Comparison of the Efficacy of 12-day Concomitant Quadruple Therapy versus 14-day High dose Dual Therapy as a First-line H. pylori Eradication Regimen.

Background/Aims: Helicobacter pylori (H. pylori) is the most prevalent infection in the world and is strongly associated with gastric adenocarcinoma, lymphoma and gastric or duodenal ulcers. Different regimens have been used for H. pylori eradication. We aimed to compare the efficacy of two different regimens as first-line H. pylori eradication regimens, in an area with high antibiotic resistance. Methods: In this RCT, we assigned 223 patients with H. pylori infection, who were naïve to treatment. They were randomly divided into two groups to receive either 12-day concomitant quadruple therapy (consisting of pantoprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg, and metronidazole 500 mg every 12 hours) or 14-day high dose dual therapy (consisting of esomeprazole 40 mg and amoxicillin 1 g TDS). H. pylori eradication was assessed eight weeks after the end of treatment. Results: H. pylori eradication rate by PP analysis for 12-day concomitant quadruple therapy and 14-day high dose dual therapy were 90.4% and 79.1%, respectively (p=0.02). According to ITT analysis, the eradication rates were 86.2% and 76.3%, respectively (p=0.06). Adverse drug reactions were 12.3% in high dose dual therapy and 36.8% in concomitant quadruple therapy (p<0.001). Conclusions: Twelve-day concomitant therapy seems to be an acceptable regimen for first-line H. pylori eradication in Iran, a country with a high rate of antibiotic resistance. Although, high dose dual therapy did not result in an ideal eradication rate, but it had fewer drug side effects than the 12-day concomitant regimen.

Non-inferiority of reverse hybrid regimen versus standard concomitant regimen for H. pylori eradication in a randomized-controlled trial.

Background: Helicobacter pylori (H. pylori) infection is strongly related to peptic ulcer disease, chronic gastritis, and gastric malignancies. Therefore, H. pylori eradication is necessary in these cases. This study was aimed to compare the efficacy of 14-day reverse hybrid therapy with standard 14-day concomitant regimen for H. pylori eradication in Iran. Methods: Of the 317 patients with dyspepsia and H. pylori infection enrolled in the study, 153 and 164 patients were randomly assigned to reverse hybrid and concomitant groups, respectively. The reverse hybrid regimen containing pantoprazole, amoxicillin, clarithromycin, and metronidazole was taken every 12 hours in the first 7 days, however, Clarithromycin and Metronidazole were discontinued within the next 7 days. Patients in the concomitant group also received the same drugs for 14-day. Eradication confirmation tests were used 8 weeks after the end of treatments. Results: A crowd of 281 patients continued the trial until the end. H. pylori eradication rates based on intention to treat analysis were 71.2% (109/153) and 83.5% (137/164) in reverse hybrid and concomitant groups, respectively (P = 0.007). By the per-protocol analysis, rates of eradication were 85.8% (109/127) and 89% (137/154), respectively (P = 0.428). Severe side effects were few in both groups. More side effects were observed in concomitant group (p < 0.001), however, the severity of side effects was not statistically different between the two regimens (P = 0.314). Reverse hybrid regimen was better tolerated (98% vs. 91.5%, P = 0.009). Conclusion: Both 14-day reverse hybrid and concomitant regimens have a fair response rate in Iran.

Effects of 14-days bismuth- and tetracycline-containing quadruple therapy with concomitant regimen for the first line Helicobacterpylori eradication.

Background: Helicobacter pylori (H. pylori) has infected about 50% of the world's population and it is the main cause for peptic ulcer, gastric adenocarcinoma and even a major cause for gastric MALT lymphoma. Methods: This study was performed in Mazandaran, Sari, situated in North of Iran. Three-hundred and twenty-eight adult patients with endoscopically approved gastric or duodenal ulcers or erosions and H. pylori infection were randomly divided into 2 groups to receive either 14 days PABT (Pantoprazole 40 mg, Amoxicillin 1 g, Bismuth 425 mg (all twice daily) and Tetracycline 500 mg four times a day) and PACM (Pantoprazole 40 mg, Amoxicillin 1g, Clarithromycin 500 mg, and Metronidazole 500 mg, all twice daily). To evaluate H. pylori eradication, fecal H. pylori antigen test was performed 8 weeks after treatment. Results: The eradication rates were 94.51% in the PABT and 91.46% in PACM group based on the intention to treat analysis. Moreover, the eradication rates were 95.58% and 92.72% according to per-protocol analysis, respectively. Also, both groups had very low rates of severe side effects. Conclusion: Regarding the ideal eradication rates achieved by both treatment groups and the low rates of severe side effects, both treatment protocols can be prescribed for H. pylori eradication in North of Iran.

Efficacy of 14-day concomitant quadruple therapy and 14-day high-dose dual therapy on H. pylori eradication.

