Original Article
Comparison of Medical and Surgical Therapy for Complicated Gastroesophageal Reflux Disease in Veterans
N Engl J Med 1992; 326:786-792March 19, 1992
- Abstract
- Abstract
Background.
Conventional medical treatment for gastroesophageal reflux disease involves lifestyle modifications and combination drug therapy, but few studies have included these features in their protocols. Antireflux surgery has seldom been studied prospectively, and there have been no trials comparing modern medical and surgical treatments for reflux disease.
Methods.
We conducted a long-term, randomized trial of medical therapy (lifestyle modifications and up to four medications) and surgical therapy (Nissen fundoplication) in 247 patients (243 men and 4 women) with peptic esophageal ulcer, stricture, erosive esophagitis, or Barrett's esophagus. They received by random assignment either continuous medical therapy, medical therapy for symptoms only, or surgical therapy. Symptoms were assessed quarterly with a disease-activity index; esophagoscopy was performed at base line and each year for two years. The outcomes evaluated at one and two years included the activity index and the endoscopic grade of esophagitis.
Results.
Follow-up data were available for 176 patients at one year and for 106 patients at two years. The mean (±SE) activity-index score (possible range, 74 to 172) decreased in one year from 108±3 to 87±2 in the group receiving continuous medical therapy, from 107±3 to 88±2 in the group receiving medical therapy for symptoms only, and from 109±3 to 78±2 in the surgical-therapy group (P<0.0001 for the change from base line, for all comparisons). The mean (±SE) grade of esophagitis (possible range, 1 to 4) decreased in the respective groups from 2.9±0.1 to 2.0±0.1, from 2.9±0.1 to 2.3±0.1, and from 2.9±0.1 to 1.4±0.1 (P<0.005 vs. base line, for all comparisons). The mean activity-index score and the grade of esophagitis were significantly better in the surgical-therapy group than in either medical-therapy group during the two years of follow-up (P<0.003).
Conclusions.
In men with complicated gastroesophageal reflux disease, surgery is significantly more effective than medical therapy in improving the symptoms and endoscopic signs of esophagitis for up to two years, although medical treatment is also effective. (N Engl J Med 1992; 326:786–92.)
Media in This Article
Figure 1
Activity-Index Scores for Patients with Gastroesophageal Reflux Disease during the Two-Year Study Period.Figure 2
Grade of Esophagitis in Patients with Gastroesophageal Reflux Disease during the Two-Year Study.Article Activity
- Article
APPROXIMATELY 40 percent of adult Americans have heartburn, the cardinal symptom of gastroesophageal reflux disease, at least once each month.1 Among patients who seek medical attention for symptoms of reflux esophagitis, 10 to 20 percent have serious complications such as esophageal stricture or Barrett's esophagus.2 3 4
The conventional medical treatment of reflux disease usually begins with modifications of lifestyle that are aimed at minimizing gastroesophageal reflux, and often involves combination drug therapy.5 , 6 Studies of reflux disease have been limited primarily to short-term observations of the effects of individual drugs, with little or no emphasis on lifestyle modifications.5 Most patients with reflux esophagitis who respond to short-term medical therapy have relapses within one year.7 Most reports of treatment lasting more than 12 weeks describe therapy with single medications and have not established the efficacy of prolonged treatment.8 , 9 Therefore, the conventional practice of prescribing long-term, combination drug therapy and lifestyle modifications has not been substantiated by formal study.
Proponents of antireflux surgery argue that an effective operation can obviate the expense, inconvenience, and risks of long-term medical therapy.10 A number of reports have described excellent results in patients treated by fundoplication, with operative mortality rates of 1 percent or less in uncomplicated cases.11 12 13 Few studies of surgical treatment have been prospective and randomized, however, and the reports have seldom specified the precise indications for surgery and the duration of follow-up. The single randomized trial that compared medical and surgical treatment of reflux disease involved only 31 patients and predated the availability of H2-receptor antagonist drugs.14
We conducted a long-term, randomized trial of conventional medical and surgical treatment in patients with complicated gastroesophageal reflux disease. A group of patients who received medical treatment only as necessary to relieve symptoms served as the control group.
Methods
This study was approved by the Human Rights Committee of the Cooperative Studies Program Coordinating Center (Perry Point, Md.). Informed consent was obtained from all study participants.
