Duodenal Ulcer Healing Rates Research Articles

Vonoprazan: A New Potassium-Competitive Acid Blocker.

Objective: To review the safety, efficacy, and tolerability of vonoprazan for the treatment of Helicobacter pylori infection in adults. Data Sources: A literature search was performed through PubMed using the following key terms: vonoprazan, Voquezna, TAK-438, potassium-competitive acid blocker, H pylori, and gastrointestinal. Study Selection and Data Extraction: Selected articles included those which described clinical studies of the pharmacology, pharmacokinetics, efficacy, safety, or tolerability of vonoprazan. Data Synthesis: Vonoprazan works by competing with potassium on the proton pump to inhibit gastric acid secretion. Phase 3 clinical trials have shown that vonoprazan is noninferior to proton pump inhibitors (PPIs) as a component of H pylori eradication regimens. Vonoprazan has also shown promise in duodenal ulcer-healing rates and in reducing symptoms of heartburn. Common adverse effects associated with vonoprazan include nasopharyngitis, diarrhea, constipation, flatulence, dyspepsia, headache, and abdominal pain. Conclusion: Clinical practice guidelines recommend PPIs as the antisecretory agent of choice in H pylori eradication regimens with histamine-2 receptor antagonists (H2RAs) as potential alternatives. However, the use of either class of medications may be limited by adverse effects, drug interactions, and tolerability. Potassium-competitive acid blockers (P-CABs), like vonoprazan, may be safe and effective alternative antisecretory agents for H pylori eradication regimens, as well as other gastrointestinal disorders.

Efficacy of proton pump inhibitors for patients with duodenal ulcers: A pairwise and network meta-analysis of randomized controlled trials

Background/Aim:To compare the efficacy and tolerance of different proton pump inhibitors (PPIs) in different doses for patients with duodenal ulcers.Materials and Methods:An electronic database was searched to collect all randomized clinical trials (RCTs), and a pairwise and network meta-analysis were performed.Results:A total of 24 RCTs involving 6188 patients were included. The network meta-analysis showed that there were no significant differences for the 4-week healing rate of duodenal ulcer treated with different PPI regimens except pantoprazle 40 mg/d versus lansoprazole 15 mg/d [Relative risk (RR) = 3.57; 95% confidence interval (CI) = 1.36–10.31)] and lansoprazole 30 mg/d versus lansoprazole 15 mg/d (RR = 2.45; 95% CI = 1.01–6.14). In comparison with H2 receptor antagonists (H2 RA), pantoprazole 40 mg/d and lansoprazole 30 mg/d significantly increase the healing rate (RR = 2.96; 95% CI = 1.78–5.14 and RR = 2.04; 95% CI = 1.13–3.53, respectively). There was no significant difference for the rate of adverse events between different regimens, including H2 RA for a duration of 4-week of follow up.Conclusion:There was no significant difference for the efficacy and tolerance between the ordinary doses of different PPIs with the exception of lansoprazle 15 mg/d.

A study on healing of peptic ulcer disease after eradication of helicobacter pylori infection

There is intimate connection between peptic ulcer & Helicobacter pylori infection. But some uncertainties still surround the relationship between status of H. pylori infection and extent & time required for ulcer healing. This prospective observational study was carried out in the department of Gastroenterology, BSMMU, Dhaka from January 2007 to January 2008 to determine whether the successful eradication of H. pylori leads to adequate ulcer healing. To see the pattern of endoscopic findings in patients still having H. pylori infection after standard triple therapy for H. pylori were also a objective. Eighty nine consecutive patients, aged 15-60 years and of both genders, coming to the gastroenterology outpatient department with the symptoms suggestive of peptic ulcer disease and dyspepsia were included and H. pylori status was defined as positive if both rapid urease test & histopathology were positive. As found in this study, H. pylori was associated with 90% of duodenal ulcers and 80% of gastric ulcers. H. pylori eradication rate was 69%. Healing rate of duodenal ulcer and gastric ulcer after standard triple therapy for 14 days were 80% and 78% respectively. Adequate ulcer healing was achieved in this study despite relatively low eradication rate. Follow-up for additional period is required for recurrence of ulcer in 84 patients whose peptic ulcer disease had resolved but could not attain H. pylori eradication and H. pylori eradicated patients who are still having ulcer at endoscopy DOI: http://dx.doi.org/10.3329/bmj.v43i2.21388 Bangladesh Med J. 2014 May; 43 (2): 84-89

