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Symptoms and Outcomes: Managing Acid-Related Disorders

Symptoms and Outcomes: Managing Acid-Related Disorders

Gastroesophageal reflux disease [GERD] is an exceedingly common syndrome, affecting between 10% and 48% of the general population (Heading, Scand J Gastroenterol 1999). Primary care clinicians need to know how to recognize and diagnose this disease, to provide effective treatment to eliminate symptoms, heal erosive esophagitis, and prevent associated esophageal and extraesophageal complications,” said Edward G. Zurad, MD, Clinical Assis-tant Professor, Department of Family Practice and Community Health, Temple University, in Philadelphia, Pennsylvania. Dr. Zurad noted that objective diagnostic measures are frequently helpful for GERD, as symptoms do not necessarily correlate with severity of disease.

GERD Symptoms and Manifestations
Gastroesophageal reflux disease, also called GERD, is defined as chronic symptoms or mucosal damage produced by the abnormal reflux of gastric contents into the esophagus (DeVault & Castell, Am J Gastroenterol 1999). While the cause of GERD is not always clearly understood, several factors may be involved. These include decreased lower esophageal sphincter (LES) pressure and LES relaxation, allowing refluxate to enter the esophagus; slower acid clearance allowing refluxate to remain in the esophagus; and acid and/or bile efluxate (most commonly acid) injuring the esophageal mucosa.

While the hallmark symptom of GERD is heartburn, patients may present with a number of esophageal and extraesophageal signs and symptoms (Table 1) (Clark et al, Postgrad Med 1996; DeVault & Castell, Am J Gastroenterol 1999). Multinational studies show that up to 59% of persons with GERD have heartburn, regurgitation, or both (Heading, Scan J Gastroenterol 1999). In addition, certain factors—such as diet and exercise habits—can aggravate or exacerbate heartburn (Table 2) (Katz, Am J Gastroenterol 1999; Scott et al, Am Fam Physician 1999; Szarka et al, Postgrad Med 1999).

Potential esophageal manifestations of GERD include erosive esophagitis, esophageal ulcers (stellate or linear), peptic strictures, Barrett’s esophagus, and esophageal adenocarcinoma. “Barrett’s esophagus is basically a metaplastic process, by which continuous bathing of the distal esophagus with acidic contents results in a transformation of normal squamous epithelium to columnar epithelium,” Dr. Zurad explained. Barrett’s esophagus is, in turn, a risk factor for evolution to esophageal adenocarcinoma, requiring frequent surveillance. Potential extraesophageal manifestations or complications of GERD include adult-onset asthma, chronic cough, reflux laryngitis, non-cardiac chest pain, dental erosion, and pulmonary fibrosis (Table 3) (Clark et al, Postgrad Med 1996).

In evaluating for GERD, clinicians may use a number of diagnostic tools, including a thorough patient history, 24-hour pH test, upper endoscopy examination, and proton pump inhibitor (PPI) therapy test. In taking a patient history, clinicians should be sensitive to a patient’s understanding of his or her symptoms. “Importantly, patients often misinterpret the terms heartburn and regurgitation. Thus, clinicians need to provide clear descriptors when asking about these and other symptoms,” Dr. Zurad noted. Heartburn can be described as “a burning feeling rising from the stomach or lower chest up toward the neck” (Carlsson et al, Scand J Gastroenterol 1998). Regurgitation may be characterized as the effortless return of acid from the stomach into the throat and mouth. This process is distinguished from vomiting by the absence of both nausea and effort (Younes et al, Gastroenterol Clin N Am 1999). That is, regurgitation typically occurs without warning or effort, whereas vomiting is usually associated with some advance notice (eg, nausea, abdominal pain) as well as pharyngeal and mouth activity in propelling the emesis.

In addition, clinicians need to be aware of the role of empiric therapy in the diagnosis of GERD. “Prescribing a 2- to 3-week course of proton pump inhibitor therapy is a practical and cost-effective test for GERD, particularly in patients with specific GERD symptoms, such as heartburn and regurgitation (Richter, Am J Gastroenterol 2000). In these patients, improvement of symptoms is rapid and is indicative of GERD. However, in those with less specific and extraesophageal manifestations of disease—such as cough, asthma, or laryngitis—a longer period of PPI therapy may be needed to observe an improvement in these symptoms,” Dr. Zurad said.

The Role of Empiric Therapy
The treatment goals for GERD are three-fold: to eliminate symptoms, to heal erosive esophagitis, and to prevent associated esophageal and extraesophageal complications. Traditional treatment options for GERD include lifestyle modification, pharmacologic management, and antireflux surgery. Pharmacologic therapy includes acid-suppressive agents, such as antacids, histamine2-receptor antagonists (H2RAs), promotility agents, and PPIs.

