Primary studies included in this systematic review

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Primary study

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Journal Digestion
Year 2008
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BACKGROUND AND AIM: Rebleeding has remained the most important determinant of poor prognosis in peptic ulcer bleeding. Gastric acid plays an important role in the pathogenesis of rebleeding. We aimed to compare the efficiency of intermittent and continuous pantoprazole infusion treatment on peptic ulcer rebleeding after endoscopic therapy. MATERIALS AND METHOD: In this prospective study, patients with active peptic ulcer bleeding or non-bleeding visible vessel were treated initially with endoscopic therapy. They were randomized to receive intermittent or continuous intravenous pantoprazole treatment. Rebleeding rate, duration of hospital stay, need for total blood transfusion and need for urgent surgery were compared among both groups. RESULTS: Rebleeding rate (6.1 vs. 8.3%), duration of hospital stay (4.17 vs. 4.41), need for total blood transfusion (2.18 vs. 2.59) and need for urgent surgery (4.1 vs. 4.2%) were similar in intermittent and continuous pantoprazole infusion therapy groups, respectively. There was no bleeding-related death in either group. CONCLUSION: In patients with peptic ulcer bleeding, intermittent and continuous pantoprazole infusion after successful endoscopic therapy have comparable outcomes in reducing rebleeding. Both have similar effects on hospital stay, need for blood transfusion and urgent surgery. Intermittent administration has application and cost advantages over continuous infusion.

Primary study

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Journal The American journal of gastroenterology
Year 2008
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BACKGROUND: The most effective schedule of proton pump inhibitor (PPI) administration following endoscopic hemostasis of bleeding ulcers remains uncertain. METHODS: Patients with actively bleeding ulcers and those with nonbleeding visible vessel or adherent clot were treated with epinephrine injection and/or thermal coagulation, and randomized to receive intravenous PPIs according to an intensive regimen (80 mg bolus followed by 8 mg/h as continuous infusion for 72 h) or a standard regimen (40 mg bolus daily followed by saline infusion for 72 h). After the infusion, all patients were given 20 mg PPI twice daily orally. The primary end point was the in-hospital rebleeding rate, as ascertained at the repeat endoscopy. RESULTS: Bleeding recurred in 28 of 238 patients (11.8%) receiving the intensive regimen, and in 19 of 236 (8.1%) patients receiving the standard regimen (P = 0.18). Most rebleeding episodes occurred during the initial 72-h infusion: 18 (7.6%) and 19 events (8.1%) in the intensive and standard groups, respectively (P = 0.32). Mean units of blood transfused were 1.7 ± 2.1 in the intensive and 1.5 ± 2.1 in the standard regimen group (P = 0.34). The duration of hospital stay was <5 days for 88 (37.0%) and 111 patients (47.0%) in the intensive and standard groups (P = 0.03). There were fewer surgical interventions in the standard versus intensive regimen (1 vs 3). Five patients in each treatment group died. CONCLUSIONS: Following endoscopic hemostasis of bleeding ulcers, standard-dose PPIs infusion was as effective as a high-dose regimen in reducing the risk of recurrent bleeding. © 2008 by Am. Coll. of Gastroenterology.

Primary study

Unclassified

Journal ANZ journal of surgery
Year 2007
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BACKGROUND: To study the effects of pantoprazole on gastric pH and recurrent bleeding after endoscopic treatment for bleeding peptic ulcers. METHODS: After endoscopic haemostasis, patients were randomly assigned to infusion group (pantoprazole 80 mg i.v. bolus followed by continuous infusion of 8 mg/h for 3 days), bolus group (pantoprazole 80 mg i.v. bolus followed by 40 mg i.v. bolus every 12 h for 3 days) and no-treatment group (no acid suppression in the first 3 days). Gastric pH was monitored. Rebleeding rate within 30 days, the need for surgery, transfusion requirement, total hospital stay, mortality rate and gastric pH were compared. RESULTS: One hundred and sixty-eight patients were included, with 15 patients excluded from the analysis. There were 54 patients in the infusion group, 49 in the bolus group and 50 in the no-treatment group. There was fewer rebleeding (3.7 vs 16.0%, P = 0.034), less operative intervention (0 vs 8.0%, P = 0.034) and shorter hospital stay (6.4 vs 8.2 days, P = 0.040) in the infusion group compared with that in no-treatment group. When the bolus group was compared with no-treatment group, there were fewer rebleed (4.1 vs 16.0%, P = 0.049) and less blood transfusion (1.5 vs 2.9 units, P = 0.007). There was no difference in mortality among the three groups. Patients who received either pantoprazole infusion or bolus had significantly higher mean pH and longer duration of pH above 6 compared with the no-treatment group. There was no difference in the rebleeding rate, transfusion requirement, need for operation and hospital stay between the infusion and bolus groups. The mean pH and the duration of pH above 6 were also similar. CONCLUSION: Pantoprazole either as infusion or bolus decreased rebleeding after endoscopic treatment for bleeding peptic ulcer.

