Table 1.
Characteristics of idiopathic gastroparesis patients overall and for females and males
| Total (N = 243) |
Females (N = 214) |
Males (N = 29) |
P value† |
||||
|---|---|---|---|---|---|---|---|
| Characteristic | No. | Statistic* | No. | Statistic* | No. | Statistic* | |
| Demographic and lifestyle: | |||||||
| Age at enrollment (years): | 0.49 | ||||||
| 18–30 | 72 | 29.6% | 62 | 29.0% | 10 | 34.5% | |
| 31–44 | 80 | 32.9% | 74 | 34.6% | 6 | 20.7% | |
| 45–59 | 67 | 27.6% | 58 | 27.1% | 9 | 31.0% | |
| 60+ | 24 | 9.9% | 20 | 9.3% | 4 | 13.8% | |
| Average age | 243 | 41.0 ± 14.1 | 214 | 40.9 ± 14.0 | 29 | 41.6 ± 14.9 | 0.78 |
| Race: | 1.00 | ||||||
| White | 218 | 89.7% | 192 | 90.0% | 26 | 90.0% | |
| Black | 16 | 6.6% | 14 | 6.5% | 2 | 6.9% | |
| Other | 9 | 3.7% | 8 | 3.7% | 1 | 3.5% | |
| Married (yes vs no) | 143 | 58.9% | 126 | 58.9% | 17 | 58.6% | 0.97 |
| College degree or higher (yes vs no) | 80 | 32.9% | 71 | 33.2% | 9 | 31.0% | 0.82 |
| Income $50,000+ (yes vs no) | 139 | 57.2% | 122 | 57.0% | 17 | 58.6% | 0.87 |
| Ever smoked regularly‡ (yes vs no) | 81 | 33.3% | 65 | 30.4% | 16 | 55.2% | 0.008 |
| Ever drink (past yr) | 96 | 39.5% | 87 | 40.7% | 9 | 31.0% | 0.32 |
| Anthropometry: | |||||||
| Height (m) | 243 | 1.64 ± 0.08 | 214 | 1.62 ± 0.06 | 29 | 1.76 ± 0.07 | <0.001 |
| Weight (kg) | 243 | 68.6 ± 19.0 | 214 | 66.8 ± 18.1 | 29 | 82.0 ± 20.8 | <0.001 |
| Waist circumference (cm) | 243 | 85.0 ± 17.7 | 214 | 83.5 ± 17.5 | 29 | 95.7 ± 15.8 | <0.001 |
| Waist to Hip ratio health risk (sex-specific)‡ | 0.01 | ||||||
| Low | 89 | 36.6% | 73 | 34.1% | 16 | 55.2% | |
| Moderate | 62 | 25.0% | 53 | 24.8% | 9 | 31.0% | |
| High | 92 | 37.9% | 88 | 41.1% | 4 | 13.8% | |
| BMI category: | 0.04 | ||||||
| Underweight (<18 kg/m2) | 19 | 7.8% | 18 | 8.4% | 1 | 3.5% | |
| Normal (18–24 kg/m2) | 113 | 46.5% | 102 | 47.7% | 11 | 37.9% | |
| Overweight (25–30 kg/m2) | 49 | 20.2% | 37 | 17.3% | 12 | 41.4% | |
| Obese (>30 kg/m2) | 62 | 25.5% | 57 | 26.6% | 5 | 17.2% | |
| BMI (kg/m2) | 243 | 25.6 ± 6.9 | 214 | 25.4 ± 7.0 | 29 | 26.3 ± 5.9 | 0.21 |
| Inflammatory markers: | |||||||
| C-reactive protein (CRP) (mg/dL) | 243 | 0.7 ± 1.2 | 214 | 0.7 ± 1.3 | 29 | 0.6 ± 0.7 | 0.45 |
| C-reactive protein elevated (>0.8 mg/dL) | 51 | 21.0% | 44 | 20.6% | 7 | 24.1% | 0.66 |
| Erythrocyte sedimentation rate (mm/hr) | 243 | 14.4 ± 14.9 | 214 | 15.3 ± 15.2 | 29 | 7.4 ± 10.3 | <0.001 |
| ESR elevated (ESR > 20.0 mm/hr) | 51 | 21.0% | 49 | 22.9% | 2 | 6.9% | 0.05 |
| Psychological function inventories: | |||||||
| State Anxiety inventory average score | 243 | 45.2 ± 13.5 | 214 | 44.9 ± 13.1 | 29 | 47.7 ± 16.3 | 0.46 |