Screening
At each study center, patients with complicated gastroesophageal reflux disease were identified by a review of clinical records and daily review of the results of ongoing endoscopic examinations and barium esophagography. Potential candidates were asked to undergo the following additional prerandomization procedures to determine whether they were eligible for the study: (1) esophageal manometry to determine the pressure and location of the lower esophageal sphincter and the adequacy of peristalsis (with the sphincter pressure measured by the station pull-through technique,15 as the vertical distance between the maximal respiratory oscillation of lower esophageal pressure and the base-line gastric expiratory pressure); (2) endoscopy to grade esophagitis (grade 1, no evidence of inflammation; grade 2, erythema, friability, or both; grade 3, esophageal erosion; and grade 4, esophageal ulcer) and to obtain esophageal-biopsy specimens, obtained at 1-cm intervals from 2 cm above the most proximal extent of Barrett's epithelium or esophagitis to the distal extent of the lower esophageal sphincter (as determined by manometric examination); (3) esophageal roentgenography with barium contrast (including swallowing a barium tablet 1.3 cm in diameter); (4) 24-hour monitoring of esophageal pH (Del Mar Avionics recording unit with a Radiometer pH probe), with the probe positioned 5 cm above the lower esophageal sphincter; (5) pulmonary-function tests, including measurement of the forced vital capacity, forced expiratory volume, maximal midex-piratory flow rate, total lung capacity, residual volume, and diffusing capacity; (6) evaluation by the study surgeon for suitability for surgery; and (7) symptom scoring according to the gastroesophageal reflux disease—activity index, a standardized system for scoring the clinical activity of esophagitis in which the patient maintains a diary of symptoms of reflux disease for one week before the clinic visit. The activity index was developed with multiple-regression techniques, to assign weighted numerical values to certain symptoms, and has been validated in a pilot study of 145 patients (reported as an abstract).16 The formula used to calculate the activity-index score is shown in Table 1.Table 1
Formula for Calculating the Score for the Gastroesophageal Reflux Disease-Activity Index. Diagnostic Criteria
Reflux disorders were diagnosed according to the following criteria: (1) Barrett's esophagus — specialized columnar epithelium in the tubular esophagus, or gastric-fundic—type or junctional-type epithelium in any biopsy specimen obtained ≥3 cm above the manometrically determined proximal border of the lower esophageal sphincter; (2) peptic esophageal ulcer — one or more esophageal ulcers (depressed white craters with an erythematous border) whose longest diameter was ≥5 mm on endoscopic examination; (3) peptic esophageal stricture — esophageal narrowing that impeded the passage of a 1.3-cm barium tablet during barium roentgenography; and (4) erosive esophagitis — two or more esophageal erosions (intensely erythematous shallow depressions in the esophageal mucosa) involving ≥3 cm of the distal esophagus.
Criteria for Eligibility and Exclusion
Patients were eligible if they had at least one of the four disorders described above and abnormal esophageal acid reflux during 24-hour monitoring of esophageal pH, as defined by one or more of the criteria of DeMeester et al.17
Patients were excluded if they were unwilling or unable to give informed consent; were less than 18 or more than 75 years old; had childbearing potential; had previously had a reflux disorder that was treated by surgery or that did not respond to medical therapy; had a coexisting condition precluding surgery; had a history of ingestion of a caustic agent or chest irradiation; had a contraindication to ranitidine; were undergoing chemotherapy; or had a coagulopathy, esophageal varices, high-grade dysplasia in Barrett's esophagus, esophageal carcinoma, achalasia, or scleroderma. Patients taking medications (e.g., diuretics or sulfonylureas) for other medical disorders (e.g., hypertension or diabetes) were not specifically excluded unless they had a coexisting condition precluding surgery.
Stratification and Randomization
Before randomization, the patients were stratified into one of five risk groups with the following conditions: (1) Barrett's esophagus with dysplasia, (2) peptic esophageal ulcer, (3) peptic esophageal stricture, (4) uncomplicated Barrett's esophagus, and (5) erosive esophagitis. Patients with more than one of these conditions were stratified into the group whose number was lowest.
Patients were randomized centrally by computer to receive continuous medical therapy, medical therapy for symptoms only, or surgical therapy.
