One-week triple therapy with omeprazole, amoxycillin and either clarithromycin or metronidazole for cure of Helicobacter pylori infection

Aim: The present study was designed to evaluate the efficacy and tolerability of 1-week triple therapy regimens for Helicobacter pylori .
Methods: In two consecutive series, 120 patients with proven H. pylori infection and peptic ulcer disease or functional dyspepsia were treated with either omeprazole 20 mg b.d., amoxycillin 1 g b.d. and clarithromycin 250 mg b.d. (OAC; n=60) or with omeprazole 20 mg b.d., amoxycillin 1 g b.d. and metronidazole 400 mg b.d. over 1 week (OAM; n=60). H. pylori infection was assessed by rapid urease test, culture and histology before and 4 weeks after cessation of the eradication therapy.
Results: H. pylori eradication succeeded in 53 out of 60 patients by omeprazole–amoxycillin–clarithromycin (OAC) (88%; 95% CI 77–95%) and in 47 out of 60 patients by omeprazole–amoxycillin–metronidazole (OAM) (78%; 95% CI 66–88%) (P=0.22). Nine patients of each group available for follow-up reported adverse events (15.0 and 15.5%, respectively) without necessity of discontinuation of the study medications. Serious adverse events were not observed.
Conclusions: Simple and convenient 1-week triple therapies consisting of omeprazole, amoxycillin and either clarithromycin or metronidazole are sufficiently effective in eradicating H. pylori infection.     

An increasing dose of omeprazole combined with amoxycillin cures Helicobacter pylori infection more effectively

Background : The combination of omeprazole and amoxycillin has demonstrated effectiveness with very few side-effects in the treatment of H. pylori infection, however cure rates have varied widely. The present study addresses the question as to the extent to which the cure rate of H. pylori infection depends on the size of the daily omeprazole dose, and investigates other patient-related factors that influence treatment success.
Methods : In a randomized, controlled and investigator-blinded trial, 163 hospitalized patients with H. pylori -associated gastritis were treated with 20 mg omeprazole once daily in the morning, 20 mg omeprazole b.d., 40 mg omeprazole b.d. or 60 mg omeprazole b.d. for 14 days. In addition, all patients received 1000 mg amoxycillin b.d. on days 5–14. Endoscopic and histological examinations were performed prior to treatment, at the end of treatment and 4 weeks after completion of treatment.
Results : H. pylori infection was cured in 18 of 40 (45%, 95% CI: 29–62%), in 22 of 39 (56.4%, 95% CI: 40–72%), in 25 of 38 (65.8%, 95% CI: 49–80%), and in 33 of 40 (82.5%, 95% CI: 67–93%) patients, respectively, ( P <0.001). Side-effects leading to discontinuation of treatment occurred in only 1.2%.
Conclusion : The daily dose of omeprazole is an important factor for the success of dual therapy comprising omeprazole and amoxycillin in curing H. pylori infection. Cure of H. pylori infection correlates positively and significantly with the size of the daily omeprazole dose. The combination of high-dose omeprazole and amoxycillin is an effective and well-tolerated regimen for the treatment of H. pylori -associated diseases.     

Efficacy and tolerability of a one-week triple therapy consisting of pantoprazole, clarithromycin and amoxycillin for cure of Helicobacter pylori infection in patients with duodenal ulcer