Almagate suspension in combination with esomeprazole for duodenal ulcer patients positive in Helicobacter pylori

Objective To observe the effect of almagate suspension in combination with esomeprazole for duodenal ulcer patients positive in Helicobacter pylori.Methods 124 duodenal ulcer patients positive in Helicobacter pylori were randomized into two groups.The control group was given esomeprazole alone after 7-day's anti-H.pylori triple therapy including esomeprazole,amoxicillin,and clarithromycin.The treatment group was treated with the same therapy plus almagate suspension.Four weeks after the treatment.both groups returned to recheck the duodenal ulcer healing by gastroscope.14C-urea breath test was (rechek) four weeks after the end of the treatment.The ulcer healing rates,total effective rates,and H.pylori eradication rates were compared between the two groups.Results There was no statistical difference in the duodenal ulcer healing rate between these two groups (61.29％ vs.66.13％,P ＞ 0.05).There was statistical difference in the duodenal ulcer total effective rate between these two groups (82.26％ vs.95.16％,x 2=5.153,P ＜ 0.05).There was no statistical difference in the duodenal ulcer H.pylori eradication rate between these two groups (82.26％ vs.79.03％,P ＞ 0.05).Conclusions Almagate suspension in combination with esomeprazole is a more effective therapy method for duodenal ulcer patients positive in Helicobacter pylori than esomeprazole alone. Key words: Duodenal ulcer; Helicobacter pylori; Almagate suspension; Esomeprazole

Ghrelin accelerates the healing of cysteamine-induced duodenal ulcers in rats

SummaryBackgroundPrevious studies have shown that administration of ghrelin exhibits protective and therapeutic effects in the gut. The aim of the present investigation was to examine the influence of ghrelin administration on the course of cysteamine-induced duodenal ulcers, as well as effects on mucosal production of oxygen free radicals and duodenal antioxidant defense.Material/MethodsDuodenal ulcers were induced in male Wistar rats by cysteamine administered intragastrically at the dose of 200 mg/kg in 1 ml of saline, 3 times at 4-h intervals. Starting 24 h after the first dose of cysteamine, rats were treated intraperitoneally twice a day with saline or ghrelin given at the dose of 4, 8 or 16 nmol/kg/dose. Seven days after administration of the first dose of cysteamine, the study was terminated.ResultsInduction of ulcers by cysteamine was accompanied by a reduction in duodenal blood flow, mucosal DNA synthesis and mucosal activity of superoxide dismutase (SOD); whereas mucosal concentration of interleukin-1β and malonyldialdehyde (MDA – an index of lipid peroxidation) were increased. Treatment with ghrelin increased healing rate of duodenal ulcers and enhanced duodenal blood flow, mucosal DNA synthesis and mucosal activity of SOD, and reduced mucosal concentration of interleukin-1β and MDA.ConclusionsTreatment with ghrelin increases the healing rate of duodenal ulcers and this effect is related, at least in part, to improvement of duodenal mucosal blood flow, mucosal cell proliferation and antioxidant defense, as well as being related to reduction in mucosal oxidative stress and inflammatory response.

Is ranitidine therapy sufficient for healing peptic ulcers associated with non-steroidal anti-inflammatory drug use?