Treatments
General Antireflux Measures
General antireflux measures prescribed for all study patients included elevation of the head of the bed on 15-cm blocks, avoidance of medications that decrease lower-esophageal-sphincter pressure (including antihistamines, anti-parkinsonism agents, calcium-channel blockers, major tranquilizers, methylxanthines, nitrates, and tricyclic antidepressants), and prohibition of smoking, alcohol ingestion, bedtime snacks, and foods that caused heartburn in the individual patient. In addition, all patients were allowed to take tablets of antacid as needed for heartburn and to undergo esophageal dilation as needed for dysphagia.
Continuous Medical Therapy
The patients received magnesium hydroxide—aluminum hydroxide antacid tablets (Maalox TC or Amphojel; two tablets one and three hours after meals) and ranitidine (150 mg twice daily). For persistent symptoms, metoclopramide was added (10 mg four times daily). For symptoms unresponsive to these medications, sucralfate was added (1 g dissolved in 10 ml of warm water, after meals). If patients became asymptomatic during treatment with metoclopramide, sucralfate, or both for at least two weeks, their physicians attempted to decrease and eliminate their use. The patients continued to take ranitidine and antacid tablets as prescribed for the duration of the study, regardless of symptoms.
Medical Therapy for Symptoms Only
Medications were used only when necessary to control symptoms; none were given to asymptomatic patients. The following were added in a stepwise fashion to control symptoms: first, magnesium hydroxide—aluminum hydroxide antacid tablets (Maalox TC or Amphojel; two tablets one and three hours after meals); second, ranitidine (150 mg twice daily); third, metoclopramide (10 mg four times daily); and finally, sucralfate (1 g dissolved in 10 ml of warm water, after meals). If patients became asymptomatic after receiving any combination of medications for at least two weeks, their physicians attempted to decrease and eliminate their use.
Surgical Therapy
Nissen fundoplication, in which a portion of the gastric fundus was wrapped entirely around the distal esophagus, was the primary antireflux operation.18 Before the start of the study, the surgeons met and agreed on a standardized transabdominal Nissen procedure that incorporated the following elements: identification of both vagus nerves and preservation of the hepatic branch of the vagus nerve; removal of the cardioesophageal fat pad and mobilization of the gastric fundus by division of the short gastric vessels; examination to ensure that the wrap was not under tension, that the gastric fundus (not the body) was used to construct the wrap, and that the wrap was properly positioned around the distal esophagus (not the proximal stomach) beneath the right vagus; use of a short length of wrap (approximately 1.5 cm); construction of the wrap over a large bougie (e.g., 60 French); and closure of the crura to keep the repaired area in the abdomen. After surgery, the patients were given no routine antireflux medication.
Follow-up
Six weeks after the beginning of therapy and every year, the patients underwent esophageal manometry, endoscopy (at which their esophagitis was graded by an endoscopist unaware of the patients' treatment assignment), barium roentgenography, and 24-hour monitoring of esophageal pH. The patients in the two medical-therapy groups received their prescribed treatment during the 24-hour pH monitoring period, except that antacids and sucralfate were withheld. The patients in the surgical-therapy group received no medications during the monitoring period.
At quarterly clinic examinations, symptoms resembling side effects and compliance with antireflux measures were assessed by the study technician (who was aware of the treatment assignment); medication counts were conducted to assess compliance; a complete blood count was performed; the patient's satisfaction with therapy was evaluated by the study technician as very satisfied, satisfied, dissatisfied, or very dissatisfied; the activity index was calculated; and whether there was a need to change therapy was determined by the principal investigator.
Statistical Analysis
We compared the efficacy of the three types of therapy by determining their effects on the activity index, the endoscopic grade of esophagitis, and the duration of acid reflux. We estimated that 260 patients would be required in order to detect a significant difference among the treatment groups in each of the three major outcome variables after one year of follow-up (with a two-tailed significance level of 0.05, a power of 0.90, and a dropout rate of 20 percent). Statistical analyses were based on the intention-to-treat concept; all patients for whom any follow-up data were available were included in the analyses. Repeated-measures analysis of covariance was used to detect significant overall differences for each score,19 and Bonferroni adjustments were used for pairwise differences.
