Bismuth subnitrate powder

BackgroundIn the eradication of Helicobacter pylori, the efficacy of bismuth remains inconclusive. We aimed to compare the efficacy of bismuth on various H. pylori eradication regimens.MethodsRandomized controlled trials were collected to compare the efficacy of bismuth to nonbismuth regimens in H. pylori eradication. We pooled information to study eradication, adverse events, and drug compliance. In addition, subgroup analyses for eradication efficacy were performed according to high or low clarithromycin-resistance area, bismuth drug form, and amount of bismuth element.ResultsRecords for a total of 2506 patients in 15 trials from 13 randomized controlled studies were included. The eradication of H. pylori was superior when bismuth compared to nonbismuth regimen (odds ratio [OR] = 1.63, 95% confidence interval [CI], 1.33-2.00 in intention-to-treat [ITT]; OR = 2.05, 95% CI, 1.58-2.68 in per-protocol [PP] analyses), without significant difference in drug compliance or adverse events. Bismuth regimens in the high clarithromycin resistance area tend to enhance the eradication rate (OR = 1.66, 95% CI, 1.34-2.05 in ITT; OR = 2.22, 95% CI, 1.67-2.95 in PP analyses). Bismuth potassium citrate and bismuth subcitrate were more effective drug forms in regard to eradication rate. Bismuth at a dosage of ConclusionsBismuth to the H. pylori eradication regimens achieve a higher eradication rate, especially in the high clarithromycin resistance area. It could be an eradication option achieving sufficient resistance rates without increasing antibiotic resistance, side effects, or poor compliance.

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This study aimed to evaluate the efficacy of adding bismuth to conventional triple therapy (modified bismuth quadruple therapy [mBQT]) for Helicobacter pylori treatment-naïve patients in an era of increasing eradication failure. We performed a comprehensive literature search up to December 2024 using PubMed, Embase, and the Cochrane Library to investigate mBQT's benefits. The comparative treatments were as follows: (1) triple therapy without bismuth (TT), (2) non-BQTs (sequential and concomitant), and (3) classic BQT (cBQT) containing metronidazole and tetracycline. Randomized controlled trials (RCTs) were analyzed to compare eradication rates, adverse drug events, and patient compliance between the mBQT and comparison groups. In total, 9162 and 8449 patients from 43 trials in 35 RCTs were included in the intention-to-treat and per-protocol analyses, respectively. The mBQT group had a superior pooled eradication rate compared to the TT group (84.8% vs. 74.1%, p p = 0.55, and OR = 1.09 [0.83-1.43] in the non-BQT group; 81.5% vs. 83.0%, p = 0.36, and OR = 0.84 [0.59-1.21] in the cBQT group). Regarding adverse drug events, there was no significant difference between the mBQT and comparison groups (25.4% vs. 27.5%, p = 0.53, and OR = 0.95 [0.80-1.12]). The subgroup analysis showed that patient adherence to mBQT was significantly higher than to cBQT (96.4% vs. 93.3%, p = 0.004, and OR = 1.83 [1.21-2.77]). Our meta-analysis showed that mBQT was an effective and tolerable first-line therapy for H. pylori eradication.

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IntroductionThis meta-analysis aims to compare the efficacy and safety of vonoprazan-amoxicillin (VA) dual therapy in comparison to bismuth-containing quadruple therapy (BQT) for patients with Helicobacter pylori (H. pylori) infection.Materials and methodsFour databases (PubMed, Embase, Web of Science, and Cochrane Library) were searched published from establishment of database to June 1, 2024, for articles studying VA dual therapy compared to BQT for patients with H. pylori infection. Meta-analyses of eradication rates, adverse events, compliance and cost were preformed.ResultsA total of 17 studies were included for meta-analysis. Compared with BQT, VA increased the incidence of H. pylori eradication rate, with significant difference under the ITT analysis (86.9% vs. 80.4%, RR = 1.07, 95% CI: 1.01-1.12, p = 0.01) but there no significant difference under the PP analysis (90.7% vs. 86.5%, RR = 1.03, 95% CI: 0.99-1.08, p = 0.13). Besides, VA significantly increased compliance (RR = 1.03, 95% CI: 1.01-1.05, p p ConclusionOur findings indicated that VA dual therapy provided a higher eradication rate, enhanced compliance, decreased adverse events, and lowered cost relative to BQT for patients with H. pylori infection.Systematic review registrationhttps://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42024576738, identifier CRD42024576738 (PROSPERO).

