Despite high satisfaction, majority of gastro-oesophageal reflux disease patients continue to use proton pump inhibitors after antireflux surgery
Dr A. Minocha, Digestive Diseases, 2500 North State Street, Jackson, MS 39216, USA.
Background While antireflux surgery is effective in controlling symptoms of gastro-oesophageal reflux, its role in eliminating the use of antireflux medicines after surgery and as such its long-term cost-effectiveness remains controversial.
Aim To assess the patient satisfaction and the continued medication use following laparoscopic Nissen fundoplication at a tertiary level community hospital.
Methods Adult patients who underwent laparoscopic Nissen fundoplication at our institution over a period of over 3 years were asked to complete a questionnaire recording their demographic information, date and reason for the surgery, preprocedure and postprocedure symptoms, smoking and alcohol use, and medication use preoperatively and post-operatively. Patients were also asked about their satisfaction with surgery.
Results One hundred patients participated in the study. Overall, 90% patients experienced satisfaction with their surgery. Eighty percentage patients were willing to undergo surgery again, if needed. Over two-thirds (67%) patients had decrease in the severity of their symptoms. None of the patients had worsening of symptoms post-operatively. However, 80% patients were still taking antireflux medications including proton pump inhibitors (53%).
Conclusions Most patients continue to use antireflux medications including after laparoscopic Nissen fundoplication despite high satisfaction with surgery.
Although both medical and surgical therapies are effective for management of gastro-oesophageal reflux disease (GERD), there is controversy about the cost-effectiveness of the antireflux surgery for long-term management of GERD. Compounding the difficulty in measuring cost-effectiveness is the fact that there is limited data on the ability of antireflux surgery to eliminate the need for antireflux medications after surgery.
Widely accepted indications for antireflux surgery in patients with GERD are threefold: (i) individuals who are intolerant of proton pump inhibitor (PPI) therapy because of side-effects, (ii) poor compliance to medical therapy and (iii) individuals who desire a permanent solution to their reflux problem that frees them of the need to chronically consume medications.1 The latter is usually related to the cost issues or that the patient may not be comfortable with taking medical therapy for potentially lifelong period because of possible risk of adverse effects from drug use over several decades.
However, does this procedure in fact provide a permanent solution to GERD problem? Are patients really freed from the need to consume pharmaceuticals? Our study attempts to answer this important question: How well can we give a guarantee to the patient that after the antireflux surgery, he or she would not require long-term antireflux medications especially the expensive PPIs.
Data from surgical literature has shown excellent response to surgery with marked decrease in medication use and improved quality of life up to 8 years after laparoscopic Nissen fundoplication (LNF).2 Data from medical literature have shown good response to surgery but with the cost of continued need to consume the medications.3 Also most of the studies have come out of major tertiary care referral centres, some of them from European centres. The big question that still looms large is whether we can replicate these data in a community setting in the United States.
We conducted a study to assess the patient satisfaction with surgery and medication use among patients who had undergone LNF in a tertiary level community hospital.
Materials and methods
The study was approved by our Institution Review Board. All patients who underwent LNF at our tertiary care community hospital between July 1997 and December 2000 were invited to participate in the study. The hospital is a level 1 trauma hospital in central Illinois with over 500 beds. It serves as one of the two major teaching hospitals for the medical school. The number of doctors on staff exceeds 500 and includes both the full-time faculty of the medical school as well as the practising doctors from the community.
Patients below the age of 18 years, those who could not be contacted, were unable to provide informed consent for any reason, were mentally challenged or were incarcerated, were excluded from the study. Patients who had repeat Nissen fundoplication as a result of any reason were excluded from the final analysis. All subjects in the study provided informed consent before participation.
