Table 3.
Severity of symptoms by GCSI* | |||||||
---|---|---|---|---|---|---|---|
Mild GCSI: 0 – 2.99 (N = 114) |
Moderate GCSI: 3.0 – 3.99 (N = 86) |
Severe GCSI:4.0 – 5.0 (N = 41) |
P value‡ |
||||
Characteristic | No. | Statistic† | No. | Statistic† | No. | Statistic† | |
Demographic and lifestyle: | |||||||
Age at enrollment (yrs) | 114 | 41.6 ± 16.0 | 86 | 41.3 ± 12.2 | 41 | 39.2 ± 12.1 | 0.68 |
Gender: Females | 95 | 83.3% | 78 | 90.7% | 40 | 97.6% | 0.01 |
Married: (yes vs no) | 63 | 55.3% | 54 | 62.8% | 25 | 61.0% | 0.38 |
College degree or higher (yes vs no) | 43 | 37.7% | 25 | 29.1% | 12 | 29.3% | 0.21 |
Income $50,000+ (yes vs no) | 72 | 63.2% | 40 | 46.5% | 26 | 63.4% | 0.46 |
Ever smoked regularly (yes vs no)§ | 33 | 29.0% | 37 | 43.0% | 10 | 24.4% | 0.82 |
Ever drink (past year) | 53 | 46.5% | 28 | 32.6% | 14 | 34.2% | 0.07 |
Anthropometry: | |||||||
Waist circumference (cm) | 114 | 85.3 ± 18.3 | 86 | 85.1 ± 18.0 | 41 | 84.3 ± 16.0 | 0.98 |
Waist to hip ratio | 114 | 0.85 ± 0.09 | 86 | 0.86 ± 0.13 | 41 | 0.84 ± 0.08 | 0.89 |
Overweight: (yes vs no)§ | 54 | 47.4% | 39 | 45.4% | 17 | 41.5% | 0.52 |
BMI (kg/m2) | 114 | 25.7 ± 7.6 | 86 | 25.2 ± 6.1 | 41 | 25.8 ± 6.8 | 0.96 |
Inflammatory markers: | |||||||
C-reactive protein (CRP) (mg/dL) | 114 | 0.7 ± 1.5 | 86 | 0.5 ± 0.6 | 41 | 1.0 ± 1.2 | 0.02 |
CRP elevated (> 0.8 mg/dL) | 21 | 18.4% | 14 | 16.3% | 16 | 39.0% | 0.03 |
ESR rate (mm/hr)§ | 114 | 13.4 ± 16.5 | 86 | 15.4 ± 13.4 | 41 | 14.8 ± 13.5 | 0.06 |
ESR elevated (> 20 mm/hr)§ | 20 | 17.5% | 20 | 23.3% | 10 | 24.4% | 0.27 |
Psychological function inventories: | |||||||
State Anxiety inventory average score | 114 | 42.8 ± 12.6 | 86 | 48.3 ± 14.2 | 41 | 45.8 ± 13.3 | 0.03 |
State Anxiety inventory score ≥ 50 | 36 | 31.6% | 37 | 43.0% | 15 | 36.6% | 0.31 |
Trait Anxiety inventory average score | 114 | 42.5 ± 12.0 | 86 | 46.2 ± 12.2 | 41 | 43.5 ± 11.7 | 0.12 |
Trait Anxiety inventory score ≥ 50 | 25 | 30.7% | 35 | 40.7% | 14 | 34.2% | 0.42 |
Beck Depression Inventory avg score | 114 | 15.5 ± 9.6 | 86 | 21.7 ± 11.0 | 41 | 21.0 ± 11.2 | < 0.001 |
Beck Depression inventory > 28 | 13 | 11.4% | 22 | 25.6% | 9 | 22.0% | 0.04 |
Medical history: | |||||||
Co-morbidities: | |||||||
Averag number of co-morbidities | 114 | 3.29 ± 2.64 | 86 | 3.76 ± 2.45 | 41 | 4.32 ± 3.24 | 0.06 |
Migraine Headache (yes vs no) | 36 | 31.6% | 37 | 43.0% | 24 | 58.5% | 0.002 |
Chronic fatigue syndrome (yes vs no) | 8 | 7.0% | 10 | 11.6% | 4 | 9.8% | 0.42 |
Fibromyalgia (yes vs no) | 16 | 14.0% | 10 | 11.6% | 5 | 12.2% | 0.68 |
