S0439 Prucalopride Improves Esophageal Contractility Ineffective Esophageal Motility: Prospective Clinical Trial
Bibliographic record
Abstract
INTRODUCTION: Ineffective esophageal motility (IEM) is a manometric diagnosis defined by the Chicago Classification (v3.0) as ≥50% of swallows achieving a distal contractile integral (DCI) of < 450 mmHg-cm-s and maybe associated with dysphagia. This pilot study assesses the effectiveness of prucalopride a 5-HT4 enterokinetic drug in IEM patients with dysphagia. METHODS: Symptomatic patients with dysphagia diagnosed with IEM following high-resolution manometry (HRM) with impedance at a tertiary care motility lab were enrolled between August 2017 and September 2019. Patients with uncontrolled GERD (DeMeester score >14.7), endoscopic erosive esophagitis, eosinophilic esophagitis, use of other prokinetic drugs, or narcotics were excluded. Patients received prucalopride 4mg PO once daily for 5 days and then underwent repeat HRM. Outcome measures included pre- and post- prucalopride esophageal HRM values, dysphagia symptom questionnaire (DSQ), and quality of life (Eq5d-3L). These outcomes were compared with paired T-test, Wilcoxon signed ranks test and McNemar test as appropriate. Patients were classified into definite or indefinite for heartburn, acid regurgitation, and GERD based on the MDQ-30 subscale. IRB-approved study (NCT03244553). RESULTS: Twenty-nine patients were enrolled; analysis was performed on twenty-five patients (13M:12F; mean age of 53.3 yrs (±13.97 SD) who completed the study. All patients had symptoms of dysphagia to solids. 76% of patients were on a PPI. The median time and IQR between baseline and post-HRM were 12 [8–18] wks. 18 patients (72%) had an improvement in mean DCI. There was a significant increase in DCI (mean 727.1 ± 548.7 vs 439.5 ± 286.7, P = 0.006), maximum DCI (mean 1198.7 ± 1198.67819.8 ± 540.5, P = 0.013), and decrease in the percentage of failed swallows (median 40 [IQR 25–70] vs 20 [10–50], P = 0.05), and acid regurgitation (P = 0.05) after prucalopride use. No improvement was seen in dysphagia or quality of life. Change in DCI correlated weakly with IRP (Spearman’s r =0.461, P = 0.021). The most common side effects were headaches (48%) and diarrhea (52%). A majority of patients (88%) reported a side effect, leading to discontinuation in 4%. CONCLUSION: In this short duration pilot study, prucalopride significantly improved the DCI, maximum DCI, number of failed swallows, and acid regurgitation in patients with IEM; however, no improvement in dysphagia or quality of life was seen. This pilot study warrants a larger study.Table 1.: Pairwise comparison of manometric values and patient-reported outcomes pre- and post- prucalopride therapyFigure 1.: Representative Pre and post-HRM picture of 3 patients who displayed significant improvement after prucalopride.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.007 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".