Comparative Effectiveness of Management Strategies for Adults with Gastroesophageal Reflux Disease
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Comparative Effectiveness of Management Strategies for Adults with Gastroesophageal Reflux Disease

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  • Comparative Effectiveness of Management Strategies for Adults With Gastroesophageal Reflux Disease: An Update This slide set is based on a comparative effectiveness review (CER) titled Comparative Effectiveness of Management Strategies for Adults With Gastroesophageal Reflux Disease: An Update, which was developed by the Tufts Evidence-based Practice Center, Tufts Medical Center, Boston, MA, for the Agency for Healthcare Research and Quality (AHRQ) under Contract No. HHSA 290-2007-10055-I and is available online at www.effectivehealthcare.ahrq.gov/gerdupdate.cfm. CERs are comprehensive systematic reviews of the literature that usually compare two or more types of treatment with usual care for the same disease. For this CER, the existing body of evidence on the comparative benefits and possible harms of different interventions used to treat gastroesophageal reflux disease (GERD) were reviewed. The literature included in this review was identified in searches for trials and studies that included terms for GERD and relevant research designs. Only studies on adults (≥18 years of age) were included. Searches were conducted for studies published through August 2010. Of note, with the exception of a noted correlation between obesity and some treatment-related outcomes, behavioral modifications to ameliorate GERD symptoms are not discussed in the CER (e.g., smoking cessation, addressing anxiety, or alcohol intake). Reference: Ip S, Chung M, Moorthy D, et al. Comparative Effectiveness of Management Strategies for Adults With Gastroesophageal Reflux Disease: An Update. Comparative Effectiveness Review No. 29 (Prepared by the Tufts Evidence-based Practice Center under Contract No. HHSA 290-2007-10055-I). Rockville, MD: Agency for Healthcare Research and Quality; September 2011. AHRQ Publication No. 11-EHC049-EF. Available at www.effectivehealthcare.ahrq.gov/gerdupdate.cfm.
  • Outline of Material The material in this presentation covers the results and conclusions from a systematic CER titled Comparative Effectiveness of Management Strategies for Adults With Gastroesophageal Reflux Disease: An Update . It begins with an introduction to GERD and the available treatment interventions. It also covers methods used to plan and execute the systematic review, clinically important questions the review sought to answer, results of the review, evidence-based conclusions about effectiveness and harms of treatment interventions, gaps in knowledge, and future research needs uncovered by the systematic review. Abbreviations: CER = comparative effectiveness review GERD = gastroesophageal reflux disease Reference: Ip S, Chung M, Moorthy D, et al. Comparative Effectiveness of Management Strategies for Adults With Gastroesophageal Reflux Disease: An Update. Comparative Effectiveness Review No. 29 (Prepared by the Tufts Evidence-based Practice Center under Contract No. HHSA 290-2007-10055-I). Rockville, MD: Agency for Healthcare Research and Quality; September 2011. AHRQ Publication No. 11-EHC049-EF. Available at www.effectivehealthcare.ahrq.gov/gerdupdate.cfm.
  • Background: Health Impact of GERD GERD is one of the most common health conditions affecting Americans. Many patients have frequent, severe symptoms that require long-term, regular use of acid-reducing medications. GERD continues to be an important disease both in terms of cost and public health. One study of an employed population in the United States estimated that more than 11,000 of 267,000 employees (4%) suffered from GERD, contributing an average incremental cost of $3,355 per employee during a 3-year observation period—approximately 65 percent related to prescription drugs. At the same time, it is well recognized that some drugs used to treat GERD (such as proton pump inhibitors) are overprescribed. The large disease burden, economic impact, and market potential for new drugs and devices explain the continued intense interest in GERD and the development of cost-effective approaches for its diagnosis and management. Furthermore, there remains considerable uncertainty about how the treatment objectives should be achieved for patients with GERD. Abbreviation: GERD = gastroesophageal reflux disease References: Ip S, Chung M, Moorthy D, et al. Comparative Effectiveness of Management Strategies for Adults With Gastroesophageal Reflux Disease: An Update. Comparative Effectiveness Review No. 29 (Prepared by the Tufts Evidence-based Practice Center under Contract No. HHSA 290-2007-10055-I). Rockville, MD: Agency for Healthcare Research and Quality; September 2011. AHRQ Publication No. 11-EHC049-EF. Available at www.effectivehealthcare.ahrq.gov/gerdupdate.cfm. Brook RA, Wahlqvist P, Kleinman NL, et al. Cost of gastro-oesophageal reflux disease to the employer: a perspective from the United States. Aliment Pharmacol Ther 2007;26(6):889-898. PMID: 17767473. Forgacs I, Loganayagam A. Overprescribing proton pump inhibitors. BMJ 2008;336(7634):2-3. PMID: 18174564
  • Background: Pathophysiology of GERD Chronic GERD is a common health condition resulting from frequent exposure of the esophagus to gastric contents, such as acid and pepsin, that may be harmful to esophageal epithelium. The physical barrier to reflux is the lower esophageal sphincter, which is anchored by the crural diaphragm. The antireflux barrier may be disrupted by a hiatal hernia or a hypotensive lower esophageal sphincter, alone or in combination. Abbreviation: GERD = gastroesophageal reflux References: Ip S, Chung M, Moorthy D, et al. Comparative Effectiveness of Management Strategies for Adults With Gastroesophageal Reflux Disease: An Update. Comparative Effectiveness Review No. 29 (Prepared by the Tufts Evidence-based Practice Center under Contract No. HHSA 290-2007-10055-I). Rockville, MD: Agency for Healthcare Research and Quality; September 2011. AHRQ Publication No. 11-EHC049-EF. Available at www.effectivehealthcare.ahrq.gov/gerdupdate.cfm.
