Health-related anxiety and the effect of open-access endoscopy in US patients with dyspepsia

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1 Aliment Pharmacol Ther 23; 17: doi: 1.146/j x Health-related anxiety and the effect of open-access endoscopy in US patients with dyspepsia A. QUADRI & N. VAKIL University of Wisconsin Medical School, Milwaukee, WI, USA Accepted for publication 3 January 23 SUMMARY Background: The role of endoscopy in dyspepsia is the subject of debate. The detection of lesions is infrequent, but patients may benefit from the knowledge that the examination is normal. We sought to determine the prevalence of health-related anxiety in dyspeptic patients referred for open-access endoscopy and to investigate the effect of endoscopy on health-related anxiety. Methods: Consecutive patients referred for open-access endoscopy from primary care were studied using a validated questionnaire for health-related anxiety before and after endoscopy, at 1 month and 6 months. Symptoms were assessed using a validated questionnaire at 1 and 6 months. Results: One hundred and nine patients were studied (69 women and 4 men; mean age, 49 ± 15 years). Thirty-six of the 19 patients (33%) had high anxiety scores at baseline (mean score, 41 ± 1), which decreased after endoscopy to 35 ± 1 (P <.5). The changes persisted at 1 month (33 ± 1) and 6 months (33 ± 1). Endoscopic findings were as follows: normal examination, 12; erosive oesophagitis, 11 (Grade A); erosive duodenitis (all Helicobacter pylori-negative), 6. Scales for preoccupation with health and fear of illness and death showed significant improvement after endoscopy, and the effects were preserved for 6 months. Anxiety scores in our population were substantially higher than in a corresponding UK population. Conclusions: Health-related anxiety is common in dyspeptic patients referred for endoscopy. Endoscopy decreases the preoccupation with health and fear of illness and death in patients with severe anxiety, and the effects persist for 6 months. INTRODUCTION Dyspepsia is a common condition in primary care. Due to the large numbers of patients with dyspeptic symptoms, investigation is neither appropriate nor necessary in most patients. In dyspeptic patients undergoing endoscopy, 4 6% have no abnormal findings (non-ulcer dyspepsia). 1 The value of an endoscopic examination that does not reveal a cause for the symptoms has been debated, but most Correspondence to: Dr N. Vakil, University of Wisconsin Medical School, Aurora Sinai Medical Center, 945 North 12th Street, Room 44, Milwaukee, WI 53233, USA. nvakil@wisc.edu economic analyses assign no benefit to such an examination. 2 Some clinical studies have suggested that health care utilization may decrease after endoscopy even if no specific abnormalities are found. 3 Other studies have demonstrated a short-term improvement in the quality of life after an endoscopy that fails to reveal any abnormality. 4 Dyspeptic subjects who consult physicians are more likely to have concerns about a serious underlying illness than those who do not. One-third of dyspeptic patients who have not undergone investigation indicate that they would feel better with a diagnostic test. 5 Mathematical models for quantifying the impact of diagnostic tests on a patient s health-related quality of life have suggested Ó 23 Blackwell Publishing Ltd 835

2 836 A. QUADRI & N. VAKIL that dyspeptic patients with high levels of anxiety about underlying cancer or serious disease may benefit from endoscopy. 6 In contrast with these studies, others have shown only short-term improvement in health-related anxiety after endoscopy, and some have demonstrated that non-invasive testing for Helicobacter pylori reassures patients as much as endoscopy. 7, 8 Much of the existing data in the literature is from European populations where patient expectations may be substantially different from those in the USA. The aim of our study was to determine the effect of endoscopy on health-related anxiety scores in patients with high degrees of healthrelated anxiety. METHODS Consecutive patients referred for upper endoscopy by primary care physicians for symptoms of uncomplicated dyspepsia were offered entry into the study. Dyspepsia was defined as pain or discomfort in the upper abdomen. Patients with predominant symptoms of reflux disease (heartburn and regurgitation) were excluded. Patients with alarm symptoms (bleeding, dysphagia, weight loss) and individuals who had undergone endoscopy in the preceding 5 years were also excluded. All patients completed two validated questionnaires before endoscopy. The health anxiety questionnaire is a validated measure of health anxiety. The questionnaire and its validation have been published previously. 