GERD Treatment Options
The initial GERD treatment algorithm typically involves a combination of lifestyle changes, over the counter medications (OTC), and prescription drug regimens. Beginning with the initial visit, qualitative and quantitative benchmarks are established with the aim of exposing the patient to the lowest dose of medication as well as to identify extraesophageal GERD manifestations and other complications. Surgery is advocated for patients who are dissatisfied with their GERD medications, continue to have manifestations and/or complications, or are dissatisfied with the impact traditional treatment regimens have on their lifestyle.
Lifestyle
Lifestyle modifications can significantly decrease the occurrence and severity of GERD in many patients and are usually the appropriate first step in the treatment process. Many of the known causes of GERD are directly related to diet, lifestyle, and everyday activities. By working with a physician, many patients are able to reduce the occurrence and severity of GERD symptoms by modifying their daily activities and behaviors.
Drugs
Drug therapies such as proton pump inhibitors (PPI) or H2 (H2RA) blockers can reduce ‘typical' GERD symptoms which are caused by acid exposure, but are not effective in treating non-acidic or alkaline reflux, and ‘atypical symptoms' like asthma, cough, or chronic obstructive pulmonary disease (COPD), since these symptoms result from the presence of reflux contents, regardless of the acidity. For some patients with motility disorders, prokinetic drugs, which help strengthen the esophageal motility and to some degree the lower esophageal sphincter and accelerate gastric emptying can also be helpful. Even if drug therapy is effective, patients will likely need drug therapy for the rest of their life, since symptoms and disease return as soon as medication is stopped.
OTC
Some patients with mild, uncomplicated GERD can be appropriately treated with over-the-counter medications such as a combination of antacids, H2 receptor antagonists (H2RA) and, lately, OTC proton pump inhibitors (PPIs). Although H2RA's and PPI's were originally only available in prescription strength, in recent years lower doses have been approved for OTC sales. OTC medications are an easily accessible, palliative (pain reducing) option for people who suffer from occasional, mild to moderate GERD. Many OTC treatments work to neutralize the acid, reduce gas, and coat the lining of the esophagus and stomach thereby reducing the symptoms. These medications can be effective for reducing symptoms short-term. If GERD symptoms persist or worsen, it is important to see your doctor who will determine if a more aggressive approach is necessary.
PPI and H2RA
Prescription medications offer many patients relief from the symptoms of GERD, but do not prevent alkaline and other stomach contents from entering the esophagus. Prescription doses of Proton Pump Inhibitors (PPI's) and/or H2RA's are effective palliative treatment options for moderate and recurrent heartburn because they reduce the amount of acid produced in the stomach.
Both PPI's and H2RA's work to inhibit secretion of acid by the parietal cells in the stomach mucosa. These medications, however, do not prevent neutralized acid from refluxing up into the esophagus, lungs, mouth, and/or nasal cavities. They also do not prevent reflux of other caustic agents, including bile, pepsin and digestive enzymes. While stomach tissue is designed to handle most of these caustic stomach acids, the tissue of the esophagus is. The continued reflux, although it doesn't ‘burn' because the acid is neutralized, may continue to damage esophageal tissue. In other words, medication treats the symptoms of GERD without addressing the root cause of GERD, reflux and regurgitation.
In addition, 10-20% of patients do not respond to these prescription medications and symptoms remain. Even on prescription medication, some patients are not able to eat large meals, eat late at night, drink alcohol, coffee, carbonized drinks etc., or eat fatty foods, chocolate, strawberries, or spicy foods without having symptoms return. Some patients may also have break-through symptoms at night, and regurgitate while sleeping. Some even find a pool of yellow fluid (bile) on the pillow when experiencing reflux at night. So called "silent aspiration" is often cited as the reason for GERD-related asthma. Raising the head of the bed is one option to help in reducing this nighttime reflux.
Some patients who respond well to prescription medication may find the efficacy of the drugs waning over time. The doctor may increase the dose of the drugs in efforts to obtain symptom control. Sometimes after increasing the dose a few times, it may be necessary to switch to a different medication to get control of symptoms again. The body has feedback loops designed to maintain balance, which sense the reduced acidity of the stomach contents and try to put out more acid. This feedback loop may be partially responsible for the loss of effectiveness of PPI's and H2RA's over time. Even in those patients where medication is highly effective, these medications must be taken every day if symptoms are frequent. When the medication is stopped, the effects of the drug also stop. Missing even a single dose can cause symptoms to reoccur. There can also be a delay between when medication is started and when the symptoms stop. In patients with severe GERD this can be quite problematic, since symptoms can remain for a few days after the start of medication.