  • Background: Treatment of GERD (1 of 2) For individuals with chronic GERD, most authorities consider the goals of therapy to be an improvement in symptoms and quality of life, healing of erosive esophagitis, and prevention of recurrent esophagitis and complications (such as Barrett ’s esophagus and esophageal stricture). However, there remains considerable uncertainty about how these objectives should be achieved. The medical treatment of GERD is based on pharmacological suppression of gastric acid. Depending on the severity of symptoms and the clinical response, intermittent (on-demand), periodic, or continuous use of prescription or over-the-counter medications, especially histamine type 2 receptor antagonists (H2RAs) and proton pump inhibitors (PPIs), may be used. Abbreviation: GERD = gastroesophageal reflux disease Reference: Ip S, Chung M, Moorthy D, et al. Comparative Effectiveness of Management Strategies for Adults With Gastroesophageal Reflux Disease: An Update. Comparative Effectiveness Review No. 29 (Prepared by the Tufts Evidence-based Practice Center under Contract No. HHSA 290-2007-10055-I). Rockville, MD: Agency for Healthcare Research and Quality; September 2011. AHRQ Publication No. 11-EHC049-EF. Available at www.effectivehealthcare.ahrq.gov/gerdupdate.cfm.
  • Background: Treatment of GERD (2 of 2) Considerable uncertainty remains about how to achieve the goals of GERD therapy. For patients treated empirically, standard treatment often involves an 8-week trial of PPIs, along with lifestyle modification (e.g., weight loss, limiting tobacco and alcohol). For those who respond and are not at high risk of an adverse outcome, step down to either continuous or as-needed H2RAs is sometimes used. Depending on the severity of symptoms and clinical response, prescription or over-the-counter medications, especially H2RAs and PPIs, may be used intermittently (on-demand), periodically, or continuously. Antireflux surgery (fundoplication) aims to correct gastroesophageal reflux by reducing a hiatal hernia, reconstructing the esophageal hiatus, and reinforcing the lower esophageal sphincter. Some patients with insufficient response to medication may improve with surgery. Surgery is typically only performed in very carefully evaluated patients whose disease is refractory to medicine, as some are not good candidates for surgery. Moreover, some patients whose disease is responsive to medication may consider surgery for certain reasons. There is no consensus about which patients are optimal surgical candidates. Endoscopic treatments have recently become available and are currently being studied, but they are mostly reserved for use in clinical trials because efficacy data are very limited. Abbreviations: GERD = gastroesophageal reflux disease H2RA = histamine type 2 receptor antagonist PPI = proton pump inhibitor Reference: Ip S, Chung M, Moorthy D, et al. Comparative Effectiveness of Management Strategies for Adults With Gastroesophageal Reflux Disease: An Update. Comparative Effectiveness Review No. 29 (Prepared by the Tufts Evidence-based Practice Center under Contract No. HHSA 290-2007-10055-I). Rockville, MD: Agency for Healthcare Research and Quality; September 2011. AHRQ Publication No. 11-EHC049-EF. Available at www.effectivehealthcare.ahrq.gov/gerdupdate.cfm.
  • Background: Additional Issues There are additional issues to consider in the management of patients with GERD: - There is no consensus about the optimal approach to evaluate and manage patients with GERD that is refractory to medical management. - The diagnosis of extraesophageal GERD presentations such as asthma, cough, and laryngeal symptoms is challenging because: a) the relationship between GERD and these symptoms is not as strong as that seen with typical symptoms like heartburn, b) these complaints may have a multifactorial etiology (for instance, allergies), and c) improvement of these symptoms after GERD treatment is less predictable. Another important issue to consider is that an October 2010 reminder from the U.S. Food and Drug Administration warns that the concomitant use of clopidogrel and the PPI omeprazole (Prilosec ® ) can result in significant reductions in the antiplatelet activity of clopidogrel. Abbreviations: GERD = gastroesophageal reflux disease PPI = proton pump inhibitor Reference: Ip S, Chung M, Moorthy D, et al. Comparative Effectiveness of Management Strategies for Adults With Gastroesophageal Reflux Disease: An Update. Comparative Effectiveness Review No. 29 (Prepared by the Tufts Evidence-based Practice Center under Contract No. HHSA 290-2007-10055-I). Rockville, MD: Agency for Healthcare Research and Quality; September 2011. AHRQ Publication No. 11-EHC049-EF. Available at www.effectivehealthcare.ahrq.gov/gerdupdate.cfm.
  • Agency for Healthcare Research and Quality (AHRQ) Comparative Effectiveness Review (CER) Development Topics are nominated through a public process, which includes submissions from health care professionals, professional organizations, the private sector, policymakers, members of the public, and others. A systematic review of all relevant clinical studies is conducted by independent researchers, funded by AHRQ, to synthesize the evidence in a report summarizing what is known and not known about the select clinical issues. The research questions and the results of the report are subject to expert input, peer review, and public comment. The results of these reviews are summarized into Clinician Research Summaries and Consumer Research Summaries for use in decisionmaking and in discussions with patients. The Summaries and the full report, with references for included and excluded studies, are available at www.effectivehealthcare.ahrq.gov.
  • Clinical Questions Addressed by the CER (1 of 3) In preparing the report on which this continuing medical education (CME) activity is based, the authors aimed to answer three Key Questions. Key Question 1 is listed below: - What is the evidence of the comparative effectiveness of medical, surgical, and other newer forms of treatments for improving objective and subjective outcomes in patients with chronic GERD? - Is there evidence that effectiveness varies by specific technique, procedure, or medication? - Objective outcomes addressed include esophagitis healing, ambulatory pH monitoring, other indicators of reflux, medication need, health care utilization, and incidence of esophageal stricture, Barrett's esophagus or esophageal adenocarcinoma. - Subjective outcomes include symptom frequency and severity, sleep/productivity, and overall quality of life. Abbreviations: CER = comparative effectiveness review GERD = gastroesophageal reflux disease Reference: Ip S, Chung M, Moorthy D, et al. Comparative Effectiveness of Management Strategies for Adults With Gastroesophageal Reflux Disease: An Update. Comparative Effectiveness Review No. 29 (Prepared by the Tufts Evidence-based Practice Center under Contract No. HHSA 290-2007-10055-I). Rockville, MD: Agency for Healthcare Research and Quality; September 2011. AHRQ Publication No. 11-EHC049-EF. Available at www.effectivehealthcare.ahrq.gov/gerdupdate.cfm.