9 The health anxiety questionnaire has 21 items, with a four-point Likert scale for each item, and has been shown to have high internal consistency (Cronbach s alpha ¼.92), test/re-test reliability (r ¼.94) and evidence of discriminative ability (it discriminates between a normal group, student nurses, medical out-patients, clinical psychology patients, patients with hypochondriasis and non-hypochondrial patients with clinical anxiety). 8, 9 It consists of four components: worry and preoccupation about health; fear of illness and death; reassurance seeking behaviour; and interference with life. Gastrointestinal symptoms were evaluated using the gastrointestinal symptom rating scale. This is a validated scale of upper gastrointestinal symptoms that has been widely used in the assessment of symptoms in dyspeptic patients It is a disease-specific instrument designed to evaluate common symptoms of gastrointestinal disorders. It consists of 15 items, each rated on a seven-point Likert scale. Following endoscopy, the endoscopist used a standardized method to describe the findings in the oesophagus, stomach and duodenum. The post-procedure interview included an explicit statement that cancer and precancerous lesions had not been found. Medical aspects of the abnormal endoscopic findings were discussed (e.g. the pathogenesis and treatment of gastro-oesophageal reflux disease). Patients repeated the health anxiety questionnaire immediately prior to discharge from the endoscopy suite, and 1 month and 6 months after endoscopy. In addition, patients also completed the gastrointestinal symptom rating scale 6 months after endoscopy. Statistical analysis Patients were divided into low (< 21), medium (21 31) and high (> 31) anxiety groups based on their composite scores on the health anxiety questionnaire at the pre-endoscopy examination, as described previously. 8 A sample size of 36 patients in the high anxiety group was estimated to be needed to detect a five-point difference in the health anxiety questionnaire before and after endoscopy, with alpha ¼.5 and 9% power. Assuming a 25% drop-out rate and onethird of patients in the high anxiety group, a minimum of 135 patients was required for the study. The results are expressed as the mean ± standard error. The mean scores of the health anxiety questionnaire and sub-scales of the health anxiety questionnaire and gastrointestinal symptom rating scale were compared before and after endoscopy using repeated measure analysis of variance. For univariate and multivariate analysis tests, a P value of less than.5 was considered to be statistically significant. For pairwise comparisons where more than two values were compared, a Bonferroni adjustment was made (i.e..5 divided by the number of comparisons) to correct for repeated observations. RESULTS All 137 patients entering the study completed the initial and post-endoscopy questionnaires; 28 patients did not respond to requests to complete the 1 month and 6 month questionnaires. Therefore, 19 patients completed all aspects of the study and are reported here. There were 69 women and 4 men with a mean age of 49 ± 15 years. There were 49 Caucasian and 6

3 FEAR OF ILLNESS AND ENDOSCOPY 837 African-American subjects. All patients had been referred by primary care physicians for endoscopy for symptoms of dyspepsia (newly diagnosed, recurrent or unresponsive to acid suppressive therapy). Most of these patients had been using acid suppressive therapy for more than 8 weeks (proton pump inhibitors, n ¼ 85; H 2 -receptor antagonists, n ¼ 17; over-the-counter medications, n ¼ 35). Non-invasive testing for H. pylori had been performed in 66 patients, four of whom had tested positive and received treatment for H. pylori. Nineteen patients were tested for H. pylori at endoscopy and 11 were positive. Endoscopic findings were as follows: normal examination, 12; erosive oesophagitis, 11 (Grade A); erosive duodenitis (all H. pylori-negative), 6. Health anxiety score High anxiety Moderate anxiety Low anxiety Pre Post 