BACKGROUND/AIMS: Proton pump inhibitors (PPIs) are frequently used to treat non-erosive reflux disease (NERD), but their effect is limited. It is not known whether a potential alternative, AlbisD, containing ranitidine hydrochloride, sucralfate hydrate, and tripotassium dicitrato bismuthate, is effective and safe in treating NERD. The aim of the study is to evaluate the efficacy and safety of AlbisD compared with omperazole in patients with NERD. METHODS: This was a multicenter, randomized, open-label, parallel-group, non-inferiority comparative study. A total of 126 patients with NERD were randomly allocated to either AlbisD twice daily or omeprazole 20 mg once daily for 4 weeks from February 2016 to August 2016. The study patients had histories of heartburn or regurgitation of moderate severity (> score 2) and a frequency of at least 2 episodes per week, and had no mucosal breaks of the esophagus on endoscopy. The primary efficacy variable was complete cure of heartburn at week 4. Secondary efficacy variables evaluating symptoms of heartburn and acid reflux as well as safety profiles were compared in the 2 groups at week 2 and 4 after treatment. RESULTS: A total of 113 patients completed the study (57 and 56 in AlbisD and omeprazole groups, respectively). The proportion of patients with complete cure of heartburn at week 4 was not significantly different between the AlbisD and omeprazole groups (35.1% vs 32.1% respectively, P = 0.740). There were no significant differences between the 2 groups in the any secondary variables including proportions of days without heartburn or acid reflux over 4 weeks (including daytime and nighttime). Adverse events were similarly reported in the 2 groups (7 [12.3%] vs 6 [10.7%]), and there were no serious adverse events. CONCLUSIONS: The efficacy and safety of AlibsD in treating NERD patients are not inferior to those of omeprazole. Therefore, AlbisD can be an alternative to PPIs for NERD.
Bismuth ; Endoscopy ; Esophagus ; Gastroesophageal Reflux ; Heartburn ; Humans ; Omeprazole ; Pilot Projects ; Proton Pump Inhibitors ; Ranitidine ; Sucralfate

PURPOSE: Annually 27,855 patients in Korea develop treatment-induced mucositis nearly doubling the cost of cancer care. It is an emergency medical condition causing unplanned treatment breaks in 4,998 patients. The subsequent reduction in optimal dose-intensity causes premature deaths due to lower 5-year survival. An additional 216 patients die from mucositis-mediated sepsis and infection. Thus complete elimination of mucositis will immediately reduce the cost of care while simultaneously eliminating 5,214 mucositis-associated deaths. High potency polymerized cross-linked sucralfate (HPPCLS) cleared by the US Food and Drug Administration has been associated with the elimination of mucositis.METHODS: Observational, self-reporting, practice-based mucositis registry. Inclusion criteria: any patient with chemoradiation-induced mucositis. Exclusion criteria: previous adverse reaction to sucralfate products. Primary outcome: rapid reversal or complete prevention. Conduct of study: 28 radiation oncologists from 21 different institutions prescribed HPPCLS to 55 patients undergoing chemoradiation for squamous cell carcinoma of head and neck and esophagus to eliminate mucositis-associated treatment breaks.RESULTS: All patients with World Health Organization grade 1 (n=6), grade 2 (n=23), grade 3 (n=16) oral mucositis, and grade 2 esophageal mucositis (n=2) experienced complete reversal of mucositis. Within 2–3 days both mucosa and swallowing normalized. Anticipated grade 3/4 mucositis was prevented in 8 out of 8 elderly patients aged 78–93 avoiding gastrostomy tube placement. Statistical analysis of outcomes: Outcomes qualified as a positive Glasziou treatment effect that was statistically significant (P<0.05).CONCLUSION: HPPCLS eliminated mucositis by rapid reversal or complete prevention, thereby eliminating unplanned treatment breaks. It may likely reduce mucositis-associated increased cost of care and premature deaths.
Aged ; Carcinoma, Squamous Cell ; Deglutition ; Drug Therapy ; Emergencies ; Esophagus ; Gastrostomy ; Head and Neck Neoplasms ; Head ; Humans ; Korea ; Mortality, Premature ; Mucositis ; Mucous Membrane ; Neck ; Polymers ; Sepsis ; Stomatitis ; Sucralfate ; United States Food and Drug Administration ; World Health Organization