  • Clinical Questions Addressed by the CER (2 of 3) In preparing the report on which this CME activity is based, the authors aimed to answer three Key Questions. Key Question 2 is listed below: - Is there evidence that effectiveness of medical, surgical, and newer forms of treatments vary for specific patient subgroups? - What are the characteristics of patients who have undergone these therapies, including the nature of previous medical therapy, severity of symptoms, age, sex, weight, and other demographic and medical factors? - What are the provider characteristics for procedures including provider volume and setting (e.g., academic vs. community)? Abbreviations: CER = comparative effectiveness review CME = continuing medical education Reference: Ip S, Chung M, Moorthy D, et al. Comparative Effectiveness of Management Strategies for Adults With Gastroesophageal Reflux Disease: An Update. Comparative Effectiveness Review No. 29 (Prepared by the Tufts Evidence-based Practice Center under Contract No. HHSA 290-2007-10055-I). Rockville, MD: Agency for Healthcare Research and Quality; September 2011. AHRQ Publication No. 11-EHC049-EF. Available at www.effectivehealthcare.ahrq.gov/gerdupdate.cfm.
  • Clinical Questions Addressed by the CER (3 of 3) In preparing the report on which this CME activity is based, the authors aimed to answer three Key Questions. Key Question 3 is listed below: - What are the short-term and long-term adverse events associated with specific medical, surgical, and other, newer forms of therapies for GERD? - Does the incidence of adverse events vary with duration of followup, specific surgical intervention, or patient characteristics? Abbreviations: CER = comparative effectiveness review CME = continuing medical education GERD = gastroesophageal reflux disease Reference: Ip S, Chung M, Moorthy D, et al. Comparative Effectiveness of Management Strategies for Adults With Gastroesophageal Reflux Disease: An Update. Comparative Effectiveness Review No. 29 (Prepared by the Tufts Evidence-based Practice Center under Contract No. HHSA 290-2007-10055-I). Rockville, MD: Agency for Healthcare Research and Quality; September 2011. AHRQ Publication No. 11-EHC049-EF. Available at www.effectivehealthcare.ahrq.gov/gerdupdate.cfm.
  • Comparative Effectiveness Review Study Criteria (1 of 2) Eligible studies evaluated in the report on which this CME activity is based were comparative, randomized, nonrandomized, and cohort studies of adults (≥18 years) with chronic GERD. Studies that focused exclusively on patients with postsurgical GERD; pregnancy-induced GERD; duodenal or peptic ulcer; gastritis; primary esophageal motility disorder; scleroderma; diabetic gastroparesis; radiation esophagitis; Zollinger-Ellison syndrome; Zenker ’s diverticulum; previous antireflux surgery; and esophagitis caused by infections, pills, or chemical burns were excluded. Abbreviations: CME = continuing medical education GERD = gastroesophageal reflux disease Reference: Ip S, Chung M, Moorthy D, et al. Comparative Effectiveness of Management Strategies for Adults With Gastroesophageal Reflux Disease: An Update. Comparative Effectiveness Review No. 29 (Prepared by the Tufts Evidence-based Practice Center under Contract No. HHSA 290-2007-10055-I). Rockville, MD: Agency for Healthcare Research and Quality; September 2011. AHRQ Publication No. 11-EHC049-EF. Available at www.effectivehealthcare.ahrq.gov/gerdupdate.cfm.
  • Comparative Effectiveness Review Study Criteria (2 of 2) Eligible studies evaluated in the report on which this CME activity is based included the following: 1) Studies on medical treatment of GERD included randomized controlled trials (RCTs), using a PPI or H2RA to treat acute symptoms or as maintenance therapy. 2) Studies with surgical procedures for GERD included only RCTs or cohort studies examining total (Nissen and Nissen-Rossetti) or partial (Toupet) fundoplication, either as an open or as a laparoscopic procedure. 3) Studies with endoscopic procedures, only RCTs or cohort studies examining products approved in the United States were included. Abbreviations: CME = continuing medical education GERD = gastroesophageal reflux disease H2RA = histamine type 2 receptor antagonist PPI = proton pump inhibitor Reference: Ip S, Chung M, Moorthy D, et al. Comparative Effectiveness of Management Strategies for Adults With Gastroesophageal Reflux Disease: An Update. Comparative Effectiveness Review No. 29 (Prepared by the Tufts Evidence-based Practice Center under Contract No. HHSA 290-2007-10055-I). Rockville, MD: Agency for Healthcare Research and Quality; September 2011. AHRQ Publication No. 11-EHC049-EF. Available at www.effectivehealthcare.ahrq.gov/gerdupdate.cfm.
  • Rating the Strength of Evidence From the CER Throughout this slide set, strength of evidence ratings are assigned to findings of the report. Strength of evidence is typically assigned to reviews of medical treatments after assessing four domains: risk of bias, consistency, directness, and precision. Although these categories were developed for assessing the strength of treatment studies, the domains apply also to studies of prevalence and screening. Available evidence for each Key Question was assessed for each of these four domains; the domains were combined qualitatively to develop the strength of evidence for each Key Question. Abbreviation: CER = comparative effectiveness review Reference: Ip S, Chung M, Moorthy D, et al. Comparative Effectiveness of Management Strategies for Adults With Gastroesophageal Reflux Disease: An Update. Comparative Effectiveness Review No. 29 (Prepared by the Tufts Evidence-based Practice Center under Contract No. HHSA 290-2007-10055-I). Rockville, MD: Agency for Healthcare Research and Quality; September 2011. AHRQ Publication No. 11-EHC049-EF. Available at www.effectivehealthcare.ahrq.gov/gerdupdate.cfm.
