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For confirming the diagnosis of gastroesophageal reflux disease (GERD) in patients suffering from upper gastrointestinal symptoms, objective testing is always recommended prior to surgical intervention.1 However, in selected patients, such testing is increasingly being employed to assess the efficacy of treatment with a proton pump inhibitor (PPI).1 As there is a growing reluctance to use long-term PPI therapy without confirmation of abnormal acid reflux, which is associated with symptoms,2 objective testing may play a role in patient management.

“For many patients, PPIs are considered to impose significant risks,3 and patients often voice concerns about these risks to clinicians,” said John E. Pandolfino, MD, Chief of the Division of Gastroenterology and Hepatology at Northwestern University Feinberg School of Medicine, in Chicago, Illinois. “Given the evidence that PPIs are not the completely innocuous medicines once commonly believed, I also have concerns about imposing such risks, and costs, in patients who are not achieving any gain taking PPIs.”

A trial of PPIs for patients with suspected GERD has long been common practice even for those without classic GERD symptoms. In the past, further testing was reserved for nonresponsive patients.3,4 However, publicity about potential PPI risks has not been the only factor to shift this standard. In the era of evidence-based medicine, there is greater emphasis on accurate and early diagnosis rather than long-term empirical treatment.

“In an otherwise healthy patient with classical reflux symptoms and no alarm signals, I may offer a trial of a PPI because the sensitivity is good, but the specificity is rather poor,” said C. Prakash Gyawali, MD, Director of the Neurogastroenterology Program at Washington University School of Medicine, in St. Louis, Missouri. “However, even in responders, you at some point need to document what you are treating.”

Dr Gyawali noted that many patients do not report purely classic GERD symptoms, such as heartburn and/or regurgitation,3 but may present with a long list of atypical symptoms, such as cough, globus, or dyspepsia.3,5 Patients also may present with atypical symptoms alone. Moreover, many patients who improve on PPIs do not become free from symptoms. Partial responders can complicate the clinical picture, increasing the value of employing an objective tool to confirm that the underlying etiology is acid-related.

“There is an increasing appreciation for the fact that many patients with upper GI complaints improve on PPIs, but still report persistent symptoms. Those concerned about side effects may want some proof that they have acid reflux and that the PPI is needed,” said Anish Sheth, MD, Director of the Esophageal Program at the University Medical Center of Princeton University, in Plainsboro, New Jersey. “With alternatives to PPIs, such as surgery and the growing list of minimally invasive devices for preventing reflux, objective evidence also is valuable when counseling patients about their options.”

The value of pH monitoring or other objective tests for establishing treatment goals also was emphasized by William C. Dengler, MD, FACS, President and Medical Director at Legato Medical Systems, in Rocky Mount, North Carolina.

As a surgeon, Dr Dengler noted that symptom response to a PPI trial, even in the context of a careful patient history “is notoriously inaccurate” for the diagnosis of GERD. Prior to fundoplication or any invasive procedure to control GERD, Dr Dengler said objective tests are mandatory, although he cautioned that relying on endoscopy alone usally is not appropriate. “Of patients with acid reflux, only about 20% will have chronic esophagitis,5 so the best metric is pH monitoring. A standard 48-hour telemetry study is sufficient in most patients, but extended monitoring for 96 hours can be utilized, if needed,” Dr Dengler said.

Dr Pandolfino noted that endoscopy typically is the first test he performs when aiming to provide an objective evaluation of upper GI symptoms. He also suggested that endoscopy is not necessarily the best test for confirming GERD. In the absence of esophagitis or other findings suggestive of abnormal reflux, pH monitoring is required to document pathologic acid levels. Correlating acid reflux with atypical symptoms is particularly helpful when predicting benefit from therapy.

“If the goal is to evaluate acid reflux, I prefer wireless 96-hour pH monitoring because it allows patients to participate in normal activities while reducing the likelihood of missing clinically significant reflux events relative to a shorter monitoring period,” Dr Pandolfino said.

Impedance testing is an alternative when weakly acidic or non-acid reflux is suspected, according to Dr Pandolfino. When performed in patients who remain on PPI therapy, non-acid reflux events that are associated with persistent symptoms strengthen the case for a causative relationship. When suspicion is high that upper GI symptoms are related to reflux, Dr Gyawali reported that he does not necessarily select endoscopy before a PPI trial, but agreed that pH monitoring is not required if esophagitis has already been documented.

“Ninety-six–hour pH monitoring is essential when you are on the fence about the contribution of acid reflux to symptoms,” Dr Gyawali said. “A prolonged recording can allow you to separate nonerosive acid reflux disease from a functional disorder, which can be reassuring for both you and the patient.” According to Dr Sheth, patients with atypical symptoms, such as voice changes, throat clearing, or chronic cough often have taken PPIs, but with ambiguous response. In these patients, the absence of pathologic acid levels on 96-hour pH monitoring can be as helpful as a positive result because it allows the patient to discontinue an unnecessary medication.

“It is becoming increasingly important to document who will not benefit from PPI therapy as much as identifying who will. This has been a shift in thinking,” Dr Sheth said.

The diagnosis of GERD is useful for documenting the basis for a prescription of PPIs, but documenting pathologic acid levels with pH monitoring is “the single best metric for predicting a successful fundoplication,” Dr Dengler said. The opposite also is true: According to Dr Dengler, fundoplication is a reliable and effective tool for GERD, making inappropriate patient selection “the most important cause of a bad surgical outcome.”

Although among the interviewed faculty, there was general agreement that pH monitoring is being offered more routinely and earlier in the evaluation of symptoms associated with GERD, Dr Dengler maintained that it is not yet used often enough. He also emphasized that negative studies rival the importance of positive findings. “For many patients, ruling out acid reflux is the goal,” Dr Dengler added. “Not only does a negative study permit clinicians to concentrate on other potential etiologies for the patient’s complaints, it allows inappropriate use of PPIs to be discontinued.”

Even among patients with a positive pH test, documenting the severity of acid reflux provides the basis for a risk–benefit analysis of any GERD treatment, including a PPI. The real or per ceived benefit-to-risk ratio of treatment is not uniform. “The question patients may ask you is, ‘Do I really need to stay on a PPI?’ Assessing acid reflux with an objective test in the context of patient concerns and symptoms can be clinically useful,” Dr Pandolfino said.

References

  1. Hirano I, Richter JE; Practice Parameters Committee of the American College of Gastroenterology. ACG practice guidelines: esophageal reflux testing. Am J Gastroenterol. 2007;102(3):668-685.
  2. Metz DC. Long-term use of proton-pump inhibitor therapy. Gastroenterol Hepatol (N Y). 2008;4(5):322-325.
  3. Katz PO, Gerson LB, Vela MF. Guidelines for the diagnosis and management of gastroesophageal reflux disease. Am J Gastroenterol. 2013;108(3):308-328.
  4. Vela MF. Diagnostic work-up of GERD. Gastrointest Endosc Clin N Am. 2014; 24(4):655-666.
  5. Chiocca JC, Olmos JA, Salis GB, et al; Argentinean Gastro-Oesophageal Reflux Study Group. Prevalence, clinical spectrum and atypical symptoms of gastro-oesophageal reflux in Argentina: a nationwide population-based study. Aliment Pharmacol Ther. 2005;22(4):331-342.