Background : Previous studies have shown that one-week triple therapy consisting of omeprazole, clarithromycin and amoxycillin may cure Helicobacter pylori infection in the vast majority of patients. The present study was designed to test the hypothesis that a triple therapy with pantoprazole, clarithromycin and amoxycillin cures the infection in 80% of duodenal ulcer patients infected with H. pylori .
Methods : In an open two-centre study, 60 duodenal ulcer patients were treated with pantoprazole 40 mg b.d., clarithromycin 500 mg b.d. and amoxycillin 1 g b.d. for 1 week. During the second week patients received pantoprazole 40 mg once in the morning. We assessed H. pylori infection before treatment and 4 weeks after cessation of the study medication by a rapid urease test, histology after Warthin–Starry stain and a ¹³C-urea breath test.
Results : Sixty patients (42 males, mean age 47.4 years) entered the trial. All patients were infected with H. pylori . One patient was withdrawn from the study because of allergy to penicillin and six patients were protocol violators. H. pylori infection was cured in 47 out of 53 patients who completed the trial according to the protocol (89%; 95% CI: 80–97%) and in 49 of 60 patients included in the trial (82%; 95% CI: 72–92%). Four weeks after the last administration of study drugs, 55 out of 60 ulcers had healed (92%). Twenty-nine patients reported 51 adverse events that were mostly mild to moderate.
Conclusions : One-week triple therapy consisting of pantoprazole, clarithromycin and amoxycillin is a simple and effective approach to the cure of H. pylori infection in patients with duodenal ulcer. In those patients who took the drugs as prescribed the H. pylori cure rate was 89%, with the lower 95% confidence limit being 80%.     

One-week low-dose triple therapy for Helicobacter pylori is sufficient for relief from symptoms and healing of duodenal ulcers

Aim : To test the hypothesis that 1-week low-dose triple therapy for H. pylori is sufficient for relief from dyspeptic symptoms and healing of duodenal ulcers.
Methods : Fifty-nine out-patients with duodenal ulcers and positive rapid urease test participated in this randomized, double-blind, two-centre study. All patients were treated for 1 week with omeprazole 20 mg b.d., clarithromycin 250 mg b.d. and metronidazole 400 mg b.d. In a double-blind fashion, patients were then randomly treated for another 3 weeks with either omeprazole 20 mg once daily or an identical-looking placebo. Patients were investigated endoscopically before treatment for H. pylori , after 2 weeks and after 4 weeks. H. pylori infection was assessed by a ¹³C-urea breath test at the time of enrolment and 4 weeks after cessation of any study medication.
Results : Fifty-two patients were included in the 'all patients treated' analysis of efficacy. The overall H. pylori cure rate was 96% (95% CI=87–100%), with no difference between the treatment groups. After 2 weeks duodenal ulcer healing was confirmed in 91% (95% CI=80–100%) of patients treated with omeprazole and in 76% (95% CI=60–91%) in the placebo group ( P =0.14). After 4 weeks all ulcers had healed. Relief from dyspeptic symptoms and adverse events (13.8 and 16.7%) did not differ between the treatment groups.
Conclusions : One-week low-dose triple therapy consisting of omeprazole, clarithromycin and metronidazole is a highly effective and well-tolerated approach to the cure of H. pylori infection in patients with a duodenal ulcer. Our data suggest that continuation of antisecretory drug therapy beyond anti- H. pylori therapy is actually excessive regarding relief from dyspeptic symptoms and healing of duodenal ulcers.     

Helicobacter pylori eradication using one-week low-dose lansoprazole plus amoxycillin and either clarithromycin or azithromycin

Aim : To evaluate and compare two 1-week low-dose triple therapies based on lansoprazole, amoxycillin and a macrolide in eradicating Helicobacter pylori .
Methods : Seventy consecutive patients, suffering from dyspeptic symptoms with H. pylori infection, were randomly allocated to one of two treatment groups: (A) (LAC; n =35) lansoprazole 30 mg once daily, amoxycillin 1000 mg b.d., clarithromycin 250 mg b.d., all for 7 days; and (B) (LAA; n =35) lansoprazole 30 mg once daily and amoxycillin 1000 mg b.d., both for 7 days, plus azithromycin 500 mg once daily for only 3 days. The H. pylori status was evaluated by means of histology and rapid urease test at entry and 8 weeks after treatment.
Results : Three patients did not complete the treatment: one in the LAC group was withdrawn owing to severe side-effects; two patients in the LAA group stopped the treatment prematurely. H. pylori eradication was obtained in 28 of 34 (82%; 95% CI=66–93%) patients in the LAC group and in 20 of 33 (61%; 95% CI=42–77%) patients in the LAA group. The difference is significant ( P <0.029). On intention-to-treat analysis, the rates of eradication were (28 of 35 patients, 80% in the LAC group and 20 of 35 patients, 57% in the LAA group. Side-effects occurred in nine (26%) and six (18%) patients in the LAC and LAA groups, respectively.
Conclusions : Low-dose lansoprazole plus amoxycillin and clarithromycin is more effective than low-dose lansoprazole plus amoxycillin and azithromycin, but it gave a greater incidence of side-effects.     

