From Our ArchivesMedical Author: Jay W. Marks, M.D.
Medical Editor: Dennis Lee, M.D.
A while back, the newspapers were trumpeting the story implying that surgery for gastro-esophageal reflux disease (GERD) was not as good as treatment with medication. The story was based on a study that evaluated a group of patients years after they participated in a study comparing the medical and surgical treatments of GERD. The study was published in the Journal of the American Medical Association.
The original study had been carried out from 1986 through 1988 in several veterans administration hospitals. Patients with severe GERD had been randomly selected to be treated with either medication or anti-reflux surgery (fundoplication). It was a reasonably large study (243 patients) that involved primarily men. (There were only 4 women.) The study followed the patients for two years after their selection to either surgery or medication. The 2-year study demonstrated that surgery was superior to medication, resulting in better control of symptoms, a need for less medication, and less cost overall.
The new study identified as many as possible of the original patients in the study to see how they were doing approximately eight years after the old study had ended. Not surprisingly, the new study found that more patients treated with medication were consuming medications for GERD than patients treated with surgery. However, a large number of the surgically-treated patient -- 62% -- were also taking medications. The authors interpreted this to mean that surgery was not effective in preventing the need for medication. The authors of the new study concluded that surgery should not be recommended with the expectation that it would prevent the need for further treatment with medication. The implication of the study-though the authors were careful to avoid the implication--was that surgery was ineffective at relieving the symptoms of GERD in the long-run.
As we did a couple of months ago in this same column (Evaluating Medical Studies: Case in Point -An Irritable Bowel Syndrome Research Report ), let's critically examine one aspect of the new study, specifically, the numbers of patients who were evaluated.
The original study involved 243 patients. For the new study, the authors found that 79 patients had died. Thirty-one patients could not or refused to participate in the study, and 10 patients who had received medication in the original study had undergone anti-reflux surgery. Thus, only 123 (50%) of the original 243 patients could be assessed for the new study.
What's wrong with this study? The same thing that was wrong with the irritable bowel syndrome study we reviewed previously. The loss of so many patients (50%) from the original study makes conclusions about the effectiveness of surgery shaky at best. There were other significant problems as well, in particular, the assumption that the use of medication meant that the surgery was ineffective. (It is well-known that patients take GERD medications for reasons other than GERD. Just last week, a study that was presented in preliminary form demonstrated that most patients taking medications for GERD after anti-reflux surgery did not have acid reflux.) The results of the study also contradict the results of several other studies that have followed patients after similar surgery. These studies showed less use of medication and good relief of symptoms.
There was a second important issue raised by the study. More patients who underwent surgery had died than patients who received medication, primarily from heart disease. It's disturbing that more patients in the surgical group died, but there is no reasonable explanation for how surgery in patients with GERD might cause death, particularly from heart disease. An important principle in science is that when there is no rational explanation for a result, the result should be considered suspect. Thus, a higher death rate in patients undergoing surgery should not yet be accepted.
So, what can we conclude? I'm afraid that we can't conclude much from this latest study about the long-term effectiveness of surgery as compared with medication. That's unfortunate because now that anti-reflux surgery has become routine, there will be no further trials comparing medical and surgical therapy. Patients and physicians will have to make decisions about treatment based on many other existing studies, none of which were designed to answer the most important question, namely, is surgery better than medication for GERD.
Who should undergo surgery for GERD? Clearly, one group of individuals who need surgery is the group with complications of GERD that does not respond to non-surgical anti-reflux measures that include potent medications. Examples would be individuals who continue to develop strictures (narrowing) of the esophagus or regurgitate stomach contents into their lungs. More and more people are choosing surgery because they do not want to take medications for life. Although the medications have proven to be safe, they are inconvenient to take. Should individuals whose GERD is well-controlled by non-surgical anti-reflux measures undergo surgery because of the inconvenience of taking medication? I think that there is still much to learn about the long-term consequences of anti-reflux surgery before it can be recommended to the latter group of individuals.
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