In many cases, empiric therapy may be an appropriate option for diagnosis and treatment. According to American College of Gastroenterology guidelines, in patients with a history typical for uncomplicated GERD, an initial trial of empiric therapy (with lifestyle modification) is appropriate. For those in whom empiric therapy is unsuccessful or those who have symptoms suggestive of complicated disease, further diagnostic testing is recommended. In addition, select individuals who have long-standing symptoms or who require continuous therapy may need endoscopic testing for Barrett’s esophagus (DeVault & Castell, Am J Gastroenterol 1999).

Options for empiric therapy include the step-up and step-down approaches (Figure 1). The step-up approach is often characterized as starting low and going slow, offering lifestyle modification and over-the-counter medication initially and moving step-wise up to PPI therapy. “However, the step-down method is now gaining prominence as an efficacious and cost-effective option. This approach involves hitting the disease hard from the beginning, using first-line PPI therapy, then rapidly stepping down to less potent therapies as symptoms resolve,” Dr. Zurad explained.

The Role of Endoscopy
An upper endoscopy examination may be required for three groups of patients: 1) those who do not respond to empiric therapy, 2) those who have alarm symptoms, suggestive of complicated GERD, and 3) those who are at increased risk for Barrett’s esophagus. According to Dr. Zurad, alarm symptoms suggestive of complicated disease include dysphagia, odynophagia, weight loss, blood in the stool, and iron-deficiency anemia. Patients at increased risk for Barrett’s esophagus include those who are 50 years or older and those who have continuous GERD for more than 5 years. “Even in these patients, initiating empiric PPI therapy can help to alleviate symptoms and minimize inflammation in the distal esophagus to allow for optimal visualization during upper endoscopy,” Dr. Zurad said.

In these three groups of patients with suspected GERD, endoscopic examination can provide a wealth of diagnostic information and direction for treatment. According to Dr. Zurad, if esophagitis is found, a GERD diagnosis is established and therapy is initiated. If an esophageal stricture is observed, PPI therapy is initiated and dilatation may be required. If Barrett’s esophagus is identified, PPI therapy is initiated and an endoscopic surveillance program is established. “In cases of dysplasia, photodynamic therapy or esophagectomy may be considered after consultation with a Barrett’s specialist,” Dr. Zurad said. Interestingly, in persons with GERD, endoscopic findings and symptoms are not necessarily correlated. Research has shown that symptom severity does not correlate with Los Angeles classification of erosive esophagitis grade, nor does heartburn severity predict the presence of erosive esophagitis (Lundell et al, Gut 1999; Venables et al, Scand J Gastroenterol 1997).

Treatment Options and Management
The treatment of GERD symptoms consists of a multipronged strategy, including lifestyle modification (Table 4), pharmacologic therapy, and, in a carefully selected subgroup of patients, surgery. Lifestyle modification (including avoidance of acidic and fatty foods, chocolate, and peppermint; eating small, frequent meals; restricting alcohol; quitting smoking; losing weight; and elevating the head of the bed) may be effective in some patients, but is rarely effective as monotherapy. Indeed, the American College of Gastroenterology recommends lifestyle modification strategies throughout the course of GERD therapy.

In addition to lifestyle modification, empiric pharmacologic therapy is often initiated to treat GERD. If symptoms do not resolve or recur, second-line treatment depends upon endoscopy results. In patients with no or LA grade A or B erosive disease, step-down long-term therapy is initiated, or antireflux surgery may be considered. In patients with LA grade C or D erosive esophagitis, high-dose PPI therapy, a PPI plus H2RA combination therapy, or surgery are options (Dent et al, Gut 1999; Katz, Am J Gastroenterol 1999).

According to Dr. Zurad, clinicians need to consider carefully which acid-suppressive therapy is right for each patient. H2RAs are often effective in patients with endoscopy-negative disease, and provide relief of heartburn and esophageal injury in 50% of patients after 1 year (Katz, Am J Gastroenterol 1999). Prokinetic therapies, such as metoclopramide, are effective in increasing esophageal and gastrointestinal motility. However, said Dr. Zurad, clinicians need to be mindful of possible cognitive effects, which occur in a significant percentage of geriatric patients taking metoclopramide.