| State Anxiety inventory score ≥ 50 (severe) | 88 | 36.2% | 77 | 36.0% | 11 | 37.9% | |
| Trait Anxiety inventory average score | 243 | 43.9 ± 12.1 | 214 | 43.8 ± 12.1 | 29 | 45.0 ± 12.3 | 0.53 |
| Trait Anxiety inventory score ≥ 50 (severe) | 84 | 34.6% | 71 | 33.2% | 13 | 44.8% | |
| Beck Depression Inventory average score | 243 | 18.6 ± 10.8 | 214 | 18.5 ± 10.7 | 29 | 19.3 ± 11.2 | 0.71 |
| Beck Depression Inv score > 28 (severe) | 44 | 18.1% | 36 | 16.8% | 8 | 27.6% | 0.16 |
| Medical history: | |||||||
| Co-morbidities: | |||||||
| Average number of co-morbidities | 243 | 3.63 ± 2.69 | 214 | 3.68 ± 2.64 | 29 | 3.28 ± 3.10 | 0.22 |
| Migraine Headache (yes vs no) | 99 | 40.7% | 92 | 43.0% | 7 | 24.1% | 0.05 |
| Chronic fatigue syndrome (yes vs no) | 22 | 9.1% | 22 | 10.3% | 0 | 0.0% | 0.09 |
| Fibromyalgia (yes vs no) | 31 | 12.8% | 30 | 14.0% | 1 | 3.5% | 0.14 |
| Major depression (yes vs no) | 53 | 21.8% | 46 | 21.5% | 7 | 24.1% | 0.75 |
| Severe anxiety (yes vs no) | 30 | 12.4% | 26 | 12.2% | 4 | 13.8% | 0.77 |
| Co-medications: | |||||||
| Gastric acid suppressants (yes vs no) | 185 | 76.1% | 162 | 75.7% | 23 | 79.3% | 0.67 |
| Prokinetics (yes vs no) | 118 | 48.6% | 103 | 48.1% | 15 | 51.7% | 0.72 |
| Anti-emetics (yes vs no) | 174 | 71.6% | 154 | 72.0% | 20 | 69.0% | 0.74 |
| Estrogen, progesterone,OCP’s (yes v no) | 58 | 23.9% | 57 | 26.6% | 1 | 3.5% | 0.006 |
| Narcotic pain medications (yes vs no) | 103 | 42.4% | 92 | 43.0% | 11 | 37.9% | 0.60 |
| Medical marijuana use (yes vs no)‡ | 3 | 1.2% | 2 | 0.9% | 1 | 3.5% | 0.32 |
| Total enteral/parenteral support (yes vs no) | 28 | 11.5% | 25 | 11.7% | 3 | 10.3% | 1.00 |
| Post-menopausal (yes vs no) | 67 | 31.3% | 67 | 31.3% | n/a | ||
| Hysterectomy (yes vs no) | 59 | 27.6% | 59 | 27.6% | n/a | ||
| Age at onset of symptoms (years): | 0.64 | ||||||
| 9 – 20 | 41 | 16.9% | 36 | 16.8% | 5 | 17.2% | |
| 21 – 30 | 59 | 24.3% | 51 | 23.8% | 8 | 27.6% | |
| 31 – 44 | 71 | 29.2% | 66 | 30.8% | 5 | 17.2% | |
| 45 – 60 | 59 | 24.3% | 50 | 23.4% | 9 | 31.0% | |
| 61 + | 13 | 5.4% | 11 | 5.1% | 2 | 6.9% | |
| Average age | 243 | 36.1 ± 14.6 | 214 | 36.1 ± 14.6 | 26 | 36.0 ± 15.2 | 0.82 |
| Duration of symptoms at enrollment (yrs): | 0.20 | ||||||
| 0 – 1 | 93 | 38.3% | 81 | 37.9% | 12 | 41.4% | |
| 2 –4 | 76 | 31.3% | 67 | 31.3% | 9 | 31.0% | |
| 5 – 9 | 45 | 18.5% | 43 | 20.1% | 2 | 6.9% | |
| 10+ | 29 | 11.9% | 23 | 10.8% | 6 | 20.7% | |
| Average duration | 243 | 4.8 ± 6.5 | 214 | 4.8 ± 6.6 | 29 | 5.0 ± 6.1 | 0.83 |
| Initial infectious prodrome: | 45 | 18.6% | 40 | 18.7% | 5 | 17.9% | 0.92 |