The impression that oral mucositis is a brief 14–28 day-consequence of chemoradiation is misguided. Clinically significant patient-reported oral mucositis may last 46 to 102 days depending on the treatment schedule and the modality used. The process of mucositis can occur in the epithelium throughout the entire GI tract and may possibly be avoided with the prescribed use of high potency polymerized cross-linked sucralfate (HPPCLS). Literature review of patient-reported mucositis occuring in the three common schedules of cancer treatment administration: daily radiation therapy, induction-based hematopoietic stem cell transplantation (HSCT), and multi-cycle chemo/immunotherapy (CT-IT). Review articles published in last 15 years focused on treatment-induced oral mucositis. The author reviewed 56 articles published in 15 years from 1999–2014 that focused primarily on treatment-induced oral mucositis. Only 6 were found to meet the criteria of providing patient-reported data from the beginning, throughout and following cancer treatment. For HSCT, radiation therapy, and CT-IT, despite active anti-mucositis treatment, patient-reported oral mucositis lasted 46–60 days, 70–84 days, and 68–102 days, respectively. Mucositis caused by cancer treatment, regardless of modality, lasts far longer than the oft quoted 2–4 weeks (range, 14–28 days). Patient reported mucositis persists from 46 to 102 days. This patient-based experience is the primary cause of treatment interruptions, delays or cancellations. It may be avoidable with HPPCLS that both prevents and rapidly reverses mucositis anywhere it occurs within the gastrointestinal tract.
Appointments and Schedules ; Drug Therapy ; Epithelium ; Gastrointestinal Tract ; Hematopoietic Stem Cell Transplantation ; Humans ; Mucositis ; Polymerization ; Polymers ; Stomatitis ; Sucralfate

No abstract available.
Endoscopy, Digestive System ; Esophagitis, Peptic/diagnosis/*drug therapy ; Humans ; Male ; Middle Aged ; Proton Pump Inhibitors/*therapeutic use ; Severity of Illness Index ; Sucralfate/therapeutic use

Solitary rectal ulcer syndrome (SRUS) is a rare, benign disorder in children that usually presents with rectal bleeding, constipation, mucous discharge, prolonged straining, tenesmus, lower abdominal pain, and localized pain in the perineal area. The underlying etiology is not well understood, but it is secondary to ischemic changes and trauma in the rectum associated with paradoxical contraction of the pelvic floor and the external anal sphincter muscles; rectal prolapse has also been implicated in the pathogenesis. This syndrome is diagnosed based on clinical symptoms and endoscopic and histological findings, but SRUS often goes unrecognized or is easily confused with other diseases such as inflammatory bowel disease, amoebiasis, malignancy, and other causes of rectal bleeding such as a juvenile polyps. SRUS should be suspected in patients experiencing rectal discharge of blood and mucus in addition to previous disorders of evacuation. We herein report six pediatric cases with SRUS.
Adolescent ; Anti-Inflammatory Agents, Non-Steroidal/therapeutic use ; Anti-Ulcer Agents/therapeutic use ; Child ; Colonoscopy ; Female ; Gastrointestinal Hemorrhage/*diagnosis ; Humans ; Male ; Mesalamine/therapeutic use ; Rectal Diseases/*diagnosis/drug therapy ; Steroids/therapeutic use ; Sucralfate/therapeutic use ; Syndrome ; Ulcer/*diagnosis/drug therapy

Acute esophageal necrosis is a rare clinical entity characterized by the endoscopic finding of extensive black discoloration of the esophageal mucosa. Acute esophageal necrosis in a patient with diabetic ketoacidosis has rarely been reported. We report a case of acute esophageal necrosis in a patient with diabetic ketoacidosis. The patient had coffee ground emesis and, after an esophagogastroduodenoscopy with mucosal biopsy, acute esophageal necrosis was diagnosed. The patient was treated conservatively with an intravenous proton pump inhibitor and oral sucralfate without any complications.
Biopsy ; Coffee ; Diabetes Mellitus ; Diabetic Ketoacidosis ; Endoscopy, Digestive System ; Esophagus ; Humans ; Mucous Membrane ; Necrosis ; Proton Pumps ; Sucralfate ; Vomiting

BACKGROUNDThe role of gastro-protecting agents on symptomatic chronic gastritis is unclear. This multicenter, open, randomized trial was designed to compare the comprehensive effects of gefarnate with sucralfate on erosive gastritis with dyspeptic symptoms.

METHODSTotally 253 dyspepsia patients confirmed with erosive gastritis were enrolled from six centers in China. They randomly received either daily 300 mg gefarnate or 3 g sucralfate for six weeks. The primary endpoint was the effective rate of both treatments on endoscopic erosion at week six.