Major depression (yes vs no) | 17 | 14.9% | 25 | 29.1% | 11 | 26.8% | 0.04 |
Severe anxiety (yes vs no) | 14 | 12.3% | 10 | 11.6% | 6 | 14.6% | 0.78 |
Co-medications: | |||||||
Gastric acid suppressants (yes vs no) | 86 | 75.4% | 64 | 74.4% | 34 | 82.9% | 0.45 |
Prokinetics (yes vs no) | 45 | 48.3% | 45 | 52.3% | 18 | 43.9% | 0.83 |
Anti-emetics (yes vs no) | 79 | 69.3% | 58 | 67.4% | 35 | 85.4% | 0.12 |
Estrogen, progesterone,OCP’s (yes) | 30 | 26.3% | 19 | 22.1% | 9 | 22.0% | 0.40 |
Narcotic pain medications (yes vs no) | 43 | 37.7% | 36 | 41.9% | 23 | 56.1% | 0.06 |
Total enteral/parenteral support (yes/no) | 9 | 7.9% | 9 | 10.5% | 9 | 22.0% | 0.02 |
Post-menopausal (yes vs no) | 29 | 30.5% | 26 | 33.3% | 12 | 30.0% | 0.95 |
Age at symptom onset (years) | 114 | 36.9 ± 16.1 | 86 | 36.1 ± 12.9 | 41 | 34.6 ± 13.6 | 0.85 |
Duration of symptoms at enrollment(yrs) | 114 | 4.7 ± 6.7 | 86 | 5.1 ± 7.1 | 41 | 4.6 ± 4.5 | 0.70 |
Initial infectious prodrome: (yes vs no) | 19 | 16.8% | 18 | 20.9% | 8 | 19.5% | 0.58 |
Predominant symptom: | |||||||
Nausea vs all others | 34 | 29.8% | 28 | 32.6% | 20 | 48.8% | 0.05 |
Vomiting vs all others | 23 | 20.2% | 18 | 20.9% | 6 | 14.6% | 0.55 |
Abdominal pain vs all others | 25 | 21.9% | 22 | 25.6% | 8 | 19.5% | 0.94 |
Type of gastroparesis symptom onset: | 0.65 | ||||||
Acute start | 57 | 50.0% | 41 | 47.7% | 23 | 56.1% | |
Insidious start | 57 | 50.0% | 45 | 52.3% | 18 | 43.9% | |
Nature of gastroparesis symptoms: | 0.005 | ||||||
Chronic, but stable | 32 | 28.1% | 20 | 23.3% | 2 | 5.0% | |
Chronic, but progressively worse | 26 | 22.8% | 33 | 38.4% | 22 | 55.0% | |
Chronic with periodic exacerbations | 42 | 36.8% | 26 | 30.2% | 12 | 30.0% | |
Cyclic pattern | 14 | 12.3% | 7 | 8.1% | 4 | 10.0% | |
Gastroparesis severity: | 0.004 | ||||||
Mild (grade 1) | 26 | 22.8% | 6 | 7.0% | 2 | 4.9% | |
Compensated (grade 2) | 62 | 54.4% | 50 | 58.1% | 24 | 58.5% | |
Gastric failure (grade 3) | 25 | 21.9% | 30 | 34.9% | 15 | 36.6% | |
Gastric failure vs less severe | 25 | 21.9% | 30 | 34.9% | 15 | 36.6% | 0.03 |
Irritable bowel syndrome or IBS§ | 0.34 | ||||||
Yes, pending exam/test | 69 | 60.5% | 60 | 69.8% | 27 | 65.8% | |
No | 45 | 39.5% | 26 | 30.2% | 14 | 34.2% | |
Gastric emptying (scintigraphy): | |||||||
Percent gastric retention at 2 hr. | 114 | 63.0 ± 16.8 | 86 | 62.0 ± 16.1 | 41 | 64.6 ± 16.1 | 0.80 |
Percent gastric retention at 4 hr. | 113 | 26.3 ± 17.6 | 86 | 27.2 ± 17.9 | 41 | 35.7 ± 22.6 | 0.06 |