| Upper respiratory flu-like illness | 11 | 4.6% | 8 | 3.7% | 3 | 10.7% | |
| Food-poisoning like symptoms | 11 | 4.6% | 9 | 4.2% | 2 | 7.1% | |
| Gastroenteritis | 16 | 6.6% | 16 | 7.5% | 0 | 0.0% | |
| Other | 8 | 3.3% | 8 | 3.7% | 0 | 0.0% | |
| Predominant symptom prompting evaluation: | |||||||
| Nausea vs all others | 83 | 34.2% | 73 | 34.1% | 10 | 34.5% | 0.97 |
| Vomiting vs all others | 47 | 19.3% | 43 | 20.1% | 4 | 13.8% | 0.42 |
| Abdominal pain vs all others | 56 | 23.1% | 51 | 23.8% | 5 | 17.2% | 0.43 |
| Bloating vs all others | 17 | 7.0% | 13 | 6.1% | 4 | 13.8% | 0.13 |
| Gastroesophageal reflux vs all others | 14 | 5.8% | 12 | 5.6% | 2 | 6.9% | 0.67 |
| Type of gastroparesis symptom onset: | 0.86 | ||||||
| Acute start | 122 | 50.2% | 107 | 50.0% | 15 | 51.7% | |
| Insidious start | 121 | 49.8% | 107 | 50.0% | 14 | 48.3% | |
| Nature of gastroparesis symptoms: | 0.91 | ||||||
| Chronic, but stable | 54 | 22.2% | 48 | 22.4% | 6 | 20.7% | |
| Chronic, but worsening | 82 | 33.7% | 73 | 34.1% | 9 | 31.0% | |
| Chronic with periodic exacerbations | 80 | 32.9% | 70 | 32.7% | 10 | 34.5% | |
| Cyclic pattern | 26 | 10.7% | 22 | 10.3% | 4 | 13.8% | |
| Gastroparesis severity: | 0.85 | ||||||
| Mild (grade 1) | 34 | 14.0% | 29 | 13.6% | 5 | 17.2% | |
| Compensated (grade 2) | 137 | 56.4% | 121 | 56.5% | 16 | 55.2% | |
| Gastric failure (grade 3) | 71 | 29.2% | 63 | 29.4% | 8 | 27.6% | |
| Irritable bowel syndrome or IBS‡ | 0.68 | ||||||
| Yes, pending exam/test | 157 | 64.6% | 137 | 64.0% | 20 | 69.0% | |
| No | 86 | 35.4% | 77 | 36.0% | 9 | 31.0% | |
| Gastric emptying (scintigraphy): | |||||||
| Percent gastric retention at 2 hr | 243 | 62.7 ± 16.6 | 214 | 63.1 ± 16.7 | 29 | 59.9 ± 16.0 | 0.38 |
| Percent gastric retention at 4 hr | 242 | 28.1 ± 18.8 | 213 | 28.9 ± 19.4 | 29 | 22.2 ± 13.3 | 0.10 |
| Severity of delayed gastric emptying - 4hr: | 0.14 | ||||||
| Mild (0 – 20%) | 108 | 44.6% | 92 | 43.2% | 16 | 55.2% | |
| Moderate (21% – 35%) | 66 | 27.3% | 58 | 27.2% | 8 | 27.6% | |
| Severe (> 35%) | 68 | 28.1% | 63 | 29.6% | 5 | 17.2% | |
| Severity of Symptoms:‡ | |||||||
| Nausea severity | 243 | 3.5 ± 1.4 | 214 | 3.6 ± 1.3 | 29 | 2.8 ± 1.7 | 0.02 |
| Retching severity | 243 | 1.8 ± 1.8 | 214 | 1.9 ± 1.8 | 29 | 1.5 ± 1.5 | 0.29 |
| Vomiting severity | 243 | 1.9 ± 1.9 | 214 | 2.0 ± 1.9 | 29 | 1.5 ± 2.0 | 0.15 |
| Feeling of stomach fullness severity | 241 | 3.7 ± 1.2 | 213 | 3.8 ± 1.1 | 28 | 3.0 ± 1.3 | <0.001 |
| Inability to finish meal severity | 243 | 3.6 ± 1.4 | 214 | 3.7 ± 1.3 | 29 | 2.8 ± 1.7 | 0.003 |
| Excessively full after meal severity | 243 | 3.7 ± 1.3 | 214 | 3.8 ± 1.2 | 29 | 3.2 ± 1.5 | 0.05 |
