A new modified concomitant therapy for Helicobacter pylori eradication in Turkey

Background: Helicobacter pylori eradication rates have tended to decrease recently, mostly due to antibiotic resistance. In the present study, our aim was to determine Hp eradication rate with the LAC plus tid metronidazole regimen and the secondary objective of this study was to identify an effective regimen for our population. Methods: Eighty‐four Hp‐positive patients with non‐ulcer dyspepsia were assigned into the same group. Patients were administered the classical LAC protocole (lansoprazole 30 mg bid, amoxicillin 1 g bid and claritromycin 500 mg bid for 14 days) plus metronidazole 500 mg tid for 14 days. Gastroscopy and histopathological assessment were performed before enrollment and C¹⁴ urea breath test and stool antigen test were performed 6 weeks after treatment. Results: All 84 patients completed the study. No patient left the study because of drug side effect. Total eradication rate was 75% (63/84). Conclusion: Although LAC plus tid metronidazole regimen achieved a much better eradication rate compared with the standard LAC regimen; this is the first study that has a relatively low success with a concomitant therapy. So in areas of high resistance like Turkey, one cannot expect a high success with any clarithromycin containing regimen and those should be avoided.     

Eradication of Helicobacter pylori by 7-day triple-therapy regimens combining pantoprazole with clarithromycin, metronidazole, or amoxicillin in patients with peptic ulcer disease: results of two double-blind, randomized studies

Aim. To compare the short‐term (7‐day) safety and efficacy of two triple‐therapy regimens using pantoprazole with those of two dual‐therapy regimens (one with pantoprazole and one without), for Helicobacter pylori eradication in patients with peptic ulcer disease. Methods. H. pylori infection was identified by rapid urease (CLOtest), and confirmed by histology and culture. Patients were enrolled into one of two randomized, double‐blind, multicenter, parallel‐group studies. In study A, patients received oral pantoprazole 40 mg, clarithromycin 500 mg, and metronidazole 500 mg (PCM); pantoprazole, clarithromycin and amoxicillin 1000 mg (PCA); or pantoprazole and clarithromycin (PC). In study B, patients received PCM, PCA, PC, or clarithromycin and metronidazole without pantoprazole (CM). Treatments were given twice daily for 7 days. H. pylori status after therapy was assessed by histology and culture at 4 weeks after completing the course of study treatment. Modified intent‐to‐treat (MITT; each study: n = 424, n = 512) and per‐protocol (PP; each study: n = 371, n = 454) populations were analyzed. The MITT population comprised all patients whose positive H. pylori status was confirmed by culture and histology; the PP population comprised patients who also complied with ≥ 85% of study medication doses. Results. A total of 1016 patients were enrolled. Cure rates among patients with clarithromycin‐susceptible H. pylori strains were 82 and 86% for PCM, and 72 and 71% for PCA, in studies A and B, respectively. Cure rates among patients with metronidazole‐susceptible H. pylori strains were 82 and 87% for PCM, and 71 and 69% for PCA, in studies A and B, respectively. The combined eradication rates observed with the PCM regimen were superior to those of all other regimens tested. Side‐effects were infrequent and mild. Conclusions. PCM had the highest overall eradication rate in these two studies examining 7‐day treatment regimens. All regimens were safe and well tolerated.     

A comparison between sequential therapy and a modified bismuth-based quadruple therapy for Helicobacter pylori eradication in Iran: a randomized clinical trial

Background: Sequential regimens have been recently reported to be superior to the standard triple therapies in Helicobacter pylori eradication, but most of these studies were performed in Europe and data from developing countries are lacking. So we designed a study to compare a sequential regimen with a bismuth‐based quadruple therapy that contains a short course of furazolidone, in Iran. Methods: Two hundred and ninety‐six patients with duodenal ulcer and naïve H. pylori infection were randomized into two groups: 148 patients received (PAB‐F) pantoprazole (40 mg‐bid), amoxicillin (1 g‐bid), and bismuth subcitrate (240 mg‐bid) for 2 weeks and furazolidone (200 mg‐bid) just during the first week. And 148 patients received (PA‐CT) pantoprazole (40 mg‐bid) for 10 days, amoxicillin (1 g‐bid) for the first 5 days, and clarithromycin (500 mg‐bid) plus tinidazole (500 mg‐bid) just during the second 5 days. C¹⁴‐urea breath test was performed 8 weeks after the treatment. Results: Two hundred and sixty‐one patients completed the study (137 patients in the PA‐CT and 124 in the PAB‐F group). The results were not statistically different between the two groups in the eradication rates and the severity of side effects. The intention to treat eradication rate was 80.4% in the PAB‐F group and 83.7% in the PA‐CT group. Per‐protocol eradication rates were 88.7% and 89.1%, respectively. Conclusion: Because the two regimens showed acceptable and similar abilities in H. pylori eradication and because of much higher cost of clarithromycin in Iran, the furazolidone containing regimen seems to be superior. Further modifications of sequential therapies are needed to make them ideal regimens in developing countries.     