  • Findings of the Comparative Effectiveness Review: Medication (1 of 3) Many patients with GERD have frequent, severe symptoms that require long-term, regular use of acid-reducing medications. Depending on the severity of symptoms and clinical response, intermittent (on-demand), periodic, or continuous use of prescription or over-the-counter medications, especially H2RAs and PPIs, may be used. Evidence of moderate strength indicates that PPIs were superior to H2RAs for esophagitis healing, patient satisfaction and compliance, and symptom remission. This evidence also indicates that all of the commercially available PPIs appeared to be similarly effective for relieving symptoms and healing esophagitis for up to 1 year. Abbreviations: GERD = gastroesophageal reflux disease H2RA = histamine type 2 receptor antagonist PPI = proton pump inhibitor Reference: Ip S, Chung M, Moorthy D, et al. Comparative Effectiveness of Management Strategies for Adults With Gastroesophageal Reflux Disease: An Update. Comparative Effectiveness Review No. 29 (Prepared by the Tufts Evidence-based Practice Center under Contract No. HHSA 290-2007-10055-I). Rockville, MD: Agency for Healthcare Research and Quality; September 2011. AHRQ Publication No. 11-EHC049-EF. Available at www.effectivehealthcare.ahrq.gov/gerdupdate.cfm.
  • Findings of the Comparative Effectiveness Review: Medication (2 of 3) Evidence of moderate strength indicates that continuous therapy with a PPI appeared to be more effective than on-demand therapy for symptom control in patients with GERD. Evidence of moderate strength also indicates that obesity, severity of baseline symptoms, and severe baseline esophagitis were significantly associated with worse outcomes from treatment with medication, but older age was associated with improved symptom control at 6 months. Evidence of low strength indicates that PPIs demonstrate no difference from placebo in resolving hoarseness but do demonstrate some improvement inconsistently in resolving cough. Evidence was insufficient concerning the effectiveness of GERD treatment for relieving asthma symptoms. Abbreviations: GERD = gastroesophageal reflux disease PPI = proton pump inhibitor Reference: Ip S, Chung M, Moorthy D, et al. Comparative Effectiveness of Management Strategies for Adults With Gastroesophageal Reflux Disease: An Update. Comparative Effectiveness Review No. 29 (Prepared by the Tufts Evidence-based Practice Center under Contract No. HHSA 290-2007-10055-I). Rockville, MD: Agency for Healthcare Research and Quality; September 2011. AHRQ Publication No. 11-EHC049-EF. Available at www.effectivehealthcare.ahrq.gov/gerdupdate.cfm.
  • Findings of the Comparative Effectiveness Review: Medication (3 of 3) Evidence was insufficient concerning the effectiveness of GERD treatment for relieving asthma symptoms. Evidence of low strength indicates that the following adverse effects were associated with PPI treatment: diarrhea, nausea or vomiting, abdominal pain, dyspepsia, headache, intestinal infection, pneumonia, and increased risk of bone fracture. Abbreviations: GERD = gastroesophageal reflux disease PPI = proton pump inhibitor Reference: Ip S, Chung M, Moorthy D, et al. Comparative Effectiveness of Management Strategies for Adults With Gastroesophageal Reflux Disease: An Update. Comparative Effectiveness Review No. 29 (Prepared by the Tufts Evidence-based Practice Center under Contract No. HHSA 290-2007-10055-I). Rockville, MD: Agency for Healthcare Research and Quality; September 2011. AHRQ Publication No. 11-EHC049-EF. Available at www.effectivehealthcare.ahrq.gov/gerdupdate.cfm.
  • Findings of the Comparative Effectiveness Review: Surgery (1 of 3) Surgery (fundoplication) is a potential treatment option for patients with GERD. Fundoplication may reduce the need for long-term use of medication. Variations on the surgical approach include laparoscopic total versus partial fundoplication, laparoscopic fundoplication with and without division of short gastric vessels, and open total versus partial fundoplication. Evidence of moderate strength indicates that these various approaches showed no significant differences in effectiveness. Abbreviation: GERD = gastroesophageal reflux disease Reference: Ip S, Chung M, Moorthy D, et al. Comparative Effectiveness of Management Strategies for Adults With Gastroesophageal Reflux Disease: An Update. Comparative Effectiveness Review No. 29 (Prepared by the Tufts Evidence-based Practice Center under Contract No. HHSA 290-2007-10055-I). Rockville, MD: Agency for Healthcare Research and Quality; September 2011. AHRQ Publication No. 11-EHC049-EF. Available at www.effectivehealthcare.ahrq.gov/gerdupdate.cfm.
  • Findings of the Comparative Effectiveness Review: Surgery (2 of 3) Evidence of low strength indicates that older age, morbid obesity, female sex, presence of baseline symptoms or esophagitis, and hiatal hernia >3 centimeters at baseline were inconsistently associated with worse surgical outcomes. Evidence was inconclusive regarding the effectiveness of surgical treatment on extraesophageal manifestations of GERD (e.g., asthma, cough, and laryngeal symptoms). Abbreviation: GERD = gastroesophageal reflux disease Reference: Ip S, Chung M, Moorthy D, et al. Comparative Effectiveness of Management Strategies for Adults With Gastroesophageal Reflux Disease: An Update. Comparative Effectiveness Review No. 29 (Prepared by the Tufts Evidence-based Practice Center under Contract No. HHSA 290-2007-10055-I). Rockville, MD: Agency for Healthcare Research and Quality; September 2011. AHRQ Publication No. 11-EHC049-EF. Available at www.effectivehealthcare.ahrq.gov/gerdupdate.cfm.
