Difficult Issues in Dyspepsia and GERD
Difficult Issues in Dyspepsia and GERD
Orlando, Wednesday, May 21, 2003 -- Dyspepsia, defined as pain or discomfort centered in the upper abdomen, is a common condition in primary care. Approaches to the management of dyspepsia have undergone evolution in recent years. Several areas in gastroesophageal reflux disease (GERD) management remain contentious. Proton-pump inhibitors (PPIs) are widely used, but nonresponders to PPI therapy are common in gastroenterology practice. Patients with complications after laparoscopic fundoplication are frequently encountered in gastroenterology practices and there are few data on the management of this population.
This report addresses some of the more key presentations on these topic areas, as held during core meeting proceedings Tuesday and Wednesday at Digestive Disease Week 2003.
Dyspepsia Helicobacter pylori Infection, Dyspepsia, and Nonulcer Dyspepsia
Test-and-treat strategies for the eradication of H pylori have been shown to be cost-effective in primary care settings for patients with uninvestigated dyspepsia. However, eradication therapy remains controversial in patients with nonulcer dyspepsia. Two recent meta-analyses have yielded conflicting results and there is uncertainty regarding how effective eradication therapy is in the setting of nonulcer dyspepsia. Recent studies suggest that eradication therapy is associated with a 9% risk reduction in dyspeptic symptoms and that 1 patient responds for every 15 treated (number needed to treat = 15).
PPI Therapy
Randomized, controlled trials have shown that PPIs may be effective in alleviating symptoms of dyspepsia, but variable results have been reported in different studies. A meta-analysis of PPI therapy suggested that the relative risk reduction was 9% and the number needed to treat was 9. However, publication bias may account for the generally optimistic results reported in the literature. Cost-effectiveness studies suggest that testing and treating for H pylori and empirical use of a PPI may be cost-effective in the treatment of functional dyspepsia. Low-dose PPI therapy may be as effective as higher doses.
Improve Motility
Meta-analyses of studies using cisapride have suggested that this drug is effective in the treatment of dyspepsia, but these studies are small, and substantial bias may exist in the selection of investigations used in publications. Recent developments include the use of drugs that enhance fundic relaxation, and agents such as sumatriptan and tegaserod may be effective in treating some forms of dyspepsia.
Centrally Acting Therapies
Antidepressants may be useful in treating some patients with dyspepsia; however, data are limited. Hypnotherapy has been shown to be effective and cognitive behavioral therapy is also effective. The latter may be time-consuming and costly.
Difficult Issues in GERD Is GERD a Progressive Disease?
Our knowledge of disease progression in GERD remains limited. It is likely that most patients with nonerosive reflux disease remain in this category and do not progress to erosive disease. The widespread availability of medical therapy clearly alters the natural history of the disease, and most patients presenting with GERD symptoms in primary and tertiary care settings have nonerosive disease. The availability of PPIs has also changed the need for esophageal dilation, with a marked decrease seen after PPIs were introduced in the United States.
PPI Failures
Many patients referred to gastroenterologists have heartburn that has failed conventional single- or double-dose PPI therapy. These patients are a challenge, and current diagnostic tests suggest that many of them do not have persistent acid reflux. The development of impedance catheters that allow measurement of nonacid reflux (liquid or gas) may be an important development, because medical treatment that inhibits transient lower esophageal sphincter relaxations is now available (baclofen).
Symptoms After Antireflux Surgery
There is a surprising lack of information on the management of complications after surgery. Dysphagia is reported by 50% of patients soon after antireflux surgery, but persistent dysphagia is reported in 3% to 30% of patients in various studies. Manometric investigations may be helpful, and patients with manometric findings of achalasia may benefit from balloon dilation. The safety of the latter procedure in the postoperative situation has not been completely clarified, however.
Endoscopic Therapies: Are They Ready for Widespread Use?
Although many endoscopic techniques have been approved by the US Food and Drug Administration (Endocinch, Stretta procedure, Enteryx injection therapy), substantial questions remain. There is little information regarding how these treatment strategies compare with conventional medical therapy. Sham-controlled trials have only been performed with the Stretta procedure, and questions remain about the true therapeutic gain with these techniques. The end points used in trials have also been criticized because they may not measure appropriate end points in reflux disease. For example, some investigations have used discontinuation of PPI therapy as an end point, but this criterion may not accurately reflect symptoms. In the sham Stretta trial, approximately one third of patients in the sham group discontinued PPI therapy.
