Table 1.
Mean (SD)* | |||
---|---|---|---|
Characteristic | Buspirone (N=47) |
Placebo (N=49) |
Total (N=96) |
Demographic/lifestyle/anthropometric | |||
Age (years) | 43.0 (15.8) | 44.2 (15.0) | 43.6 (15.3) |
Women, No. (%) | 43 (91%) | 45 (92%) | 88 (92%) |
Hispanic, No. (%) | 13 (28%) | 17 (35%) | 30 (31%) |
Race, No. (%) | |||
White | 43 (91%) | 41 (85%) | 84 (88%) |
Black | 2 (4%) | 5 (10%) | 7 (7%) |
Other† | 2 (4%) | 2 (4%) | 4 (4%) |
Married, No. (%) | 16 (34%) | 21 (43%) | 37 (39%) |
Diabetes type 1 or type 2†, No. (%) | 16 (34%) | 21 (43%) | 37 (39%) |
Diabetes type 1 | 3 (6%) | 6 (12%) | 9 (9%) |
Diabetes type 2 | 13 (28%) | 15 (31%) | 28 (29%) |
Body mass index (BMI) (kg/m2), mean (SD) | 29.5 (7.5) | 29.8 (7.3) | 29.7 (7.4) |
Overweight to obese (BMI ≥ 25 kg/m2) | 31 (66%) | 37 (76%) | 68 (71%) |
Weight (kg), mean (SD) | 78.1 (21.2) | 80.2 (22.2) | 79.2 (21.6) |
Waist circumference (cm), mean (SD) | 98.1 (22.2) | 98.2 (19.6) | 98.1 (20.8) |
Medications taken in past month, No. (%) | |||
Proton pump inhibitors | 35 (74%) | 34 (69%) | 69 (72%) |
Anxiolytic | 1 (2%) | 0 (0%) | 1 (1%) |
Prokinetic | 12 (26%) | 13 (27%) | 25 (26%) |
Antiemetic | 31 (66%) | 25 (51%) | 56 (58%) |
Narcotic (3X/week or less) | 2 (4%) | 4 (8%) | 6 (6%) |
Anti-depressant | 22 (47%) | 22 (45%) | 44 (46%) |
Neuropathic or pain modulator, anti-seizure, or other psychiatric medication | 28 (60%) | 31 (63%) | 59 (61%) |
Gastroparesis symptoms inventories | |||
PAGI-SYM Severity index (symptoms each scored 0 to 5, none to very severe over past 2 weeks) | |||
Gastroparesis Cardinal Symptom Index (GCSI), total score | 3.6 (0.7) | 3.5 (0.6) | 3.5 (0.6) |
Nausea/vomiting severity subscale | 2.5 (1.3) | 2.4 (1.3) | 2.5 (1.3) |
Nausea severity | 3.6 (1.3) | 3.6 (1.2) | 3.6 (1.3) |
Retching severity | 2.1 (1.7) | 1.8 (1.6) | 2.0 (1.6) |
Vomiting severity | 1.9 (1.8) | 1.8 (1.7) | 1.8 (1.7) |
Fullness/ early satiety subscale | 4.0 (0.6) | 4.0 (0.6) | 4.0 (0.6) |
Stomach fullness severity | 4.2 (0.8) | 4.2 (0.7) | 4.2 (0.7) |
Unable to finish meal severity | 4.0 (1.0) | 4.0 (0.9) | 4.0 (0.9) |
Excessive fullness severity | 4.2 (0.9) | 4.3 (0.7) | 4.3 (0.8) |
Loss of appetite severity | 3.6 (1.3) | 3.5 (1.2) | 3.5 (1.2) |
Bloating subscale | 4.2 (1.0) | 3.9 (1.0) | 4.1 (1.0) |
Bloating severity | 4.4 (0.9) | 4.0 (1.1) | 4.2 (1.0) |
Stomach distension severity | 4.0 (1.2) | 3.9 (1.1) | 4.0 (1.1) |
Upper abdominal pain subscale | 3.3 (1.3) | 3.0 (1.2) | 3.1 (1.2) |
Gastroesophageal Reflux (GERD) subscale | 2.1 (1.4) | 2.3 (1.2) | 2.2 (1.3) |
Predominant symptom cluster†, No. (%) | |||
Excessive fullness | 4 (9%) | 13 (27%) | 17 (18%) |
Early satiety or loss of appetite | 2 (4%) | 4 (8%) | 6 (6%) |
Bloating or distended stomach | 14 (30%) | 10 (21%) | 24 (26%) |
Nausea or vomiting or retching | 15 (33%) | 13 (27%) | 28 (30%) |
Upper abdominal pain or discomfort | 5 (11%) | 1 (2%) | 6 (6%) |
Lower abdominal pain or discomfort | 4 (9%) | 1 (2%) | 5 (5%) |
Gastrointestinal Symptom Rating Scale (GSRS) (items coded 0 to 7, no to very severe discomfort) | |||
Total score, mean (SD) | 3.8 (1.0) | 3.7 (1.1) | 3.8 (1.0) |