Eradication of H. pylori with pantoprazole, clarithromycin, and metronidazole in duodenal ulcer patients: a head-to-head comparison between two regimens of different duration

Background. The study was conducted to compare the efficacy and tolerability of two pantoprazole-based triple therapies of different length in the eradication of H. pylori.
Methods. In this double-blind, multicenter parallel group comparison, H. pylori -positive patients were randomly assigned to either the PCM-7 group (7 days of pantoprazole 40 mg bid, clarithromycin 500 mg bid, metronidazole 500 mg bid) or the PCM-14 m group (modified 14 day therapy of the same regimen with metronidazole only given for 10 days due to labeling reasons). H. pylori status was determined by urease test, histology, culture, and ¹³C-urea breath test. Treatment outcome was assessed 6 weeks after intake of the last study medication.
Results. The following eradication rates were achieved: for PCM-7 in the MITT population 83% (89/107), in the PP population 84% (81/97); for PCM-14 m in MITT 87% (92/106), in PP 88% (91/104). Ulcer healing rates were: for PCM-7 in MITT population 99% (106/107), in the PP population 99% (96/97); for PCM-14 m in MITT 99% (105/106), in PP 99% (103/104). Gastrointestinal symptoms and gastritis scores decreased in both treatment groups. Equivalence of treatment regimens could be proven for all populations. In total, 64 patients reported adverse events. Five serious adverse events occurred, all unrelated to the study medication.
Conclusion. The two pantoprazole-based triple therapies tested in this study are equally effective in H. pylori eradication, ulcer healing and relief from ulcer pain. It is concluded that 7 days of triple therapy are generally sufficient.     

Double-blind, Multicenter, Placebo-Controlled Evaluation Of Clarithromycin And Omeprazole For Helicobacter Pylori-Associated Duodenal Ulcer

Background. Eradication of Helicobacter pylori leads to faster ulcer healing and a significant decrease in ulcer recurrence. Clarithromycin is the most effective monotherapy for eradicating H. pylori from the gastric mucosa, and omeprazole frequently is used for the treatment of duodenal ulcer disease, prompting the interest to investigate rigorously the combination of clarithromycin and omeprazole for eradicating H. pylori. Materials and Methods. The aim of this double-blind, randomized, multicenter (n=30), multinational (n=10) study was to compare clarithromycin and omeprazole with omeprazole monotherapy for the eradication of H. pylori from the gastric mucosa, endoscopic healing, and reduction of symptoms and ulcer recurrence in patients with active duodenal ulcer. Patients with active duodenal ulcer associated with H. pylori infection were randomized to receive omeprazole, 40 mg every morning for 14 days, with either clarithromycin, 500 mg, or placebo three times daily, which was followed by omeprazole, 20 mg every morning for 14 days. Patients underwent endoscopy before enrolling in the study, immediately after finishing treatment, and at 4- to 6-week and 6-month follow-up evaluations or at the recurrence of symptoms. Results. Two hundred and eight patients with active duodenal ulcer associated with confirmed H. pylori infection were randomized to treatment with either clarithromycin and omeprazole (n=102) or omeprazole and placebo (n=106). Four to six weeks after treatment was completed, H. pylori was eradicated in 74% (95% confidence interval, 63.0%–82.4%) of patients receiving clarithromycin and omeprazole, compared with 1% (0.0%–6.2%) of patients receiving omeprazole monotherapy (p < .001). Clarithromycin resistance developed in eight patients treated with clarithromycin and omeprazole and in none given omeprazole and placebo. Ulcers, which were healed following treatment in more than 95% of study patients, recurred by the 6-month follow-up visit in 10% (5%–19%) of dual therapy recipients, compared with 50% (39%–61%) of those who took omeprazole alone (p <.001). Conclusion. Clarithromycin and omeprazole dual therapy is simple and well-tolerated and leads to consistently high eradication rates for patients with duodenal ulcer associated with H. pylori infection.     