The patients who agreed to participate in the study were asked to fill out a questionnaire recording their demographic information, date and reason for LNF, their symptoms pre-LNF and post-LNF, smoking and alcohol use habits and medication use preprocedure and postprocedure to control heartburn and other GERD-related symptoms. Regarding the use of medicines, we asked, ‘Do you currently take any antacids (Tums, Rolaids, Maalox, Mylanta, etc.), H2-blockers (Zantac, Tagamet, Pepcid, Axid) or PPIs (Prilosec, Aciphex, Protonix, Nexium, Prevacid)? If yes, Do you take same, more, less of this medication since your surgery'? In addition, we asked for history of any chronic pain syndromes and/or psychological or psychiatric morbidity including depression, anxiety, panic attacks, bipolar disorder, chronic fatigue syndrome, fibromyalgia and any other psychiatric illness. Patients were also asked about their overall satisfaction with the surgery and whether they would be willing to undergo surgery again.
Descriptive statistics (mean + S.E.M.; percentages, etc.) were used to describe the demographic and clinical characteristics as well as patient satisfaction and willingness to undergo surgery again. McNemar's chi-square test was performed to compare the preoperative and post-operative medication usage.
A total of 147 LNF surgeries were performed at our institution between July 1997 and December 2000. Attempts were made to contact these patients over the phone. Patients who could not be contacted over the phone were mailed a letter inviting them to participate in the study and they were asked to contact our research office to discuss the study further and obtain informed consent.
We were able to establish contact with 119 patients of which 102 patients agreed to participate in the study. Two patients did not return their questionnaires and were excluded from the analysis. We obtained complete study data from 100 patients and only these data were used in all kind of analysis. All the above LNF surgeries were performed by a single community-based cardio-thoracic surgeon who had been practicing in the community for the last approximately 11 years and has been actively performing Nissen's fundoplication surgery during this time. This surgeon was not part of the research team.
Table 1 outlines the demographic characteristics of patients who participated in the study. The main reason for performing the LNF surgery was GERD-related symptoms refractory to therapy with standard PPIs and was documented in 65% of our patients. Other reasons included hiatal hernia (27%), medication side-effects (93%) and patient request in 5% of the patients. All patients had preoperative oesophagogastroduodenoscopy (EGD), 24-h oesophageal pH study and oesophageal manometry performed. However, no tailoring of the LNF procedure was undertaken based upon the findings of oesophageal manometry. The median postsurgical follow-up for the above patients was 3 years (range: 2–4.2; mean 3.1 years). Thirty-nine percentage of patients gave history of psychiatric morbidity and/or chronic pain syndromes. However, the number of individual disorders in this category was too small to allow for any meaningful statistical analysis and as such they were combined and analysed as one entity.
Table 1. Baseline characteristics of patients (n = 100)
|Age (years ± S.E.M.)||50.1 ± 0.72|
|Preoperative medication use|
| H2-RA|| 6|
| Others|| 0|
Overall, 90% study patients experienced satisfaction from their surgery. The various reasons for satisfaction were described in the form of GERD symptom reduction, improvement in quality of life, decreased GERD-related medication use and decrease in money spent on medications, hospital and doctors’ office visits. Also, patients described a reduction in work hours lost due to GERD-related symptoms. Six subjects developed mild to moderate dysphagia post-operatively and four had gas bloat syndrome resulting in their dissatisfaction with the procedure. When asked about willingness to undergo surgery again, if needed, 80% patients responded affirmatively.
There was no relationship observed between surgical satisfaction or willingness to undergo surgery again and the psychiatric morbidity and/or chronic pain syndromes. No correlation was observed between smoking and alcohol use habits and surgical satisfaction post-LNF. Most of the patients who had decrease in their symptoms post-operatively were willing to undergo surgery again if needed.
Preprocedure symptoms decreased in severity in 67% patients. Not a single patient had worsening of their preprocedure symptoms. However, we should note here that one-third of patients continued to experience various GERD-related symptoms. More importantly as Table 2 shows, 80% patients were still on some kind of antireflux medications (P < 0.01). Out of these, approximately two-thirds were still of same or lesser doses of PPIs, the others being on H2-receptor antagonists or other antacids (Table 2). Overall, 76% patients noticed decrease in their medication use post-operatively.