Primary study

Unclassified

Authors Lin HJ , Lo WC , Cheng YC , Perng CL
Journal The American journal of gastroenterology
Year 2006
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BACKGROUND: Epinephrine injection is the most common endoscopic therapy for peptic ulcer bleeding. Controversy exists concerning the optimal dose of proton pump inhibitors (PPI) for patients with bleeding peptic ulcers after successful endoscopic therapy. The objective of this study was to determine the optimal dose of PPI after successful endoscopic epinephrine injection in patients with bleeding peptic ulcers. METHODS: A total of 200 peptic ulcer patients with active bleeding or nonbleeding visible vessels (NBVV) who had obtained initial hemostasis with endoscopic injection of epinephrine were randomized to receive omeprazole 40 mg infusion every 6 h, omeprazole 40 mg infusion every 12 h or cimetidine (CIM) 400 mg infusion every 12 h. Outcomes were checked at 14 days after enrollment. RESULTS: Rebleeding episodes were fewer in the group with omeprazole 40 mg infusion every 6 h (6/67, 9%) as compared with that of the CIM infusion group (22/67, 32.8%, p < 0.01). The volume of blood transfusion was less in the group with omeprazole 40 mg every 6 h than in those groups with omepraole 40 mg infusion every 12 h (p= 0.001) and CIM 400 mg infusion every 12 h (p < 0.001). The hospital stay, number of patients requiring urgent operation, and death rate were not statistically different among the three groups. CONCLUSION: A combination of endoscopic epinephrine injection and a large dose of omeprazole infusion is superior to combined endoscopic epinephrine injection with CIM infusion for preventing recurrent bleeding from peptic ulcers with active bleeding or NBVV.

Primary study

Unclassified

Authors Cheng HC , Kao AW , Chuang CH , Sheu BS
Journal Digestive diseases and sciences
Year 2005
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This study sought to determine if high-dose omeprazole infusion could improve the control of rebleeding in patients with comorbid illnesses and bleeding peptic ulcers. After achieving hemostasis by endoscopy, 105 patients were randomized into high-dose (n = 52) and low-dose (n = 53) groups, receiving 200 and 80 mg/day omeprazole, respectively, as a continuous infusion for 3 days. Thereafter, oral omeprazole, 20 mg/day, was given. The cumulative rebleeding rates comparatively rose in both groups (high-dose vs. low-dose group), beginning on day 3 (15.4% vs. 11.3%), day 7 (19.6% vs. 20%), and day 14 (32.7% vs. 28.9%), until day 28 (35.4% vs. 33.3%), and were not significantly different between the two groups (P > 0.50). Multiple logistic regression confirmed that a serum albumin level <3 g/dL was an independent factor associated with rebleeding (P = 0.002). For patients with comorbidities, 3-day omeprazole infusion, despite increasing the daily dose from 80 to 200 mg, was not adequate to control peptic ulcer rebleeding.

Primary study

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INTRODUCTION: The mainstay of manageming patients with peptic ulcer bleeding (PUB) is endoscopic hemostasis, coupled with medical treatment i.e. fluid resuscitation, transfusion and antacids. Proton pump inhibitors (PPIs) are the most potent antacids and current data support that large, continuous doses yield maximal acid suppression. AIMS & METHODS: To evaluate the outcome of patients with (PUB) treated with bolus or continuous intravenous administration of omeprazole in conjunction with endoscopic hemostasis. All patients presenting with PUB were prospectively randomized to either bolus intravenous omeprazole 40 mg b.i.d. (Group A: n=36), or continuous intravenous omeprazole infusion 160 mg/24h after a loading dose of 80 mg omeprazole bolus IV (Group B: n=40). All patients underwent EGD in either an emergent or scheduled setting, according to their clinical status, during the first 24 hours of admission. Patients with malignant gastric ulcers were not included in this study as were patients with bleeding of non peptic ulcer origin. Endoscopic hemostasis was performed in Forrest I, IIa, and IIb lesions. The endoscopist during the examination was the judge of the hemostatic means employed on each patient. Data collected included age, gender, smoking and drinking habits, Helicobacter Pylori infection, NSAIDs and/or aspirin prior use, hospital stay, number of transfusions, and the need for surgical intervention and death. RESULTS: Endoscopic hemostasis was performed on 14 patients in Group A (38.9%) and on 10 patients in Group B (25%), by means of adrenaline injection, endoclip placement and band ligation. Mean transfusions in Group A were 2.5 units whereas in Group B 3.25 units (p=0.9). Patients of Group A were hospitalized for a mean of 6.1±2.3 days while the length of hospital stay for Group B patients was 5.8±2.3 days (p=0.84). All other parameters studied (age, sex, smoking and drinking habits, Helicobacter Pylori infection, NSAIDs and/or aspirin prior use) presented no statistical differences. One patient of Group B was ultimately surgically treated, and self-limited bleeding relapse was observed on two Group-A patients, which was treated conservatively. No deaths occurred. CONCLUSION: Both regimens proved equally effective in the treatment of PUB. More clinical trials are needed in order to specify the appropriate PPI regimen for patients with PUB.