Two-week dual vs. one-week triple therapy for cure of Helicobacter pylori infection in primary care: a multicentre, randomized trial

BACKGROUND: One-week triple therapy has been suggested to be superior to two-week omeprazole-clarithromycin therapy for the cure of Helicobacter pylori infection. However, direct comparisons of the two treatments are scarce. AIM: To compare triple with dual therapy for H. pylori infection in the primary care setting. METHODS: One hundred and forty-five patients with duodenal ulcer and H. pylori infection were randomized to receive omeprazole 20 mg b.d. and clarithromycin 500 mg t.d.s. for 14 days (OC14 group, 69 patients) or omeprazole 20 mg b.d., clarithromycin 500 mg b.d. and amoxycillin 1 g b.d. for 7 days (OCA7 group, 76 patients). Eradication was evaluated by the 13C-urea breath-test. RESULTS: Intention-to-treat analysis showed a cure rate of 48% (95% CI: 36-60%) in the OC14 group, and 71% (95% CI: 59-80%) in the OCA7 group (P=0.0004). Per protocol analysis showed cure rates of 51% (95% CI: 38-63%, 33/65 patients) and 82% (95% CI: 70-90%, 54/66 patients), respectively (P=0.0001). There were no significant differences in compliance or side-effects. CONCLUSION: One-week twice-daily triple therapy is superior to 2-week dual therapy, but the cure rate in primary care was far below 90%.     

Immediate repeat course of amoxycillin, metronidazole and omeprazole to eradicate Helicobacter pylori

Aim : To investigate a repeat treatment regimen with the same antibiotic combination of amoxycillin and metronidazole in patients with continuing Helicobacter pylori infection.
Methods : Eighty-two patients with severe peptic ulcer disease and concurrent Helicobacter pylori infection were treated with a two week regimen of omeprazole (40 mg once daily), amoxycillin (750 mg t.d.s.) and metronidazole (400 mg t.d.s.). Upper gastrointestinal tract endoscopy was performed before, and approximately 2 months after, completion of antibiotic therapy. Biopsies were taken for rapid urease testing and the histological demonstration of H. pylori infection. Patients with persistent H. pylori infection at follow-up endoscopy were re-treated with a second and identical antibiotic treatment course. A subsequent endoscopic examination with accompanying biopsies was performed at least 6 weeks after the second treatment course and after a further 6, 18 and 30 months.
Results : Eradication of H. pylori was achieved in 69 patients (84%, 95% CI: 75–90%) after the first treatment. Four patients (4/82=5%) were withdrawn from the study because of side-effects. All of the remaining nine patients had their H. pylori infection eradicated after the second treatment course (95% CI: 70–100%). Seventy-eight patients had a follow-up examination after a median 30 months of the initial eradication of H. pylori , and all but one remained free of infection and none had an ulcer relapse.
Conclusions : This study demonstrates that patients with persistent H. pylori infection after completing a primary course of omeprazole (40 mg once daily), amoxycillin (750 mg t.d.s.) and metronidazole (400 mg t.d.s.) will probably respond to a repeat course of treatment with the same antibiotic combination.     

