Introduction

Heartburn is the most common symptom leading to gastroenterology referral. The Lyon 2.0 consensus advocates up-front OFF-PPI ambulatory pH testing in unproven GERD when erosive esophagitis is absent, followed by ON-PPI pH-impedance testing when PPI therapy fails in proven GERD. Due to cost concerns with routine diagnostic testing and since wireless pH testing is not widely available in parts of the world, most patients receive rotating, prolonged courses of PPIs for persistent symptoms. We performed an economic analysis to compare evaluation/management strategies for heartburn in routine practice.

Aims & Methods

We developed a Markov model to compare routine care strategies for patients with heartburn and no alarm features: (1) Reassurance alone; (2) EGD with PPI optimization; (3) EGD with a PPI discontinuation trial when erosive esophagitis is absent; EGD with OFF-PPI (4) wireless pH testing or (5) pH-impedance testing to phenotype care based on physiology; (6) EGD with OFF-PPI wireless pH testing followed by ON-PPI pH-impedance testing when needed following Lyon 2.0. Definitions to interpret diagnostic tests and treatment recommendations were extracted from practice guidelines. Model inputs were extracted from appropriate US cost databases and from systematic reviews, clinical trials, and national observational studies that considered diagnostics and clinical outcomes. We used a one-year time horizon and a willingness-to-pay threshold of $100,000/quality-adjusted-life-year (QALY) gained.

Results

Reassurance alone (Strategy 1) cost $3,936/year to insurers due to repeated diagnostics and visits, and $2,976/year to patients due to out-of-pocket expenses and impaired work productivity. EGD with a trial of PPI optimization (Strategy 2) or discontinuation (Strategy 3) was more expensive and less effective than strategies that involved up-front pH testing, because EGD-only strategies exclude erosive esophagitis but do not optimize treatment. Up-front wireless pH (Strategy 4) or pH-impedance (Strategy 5) monitoring defining GERD were similarly cost-effective. The most cost-effective strategy was to follow Lyon 2.0 (Strategy 6), resulting in $2,542 annual savings to patients, $2,311 annual savings to insurers, and health gains of +0.07 QALY or 23 more healthy days per year. Findings were similar from insurer and patient perspectives.

TABLE: Cost-effectiveness of routine strategies to manage heartburn in general gastroenterology from insurer and patient perspectives. Strategies 1-5 are updated from our previous report (doi 10.1016/j.cgh.2023.08.026) to reflect availability of Lyon 2.0.

Conclusion

By matching patients to the appropriate therapeutic targets based on diagnostics and PPI response, Lyon 2.0 optimizes the cost-effective care pathway for heartburn in general gastroenterology. Since wireless pH and pH-impedance monitoring are equivalent strategies, availability of technique and local expertise should dictate choice for evaluation of heartburn. Our findings advocate the need for access to, coverage for, and usage of diagnostic testing and broad adoption of the Lyon 2.0 consensus.

Disclosure

EDS consults for Ardelyx, Laborie, Mahana, Mylan, Neuraxis, Salix, Sanofi, and Takeda.

Introduction

Both the effectiveness and tolerability of Helicobacter pylori (H.p.) eradication therapy regimens are important in the management of H.p. infection, since the presence of side effects significantly reduces compliance between the doctor and the patient and sometimes can lead to treatment interruption. Our study aimed to compare the efficacy and tolerability of eradication therapy depending on the addition of Saccharomyces boulardii or a synbiotic complex.

Aims & Methods

The study included 78 patients (54 women and 24 men) with confirmed H.p. infection using validated tests, without previous eradication in the anamnesis. All patients underwent a course of eradication therapy, which included proton pump inhibitor (PPI) + amoxicillin (A) + clarithromycin (C) + bismuth subcitrate (B). Patients were divided into 2 groups: in group A (37 patients, 25 women, 12 men, mean age 44±3.2 years) S. boulardii CNCM I-745 was added to the mentioned regimen. In group B (41 patients, 29 women, 12 men, mean age 47±2.8 years), a synbiotic complex containing strains of probiotic bacteria Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus delbrueckii subsp. bulgaricus, Lactobacillus fermentum, Lactobacillus rhamnosus, Lactobacillus casei subsp. сasei, Streptococcus thermophilus, Bifidobacterium bifidum, Bifidobacterium longum, Bifidobacterium adolescentis, Propionibacterium freudenreichii subsp. Shermanii, prebiotics inulin and lactulose were added to the indicated regimen. The duration of eradication therapy was 10 days. The duration of taking the probiotic and synbiotic complex ‒ 15 days.

Results

In group A, the effectiveness of the PPI+A+C+B regimen with the addition of S. boulardii was 75.7%. In group B (with the addition of a synbiotic) - 87.8%. We compared the tolerability of the indicated regimens. In no case (in both groups) was the treatment interrupted due to the presence of serious side effects. In total, 20 (54.1%) patients from group A and 17 patients (41.5%) from group B reported non-serious adverse events, including nausea (group A ‒ 8 patients (21.6%), group B ‒ 6 (14.6%), bitter taste in the mouth (group A ‒ 16 patients (43.2%), group B ‒ 15 (36.6%), and diarrhoea (group A ‒ 6 patients (16.2%), group B ‒ 0 (0%). No other adverse events were documented. Comparing gastrointestinal symptoms using the Gastrointestinal Symptom Rating Scale (GSRS) showed that in group A, mean values of the total score before treatment were 35.9±3.14 points, vs 26.2±1.64 points 20 days after the eradication course (p<0.05). In group B 34.1±2.44 points before treatment, vs 21.7±1.98 points 20 days after the eradication course (p<0.05). Comparing the total score of the GSRS questionnaire after treatment between groups A and B also showed a significant difference: 26.2±1.64 points in group A vs 21.7±1.98 points in group B (p<0.05).

Conclusion

Our study revealed better efficacy (87.8%) of the eradication regimen PPI+A+C+B with the addition of a synbiotic compared to the similar regimen with the addition of Saccharomyces boulardii (75.7%) in patients from Vinnytsia region, Ukraine. In addition, it was found that when the synbiotic complex was added, side effects of eradication therapy were noted in a smaller percentage of patients and significantly (p<0.05) lower values of the total score of the GSRS questionnaire were noted 20 days after treatment, in contrast to the regimen with the addition of Saccharomyces boulardii.