  • Findings of the Comparative Effectiveness Review: Surgery (3 of 3) Evidence of low strength indicates that serious adverse effects associated with surgical treatments for GERD included bloating and dysphagia. This same evidence also indicates that fundoplication was associated with procedural complications such as postoperative infections and incisional hernia. Abbreviation: GERD = gastroesophageal reflux disease Reference: Ip S, Chung M, Moorthy D, et al. Comparative Effectiveness of Management Strategies for Adults With Gastroesophageal Reflux Disease: An Update. Comparative Effectiveness Review No. 29 (Prepared by the Tufts Evidence-based Practice Center under Contract No. HHSA 290-2007-10055-I). Rockville, MD: Agency for Healthcare Research and Quality; September 2011. AHRQ Publication No. 11-EHC049-EF. Available at www.effectivehealthcare.ahrq.gov/gerdupdate.cfm.
  • Findings of the Comparative Effectiveness Review: Medication Versus Surgery Many patients with GERD have frequent, severe symptoms that require long-term use of acid-reducing medications. Intermittent (on-demand), periodic, or continuous use of prescription or over-the-counter medications, especially H2RAs and PPIs, may be used. Surgery (fundoplication) is also a potential treatment option that may reduce the need for long-term medication use. Evidence of moderate strength indicates that fundoplication was at least as effective as continued medical treatment (and in some cases superior) in controlling GERD-related symptoms. Five of the seven evaluated studies for this comparison included only patients whose symptoms were already well controlled by medication. However, evidence of low strength indicates that serious adverse effects could be more common for surgery than for medical treatment. Evidence was insufficient to determine whether prevention of long-term complications (such as Barrett’s esophagus and esophageal adenocarcinoma) is equivalent between medical and surgical treatments. Abbreviations: GERD = gastroesophageal reflux disease H2RA = histamine type 2 receptor antagonist PPI = proton pump inhibitor Reference: Ip S, Chung M, Moorthy D, et al. Comparative Effectiveness of Management Strategies for Adults With Gastroesophageal Reflux Disease: An Update. Comparative Effectiveness Review No. 29 (Prepared by the Tufts Evidence-based Practice Center under Contract No. HHSA 290-2007-10055-I). Rockville, MD: Agency for Healthcare Research and Quality; September 2011. AHRQ Publication No. 11-EHC049-EF. Available at www.effectivehealthcare.ahrq.gov/gerdupdate.cfm.
  • Findings of the Comparative Effectiveness Review: Endoscopic Treatments (1 of 2) Recently, endoscopic treatments have been proposed to reduce the need for long-term use of acid-reducing medications in patients with GERD. The original 2005 review on GERD treatments evaluated studies on four endoscopic procedures: the EndoCinch™ Suturing System, Stretta ® , Enteryx™, and the NDO Plicator™. The present updated report excluded Enteryx and the NDO Plicator because they are no longer available in the United States. Stretta was removed from the market but reintroduced in 2010 by a separate manufacturer. Another device, EsophyX™, was commercialized after the original review. Evidence of low strength yielded mixed results regarding the effectiveness of the endoscopic treatment EndoCinch for improving symptoms, quality of life, and healing of esophagitis. No studies directly comparing endoscopic treatments were identified for this update; however, a number of sham-controlled and cohort studies examining the effectiveness of the individual procedures were reviewed. Abbreviation: GERD = gastroesophageal reflux disease Reference: Ip S, Chung M, Moorthy D, et al. Comparative Effectiveness of Management Strategies for Adults With Gastroesophageal Reflux Disease: An Update. Comparative Effectiveness Review No. 29 (Prepared by the Tufts Evidence-based Practice Center under Contract No. HHSA 290-2007-10055-I). Rockville, MD: Agency for Healthcare Research and Quality; September 2011. AHRQ Publication No. 11-EHC049-EF. Available at www.effectivehealthcare.ahrq.gov/gerdupdate.cfm.
  • Findings of the Comparative Effectiveness Review: Endoscopic Treatments (2 of 2) Evidence was insufficient to evaluate endoscopic procedures for GERD other than EndoCinch or to compare endoscopic treatments to medication or surgery. Evidence of low strength indicates that lesser degrees of esophagitis were associated with a reduction in the need for PPIs after endoscopic treatment. Evidence of low strength also indicates that sex did not appear to influence outcomes. Evidence of low strength indicates that the following adverse effects were associated with endoscopic treatments: chest or abdominal pain, bleeding, dysphagia, and bloating. Abbreviations: GERD = gastroesophageal reflux disease PPI = proton pump inhibitor Reference: Ip S, Chung M, Moorthy D, et al. Comparative Effectiveness of Management Strategies for Adults With Gastroesophageal Reflux Disease: An Update. Comparative Effectiveness Review No. 29 (Prepared by the Tufts Evidence-based Practice Center under Contract No. HHSA 290-2007-10055-I ). Rockville, MD: Agency for Healthcare Research and Quality; September 2011. AHRQ Publication No. 11-EHC049-EF. Available at www.effectivehealthcare.ahrq.gov/gerdupdate.cfm.
  • Conclusions In summary, the CER of treatments for GERD found the following: PPIs appear to be superior to H2RAs for the treatment of chronic GERD, but comparisons among different PPIs or among different dosages and dosing regimens of PPIs show few consistent differences. Limited studies suggest that continuous daily dosing provides improved symptom control and quality of life at 6 months when compared to on-demand dosing. Through up to 3 years of followup, surgery is as effective as medication, but serious adverse effects may be more common with surgical treatments. Evidence to evaluate endoscopic treatments is lacking. Medication, surgery, and endoscopic treatments all have associated adverse effects, some of them serious. Abbreviations: CER = comparative effectiveness review GERD = gastroesophageal reflux disease H2RA = histamine type 2 receptor antagonist PPI = proton pump inhibitor Reference: Ip S, Chung M, Moorthy D, et al. Comparative Effectiveness of Management Strategies for Adults With Gastroesophageal Reflux Disease: An Update. Comparative Effectiveness Review No. 29 (Prepared by the Tufts Evidence-based Practice Center under Contract No. HHSA 290-2007-10055-I). Rockville, MD: Agency for Healthcare Research and Quality; September 2011. AHRQ Publication No. 11-EHC049-EF. Available at www.effectivehealthcare.ahrq.gov/gerdupdate.cfm.
