Mary Ellen Jensen

A Controlled Study of Ranitidine for the Prevention of Recurrent Hemorrhage from Duodenal Ulcer

BACKGROUND Hemorrhage is the most common complication of duodenal ulcer disease, but there is little information about the effectiveness and safety of long-term maintenance therapy with histamine H2-receptor blockers. METHODS We conducted a double-blind study in patients with endoscopically documented hemorrhage from duodenal ulcers. Patients were randomly assigned to maintenance therapy with ranitidine (150 mg at night) or placebo and were followed for up to three years. Endoscopy was performed at base line (to document that the ulcers had healed), at exit from the study, and when a patient had persistent ulcer symptoms unrelieved by antacids or had gastrointestinal bleeding. Symptomatic relapses without bleeding were treated with ranitidine; if the ulcer healed within eight weeks, the patient resumed taking the assigned study medication. RESULTS The two groups were similar at entry, which usually occurred about three months after the index hemorrhage. After a mean follow-up of 61 weeks, 3 of the 32 patients treated with ranitidine had recurrent hemorrhage, as compared with 12 of the 33 given placebo (P < 0.05). Half the episodes of recurrent bleeding were asymptomatic. One patient in the ranitidine group withdrew from the study because of asymptomatic thrombocytopenia during the first month. CONCLUSIONS For patients whose duodenal ulcers heal after severe hemorrhage, long-term maintenance therapy with ranitidine is safe and reduces the risk of recurrent bleeding.

An economic analysis of patients with active arterial peptic ulcer hemorrhage treated with endoscopic heater probe, injection sclerosis, or surgery in a prospective, randomized trial☆☆☆★★★

BACKGROUND There are no published, detailed assessments of the direct costs of endoscopic hemostasis for actively bleeding peptic ulcers. We compared the direct costs of care for patients with active ulcer hemorrhage treated with endoscopic or medical-surgical therapies and correlated these costs with patient outcomes. METHODS In a prospective, randomized, controlled trial, 31 patients with active ulcer hemorrhage at emergency endoscopy were randomly assigned to heater probe, injection, or medical-surgical treatment. For further ulcer bleeding, heater probe and injection patients were re-treated endoscopically and medical-surgical patients were referred for surgery. Direct costs were estimated using fixed and variable costs for resources consumed and Medicare reimbursement rates for physician fees. RESULTS Compared to medical-surgical treatment, the heater probe and injection groups had significantly higher primary hemostasis rates (100% and 90% vs 8%) and lower rates of emergency surgery (0% and 10% vs 75%), blood transfusions, and median direct costs per patient (

Prospective randomized comparative study of bipolar electrocoagulation versus heater probe for treatment of chronically bleeding internal hemorrhoids

4153 and

Prospective randomized comparative study of bipolar versus direct current electrocoagulation for treatment of bleeding internal hemorrhoids

5247 vs

⁎⁎⁎4461 Randomized, controlled trial of medical therapy compared with endoscopic therapy for prevention of recurrent ulcer hemorrhage in patients with non-bleeding adherent clots.

11,149). Furthermore, compared to medical-surgical treatment, the heater probe group had a significantly lower incidence of severe ulcer rebleeding (11% vs 75%). CONCLUSIONS Heater probe and injection sclerosis are similarly efficacious treatments for active ulcer hemorrhage, and both treatments yield significantly lower direct costs of medical care and cost savings.

Independent risk factors of 30‐day outcomes in 1264 patients with peptic ulcer bleeding in the USA: large ulcers do worse

BACKGROUND Our purpose was to compare the efficacy, complications, failure rates, and crossovers of heater and bipolar probe treatments of chronically bleeding internal hemorrhoids. METHODS Eighty-one patients (31 female, 50 male) with mean age of 53 years had large (grade 2 to 3) internal hemorrhoids with bleeding for a mean of 12 years, had failed medical management, and were randomized in a prospective study of anoscopic treatments to heater versus bipolar probes. Failure was defined as a major complication or failure to reduce the size of all internal hemorrhoids with three or more treatments. RESULTS With similar background variables and no difference in treatment times, rectal bleeding and other symptoms were controlled in a shorter time with the heater probe than with the bipolar probe (77 versus 121 days). Five complications (fissures, bleeding, or rectal spasm) occurred with the bipolar probe, and two occurred with the heater probe. The heater probe caused more pain during treatments but had significantly fewer failures and crossovers. CONCLUSIONS For patients who had failed medical management of chronically bleeding internal hemorrhoids, the techniques and complications of heater and bipolar probes were similar, but pain was more common, failures and crossovers were less frequent, and the time to symptom relief was shorter with the heater probe than with the bipolar probe.

