Skip to main content
. Author manuscript; available in PMC: 2024 Jun 1.
Published in final edited form as: Aliment Pharmacol Ther. 2023 Apr 13;57(11):1272–1289. doi: 10.1111/apt.17479

Table 1.

Baseline characteristics of the study population by treatment group

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.