  • Knowledge Gaps and Future Research Needs Due to a paucity of studies, the long-term comparative effectiveness of laparoscopic fundoplication versus medical treatments for the management of GERD cannot be determined. This is especially so with regard to adverse effects—the potential for lifelong PPI or H2RA treatment necessitates the study of long-term safety concerns. Most studies do not evaluate options for patients whose disease does not respond well to medications. Evidence is lacking to determine the role and value of endoscopic procedures. Evidence is sparse regarding the treatment of extraesophageal manifestations of GERD (e.g., asthma, cough, and laryngeal symptoms). Behavioral modifications to ameliorate GERD symptoms are not discussed in this report (e.g., smoking cessation, addressing anxiety, or reducing alcohol intake). Abbreviation: GERD = gastroesophageal reflux disease Reference: Ip S, Chung M, Moorthy D, et al. Comparative Effectiveness of Management Strategies for Adults With Gastroesophageal Reflux Disease: An Update. Comparative Effectiveness Review No. 29 (Prepared by the Tufts Evidence-based Practice Center under Contract No. HHSA 290-2007-10055-I). Rockville, MD: Agency for Healthcare Research and Quality; September 2011. AHRQ Publication No. 11-EHC049-EF. Available at www.effectivehealthcare.ahrq.gov/gerdupdate.cfm.
  • What To Discuss With Your Patients Things you should discuss with your patients and their caregivers regarding GERD and its treatment include: - The role that the severity of GERD symptoms plays in determining treatment - The potential risks for complications from untreated GERD - The need for consistent use of GERD medications if prescribed - The availability of GERD treatments without prescription - The U.S. Food and Drug Administration warning about clopidogrel and omeprazole - The effect of obesity on GERD treatment outcomes - The advantages and disadvantages of medical versus surgical GERD treatments Abbreviation: GERD = gastroesophageal reflux disease Reference: Ip S, Chung M, Moorthy D, et al. Comparative Effectiveness of Management Strategies for Adults With Gastroesophageal Reflux Disease: An Update. Comparative Effectiveness Review No. 29 (Prepared by the Tufts Evidence-based Practice Center under Contract No. HHSA 290-2007-10055-I). Rockville, MD: Agency for Healthcare Research and Quality; September 2011. AHRQ Publication No. 11-EHC049-EF. Available at www.effectivehealthcare.ahrq.gov/gerdupdate.cfm.

Comparative Effectiveness of Management Strategies for Adults with Gastroesophageal Reflux Disease Comparative Effectiveness of Management Strategies for Adults with Gastroesophageal Reflux Disease Presentation Transcript

  • Comparative Effectiveness ofManagement Strategies for Adults With Gastroesophageal Reflux Disease: An Update Prepared for: Agency for Healthcare Research and Quality (AHRQ) www.ahrq.gov
  • Outline of Material Introduction to GERD and treatment interventions Systematic review methods The clinical questions addressed by the CER Results of studies and evidence-based conclusions about the effectiveness and harms of GERD treatment Gaps in knowledge and future research needs What to discuss with patients and their caregivers
  • Background: Health Impact of GERD Chronic GERD is one of the most common health conditions affecting Americans. Many patients have frequent, severe symptoms that require long-term, regular use of acid-reducing medications. Considerable uncertainty remains about how the treatment objectives should be achieved for patients with GERD.Ip S, Chung M, Moorthy D, et al. AHRQ Comparative Effectiveness Review No. 29.Available at www.effectivehealthcare.ahrq.gov/gerdupdate.cfm.Brook RA, Wahlqvist P, Kleinman NL, et al. Pharmacol Ther 2007;6(6):889-898. PMID: 17767473.Forgacs I, Loganayagam A. BMJ 2008;336(7634):2-3. PMID: 18174564.
  • Background: Pathophysiology of GERD GERD results from frequent exposure of the esophagus to gastric contents that may be harmful to esophageal epithelium. The physical barrier to reflux is the lower esophageal sphincter, which is anchored by the crural diaphragm. The antireflux barrier may be disrupted by a hiatal hernia or a hypotensive lower esophageal sphincter, alone or in combination.Ip S, Chung M, Moorthy D, et al. AHRQ Comparative Effectiveness Review No. 29.Available at www.effectivehealthcare.ahrq.gov/gerdupdate.cfm.
  • Background: Treatment of GERD (1 of 2) Generally, the goals of therapy for chronic GERD are:  An improvement in symptoms  An improvement in quality of life  Healing of erosive esophagitis  Prevention of complications Medical treatment of GERD often involves intermittent, periodic, or continuous use of medications, especially:  Histamine type 2 receptor antagonists (H2RAs)  Proton pump inhibitors (PPIs) Ip S, Chung M, Moorthy D, et al. AHRQ Comparative Effectiveness Review No. 29. Available at www.effectivehealthcare.ahrq.gov/gerdupdate.cfm.
  • Background: Treatment of GERD (2 of 2) Standard treatment often involves:  An 8-week trial of PPIs.  Lifestyle modification (e.g., weight loss, limiting tobacco and alcohol). Surgical management of GERD, another treatment option, is based on repair and strengthening of the physical antireflux barrier. More recently, endoscopic treatments have been developed, but they are mostly reserved for use in clinical trials. Ip S, Chung M, Moorthy D, et al. AHRQ Comparative Effectiveness Review No. 29. Available at www.effectivehealthcare.ahrq.gov/gerdupdate.cfm.
  • Background: Additional Issues Challenges to the diagnosis of GERD include how to evaluate:  Patients with refractory symptoms.  Patients with extraesophageal presentations. An October 2010 reminder from the U.S. Food and Drug Administration warns that the concomitant use of clopidogrel and the PPI omeprazole (Prilosec®) can result in significant reductions in the antiplatelet activity of clopidogrel. Ip S, Chung M, Moorthy D, et al. AHRQ Comparative Effectiveness Review No. 29. Available at www.effectivehealthcare.ahrq.gov/gerdupdate.cfm.
