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Diagnostic Dilemmas: Changing Perspectives in GERD Management

Defining ENT-Related Symptoms: A Case-Based Approach

“The prevalence of gastroesophageal reflux disease [GERD] in persons with a voice disorder may be as high as 50%; therefore, clinicians need to conduct the differential diagnosis in these patients with a high index of suspicion that GERD may be a contributing factor,” said Peter C. Belafsky, MD, PhD, MPH, Director, Scripps Center for Voice and Swallowing, La Jolla, California. Using a patient case study and with permission of the patient, Dr. Belafsky provided an overview of the diagnosis and treatment of GERD-related ear, nose, and throat manifestations (Koufman et al. Otolaryngol Head Neck Surg 2000; 123(4):385-8).

Patient History
After providing relief at the World Trade Center site in September 2001, LC, a 44-year-old California firefighter, began experiencing ear, nose, and throat symptoms. LC presented to a physician with a 16-month history of intermittent dysphonia, globus, excessive throat clearing, dry unproductive cough, wheezing, and dyspnea on exertion. The patient did not report having heartburn. Chest x-ray, high-resolution chest computed tomography (CT) scan, bronchoscopy, and pulmonary function tests were negative. At that time, LC was diagnosed with reactive airway dysfunction syndrome, or occupational asthma, as defined by Brooks and colleagues (Brooks et al. Chest 1985;88:376-84). LC was treated with several oral inhaler agents, including corticosteroids (fluticasone propionate) and bronchodilators (ipratropium bromide, albuterol).

Continued Symptomatology: Differential Diagnosis
When LC finally presented to Dr. Belafsky, he was still symptomatic in terms of cough, respiratory complaints, and worsening dysphonia. “LC reported feeling like he was being choked, which is common in patients having laryngospasm,” Dr. Belafsky explained. In addition, LC’s predominant complaints—intermittent dysphonia and laryngospasm-type symptoms—were interfering with his day-to-day functioning.

Administration of the Reflux Symptom Index, a nine-item self-administered outcomes survey, revealed a markedly high score of 24 of a possible 0 to 45. This instrument was previously validated, and shown to produce a median score of 10 in the general population. In addition, using the gold standard of extraesophageal pH monitoring, the predictive value [for reflux] of a symptom index score greater than 10 is approximately 85%,” Dr. Belafsky reported (Belafsky et al. Laryngoscope 2001;111: 979-81). The Reflux Finding Score, an outcome instrument used to quantify endoscopic findings of laryngeal inflammation, also previously validated, yielded a similarly high score of 10 (Belafsky et al. Laryngoscope 2001;111:1313-17. Belafsky et al. Otolaryngol Head Neck Surg 2002;126:649-52).

Head and neck examination revealed hypertrophied inferior turbinates upon strobovideolaryngoscopy. “Impor-tantly, the patient also had edema of the undersurface of the vocal fold. This finding alone can be 80% sensitive in diagnosing pH-documented laryngopharyn- geal reflux,” Dr. Belafsky noted. Unsedated transnasal esophagoscopy showed high-grade erosive esophagitis. According to Dr. Belafsky, only 12% of patients with GERD-related extra-esophageal symptoms have esophagitis (Koufman et al. Laryngoscope 2002; 112(9):1606-9). Forty-eight-hour wireless pH testing revealed a composite score of 35 (normal < 14.72) and a 99% symptom association probability for cough.

Based on these clinical findings, LC was diagnosed with major laryngopharyngeal reflux disease.

Treatment and Outcome
Based on his diagnosis of major laryngopharyngeal reflux, LC was treated with a proton pump inhibitor (PPI) twice daily; a histamine2 receptor antagonist (H2RA) once per day at night; and a nasal antihistamine spray twice daily. LC’s cough resolved in 6 days, his throat-clearing in 6 weeks. “The dysphonia resolved once the patient was weaned off of inhaled corticosteroids,” Dr. Belafsky said.

Dr. Belafsky noted that he typically treats patients according to whether they have “minor laryngopharyngeal reflux” (bothersome symptoms, no effect on quality of life) or “major laryngopharyngeal reflux” (severe symptoms, effect on quality of life). Dr. Belafsky and colleagues typically treat patients with major disease, beginning with twice daily PPI therapy and an H2RA for nocturnal acid breakthrough. Treatment for minor disease may involve use of a PPI or an H2RA.

In closing, Dr. Belafsky emphasized the need for clinicians to consider reflux as a contributing factor to ear, nose, and throat symptomatology. “Appropriate acid suppressive therapy can result in effective resolution of symptoms and have a profound impact on quality of life in patients with reflux—as was observed in our firefighter with major laryngopharyngeal reflux disease,” he concluded.