Long-term use of non-steroidal anti-inflammatory drugs (NSAIDs) increases the risk of serious gastroduodenal events. To minimise these risks, patients often require concomitant acid-suppressive therapy. We conducted a literature review of clinical trials examining use of ranitidine 150 mg twice daily to heal gastroduodenal ulcers (GU) in NSAID recipients. Seven studies were identified. After 8 weeks’ treatment with ranitidine, GU healing rates ranged from 50% to 74% and rates of duodenal ulcer (DU) healing ranged from 81% to 84%. Ranitidine was more effective when NSAIDs were discontinued (healing rates reaching 95% and 100%, respectively). The ulcer healing rate with sucralfate was similar to that of ranitidine. However, proton pump inhibitor (PPI) therapy was associated with significantly greater rates of both GU and DU healing than ranitidine; 8-week GU rates were 92% and 88% with esomeprazole 40 mg and 20 mg, respectively (vs. 74% with ranitidine, p < 0.01). For omeprazole, 8-week healing rates were 87% with omeprazole 40 mg and 84% with omeprazole 20 mg (vs. 64% for ranitidine, p < 0.001), and for lansoprazole the corresponding values were 73–74% and 66–69% for the 30 mg and 15 mg doses, respectively (vs. 50–53% for ranitidine, p < 0.05). In the PPI study reporting DU healing the values were 92% for omeprazole 20 mg (vs. 81% for ranitidine, p < 0.05) and 88% for omeprazole 40 mg (p = 0.17 vs. ranitidine). NSAID-associated GU are more likely to heal when patients receive concomitant treatment with a PPI rather than ranitidine.

Management of gastroduodenal ulcers and gastrointestinal symptoms associated with nonsteroidal anti-inflammatory drug therapy: A summary of four comparative trials with omeprazole, ranitidine, misoprostol, and placebo

Background: Nonsteroidal anti-inflammatory drugs (NSAIDs) are effective in the treatment of systemic diseases such as rheumatoid arthritis but are associated with a range of adverse gastrointestinal (GI) side effects, including dyspepsia, peptic ulcer, and ulcer complications. Several studies have compared the relative efficacy and tolerability of omeprazole, ranitidine, and misoprostol in the management of NSAID-associated GI adverse events. Objective: The purpose of this paper is to summarize and evaluate the results of 4 clinical studies that compared the efficacy and tolerability of omeprazole, misoprostol, and ranitidine in the acute and maintenance treatment of NSAID-associated gastroduodenal ulcers and GI symptoms. Methods: The 4 trials, which included 1822 patients being treated continuously with NSAIDs, studied omeprazole (20 and 40 mg once daily) as acute treatment for healing gastroduodenal ulcers and erosions and as prophylaxis (20 mg once daily) over 3 to 6 months. Comparators were misoprostol 200 μg 4 times daily or ranitidine 150 mg twice daily in the acute phases and misoprostol 200 μg twice daily, ranitidine 150 mg twice daily, or placebo in the prophylactic phases. Results: Gastric and duodenal ulcer healing rates were higher with omeprazole than with either misoprostol ( P = 0.004 for gastric ulcers; P < 0.001 for duodenal ulcers) or ranitidine ( P < 0.001 for gastric ulcers; P = 0.032 for duodenal ulcers). A significantly larger percentage of patients taking misoprostol had the number of gastric or duodenal erosions reduced from >10 to <5 compared with patients taking omeprazole ( P < 0.001), whereas a significantly larger percentage of patients taking omeprazole achieved the same reduction in number of erosions compared with patients taking ranitidine ( P = 0.008). More patients taking omeprazole remained in remission than patients taking misprostol ( P = 0.001), ranitidine ( P = 0.004), or placebo ( P < 0.001). More patients taking misoprostol (16.9%) or ranitidine (14.1%) discontinued treatment because of adverse events, lack of efficacy, or other reasons compared with patients taking omeprazole (9.9% and 10.2% in 2 studies). Conclusions: Omeprazole was more effective in healing and prophylaxis of NSAID-associated gastroduodenal ulceration and symptoms than misoprostol and ranitidine in chronic NSAID users, and was better tolerated than misoprostol.

Lansoprazole-based triple therapy versus ranitidine bismuth citrate-based dual therapy in the eradication of Helicobacter pylori in patients with duodenal ulcer: a multicenter, randomized, double-dummy study