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Background and aimsThe eradication of Helicobacter pylori (H. pylori) reduces the incidence of gastric cancer. However, the efficacy of the widely used triple therapy for eradicating H. pylori has progressively reduced. This may have resulted from the increase in clarithromycin resistance in recent years. Recent guidelines recommend the use of bismuth quadruple therapy (BQT) as first-line eradication therapy for H. pylori infection in areas with high (>15%) or unknown clarithromycin resistance. However, the eradication rates of proton pump inhibitor (PPI)-based BQT remain below the required standard. This systematic review aimed to evaluate the use of novel acid suppressant (potassium-competitive acid blocker [P-CAB])-based BQT compared with PPI-based BQT for H. pylori eradication.MethodsA systematic review and network meta-analysis were conducted using the PubMed, Cochrane Library, ProQuest, and Scopus databases, along with randomized controlled trials comparing P-CAB-based and PPI-based BQT for H. pylori eradication.ResultsIntention-to-treat analysis showed a pooled risk ratio (RR) of 1.04 (95% confidence interval: 1.02-1.06, I2 = 0) and per-protocol set analysis yielded an RR of 1.04 (95% confidence interval: 1.01-1.07, I2 = 0), favoring P-CAB-based BQT with minimal heterogeneity. Seven studies (n = 2222) reported no significant difference in adverse events (RR: 1.06 [0.99-1.14, I2 = 30.6%]).ConclusionMeta-analysis showed the P-CAB-based BQT had slightly higher efficacy than PPI-based BQT. However, network meta-analysis revealed that vonoprazan-based BQT did not show superiority over esomeprazole-based BQT. Therefore, tailored therapies based on local resistance patterns remain critical considerations in clinical practice.

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BackgroundIn Tunisia, concomitant quadruple therapy (QTC) has been the standard first-line treatment for Helicobacter pylori (H. pylori) infection. However, increasing resistance to clarithromycin (28%) has raised concerns about its long-term efficacy. Bismuth-based quadruple therapy (QTB) offers an alternative, yet its higher cost and safety profile remain debated. This study aimed to compare the efficacy, safety, and cost of both regimens.MethodsWe conducted a prospective, randomized, open-label study enrolling 200 patients naïve to any anti-HP treatment. Patients were randomized to either 10 days of bismuth therapy (QTB: potassium bismuth subcitrate, metronidazole, and tetracycline hydrochloride, omeprazole) or 14 days of concomitant quadruple therapy (QTC: amoxicillin, clarithromycin, metronidazole, esomeprazole). H. pylori eradication as defined by a negative urea breath test 4-6 weeks after treatment.ResultsAmong 200 patients, the intention-to-treat eradication rate was 82% for QTC and 87% for QTB (p = 0.29); per-protocol rates were 84.53% and 89.58%, respectively (p = 0.39). Compliance was high (97% in QTC vs 96% in QTB; p = 0.32). Adverse events were similar between groups (61.85% for QTB vs 69% for QTC; p = 0.29).ConclusionBismuth and concomitant quadruple therapies were comparable in terms of efficacy and safety but didn't achieve the accepted minimum eradication rate (90%).

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Background/aimsThe eradication efficacy of proton pump inhibitor (PPI)-based standard triple therapy (STT) for Helicobacter pylori infection has declined in Korea, largely because of increasing clarithromycin resistance. High-dose dual therapy (HDDT) using potent acid suppression represents a promising clarithromycin-sparing strategy. This study evaluated the efficacy and safety of fexuprazan-based modified HDDT (m-HDDT) including bismuth, compared with conventional PPI-based STT as first-line eradication therapy.MethodsThis prospective, multicenter, randomized, open-label, non-inferiority trial was conducted at eight tertiary hospitals in Korea. Treatment-naïve adults with confirmed H. pylori infection were randomized to receive either m-HDDT (fexuprazan 40 mg twice daily, amoxicillin 1000 mg three times daily, and bismuth subcitrate potassium 300 mg three times daily) or STT (lansoprazole 30 mg, amoxicillin 1000 mg, and clarithromycin 500 mg, all twice daily) for 14 days. Eradication was assessed by urea breath test 4-8 weeks after therapy. The primary endpoint was the eradication rate in the full analysis set (FAS), with a prespecified non-inferiority margin of -10%. Safety and compliance were evaluated as secondary outcomes.ResultsIn total, 196 patients were included in the FAS (m-HDDT, n = 96; STT, n = 100). Helicobacter pylori eradication was achieved in 81.3% of patients in the m-HDDT group and 79.0% in the STT group, demonstrating non-inferiority of m-HDDT (one-sided Wald test, p = 0.0158). Per-protocol analysis yielded consistent results (p = 0.0215). Drug compliance was high in both groups, with mean compliance rates of 97.0% in the m-HDDT group and 99.0% in the STT group; more than 95% of patients in each group achieved ≥ 80% compliance. The incidence of treatment-emergent adverse events was comparable between groups (16.7% vs. 14.0%); most events consisted of mild gastrointestinal symptoms. No serious adverse events or treatment discontinuations due to adverse events were observed in either group.ConclusionsFexuprazan-based m-HDDT with bismuth was non-inferior to PPI-based STT for H. pylori eradication and demonstrated comparable safety and excellent compliance. This clarithromycin-sparing regimen can be considered an alternative treatment option in regions with high macrolide resistance.