Ten‐Day Sequential Therapy as First‐line Treatment for Helicobacter pylori Infection in Korea: A Retrospective Study

Background and Aims: The eradication rate of proton‐pump inhibitor‐based triple therapy for Helicobacter pylori infection is low due to increasing antibiotics resistance, especially clarithromycin. Recently, it was reported in Europe that a 10‐day sequential strategy produced good outcomes. The aim of this study was to assess the efficacy of sequential therapy as first‐line treatment for eradication of H. pylori in clinical practice in Korea. Materials and Methods: A total of 98 patients (mean age 55.2 years and male 47, female 51) with proven H. pylori infection received 10‐day sequential therapy (20 mg of rabeprazole, and 1 g of amoxicillin, twice daily for the first 5 days, followed by 20 mg of rabeprazole, 500 mg of clarithromycin, and 500 mg of metronidazole, twice daily for the remaining 5 days). Eradication was evaluated 4 weeks later, after completion of treatment by 13^C‐urea breath testing. Eradication rates were calculated by intention‐to‐treat (ITT) and by per protocol (PP). Compliance and adverse events were also assessed in study group. Results: The eradication rate of sequential therapy was 91.8% (90/98) by ITT and same result was reported by PP analysis (89/97). The study group consisted of 66 H. pylori associated gastritis, 7 gastric ulcer, and 25 duodenal ulcer patients (67.3%, 7.1%, 25.5%, respectively). Mild adverse events happened frequently (21.4%) but the treatment was well tolerable. The most common adverse event was a bitter taste (9.2%) followed by nausea and diarrhea (4.1%). Conclusions: Ten‐day sequential therapy is found to effectively eradicate H. pylori infection as first‐line treatment in Korea.     

Pretreatment Antibiotic Resistance in Helicobacter pylori Infection: Results of Three Randomized Controlled Studies

Background. Although combinations of antibiotics and antisecretory drugs are useful for treatment of Helicobacter pylori infection, treatment failure is common. The aim of this study was to evaluate the relation between pretreatment antibiotic resistance and outcome by using six different treatment regimens for H. pylori infection. Patients and Methods. Three hundred sixty-nine consecutive H. pylori–infected patients with dyspeptic symptoms were enrolled in three consecutive randomized, controlled, single-center clinical trials: trial A, 128 patients; trial B, 125 patients; trial C, 116 patients. Treatments consisted of (A) a 15-day course of dual therapy (omeprazole, 20 mg bid, and amoxicillin, 1 gm bid, or clarithromycin, 500 mg tid) (OA vs OC); (B) a 7-day triple therapy of omeprazole, 20 mg bid, plus metronidazole, 500 mg bid, and amoxicillin, 1,000 mg bid, or clarithromycin, 500 mg tid (OMA vs OMC); or (C) omeprazole, 20 mg bid, plus metronidazole, 500 mg bid, plus tetracycline, 500 mg qid, or doxycycline, 100 mg tid (OMT vs OMD). Diagnostic endoscopy was made in all patients before and 5 to 6 weeks after therapy. Six biopsies were taken from each patient for histology, rapid urease test, and H. pylori culture; antibiotic susceptibility testing was performed using the E-test method. Results. Overall cure rates were poor for both dual therapies OA and OC (38% and 37%, respectively) and for triple therapies OMA, OMC, and OMD (57%, 55%, and 58%, respectively). The OMT combination was successful in 91% (95% confidence interval [CI], 80.4%–97%). Metronidazole resistance was present in 29.7% (95% CI, 24%–35%), amoxicillin resistance was present in 26% (95% CI, 21%–32%), clarithromycin resistance was present in 23.1% (95% CI, 18%–29%), tetracycline resistance was present in 14% (95% CI, 10%–20%), and doxycycline resistance was present in 33.3% (95% CI, 21%–47%). Antibiotic resistance markedly reduced the cure rates and accounted for most of the poor results with the triple therapies: 89% versus 23%; 77% versus 26%; 100% versus 60%; and 67% versus 23% for OMC, OMA, OMT, and OMD, respectively. OMT appeared to be the best because of the high success rate with metronidazole-resistant H. pylori (71%) and in low-level tetracycline resistance. Conclusions. Pretreatment antibiotic-resistant H. pylori can, in part, explain the low cure rate of the infection and the variability in outcome in reported trials.     