Severity of delayed gastric emptying 4 hr: | 0.03 | ||||||
Mild (0 – 20%) | 55 | 48.7% | 35 | 40.7% | 16 | 39.0% | |
Moderate (21% – 35%) | 32 | 28.3% | 28 | 32.6% | 6 | 14.6% | |
Severe (> 35%) | 26 | 23.0% | 23 | 26.7% | 19 | 46.3% | |
Severity of symptoms:* | |||||||
Nausea severity | 114 | 2.7 ± 1.4 | 86 | 3.9 ± 1.0 | 41 | 4.7 ± 0.6 | n/a |
Retching severity | 114 | 1.1 ± 1.4 | 86 | 1.9 ± 1.6 | 41 | 3.8 ± 1.4 | n/a |
Vomiting severity | 114 | 1.2 ± 1.7 | 86 | 1.9 ± 1.8 | 41 | 4.0 ± 1.0 | n/a |
Stomach fullness severity | 114 | 3.0 ± 1.1 | 86 | 4.2 ± 0.8 | 41 | 4.7 ± 0.5 | n/a |
Inability to finish meal severity | 114 | 3.0 ± 1.5 | 86 | 4.1 ± 1.0 | 41 | 4.4 ± 0.8 | n/a |
Excessively full post meal severity | 114 | 3.0 ± 1.3 | 86 | 4.3 ± 0.9 | 41 | 4.6 ± 0.6 | n/a |
Loss of appetite severity | 114 | 2.4 ± 1.4 | 86 | 3.6 ± 1.3 | 41 | 3.9 ± 1.2 | n/a |
Bloating severity | 114 | 2.2 ± 1.4 | 86 | 4.0 ± 1.0 | 41 | 4.8 ± 0.4 | n/a |
Visibly larger stomach severity | 114 | 1.6 ± 1.5 | 86 | 3.7 ± 1.3 | 41 | 4.5 ± 0.7 | n/a |
Cardinal symptom index (GCSI)* | 114 | 2.1 ± 0.6 | 86 | 3.5 ± 0.3 | 41 | 4.4 ± 0.3 | n/a |
Upper abdominal pain | 114 | 2.4 ± 1.7 | 86 | 3.8 ± 1.2 | 41 | 3.9 ± 1.4 | < 0.001 |
Upper abdominal discomfort | 114 | 2.6 ± 1.6 | 86 | 3.9 ± 1.1 | 41 | 4.2 ± 1.0 | < 0.001 |
Lower abdominal pain | 114 | 1.5 ± 1.5 | 86 | 2.6 ± 1.6 | 41 | 3.3 ± 1.5 | < 0.001 |
Lower abdominal discomfort | 114 | 1.7 ± 1.5 | 86 | 2.7 ± 1.7 | 41 | 3.2 ± 1.5 | < 0.001 |
GERD sub-scale | 114 | 1.5 ± 1.2 | 86 | 2.2 ± 1.4 | 41 | 3.1 ± 1.4 | < 0.001 |
Constipation severity | 114 | 1.8 ± 1.6 | 86 | 2.8 ± 1.8 | 41 | 3.5 ± 1.7 | < 0.001 |
Diarrhea severity | 114 | 1.6 ± 1.5 | 86 | 2.0 ± 1.8 | 41 | 2.4 ± 1.9 | 0.05 |
Severity of symptoms based on the Gastroparesis Cardinal Index Score from the PAGI-SYM (Patient Assessment of GI Symptoms) questionnaires, scores range from 0–5): Mild= 0–2.9, Moderate= 3.0–3.99, Severe= 4.0–5.0. Two subjects were excluded due to a missing score on the Stomach Fullness Severity score.
Gastroparesis cardinal symptom index (GCSI) = mean of sub-scores for nausea, postprandial fullness, and bloating
Means ± standard deviations or percents (%).
The significance of difference in categorical variables between groups was tested with either the Cochran-Armitage test for trend for ordered categories or Fisher’s exact test, 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.
Overweight = BMI ≥ 25 kg/m2
ESR = Erythrocyte sedimentation rate
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/).