Background: The optimal treatment regimen for eradication of Helicobacter pylori in patients with duodenal ulcer has yet to be determined. Based on a search of MEDLINE ® no studies have been performed comparing a proton pump inhibitor-based triple therapy regimen with a ranitidine bismuth citrate (RBC)—based dual therapy regimen, both containing clarithromycin. Objective: This study was undertaken to compare the efficacy of lansoprazole (LAN)-based triple therapy with that of RBC-based dual therapy in H pylori—infected patients with duodenal ulcer. Methods: Patients were randomized to receive either 1 week of triple therapy with LAN 30 mg BID, clarithromycin 500 mg BID, and tinidazole 500 mg BID, followed by 3 weeks of LAN 30 mg BID, or 2 weeks of dual therapy with RBC 400 mg BID plus clarithromycin 500 mg BID, followed by 2 weeks of RBC 400 mg BID. Eradication of H pylori was defined as negative results on both the urease quick test and histologic examination ≥4 weeks after the end of treatment. Duodenal healing and recurrence rates were assessed endoscopically at 8 weeks and 6 months. A per-protocol (PP) analysis was conducted for each efficacy end point. Also conducted were an intent-to-treat (ITT) analysis in which patients with missing data were considered failures, and an observed analysis (OBS), which included patients with an evaluable result after treatment, regardless of compliance. Results: One hundred eighty-five patients (126 men, 59 women; age range, 18–76 years; mean age, 43 years) were enrolled and randomized to treatment. In the LAN and RBC groups, respectively, H pylori eradication rates were 92.6%, 93.1%, and 72.8% versus 78.6%, 77.9%, and 64.5% in the PP ( P = 0.02), OBS ( P = 0.01), and ITT analyses. The corresponding duodenal ulcer healing rates were 98.6%, 98.7%, and 83.7% versus 90.8%, 91.5%, and 81.7%; these differences were not statistically significant. Side effects were mild, occurring in 20.7% of LAN patients and 17.2% of RBC patients. Ulcer recurred in 2 RBC patients. No difference was observed between treatments in terms of the occurrence of gastritis or improvement of symptoms. Conclusion: Based on the results of the PP and OBS analyses, LAN-based triple therapy was superior to RBC-based dual therapy for the eradication of H pylori in patients with duodenal ulcer.

Efficacy observation on Yunnan Baiyao ("Equation missing" ) combined with antibiotics in treating Helicobacter pylori related duodenal ulcer) combined with antibiotics in treating Helicobacter pylori related duodenal ulcer

Objective: To observe the clinical efficacy of Yunnan Baiyao ( , YNBY) combined with antibiotics in treating Helicobacter pylori (HP) related duodenal ulcer (DU).Methods: Eighty-two HP positive DU patients were randomly divided into two groups: Treated group (44 cases) used YNBY plus amoxicillin and metronidazole; control group (38 cases) used de-nol plus amoxicillin and metronidazole).Results: After a 2-week treatment course, the effect of epigastric pain relief was 68.3% in treated group, and 44.4% in control group, the difference between them was significant (P < 0.05). Marked effect in acid regurgitation and belching relief was observed in both groups. The rate of DU healing in treated and control group was respectively 88.6% and 89.5%; the clearance of HP 84.1% and 89.5%; and the side-effects 4.5% and 13.5%, with insignificant difference between these two groups.Conclusion: YNBY combined with antibiotics in treating DU, and clearance of HP is an economic, safe and effective therapy.

One-Week Triple Regime Therapy Consisting of Pantoprazole, Amoxicillin and Clarithromycin for Cure of Helicobacter pylori-Associated Upper Gastrointestinal Diseases

This study was designed to determine the efficacy and safety of 1-week triple therapy regime consisting of pantoprazole, amoxicillin and clarithromycin in the cure of Helicobacter pylori infection leading to duodenal ulcer disease and/or gastritis. Sixty-one patients (47 males, 14 females with a mean age of 34 years) belonging to different ethnic groups suffering from H. pylori-associated duodenal ulcer and/or gastritis for an average of 2.46 years were recruited. Having satisfied primary selection criteria, patients received pantoprazole 40 mg b.i.d., clarithromycin 500 mg b.i.d. and amoxicillin 1,000 mg b.i.d. for 7 days. All medications were stopped there after H. pylori eradication was determined 4–6 weeks after treatment by a repeat endoscopy, a rapid urease test, H. pylori culture and histology assessment as indicators of cure. All three tests must be negative to consider the infection to have been successfully eradicated. Fifty-seven patients completed the efficacy analysis per protocol. Dramatic symptomatic improvement was noted in most patients immediately after stopping treatment and it was sustained at 6 weeks. At the end of the study, the healing rate of duodenal ulcers (complete re-epithelialization) following 1-week treatment only, as indicated above, and without any maintenance therapy was 66.7%, that of gastritis was 55.7%, and that of erosions was 64.3%. The overall eradication rate for H. pylori, however, was 93% (95% CI 83.0–98.1%). Furthermore, histologic evaluation revealed a remarkable resolution in the activity of gastritis in all the patients who had successful eradication of the infection.

