Gastroesophageal reflux disease with refractory symptoms despite proton pump inhibitor therapy or an inability to discontinue medical treatment due to early recurrence of symptoms Digestive System
Conditions
Interventions
The study is unblinded, the patients are self-controlled, and the intervention involves physiotherapy performed by a specialist physiotherapist and consists mainly of visceral manipulation techniques
Sponsors
Charles University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with GERD with persistent symptoms despite lifestyle modification and maintenance therapy with proton pump inhibitors, or patients who cannot discontinue antireflux medication due to early recurrence of their symptoms. GERD is diagnosed by positive EGDS and/or positive 24-hour esophageal pH monitoring with impedance and symptoms of GERD are present for at least 6 months prior to diagnosis. 1.1. Positive EGDS = evidence of reflux esophagitis according to the Los Angeles classification 1.2. Positive 24-hour esophageal pH monitoring with impedance = AET > 6% and/or number of reflux episodes >80/24 h performed without antireflux medication (off proton pump inhibitor [PPI] 14 days prior to testing) 2. Patients with GERD who are interested in incorporating diaphragmatic breathing training into their treatment 3. PPI dosing on a long-term on-demand basis or regular basis, in either a standard dose (once daily) or full dose (twice daily). 4. Age 18 years and above 5. Signed informed consent
Exclusion criteria
Exclusion criteria: 1. Severe reflux esophagitis, i.e. reflux esophagitis LA C and D, esophageal stenosis undergoing dilatation therapy, esophageal varices 2. Other primary esophageal diseases such as achalasia, esophageal tumors 3. Behavioural oesophageal disorders such as rumination and supragastric belching 4. Large hiatal hernia, i.e. manometric EGJ type III with LES-CD separation =3 cm 5. Severe comorbidities (diabetes mellitus with organ complications, advanced organ failure, i.e. chronic heart failure, severe COPD, severe renal or hepatic dysfunction, scleroderma or other connective tissue disease, mental disorders, neuropathy) 6. Other GIT disorders requiring regular antisecretory medication that do not allow discontinuation (e.g., Barrett's esophagus, gastroduodenal ulcer disease) 7. Pregnancy, lactation 8. Morbid obesity with BMI above 35 kg/m² 9. Severe musculoskeletal conditions or disorders not allowing training and practice of diaphragmatic breathing (e.g. conditions following spinal surgery) 10. Inability to undergo EGDS, HRM and 24-hour esophageal pH monitoring with impedance (e.g. conditions following nasal surgery with inability to insert transnasal probes)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reflux symptoms and quality of life in GERD patients after 3 months of diaphragmatic breathing training are measured using a Gastroesophageal Reflux Disease Questionnaire (GerdQ) and GERD – Health Related Quality of Life (GERD-HRQL) questionnaire. The questionnaires are assessed at baseline, 3, 6, 9, 12 and 15 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proton pump inhibitor consumption after diaphragmatic breathing training, measured in mg per week at baseline, 9, 12 and 15 weeks: 1.1. Omeprazole dose – mg/week 1.2. Pantoprazole dose – mg/week 1.3. Esomeprazole dose – mg/week 1.4. Lansoprazole dose – mg/week 1.5. Rabeprazole dose – mg/week 2. Antireflux barrier function after diaphragmatic breathing training, evaluated by high-resolution manometry and 24-hour esophageal pH monitoring with impedance at 3, 6 and 15 months 3. Variables overview evaluated according to the latest version of Chicago classification 4.0: 3.1. Mean LES pressure, mmHg 3.2. IRP (integrated relaxation pressure), mmHg 3.3. EGJ type – EGJ I – III (a, b) 3.4. DCI (distal contractile integral), mmHg.cm.s 3.5. Ineffective esophageal motility, % 3.6. EGJ-CI (EGJ – contractile integral), mmHg.cm 3.7. Mean intragastric pressure, mmHg 3.8. LES function optimization – improvement in mean LES pressure and/or IRP and/or EGJ-CI, yes/no 3.9. AET (acid exposure time), % 3.10. Total number of reflux episodes on impedance/24 h 3.11. SI (symptom index), % 3.12. SAP (symptom association probability), % 3.13. MNBI (mean nocturnal baseline impedance), Ohm 3.14. Proximal reflux episodes (15 cm above LES), % Other variables overview: 4. Demographic parameters assessed as standard at baseline, 3, 6 and 15 months: 4.1. Age, years 4.2. Sex, male/female 4.3. BMI, kg/m² 5. Macroscopic changes on esophagogastroduodenoscopy (EGDS) evaluated according to the Los Angeles classification (LA A-D) at baseline, 6 and 15 months 6. Microscopic reflux changes of esophageal mucosa evaluated according to Esohisto project 2010, score 0-12 points at baseline, 6 and 15 months 7. Abdominal cavity expansiveness (intraabdominal pressure) evaluated using the DNS brase instrument based on the publication by Jakub Novak at 3 and 6 months | — |
Countries
Czech Republic
Outcome results
None listed