Results
Formation of the Treatment Groups
Patients were recruited from July 1986 through October 1988. Follow-up was completed by November 1989.
Six hundred forty-four patients participated in prerandomization screening. Twenty-eight patients were excluded because they did not fulfill the criteria for eligibility, 261 were excluded because exclusionary factors were present, and 108 withdrew before or immediately after the prerandomization procedures were completed. Two hundred forty-seven patients entered the trial. The patients who were excluded did not differ significantly in age and sex from those who entered the study; however, the ratio of the number of patients entered to the number screened was significantly lower (P = 0.04) among black patients (16 percent) than among white (40 percent), Hispanic (44 percent), or Native American (31 percent) patients.
Of the 247 patients, 243 were men and 4 were women; 223 were white, 5 were black, 14 were Hispanic, and 5 were Native American. The mean age was 58 years (range, 25 to 75). The diagnostic criteria for Barrett's esophagus were fulfilled in 146 patients, those for peptic esophageal ulcer in 66, those for peptic esophageal stricture in 52, and those for erosive esophagitis in 113.
Seventy-seven patients were randomly assigned to receive continuous medical therapy, 88 to medical therapy for symptoms only, and 82 to surgery. There were no significant differences among the three groups in their demographic or functional status (Table 2Table 2
Base-Line Characteristics of the Three Treatment Groups.*). Forty patients decided not to participate in the study before they received the assigned treatment; thus, 207 patients were treated as assigned (68 received continuous medical therapy, 81 received medical therapy for symptoms, and 58 received surgical therapy). The characteristics of these 40 patients did not differ significantly from those of the 207 treated.Surgical Procedures
In addition to the 58 patients assigned to surgery, 7 patients assigned to receive medical therapy (6 assigned to continuous therapy and 1 assigned to therapy for symptoms) also underwent antireflux operations after medical therapy failed. Also, one patient had three operations. Of the 67 operations, 66 were Nissen fundoplications and 1 was a Belsey cardioplasty.
Outcome
Follow-up data were available for 201 patients at six weeks (81 percent of the patients who could be evaluated), for 176 at one year (71 percent), and for 106 at two years (68 percent).
At the quarterly clinic visits of the patients in the medical-therapy groups, metoclopramide and sucralfate were added in a stepwise fashion to treat symptoms of reflux that were not adequately controlled by the combination of lifestyle modifications, antacids, and ranitidine. During the first year, metoclopramide was added to the treatment of 38 percent of the patients in both these groups combined, and sucralfate to the treatment of 27 percent; neither drug was used in 62 percent of these patients. After two years, metoclopramide had been used in 45 percent and sucralfate in 34 percent of patients in the two medical-therapy groups combined; neither drug had been used in 55 percent of these patients.
The level of disease activity (activity index), esophagitis, and acid reflux all improved significantly from base line in the three treatment groups (Table 3). After one year, the activity-index score had decreased significantly in all three groups (P<0.001 for all decreases), as did the endoscopic grade of esophagitis (P<0.005 for all decreases) and the mean percentage of the total monitoring period during which the esophageal pH was less than 4 (P<0.05 for all decreases). Repeated-measures analysis of covariance showed that the mean activity-index score and grade of esophagitis were significantly lower in the surgical-therapy group than in either medical-therapy group throughout the two-year follow-up period (P<0.003) (Fig. 1 and 2). Throughout these two years, the percentage of the total monitoring period during which the pH was less than 4 was significantly lower in the surgical-therapy group than in the group given medical therapy for symptoms (P<0.003); however, the percentage in the surgery group did not differ significantly from that in the group given continuous medical therapy.
Repeated-measures analysis of variance also showed that the patients' satisfaction with therapy was significantly greater in the surgical-therapy group than in the group given continuous medical therapy (P = 0.024) or the group given medical therapy for symptoms (P = 0.006), throughout the two-year follow-up period. The patient-satisfaction scores determined at one and two years are shown in Table 4Table 4
Patients' Satisfaction with Treatment at One and Two Years..After one year, the mean (±SE) lower-esophagealsphincter pressure was 23 ±1 mm Hg in the group given continuous medical therapy, 26± 1 mm Hg in the group given medical therapy for symptoms, and 31 ±1 mm Hg in the surgical-therapy group; the pressure in the surgical-therapy group was significantly higher than it had been at base line and significantly higher than the pressure in the two medical-therapy groups.
