Safety and efficacy of treatment for chronic hepatitis C during pregnancy: A prospective observational study in Srinagar, India.

In India, the estimated prevalence of antenatal HCV infection is 0.3%-2.8%, and the rate of mother-to-child transmission has been estimated at 5%-15%. HCV treatment during pregnancy could reduce maternal complications from HCV infection, prevent transmission to the infant, and reduce HCV infection overall in women of childbearing age. However, there are limited studies of HCV treatment with direct-acting antiviral medications during pregnancy, and therefore, direct-acting antivirals are not commonly used for treatment during pregnancy. We describe our institutional experience in this prospective observational study over 3 years at the Sher-I-Kashmir Institute of Medical Sciences, Srinagar, India. Patients with chronic hepatitis C in pregnancy were enrolled and treated with ledipasvir and sofosbuvir after the first trimester. Primary end points were sustained virologic response at 12 weeks, adverse drug reactions, and congenital malformation of the infant. The secondary end point was the transmission of HCV infection to the infant. We enrolled 26 patients in our study. The mean age was 28 years (range of 21-36 y). All patients were noncirrhotic and treatment-naive. The mean HCV RNA before treatment was 9.2 ×10^5 IU/ml. Among the enrolled patients, 19 (73%) were genotype 3, 5 (19%) were genotype 1, and 2 (8%) were genotype 4. All patients achieved sustained virologic response at 12 weeks. Some patients reported nausea (27%), headache (27%), and fatigue (16%). All patients had institutional delivery, and no infant was found to have congenital malformations. No child had detectable HCV RNA at 6 months of age. To our knowledge, we here report results from the largest cohort of pregnant women treated for HCV infection globally. Ledipasvir and sofosbuvir were well tolerated and highly effective for both HCV cure in the mother and elimination of mother-to-child transmission. No congenital abnormalities were detected in our cohort. Elimination of mother-to-child transmission is urgently needed, and this study has shown that treatment of HCV during pregnancy may be a pragmatic approach for the greater benefit of both mother and the newborn.

Endoscopic Yield, Appropriateness, and Complications of Pediatric Upper Gastrointestinal Endoscopy in an Adult Suite: A Retrospective Study of 822 Children.

BACKGROUND/AIMS: This study aimed to study the endoscopic yield, appropriateness, and complications of pediatric endoscopy performed by adult gastroenterologists in an adult endoscopic suite. METHODS: This a retrospective study in which records of all the patients less than 18 years of age who underwent endoscopy in the last 5 years were studied. The indications of endoscopy in children were categorized as appropriate or inappropriate per the latest guidelines by American Society for Gastrointestinal Endoscopy and North American Society for Pediatric Gastroenterology, Hepatology and Nutrition. Positive endoscopic yield was defined as the presence of any abnormality on endoscopy. RESULTS: Among the total of 822 children (age <18 years), the most common indications were variceal surveillance/eradication in 157 (19.1%), followed by dyspepsia in 143 (17.4%), upper gastrointestinal (UGI) bleeding in 136 (16.5%), recurrent abdominal pain in 94 (11.4%), unexplained anemia in 74 (9%), recurrent vomiting in 50 (6.08%), chronic refractory gastroesophageal reflux disease in 34 (4.1%) and others; 780 out of 822 endoscopic procedures (94.9%) done in children were appropriate as per the guidelines. The endoscopic yield was 45.8%, highest in patients with UGI bleeding (71.3%), followed by variceal surveillance (54.8%), recurrent vomiting (38%), dyspepsia (37.8%), and recurrent abdominal pain (36%). Minor adverse events occurred in 7.3% of children. CONCLUSION: Pediatric endoscopy performed by an experienced adult gastroenterologist may be acceptable if done in cooperation with a pediatrician.

Indian consensus on gastroesophageal reflux disease in adults: A position statement of the Indian Society of Gastroenterology.

The Indian Society of Gastroenterology developed this evidence-based practice guideline for management of gastroesophageal reflux disease (GERD) in adults. A modified Delphi process was used to develop this consensus containing 58 statements, which were generated by electronic voting iteration as well as face-to-face meeting and review of the supporting literature primarily from India. These statements include 10 on epidemiology, 8 on clinical presentation, 10 on investigations, 23 on treatment (including medical, endoscopic, and surgical modalities), and 7 on complications of GERD. When the proportion of those who voted either to accept completely or with minor reservation was 80% or higher, the statement was regarded as accepted. The prevalence of GERD in India ranges from 7.6% to 30%, being < 10% in most population studies, and higher in cohort studies. The dietary factors associated with GERD include use of spices and non-vegetarian food. Helicobacter pylori is thought to have a negative relation with GERD; H. pylori negative patients have higher grade of symptoms of GERD and esophagitis. Less than 10% of GERD patients in India have erosive esophagitis. In patients with occasional or mild symptoms, antacids and histamine H2 receptor blockers (H2RAs) may be used, and proton pump inhibitors (PPI) should be used in patients with frequent or severe symptoms. Prokinetics have limited proven role in management of GERD.