| Loss of appetite severity | 243 | 3.1 ± 1.5 | 214 | 3.1 ± 1.5 | 29 | 2.7 ± 1.7 | 0.24 |
| Bloating severity | 243 | 3.3 ± 1.5 | 214 | 3.4 ± 1.5 | 29 | 2.7 ± 1.6 | 0.03 |
| Visibly larger stomach severity | 243 | 2.9 ± 1.8 | 214 | 3.0 ± 1.8 | 29 | 2.0 ± 1.9 | 0.008 |
| Cardinal symptom index (GCSI)‡ | 241 | 3.0 ± 1.0 | 213 | 3.1 ± 1.0 | 28 | 2.5 ± 1.1 | 0.008 |
| Upper abdominal pain | 243 | 3.2 ± 1.7 | 214 | 3.2 ± 1.6 | 29 | 2.7 ± 1.8 | 0.09 |
| Upper abdominal discomfort | 243 | 3.3 ± 1.5 | 214 | 3.4 ± 1.5 | 29 | 3.0 ± 1.6 | 0.30 |
| GERD sub-scale‡ | 243 | 2.0 ± 1.4 | 214 | 2.0 ± 1.4 | 29 | 1.9 ± 1.3 | 0.73 |
| Constipation severity | 243 | 2.4 ± 1.8 | 214 | 2.6 ± 1.8 | 29 | 1.4 ± 1.5 | < 0.001 |
| Diarrhea severity | 243 | 1.9 ± 1.7 | 214 | 1.9 ± 1.7 | 29 | 2.1 ± 1.9 | 0.55 |
*
Means ± standard deviations or percents (%).
†
The significance of difference in categorical variables between groups was tested with either a chi-square test or Fisher’s Exact Test for non-ordered categories, the Cochran-Armitage test for trend for ordered categories, or with the Wilcoxon rank sum test for continuous measures. All P values are two-sided.
‡
Definitions:
Ever smoked regularly defined as smoking ≥ 20 packs of cigarettes in a lifetime or ≥ 1 cigarette per day for a year.
Waist to hip ratio cardiovascular disease and diabetes health risk category based on NIDDK guidelines defined as follows: Low risk (≤ 0.95 for males, ≤ 0.80 for females), moderate risk (0.96 to 1.0 for males, 0.81 to 0.85 for females), high risk (≥ 1.0 for males, ≥ 0.85 for females)
Medical marijuana use determined via self-reported use in an “other category” of alternative therapies.
Irritable Bowel Syndrome or IBS diagnosis determined from the Rome III Diagnostic Questionnaire analyzed using an analysis program developed by the Rome Foundation (http://www.romecriteria.org/rome_iii_sas/, accessed 03 February 2010).
Symptom severity from the PAGI-SYM (Patient Assessment of GI Symptoms) questionnaire, scores range from 0–5
Gastroparesis cardinal symptom index (GCSI) = mean of the sub-scores for nausea, postprandial fullness, and bloating where:
- Nausea sub-score = mean of the scores for nausea, retching, and vomiting
- Postprandial fullness/early satiety sub-score = mean of the scores for stomach fullness, inability to finish meal, excessive fullness, and loss of appetite
- Bloating sub-score = mean of the scores for bloating and large stomach
Gastroesophageal (GERD) sub-scale = mean of the scores for daytime heartburn, heartburn lying down, daytime chest discomfort, nighttime chest discomfort, daytime reflux, nighttime reflux, and bitter taste