Analyses of the results in the patients who actually received treatment yielded results virtually identical to those of the intention-to-treat analyses described above. The surgical-therapy group had significantly lower activity-index scores and grades of esophagitis than the medical-therapy groups throughout the two-year follow-up period (P<0.003). The duration of acid reflux determined by pH monitoring was significantly lower in the surgical-therapy group than in the group given medical treatment for symptoms (P<0.003), but it was not significantly lower in the surgical-therapy group than in the group given continuous medical therapy.
Medications and Compliance
The rate of compliance with ranitidine therapy was more than 85 percent throughout the study. Compliance rates with the general measures for antireflux treatment are shown in Table 5Table 5
Compliance with General Antireflux Measures at One Year in the Three Treatment Groups..Operative and Postoperative Complications
There were no operative deaths. Ten patients (15 percent) had one or more operative complications, including splenic injury not requiring splenectomy (five patients), splenic injury requiring splenectomy and blood transfusion (one patient), esophageal perforation (one patient), gastric perforation (two patients), inadvertent vagotomy (one patient), and tearing of the liver capsule (one patient). Twelve patients (18 percent) had one or more postoperative complications, including wound infection (one patient), wound dehiscence (one patient), pulmonary embolism (one patient), pleural effusion (one patient), ileus lasting more than five days (two patients), bleeding requiring transfusion (two patients), mediastinal abscess (one patient), intraperitoneal abscess (one patient), and other complications (four patients). No complication was fatal, and all resolved without apparent sequelae.
Side Effect-Type Symptoms
The frequency of side effects is shown in Table 6Table 6
Frequency of Side-Effect—like Symptoms in the Treatment Groups during the First Year of the Study.. Overall, side effects of both medical and surgical types occurred in 88 percent of the patients given continuous medical therapy, 88 percent of those given medical therapy for symptoms, and 84 percent of those given surgical therapy.Treatment Failure
Treatment failure was defined prospectively and was indicated by one or more of the following events: intractable heartburn interfering with activities of daily living so that the patient was unable to function effectively for at least three months, development of high-grade dysplasia or esophageal carcinoma, aspiration pneumonia due to reflux, dysphagia not responsive to esophageal dilation for at least three months, and esophageal bleeding requiring blood transfusion. There were 13 treatment failures (6 in the group given continuous medical therapy, 5 in the group given medical therapy for symptoms, and 2 in the surgical-therapy group), all due to intractable heartburn.
Deaths
There were eight deaths during the follow-up period (two in the group given continuous medical therapy, two in the group given medical therapy for symptoms, and four in the surgical-therapy group). The causes of death included myocardial infarction (two patients), pulmonary failure (two patients), cardiopulmonary arrest (one patient), pneumonia (one patient), cerebrovascular accident (one patient), and extraesophageal cancer (one patient). No death appeared to be related to reflux disease or its therapy.
Discussion
In our patients with complicated gastroesophageal reflux disease, antireflux surgery was significantly more effective than conventional medical therapy in improving the symptoms and endoscopic signs of esophagitis for up to two years. The lesser effects of medical treatment did not appear to have resulted from poor compliance with therapy. Indeed, the compliance rates for some general antireflux measures were higher in the medical-therapy groups, and compliance with ranitidine treatment exceeded 85 percent. It is important to note that our excellent surgical results were obtained by surgeons skilled in the techniques of fundoplication, in patients with normal esophageal peristalsis documented by preoperative manometric testing.
There are several possible explanations for the high frequency of side effects in our patients. All were evaluated at each quarterly visit for both medical and surgical symptoms suggestive of side effects. Medically treated patients ordinarily are not questioned specifically about symptoms attributed to antireflux surgery, such as abdominal fullness or inability to vomit. Conceivably, some symptoms may have been due to disorders sometimes associated with reflux disease, such as aerophagia or delayed gastric emptying.20 , 21 Unlike investigators in most medical studies of reflux disease, who give their patients a single drug for 4 to 12 weeks, we treated our patients with up to four medications simultaneously for at least 1 year. We also permitted them to take nonstudy medications to treat concurrent medical problems, and these drugs may have caused some side effects. Finally, some of the symptoms may have been unrelated to therapy, and their frequency may simply have reflected their prevalence in a carefully studied, older population. Regardless of the precise mechanisms involved, our findings suggest that most patients with complicated gastroesophageal reflux disease will have side effect—like symptoms no matter how they are treated. In our patients, these symptoms were seldom disabling, however, and their presence did not preclude overall satisfaction with therapy among the patients.
