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Early Referral for Esophageal pH Monitoring Is More Cost-Effective Than Prolonged Empiric Trials of Proton-Pump Inhibitors for Suspected Gastroesophageal Reflux Disease

  • 2013 SSAT Plenary Presentation
  • Published:
Journal of Gastrointestinal Surgery Aims and scope

Abstract

Introduction

The most cost-effective diagnostic algorithm for gastroesophageal reflux disease (GERD) remains controversial. We hypothesized that prompt referral for esophageal pH monitoring is more cost-effective than prolonged empiric courses of proton-pump inhibitors (PPIs).

Discussion

A cost model was created based on a cohort of 100 patients with possible GERD who underwent pH monitoring. The additional costs incurred from pH monitoring were compared to the potential savings from avoiding unnecessary PPI usage in patients with a negative pH study. The costs of PPI therapy reach equivalence with pH monitoring after 6.4 to 23.7 weeks, depending on the PPI regimen. A total of 21,411 weeks of PPIs were prescribed beyond the recommended 8-week trial, of which 32 % were for patients who had a negative 24-h pH monitoring study. If the sensitivity of pH monitoring was 96 %, early referral for pH monitoring would have saved between $1,197 and $6,303 per patient over 10 years. This strategy remains cost-effective as long as the sensitivity of pH monitoring is above 35 %. Prompt referral for pH monitoring after a brief empiric PPI trial is a more cost-effective strategy than prolonged empiric PPI trials for patients with both esophageal and extraesophageal GERD symptoms.

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Acknowledgments

This study was supported in part by grant TL1RR000459 of the Clinical and Translational Science Center at Weill Cornell Medical College.

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Authors and Affiliations

  1. Division of Endocrine and Minimally Invasive Surgery, Department of Surgery, New York Presbyterian Hospital—Weill Cornell Medical College, New York, NY, USA

    David A. Kleiman, Toni Beninato, Thomas J. Fahey III & Rasa Zarnegar

  2. Division of Gastroenterology and Hepatology, Department of Medicine, New York Presbyterian Hospital—Weill Cornell Medical College, New York, NY, USA

    Brian P. Bosworth, Carl V. Crawford Jr & Brian G. Turner

  3. Division of Pediatric Gastroenterology, Department of Pediatrics, New York Presbyterian Hospital—Weill Cornell Medical College, New York, NY, USA

    Thomas Ciecierega

  4. Division of Visceral and Endocrine Surgery, Department of Surgery, University Hospital Nancy, Brabois, France

    Laurent Brunaud

  5. Department of Surgery, Weill Cornell Medical College, 525 East 68th Street, F-2024, New York, NY, 10065, USA

    Rasa Zarnegar

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  1. David A. Kleiman
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Correspondence to Rasa Zarnegar.

Additional information

Discussant

Dr. Steven DeMeester (Los Angeles, California): This work follows on your original publication showing that in 100 patients evaluated at your center for esophageal or extra-esophageal symptoms potentially related to reflux only 69 % of patients with esophageal symptoms and 29 % of those with extra-esophageal symptoms had a positive pH test. You have now extended that work and assessed the costs associated with unnecessary PPI therapy. You nicely show that early pH monitoring is cost-effective provided the sensitivity of pH monitoring is at least 35 %.

This ties in to studies from Denmark showing that in a group of patients on long-term PPI therapy, 73 % did not have a verified indication to be on the medications, and only 0.3 % had ever had a pH test. These same authors from Denmark also showed in the Diamond study that the PPI test is unreliable, since it was positive in only 54 % of proven GERD patients and was also positive in 35 % of patients proven not to have GERD.

I have three questions:

You performed careful pH monitoring with manometric placement of the pH catheter. Do you think some of the inaccuracy we see with pH monitoring is related to endoscopic placement of a Bravo probe? And what would you recommend for patients with symptoms that improve on PPI but have a negative endoscopy and negative pH test?

Second,

Is 8 weeks of PPI for the PPI test to long given evidence that relief of symptoms doesn’t change much after 5 days of PPI therapy and that even normal subjects will have symptoms related to PPI withdrawal after 8 weeks of therapy?

Lastly,

Your study doesn’t take into account the costs of side effects and complications of unnecessary PPI use, can you comment on that issue?

Closing Discussant

Dr. David Kleiman: Thank you very much, Dr. DeMeester, for those insightful comments and questions. In response to your first question, there are data that show that 48 h of pH monitoring using a wireless Bravo probe increases the sensitivity of the test compared to a 24-h study using a wired probe. However, this also comes with a higher risk of false positives that occur when the Bravo probe becomes dislodged and migrates distally into the stomach. In the scenario that you described of a patient whose symptoms improve on a PPI despite a normal endoscopy and 24-h pH test, that patient may benefit from also undergoing the more sensitive 48-h Bravo study. If the Bravo study is also normal, then I think it is safe to conclude that the patient does not suffer from acid reflux. Their response to the PPI could be attributed to a placebo effect, which is a very real and well-documented phenomenon when it comes to PPIs and GERD symptoms.

As for your second question, it is very difficult to say what the optimal duration of the PPI trial should be. Eight weeks certainly seems conservative, and if a patient is still experiencing symptoms after 8 weeks of medical treatment, they warrant further evaluation. For this study, we chose to utilize the 8-week empiric trial because that is what is recommended by both the American Gastroenterological Association and the American College of Gastroenterology, and we wanted to highlight the discrepancy between what is recommended and what actually occurs.

Finally, as you correctly pointed out, this study did not include the costs of side effects and complications of unnecessary PPI use. Additionally, we did not consider other related costs, such as lost wages while undergoing the test nor the potential savings associated with earlier diagnosis of potentially serious alternative conditions, such as heart disease. We intentionally omitted these issues from this analysis because including them would have required us to assign subjective and rather arbitrary utility values. Therefore, we chose to limit this study to only a direct cost comparison based on objective data collected from our own patients.

This study was a Plenary Presentation at the Society for Surgery of Alimentary Tract (SSAT) Annual Meeting on May 19, 2013 in Orlando, FL.

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Kleiman, D.A., Beninato, T., Bosworth, B.P. et al. Early Referral for Esophageal pH Monitoring Is More Cost-Effective Than Prolonged Empiric Trials of Proton-Pump Inhibitors for Suspected Gastroesophageal Reflux Disease. J Gastrointest Surg 18, 26–34 (2014). https://doi.org/10.1007/s11605-013-2327-x

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