome III classification.
Gastroparesis defined as percent retention from a GET being > 60% at 2-hours and/or > 10% at 4-hours.
Percentages or averages for each characteristic determined from patients with non-missing data for that characteristic.
Of the 48 characteristics compared, 3 would be likely be significant (at alpha=.05) due to chance.
P value (2-sided) derived from either a t-test or ANOVA for continuous predictors, or Pearson’s chi-square test for categorical predictors. Bold font denotes a P <.05. n/a denotes not applicable.
PAGI-SYM scores report patient-rated severity of symptoms from 0 (none) to 5 (severe) in the past 2 weeks.
Predominant symptom at presentation (baseline visit) is the main reason for evaluation that the patient reported; it was categorized to report the 3 most frequent issues; the other category includes bloating, early satiety, post-prandial fullness, diarrhea, constipation, anorexia, GERD symptoms, poorly managed diabetes or glycemic control and a weight change (loss or gain).
Abdominal pain moderate/severe defined as either upper abdominal pain or discomfort PAGI-SYM symptom score ≥ 3
The 46 patients without delayed emptying at 4-hours (due to missing % retention data) were delayed emptying at 2-hours.
Inflammation defined as either CRP > 1.0 mg/dL or ESR > 20 mm/hr
Beck Depression Inventory (BDI) > 20 indicates moderate or more severe depression.
STAI scores ≥ 50 indicate severe state or trait anxiety.
PAGI-QOL score increases with increased quality of life due to gastroparesis symptoms in past 2 weeks.
SF-36v2 score increases with increased general quality of life in the past 4 weeks.