Low efficacy of clarithromycin including sequential regimens for Helicobacter pylori infection

Background: Sequential treatment for Helicobacter pylori (H. pylori) appears to achieve a better eradication rate than triple therapy. However, most of the data have been reported from the Italy, and studies from different population are needed before it is recommended in clinical practice. The present study aimed to assess and compare the efficacy of two separate clarithromycin including sequential regimens in Turkey which is well known with high clarithromycin and metronidazole resistance to H. pylori. Methods: Consecutive H. pylori ‐positive patients with non‐ulcer dyspepsia were randomly allocated to one of the two sequential regimens; the first group was given lansoprazole 30 mg b.i.d. plus amoxicillin 1 g b.i.d. for the first week, followed by lansoprazole 30 mg b.i.d., clarithromycin 500 mg b.i.d., and metronidazole 500 mg t.i.d. for the second week (LA‐CM). The second arm was given the same regimen but tetracycline500 g q.i.d. instead of metronidazole (LA‐CT). H. pylori was detected with urea breath test (UBT) and histology before enrollment. UBT was repeated at 6th weeks after treatment. Results: A total of 200 patients were enrolled in groups and 179 of them completed their protocols. The cumulative per protocol (“PP”) and intention‐to‐treat (“ITT”) eradication rates were 74.3% and 66.5% in all patients, respectively. Both “PP” (78.2% vs 70.1%) and “ITT” (72% vs 61%) eradication rates were better in LA‐CT group than LA‐CM group, but the differences were not statistically significant (p > .05). Both regimens were well tolerated, and the incidence of adverse effects was comparable. Conclusion: Two weeks clarithromycin including sequential regimens with metronidazole or tetracycline were not achieved acceptable eradication rates in Turkey.     

An Alternative Non-Macrolide, Non-Imidazole Treatment Regimen for Curing Helicobacter pylori and Duodenal Ulcers: Ranitidine Bismuth Citrate Plus Amoxicillin

Background. Because patients who fail to be cured of H. pylori infection following macrolide or imidazole therapy are difficult to treat, there is a clear need for a reasonably effective and simple second-line treatment regimen. The purpose of these two studies was to evaluate the efficacy of ranitidine bismuth citrate (RBC) plus amoxicillin for the cure of H. pylori infection and for healing duodenal ulcers and preventing ulcer relapse.
Materials and Methods. Two identically designed randomized, double-blind, double-dummy studies were conducted in patients with an H. pylori -associated duodenal ulcer. Patients were treated with either RBC 400 mg bid for 4 weeks plus amoxicillin 500 mg qid for 2 weeks, RBC 400 mg bid for 4 weeks and placebo qid for 2 weeks, placebo bid for 4 weeks and amoxicillin 500 mg qid for 2 weeks, or placebo bid for 4 weeks and placebo qid for 2 weeks. Patients with healed ulcers after 4 weeks of treatment were eligible for entry into a 24-week observation phase for the assessment of H. pylori status (culture, histology, and CLOtest^TM) and ulcer relapse.
Results. A total of 229 patients with confirmed H. pylori infection at baseline were evaluated. Of these, 132 whose ulcers had healed entered the 24-week posttreatment observation phase. The combination of RBC plus amoxicillin resulted in higher H. pylori cure rates (55%) and higher duodenal ulcer healing (74%) than did either treatment alone. All treatments were well tolerated.
Conclusions. The combination of ranitidine bismuth citrate plus amoxicillin cures H. pylori infection in more than half of the patients treated. This treatment regimen shows promise as the basis for future non-macrolide, non-imidazole triple therapy regimens for curing H. pylori infection. Such regimens may be appropriate second-line treatment for patients who are resistant to or who are unable to tolerate macrolide- or imidazole-containing therapies.     

Current Strategies in Ulcer Management with Special Reference to the Use of Antibiotics

Antibiotics, commonly amoxycillin, tetracycline, metronidazole and clarithromycin, are presently used in combination with anti-ulcer agents such as omeprazole, colloidal bismuth subcitrate, and sucralfate to treat Helicobacter pylori infection in patients with peptic ulcer, and compelling evidence has accumulated that eradication of the organism prevents duodenal ulcer relapse. The latest combination (MACH I) involved omeprazole, amoxycillin or metronidazole, and clarithromycin and claimed 90-96 percent success in H. pylori eradication. While the eradication rates of the bacteria are usually between 60-80 percent, the healing rates of duodenal ulcer using these regimens have been remarkably high, often over 90 percent, even with regimens that do not contain proton-pump inhibitors. Antibiotics alone, such as furazolidone and metronidazole, have been reported to heal peptic ulcer with various successes. In a recent double-blind placebo-controlled study, we showed that antibiotics alone, in the form of metronidazole, amoxycillin and clarithromycin, effectively healed 92.5 percent of patients with duodenal ulcer, and that the healing was largely accountable by clearance of H. pylori. Thus, the present day evidence indicates that both healing and prevention of relapse of peptic ulcer can be achieved by treatment of H. pylori. Metronidazole resistance is emerging rapidly, especially in Asia, and is likely to affect eradication success. At this point in time, the best regimen for peptic ulcer associated with H. pylori includes the use of a proton-pump inhibitor plus two antibiotics for one to two weeks.     