High-dose proton pump inhibitor plus amoxycillin for the treatment or retreatment of Helicobacter pylori infection

Background : The combination of 120 mg of omeprazole (40 mg t.d.s.) and amoxycillin has been reported to be effective for treating H. pylori infections.
Methods : Normal volunteers with H. pylori infection received high-dose omeprazole (40 mg t.d.s.) or lansoprazole (60 mg t.d.s.) plus amoxycillin 750 mg t.d.s. for 14 days. The studies were open label and not randomized as those receiving omeprazole plus amoxycillin had previously failed lower dose omeprazole (20 mg b.d.) plus amoxycillin therapy more than 6 months previously. Those receiving lansoprazole plus amoxycillin had not been previously treated. Four to 6 weeks after ending antimicrobial therapy, H. pylori status was determined by Genta stain of gastric mucosal biopsies.
Results : Forty-three volunteers entered the study and 41 completed it. The overall success with high-dose proton pump inhibitor plus amoxycillin was 34.9%. For the individual regimens the per-protocol results were 48% (95% CI=28–69%) with lansoprazole and 12.5% (95% CI=2–38%) with omeprazole. Compliance was >95% for both regimens. Side-effects were experienced by four lansoprazole and three omeprazole subjects, and caused two omeprazole subjects to withdraw. Cure rates were similar among different races and ethnic groups, between men and women, and between smokers and non-smokers. The level of the pre-treatment urea breath test also did not predict outcome.
Conclusion : High-dose proton pump inhibitor plus amoxycillin combinations for treatment of H. pylori infection yielded unacceptable results, as the 95% confidence intervals did not include an 80% cure rate. These combinations do not yield consistent results worldwide and cannot be recommended as primary therapy.     

Randomized study comparing omeprazole plus amoxycillin versus omeprazole plus clarithromycin for eradication of Helicobacter pylori

Background : Dual therapy with omeprazole plus amoxycillin or with omeprazole plus clarithromycin has been proposed for eradication of Helicobacter pylori . The main problem is the great variability in the rate of eradication.
Methods : A group of 287 consecutive patients with active peptic ulcers and H. pylori infections were admitted to a prospective, randomized, multicentre study, to be given omeprazole 20 mg b.d. plus either amoxycillin 1 g b.d. or clarithromycin 500 mg t.d.s. for 2 weeks. Cure was defined as the absence of H. pylori infection, 4–6 weeks after completing anti-microbial therapy, assessed by urease activity and histology of antral and body gastric biopsies.
Results : The bacteria were eradicated in 68/143 patients (48%) treated with amoxycillin and omeprazole and 70/144 patients (49%) treated with clarithromycin and omeprazole (intention-to-treat analysis). The ulcers were healed in 118/127 patients (93%) treated with amoxycillin and in 115/123 (94%) of those treated with clarithromycin. Undesirable effects were rare with both treatments.
Conclusions : Combined treatment with omeprazole plus either amoxycillin or clarithromycin produced a high percentage of short-term healing of ulcers and was well tolerated, but is not useful as first-line anti- Helicobacter pylori treatment.     

Randomized comparison of differing periods of twice-a-day triple therapy for the eradication of Helicobacter pylori

Background : We assessed the efficacy, compliance, and tolerability of the twice-a-day triple therapy, amoxycillin, omeprazole, and clarithromycin, for Helicobacter pylori and studied the effect of treatment duration (7, 10 or 14 days) on these factors.
Methods : One-hundred and fifty subjects with H. pylori infection documented by ¹³C-urea breath test were randomly assigned to a 7, 10 or 14-day course of amoxycillin 1 g b.d., omeprazole 20 mg b.d. and clarithromycin 500 mg b.d. Subjects returned at the end of therapy for pill count and assessment of side-effects. Subjects returned for a repeat ¹³C-urea breath test 4 weeks after the end of therapy.
Results : Poor compliance (<80% of medications taken) was seen in 0 subjects at 7 days, 6% at 10 days, and 10% at 14 days ( P =0.03 by χ² test for trend; difference for 7 vs. 14 days=10%; 95% CI, −2% to 18%; P =0.056). Intention-to-treat eradication rates were 86% at 7 days, 90% at 10 days and 92% at 14 days. Per-protocol eradication rates were 86% at 7 days, 91% at 10 days, and 95% at 14 days ( P =0.11; difference for 7 vs. 14 days=9%; 95% CI, −2% to 21%; P =0.17).
Conclusions : One week of twice-a-day amoxycillin, omeprazole and clarithromycin is well tolerated and provides a good rate of H. pylori eradication. Increasing the duration of therapy decreases compliance but has the potential to modestly improve efficacy if the patient takes the full complement of medication.     

