sodium-bicarbonate and Barrett-Esophagus

Morning dose or twice-daily proton pump inhibitor (PPI) use is often prescribed to heal severe reflux esophagitis.. Compare the effect of single dose morning (control arm) versus nighttime (experimental arm) omeprazole/sodium bicarbonate (Zegerid(®)) (IR-OME) on esophagitis and gastroesophageal reflux symptoms.. Adult outpatients with Los Angeles grade C or D esophagitis were allocated to open-label 40 mg IR-OME once a day for 8 weeks in a prospective, randomized, parallel design, single center study. Esophagogastroduodenoscopy (EGD) and validated self-report symptom questionnaires were completed at baseline and follow-up. Intention-to-treat and per-protocol analyses were performed.. Ninety-two of 128 (72 %) eligible subjects participated [64 (70 %) male, mean age 58 (range 19-86), median BMI 29 (range 21-51), 58 C:34 D]. Overall, 81 (88 %) subjects healed [n = 70 (76 %)] or improved [n = 11 (12 %)] erosions. There was no significant difference (morning vs. night) in mucosal healing [81 vs. 71 %, (p = 0.44)] or symptom resolution [heartburn (77 vs. 65 %, p = 0.12), acid regurgitation (82 vs. 73 %, p = 0.28)]. Prevalence of newly identified Barrett's esophagus was 14 % with half diagnosed only after treatment.. Once-daily IR-OME (taken morning or night) effectively heals severe reflux esophagitis and improves GERD symptoms. Results support the clinical practice recommendation to repeat EGD after 8 weeks PPI therapy in severe esophagitis patients to assure healing and exclude Barrett's esophagus.

Topics: Adult; Aged; Aged, 80 and over; Barrett Esophagus; Comorbidity; Drug Combinations; Endoscopy, Digestive System; Endoscopy, Gastrointestinal; Esophagitis, Peptic; Female; Humans; Intention to Treat Analysis; Male; Middle Aged; Mucous Membrane; Omeprazole; Prospective Studies; Proton Pump Inhibitors; Sodium Bicarbonate

Approximately 30-40% of patients with Barrett's oesophagus (BE) patients manifest abnormal oesophageal pH profiles despite proton pump inhibitor (PPI) therapy.. To determine control of oesophageal reflux using Bravo pH monitoring in patients BE on omeprazole-sodium bicarbonate oral suspension powder (Ome-NaBic) 40 mg twice daily.. Initial pH monitoring off PPI for 1 week was performed. All patients underwent repeat pH testing on Ome-NaBic administered before breakfast and at bedtime after 21-28 days of therapy depending upon the prior PPI therapy. The goal was to enroll 30 subjects, however, the trial was terminated prematurely when the sponsor lost financing due to a change in business strategy.. A total of 88 patients responded to the study invitation, 27 patients signed informed consent, and 21 patients underwent pH testing of PPI. A total of 15 patients completed the protocol (13 men, 2 women). Demographic information for patients completing at least one Bravo study included a mean (±s.d.) age 62 ± 9 years; body mass index 31 ± 8 kg/m(2) (range 23-48); mean BE length of 2.6 ± 2 cm; 9 (43%) patients with long segment BE. All (100%) patients demonstrated normalisation of supine pH on both days of Ome-NaBic therapy. One patient (6%) demonstrated abnormal upright reflux on the second day of monitoring on Ome-NaBic therapy; all the other patients demonstrated normal pH scores on therapy.. Administration of twice daily Ome-NaBic demonstrated control of nocturnal oesophageal reflux in 100% of patients with Barrett's oesophagus, and complete control of oesophageal pH during 97% of the 24-h recording periods.

Topics: Aged; Barrett Esophagus; Body Mass Index; Cohort Studies; Female; Gastroesophageal Reflux; Humans; Hydrogen-Ion Concentration; Male; Middle Aged; Omeprazole; Prospective Studies; Proton Pump Inhibitors; Sodium Bicarbonate; Supine Position; Time Factors; Treatment Outcome

Forty-five patients with histologically proven Barrett's columnar-lined oesophagus (CLO) were treated in one unit over a 9-year period. Patients were studied prospectively as part of a surveillance programme; all initially received standard conservative treatment including high-dose H2-receptor antagonists. A satisfactory initial response was seen in 21 patients, but in 24 the symptoms were unchanged or progressed; 19 patients in the latter group were considered suitable for antireflux surgery and underwent fundoplication. Symptoms of heartburn or dysphagia persisted or recurred in 88 per cent of patients receiving medical treatment alone and complications developed in 38 per cent, including nine strictures and one adenocarcinoma. In patients undergoing antireflux surgery, symptoms persisted or recurred in 21 per cent and complications developed in 16 per cent (P < 0.01). Complete regression of Barrett's CLO occurred in two patients (11 per cent) after antireflux surgery. The results of this study suggest the superiority of antireflux surgery over pharmacological acid suppression in the control of symptoms and prevention of complications in patients with Barrett's CLO.

Topics: Adult; Aged; Aged, 80 and over; Alginates; Aluminum Hydroxide; Antacids; Barrett Esophagus; Bicarbonates; Drug Combinations; Esophagus; Female; Gastric Fundus; Gastroesophageal Reflux; Humans; Hydrogen-Ion Concentration; Male; Middle Aged; Postoperative Complications; Prospective Studies; Ranitidine; Silicic Acid; Sodium Bicarbonate; Treatment Outcome