The efficacy of accelerated, multiple, double-dose hepatitis B vaccine against hepatitis B virus infection in cancer patients receiving chemotherapy.

BACKGROUND: Hepatitis B virus (HBV) infection in cancer patients receiving chemotherapy carries high morbidity and mortality. Conventional hepatitis B vaccination with three doses at 0, 1, and 6 months apart is ineffective in prevention of HBV infection. OBJECTIVES: To compare the efficacy of accelerated, multiple, double-dose HB vaccine with conventional HB vaccine in cancer patients receiving chemotherapy (CT). METHODS: Patients of cancer who were planned for CT were screened for HBV markers (HBsAg, total anti-HB core, anti-HBs antibody and HBV DNA). Patients with negative HBV serum markers received HB vaccine in two groups. Group A received three double doses (40 µg) of recombinant HB vaccine at 0, 1, and 3 weeks before CT and additional three double doses post CT. Group B received HB vaccine (20 µg) at 0, 1, and 6 months. Efficacy of vaccine in the two groups was compared by anti-HBs titers achieved at 3, 6, and 9 months and by HBsAg positivity following CT at 1 year follow up. RESULTS: Protective anti-HBs titers (>10 mIU/mL) at 3, 6, and 9 months in group A and B was 41.1 %, 66.2 %, and 76% and 26 %, 37.7 %, and 49% respectively (p = 0.001). Seven of 454 (1.5%) patients in group A became HBsAg positive after vaccination compared to 19/472 (4.0%) in group B (p = 0.022). CONCLUSION: Accelerated, multiple, double-dose HB vaccine increases seroprotection and is more effective than conventional HB vaccine in preventing HBV infection.

Prevalence of gallstone disease in patients with type 2 diabetes and the risk factors in North Indian population: a case control study.

BACKGROUND: Age, female sex, and obesity are considered to be risk factors for gallstone disease. The role of type 2 diabetes (T2D) in gallstone formation is still uncertain, and data in Indians is limited. OBJECTIVES: This is a case-control study to determine the prevalence of gallstones (GS) in patients with T2D, risk factors, and the relative risk compared with subjects without diabetes, selected from the general population. METHODS: Among 450 cases with T2D of a ≥2-year duration, 377 (88.8 %) participated. Diagnosis of GS was made at ultrasonography and history of cholecystectomy for GS. Controls were selected from the general population and diabetes excluded by oral glucose tolerance test. Cases and controls were matched for age, gender, and body mass index (BMI). RESULTS: Gallstones were seen in 67 (17.7 %) cases compared to 40 (5.8 %) in controls (p = 0.001). Prevalence increased with increasing age with peak in the sixth decade (23.4 % in cases and 4.4 % in controls (p = 0.001) and was higher in women (27.9 %) in cases and (7.8 %) in controls, (p = 0.001). In univariate analysis, risk factors for GS included age, female sex, BMI, multiparity, family history of GS, and high triglycerides and cholesterol with low high-density lipoprotein cholesterol. In multivariate analysis, age, (relative risk [RR] 1.54, confidence interval [CI] 1.1-2.1), female sex (RR 1.6, CI 1.0-1.9), and BMI (RR 1.5, CI 1.3-2.5) were the independent risk factors in gallstone formation. CONCLUSION: Patients with T2D had higher probability of having GS compared to the general population. Increasing age, female sex, and higher BMI were independently associated with gallstone disease.

Efficacy and safety of sequential therapy versus standard triple therapy in Helicobacter pylori eradication in Kashmir India: a randomized comparative trial.