Enhanced eradication of Helicobacter pylori by pre- versus post-prandial amoxycillin suspension with omeprazole: implications for antibiotic delivery

Background : Strategies to improve antibiotic treatment of Helicobacter pylori infection are hampered by lack of knowledge about the route of antibiotic delivery. Post-prandial dosing with antibiotics prolongs their gastric residence time and improves their intragastric distribution, leading to improved local delivery compared with pre-prandial dosing. We aimed to assess whether pre- or post-prandial dosing with amoxycillin suspension was more effective for H. pylori eradication in an amoxycillin/omeprazole regimen.
Methods : Seventy-nine patients with H. pylori infection were treated with omeprazole 40 mg o.m. for 28 days and amoxycillin suspension 500 mg q.d.s. for days 15–28, the amoxycillin being randomized to either 1 h before or immediately after food.
Results : The H. pylori eradication rate, for those completing the trial, was 67% (22/33) when amoxycillin suspension was given pre-prandially, compared with 39% (15/38) when it was given post-prandially ( P <0.05). Good compliance was achieved, with H. pylori eradication in 59% (28/46) of good compliers compared with 36% (9/25) of others completing the protocol ( P <0.05).
Conclusion : When given with omeprazole, pre-prandial dosing with amoxycillin suspension is more effective for H. pylori eradication than post-prandial dosing. This is consistent with the hypothesis that systemic rather than local delivery of amoxycillin is important for H. pylori eradication.     

Efficacy of two different dosage regimens of omeprazole, amoxycillin and metronidazole for the cure of Helicobacter pylori infection

BACKGROUND: While addition of metronidazole to the omeprazole-amoxycillin combination has been shown to be advantageous, the optimal dosage and drug distribution of the antimicrobials has not been sufficiently evaluated. AIM: To investigate the efficacy of two different regimens of omeprazole, amoxycillin and metronidazole for the cure of Helicobacter pylori infection. METHODS: Two hundred and fifty-five patients with H. pylori associated duodenal ulcers were randomly treated with either a 1-week regimen of omeprazole 20 mg b.d., amoxycillin 1000 mg b.d. and metronidazole 800 mg b.d. (OAM b.d.) or a combination of omeprazole 40 mg o.d., amoxycillin 500 mg t.d.s. and metronidazole 400 mg t.d.s. (OAM t.d.s.). All patients subsequently received omeprazole 20 mg o.d. for an additional 3 weeks. H. pylori status was assessed by histology and 13C-UBT prior to treatment and 8 weeks after randomization. Additional biopsies were obtained for H. pylori culture to determine primary and secondary resistance to metronidazole by agar dilution. RESULTS: Two hundred and thirty-seven patients were included in the intention-to-treat analysis and 198 patients in the per protocol analysis. With intention-to-treat analysis, the cure rate was 77% after treatment with OAM b.d. (95% CI, 69%-85%) and 76% after OAM t. d.s. therapy (95% CI, 67%-83%). Ulcer healing (intention-to-treat analysis) was documented in 95% of patients in the OAM b.d. group (n=122) and in 97% of patients in the OAM t.d.s. group (n=115). Adverse events were reported in 26 (20%) and in 18 (14%) patients in the OAM b.d. and OAM t.d.s. groups, respectively. None resulted in discontinuation of treatment. Overall primary resistance of H. pylori against metronidazole was found in 22 of 116 strains (19%). CONCLUSIONS: The combination of omeprazole, amoxycillin and metronidazole achieves about an 80% cure rate of H. pylori infection even in active ulcers. The total daily dose, and the choice of twice or three times daily dosing does not seem critical with this regimen.     