Distinguishing Impaired Quality of Sleep and Sleep Disturbances

In persons who report daytime heartburn three to four times per week, 75% also have nocturnal heartburn (Shaker et al. Am J Gastroenterol 2003;98:1487-93). “Thus, of the 4% to 5% of Americans who experience heartburn on a daily basis, it can be estimated that 1.5% to 2% also have significant nighttime reflux,” according to William C. Orr, PhD, President and CEO, Lynn Health Science Institute, and Clinical Professor of Medicine, University of Oklahoma Health Sciences Center, Oklahoma City (Shaker et al. Am J Gastroenterol 2003;98:1487-93). Dr. Orr presented the case study of a patient with daytime and nighttime heartburn, demonstrating the relationship between gastroesophageal reflux disease (GERD), nocturnal reflux, and sleep disburbances.

Patient History
GW, a 46-year-old male, 5’7” in height and 232 pounds in weight, presented with GERD symptoms and overlapping sleep disorder. GW’s past medical history included borderline diabetes, and significant daytime heartburn that began at about 16 years old. His heartburn was exacerbated by spicy food, caffeine, and stress. GW saw a physician who diagnosed him with gastritis and treated him with promethazine. He was subsequently treated with ranitidine, which resulted in considerable relief. “Although the relief was not complete with ranitidine, the patient reported that this therapy ‘took the edge off’,” Dr. Orr explained. However, at age 18, GW became medically indigent, stopped taking ranitidine, and treated his heartburn with only over-the-counter antacids for several years, experiencing quick but temporary relief. In his early to mid 20s, GW underwent a period of heavy alcohol use. Also in his mid 20s, GW began experiencing nighttime heartburn, awakening with heartburn or regurgitation at least four times per week.

Differential Diagnosis, Treatment, and Outcome
In his mid 40s, GW presented to Dr. Orr with nighttime symptoms and overlapping sleep disturbance. “The patient characterized his symptoms as a choking sensation or acid taste in his mouth,” said Dr. Orr, adding that the patient commented that “you feel burning down in your lungs.” Importantly, GW also complained of a classic symptom of sleep disturbance: non-restorative sleep. “The patient reported feeling unrefreshed upon awakening in the morning, and tired and irritable during the day,” Dr. Orr explained.

Because GW was medically indigent, Dr. Orr admitted him to a research study investigating use of daily proton pump inhibitor (PPI) therapy. Baseline endoscopy revealed severe erosive esophagitis. After 4 weeks of daily PPI therapy, GW had partial healing, and after 8 weeks, complete healing of his erosive esophagitis (Figure 1). The patient also reported immediate resolution of his nighttime symptoms, improved sleep, and elimination of daytime symptoms of irritability and tiredness.

Nocturnal Reflux: Other Considerations
Nocturnal GERD is often interrelated with sleep disturbance: acid is infused into the distal esophagus during sleep, inducing an arousal response to protect from the serious effects of acid mucosal contact. However, because swallowing and salivary flow are markedly diminished during sleep, acid mucosal contact still can be prolonged, increasing the risk for erosive esophagitis and extraesophageal complications (Orr. Am J Med 2003;115:109-13).

In closing, Dr. Orr stressed the need for clinicians to ask all patients with daytime GERD symptoms about possible nocturnal manifestations as well. “It is important to note that, while nighttime heartburn is indicative of acid mucosal contact, many patients also have silent reflux—with one of the most common indicators of silent reflux being unrefreshed sleep,” Dr. Orr concluded.

Endoscopic Solutions in the Diagnosis and Treatment of GERD

Several treatment modalities are currently available for persons with gastroesophageal reflux disease (GERD), including lifestyle modification, pharmaceutical therapies, antireflux surgery, and newer endoscopic techniques. “A number of endoscopic procedures are now being used, and research continues in order to develop more effective techniques for patients with GERD,” said Jeffrey Lee, MD, Associate Professor of Medicine, MD Anderson Cancer Center, Houston. According to Dr. Lee, endoscopic techniques must be evaluated according to their own risks, benefits, and suitability for each individual
patient.

Surgery: Risks and Benefits
Fundoplication for patients with GERD is successful in 76% to 98% of cases; results in elimination of the need for antisecretory drugs in 90%; improves quality of life scores; and leads to resolution of esophagitis in 75%. However, the procedure can also be associated with dysphagia in 4% to 31%, bloating in 5% to 50%, and excessive flatulence in 2% to 80% of cases. “Importantly, up to 60% of patients also resume use of antisecretory medications within 10 years of the procedure,” Dr. Lee noted. For this reason, researchers and clinicians continue to look to newer endoscopic therapies for the treatment of patients with GERD.

Endoscopic Therapies: Risks and Benefits
The use of endoscopic procedures to treat GERD represents an area in which great strides have been made, and continued research holds promise for future advances, Dr. Lee noted, reviewing the advantages and disadvantages of the Stretta, EndoCinch, full-thickness endoscopic plication, and Enteryx techniques.