Intraesophageal pH returns to normal in a proportion of patients with GERD, but many individuals continue to have reflux into the esophagus. Changes in compliance at the level of the lower esophageal sphincter may be the mechanism by which some of these endoscopic techniques work, but destruction of sensory nerves that mediate heartburn may also play a role.
Please note: The following announcement supercedes any information contained in this article. On September 23, 2005, Boston Scientific issued a recall of all Enteryx Procedure Kits and Enteryx Injector Single Packs from commercial distribution. Serious adverse events, including death, occurred in patients treated with Enteryx, a liquid chemical polymer which is intended to be injected into the lower esophageal sphincter for treatment of gastroesophageal reflux disease. The serious adverse events involve unrecognized transmural injections of Enteryx into structures surrounding the esophagus.
References
Orlando, Wednesday, May 21, 2003 -- Dyspepsia, defined as pain or discomfort centered in the upper abdomen, is a common condition in primary care. Approaches to the management of dyspepsia have undergone evolution in recent years. Several areas in gastroesophageal reflux disease (GERD) management remain contentious. Proton-pump inhibitors (PPIs) are widely used, but nonresponders to PPI therapy are common in gastroenterology practice. Patients with complications after laparoscopic fundoplication are frequently encountered in gastroenterology practices and there are few data on the management of this population.
This report addresses some of the more key presentations on these topic areas, as held during core meeting proceedings Tuesday and Wednesday at Digestive Disease Week 2003.
Dyspepsia Helicobacter pylori Infection, Dyspepsia, and Nonulcer Dyspepsia
Test-and-treat strategies for the eradication of H pylori have been shown to be cost-effective in primary care settings for patients with uninvestigated dyspepsia. However, eradication therapy remains controversial in patients with nonulcer dyspepsia. Two recent meta-analyses have yielded conflicting results and there is uncertainty regarding how effective eradication therapy is in the setting of nonulcer dyspepsia. Recent studies suggest that eradication therapy is associated with a 9% risk reduction in dyspeptic symptoms and that 1 patient responds for every 15 treated (number needed to treat = 15).
PPI Therapy
Randomized, controlled trials have shown that PPIs may be effective in alleviating symptoms of dyspepsia, but variable results have been reported in different studies. A meta-analysis of PPI therapy suggested that the relative risk reduction was 9% and the number needed to treat was 9. However, publication bias may account for the generally optimistic results reported in the literature. Cost-effectiveness studies suggest that testing and treating for H pylori and empirical use of a PPI may be cost-effective in the treatment of functional dyspepsia. Low-dose PPI therapy may be as effective as higher doses.
Improve Motility
Meta-analyses of studies using cisapride have suggested that this drug is effective in the treatment of dyspepsia, but these studies are small, and substantial bias may exist in the selection of investigations used in publications. Recent developments include the use of drugs that enhance fundic relaxation, and agents such as sumatriptan and tegaserod may be effective in treating some forms of dyspepsia.
Centrally Acting Therapies
Antidepressants may be useful in treating some patients with dyspepsia; however, data are limited. Hypnotherapy has been shown to be effective and cognitive behavioral therapy is also effective. The latter may be time-consuming and costly.
Difficult Issues in GERD Is GERD a Progressive Disease?
Our knowledge of disease progression in GERD remains limited. It is likely that most patients with nonerosive reflux disease remain in this category and do not progress to erosive disease. The widespread availability of medical therapy clearly alters the natural history of the disease, and most patients presenting with GERD symptoms in primary and tertiary care settings have nonerosive disease. The availability of PPIs has also changed the need for esophageal dilation, with a marked decrease seen after PPIs were introduced in the United States.
PPI Failures
Many patients referred to gastroenterologists have heartburn that has failed conventional single- or double-dose PPI therapy. These patients are a challenge, and current diagnostic tests suggest that many of them do not have persistent acid reflux. The development of impedance catheters that allow measurement of nonacid reflux (liquid or gas) may be an important development, because medical treatment that inhibits transient lower esophageal sphincter relaxations is now available (baclofen).