  • Agency for Healthcare Research and Quality (AHRQ)Comparative Effectiveness Review (CER) Development Topics are nominated through a public process, which includes submissions from health care professionals, professional organizations, the private sector, policymakers, members of the public, and others. A systematic review of all relevant clinical studies is conducted by independent researchers, funded by AHRQ, to synthesize the evidence in a report summarizing what is known and not known about the select clinical issues. The research questions and the results of the report are subject to expert input, peer review, and public comment. The results of these reviews are summarized into Clinician Research Summaries and Consumer Research Summaries for use in decisionmaking and in discussions with patients. The Summaries and the full report, with references for included and excluded studies, are available at www.effectivehealthcare.ahrq.gov/gerdupdate.cfm.
  • Clinical Questions Addressed by the CER (1 of 3) Key Question 1:  What is the evidence of the comparative effectiveness of medical, surgical, and other newer forms of treatments for improving objective and subjective outcomes in patients with chronic GERD?  Is there evidence that effectiveness varies by specific technique, procedure, or medication?  Objective outcomes addressed include esophagitis healing, ambulatory pH monitoring, other indicators of reflux, medication need, healthcare utilization, and incidence of esophageal stricture, Barretts esophagus, or esophageal adenocarcinoma.  Subjective outcomes include symptom frequency and severity, sleep/productivity, and overall quality of life. Ip S, Chung M, Moorthy D, et al. AHRQ Comparative Effectiveness Review No. 29. Available at www.effectivehealthcare.ahrq.gov/gerdupdate.cfm.
  • Clinical Questions Addressed by the CER (2 of 3) Key Question 2:  Is there evidence that effectiveness of medical, surgical, and newer forms of treatments vary for specific patient subgroups?  What are the characteristics of patients who have undergone these therapies, including the nature of previous medical therapy, severity of symptoms, age, sex, weight, and other demographic and medical factors?  What are the provider characteristics for procedures including provider volume and setting (e.g., academic vs. community)? Ip S, Chung M, Moorthy D, et al. AHRQ Comparative Effectiveness Review No. 29. Available at www.effectivehealthcare.ahrq.gov/gerdupdate.cfm.
  • Clinical Questions Addressed by the CER (3 of 3) Key Question 3:  What are the short-term and long-term adverse events associated with specific medical, surgical, and other, newer forms of therapies for GERD?  Does the incidence of adverse events vary with duration of followup, specific surgical intervention, or patient characteristics? Ip S, Chung M, Moorthy D, et al. AHRQ Comparative Effectiveness Review No. 29. Available at www.effectivehealthcare.ahrq.gov/gerdupdate.cfm.
  • Comparative Effectiveness Review Study Criteria(1 of 2) Eligible studies were comparative, randomized, nonrandomized, and cohort studies of adults (≥18 years) with chronic GERD. Studies that focused exclusively on patients with postsurgical GERD; pregnancy-induced GERD; duodenal or peptic ulcer; gastritis; primary esophageal motility disorder; scleroderma; diabetic gastroparesis; radiation esophagitis; Zollinger-Ellison syndrome; Zenker’s diverticulum; previous antireflux surgery; and esophagitis caused by infections, pills, or chemical burns were excluded. Ip S, Chung M, Moorthy D, et al. AHRQ Comparative Effectiveness Review No. 29. Available at www.effectivehealthcare.ahrq.gov/gerdupdate.cfm.
  • Comparative Effectiveness Review Study Criteria(2 of 2) Studies on medical treatment of GERD included randomized controlled trials (RCTs) using a PPI or H2RA for the treatment of acute symptoms or as maintenance therapy. Studies with surgical procedures for GERD included only RCTs or cohort studies examining total (Nissen and Nissen-Rossetti) or partial (Toupet) fundoplication, either as an open or as a laparoscopic procedure. For studies with endoscopic procedures for GERD, only RCTs or cohort studies examining products approved in the United States were included. Ip S, Chung M, Moorthy D, et al. AHRQ Comparative Effectiveness Review No. 29. Available at www.effectivehealthcare.ahrq.gov/gerdupdate.cfm.
  • Rating the Strength of Evidence From the CER The strength of evidence was classified into four broad categories: Ip S, Chung M, Moorthy D, et al. AHRQ Comparative Effectiveness Review No. 29. Available at www.effectivehealthcare.ahrq.gov/gerdupdate.cfm.
  • Findings of the Comparative EffectivenessReview: Medication (1 of 3) Two major comparators: H2RAs and PPIs PPIs were superior to H2RAs for esophagitis healing, patient satisfaction and compliance, and symptom remission. Strength of Evidence = Moderate All of the commercially available PPIs appeared to be similarly effective for relieving symptoms and healing esophagitis for up to 1 year. Strength of Evidence = Moderate Ip S, Chung M, Moorthy D, et al. AHRQ Comparative Effectiveness Review No. 29. Available at www.effectivehealthcare.ahrq.gov/gerdupdate.cfm.
  • Findings of the Comparative EffectivenessReview: Medication (2 of 3) Continuous therapy with a PPI appeared to be more effective than on-demand therapy for symptom control and quality of life in patients with GERD. Strength of Evidence = Moderate Obesity, baseline symptoms, and severe baseline esophagitis were associated with worse outcomes. Older age was associated with improved symptom control. Strength of Evidence = Moderate PPIs demonstrated no difference from placebo in resolving hoarseness but did demonstrate some improvement inconsistently in resolving cough. Strength of Evidence = Low Ip S, Chung M, Moorthy D, et al. AHRQ Comparative Effectiveness Review No. 29. Available at www.effectivehealthcare.ahrq.gov/gerdupdate.cfm.