BACKGROUND: Increasing resistance against Helicobacter pylori has resulted in reduced eradication rates. OBJECTIVE: This study aims to determine whether eradication rates for H. pylori infection with sequential therapy is better than standard triple therapy. PATIENTS: Patients with endoscopy documented peptic ulcer and H. pylori infection confirmed by histology and rapid urease test. INTERVENTION: Patients were randomized into two groups; 134 received standard triple therapy (pantoprazole 40 mg, clarithromycin 500 mg and amoxicillin 1 g each administered twice daily) for 10 days and 138 received sequential regimen (pantoprazole 40 mg plus amoxicillin 1 g twice daily for 5 days followed by 40 mg pantoprazole, 500 mg clarithromycin, and 500 mg tinidazole each administered twice daily for 5 days). Eradication was confirmed by histology and rapid urease test. Compliance and adverse effects were determined by the recovery of empty medicine strips and questioning. RESULTS: The eradication rates with sequential therapy were significantly greater than with standard therapy on both intention-to-treat analysis (76.0 % vs. 61.9 %, p = 0.005; difference, 14.1 % [95 % CI, 6.5-19 %] and per protocol analysis (84.6 % vs. 67.4 %, p = 0.002; difference, 17.2 % [95 % CI, 8.5-23.5 %]). The incidence of side effects did not differ between the two therapy groups. One patient in standard therapy discontinued treatment due to side effects. LIMITATION: Cultures were not performed. Loss to follow up was 5.2 % in standard therapy and 6.5 % in sequential therapy. CONCLUSION: Sequential therapy was significantly more effective than standard therapy for eradicating H. pylori infection in peptic ulcer disease in Asian patients. Side effects were similar.

Occult hepatitis B virus infection as a cause of posttransfusion hepatitis in patients with cancers.

BACKGROUND: Prevalence of hepatitis B virus (HBV) infection is increased in patients of cancer with increased mortality. Multiple transfusions of blood and blood-related products are a potential source. AIMS: This study aims to assess the incidence of hepatitis B surface antigen (HBsAg) seroconversion in cancer patients receiving transfusion of blood or blood-related products and identify possible reasons for infection in these patients. MATERIAL AND METHODS: Patients of cancer receiving blood products, who were HBsAg-, anti-hepatitis B core (HBc)-, and HBV DNA-negative prior to transfusion, were tested for HBsAg by ELISA at 6, 12, and 24 weeks after the last transfusion. Blood donors were screened for HBsAg by ELISA. RESULTS: Twenty of 3,600 (0.56 %) blood donors tested positive for HBsAg and were rejected. Nine of 150 (6 %) cancer patients became HBsAg-positive posttransfusion which included seven patients who presented with acute hepatitis B and other two patients who remained HBsAg-positive without hepatitis. In 6/9 (66.6 %) patients, HBsAg positivity was related to blood transfusion as their corresponding blood donors on retesting the stored samples were positive for anti-HBc antibody and HBV DNA. In other three patients, the cause of their HBsAg positivity could not be ascertained. CONCLUSION: Occult HBV infection in blood donors is a potential source of posttransfusion HBV infection in recipients. Anti-HBc antibody and HBV DNA should be tested in blood donors especially when blood is given to cancer patients receiving chemotherapy.

Prevalence of Helicobacter pylori infection and the effect of its eradication on symptoms of functional dyspepsia in Kashmir, India.

BACKGROUND AND AIM: Epidemiology of Helicobacter pylori infection has regional variation. Effect of eradication of H. pylori on symptoms of functional dyspepsia is uncertain, and the data in Asian scenario are scanty. The study aimed to see H. pylori positivity rate in patients of functional dyspepsia and the effect of its eradication on symptoms. METHODS: Randomized, double-blind, placebo-controlled study was the study design used. Patients of functional dyspepsia defined as per Rome 2 criteria were tested for H. pylori infection by rapid urease test and gastric biopsy. H. pylori-positive patients were randomly allocated to triple therapy (20 mg of omeprazole, 500 mg of clarithromycin, and 1000 mg of amoxicillin orally two times daily) and omeperazole plus identical placebo for 2 weeks. Symptoms were assessed with the weekly Likert scale. RESULTS: H. pylori positivity rate in functional dyspepsia was 1160/2000 (58%). At 6 weeks, the eradication rate for H. pylori in triple therapy and placebo group was (181/259 [69.8%] and 13/260 [5.0%], P = 0.001), respectively. On intention-to-treat analysis, the symptom resolution at 1 month was (157/259 [60.7%] and 136/260 [52.3%], P = 0.38), respectively. At 12 months, H. pylori eradication and healing of gastritis in triple therapy and placebo group were (116/174 [66.7%] and 12/180 [6.7%], P = 0.001) and (132/174 [75.9%] and 11/180 [6.1%], P = 0.001), respectively. On intension to treat, the resolution of symptoms in triple therapy and placebo group was (95/217 [43.7%] and 72/195 [36.9%], P = 0.13). CONCLUSION: There is high H. pylori positivity rate in patients of functional dyspepsia. The eradication of H. pylori does not resolve the symptoms despite healing of gastritis.