1 month 6 months Treatment All patients infected with H. pylori were offered treatment and told that eradication might not relieve their symptoms. In patients with normal endoscopy, no specific therapy was prescribed. Patients with erosive oesophagitis and duodenitis received an 8-week treatment course with a proton pump inhibitor, after which they were asked to see their primary care physicians. Health anxiety questionnaire At baseline, 36 of the 19 patients (33%) had high health anxiety scores, 36 patients (33%) had moderate health anxiety scores and 37 patients (34%) had low health anxiety scores. Figure 1 shows the changes in overall health anxiety in the three groups. The score decreased significantly after endoscopy in patients with moderate or high anxiety. Values were significantly lower than baseline in the high anxiety and moderate anxiety groups at 1 month and 6 months (P <.5). There was no significant change in the low anxiety group. Components of the health anxiety questionnaire In patients with high anxiety, a significant reduction was noted in the sub-scales of worry and preoccupation about health and fear of illness and death immediately after endoscopy, and the effects were sustained for 6 months (Figure 2). In the medium anxiety group, worry and preoccupation about health decreased significantly after endoscopy, and the effect was significant at 6 months, but the rest of the components did not show Figure 1. Health anxiety scores in patients with high, medium and low health-related anxiety before endoscopy (Pre), after endoscopy (Post) and at 1 month and 6 months. Health anxiety sub-scales Preoccupation with health Fear of illness & death Reassurance seeking behaviour Interference with life Pre Post 1 month 6 months Figure 2. Scales of the health anxiety questionnaire in patients with high anxiety. Worry and preoccupation about health and fear of illness and death show a significant decrease after endoscopy, which is sustained for 6 months. a significant change (Figure 3). No significant changes were noted in any sub-scales in the low anxiety group (Figure 4). Dimensions of the gastrointestinal symptom rating scale The baseline score for abdominal pain was 3.3 ±.2, and was significantly improved at 6 months (2.3 ±.2; P <.5). For the indigestion syndrome, the baseline value was 3.2 ±.2 and decreased to 2.5 ±.2

4 838 A. QUADRI & N. VAKIL Health anxiety sub-scales Health anxiety sub-scales Preoccupation with health Fear of illness & death Reassurance seeking behaviour Interference with life Pre Post 1 month 6 months Figure 3. Scales of the health anxiety questionnaire in patients with moderate anxiety. Worry and preoccupation about health shows a significant decrease after endoscopy, which is sustained for 6 months. Preoccupation with health Fear of illness & death Reassurance seeking behaviour Interference with life Pre Post 1 month 6 months Figure 4. Scales of the health anxiety questionnaire in patients with low anxiety. No significant change in any of the four scales is noted after endoscopy. (P <.5) at 6 months. For the reflux syndrome, the baseline value was 3.1 ±.2 and decreased to 2.6 ±.2 (P <.5). For the constipation syndrome, the baseline score was 2.8 ±.1 and decreased to 2 ±.1 (P <.5). For the diarrhoea syndrome, the baseline score was 2.4 ±.2 and decreased to 2 ±.2. The study was not powered to detect differences in symptom improvement between the high, medium and low anxiety groups. DISCUSSION This study shows that health-related anxiety is common in dyspeptic patients undergoing open-access endoscopy. An absence of serious lesions at endoscopy and reassurance provided by the endoscopist are associated with a significant decrease in health anxiety scores, which persists for 6 months in patients with moderate or severe anxiety. Patients with little or no anxiety show no change in their scores after endoscopy. Analysis of the sub-scales showed that most of the improvement was in the sub-scales of worry and preoccupation about health and fear of illness and death. With regard to symptoms, the greatest improvement was seen in the abdominal pain scale. The abdominal pain scale most strongly correlates with generic health status and psychological well-being. 