PPI therapy has been shown to provide superior GERD symptom and esophageal esophagitis healing compared with H2RAs and placebo. In addition, continuous PPI therapy often maintains symptom relief and healing in patients whose disease is refractory to H2RA treatment. Available PPI agents include omeprazole (20 mg every morning), lansoprazole (30 mg every morning), pantoprazole (40 mg every morning), rabeprazole (20 mg every morning), and esomeprazole (40 mg every morning). Esomeprazole (88%-94%), lansoprazole (55%-90%), and omeprazole (83%-86%) have shown efficacy in maintaining healing of erosive esophagitis (Vakil et al, Aliment Pharmacol Ther 2001; Johnson et al, Am J Gastroenterol 2001; Lansoprazole package insert 2003; Omeprazole package insert 2003). In addition, omeprazole (10 mg and 20 mg) has been shown to enhance quality of life over placebo in patients with non-erosive reflux disease (Havelund et al, Am J Gastroenterol 1999).

In one study, four therapeutic strategies to alleviate heartburn were compared. The groups included those receiving continuous lansoprazole 30 mg/day; continuous ranitidine 150 mg bid; step-up therapy (ranitidine for 8 wks, then lansoprazole for 12 wks); and step-down therapy (lansoprazole for 8 wks, then ranitidine for 12 wks). After 20 weeks, the best results were found in those groups receiving continuous lansoprazole or the step-down therapy approaches. “These findings may indicate the need to consider use of the step-down therapy approach, which not only results in increased efficacy but also a shifting of the economic burden from long-term to initial therapy for patients with uncomplicated GERD,” Dr. Zurad noted. In contrast, patients who are most likely to benefit from the step-up approach include those who are younger than age 60, and who present with severe heartburn. According to Dr. Zurad, continuity of care is a key component, as many of these patients may relapse within 2 to 3 months.

In addition, Dr. Zurad noted that several new endoscopic procedures are available for use in patients with GERD. One such procedure is the Bard EndoCinch™ procedure, a Food and Drug Administration (FDA)-approved endoscopic suturing technique. Another procedure is the Stretta™ system, an FDA-approved radiofrequency energy technique. New submucosal bulking procedures are also under study, with the Enteryx™ procedure currently under FDA review. This technique involves injection of inert ethylene vinyl alcohol into the esophagus to enhance the esophageal barrier. “These new techniques offer promise for the treatment of GERD, but long-term efficacy and safety data are needed,” Dr. Zurad noted.

Finally, antireflux surgery may be an appropriate option for a carefully selected subgroup of patients with GERD. “It is essential that antireflux surgery be performed by an experienced surgeon, and only as a maintenance option for well informed patient with well documented GERD,” Dr. Zurad said (Dent et al, Gut 1999; DeVault & Castell, Am J Gastroenterol 1999). According to Dr. Zurad, antireflux surgery should only be considered in persons with GERD documented by pH testing and endoscopy, persistence of symptomatic esophagitis after medical therapy, persistence of aspiration symptoms, and/or reluctance to continue long-term medical therapy. Many experts recommend manometry prior to a surgical decision. Patients who are most likely to respond well to surgery are those who presented with typical GERD symptoms and had complete suppression of symptoms with medical therapy. In addition, clinicians need to ensure that patients understand the potential effects of a successful and unsuccessful surgery.

Antireflux surgery has a 50% to 90% success rate, with up to 62% of patients after 10 years and 32% after 10 to 30 months requiring re-start of acid-suppressive medical therapy. In addition, 16% of patients have been shown to undergo more than one antireflux surgery within 10 years. Side effects and new symptoms are a risk, with 11% of patients requiring esophageal dilatation for dysphagia and 67% reporting new symptoms after surgery. Adverse effects with surgery can include excessive gas, dysphagia, bloating, and rarely complications-related death (0.2%). As many as 5% to 29% of patients ultimately experience a recurrence of esophagitis 3 to 7 years after surgery (Spechler et al, JAMA 2001; Vakil et al, Am J Med 2003; Kahrilas, Semin Gastrointest Dis 2001). Ultimately, Spechler and colleagues investigated patient satisfaction with antireflux surgery versus medical therapy, and found that 89% of those undergoing surgery compared with 96% of those receiving medical therapy, reported being very satisfied or satisfied with their treatment (Spechler et al, JAMA 2001). “Surgery can be an option for certain patients with GERD, as long as they meet the selection criteria and are fully informed of the potential benefits and risks,” Dr. Zurad summarized.

Conclusion
GERD, characterized by multiple symptom presentation, is a challenging disease to treat and manage. Clinicians need to be aware of the potential for erosive esophagitis in patients with GERD symptoms, but note that symptom severity does not predict the presence of erosive esophagitis. While surgical and endoscopic procedures offer options for treatment and maintenance, acid-suppressive medical therapy is the mainstay for GERD treatment. New research indicates that a step-down approach, utilizing initial high-dose PPI therapy and scaling back to less potent drugs, may be an efficacious and cost-effective treatment strategy for GERD. “Ultimately, clinicians need to consider which approach is right for each individual, to ensure optimal efficacy and quality of life for patients with GERD,” Dr. Zurad concluded.

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