Quality of life in duodenal ulcer treatment: A comparison of omeprazole and ranitidine in acute and intermittent treatment

This study aimed to compare omeprazole 20 mg each morning and ranitidine 300 mg at 6 pm in the acute treatment of duodenal ulcer and during 12-month's follow-up with intermittent on-demand treatment. Symptomatic relapse was treated with the same drug as initial treatment for two or, if needed, four, or eight weeks. The study was randomized and double-blind. Changes in quality of life and healing rale were the criteria of outcome. Disease specific symptoms were evaluated with the Ulcer Esophagitis Subjective Symptoms Scale (UESS) and the Gastrointestinal Symptom Rating Scale (GSRS), general body symptoms with the Complaint Score (CS) and general wellbeing with the Psychological General Wellbeing Index (PGWB). In the healing part of up to four weeks of treatment, 393 patients were included. Pre-treatment mean quality of life scores were low but rose to significantly higher values in both groups after two weeks' treatment and during follow-up. No between-groups differences were found. Healing at two weeks was significantly better in the omeprazole group, 67% versus 57% in the ranitidine group (p = 0.05). A total of 353 patients entered the follow-up study. No statistically significant difference in relapse rate was noted. Omeprazole 20 mg o. d (in the morning) is superior to ranitidine 300 mg o. d. (6 pm) in two-week duodenal ulcer healing rate, but patients' quality of life, which was low before diagnosis, normalized with both treatment regimens.

Cure of Helicobacter pylori infection and healing of duodenal ulcer: comparison of pantoprazole-based one-week modified triple therapy versus two-week dual therapy

Objective: Eradication of Helicobacter pylori ( H. pylori) is recommended as the first-line therapeutic concept for reliable long-term prevention of duodenal ulcer (DU) relapse. Current treatment regimens vary in efficacy, complexity, and compliance. To assess the efficacy of pantoprazole in H. pylori eradication in parallel groups of patients using two eradication regimens. Methods: Patients, (18–85 yr old; intention-to-treat, n = 286) with proven DU, positive rapid urease test (biopsy), and 13C-urea breath test (UBT) were included in a prospective, randomized, multicenter study. Modified triple therapy consisted of 40 mg pantoprazole b.i.d., 500 mg clarithromycin t.i.d., and 500 mg metronidazole t.i.d. for 7 days (PCM therapy); dual therapy consisted of 40 mg pantoprazole b.i.d. and 500 mg clarithromycin t.i.d. for 14 days (PC therapy). In both groups 40 mg pantoprazole o.d. was given until day 28 when healing of DU was evaluated endoscopically; H. pylori status was assessed by UBT on day 56. Results: H. pylori eradication rate was 95% in PCM versus 60% in PC therapy groups (per-protocol population, p < 0.001), and 82% in PCM versus 50% in PC therapy in the intention-to-treat patient population ( p < 0.001). The DU healing rate was 98% in the PCM and 95% in the PC therapy groups (per-protocol population). Both regimens were similarly well tolerated. Adverse events in both regimens included taste disturbance, diarrhea, and increased serum concentration of liver enzymes, at an incidence of < 10%. Conclusions: Compared to 2-wk PC therapy (pantoprazole and clarithromycin), the 1-wk PCM therapy (pantoprazole, clarithromycin, and metronidazole) is a significantly superior and highly promising strategy for eradication of H. pylori.

Ranitidine bismuth citrate in the treatment of Helicobacter pylori infection and duodenal ulcer.