Omeprazole versus ranitidine: short-term triple-therapy in patients with Helicobacter pylori-positive duodenal ulcers

Aim : To compare the results of two short triple-therapy regimens, different only in the antisecretory drugs used, in patients with active duodenal ulcer and Helicobacter pylori infection.
Methods : All patients received a combination of clarithromycin 250 mg b.d. and tinidazole 500 mg b.d. for 1 week, in addition to an antisecretory drug: omeprazole 20 mg (50 patients) or ranitidine 300 mg (50 patients) twice daily for 1 week, followed by a single daily dose for a further 3 weeks. Upper gastrointestinal endoscopy, with rapid urease test and histological examination of antral and corpus biopsies, was performed prior to the treatment and at least 2 months after the discontinuation of the antisecretory therapy.
Results : Duodenal ulcer healing was documented in all patients at the endoscopic examination after therapy. H. pylori eradication was achieved in 46 of 50 patients (92%, 95% CI=85–99%) in the omeprazole group and in 43 of 50 patients (86%, 95% CI=76–96%) in the ranitidine group; the difference is not significant.
Conclusion : Omeprazole or ranitidine, in combination with clarithromycin and tinidazole, are equally effective in the eradication of H. pylori infection and healing of duodenal ulcers.     

The GU-MACH study: the effect of 1-week omeprazole triple therapy on Helicobacter pylori infection in patients with gastric ulcer

AIMS: To study the efficacy of omeprazole triple therapy in the eradication of Helicobacter pylori in patients with active gastric ulcer, and to assess healing and relapse of gastric ulcer. METHODS: A double-blind, randomized study was carried out in 18 centres in Germany, Hungary and Poland. Patients (n = 160) with gastric ulcer and a positive H. pylori screening test were randomized to a 7-day twice daily treatment with omeprazole 20 mg, clarithromycin 500 mg and amoxycillin 1000 mg (OAC) or omeprazole 20 mg, clarithromycin 250 mg and metronidazole 400 mg (OMC), or with omeprazole 20 mg once daily (O). After completion of this 1-week treatment, patients were treated with omeprazole until healing (maximum 12 weeks), and followed for 6 months. H. pylori was assessed by urea breath test (UBT) and histology. RESULTS: Eradication rates ITT were OAC 79% (95% CI: 65-90%), OMC 86% (95% CI: 73-94%) and O 4% (95% CI: 0-14%). Eradication rates PP were OAC 83% (95% CI: 68-93%), OMC 93% (95% CI: 80-98%) and O 3% (95% CI: 0-13%). Gastric ulcer relapses occurred in 5, 0 and 11 patients in the groups, respectively. CONCLUSIONS: The results from the study demonstrate that OMC and OAC 1-week regimens are safe and effective for eradication of H. pylori in gastric ulcer patients, and that ulcer relapse is infrequent after successful eradication.     

Low-dose omeprazole plus clarithromycin and either tinidazole or amoxycillin for Helicobacter pylori infection.

BACKGROUND: The aim of our study was to compare two 1-week, low-dose triple therapies for Helicobacter pylori eradication. METHODS: One hundred consecutive patients, suffering from dyspeptic symptoms with H. pylori infection, were randomly allocated to 7 days of treatment with omeprazole 20 mg o.m. plus clarithromycin 250 mg b.d. and either tinidazole 500 mg b.d. (group A: n = 50, 19 with peptic ulcer) or amoxycillin 1000 mg b.d. (group B: n = 50, 20 with peptic ulcer). H. pylori-status was evaluated by means of histology, culture and urease test, at entry and 8 weeks after treatment. RESULTS: Three patients did not complete the treatment. H. pylori eradication was obtained in 35 patients from group A (73%) (95% CI, 55-82%) and in 40 patients from group B (82%) (95% CI, 66-90%). On intention-to-treat analysis, the rates of eradication were similar. Side-effects occurred in seven patients from group A (14.58%) and in four patients from group B (8.33%), but none discontinued therapy because of side-effects. CONCLUSION: Both triple 1-week, low-dose omeprazole therapies gave good eradication rates with infrequent side-effects.     

