Wednesday, May 23, 2007

When are symptoms of GERD not really GERD symptoms?

Getting information that tends to support one's own biases is generally warmly satisfying --- sort of like getting how a child feels receiving unexpected presents in the few days after Christmas. Such is the case for me with a study published in this month's Journal of Gastrointestinal Surgery. The study, entitled Recurrent Heartburn after Laparoscopic Fundoplication is Not Always Recurrent Reflux, comes from Aussie surgeons at the University of Adelaide, and it is another salvo in the continuing debate between us peaceable and fun-loving surgeons and those nasty and dastardly gastroenterologists. Think Dudley Do-Right and Snidely Whiplash, if it suits you.

Skip this part if you don't want a 10¢ primer on reflux disease.

Perhaps a little background is in order. A whole lotta people suffer from heartburn --- gastroesophageal reflux disease, or GERD, to be technically correct. Some of them, however, don't just get the occasional dyspepsia from being forced to watch 24-hour news coverage of Paris Hilton, but really suffer from reflux of stomach contents (and acid) for a considerable part of each day. Some Smart GuysTM invented great medications to help with this, relegating antacids to the back burner --- first H2 blockers and then proton pump inhibitors (PPIs). These meds provide great relief to a huge number of patients. However, they really provide a chemical solution --- stopping acid production in the stomach --- to a mechanical problem: the process of acid and other stomach contents washing back up into the esophagus, due to an ineffective lower esophageal sphincter. You see, the issue is not that these patients make "too much" acid, it is that the acid (and bile, and food, and -- well, you get the picture) goes the wrong direction, and the esophagus really doesn't like that very much, so the patient feels like they just swallowed a cup of battery acid and chased it with $3/quart tequila.

Those of you who are quick on the uptake are now asking "well, why doesn't some other Smart GuyTM come up with a mechanical solution to GERD?" Actually, we have an operation that does just that --- it's called a fundoplication (or Nissen fundoplication, named after a pretty Smart SurgeonTM named Rudolf Nissen who devised it several decades ago). Briefly, it involves wrapping the upper part of the stomach (the fundus) around the bottom of the esophagus, sort of like putting a hot dog in a bun. This creates a modest increase in pressure that is designed to be an effective barrier similar to the (ineffective) lower esophageal sphincter.

OK, cool! So, why doesn't everybody with significant heartburn go see their friendly neighborhood general surgeon and ask for one of these operations? Well, there are many reasons, but there are a few important things to keep in mind:

  1. Fundoplications should really be done only on the really, really symptomatic patient with oh-my-God GERD. The medications we have are really quite effective, and as much as it pains me to admit it, not everybody really needs an operation.
  2. There are a number of side effects to the operation. Most are minor, but need to be anticipated and patients have to understand that they are trading a set of severe symptoms for some that will need to be tolerated.
  3. Most importantly, the operation will sometimes fail --- the fundoplication falls apart or loses some of its efficacy over time, and patients get some or all of their symptoms back.

Getting back to the original point of the article and my post, it is this last point that is the major bone of contention between those evil gastroenterologists an us well-intentioned surgeons. The operation sometimes fails, with recurrence of symptoms --- but how often? Many patients return to their gastroenterologists with complaints of recurrent, or even persistent, symptoms --- but surgeons say this should happen on the order of 20-25% of the time, and some gastroenterologists state it happens nearly always! There is a widely discussed study published in JAMA (as a follow-up to a prior report published in NEJM) reviewing long-term results from a randomized trial of surgical vs. medical therapy for GERD in a cohort of VA patients that stated that an whopping 62% of patients who underwent Nissen fundoplication eventually took acid-reducing medications on a regular basis.

(Put in your own sound effects here --- surgeon scratching his head desperately trying to get the spirochetes to wake wake the few remaining neurons there...) OK. The surgeons feel like they are doing a good operation, but some (perhaps most?) patients get recurrent symptoms. But have the operations mechanically failed? Well, these guys actually studied their patients who came back with symptoms that suggested a failed fundoplication:
Methods We identified all patients from an existing database who had undergone pH monitoring for “recurrent heartburn” after fundoplication. These patients were then cross-referenced to another database, which recorded the outcomes for patients who had undergone a laparoscopic fundoplication. Patients complaining of dysphagia or other problems without heartburn were excluded from analysis.

Results Seventy-six patients were identified who met the inclusion criteria. Fifty-six (74%) of these had a normal 24-h pH study. Thirty-five patients (63%) with a normal pH study were on medication for heartburn at the time of referral. Three factors were found to be associated with an abnormal 24-h pH study: a partial fundoplication (P = 0.039), onset of symptoms 6 months or more after surgery (P < 0.001), and a good symptom response when antireflux medication was recommenced (P = 0.015).
Very interesting. In this study, almost 3/4 of the patients who had an antireflux operation and subsequently presented with complaints of recurrent symptoms were not refluxing! The true surgical failure rate in this selected symptomatic group was 26% --- and this builds on the evidence from a few prior studies that found a true surgical failure was found in 23-39% of similar patients. Interestingly, these authors found something that I have clearly seen (anecdotally, of course) through several years and many such surgeries --- the patients that complain of heartburn symptoms after an antireflux surgery that cannot be demonstrated to actually be refluxing most often state that acid-reducing medications provide them with no relief.

That leaves us with three unanswered questions:
  1. What, if anything, is causing these patients to complain of these symptoms? Er, I'm not really sure, but the authors propose a whole host of things, such as gastritis, gallbladder disease, irritable bowel syndrome, and functional dyspepsia. They say they're in the process of studying these patients as we speak.
  2. What about the patients who really do have a failed fundoplication? What can they do? Actually, although it is a considerably more complicated procedure, a truly failed fundoplication can (almost always) be redone, if the patient's symptoms are severe enough that they wish to travel down that road again.
  3. Most importantly, is it worth doing this operation if it has a significant risk of failing? I always feel guilty answering this question --- I could probably eat a chili cheese dog, chase it with rot gut tequila, and the be forced to watch Barbra Streisand movies for 8 hours in a row and not get heartburn. However, for the right patient, who has severe symptoms, and who has undergone an appropriate evaluation, a laparoscopic Nissen fundoplication is still a very good operation which provides a very good chance for long-term relief of symptoms.
That, at least, is my view. If you want the perspective of a GI doc ............... get a copy of this study to take with you. He may not read it, but it will be good for you to have something to read while you're doing the bowel prep for the colonoscopy he's sure to recommend.