To review the clinical pharmacology of ranitidine bismuth citrate in the treatment of Helicobacter pylori (HP) infection and duodenal ulcer. A MEDLINE search of the English-language literature from 1992 to January 1997 was conducting using the key terms Tritec, ranitidine, and bismuth. References of articles pertaining to treatment of duodenal ulcer or HP were extensively searched for relevant sources. All articles pertaining to ranitidine bismuth citrate were considered for inclusion, with emphasis placed on randomized, double-blind trials. Priority was placed on data pertaining to regimens that are currently approved by the Food and Drug Administration for the treatment of duodenal ulcer in conjunction with HP. Each tablet of ranitidine bismuth citrate 400 mg contains 162 mg of ranitidine base, 128 mg of trivalent bismuth, and 110 mg of citrate. It uses the acid-suppressive actions of ranitidine and the antimicrobial and mucosal protective effects of bismuth to eradicate HP. Ranitidine bismuth citrate in conjunction with clarithromycin represents one of four treatment regimens currently approved in the US for duodenal ulcer associated with HP infection. In four double-blind, randomized trials, this agent has achieved HP eradication rates of 73-94% and duodenal ulcer healing rates of 73-89%. It is given twice daily for 28 days, and is associated with very low rates of adverse effects. Relative to some therapeutic alternatives, ranitidine bismuth citrate plus clarithromycin may be simpler to take and have less adverse effects, but may be more expensive. Compared with omeprazole plus clarithromycin, it is less expensive, may have lower ulcer healing rates, but may be more effective in eradicating HP. The role of ranitidine bismuth citrate will continue to evolve as more patients are treated, and other regimens continue to be tested for duodenal ulcer healing and HP eradication.

Ranitidine bismuth citrate with clarithromycin given twice daily effectively eradicates helicobacter pylori and heals duodenal ulcers

Objective: Ranitidine bismuth citrate (RBC) b.i.d. with Clarithromycin q.i.d. eradicates Helicobacter pylori (H. pylori) in 82–94% of patients, and heals duodenal ulcers in 88–90% of patients. This double blind, placebo-controlled study examines the efficacy of a simpler b.i.d. treatment regimen, and examines the potential benefit of including a second antibiotic, metronidazole, to the b.i.d. treatment regimen. Methods: A total of 648 patients with active duodenal ulcer received RBC 400 mg b.i.d. for 4 wk, coprescribed with Clarithromycin 250 mg q.i.d., Clarithromycin 500 mg b.i.d., or Clarithromycin 500 mg b.i.d. with metronidazole 400 mg b.i.d. for the first 2 wk of treatment. Endoscopies were performed prestudy, after 4 wk of treatment, and at least 4 wk posttreatment. H. pylori status was assessed by CLOtest, 13C-urea breath test (UBT), and histology prestudy, and by UBT and histology at least 4 wk posttreatment. Adverse events were recorded at each visit. Results: All three regimens were highly effective and well tolerated. H. pylori eradication rates were 84–94% and duodenal ulcer healing rates were 92–96% (observed data). Highest H. pylori eradication and ulcer healing rates were achieved with RBC 400 mg b.i.d. with Clarithromycin 500 mg b.i.d. Conclusion: Ranitidine bismuth citrate with Clarithromycin 500 mg b.i.d. provides an effective, simple and well tolerated regimen for the eradication of H. pylori and healing of duodenal ulcers.

Ranitidine Bismuth Citrate With Clarithromycin Given Twice Daily Effectively Eradicates Helicobacter pylori and Heals Duodenal Ulcers

Ranitidine bismuth citrate (RBC) b.i.d. with clarithromycin q.i.d. eradicates Helicobacter pylori (H. pylori) in 82-94% of patients, and heals duodenal ulcers in 88-90% of patients. This double blind, placebo-controlled study examines the efficacy of a simpler b.i.d. treatment regimen, and examines the potential benefit of including a second antibiotic, metronidazole, to the b.i.d. treatment regimen. A total of 648 patients with active duodenal ulcer received RBC 400 mg b.i.d. for 4 wk, coprescribed with clarithromycin 250 mg q.i.d., clarithromycin 500 mg b.i.d., or clarithromycin 500 mg b.i.d. with metronidazole 400 mg b.i.d. for the first 2 wk of treatment. Endoscopies were performed prestudy, after 4 wk of treatment, and at least 4 wk posttreatment. H. pylori status was assessed by CLOtest, 13C-urea breath test (UBT), and histology prestudy, and by UBT and histology at least 4 wk posttreatment. Adverse events were recorded at each visit. All three regimens were highly effective and well tolerated. H. pylori eradication rates were 84-94% and duodenal ulcer healing rates were 92-96% (observed data). Highest H. pylori eradication and ulcer healing rates were achieved with RBC 400 mg b.i.d. with clarithromycin 500 mg b.i.d. Ranitidine bismuth citrate with clarithromycin 500 mg b.i.d. provides an effective, simple and well tolerated regimen for the eradication of H. pylori and healing of duodenal ulcers.