  • Findings of the Comparative EffectivenessReview: Medication (3 of 3) Findings concerning the effectiveness of treatment of GERD on asthma symptoms were inconsistent. Strength of Evidence = Insufficient Adverse Effects: Potential adverse effects from PPI treatment included diarrhea, nausea or vomiting, abdominal pain, dyspepsia, headache, intestinal infection, pneumonia, and increased risk of bone fracture. Strength of Evidence = Low Ip S, Chung M, Moorthy D, et al. AHRQ Comparative Effectiveness Review No. 29. Available at www.effectivehealthcare.ahrq.gov/gerdupdate.cfm.
  • Findings of the Comparative EffectivenessReview: Surgery (1 of 3) Major comparators:  Laparoscopic total and partial fundoplication  Laparoscopic fundoplication with and without division of short gastric vessels  Open total and partial fundoplication There were no significant differences in effectiveness between the above comparators. Strength of Evidence = Moderate Ip S, Chung M, Moorthy D, et al. AHRQ Comparative Effectiveness Review No. 29. Available at www.effectivehealthcare.ahrq.gov/gerdupdate.cfm.
  • Findings of the Comparative EffectivenessReview: Surgery (2 of 3) Older age, morbid obesity, female sex, presence of baseline symptoms or esophagitis, and a hiatal hernia >3 centimeters at baseline were inconsistently associated with worse surgical outcomes. Strength of Evidence = Low Evidence was inconclusive regarding the effectiveness of surgical treatment on extraesophageal manifestations of GERD. Strength of Evidence = Insufficient Ip S, Chung M, Moorthy D, et al. AHRQ Comparative Effectiveness Review No. 29. Available at www.effectivehealthcare.ahrq.gov/gerdupdate.cfm.
  • Findings of the Comparative EffectivenessReview: Surgery (3 of 3) Adverse Effects: Serious adverse effects included bloating and dysphagia. Fundoplication was also associated with procedural complications such as postoperative infections and incisional hernia. Strength of Evidence = Low Ip S, Chung M, Moorthy D, et al. AHRQ Comparative Effectiveness Review No. 29. Available at www.effectivehealthcare.ahrq.gov/gerdupdate.cfm.
  • Findings of the Comparative EffectivenessReview: Medication Versus Surgery Fundoplication was as effective as continued medical treatment in controlling GERD-related symptoms. Strength of Evidence = Moderate Serious adverse effects could be more common for surgery than for medical treatment. Strength of Evidence = Low Evidence was insufficient to determine whether prevention of long-term complications is equivalent between medical and surgical treatments. Ip S, Chung M, Moorthy D, et al. AHRQ Comparative Effectiveness Review No. 29. Available at www.effectivehealthcare.ahrq.gov/gerdupdate.cfm.
  • Findings of the Comparative EffectivenessReview: Endoscopic Treatments (1 of 2) Three evaluated types: the EndoCinch™ Suturing System, Stretta®, and EsophyX™ A number of sham-controlled and cohort studies examining the effectiveness of the individual procedures were reviewed.  No studies directly comparing endoscopic treatments were identified. Evidence of the effectiveness of the endoscopic treatment EndoCinch was mixed regarding improvement in symptoms, quality of life, and healing of esophagitis. Strength of Evidence: LowIp S, Chung M, Moorthy D, et al. AHRQ Comparative Effectiveness Review No. 29.Available at www.effectivehealthcare.ahrq.gov/gerdupdate.cfm.
  • Findings of the Comparative EffectivenessReview: Endoscopic Treatments (2 of 2) Evidence was insufficient to evaluate endoscopic procedures for GERD other than EndoCinch or to compare endoscopic treatments to medication or surgery. Lesser degrees of esophagitis were associated with a reduction in the need for PPIs after treatment. Sex did not appear to influence outcomes. Strength of Evidence: Low Adverse Effects: Common adverse effects from endoscopic suturing included chest or abdominal pain, bleeding, dysphagia, and bloating. Strength of Evidence: LowIp S, Chung M, Moorthy D, et al. AHRQ Comparative Effectiveness Review No. 29.Available at www.effectivehealthcare.ahrq.gov/gerdupdate.cfm.
  • Conclusions PPIs are superior to H2RAs for the treatment of chronic GERD. Comparisons among different PPIs or among different dosages and dosing regimens of PPIs show few consistent differences. Limited studies suggest that continuous daily dosing provides improved symptom control and quality of life at 6 months when compared to on-demand dosing. Through up to 3 years of followup, surgery is as effective as medication, but serious adverse effects may be more common with surgical treatments. Evidence to evaluate endoscopic treatments is lacking.Ip S, Chung M, Moorthy D, et al. AHRQ Comparative Effectiveness Review No. 29.Available at www.effectivehealthcare.ahrq.gov/gerdupdate.cfm.
  • Knowledge Gaps and Future Research Needs Currently, the long-term (i.e., 5+ years) comparative effectiveness of laparoscopic fundoplication versus medical treatments for GERD cannot be determined. Most studies do not evaluate options for patients whose disease does not respond well to medications. Evidence is lacking to determine the role and value of endoscopic procedures. Evidence is sparse regarding the prevention of long-term complications or the treatment of extraesophageal manifestations of GERD. Behavioral modifications to ameliorate GERD symptoms are not discussed in this report.Ip S, Chung M, Moorthy D, et al. AHRQ Comparative Effectiveness Review No. 29.Available at www.effectivehealthcare.ahrq.gov/gerdupdate.cfm.
  • What To Discuss With Your Patients The need for consistent use of GERD medications if prescribed The availability of GERD treatments without a prescription The U.S. Food and Drug Administration warning about clopidogrel and omeprazole The effect of obesity on GERD treatment outcomes The advantages and disadvantages of medical versus surgical GERD treatmentsIp S, Chung M, Moorthy D, et al. AHRQ Comparative Effectiveness Review No. 29.Available at www.effectivehealthcare.ahrq.gov/gerdupdate.cfm.