Increased primary resistance to recommended antibiotics negatively affects Helicobacter pylori eradication

Objective. To evaluate the efficacy of two commonly employed treatments for Helicobacter pylori infection and the impact of bacterial resistance to antibiotics on eradication rate. Methods. Ninety‐two consecutive H. pylori‐positive patients with active peptic ulcer disease were randomly enrolled to receive a 7‐day treatment with either lansoprazole 30 mg plus amoxicillin 1 g and clarithromycin 500 mg [all twice a day (b.i.d.), Group A, n = 46]; or bismuth subcitrate 125 mg four times a day (q.i.d.) plus tetracycline 500 mg q.i.d and furazolidone 200 mg b.i.d. (Group B, n = 46) H. pylori status was reassessed 30 days after completion of the therapy and bacterial resistance to the antibiotics was investigated using an in vitro assay. Results. Five patients from each study group were lost to follow up. Both treatments resulted in similar H. pylori eradication rate: 66–60% (per protocol), 59–52% (intention‐to‐treat) in Groups A and B, respectively (non significant). However, eradication improved to 79% in the absence of H. pylori resistance to clarithromycin or amoxicillin. Conclusion. Primary resistance to clarithromycin or amoxicillin may underscore a potentially serious problem for the eradication of H. pylori infection. Testing for bacterial resistance may become necessary to improve therapeutic efficacy.     

Sequential metronidazole-furazolidone or clarithromycin-furazolidone compared to clarithromycin-based quadruple regimens for the eradication of Helicobacter pylori in peptic ulcer disease: a double-blind randomized controlled trial

Background: Furazolidone is a much cheaper drug with a very low resistance against Helicobacter pylori compared to clarithromycin. We aim to evaluate safety and efficacy of a sequential furazolidone‐based regimen versus clarithromycin‐based therapy in H. pylori eradication for ulcer disease. Materials: Patients with proven peptic ulcer or duodenitis were randomized into three groups: OAB‐M‐F; metronidazole (M) (500 mg bid) for the first 5 days, followed by furazolidone (F) (200 mg bid) for the second 5 days; OAC‐P; clarithromycin (C) (500 mg bid) for 10 days; and OAB‐C‐F; clarithromycin (500 mg bid) for the first 5 days and furazolidone (200 mg bid) for the second 5 days. All groups received omeprazole (O) (20 mg bid) and amoxicillin (A) (1 g bid). Groups OAB‐M‐F and OAB‐C‐F were also given bismuth subcitrate (B) (240 mg bid), whereas a placebo (P) was given to group OAC‐P. Adverse events were scored and recorded. Two months after treatment, a C¹³‐urea breath test was performed. Results: Three hundred and ten patients were enrolled and 92 (OAB‐M‐F), 95 (OAC‐P), and 98 (OAB‐C‐F) completed the study. The intention‐to‐treat eradication rates were 78.5% (95% CI = 69–85), 81.1% (95% CI = 73–88), and 82% (95% CI = 74–89), and per‐protocol eradication rates were 91.3% (95% CI = 83–96), 90.4% (95% CI = 82–95), and 88.7% (95% CI = 81–94), for group OAB‐M‐F, OAC‐P, and OAB‐C‐F, respectively. Eradication rate differences did not reach statistical significance. The most common adverse event, bad taste, occurred in all groups, but more frequently in groups OAC‐P (34%) and OAB‐C‐F (32%), than OAB‐M‐F (14%) (p < .05). Adverse symptoms score were 0.88 ± 2.05 in group OAB‐M‐F, 1.15 ± 1.40 in group OAC‐P, and 1.87 ± 1.62 in group OAB‐C‐F. Conclusion: Furazolidone can replace clarithromycin in H. pylori eradication regimens because of lack of development of resistance and very low cost.     