Safety and efficacy of 1-week levofloxacin-based triple therapy in first-line treatment for Helicobacter pylori-related peptic ulcer disease in Kashmir, India.

BACKGROUND AND OBJECTIVES: There is no ideal therapy for eradication of Helicobacter pylori infection. We evaluated the efficacy and safety of 1-week triple therapy with rabeprazole, levofloxacin, and tinidazole in a metronidazole resistance prevalent region for eradicating H. pylori infection in patients with gastroduodenal ulcers. METHODS: This was an open-label, prospective study. Consecutive patients with endoscopy-proven duodenal or gastric ulcer and who were H. pylori-positive were treated with levofloxacin 500 mg once a day, rabeprazole 20 mg twice a day, and tinidazole 500 mg twice daily for 7 days followed by rabeprazole 20 mg OD for 8 weeks. Endoscopy was repeated 8 weeks after the end of therapy to check for ulcer healing and H. pylori status. RESULTS: One hundred and thirty-one patients with gastroduodenal ulcers (duodenal 118, and gastric 13) were included. Drug compliance was 97.7 %. The eradication rate of H. pylori by intention-to-treat analysis was 85.5 % (95 % confidence interval 79.5-91.5) (112 of 131 patients) and by per-protocol analysis was 91.8 % (95 % confidence interval 86.9-96.7) (112 of 122 patients). Adverse effects were reported in 17 %: abdominal pain in 3.05 %, metallic taste in 6.87 %, and nausea and vomiting in 4.58 %. CONCLUSIONS: Levofloxacin-tinidazole-based triple therapy was highly effective and safe as a first-line regimen in Indian patients with gastroduodenal ulcer disease associated with H. pylori infection. The regimen was well tolerated.

64-section multiphase CT enterography as a diagnostic tool in the evaluation of obscure gastrointestinal bleeding.

BACKGROUND AND AIM: Small bowel follow through (SBFT) and enteroclysis have low sensitivity in picking up lesions in obscure gastrointestinal bleed (OGIB). Computed tomographic enterography (CT-EG), performed with 64-slice multiphase CT system by using large volumes of ingested neutral enteric contrast material, has high spatial and temporal resolution in visualization of the small bowel wall and lumen. The role of 64-slice multiphase CT-EG in the evaluation of OGIB is still evolving, and data on this role are scarce. We evaluated the efficacy of 64-slice multiphase CT-EG using polyethylene glycol (PEG) electrolyte solution as neutral contrast in patients of OGIB. METHODS: CT-EG was performed with 64-slice multiphase CT system using large volume (2,000 mL) of PEG electrolyte solution as oral contrast in patients of OGIB. RESULTS: Thirty-five patients (21 men, age 41.4 [13.5] y, range 19-70 year) with OGIB underwent CT-EG; 20 patients had overt OGIB whereas 15 patients had occult OGIB. Among 15 patients with occult OGIB, 10 patients had iron deficiency anemia (IDA) with fecal occult blood test (FOBT) positive and 5 had IDA with FOBT negative. Thirty-two patients (92 %) completed the procedure successfully. The total time taken for the ingestion of 2,000 mL of PEG electrolyte solution was median 64 (range 60-78) minutes. Adequate luminal distension of small bowel was seen in 29 (90.6 %) patients for successful interpretation of radiological images. Fifteen of 32 (46.9 %) patients had positive findings on CT-EG; 12 of them underwent exploratory laparotomy. The surgical findings were in conformity with CT-EG findings in all patients, which included gastrointestinal stromal tumors (GIST; n = 6), carcinoid (1), Meckel's diverticulum (1), small bowel adenocarcinoma (2) and jejunal vascular malformation (2). CONCLUSION: 64-slice multiphase CT-EG is a useful investigation in the evaluation of both occult and overt OGIB.

Effect of bed head elevation during sleep in symptomatic patients of nocturnal gastroesophageal reflux.