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BackgroundTo achieve eradication rates > 90%, the ESPGHAN/NASPGHAN guidelines for pediatric Helicobacter pylori infection recommend tailored antimicrobial therapy using sufficiently high doses over 10-14 days. However, prolonged treatment often leads to suboptimal compliance in children, which is a major contributor to reduced eradication rates. To address this, we evaluated the efficacy and safety of a shorter, 7 day triple therapy with bismuth compared with the 14 day standard triple therapy without bismuth in H. pylori infected children.Materials and methodsFrom 2020 to 2024, we carried out a randomized controlled trial involving treatment-naïve children and adolescents (5-18 years old) with confirmed H. pylori infection. Eligible participants were randomly allocated to receive either a 7 day triple therapy with bismuth (bismuth subcitrate, a proton pump inhibitor [PPI], amoxicillin, plus clarithromycin/metronidazole) or a 14 day standard triple therapy (a PPI, amoxicillin, plus clarithromycin/metronidazole) without bismuth. Two months after completing therapy, treatment success was determined using either a two-step monoclonal stool antigen assay or a urea breath test. Any adverse events were documented using a structured questionnaire.ResultsSeventy-three children were enrolled in the study. In the intention-to-treat analysis, eradication was achieved in 91% of children treated with the 7 day triple therapy with bismuth and 87% of those receiving the 14 day standard triple therapy (p = 0.695). Per-protocol eradication rates were 94% and 87%, respectively (p = 0.418). No serious adverse events were reported, and most adverse events were mild to moderate. A metallic taste was significantly more frequent in the 14 day standard triple therapy group, while other adverse events occurred with similar frequency.ConclusionsAdding bismuth to a 7 day triple regimen achieved high eradication rates and a safety profile similar to 14 day standard triple therapy, supporting its use as an effective and safe treatment option for pediatric H. pylori infection.

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BackgroundThis study comprehensively analyzes the diagnostic criteria, eradication indications, treatment, and other information in the latest guidelines published by various countries around the world, so that researchers can have a systematic understanding of Helicobacter pylori and further provide a basis for clinical H. pylori diagnosis and treatment.MethodsNine online databases were searched to find the latest version of guidelines for H. pylori worldwide. Two researchers read the included guidelines independently and extracted the eradication indications, diagnostic criteria, and treatment in the guidelines, conducting a summary of them.ResultsA total of 25 guidelines or consensus were included. Among all diagnostic methods for H. pylori infection, the urea breath test is widely recommended as the first choice. A total of 20 guidelines mentioned indications for H. pylori eradication. Among them, the indications with a higher proportion of recommendations were long-term use of non-steroidal anti-inflammatory drugs (including low-dose aspirin) in 90% of patients with peptic ulcer history or active peptic ulcer disease 80%; gastric mucosa-associated lymphoid tissue (MALT) lymphoma 75%. It is worth mentioning that 40% of the guidelines pointed out that, as long as H. pylori infection is confirmed, it should be eradicated. A total of 24 guidelines mentioned treatment for H. pylori. Among them, bismuth quadruple therapy (a combination of a bismuth, two antibiotics, and a proton pump inhibitor (PPI)) was the most recommended first-line therapy. Levofloxacin triple therapy (a combining of a bismuth, an antibiotic, and a PPI) was the most recommended second-line therapy.ConclusionCurrent global Helicobacter pylori management guidelines share foundational consensus, yet exhibit regional variations in diagnostic criteria, eradication indications, and therapeutic regimens due to context-specific epidemiological, socioeconomic, and antimicrobial resistance profiles. Clinical practice should prioritize regionally tailored approaches, integrating local guidelines while maintaining awareness of international recommendations to optimize decision-making. Moreover, health authorities responsible for guideline development must ensure timely updates based on dynamic surveillance of local resistance patterns and socioeconomic realities.

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BackgroundClassic bismuth quadruple therapy (BQT)-the combination of a proton pump inhibitor, bismuth, tetracycline, and metronidazole-is a standard regimen for treating Helicobacter pylori infection.AimsThis review addresses practical questions regarding its current role in managing the infection.MethodsA comprehensive bibliographic search was conducted to identify studies evaluating the efficacy, safety and optimization of BQT in different clinical contexts.ResultsBQT is a cornerstone of H. pylori eradication, combining agents with complementary mechanisms of action and maintaining high efficacy even in the presence of antibiotic resistance. Optimal acid suppression with a double proton pump inhibitor dose twice daily maximises therapeutic success. When tetracycline is unavailable, minocycline may serve as an alternative, whereas doxycycline is not recommended due to lower efficacy. Ten-day regimens achieve eradication rates comparable to 14-day courses, with similar or better tolerability. The three-in-one single-capsule formulation simplifies administration, enhances adherence, and maintains high efficacy (> 90%). BQT is endorsed as first-line therapy in most international guidelines, particularly in regions with clarithromycin resistance exceeding 15%, and remains the most reliable rescue option after failure of clarithromycin- or fluoroquinolone-based regimens. It is also the treatment of choice for patients with penicillin allergy. The regimen is generally well tolerated, with mostly mild, transient and gastrointestinal adverse events.ConclusionsBQT remains the most effective, safe, and practical regimen for H. pylori eradication, ensuring high cure rates across diverse resistance patterns and clinical settings. Simplified formulations further improve convenience and adherence, reinforcing its role as a globally applicable therapy.

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