Primary study

Unclassified

Journal Gastrointestinal Endoscopy
Year 2003
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Primary study

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Journal Scandinavian journal of gastroenterology
Year 2001
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BACKGROUND: It has been suggested that profound acid inhibition along with endoscopic therapy might prevent rebleeding and reduce mortality in patients with peptic ulcer bleeding. The aim of the study was to test the possible equivalence of a high dose and the regular dose of omeprazole in peptic ulcer bleeding. METHODS: We performed a prospective randomized double-blind study involving 142 patients with acute peptic ulcer bleeding (Forrest classification I-II: spurting or oozing bleeding, non-bleeding visible vessel, clot and black base). One-hundred-and-two (71.8%) patients received endoscopic treatment (adrenaline injection and/or heater probe) in pre-entry. Patients were randomly assigned to receive the regular dose of omeprazole intravenously (20 mg once a day for 3 days, i.e. 60 mg/72 h) or a high dose of omeprazole (80 mg bolus + 8 mg/h for 3 days, i.e. 652 mg/72 h). Rebleeding, surgery and death were the outcome measures. RESULTS: Six (8.2%) of the 73 patients receiving the regular dose of omeprazole and 8 (11.6%) of the 69 patients receiving the high dose of omeprazole rebled (P = 0.002 for equivalence, equivalence limit 0.15). Three (4.1%) of the former patients and 5 (7.2%) of the latter group underwent surgery. Four (5.5%) patients in the regular-dose and 2 (2.9%) in the high-dose group died within 30 days. CONCLUSION: Under the defined tolerance limits, the regular dose of omeprazole is as successful as a high dose in preventing peptic ulcer rebleeding.

Primary study

Unclassified

Journal Gastroenterology
Year 1999
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AIM: To compare the effect of two doses of intravenous pant0prazole (PAN), 40 mg injection once daily for 3 days (low dose) and 40 mG initial followed by continuous infusion of 8 mg/h for 3 days (high dose), in the prevention of peptic ulcer rebleeding. METHODS: Maximally 1 h after endoscopic haemostasis (adrenaline) of peptic ulcer bleeding Forrest la, lb and Ila, 68 inpatients of either sex were randomized to receive intravenous PAN therapy with either low dose or high dose for 3 days in this multicenter, double-blind, parallel-group comparison. Initial H. pylori status was assessed. An endoscopy was routinely repeated 72 h after initial endoscopic hemostasis or on suspicion of rebleeding. Patients were followed for 14 days after initial endoscopy. RESULTS: 82 patients were included in the low dose group and 86 patients in the high dose group (intention-to-treat), of which 74 low dose patients and 76 high dose patients completed the study per-protocol. Both treatment groups were comparable with respect to sex, H. pylori status, age, alcohol consumption, smoking, weight, height, body-mass-index and Forrest stages of peptic ulcer bleeding. The 72-h rebleeding rates were 12% (9/74) in the low dose group and 13% (10/76) in the high dose group (Cochran-Mantel-Haenszel test: n. s.: per-protocol). No influence of the initial H. pylori status on the clinical outcome of rebleeding was apparent. Need for blood transfusions over 72 h was similar in both treatments. The mortality rates after 14 days were 2.5% (2/78) in the low dose group and 2.4% (2/80) in the high dose group {Fisher's Exact Test: n. s.; intention-to-treat). Adverse events were more frequent in the low dose group. CONCLUSIONS: The results of this pilot study indicate that after initial endoscopic haemostasis both pantoprazole continuous infusion following an initial loading dose and repeated injections are similarly effective in the prevention of peptic ulcer rebleeding.