RESULTSGefarnate showed an effective rate of 72% and 67% on endoscopic score and dyspeptic symptom release, which is statistically higher than sucralfate (40.1% and 39.3%, P < 0.001, intension-to-treat). For histological improvement, gefarnate showed both effective in decreasing mucosal chronic inflammation (57.7% vs. 24.8%, P < 0.001, intension-to-treat) and active inflammation (36.4% vs. 23.1%, P < 0.05, intension-to-treat) than the control. A significant increase of prostaglandins and decrease of myeloperoxidase in mucosa were observed in gefarnate group. Severity of erosion is non-relevant to symptoms but Helicobacter pylori (H. pylori) status does affect the outcome of therapy.

CONCLUSIONSGefarnate demonstrates an effective outcome on the mucosal inflammation in patients with chronic erosive gastritis. Endoscopic and inflammation score should be the major indexes used in gastritis-related trials.

Adolescent ; Adult ; Aged ; Anti-Ulcer Agents ; therapeutic use ; Dyspepsia ; drug therapy ; Female ; Gastritis ; drug therapy ; Gefarnate ; therapeutic use ; Humans ; Male ; Middle Aged ; Sucralfate ; therapeutic use ; Treatment Outcome ; Young Adult

BACKGROUND/AIMS: Albis(R) is a newly developed drug comprised of ranitidine, bismuth and sucralfate. The aim of the study was to demonstrate the efficacy and safety superiority of Albis(R) compared to Stillen(R) for treating erosive gastritis. METHODS: This study was a randomized, double-blind, multi-center trial. The primary endpoint was 2 weeks of treatment. RESULTS: Of the 229 patients in the intention-to-treat (ITT) population, 87 from the Albis(R), and 96 from the Stillen(R) group were included in the per protocol (PP) analysis. The endoscopic improvement rate was not different between the Albis(R)(R) group and the control in both the PP (42.5%, 39.6%) and ITT (35.3%, 34.5%) populations. The endoscopic cure of erosion was also not different in the Albis(R) group than that in the control group in both the PP (32.3%, 31.3%) and ITT (27.6%, 27.4%) populations. The endoscopic improvement rate for hemorrhage, edema, and erythema were also not different between the two groups in both the PP and ITT populations. No statistically significant differences were observed for adverse events between the two groups. CONCLUSIONS: Half of the approved dose of Albis(R) for peptic ulcers was superior to Stillen(R). A low dosage of Albis(R) is more cost efficient and safe than that of Stillen(R).
Bismuth ; Edema ; Erythema ; Hemorrhage ; Humans ; Peptic Ulcer ; Ranitidine ; Sucralfate

Black esophagus is a rare condition of the esophagus that manifests as endoscopic findings of black-colored esophageal mucosa, which is usually caused by acute esophageal necrosis. We report a case of alcoholic patient who developed black esophagus. The 85-year-old man was admitted to Severance Hospital due to copious hematemesis over 2 days. Upper gastrointestinal endoscopy showed black-colored mucosa in the distal esophagus. Endoscopic biopsies of the esophagus revealed necrotic tissue, without any viable cells. Follow-up upper gastrointestinal endoscopy performed after supportive care with a proton-pump inhibitor, sucralfate, and total parenteral nutrition resulted in the remarkable healing of the esophageal wall with no complications.
Aged, 80 and over ; Alcoholics ; Alcoholism ; Biopsy ; Endoscopy, Gastrointestinal ; Esophagus ; Follow-Up Studies ; Hematemesis ; Humans ; Mucous Membrane ; Necrosis ; Parenteral Nutrition, Total ; Sucralfate

Gastric mucosal calcinosis (GMC) is a very rare condition that is characterized by the nodular deposition of calcium salts in the gastric mucosa. It has been associated with renal failure, gastric cancer, ingestion of aluminum- containing antacids and the use of sucralfate in organ transplant patients. The etiology of this condition is uncertain, but several theories have been proposed; the condition is due secondarily to hyperparathyroidism in renal failure and to the alkalinization of the gastric mucosa. We report here on two patients who had long-term use of bismuth and/or aluminum-containing antacids to treat their gastro-esophageal reflux symptoms. The esophagogastroduodenoscopy revealed acute gastritis patterns, and GMC was confirmed histologically with biopsy. When one patient stopped ingesting bismuth-containing antacid solution, the follow-up esophagogastroduodenoscopy and the biopsy revealed a completely improved state. We report here on these interesting cases and we include a brief review of the literature.
Antacids ; Biopsy ; Bismuth ; Calcinosis* ; Calcium ; Eating ; Endoscopy, Digestive System ; Follow-Up Studies ; Gastric Mucosa ; Gastritis ; Gastroesophageal Reflux ; Humans ; Hyperparathyroidism ; Renal Insufficiency ; Salts ; Stomach Neoplasms ; Sucralfate ; Transplants