The LOTUS study, a randomized clinical trial, was published in 2011 in JAMA (Journal of the American Medical Association). The study compared laparoscopic Nissen fundoplication and hiatal hernia repair to daily high dose Nexium (up to 40 mg twice daily) for treatment of GERD.
266 patients were randomized to receive medical treatment with Nexium, and 248 patients were randomized to Laparoscopic hiatal hernia repair and Nissen fundoplication. The primary outcome measure of this trial was the time to treatment failure, which was defined as inadequate symptom control after dose adjustment in the Nexium group and the need for acid suppression in the anti-reflux surgery group.
Follow-up included a clinic visit every 6 months after randomization. Upper endoscopy was scheduled at 1, 3, and 5 years, and distal esophageal acid exposure was assessed at baseline, 6 months, and 5 years respectively.
Key findings
Both Nissen fundoplication and Nexium normalized distal esophagus acid exposure leading to excellent heartburn and epigastric pain control. However, food regurgitation was better controlled in the surgical group.
Higher rates of dysphagia, bloating and flatulence were noted in the surgical group.
Treatment failure occurred in 33/180 surgical vs 19/192 medical patients at 5 years.
Laparoscopic hiatal hernia repair and Nissen fundoplication was associated with 3% surgical morbidity but no mortality.
Study Limitations
- Patients enrolled in the study are limited to PPI responders. Non responders, patients with refractory GERD to medical treatment, were excluded.
- Surgical technique was not standardized among participating surgeons.
Conclusion
So, what does the LOTUS trial mean to you as a GERD patient in Houston?
Escalating doses of Nexium reliably control some acid reflux symptoms like heartburn but not food regurgitation. Furthermore, GERD is a progressive disease, and symptoms get worse over time despite high dose Nexium.
On the other hand, Nissen fundoplication is superior in terms of complete acid reflux symptom control. This is not surprising since Nissen fundoplication, unlike Nexium, eliminates acid reflux by restoring the anti-reflux barrier. Nexium does not alter the anti-reflux barrier. Nexium simply decreases acid secretion by the stomach. Thus, you will continue to reflux with Nexium but the refluxate is less acidic.
Key to Nissen fundoplication success, however, is finding a competent acid reflux surgeon who can perform flawless surgery. A properly performed Nissen fundoplication, for the right patient, has 0% dysphagia rate (difficulty swallowing after surgery) and 100% success rate.
The durability of Nissen fundoplication not only depends on surgical technique, but also on patient tissue quality. In other words, GERD is a progressive disease because of progressive tissue damage by acid reflux to the gastroesophageal junction.
The lower esophageal sphincter gets shorter and less competent as acid reflux disease progresses. Esophageal motility also is progressively weaker.
The fibromuscular tissues of the hiatus (the opening in the breathing muscle) lose strength and tone leading to a larger hiatal hernia. All these tissues are needed are needed to reconstruct the acid reflux barrier because of damage from constant acid reflux.
So, if you are on escalating doses of Nexium, it is time to think about acid reflux surgery before it is too late. At Houston heartburn and Reflux Center, we recommend early surgical intervention as opposed to chronic and escalating doses of Nexium. Early intervention allows for solid reflux barrier reconstruction thus leading to durable repair.
If you suffer from acid reflux and you are currently dependent on daily Nexium to fully or partially control your acid reflux symptoms give us a call at 832-945-8717 to learn about safe and reliable acid reflux treatment options.