“I can’t believe I ate the whole thing.” Remember those humorous Alka-Seltzer commercials from the 1970s? For patients suffering from chronic gastroesophageal reflux disease (GERD), the symptoms are no laughing matter.
GERD is a digestive disorder that affects the lower esophageal sphincter (LES), the muscle that connects the esophagus with the stomach. When operating properly, the LES opens briefly when you swallow food and then quickly shuts after allowing food to pass from the esophagus to the stomach. In GERD, the LES malfunctions and allows food and stomach acid to flow back into the esophagus.
Heartburn is a classic symptom of GERD. Other symptoms may include a sour-tasting fluid backing up into the mouth; discomfort that get worse after eating, bending over or lying down; difficulty or pain when swallowing; and hoarseness, among others.
A recent study reported in the May 18 issue of the Journal of the American Medical Association suggests that laparoscopic surgery and the use of long-term medication (proton pump inhibitors) are equally effective for treatment of chronic GERD.
I don’t entirely agree with the results of the study, because I don’t think it takes into account the full spectrum of the disease. Early in the disease, medications may work well at relieving symptoms. Often, however, medications become less effective after prolonged use. After five to ten years, effective treatment may require a greater dosage, and sometimes medications lose their effectiveness altogether. Additionally, medication for the treatment of GERD is often not covered by insurance, and the cost can be prohibitive for some patients.
Another factor to consider is that even though medication may decrease acid so that heartburn isn’t as noticeable, there is still reflux, which can be damaging. Chronic reflux can lead to changes in the esophagus that are precursors to cancer; can cause damage to the upper respiratory tract, throat or vocal chords; and can cause asthma and breathing problems. I’ve even treated patients who were referred by dentists because the acid was eroding their teeth.
While I let my patients make the decision of whether to treat their GERD with medication or surgery, patients typically come to see me after they’ve tried everything else without success and are at the end of their ropes. Often, their visit is the result of urging from family members who have watched them struggle with the symptoms of GERD.
Because GERD starts subtly and progresses over the years, patients often don’t realize how much it is affecting their daily life until they experience the joy of being symptom-free. After surgery, most patients say, that surgery “gives them their life back” and that they wish they had done it much sooner.
Medscape.com published an article on May 25, 2011, regarding a multicenter clinical trial comparing esomeprazole therapy versus standardized laparoscopic antireflux surgery (LARS) for the treatment of GERD. For the reasons stated above, I don’t entirely agree with the findings of the study.
The LOTUS trial was conducted between Oct. 2001 and April 2009 in academic hospitals in 11 European countries. The goal of this five-year exploratory, randomized, open, parallel-group trial was to compare optimized esomeprazole therapy (20 – 40 mg/day, allowing for dose adjustments; n = 266) vs. standardized LARS (n = 288) in patients with well-established chronic GERD who initially responded to acid suppression.
The study concluded that esomeprazole therapy and standardized laparoscopic anti-reflux surgery (LARS) are both effective in achieving and maintaining remission at five years in patients with GERD.
Of the 288 patients assigned to undergo LARS, 248 actually underwent the operation. Of 372 patients who completed five-year follow-up, 192 were randomly assigned to receive esomeprazole, and 180 were randomly assigned to undergo LARS. The main study endpoint was time to treatment failure, defined as the need for acid-suppressive therapy after LARS, and as inadequate symptom control after dose adjustment for esomeprazole.
At five years, estimated remission rates were 92 percent in the esomeprazole group vs. 85 percent in the LARS group. By use of best-case scenario modeling of the impact of study dropout, the between-group difference was no longer statistically significant.
At five years, symptom prevalence and severity in the esomeprazole and LARS groups, respectively, were: 16 and 8 percent for heartburn; 13 and 2 percent for acid regurgitation; 5 and 11 percent for dysphagia; 28 and 40 percent for bloating; and 40 and 57 percent for flatulence.
During the study, there were four deaths in the esomeprazole group and one death in the LARS group, none of which were attributed to treatment. Both groups had similar percentages of patients reporting serious adverse events (24.1 percent for esomeprazole and 28.6 percent for LARS).
Summary of Findings
This paper, besides providing scientific data regarding the efficacy of esomeprazole in symptom control of PPI-responsive patients at five years follow-up, also provides clear evidence about the efficacy of LARS in the treatment of GERD.
Summary of Commentator Side Statements
- Although there seem to be no statistical differences regarding the success of both methods, all patients in the esomeprazole group must continue their medication in even higher doses and for an indefinite amount of time, most probably for life. New, adverse effects of continuing lifelong medication are yet to develop.
- Surgical success has the potential to spare patients from lifelong medication and its costs and side effects. Furthermore, proton pump inhibitors (PPIs) cannot prevent the reflux of gastric contents into the esophagus and therefore only provide relief of symptoms without curing GERD.
- Longer follow-up results will be of interest, especially for possible under-diagnosed side effects of PPIs.