Aim: We compared the efficacy of two different regimens for H. pylori eradication in areas with high antibiotic resistance. Background: Helicobacter pylori (H. pylori) is a gram-negative bacillus that has a strong association with chronic gastritis and peptic ulcer disease. Different regimens with varying degrees of effectiveness have been used for H. pylori eradication. Methods: The current randomized controlled trial (RCT) randomly assigned 217 patients who had indications for H. pylori eradication therapy to two groups. One group were administered concomitant quadruple therapy (pantoprazole 40 mg, amoxicillin 1 gr, clarithromycin 500 mg, and metronidazole 500 mg every 12 hours) for 14 days, and the second group received 14 days of high-dose dual therapy, consisting of esomeprazole 40 mg BID and amoxicillin 1g TDS. H. pylori eradication was assessed eight weeks after the end of treatment. Results: H. pylori eradication rates by PP analysis for 14 days concomitant quadruple therapy and high-dose dual therapy were 88.6% (95% CI, 80.3-92.8) and 82.2% (95% CI, 74.8-89.5), respectively (p = 0.19). According to intention-to-treat (ITT) analysis, the eradication rates were 81.6% (95% CI, 74.5-88.6) and 80.6% (95% CI, 73-88.1), respectively (p = 0.58). Overall drug side effects were 20.8% in high-dose dual therapy and 49.6% in concomitant quadruple therapy (p < 0.001). Conclusion: Fourteen days concomitant quadruple therapy can be considered as a relatively acceptable regimen for H. pylori eradication in areas with high clarithromycin and metronidazole resistance. It seems that high-dose dual therapy could be a promising alternative regimen in these areas.

Prevalence of Helicobacter Pylori Infection in Patients with Dyspepsia in North of Iran.

BACKGROUND Dyspepsia is a common complaint among patients who refer to gastroenterology clinics. Studies have shown that there is a strong relationship between dyspepsia and Helicobacter pylori (HP) infection. We have investigated the prevalence of HP infection in patients with dyspepsia and its correlation with age and socioeconomic status (SES) of patients in Mazandaran province, northern Iran. METHODS In this cross-sectional study, patients with dyspepsia who had undergone upper gastrointestinal endoscopy were enrolled. Diagnosis of HP infection was according to the results of rapid urease test (RUT), and Giemsa staining of pathology samples. A questionnaire including endoscopic findings, demographic data, and SES information was completed for each patient. RESULTS The mean age of the 614 patients was 45.8±5 years, and 60% of them were female. Most patients had normal endoscopy (56.1%), and gastric ulcer and erosion was the most common abnormal endoscopic finding (24.7%). The prevalence of HP infection in patients with dyspepsia was about 66.6%. HP infection was associated with a lower prevalence in people aged below 30 years and good SES. CONCLUSION The prevalence of HP infection in patients with dyspepsia was 66.6%. In addition, HP infection rate was lower in people under the age of 30 years and patients with good SES.

Is gastric mapping needed in the endoscopy of dyspeptic patients?

AIM: Our study aimed to determine the prevalence of intestinal metaplasia in dyspeptic patients who underwent upper GI endoscopy. BACKGROUND: Intestinal metaplasia, which is defined as the replacement of normal gastric mucosa by metaplastic intestinal epithelium, has been described as a premalignant gastric lesion. METHODS: Six hundred two consecutive patients with dyspeptic symptoms who had undergone upper GI endoscopy were included in the study. For all patients, gastric mapping was performed to determine the presence of intestinal metaplasia. All histologic samples were reported according to the updated Sydney classification. RESULTS: Total of 61.3% of the patients were female. The mean age of the patients was 46±15 years. The overall prevalence of intestinal metaplasia was 22%. The distribution of intestinal metaplasia in the stomach was 15.1% in the antrum, 4.3% in the body, and 2.6% in the antrum and body together. Also, the prevalence of intestinal metaplasia in the age group of under 40 years was 9.5% and in patients over 40 years it was 29.5%.. CONCLUSION: The results of this study have shown that more than one-fifth of the patients with dyspepsia have intestinal metaplasia. This indicates that gastric mapping in patients with dyspepsia may lead to the detection of precancerous lesions especially after the age of 40.

Comparison of Oral versus Intravenous Proton Pump Inhibitors in Preventing Re-bleeding from Peptic Ulcer after Successful Endoscopic Therapy.

BACKGROUND Proton pump inhibitors (PPIs) are now widely prescribed for the management of patients with acute upper gastrointestinal bleeding; although its optimal dose and route of administration has remained a controversial issue. The aim of this study was to assess the clinical effectiveness of high dose oral versus intravenous (IV) PPI after successful endoscopic therapy in patients with bleeding peptic ulcer disease. METHODS 178 patients with active upper gastrointestinal bleeding due to a peptic ulcer with stigmata of high risk for re-bleeding entered the study. After successful endoscopic hemostasis, they were randomized to receive either high dose oral pantoprazole (80 mg stat and 80 mg twice daily for 3 days) or high dose intravenous pantoprazole (80 mg IV infusion within 30 minutes and 8 mg per hour for 3 days). After the 3rd day, the patients in both groups received oral pantoprazole 40 mg twice daily for one month. The end points were comparing the rate of re-bleeding or mortality, and the need for blood transfusion or surgery during the first month between the two groups. RESULTS There were not significant statistical differences between the two groups in the volume of blood transfusion, mean duration of hospital stay, need to surgery, or mortality rates. However, the rates of re-bleeding were 2.3% (2:88) in the IV group and 3.3% (3:90) in the oral group (p = 0.6). CONCLUSION According to our findings, it seems that high dose oral PPI can be a good alternative to high dose IV PPI in patients with bleeding peptic ulcer who are at high risk of re-bleeding. Due to the lower cost and the availability of oral PPIs, their use can be economically much more affordable.