1 Not surprisingly, this scale showed the greatest change, but improvements occurred in other scales as well. The non-specific improvement in symptoms may reflect the overall benefit of reassurance rather than a response to specific therapy, because most patients had normal endoscopy and were not prescribed specific therapy. It has been speculated that unexplained gastrointestinal symptoms may be mediated by psychosocial factors, and anxiety could be one such factor. 13 Fear of serious illness and fear of cancer have been shown to be important causes of health care utilization in patients with dyspepsia. 14 Dyspeptic patients who present to physicians for consultation do not have more frequent or more severe symptoms than individuals who do not. 14 The most striking difference between these two groups is that individuals who seek medical attention are more concerned about the possible seriousness of their symptoms and are more likely to be concerned about underlying cancer. 15 Health anxiety has been shown to lead to a cycle of repeated medical consultations. In a study of primary care patients undergoing open-access endoscopy, Hungin et al. demonstrated that consultations for dyspepsia fell by 57% in patients with normal endoscopy and by 37% in patients with minor abnormalities at endoscopy. In 6% of patients with normal endoscopy, medication use was terminated or decreased. 3 A number of empirical strategies have been proposed for the management of dyspeptic patients. Empirical H 2 -receptor antagonist treatment was originally proposed as a strategy instead of early endoscopy. 16 In a Danish study comparing empirical H 2 -receptor antagonist therapy with early endoscopy, patients

5 FEAR OF ILLNESS AND ENDOSCOPY 839 randomized to empirical treatment were less satisfied than those undergoing early endoscopy. 17 More recently, a test and treat strategy for H. pylori has been proposed in primary care. 18 This strategy has been shown to decrease the number of endoscopies performed in a dyspeptic Danish population, but patient satisfaction was lower with empirical therapy than with early endoscopy. 19 The cause of the dissatisfaction was not evaluated in these studies, but it is possible that the empirical strategies did not provide the reassurance provided by endoscopy. In contrast with these studies, a recent investigation from Scotland compared non-invasive testing for H. pylori (using a breath test) with early endoscopy and found that the reassurance value was similar in the two groups. Differences in patient expectations in different countries could account for these differences in satisfaction. 2 In our study, non-invasive testing for H. pylori was performed by primary care physicians in a little over one-half of subjects before endoscopy. This reflects the limited uptake of the test and treat strategy by primary care 21, 22 physicians in the USA. Studies in the UK with the health anxiety questionnaire have shown that health-related anxiety and illness belief decrease markedly after endoscopy. 8 In keeping with that study, we found no significant improvement in anxiety in patients who had low anxiety at the baseline examination. In these individuals, endoscopy and the reassurance that it can offer had little impact on health anxiety. In keeping with that study, we also found a significant decrease in health anxiety scores in patients with moderate or severe anxiety. In patients with high anxiety at baseline, however, reassurance was short-lived and illness belief and worry about health returned to baseline values within 24 h. 8 In our study, however, the reassurance afforded by endoscopy was sustained over 6 months in the high anxiety group as well as in the medium anxiety group. It is noteworthy that the mean scores in each of our groups (high, medium and low anxiety) were twice as high as those in a similar UK population undergoing out-patient endoscopy. These data suggest that healthrelated anxiety may vary in different populations and that the degree of anxiety may influence the outcome. Our results cannot be explained by the eradication of H. pylori or the improvement in symptoms with medical therapy because the results were immediately apparent after endoscopy and did not change appreciably over the course of 6 months. In most cases, medical therapy was not prescribed after endoscopy. The improvements in the specific sub-scales relating to worry and preoccupation about health and fear of illness and death suggest that the relief in anxiety was due to reassurance about the disease