Management of Reflux Symptoms with Over-the-Counter Proton Pump Inhibitors: Issues and Proposed Guidelines

Abstract

Background: Symptoms of gastroesophageal reflux are widely prevalent. There is a continuum between subjects with mild reflux symptoms and those severely affected by gastroesophageal reflux disease (GERD). Both groups may at times access over-the-counter (OTC) therapies. For the purpose of this review, relevant papers, including national and international guidelines were reviewed and recommendations made for appropriate use of OTC proton pump inhibitor (PPI) therapy. Results: PPIs are the gold standard for treatment of reflux symptoms. OTC therapy with histamine₂ receptor antagonists (H2RAs) also plays a role. For the majority affected by reflux symptoms, effective symptom control is the most important outcome, as only a subgroup requires investigations or interventions. However, patients with alarm features (i.e. troublesome dysphagia, weight loss, predominant upper abdominal pain) are not recommended for OTC therapy and need prompt medical referral. Frequent relapses or failure to adequately respond to OTC therapy are additional triggers for medical assessment. Conclusions: OTC treatment of typical reflux symptoms (acid regurgitation, heartburn) with antacids and H2RAs is now accepted as safe and results in short-term relief of symptoms. There is no evidence of additional risk with OTC PPIs compared to these existing OTC therapies and PPIs are significantly more efficacious.

Langzeit-Therapie mit Protonenpumpenhemmern: Wirklich unbedenklich?

“…Beinahe alle PPIs sind mittlerweile auch in Deutschland "over-the-counter" (OTC) erhältlich, während dies in zahlreichen anderen Ländern bereits seit Jahren der Fall ist [6]. Wenn auch die OTC-Packungsgröße auf 7 bis maximal 14 Tabletten begrenzt ist, so stehen diese Medikamente damit einer großen Zahl Betroffener zur Verfügung und sind nicht mehr ausschließ-lich rezeptpflichtig.…”

Short and long-term PPI treatment for GERD. Do we need more-potent anti-secretory drugs?

“…Safety is also an important consideration in the perspective of development of OTC-use in many countries. However, recommendations for appropriate OTC PPI use have been reviewed by Haag et al [126] who concluded that there is no evidence of additional risk with OTC PPIs compared with other existing anti-reflux therapies.…”

Analysis of 2-Week Data from Two Randomized, Controlled Trials Conducted in Subjects with Frequent Heartburn Treated with Esomeprazole 20 mg

“…1,3,4 The frequency and severity of GER symptoms vary from person to person; therefore, treatment must be tailored toward an individual's given symptom profile. 3,5 Both moderate and severe GER symptoms produce significant impairments in occupational and psychosocial functioning, cause sleep disruptions, increase health care resource utilization, and reduce overall health-related quality of life. [6][7][8][9] Proton pump inhibitors (PPIs) are among the most effective and, therefore, widely used treatments for GER symptoms.…”

“…[6][7][8][9] Proton pump inhibitors (PPIs) are among the most effective and, therefore, widely used treatments for GER symptoms. 5 A Cochrane Database systematic review of short-term (2-to 8-week) clinical trials of PPIs, histamine-2 receptor antagonists (H2RAs), and prokinetics demonstrated the effectiveness of these commonly utilized treatments in managing GER symptoms. 10 These analyses found that PPIs offer a benefit over H2RAs and prokinetics, particularly in those whose diagnosis is based on symptomology (ie, the presence of heartburn) and not on endoscopic testing.…”

“…11,12 These individuals often utilize self-care treatment options such as OTC antacids and PPIs to manage their symptoms. 5,13 Esomeprazole is a PPI approved by the US Food and Drug Administration (FDA) for short-term (14 days) OTC use for treating frequent (Z2 d/wk) heartburn. 14 In the European Union, esomeprazole has been approved for treating GER symptoms, such as heartburn and acid regurgitation, at the same dosage for the same duration.…”