Prevalence of H. pylori and aspirin or NSAID utilization in patients with ulcer hemorrhage: Results of screening for a large multicenter U.S. trial

Internal hemorrhoids are the most common cause of lower gastrointestinal bleeding. Although new anoscopic therapies are available, few comparative randomized studies have evaluated them in regard to long-term efficacy, recurrence rates, and safety. Our purpose was to compare the treatment of internal hemorrhoids with direct current (Ultroid, Cabot Medical, Langhorn, Pa.) and bipolar (BICAP, Circon ACMI, Stamford, Conn.) hemorrhoid probes. One hundred patients with symptomatic internal hemorrhoids were randomized: 50 to direct current electrocoagulation and 50 to bipolar electrocoagulation. Follow-up and treatment were at 3- to 4-weekly intervals; two to three hemorrhoid segments were treated at each session until relief of symptoms (bleeding, prolapse, and discharge) and a reduction in hemorrhoid size to grade 1 or 0 were noted. The hemorrhoids of 98% of all patients studied were grade 2 or 3; 2% of patients had grade 1 hemorrhoids and none had grade 4 hemorrhoids. At 1 year after treatment, most patients had no (69%) or only mild (23%) recurrence, and a few had severe, symptomatic (8%) hemorrhoid recurrence. A greater recurrence rate was noted after direct current treatment (34%) than bipolar treatment (29%). In contrast, rebleeding at 1 year occurred less frequently after direct current treatment (5%) than after bipolar treatment (20%). Our conclusions were as follows: (1) Both direct current and bipolar probes were effective for control of chronic bleeding from grade 1 to 3 internal hemorrhoids. (2) Bipolar probe was significantly faster than direct current probe. (3) Direct current treatment produced fewer complications than bipolar treatment (12% versus 14%). (4) Recurrence rates were low after 1 year with either device (8%).(ABSTRACT TRUNCATED AT 250 WORDS)

Comparison of Three Risk Scores to Predict Outcomes of Severe Lower Gastrointestinal Bleeding.

The treatment of high risk patients with non-bleeding adherent clots (CLOTS) on ulcers is a controversy. In a previous RCT, there was no benefit to endoscopic injection or heater probe compared to medical therapy for prevention of recurrent ulcer hemorrhage. The purpose of this study is to test the hypothesis that patients treated with endoscopic combination therapy of CLOTS would have significantly lower rebleeding rates than those treated with medical therapy alone. Methods. In this RCT, 31 elderly patients with co-morbid conditions, severe ulcer hemorrhage, and endoscopic non-bleeding CLOTS resistent to target irrigation were randomized to medical therapy alone (PPIs BID, transfusions, and correction of coagulopathies)and sham endoscopic therapy (washing but no contact or endoscopic treatment) or to combination therapy with epinephrine injection (1:10,000, 4 quadrant in 1 cc aliquots), shaving down the CLOT with cold guillotining (snare without cautery), bipolar coagulation (Gold probe, 15- 20W, 10 sec pulses, firm tamponade) on the underlying stigmata and medical therapy. Physicians blinded to the endoscopic therapy managed all patients. Results. Patients were similar at study entry, except for older age and higher rates of NSAID or aspirin ingestion before their hemorrhage in the medical group. See table for details. By the time of discharge, significantly more medical patients-4/15 (26.7%)-than endoscopically treated patients-0/16 (0%)-rebled (p=0.027). There were no complications of the combination treatment. Conclusions: 1) Combination endoscopic therapy (epinephrine injection, cold guillotining to reveal stigmata and GP coagulation) and medical treatment of non-bleeding CLOTS significantly reduced early rebleeding rates in high risk patients compared to medical therapy alone. 2) This endoscopic treatment was safe. Funded by NIH DK33273 and partially by Microvasive-Boston Scientific.

⁎⁎3638 Randomized, prospective trial of endoscopic rubber band ligation compared to bipolar coagulation for bleeding internal hemorrhoids

Predictors of worse outcomes (rebleeding, surgery and death) of peptic ulcer bleeds (PUBs) are essential indicators because of significant morbidity and mortality rates of PUBs. However those have been infrequently reported since changes in medical therapy (PPI, proton pump inhibitors) and application of newer endoscopic haemostatic technique.

3575 Randomized controlled study of combination epinephrine injection and gold probe compared to gold probe alone for hemostasis of actively bleeding peptic ulcers.

tO be similar in both groups, i.e. 271100 (27.0%) in the LAN30 and 25192 (27.2%) in the LAN15 group. Of these 192 patients, 9 were not available for the estimation of the endoscopic relapse rate (6 stopped the trial prematurely without any indication of endoscopic relapse and 3 had no 1-year endoscopy). The endoscopic relapse rate after 1 year was also found to be similar in both groups, i.e. 21/94 (22.3%) in the LAN30 and 21189 (23.6%) in the LAN15 group. However, further analysis revealed that the previous episode of acute reflux oesophagitis had been more severe in the LAN30 than in the LAN15 group (p=0.024) and that a positive correlation existed between the grade of previous reflux oesophagitis and endoscopic relapse (p < 0.05). For the more severe oesophagitis grades (IJI-IV) endoscopic relapse rate was slightly lower in the LAN30 than in the LAN15 group i.e. 8•34 (23.5%) versus 5/17 (29.4%), but this was not of statistical significance. The number of patients with an adverse experience was also similar in both groups and no serious adverse experiences related to the trial medication were encountered. Conclusion 30mg and 15rag were equally effective, so 15rag once a day appears to be sufficient in the maintenance treatment of reflux oesophagitis with lansoprazole. This research was funded in collaboration by Hoechst Marion Roussel, Hoevelaken, and Janssen-Cilag B.V., Tilburg, The Netherlands.