This study was initiated before omeprazole was released for use in the United States. The Food and Drug Administration has approved its use for the short-term treatment (four to eight weeks) of severe erosive esophagitis or symptomatic reflux that is poorly responsive to "customary" medical treatment. Although short-term omeprazole therapy is dramatically effective in healing mild-to-moderately-severe esophagitis,22 signs and symptoms of reflux return in the vast majority of patients shortly after the drug is stopped.22 23 24 Omeprazole is not approved for long-term use primarily because of concern about carcinogenicity related to profound, chronic suppression of gastric acid secretion,25 26 27 and this concern is not likely to be resolved in the near future. Recent studies have shown that refractory esophagitis may respond to histamine H2-receptor—blocking agents administered in doses sufficient to cause profound suppression of gastric acid secretion.28 As in the case of omeprazole, however, the safety of long-term therapy with high doses of H2-receptor—blockers for reflux esophagitis has not been established.
Despite the advent of omeprazole, the medical therapy used in this study still reflects conventional medical treatment for gastroesophageal reflux disease, the efficacy of which had not been substantiated by formal investigation. Medical therapy improved the symptoms and signs of esophagitis significantly for up to two years. In most patients, furthermore, symptoms were controlled by a combination of lifestyle modifications, antacids, and ranitidine in conventional doses, without additional medications. This suggests that even in patients with complicated reflux disease, symptoms can be controlled in most cases by conventional medical treatment without omeprazole, albeit not as effectively as they can be controlled by antireflux surgery.
In summary, we found that antireflux surgery was significantly more effective than conventional medical therapy (without omeprazole) in improving the symptoms and endoscopic signs of esophagitis for up to two years in a predominantly male population of patients with complicated gastroesophageal reflux disease. These results suggest that antireflux surgery performed by a skilled surgeon is a valid alternative to protracted medical therapy in such patients.
Supported by the Department of Veterans Affairs Medical Research Service Cooperative Studies Program (CSP 277). Address reprint requests to Dr. Spechler at the Treatment and Research Center for Swallowing and Motility Disorders, Beth Israel Hospital, 330 Brookline Ave., Boston, MA 02215.
We are indebted to Drs. Donald O. Castell, Daniel Deykin, Alex G. Little, Alan H. Robbins, and Elihu M. Schimmel for their assistance with the study; to Glaxo Pharmaceuticals for donating the Zantac (ranitidine); to Marion Merrell Dow, Inc., for donating the Carafate (sucralfate); and to Rorer Pharmaceuticals for donating the Maalox TC tablets (magnesium hydroxide—aluminum hydroxide) used in the study.
Source Information
*The investigators and institutions participating in the study are listed in the Appendix.
Appendix
The following investigators and institutions participated in the Gastroesophageal Reflux Disease Study.
Clinical investigators, according to Veterans Affairs medical center: Denver, Colo. — D.J. Ahnen, J. Goff, and G. Stiegmann; Hines, Ill. — H. Greenlee, T. Schnell, and S.J. Sontag; Little Rock, Ark. —A.T. Kishore, H. Pinkas, and R.C. Read; Omaha, Nebr. — T.R. DeMeester, S. Lanspa, and R.D. Zetterman; Phoenix, Ariz. — C.H. Fredell, S. Levenson, R. Sanowski, and J.P. Waring; Richmond, Va. — D.F. Kirby and H.H. McGuire; Tucson, Ariz. — G. Dunnington, J. Mohr, and R.E. Sampliner; West Roxbury, Mass. —M. Apstein, M. Berman, D. Brooks, and S. Chopra.
Other participants: P. Day, W.G. Doos, G.L. Eastwood, C. Fye, R.K. Goyal, B. Iglewicz, S. Kim, W. Krol, A.G. Mulley, A.I. Mushlin, H.C. Polk, Jr., C. Pope, II, R.H. Riddell, D. Skinner, and W.O. Williford.
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