The effects of nocturnal acid breakthrough on Helicobacter pylori eradication

Background. The effects of nocturnal gastric acid breakthrough (NAB) on Helicobacter pylori eradication are still unknown in peptic ulcer patients. The purposes of this study were to compare the effect of lansoprazole 30 mg twice a day (bid) to lansoprazole 60 mg once a day (qd) on the prevalence of NAB, and to determine whether NAB affects the eradication of H. pylori in peptic ulcer patients. Methods. Experiments were carried out in 67 patients with H. pylori‐positive peptic ulcers. They were randomized into two groups, one treated with a combination of lansoprazole 60 mg, clarithromycin 1.0 g, and amoxycillin 2.0 g once a day before breakfast (qd group), and the other, divided doses of the drugs were given before breakfast and dinner (bid group) for 2 weeks. Results. NAB occurred in 31 patients, 55.2% in qd group, and 39.5% in bid group (p = .226). H. pylori eradication was achieved in 61.3% in NAB positive group and 83.3% in NAB negative group (p = .055). The mean duration of NAB for H. pylori eradication group was 99.3 ± 22.7 min, and 293.2 ± 49.8 min for H. pylori persistence group (p < .05). The median intragastric pH of the H. pylori eradication and persistence group was 5.7 ± 0.2 and 4.2 ± 0.4, respectively (p < .05). Conclusions. Neither the morning dose and the divided dose regimen of lansoprazole affected the intragastric acidity and occurrence of the NAB. NAB did not influence H. pylori eradication in peptic ulcer patients, but the duration of NAB and total intragastric median pH were found to influence the H. pylori eradication.     

Rank order of success favors longer duration of imidazole-based therapy for Helicobacter pylori in duodenal ulcer disease: a randomized pilot study

Background. Studies on eradication therapy in developing countries have shown a success rate of 70–85%, which is suboptimal. Duration of therapy may be an important factor dictating eradication success in such regions. Aim. The study was undertaken to evaluate the effect of increasing the treatment period on eradication of Helicobacter pylori in duodenal ulcer disease. Methods. A randomized trial was carried out in which 64 consecutive H. pylori‐infected patients with duodenal ulcer disease were enrolled. The patients were randomized to one of the three trial arms. Therapy consisted of lansoprazole 30 mg twice a day (b.i.d.), amoxycillin 1 g b.i.d. and tinidazole 500 mg b.i.d. The treatment period was 1 week in group I, 2 weeks in group II and 3 weeks in group III. At inclusion, patients underwent endoscopy and the presence of H. pylori was documented by a positive urease test and C14 urea breath test. Four weeks after completion of eradication therapy, the patients were subjected to repeat endoscopy to assess ulcer healing and tests for H. pylori infection. Results. Sixty‐four patients (55 male and nine female; mean age 35.5 years) were enrolled in each group. The H. pylori eradication rate for group I (1 week of therapy) was 47.6%, that for group II (2 weeks of therapy) was 80%, and that for group III (3 weeks of therapy) was 91.3% (p = .003). The ulcer healing rates were 71.4, 80 and 95.6% in groups I, II and III, respectively (p = .09). Conclusion. The 3‐week regimen significantly improved the eradication rate as compared with the 1‐week regime. Increasing the duration of therapy significantly improved the chances of eradication of H. pylori in duodenal ulcer disease.     

Normalization of phospholipids concentration of the gastric mucosa was observed in patients with peptic ulcer after eradication of Helicobacter pylori

Background. Phospholipids concentration in the gastric mucosa decreased in patients with Helicobacter pylori infection. The aim of this study is to examine the effects of eradication of H. pylori on decreasing the phospholipids concentration in the gastric mucosa in patients with gastric or duodenal ulcer. Materials and Methods. Phospholipids (phosphatidylcholine, phosphatidylethanolamine, and sphingonomyeline) were measured in biopsy specimens from the antrum and corpus using thin‐layer chromatography. In H. pylori positive patients with gastric ulcer (n = 26) and duodenal ulcer (n = 13), and H. pylori negative controls (n = 20), the biopsy specimens were obtained before and 3 months after eradication. Eradication was performed using lansoprazole, amoxycillin, and clarithromycin. Results. Compared with the H. pylori negative control group, the concentrations of phosphatidylcholine and phosphatidylethanolamine decreased significantly in the gastric ulcer group in both antrum and corpus mucosa, and in the duodenal ulcer group in antrum mucosa. This decrease returned to the control level after eradication. Conclusions. This study demonstrates that the eradication of H. pylori in patients with peptic ulcer normalized the decrease of phosphatidylcholine and phosphatidylethanolamine in the gastric mucosa.     