Table 2. Preoperative and post-operative medication usage
While the advent of acid-suppressive medications especially PPIs has radically altered the way GERD is treated these days, these drugs do not address the pathophysiology of GERD. LNF has emerged as an excellent mode of therapy for GERD that actually targets the mechanisms involved in the pathogenesis. One of the attractiveness of surgery is to be able to avoid lifelong use of expensive and potentially toxic drugs. Our study debunks the myth that the latter goal can be achieved in most patients.
Conflicting results have been reported about the cost-effectiveness of the surgery by the surgeons and gastroenterologists. Good results have been observed up to 5 years of post-operative follow-up in terms of GERD symptom control and healing of oesophagitis.4 Granderath et al. from Austria showed improved quality of life and observed that 98% of patients needed no renewed medical treatment because of recurrent GERD symptoms up to 3 years after surgery.5 Kamolz et al. reported a 95% satisfaction with antireflux surgery.6 In another study carried out by the same group of investigators, they concluded even if they are good surgical candidates from a physiological point of view, GERD patients with concomitant major depression should be selected carefully because such patients report less symptomatic relief, suffer from post-operative dysphagia, and showed less quality of life improvement.7
The follow-up VA study carried out by Spechler et al. determined the long-term outcome of medical and surgical therapies for GERD.3 Patients were followed for mean duration of 9.1 years. They found that 62% of surgically treated patients continue to use antireflux medications regularly. This well-done study created a lot of controversy between gastroenterologists and surgeons. Many critics questioned the validity of the study in the new millennium because of technological advances as well as the fact that the surgical technique has undergone continued refinement during the recent years.
In contrast to the Spechler et al.3 study, Vakil et al. in a study conducted in a community hospital found only 32% were taking medications after 20 ± 10 months of follow-up.8 They also reported that 61% of their patients were satisfied with the antireflux procedure. In contrast to our results, two-thirds of their patients reported new symptoms after surgery.
Our study was conducted in a large tertiary care community hospital and assessed the success of LNF as a patient might see it after a period of over 3 years. We demonstrated 90% patient satisfaction after the surgery. Two-thirds of our patients had improvement in their preprocedure symptoms while one-third patients continued to experience similar or lesser symptoms post-operatively. High satisfaction notwithstanding, 80% of subjects in our study continue to take some form of acid-suppressive therapy at 3-year follow-up, the majority of them being on PPI therapy.
It is well known that the learning curve for this mode of therapy and steep and results from tertiary care and specialized centres cannot be generalized to different settings in the community at large. However, the surgeon performing the operations in our study would be considered an expert by any measure.
It is counterintuitive that an overwhelming majority of patients would continue to take medications including PPIs and yet feel satisfied with the surgery and would be willing to repeat it again. The reasons for these contradictory findings are unclear. While cynics could argue that the surgery acts as a placebo in many such patients, the likely possibility is that the surgery provides only partial but significant relief to majority of patients. Another possibility is that the patients continue PPIs because attempts at withdrawal of these drugs may have been unsuccessful because of rebound hyperacidity if withdrawn abruptly. Still another possibility is that the patients may not wish to express their disapproval of the surgery as this might reflect on their judgement and decision to go to surgery in the first place. The latter is, however, unlikely because most of them were also willing to repeat the surgery if needed.
Our study has several limitations, the major one being that it is not a head-to-head prospective study with a separate control group. Each subject served as his/her own control in our study and there is a potential for recall bias. A second significant weakness is the lack of sufficient detail regarding drug usage, i.e. whether patients were taking PPIs every day or intermittently. Another drawback is that 32% of the patients declined to participate. While it is impossible to predict the results if they had all participated, we feel that those who declined are more likely to be the people who were unhappy with the surgery than the ones pleased with the surgical results.
So what is the answer to the questions we wished to answer: (1) Does this procedure in fact provide a permanent solution to GERD problem? (2) Are patients really freed from the need to consume pharmaceuticals? The answer is clearly negative for both the questions in case of most of the patients. (3) How well can we give a guarantee to the patient that after the antireflux surgery, he or she would not require long-term antireflux medications especially the expensive proton pump inhibitors? Again, the answer is that most of them would continue to need antireflux medications including PPIs.
No external funding was received for this study.