Stretta technique
In April 2000, the US Food and Drug Administration approved the Stretta procedure for use in select patients with GERD. The Stretta technique involves the temperature-controlled delivery of radiofrequency energy (465 kHz, 2-5 W), which may disrupt the aberrant intramural vagal afferent nerve pathways within the gastroesophageal junction.

In one study, Triadafilopoulos and colleagues investigated the safety and efficacy of the Stretta procedure. Patients were eligible for the procedure if they had: chronic heartburn and/or regurgitation; antisecretory medication on a daily basis, at least partial response to drug therapy, normal peristalsis when swallowing, esophageal acid exposure time > 4.0% or a DeMeester score of > 14.7, normal esophageal mucosa or Hetzel-Dent grade I or II, or hiatal hernia < 2 cm. Results showed that heartburn, GERD-HRQL scores, dysphagia, flatulence and bloating, and regurgitation were significantly decreased after the procedure. In addition, the median medication required and esophagitis decreased significantly, while median distal esophageal acid exposure time and DeMeester scores also fell. Adverse effects included fever, odynophagia, mucosal injury, and discomfort from inflation and delivery of radiofrequency energy, with 4% having severe discomfort (Triadafilopoulos et al. Gastrointest Endosc 2001;53:407-15).

In a more recent randomized, double-blind, sham-controlled trial, Corley and colleagues showed some conflicting efficacy results in that daily medication use and median 24-hour pH < 4 did not change after the Stretta procedure (Corley et al. Gastroenterology 2003; 125:668-76). “The question is, does the Stretta procedure truly treat GERD, or does it simply decrease visceral sensitivity to pain,” Dr. Lee explained. Further studies may be required to answer this question.

EndoCinch technique
The EndoCinch is an outpatient endoluminal plication procedure, performed mainly under conscious sedation. “The EndoCinch procedure is used primarily in patients who have GERD and a small hiatal hernia less than 2 cm,” Dr. Lee
explained. The EndoCinch is the first system to allow suturing in the gastrointestinal tract using a flexible endoscope. The procedure consists of advancement of a scope with needle (through an overtube) to the LES. Ultimately, tissue is captured and two adjacent stitches are placed in an effort to eliminate reflux into the esophagus.

In one study, Mahmood and colleagues treated 22 patients with GERD with the EndoCinch technique. The outcomes showed that the mean heartburn symptom score (P < .0001), regurgitation score, mean pH DeMeester acid score, and use of proton pump inhibitor therapy were decreased after the procedure (Mahmood et al. Gut 2003;52:34-9). “Adverse effects with this procedure can include vomiting, abdominal pain, chest pain, mucosal tear, hypoxia, gastric bleeding, and suture perforation. Pharygitis can also occur, but can be minimized by extending the neck with introduction of the overtube,” Dr. Lee reported. Dr. Lee also noted that, at times, the EndoCinch sutures did
not hold.

Full-thickness endoscopic plication
To research the use of a full-thickness plication method for GERD, Chuttani and colleagues performed 16 plications at the GE juncture in 11 mini swine (35-45 kg). In one swine, laparoscopy was used to confirm serosa-to-serosa full-thickness plication. No complications were observed. After 12 weeks of follow-up, the distal esophagus and stomach were excised, revealing full-thickness plication within 1 cm of the GE juncture and no other significant changes (Chuttani et al. Gastrointest Endosc 2002;56:116-22).

Enteryx technique
This new endoscopic procedure allows the injection of an ethylene vinyl alcohol co-polymer (dissolved in dimethyl sulfoxide) into the distal esophagus in an effort to reduce reflux into the esophagus. The polymer is biocompatible, non-biodegradable, and causes minimal tissue reaction. “It is not radiopaque, so the solution is mixed with miconized tantalum powder for visualization under fluoroscopy,” Dr. Lee explained.

In one multicenter trial, Johnson and colleagues performed Enteryx implantation in 85 patients who had GERD symptoms. At 12 months’ follow-up, medication use was significantly decreased, with 80.3% reducing their PPI dose by 50% or greater and 70.4% reported no use of a PPI. Symptoms were also improved with 73% having a heartburn score < 15, 92% with a regurgitation score < 11. A significant reduction in the esophageal exposure to pH < 4 was also observed. No changes were seen in LES pressure or length, peristaltic amplitude, or esophagitis. Adverse events included transient chest pain and dysphagia (Johnson et al. Am J Gastroenterol 2003;98:1921-30).

Future Directions
These and other endoscopic techniques, such as the Plexiglas and Gatekeeper prosthesis, offer promising new options for patients needing treatment for GERD symptoms. “Further long-term study of these techniques is needed, along with the development of novel new approaches to endoscopic therapy for GERD,” Dr. Lee concluded.

Table 1.Endoscopic Therapies for GERD

- Stretta
- EndoCinch
- Full-thickness plication
- Enteryx
- Plexiglas
- Gatekeeper prosthesis

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