High eradication rates of Helicobacter pylori infection following sequential therapy: the Israeli experience treating naïve patients

Background: Helicobacter pylori eradication rates following triple therapy are decreasing. Cure rates as low as 57%, mainly to claritromycin resistance, have been reported in Israel. Studies performed in Italy have shown eradication rates of 93%, following sequential therapy. Our aim was to evaluate the effect of sequential therapy on eradication rates of H. pylori in naïve Israeli patients. Material and Methods: Consecutive patients referred for esophagogastroduodenoscopy with a positive rapid urease test and positive ¹³C urea breath test were included. Patients received omeprazole 20 mg bid and amoxicillin 1 g bid for 5 days followed by omeprazole 20 mg bid, clarithromycin 500 mg bid and tinidazole 500 mg bid for the subsequent 5 days. A second ¹³C urea breath test was performed at least 4 weeks after completion of therapy. Patients were asked to avoid antibiotics, bismuth compounds or proton pump inhibitor until after the second ¹³C urea breath test. Adverse effects were documented by a questionnaire. Results: One hundred and twenty‐four patients (mean age 56.1 ± 12.5 years, 55.6% women) were included; 120/124 (96.8%) completed treatment and performed the second ¹³C urea breath test. Two patients (1.6%) were lost to follow‐up; 2 (1.6%) were noncompliant with study regulations. One hundred and fifteen patients achieved eradication of H. pylori. The eradication rate was 95.8% by per protocol analysis and 92.7% by intention to treat analysis. Conclusion: The sequential regimen attained significantly higher eradication rates in naïve patients than usually reported for conventional triple therapy. Sequential therapy may be an alternative first‐line therapy in eradicating H. pylori in Israel.     

Systematic review and meta-analysis: Helicobacter pylori eradication therapy after simple closure of perforated duodenal ulcer

Background: The most common complications of peptic ulcer are bleeding and perforation. In many regions, definitive acid reduction surgery has given way to simple closure and Helicobacter pylori eradication. Aim: To perform a systematic review and meta‐analysis to ask whether this change in practice is in fact justified. Materials and Methods: A search on the Cochrane Controlled Trials Register, Medline, and Embase was made for controlled trials of duodenal ulcer perforation patients using simple closure method plus postoperative H. pylori eradication therapy versus simple closure plus antisecretory non‐eradication therapy. The long‐term results for prevention of ulcer recurrence were compared. Results: The pooled incidence of 1‐year ulcer recurrence in H. pylori eradication group was 5.2% [95% confidence interval (CI) of 0.7 and 9.7], which is significantly lower than that of the control group (35.2%) with 95% CI of 0.25 and 0.45. The pooled relative risk was 0.15 with 95% CI of 0.06 and 0.37. Conclusions: Helicobacter pylori eradication after simple closure of duodenal ulcer perforation gives better result than the operation plus antisecretory non‐eradication therapy for prevention of ulcer recurrence. All duodenal ulcer perforation patients should be tested for H. pylori infection, and eradication therapy is required in all infected patients.     

Colloidal Bismuth Pectin: An Alternative to Bismuth Subcitrate for the Treatment of Helicobacter pylori– Positive Duodenal Ulcer

Background. Bismuth triple therapy provides consistently good results in Helicobacter pylori eradication worldwide, whereas quadruple therapy using a combination of omeprazole and bismuth triple regimen has produced cure rates in excess of 90%. The prevalence of metronidazole-resistant strains was 26.8% in our area. Colloidal bismuth pectin (CBP) is a new, lower-priced bismuth salt made in China. The purpose of this study was to investigate the efficacy and safety of CBP triple and quadruple regimens in the treatment of H. pylori–positive duodenal ulcer. Materials and Methods. In this prospective trial, 205 patients with H. pylori–positive duodenal ulcer were allocated randomly to receive one of four regimens: metronidazole, 200 mg; amoxicillin, 250 mg; and colloidal bismuth subcitrate (CBS), 120 mg (group 1), or CBP, 100 mg qid (group 2) for 2 weeks, then continued CBS, 240 mg, or CBP, 200 mg bid for a further 2 weeks. A quadruple regimen using a combination of omeprazole, 20 mg bid, and CBS triple therapy (group 3) or CBP triple therapy (group 4), respectively, was given to patients for 1 week, followed by omeprazole, 20 mg once daily for a further 3 weeks. Further endoscopy was performed at least 4 weeks after cessation of the treatment. H. pylori status was determined by histology, a ¹⁴C urea breath test, and a urease test. Results. The per-protocol H. pylori cure rates were 85% (22 of 26 patients), 90% (35 of 39), 96% (46 of 48), and 95% (75 of 79) for groups 1 through 4. In the intention-to-treat analysis, cure rates were 79% (22 of 28), 83% (35 of 42), 90% (46 of 51), and 89% (75 of 84), respectively. The cure rates of quadruple therapy were higher than those of triple therapy; an 8.2% difference was not statistically significant (95% confidence interval [CI], 2.3–18.7%). The ulcer-healing rates were 88%, 87%, 98%, and 97%, respectively, for groups 1 through 4. The ulcer pain was relieved more rapidly in quadruple- than in triple-therapy regimens. Two patients discontinued treatment prematurely owing to drug-related side effects. Conclusion. One-week quadruple therapy is highly effective and safe in H. pylori eradication in Chinese patients. CBP is as effective as CBS.     