Randomized clinical trial comparing two one-week triple-therapy regimens for the eradication of Helicobacter pylori infection and duodenal ulcer healing

Objective: One-week triple therapy has been shown to be effective in Helicobacter pylori eradication and duodenal ulcer healing. However, the optimal therapeutic combination has not yet been identified. Bismuth-containing regimens have the advantage of requiring only one antibiotic. It has been suggested that high doses of omeprazole improve the bactericidal efficacy of antimicrobial regimens against H. pylori. We evaluated the efficacy of two 1-wk triple-therapy regimens for H. pylori eradication and duodenal ulcer healing. Methods: On an intention-to-treat basis, 182 patients with H. pylori-associated duodenal ulcer were randomized. Group OCB patients (n = 91) were given omeprazole 40 mg b.i.d., clarithromycin 500 mg b.i.d., and colloidal bismuth subcitrate 120 mg q.i.d. for 7 days. Group OCA patients (n = 91) were treated with omeprazole and clarithromycin at the same doses plus amoxicillin 1 g b.i.d., also for 7 days. Endoscopies were performed at entry and at 4 wk after the end of treatment. The presence of H. pylori was assessed by urease test, histology, Gram stain, and culture. No patient received follow-up treatment. Results: H. pylori eradication rates achieved in the OCB and OCA groups were similar whether by intention-to-treat (82.4% vs 88.9%; p = 0.21) or per protocol analysis (83.3% vs 89.9%; p = 0.19). Duodenal ulcer healing rates also were the same for OCB and OCA in intention-to treat (91.2% vs 91.1%) and per protocol analysis (92.2% vs 92.1%), respectively ( p = 0.98). Conclusions: High rates of H. pylori eradication and duodenal ulcer healing were obtained with both short-treatment regimens, which were safe and well-tolerated. Colloidal bismuth subcitrate seems to be a good alternative to amoxicillin in the triple-therapy combination with omeprazole and clarithromycin. The omeprazole dose does not seem to play a major role in H. pylori eradication in these therapeutic combinations.

DOES SMOKING INFLUENCE THE ERADICATION OF HELICOBACTER PYLORI AND DUODENAL ULCER HEALING WITH DIFFERENT REGIMENS?

SUMMARYTo determine the effect of smoking on Helicobacter pylori eradication and ulcer healing, we investigated 232 patients with H. pylori‐positive duodenal ulcer. Patients were given one of seven different treatment protocols and divided into three groups according to smoking habits. Group 1 (n=128) consisted of non‐smokers, group 2 (n=65) of mild smokers (5‐20 cigarettes/day) and group 3 (n=39) of heavy smokers (&gt;20/day). The eradication of H. pylori and ulcer healing rate was controlled eight weeks later after ceasing the therapy. The overall eradication rate was 66% in all patients and 68%, 66%, 59% in each group, respectively. The eradication rates showed no statistical difference between groups. Complete ulcer healing was achieved in 84% of all patients and ulcer healing rate between groups did not show any significance (85%, 83% and 82% respectively). These results suggest that smoking status does not influence the eradication of H. pylori and duodenal ulcer healing rates at eight weeks in patients on different treatment schedules.

Endogenous zinc concentrations in cysteamine-induced duodenal ulcers in the rat.