Symptoms After Antireflux Surgery
There is a surprising lack of information on the management of complications after surgery. Dysphagia is reported by 50% of patients soon after antireflux surgery, but persistent dysphagia is reported in 3% to 30% of patients in various studies. Manometric investigations may be helpful, and patients with manometric findings of achalasia may benefit from balloon dilation. The safety of the latter procedure in the postoperative situation has not been completely clarified, however.
Endoscopic Therapies: Are They Ready for Widespread Use?
Although many endoscopic techniques have been approved by the US Food and Drug Administration (Endocinch, Stretta procedure, Enteryx injection therapy), substantial questions remain. There is little information regarding how these treatment strategies compare with conventional medical therapy. Sham-controlled trials have only been performed with the Stretta procedure, and questions remain about the true therapeutic gain with these techniques. The end points used in trials have also been criticized because they may not measure appropriate end points in reflux disease. For example, some investigations have used discontinuation of PPI therapy as an end point, but this criterion may not accurately reflect symptoms. In the sham Stretta trial, approximately one third of patients in the sham group discontinued PPI therapy.
Intraesophageal pH returns to normal in a proportion of patients with GERD, but many individuals continue to have reflux into the esophagus. Changes in compliance at the level of the lower esophageal sphincter may be the mechanism by which some of these endoscopic techniques work, but destruction of sensory nerves that mediate heartburn may also play a role.
Please note: The following announcement supercedes any information contained in this article. On September 23, 2005, Boston Scientific issued a recall of all Enteryx Procedure Kits and Enteryx Injector Single Packs from commercial distribution. Serious adverse events, including death, occurred in patients treated with Enteryx, a liquid chemical polymer which is intended to be injected into the lower esophageal sphincter for treatment of gastroesophageal reflux disease. The serious adverse events involve unrecognized transmural injections of Enteryx into structures surrounding the esophagus.
References
Chey D. Kill the bug. In: AGA Clinical Symposium -- Dyspepsia management: Drugs, bugs, or padded rooms? Program and abstracts of Digestive Disease Week 2003; May 18-21, 2003; Orlando, Florida. [Sp521]
Vakil NB. Block the pump. In: AGA Clinical Symposium -- Dyspepsia management: Drugs, bugs, or padded rooms? Program and abstracts of Digestive Disease Week 2003; May 18-21, 2003; Orlando, Florida. [Sp522]
Moayyedi P, Vakil N, Delaney B. A systematic review and economic analysis of the cost-effectiveness of proton pump inhibitor therapy in non-ulcer dyspepsia. Gastroenterology. 2003;124:A-182. [Poster # S1252]
Talley NJ. Improve motility. In: AGA Clinical Symposium -- Dyspepsia management: Drugs, bugs, or padded rooms? Program and abstracts of Digestive Disease Week 2003; May 18-21, 2003; Orlando, Florida. [Sp523]
Olden K. Modulate visceral sensitivity. In: AGA Clinical Symposium -- Dyspepsia management: Drugs, bugs, or padded rooms? Program and abstracts of Digestive Disease Week 2003; May 18-21, 2003; Orlando, Florida. [Sp524]
Ofman J. The natural history of GERD. Can the disease progress? In: AGA Clinical Symposium -- GERD: Unresolved issues. Program and abstracts of Digestive Disease Week 2003; May 18-21, 2003; Orlando, Florida. [Sp383]
Guda N, Vakil N. Proton pump inhibitors and the time trends of esophageal dilation and upper gastrointestinal endoscopy. Gastroenterology. 2003;124:A-535. [Poster # T1625]
Fass R. PPI failures: what to do? In: AGA Clinical Symposium -- GERD: Unresolved issues. Program and abstracts of Digestive Disease Week 2003; May 18-21, 2003; Orlando, Florida. [Sp384]
Spechler S. Management of symptoms after anti-reflux surgery? In: AGA Clinical Symposium -- GERD: Unresolved issues. Program and abstracts of Digestive Disease Week 2003; May 18-21, 2003; Orlando, Florida. [Sp385]
Hogan W. Endoscopic therapies: Side show or ready for prime time? In: AGA Clinical Symposium -- GERD: Unresolved issues. Program and abstracts of Digestive Disease Week 2003; May 18-21, 2003; Orlando, Florida. [Sp386]
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