Original article—alimentary tractCaution About Overinterpretation of Symptom Indexes in Reflux Monitoring for Refractory Gastroesophageal Reflux Disease
Section snippets
Methods
The study was performed in accordance with the Declaration of Helsinki, good clinical practice, and applicable regulatory requirements. The Vanderbilt Institutional Review Board approved this clinical trial (IRB#101110) (NCT01204931).
Demographics
Two hundred fifty-four patients underwent: (1) esophagogastroduodenoscopy with wireless pH monitoring off PPI therapy (n = 127), (2) impedance/pH monitoring off PPI therapy (n = 41), or (3) impedance/pH monitoring on BID PPI therapy (n = 86) (Table 1). The primary and mutually exclusive symptom complaints included cough, heartburn, regurgitation, and chest pain. Esophagitis (LA grades of esophagitis: A = 50%, B = 27%; C = 16%, and D = 7%) was present in 15/127 (12%) patients who underwent
Discussion
This study is the first to critically assess the clinical utility of SI and SAP in patients with symptoms refractory to PPI therapy and to determine test characteristics which impact both indexes. Our data and findings are derived from all possible clinically relevant modes of therapy (off vs on therapy) and reflux monitoring methods (acid, nonacid, and total reflux events) with overwhelming implications. We found that the likelihood of abnormal SI and SAP in this group of patients is low and
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The Utility of Symptom Association Probability (SAP) in Predicting Outcome After Laparoscopic Fundoplication in Patients with Abnormal Esophageal Acid Exposure
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2023, Digestive and Liver DiseaseCitation Excerpt :It is known that both SAP and SI represent indexes assessing the temporal relationship between symptoms and reflux episodes. However, the diagnostic limits of these variables have long been recognized in patients with typical symptoms [36,37]. Moreover, it has also been demonstrated that patients with heartburn and normal AET and SAP/SI may respond to PPI therapy [36].
Gastroesophageal reflux disease (GERD)
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2022, Current Opinion in PharmacologyCitation Excerpt :The symptom index (SI) and the symptom association probability (SAP) have been used for many years in order to establish the above relationship [34]. Their diagnostic yield is high when many symptoms are recorded and the patient indicates the symptom promptly upon occurrence [35], but both indices have relevant methodological limitations [36]. Anyway, they have been of great help in favoring the subdivision of the complex NERD population into various phenotypes and in particular in the identification of patients with hypersensitivity to acid or weakly acidic reflux, despite the presence of normal AET [37].
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Conflicts of interest This author discloses the following: Dr Vaezi had research grant support from Takeda Pharmaceuticals North America, Inc, for the conduct of this study. The remaining authors disclose no conflicts.