Table 2.
48-week changes from baseline in gastroparesis symptoms (GCSI), anthropometry, clinical factors, depression and quality of life in patients with gastroparesis and functional dyspepsia (FD)
| FD* (N=159) | Gastroparesis (Gp)* (N=456) | P‡ | Mean net change: FD-Gp | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Outcome characteristics | Mean | Mean | 95% | Mean | Mean | 95% | FD vs | Mean Net Δ | Mean Net Δ | |
| Baseline | Δ† | C.I. | Baseline | Δ† | C.I. | Gp | ΔFD - ΔGp | C.I. | P§ | |
| Symptom Severity: | ||||||||||
| Patient-rated overall GCSI score (PAGI-SYM) | 3.1 | −0.40 | −0.57,−0.23 | 2.9 | −0.37 | −0.47,−0.27 | .88 | −.03 | −0.23,0.18 | .80 |
| Patient-rated improvement in GCSI of 1+ points from BL | n/a | 27% | 19, 35% | n/a | 26% | 22, 30% | .86 | 1% | −8%, 9% | .86 |
| Anthropometric: | ||||||||||
| BMI (kg/m2) | 27.6 | 0.26 | −0.14,0.67 | 27.5 | 0.56 | 0.31,0.82 | .24 | −0.30 | −0.81,0.22 | .26 |
| Weight (kg) | 76.3 | 0.77 | −0.32,1.87 | 74.3 | 1.44 | 0.78,2.10 | .28 | −0.67 | −2.00,0.66 | .32 |
| Clinical factors¶: | ||||||||||
| Total hospitalizations (no.)** | 1.1 | −0.47 | −94,0.0001 | 2.1 | −0.91 | −1.26,−0.56 | .12 | −0.51 | −1.14,0.13 | .12 |
| On Total Parental Nutrition (%) | 2.8% | 2.1% | −1.6,5.8% | 7.2% | −2.8% | −5.4,− 03% | .54 | 4.9% | −0.5,10.2% | .07 |
| Psychological & Quality of Life | ||||||||||
| Depression (BDI) | 18.3 | 0.17 | −1.23,1.58 | 18.5 | −0.48 | −1.40,0.44 | .42 | 0.65 | −1.21,2.51 | .49 |
| State Anxiety total score | 43.3 | 1.03 | −0.94,2.99 | 44.0 | 0.27 | −−1.00,1.53 | .56 | 0.76 | −1.81,3.33 | .56 |
| Trait Anxiety total score | 43.1 | 1.16 | −0.43,2.75 | 43.6 | 0.21 | −0.78,1.20 | .34 | 0.95 | −1.07,2.98 | .36 |
| PAGI-QOL total score | 2.5 | 0.26 | 0.11,0.42 | 2.6 | 0.24 | 0.15,0.33 | .92 | 0.02 | −0.16,0.20 | .82 |
| SF-36v2 physical component | 33.3 | 1.51 | 0.09,2.93 | 33.5 | 1.11 | 0.27,1.95 | .54 | 0.41 | −1.33,2.14 | .64 |
| SF-36v2 mental component | 40.3 | 0.19 | −1.63,2.01 | 38.7 | 1.39 | 0.23,2.55 | .57 | −1.20 | −3.55,1.16 | .32 |
Total N determined by the value for the outcome being available at baseline and at 48 weeks; Total N varies between 449 and 456 for number of patients with gastroparesis; and for those with normal emptying and functional dyspepsia using Rome III (FD), between 130 and 159, and overall total patients between 579 and 615.
Gastroparesis (Gp) patients have delayed gastric emptying defined as delayed gastric emptying scintigraphy of > 60% at 2-hour or > 10% at 4-hour. FD patients have gastroparesis symptoms and normal gastric emptying. Patients with idiopathic or diabetic etiology and without rapid emptying were included.
Mean change of outcome (48 weeks – baseline) and 95% confidence interval (C.I.) for the mean change presented, as well as the mean change in the mean changes of each subgroup (mean change of outcome for FD – mean change of outcome for gastroparesis).
P values for continuous outcome characteristics determined using ANCOVA of each characteristic of change at 48-weeks from baseline in relation to delayed gastric retention indicator (FD vs Gastroparesis) with adjustment for the baseline value of the characteristic. P for 1+ point improvement in GCSI was determined from a generalized linear model (GLM) with binomial distribution. P for the total hospitalizations in past year determined from a zero-inflated negative binomial regression of total hospitalizations in relation to delay indicator with adjustment for the total hospitalizations in year prior to baseline. P value for TPN as a percent was derived from a Wald test to assess whether change in TPN use varied by delayed retention adjusting for the baseline. TPN use using ANCOVA with robust variance.
For continuous variables, mean net change defined as the difference of the mean change in outcome indicator (value at 48 weeks – at baseline) in patients with FD classification minus the mean change in outcome indicator in patients with gastroparesis; 95% confidence intervals (C.I.) for the net mean change between gastric retention groups computed from a t-test. For GCSI 1+ improvement, the difference, 95% C.I. and P determined using the 2-subgroup proportion test.
ED visits were not reported at baseline. The total number of ED visits from baseline to 48 weeks was: 1.71±4.13 for all patients, 1.38±3.41 for the FD patients, 1.81±4.33 for gastroparesis patients, P=12 (determined using a zero-inflated negative binomial regression with robust variance).
Total hospitalizations since baseline excluded enterra placement or removal.