Oxidative Stress in Helicobacter pylori Infection: Does Supplementation with Vitamins C and E Increase the Eradication Rate?

Aim: This study aims to assess the antioxidant property of vitamins E and C in Helicobacter pylori infection, and to determine if adding them to standard triple therapy plus bismuth subcitrate increases the H. pylori eradication rate. Methods: This study included 160 patients infected with H. pylori, who were randomized into one of two groups. Patients in group A (n = 80) received lansoprazole (30 mg, b.i.d.), amoxicillin (1000 mg, b.i.d.), clarithromycin (500 mg, b.i.d.), and bismuth subcitrate (300 mg, q.i.d.) for 14 days, while patients in group B (n = 80) received vitamin C (500 mg, b.i.d.) and vitamin E (200 IU, b.i.d.) for 30 days, in addition to lansoprazole (30 mg, b.i.d.), amoxicillin (1000 mg, b.i.d.), clarithromycin (500 mg, b.i.d.), and bismuth subcitrate (300 mg, q.i.d.) for 14 days. Total antioxidant capacity (TAC) was evaluated with a Randox kit. Success rate was calculated using both intention‐to‐treat (ITT) and per‐protocol (PP) analyses. Results: One hundred and sixty patients were analyzed using ITT analysis. One hundred and fifty‐three patients completed the study. In group A, H. pylori eradication was achieved in 48 (60%) of the 80 patients included in the ITT analysis, and in 48 (64%) of the 75 patients included in the PP analysis. In group B, H. pylori eradication was achieved in 73 (91.25%) of the 80 included in the ITT analysis and in 73 (93.5%) of the 78 patients included in the PP analysis. The eradication rate was significantly higher in group B than in group A (p < .005). TAC was at the lower limit of normal in both groups and the difference between them was not statistically significant (p > .05). Conclusion: In group B, H. pylori eradication rate was 91.25%, which is higher than the ideal 80% eradication rate. The results of the present study show that adding the prescribed doses of vitamins E and C to antimicrobial therapy is effective in eradicating H. pylori infection.     

A modified bismuth-containing quadruple therapy including a short course of furazolidone for Helicobacter pylori eradication after sequential therapy failure

Background: Helicobacter pylori eradication has still remained a challenge, especially in case of failure to novel treatments. Therefore, we designed a study to evaluate the effects of a modified bismuth‐containing quadruple therapy including a short course of furazolidone on a group of patients whose sequential therapy had been unsuccessful. Materials and Methods: Thirty‐six H. pylori‐positive patients who had previously failed a clarithromycin‐containing sequential therapy enrolled the study. They received pantoprazole (40 mg‐bid), amoxicillin (1 g‐bid), and bismuth subcitrate (240 mg‐bid) for 2 weeks and furazolidone (200 mg‐bid) just during the first week. Eight weeks after treatment, H. pylori eradication was reassessed using C14‐urea breath test. Results: Thirty five patients completed the study. H. pylori eradication rates were 80.6% (95% CI = 67.6–93.5) and 82.9% (95% CI = 70.6–95.2) according to intention‐to‐treat and per‐protocol analyses, respectively. All patients had excellent compliance to treatment, and no one interrupted therapy owing to adverse effects. Conclusion: Regarding the eradication rate (>80%), low price, and very low adverse effects, a 2‐week bismuth‐containing quadruple regimen including a short course of furazolidone can be an encouraging regimen for second‐line H. pylori eradication in case of sequential therapy failure. Possibly, it can be improved by alterations in dose, dosing intervals, and/or duration.