BACKGROUND AND AIM: Nocturnal gastro-esophageal reflux causes heartburn and sleep disturbances impairing quality of life. Lifestyle modifications, like bed head elevation during sleep, are thought to alleviate the symptoms of gastroesophageal reflux. We tested the hypothesis that bed head elevation might decrease recumbent acid exposure compared to sleeping in a flat bed. METHODS: Patients of symptomatic nocturnal reflux and documented recumbent (supine) reflux verified by esophageal pH test entered the trial. On day 1, baseline pH was measured while the patient slept on a flat bed. Then patients slept on a bed with the head end elevated by a 20-cm block for the next 6 consecutive days from day 2 to day 7. The pH test was repeated on day 2 and day 7. Each patient acted as his own control. RESULTS: Twenty of 24 (83.3%) patients with mean age of 36 ± 5.5 years completed the trial. The mean (± SD) supine reflux time %, acid clearance time, number of refluxes 5 min longer and symptom score on day 1 and day 7 were 15.0 ± 8.4 and 13.7 ± 7.2; P = 0.001, 3.8 ± 2.0 and 3.0 ± 1.6; P = 0.001, 3.3 ± 2.2 and 1.0 ± 1.2; P = 0.001, and 2.3 ± 0.6 and 1.5 ± 0.6; P = 0.04, respectively. The sleep disturbances improved in 13 (65%) patients. CONCLUSIONS: Bed head elevation reduced esophageal acid exposure and acid clearance time in nocturnal (supine) refluxers and led to some relief from heartburn and sleep disturbance.

Incidence of colorectal cancer in Kashmir valley, India.

BACKGROUND: There is wide variation in the incidence of colorectal cancer globally and also within the same country among different racial or ethnic groups. The present population-based study was undertaken to determine the incidence of colorectal cancer in Kashmiri population which is non-migratory and ethnically homogeneous having stable food habits. METHODS: Over a period of one year, all newly diagnosed and histological proved cases of colorectal cancer in all possible areas, where such patients are diagnosed and treated were prospectively registered. RESULTS: A total of 212 cases of colorectal cancers were registered; of them 113 (53.3%) originated in the colon and other 99 (46.7%) in rectum. Male to female ratio was 1.2:1. The crude incidence rate of colorectal cancer was 3.65/100,000; it was 3.78 in males, and 3.50/100,000 in females. The incidence rates for colorectal cancer in Muslims and Hindus were different. The crude incidence rate for colorectal carcinoma was highest for district Srinagar 6.19/100,000 (urban area) and lowest for district Kupwara (rural area) 1.59/100,000. The highest numbers of cases were detected in the age group 55-59 years (n = 34). The age-specific rate for colorectal carcinoma was highest in the age group 55-59 years (17.21/100,000), followed by 65-69 years (14.86/100,000). The age standardized incidence rate was 4.52/100,000 per year. The truncated age adjusted incidence rates in age group 35-64 years was 8.31/100,000; while that for colorectal carcinoma was 8.77/100,000 in males and 7.66/100,000 in females. CONCLUSION: We conclude that the incidence of colorectal cancer in Kashmir valley is similar to that reported in the rest of India.

Comparison of p.o. or i.v. proton pump inhibitors on 72-h intragastric pH in bleeding peptic ulcer.

BACKGROUND AND AIMS: After successful endoscopic hemostasis in bleeding peptic ulcer, addition of proton pump inhibitors reduce the rate of recurrent bleeding by maintaining intragastric pH at neutral level. The aim of the present study was to evaluate the effect of various proton pump inhibitors given through different routes on intragastric pH over 72 h after endoscopic hemostasis in bleeding peptic ulcer. METHODS: Ninety consecutive patients who had successful endoscopic therapy of bleeding peptic ulcer underwent 72-h continuous ambulatory intragastric pH study, were randomly assigned to receive p.o. omeprazole 80 mg bolus followed by 40 mg every 12 h for 72 h or i.v. 80 mg omeprazole followed by infusion 8 mg/h for 72 h. Oral pantoprazole 80 mg bolus followed by 80 mg every 12 h for 72 h or i.v. 80 mg pantoprazole followed by infusion of 8 mg/h for 72 h. Oral rabeprazole 80 mg bolus followed by 40 mg every 12 h for 72 h or i.v. 80 mg rabeprazole followed by infusion 8 mg/h for 72 h. Five patients received no treatment after successful endoscopic therapy and underwent 72-h pH study. RESULTS: Mean 72-h intragastric pH for p.o. omeprazole was 6.56 versus 6.93 for omeprazole infusion (P = 0.48). Mean 72-h intragastric pH for p.o. pantoprazole was 6.34 versus 6.32 for pantoprazole infusion (P = 0.62). Mean 72-h intragastric pH for rabeprazole p.o. was 6.11 versus 6.18 rabeprazole i.v. (P = 0.55). Mean 72-h pH for the no proton pump inhibitor group was 2.04. CONCLUSION: There was no significant difference among various proton pump inhibitors given through different routes on raising intragastric pH above 6 for 72 h after successful endoscopic hemostasis in bleeding peptic ulcer.