One-week triple therapy with omeprazole, amoxycillin and tinidazole for Helicobacter pylori infection: the significance of imidazole resistance

Background : Triple therapy involving a proton pump inhibitor and two antibiotics has been suggested as an effective treatment for Helicobacter pylori infection. The impact of imidazole resistance on the efficacy of such regimens is largely unknown.
Methods : One hundred patients with culture proven H. pylori infection were treated with omeprazole 40 mg b.d., amoxycillin 1000 mg b.d., and tinidazole 500 mg b.d. for one week. Pre-treatment imidazole susceptibility was measured by disk diffusion. Resistance was confirmed by E -test. Eradication was assessed by endoscopy 6–8 weeks after the end of treatment. In cases of doubt a ¹³C-urea breath test was performed. Side-effects were scored using a semiquantitative scale.
Results : H. pylori was eradicated in 95% of the patients with an imidazole-susceptible strain and in 69% of the patients with a resistant strain ( P <0.005). Significant side-effects were seen in 12%.
Conclusion : This proton pump inhibitor triple therapy is a simple, reasonably effective regimen with few significant side-effects. The efficacy is dependent on the susceptibility of the infecting H. pylori strain.     

A new highly effective short-term therapy schedule for Helicobacter pylori eradication

BACKGROUND: Although triple therapy regimens suggested in the Current European guidelines give fairly good results, several studies have reported an unsatisfactory Helicobacter pylori eradication rate (< 80%). AIM: To evaluate the efficacy of a new short-term treatment sequence on H. pylori eradication. METHODS: A total of 52 patients with H. pylori infection and either non-ulcer dyspepsia (34 patients) or peptic ulcer (18 patients) were enrolled to receive a 10-day therapy: omeprazole 20 mg b.d. plus amoxycillin 1 g b.d. for the first 5 days, followed by omeprazole 20 mg b.d., clarithromycin 500 mg b.d. and tinidazole 500 mg b.d. for the remaining 5 days. H. pylori infection at entry was assessed by rapid urease test and histology on biopsies from the antrum and the corpus. Bacterial eradication was assessed by endoscopy (peptic ulcer patients) or 13C urea breath test (non-ulcer dyspepsia patients) 4-6 weeks after therapy had ended. RESULTS: All patients completed the study. H. pylori eradication was achieved in all but one patient, with an eradication rate of 98% (95% CI: 94.3-100) with intention-to-treat analysis. Patient compliance was good (consumption of prescribed drugs > 95%) for all but one patient, who took the triple therapy regimen for 4 days instead of 5 days. No major side-effects were reported but three (6%) patients complained of mild side-effects. CONCLUSIONS: The use of this 'five plus five' therapy schedule as an initial treatment for H. pylori deserves further investigation.     

Pantoprazole, amoxycillin and either azithromycin or clarithromycin for eradication of Helicobacter pylori in duodenal ulcer

BACKGROUND: Studies have shown that 1-week triple therapy consisting of a proton pump inhibitor, amoxycillin and clarithromycin may cure Helicobacter pylori infection in the majority of patients. AIM: To establish whether pantoprazole plus amoxycillin in association with either azithromycin or clarithromycin is useful in curing H. pylori infection in patients with a duodenal ulcer. METHODS: One hundred and ten patients with active duodenal ulcers and H. pylori infection were treated with pantoprazole (days 1-7, 40 mg b.d.; days 8-28 40 mg o.d.) plus amoxycillin 1 g b.d. for the first 7 days. Patients were randomly assigned to receive either azithromycin 500 mg o.d. for the first 6 days (PAAz group; n=55) or clarithromycin 500 mg b.d. for the first 7 days of treatment (PAC group; n=55). H. pylori status was determined by urease test and histology before the treatment, and again 4 weeks after cessation of any medication. RESULTS: One hundred and three patients completed the study. H. pylori infection was eradicated in 78% (39/50) of patients in the PAAz group (ITT analysis: 71%, 95% CI: 61-83%) vs. 81% (43/53) of patients in the PAC group (ITT analysis: 78%, 95% CI: 69-90%) (N.S.). All ulcers had healed. CONCLUSION: Our study shows that 1-week triple therapy with pantoprazole, amoxycillin and either azithromycin or clarithromycin is not satisfactory (<80% ITT H. pylori eradication rate).     