Exogenously administered zinc compounds have been shown to possess anti-ulcer activity against a wide variety of ulcerogenic agents, both in laboratory animal models and in human peptic ulcer disease. However, a strong possibility exists that endogenous zinc may also play an important role during noxious events by various mechanisms. Therefore, the aim of this study was to focus on the changes of endogenous zinc serum and tissue concentrations in cysteamine-induced duodenal lesions. We used atomic absorption spectrophotometry to determine the tissue and serum concentrations of zinc in normal (control) rats and those with cysteamine-induced duodenal ulcers. The results obtained in this study indicated that the onset, development and spontaneous healing of ulcer lesions were associated with certain shifts in zinc serum and tissue concentrations. Prior to ulcer formation, a significant increase was noted in serum zinc values. With the onset of duodenal lesions, zinc serum concentrations significantly decreased, while there was a significant increase in duodenal tissue concentrations when compared to healthy control animals. Zinc tissue concentrations decreased and returned to starting values by the end of the first week of spontaneous healing. This decrease in zinc tissue concentration corresponded to the healing rate of the duodenal ulcers. Serum zinc concentrations also returned to starting values within the first week period. These observations indicate and confirm that zinc could play an important role in duodenal ulcer disease and represent a natural defense system in the body.

Eradication of Helicobacter pylori infection.

Helicobacter pylori is probably the most common bacterial infection worldwide and the accepted cause of chronic active gastritis. It has a critical role in duodenal ulcer, where the prevalence of infection is 90-95%. There is a dramatic reduction in the rate of ulcer recurrence after successful eradication of the organism to about 4% per annum compared with up to 80% when the infection persists. What is true for duodenal ulcers is also true for patients with gastric ulcer who are infected with H. pylori. The risk of recurrent ulcer complications with bleeding is virtually abolished following successful eradication of H. pylori; in contrast, the risk of rebleeding is about 33% in patients still harboring the organism. The treatment of H. pylori infection in patients with confirmed peptic ulcer on first presentation or recurrence has been advocated by a Consensus Conference of the National Institutes of Health. The most evaluated regimens include dual therapy with a proton pump inhibitor and either amoxicillin or clarithromycin, and bismuth-based triple therapy with metronidazole and tetracycline. The use of a proton pump inhibitor-containing regimen offers the advantage of rapid symptom relief and the highest rates of duodenal ulcer healing. Moreover, combinations of a proton pump inhibitor and clarithromycin show more predictable and higher eradication rates than amoxicillin combinations. Newer triple therapies with a proton pump inhibitor plus two antibacterial agents given for 7-1O days are being increasingly described and may become the treatment of choice if initial results are confirmed. However, the optimum dosage regimen needs to be established. A new combination of ranitidine bismuth citrate and clarithromycin has also recently been shown to be effective. At this time it is reasonable to consider all patients with confirmed duodenal or gastric ulcer for eradication of H. pylori, and no patient should be considered for elective surgery without first being offered eradication therapy.

GR122311X (ranitidine bismuth citrate), a new drug for the treatment of duodenal ulcer

Ranitidine bismuth citrate (GR122311X) is a new drug which offers potential benefits in healing duodenal ulcers and prevention of relapse. This randomized, multi-centre double-blind study of 1620 patients compared the effect of 4 weeks of treatment with GR122311X 200 mg b.d. (n = 401), 400 mg b.d. (n = 404) or 800 mg b.d. (n = 404) or ranitidine hydrochloride 150 mg b.d. (n = 411) on the rates of duodenal ulcer healing and of overall success (ulcers healed and remaining ulcer free in the 24-week follow-up phase). All four treatments were equally effective at ulcer healing (79%, 85%, 84% and 81% of patients, respectively). GR122311X 400 mg b.d. (38%) and 800 mg b.d. (37%) were significantly more effective than ranitidine hydrochloride 150 mg b.d. (32%) with respect to overall success (P = 0.050 and P = 0.030, respectively) but there was no difference with GR122311X 200 mg b.d. (31%). GR122311X caused effective, dose-related suppression of H. pylori (47%, 61% and 74%); H. pylori eradication rates were 18%, 21% and 22%. GR122311X was safe and well tolerated, with an adverse event profile similar to that of ranitidine hydrochloride 150 mg b.d. Median week 4 trough plasma bismuth levels were 1.3 ng/mL, 2.3 ng/mL and 3.3 ng/mL with GR122311X 200 mg b.d., 400 mg b.d. and 800 mg b.d. respectively. No individual plasma bismuth concentrations were of clinical concern. GR122311X is a safe and effective ulcer healing drug, and provides a platform on which anti-H. pylori therapy can be based.