Effect of bending exercise on gastroesophageal reflux in symptomatic patients.

BACKGROUND: Recumbency and bending are thought to provoke symptoms of reflux in patients with gastroesophageal reflux disease (GERD). The effect of exercise which involved bending and abdominal contractions was evaluated in symptomatic patients of GERD using continuous 24-hour ambulatory esophageal pH test. METHODS: Twenty-five patients with GERD, confirmed by abnormal 24-hour esophageal pH study, performed exercise for 30 minutes consisting of 5 sessions of 6 minutes each. The exercise involved toe touching from supine, sitting and standing position of 2 minutes' duration each. Each 2 minutes' period included 8 repetitions of the same exercise of 15 seconds' duration. 24-hour esophageal pHmetry was done on day 1 without exercise and on day 2 with 30-minute exercise. Reflux time percent (RT%) pH <4 was compared between days 1 and 2 and 30 minutes before and during exercise. RESULTS: Fourteen patients were upright refluxers and 11 patients were combined refluxers, which included 4 patients with supine reflux and 7 patients who refluxed both in supine and upright positions. The median (range) 24-hour RT% on day 1 and day 2 was 7 (5-40) and 7 (4-46), respectively (p=0.15). RT% during 30 minutes exercise compared with 30 minutes before exercise was 6.6 (0-60) and 0.0 (0.0-80) (p=0.02), respectively. In combined and upright refluxers, RT% during and before exercise was 13 (0-53) and 0.0 (0.0-42) (p=0.008), respectively and 0.0 (0-60) and 0.0 (0-80), (p=0.71), respectively. RT% between upright and combined refluxers during exercise was 0.0 (0-60) and 13 (0-53), respectively (p=0.004). The mean (SD) LES pressure in mmHg in combined and upright refluxers was 7 (2.9) and 19.6 (6.8), respectively (p=0.008). Esophagitis in combined and upright refluxers was seen in 8 patients (72.7%) and 2 patients (14.3%), respectively. Two patients (8%) developed symptoms during exercise. CONCLUSION: Exercise which involves bending precipitates reflux in patients with moderate-to-severe GERD.

Vesicoperitoneal fistula--an unusual cause of tense ascites.

We report a 55-year-old man who developed tense ascites due to vesicoperitoneal fistula. He had undergone surgery 32 years ago for excision of an infected urachal cyst, the tract and the umbilicus.

Pantoprazole infusion as adjuvant therapy to endoscopic treatment in patients with peptic ulcer bleeding: prospective randomized controlled trial.

BACKGROUND AND AIM: Following successful endoscopic therapy in patients with peptic ulcer bleeding, rebleeding occurs in 20% of patients. Rebleeding remains the most important determinant of poor prognosis. We investigated whether or not administration of pantoprazole infusion would improve the outcome in ulcer bleeding following successful endoscopic therapy. METHODS: In this double-blind, placebo-controlled, prospective trial, patients who had gastric or duodenal ulcers with active bleeding or non-bleeding visible vessel received combined endoscopy therapy with injection of epinephrine and heater probe application. Patients who achieved hemostasis were randomly assigned to receive pantoprazole (80 mg intravenous bolus followed by an infusion at a rate of 8 mg per hour) or placebo for 72 h. The primary end-point was the rate of rebleeding. RESULTS: Rebleeding was lower in the pantoprazole group (8 of 102 patients, 7.8%) than in the placebo group (20 of 101 patients, 19.8%; P = 0.01). Patients in the pantoprazole group required significantly fewer transfusions (1 +/- 2.5 vs 2 +/- 3.3; P = 0.003) and days of hospitalization (5.6 +/- 5.3 vs 7.7 +/- 7.3; P = 0.0003). Rescue therapies were needed more frequently in the placebo group (7.8% vs 19.8%; P = 0.01). Three (2.9%) patients in the pantoprazole group and eight (7.9%) in the placebo group required surgery to control their bleeding (P = 0.12). Two patients in the pantoprazole group and four in the placebo group died (P = 0.45). CONCLUSION: In patients with bleeding peptic ulcers, the use of high dose pantoprazole infusion following successful endoscopic therapy is effective in reducing rebleeding, transfusion requirements and hospital stay.