A new quadruple therapy for Helicobacter pylori: influence of resistant strains on treatment outcome

BACKGROUND: There have been no reports concerning the efficacy and safety of a 1-week quadruple therapy regimen of omeprazole, amoxycillin, roxithromycin and metronidazole for Helicobacter pylori infections and the impact of primary resistance on the eradication rate. METHODS: One hundred and sixty-nine consecutive patients with peptic ulcer disease as well as gastritis with biopsy-proven H. pylori infection were entered into an open study of omeprazole 20 mg o.m., amoxycillin 500 mg t.d.s., roxithromycin 150 mg b.d., and metronidazole 250 mg t.d.s. Helicobacter pylori status was determined by urease test, histology and culture. Susceptibility to amoxycillin, metronidazole and roxithromycin was determined by the E-test. RESULTS: H. pylori was eradicated in 155 out of 169 (92%; 95% CI 88-96%) by intention-to-treat analysis, and in 155 out of 163 (95%; 95% CI 92-98%) by per protocol analysis. The prevalence of primary resistance against amoxycillin, roxithromycin and metronidazole was 2 out of 166 (1%), 16 out of 166 (10%) and 27 out of 166 (16%), respectively. H. pylori was eradicated in 25 out of 27 (93%) patients with metronidazole-resistant strains compared with 130 out of 136 (96%) in patients with metronidazole-sensitive strains of H. pylori. It was eradicated in 15 out of 16 (94%) patients with roxithromycin-resistant strains while in 140 out of 147 (95%) patients with roxithromycin-sensitive strains of H. pylori, and in two out of two (100%) patients with amoxycillin-resistant stains compared with 153 out of 161 (95%) in patients with amoxycillin-sensitive strains. H. pylori was eradicated in three out of four (75%) patients with double resistance against metronidazole and roxithromycin compared with 152 out of 159 (96%) patients with sensitive strains to metronidazole and or roxithromycin. None of these differences were statistically significant. Severe side-effects were found in only one out of 169 patients-anaphylaxis due to penicillin. CONCLUSIONS: The 1-week quadruple therapy with omeprazole, amoxycillin, metronidazole and roxithromycin was found to eradicate H. pylori in over 90% of all patients. This regimen was also found to be beneficial for patients with pre-treatment resistant strains to metronidazole, roxithromycin or amoxycillin, and was observed to be safe and well-tolerated.     

Omeprazole-amoxycillin versus omeprazole-amoxycillin-clarithromycin in the eradication of Helicobacter pylori.

AIM: To assess the effect of adding clarithromycin to the combination of omeprazole and amoxycillin for the eradication of H. pylori infection. PATIENTS AND METHODS: In an open, randomized, three-centre study 120 patients (69 men, mean age 47 years, caucasians 74%) with symptoms of dyspepsia had normal gastroscopic examination and a positive urease test. They underwent a 13C-urea breath test and received, for 14 days, either omeprazole 40 mg b.d. plus amoxycillin 750 mg b.d., or the same regimen plus clarithromycin 250 mg b.d. Compliance was assessed by returned tablet counts. H. pylori clearance at the end of treatment and eradication 4 weeks after finishing treatment were assessed by 13C-urea breath test. RESULTS: Results are expressed according to 'all patients treated analysis', excluding patients who did not receive treatment and patients who had no final 13C-urea breath test assessment. In the groups treated with omeprazole- amoxycillin or omeprazole-amoxycillin-clarithromycin good compliance (> or = 90%) was observed in 85% vs. 76% (N.S.) of patients but 25% vs. 34% (N.S.) experienced at least one adverse event. Adverse events were minor, and no patient reported a metallic taste. Four weeks after finishing treatment eradication rates were 26% (95% CI: 15-37%) vs. 93% (95% CI: 86-99%) (P < 0.001). CONCLUSION: These results show that dual therapy with omeprazole plus amoxycillin achieves an unacceptably low H. pylori eradication rate. Addition of clarithromycin at low dosage (250 mg b.d.) proved to be useful, achieving a high eradication rate without increasing side-effects.