Patient Health Questionnaire somatization severity scale (PHQ-15) (0 to 30, 30 items rated not (0) to very bothered a lot (3)) | |||
Total score, mean (SD) | 14.7 (5.0) | 14.9 (4.1) | 14.8 (4.5) |
ANMS Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) (all items scored 0 to 4, none to very severe) | |||
Fullness/early satiety subscale | 2.62 (0.94) | 2.68 (0.86) | 2.65 (0.90) |
Early satiety severity | 2.56 (0.78) | 2.59 (0.86) | 2.57 (0.94) |
Excessive fullness severity | 2.40 (0.98) | 2.77 (0.98) | 2.74 (0.94) |
Depression, Anxiety & Quality of Life (QOL) | |||
PAGI-QOL disease-specific QOL (items coded 0 to 5, none to all of the time in past 2 weeks) | |||
Total score, mean (SD) | 2.3 (1.1) | 2.4 (1.1) | 2.4 (1.1) |
Hospital Anxiety and Depression Scale (HADS) (each of 16 items scored 1 to 4, with higher total scores indicating more severe), mean (SD) | |||
HADS-A total score | 9.3 (4.5) | 9.1 (4.8) | 9.2 (4.6) |
HADS-D total score | 6.7 (5.1) | 6.8 (4.7) | 6.8 (4.9) |
SF-36 Quality of Life (QOL) (0 to 100, low to high over the past 4 weeks), mean (SD) | |||
Physical component summary score | 33.7 (8.2) | 33.3 (9.0) | 33.5 (8.6) |
Mental component summary score | 37.9 (15.6) | 41.3 (13.8) | 39.6 (14.7) |
Physiological tests | |||
Gastric emptying scintigraphy (GES)† | |||
Not delayed gastric emptying‡ | 20 (43%) | 25 (51%) | 45 (47%) |
Delayed gastric emptying‡, No. (%) | 26 (55%) | 22 (45%) | 48 (50%) |
Rapid gastric emptying‡, No. (%) | 1 (2%) | 2 (4%) | 3 (3%) |
Intra-gastric meal distribution (IMD) category | |||
Normal (0.644 – 1.00) | 17 (87%) | 25 (76%) | 52 (81%) |
Borderline (0.568 – 0.643) | 0 (0%) | 3 (9%) | 3 (5 %) |
Impaired (<0.568) | 4 (13%) | 5 (15%) | 9 (14%) |
Water load test | |||
Volume water consumed (mL), median (Q1,Q3) | 415.9 (217.0) | 401.7 (198.0) | 408.5 (206.3) |
Consumed low volume (< 238 mL), No. (%) | 9 (20%) | 10 (20%) | 19 (20%) |
Data are mean (SD), unless otherwise noted.
There were no significant differences by treatment group due to chance of the 57 baseline characteristics analyzed (denoted by an asterisk (*)). P value (2-sided) determined using Fisher’s exact test for categorical variables and a t-test for continuous variables.
Other race: 1 Placebo participant reported American indian,1 Buspirone participant reported Asian, 1 Placebo participant reported Pacific Islander, 1 Buspirone subject reported mixed race, 1 Buspirone subject did not report a race; PAGI-SYM predominant symptom: 1 Buspirone, 1Placebo subject did not report a predominant symptom; for gastric emptying scintigraphy (GES): 2 Buspirone, 3 Placebo participants did not have GES recorded at 1 hour or 4 hours, 1 Buspirone subject did not have GES recorded at 2 hours; 1 Buspirone, 1 Placebo subject did not have EGG and satiety results; 64 total patients had an evaluable IMD result, 21 Buspirone did not have, 19 Placebo did not have.
Delayed gastric emptying defined as gastric emptying scintigraphy of > 60% retention at 2 hours OR > 10% retention at 4 hours; rapid gastric emptying defined as gastric emptying scintigraphy of < 30% retention at 1 hour.