Surgery
Open and laparoscopic surgical procedures are highly effective but are rather invasive, expensive, and adverse events like gas bloat syndrome and dysphagia are common. For this reason, less than 1% of the relevant GERD patients are treated with surgical therapy to treat GERD. Typically, open and laparoscopic surgeries have been performed on patients who suffer from severe GERD, whose symptoms occur almost every day, and who have tried lifestyle changes, OTC, and prescription medicines. Open and laparoscopic surgery carries surgical risk to patients and can result in side effects including pain, difficulty swallowing, the inability to belch or vomit. Despite these risks, surgical treatment of GERD has been utilized for more than 50 years and can be effective in up to 90% of patients.
Nissen fundoplication, introduced in 1951 as an open procedure, demonstrated that reconstructing the natural anatomy of the gastro-esophageal junction not only reduces the occurrence of symptoms but also improves the physiological conditions necessary to prevent reflux. In the early 1990's, the Laparoscopic Nissen Fundoplication (LNF) was introduced and became the most widely used surgical procedure for the treatment of GERD.[9, 10] LNF attempts to recreate the natural anatomy of the gastroesophageal junction as well as reduce hiatal hernia. In studies, LNF has been show to be effective in 75 to 90 percent of patients in alleviating heartburn and 50 to 75 percent in alleviating cough, asthma, and laryngitis.[11]
In addition, anti-reflux surgery has been shown to be superior to drug therapy in preventing Barrett's metaplasia.[12] The etiology of Barrett's metaplasia, a precancerous condition, presents strong evidence linking alkaline duodenogastric reflux to the development of esophageal mucosal damage which can best be prevented by restoring the ARB.[13]
Nissen, both LNF and open, requires significant changes to the natural anatomy in order to recreate the gastroesophageal valve. During the procedure, the fundus of the stomach, the short gastric vessels, and the phrenoesophageal membrane are typically dissected. The fundus is then wrapped around the esophagus and stitched to the anterior aspect of the stomach creating a loose wrap around the distal esophagus and the GEJ. Complications may include a long-lasting dysphagia, gas bloat syndrome, scarring, and, rarely, achalasia. The fundus is lost and belching may be impossible. In addition, LNF results in permanent anatomical modifications that are difficult to undo.
A 5-year longitudinal study of LNF determined the five-year cost-benefit of LNF to be higher in comparison with PPIs (omeprazol), largely due to the costs associated directly with the procedure itself as well as indirect costs, such as time away from work.[14] A recent UK study did conclude that by year eight the cost of LNF was break even with a PPI regimen and included as determining factors both the cost of the surgery (which may vary greatly) and the increase/decrease in cost and/or patient use of PPI into the future.[15]
The effectiveness and long-term cost-savings of LNF compared to a lifelong regimen of drugs demonstrate the need for an endoluminal solution to GERD that emulates LNF, but without incisions. Solutions are needed that provide substantive anatomical changes to restore the ARB and which address the underlying cause of GERD.
Endoluminal Surgery
Until recently, endoluminal technologies for the treatment of GERD primarily focused on tightening the Lower Esophageal Sphincter (LES) with the aim of improving this component of the compromised antireflux barrier (ARB) through one of three methods:
- Thermal tissue remodeling by delivering radiofrequency
- Injection/implantation of non-absorbable material
- Esophageal tissue pleats at the LES level by endoscopic suturing
These previously mentioned technologies do not emulate surgery. The TIF (Transoral Incisionless Fundoplicaton) procedure, however, focuses on re-establishing the anatomy of the ARB in a similar fashion as the open and laparoscopic fundoplication procedures performed for the last 50 years. In particular, the goals of the TIF surgical procedure are to:
- Re-establish the Angle of His
- Lengthen the intraabdominal esophagus
- Reduce hiatal hernia.
- Promote serosa-to-serosa fusion
TIF delivers similar benefits as the time-proven laparoscopic antireflux procedures, by reducing hiatal hernia and creating a Gastroesophageal Valve (GEV). The key differences are that the TIF surgical approach is transorally performed (through the mouth), does not require skin incisions, and does not dissect any part of the natural internal anatomy.
While emulating principles of the Antireflux Surgery (ARS), the TIF procedure is intended to reduce invasiveness, allow for faster recovery, and be more versatile than open or laparoscopic surgery. Similar to open and laparoscopic procedures, the TIF procedure can be tailored for the specific patient and anatomy. Unlike open and laparoscopic Nissen fundoplications (NF), the TIF procedure has been shown to be more comparable to partial fundoplications, which generally have fewer adverse effects such as dysphasia and gas bloat syndrome than NF surgery.
