This is a personal opinion as a surgeon and citizen of this world we live, based on my own experience and proved by clinical evidence data.
There are 20 million patients in the USA that have acid reflux and who are on PPI medication, a group of drugs that reduce the secretion of gastric (stomach) acid. The most commonly used is the Omeprazole. Unfortunately PPI’s just do not really work for all patients!
As a surgeon and citizen I have major and alarming concerns!
Medicine has dramatically progressed in the last few decades. While we are successful in reducing the frequency of the heart disease or have patients surviving cancer by more effective treatments, we do not see the same progress in GERD. Every 10 years there is a 30% increase in GERD (short for Gastro Esophageal Reflux Disease) commonly named Acid Reflux, with main symptom being heartburn. Not only the GERD progression increases, but 10% of these patients develop Barrett’s (a pre-cancer stage), of which 2.5% progress to cancer. Forty percent (40%) of patients on PPI’s have only partial relief of symptoms. And despite this high percentage of patients who are partial responders, less than 1% of the 20 million patients in the United States seek surgical therapy as an option to medical therapy.
These important and alarming concerns justify that the time has come for a change in the treatment strategy of GERD.
The disappointment in PPI therapy is likely due to a misunderstanding that GERD a/o Acid Reflux (a/o Heartburn) is primarily an acid peptic disease. The primarily abnormality in GERD is not modification of the acidity (we need acid in the stomach for effective food digestion and for neutralizing potential germs ingested), but the loss of an effective muscle sphincter at the bottom of the esophagus to keep the acidic gastric juice in the stomach. Stomach lining is full of cells that create mucous, which forms a protective barrier for gastric acids. This barrier does not exist in esophagus lining where acid should never be present (if the valve at the junction between the esophagus and the stomach is anatomically intact). If gastric acid is present in the esophagus, heartburn and damage is created. When patients are placed on PPI’s, reflux episodes continue at the frequency they did when patients are off PPI’s. The only difference is the pH of the reflux episode, which is higher, and so, less acidic.
Surgeons all agree that the gold standard in surgery is laparoscopic Nissen, which is an invasive procedure. The outcomes vary in their effectiveness and durability and the rate of early revisional surgery post-Nissen is too high. Nissen surgical therapy has significant side effects: patients are unable to belch or vomit; they have increased flatulence, and exhibit postprandial bloating and significant persistent dysphagia, after almost each meal.
Prescriptions for double dose, or maximum dose PPI’s, has increased by 50% in the last seven years. Eighty-five percent (85%) of patients on PPI’s still experience some symptoms and in 40% of cases, the symptoms have reached a level to cause significant dissatisfaction with PPI’s.
As PPI’s do not affect the lower esophageal sphincter muscle, consequently they are symptomatic therapy, in other words, just Band-Aids.
More importantly, PPi’s do not stop the progression to pre-cancerous and cancer complications of GERD and do not stop the GERD progression itself.
PPI’s do have side effects. Patients, when surveyed, state that their most common reason for dissatisfaction with PPI therapy is concern about long term effects of PPI’s (increased risk of hip fractures, osteoporosis, drug interaction with Plavix, Clostridium difficile disease) and the continuation of their symptoms while on medication. Others, who simply desire to eliminate medication, are frustrated by not having an acceptable option other than surgery and its problems.
Interestingly enough, FDA recommends PPI therapy no longer than 8 weeks on their label! But majority of patients are on lifelong therapy with still unknown potential side effects.
The therapy of GERD has reached its limit. We must find either a major development in medical therapy or most importantly, a significant improvement in surgical therapy. We must find this now!
One clinically proved solution may be an already existing new surgical technique, through a transoral approach, without any surgical incisions. So called TIF (Transoral Incisionless Fundoplication), using EsophyX device, manufactured by EndoGastric Solutions, this procedure has proved its efficacy and safety since 2007 when approved by the FDA. It was evaluated in more than 30 peer-reviewed publications with follow up on more than 700 patients. Published studies demonstrated positive and durable results. Three multi-center randomized controlled trials are underway worldwide. This procedure respects all principles of anti-reflux surgery (principles well established since decades and confirmed by SAGES – Society of American Gastrointestinal and Endoscopic Surgeons – Guidelines), with proved effectiveness and without long term side effects encountered in post-Nissen cases. TIF treats the root cause by restoring the gastro esophageal junction (and its sphincter muscle function) to its natural and anatomical shape. Two surgical societies support the procedure: SAGES and ASGS have published position statements on this.
With more than 14,000 patients treated worldwide and no mortality, with excellent and extremely high safety profile, good effectiveness, shorter hospital stay, faster recovery time and return to normal activities, this technique becomes more and more popular in filling the gap between medication and existing surgery.
The first Worldwide Randomized Clinical Trial orally presented on podium at Digestive Disease Week World Meeting in 2013 at Orlando, Florida demonstrated its effectiveness and safety compared to maximum dose of PPI’s. A second Randomized Clinical Trial comparing TIF vs SHAM and PPI’s has ended the patient enrollment. The data is in collection progress; this study is to be published soon.