rather than emotional relief at having completed the procedure. Relief at having completed the procedure should improve all sub-scales without the selective improvement in worry and preoccupation about health and fear of illness and death. As with all investigations, our study has some advantages and some limitations. It is one of the few studies on this subject in a US population, and provides an estimate of the prevalence of health-related anxiety in dyspeptic patients. It examines patients in real-life settings and mimics current US clinical practice. We studied health-related anxiety rather than a surrogate marker such as quality of life or patient satisfaction, which may measure other aspects of health care delivery or the health state. We used scales for symptoms and anxiety that have been validated in patients with gastrointestinal disorders. We did not study the reassurance value of consultation with a gastroenterologist without endoscopy. Patients with uncomplicated dyspepsia are much more likely to undergo open-access endoscopy than consultation with a gastroenterologist in the office in the USA. Our design therefore mimics real-life conditions. One limitation of our study is that we did not investigate health care utilization. This was not the focus of our study, but previous investigations have shown that successful reassurance results in decreased health care resource utilization. 3 We conclude that health-related anxiety is common in dyspeptic patients referred for open-access endoscopy, and that endoscopy may be of benefit in some dyspeptic patients with severe anxiety. ACKNOWLEDGEMENT Dr A. Quadri, Fellow in Gastroenterology, received the Lawlor award of the American College of Gastroenterology for this study. REFERENCES 1 Kagevi I, Lofstedt S, Persson L-G. Endoscopic findings and diagnoses in unselected dyspeptic patients at a primary health care center. Scand J Gastroenterol 1989; 24: Spiegel B, Vakil N, Ofman J. Dyspepsia management in primary care: a decision analysis of competing strategies. Gastroenterology 22; 122:

6 84 A. QUADRI & N. VAKIL 3 Hungin A, Thomas P, Bramble M, et al. What happens to patients following open access gastroscopy? An outcome study from general practice. Br J Gen Pract 1994; 44: Wiklund I, Glise H, Jerndaln P, Carlsson J, Talley N. Does endoscopy have a positive impact on quality of life in dyspepsia? Gastrointest Endosc 1998; 47(6): Kurata J, Nogawa A, Chen Y, Parker C. Dyspepsia in primary care: perceived causes, reasons for improvement and satisfaction with care. J Fam Pract 1997; 44: Sonnenberg A, Vakil N. The benefit of negative tests in nonulcer dyspepsia. Med Decis Making 22; 22(3): McColl KE, Murray LS, Gillen D, et al. Randomised trial of endoscopy with testing for Helicobacter pylori compared with non-invasive H. pylori testing alone in the management of dyspepsia. Br Med J 22; 324(7344): Lucock M, Morley S, White C, Peake M. Responses of consecutive patients to reassurance after gastroscopy: results of self administered questionnaire survey. Br Med J 1997; 315: Lucock M, Morley S. The Health Anxiety Questionnaire. Br J Health Psychol 1996; 1: Revicki D, Wood M, Wiklund I, Crawley J. Reliability and validity of the gastrointestinal symptom rating scale in patients with gastrointestinal reflux disease. Qual Life Res 1998; 7: Dimenas E, Glise H, Hallerback B, et al. Well-being and gastrointestinal symptoms among patients referred to endoscopy owing to suspected duodenal ulcer. Scand J Gastroenterol 1995; 3: Talley NJ, Vakil N, Ballard ED, Fennerty B. Absence of benefit of eradicating Helicobacter pylori in patients with nonulcer dyspepsia. N Engl J Med 1999; 341: Baker LH, Lieberman D, Oehlke M. Psychological distress in patients with gastroesophageal reflux disease. Am J Gastroenterol 1995; 9: Howell S, Talley NJ. Does fear of serious disease predict consulting behaviour amongst patients with dyspepsia in general practice. Eur J Gastroenterol Hepatol 1999; 11: Lydeard S, Jones R. Factors affecting the decision to consult with dyspepsia: comparison of consulters and non-consulters. J R Coll Gen Pract 1989; 39: Health and Policy Committee, American College of Physicians. Endoscopy in the evaluation of dyspepsia. Ann Intern Med 1985; 12: Bytzer P, Hansen J, de Muckadell O. Empirical H2 blocker therapy or prompt endoscopy in management of dyspepsia. Lancet 1994; 343: The European H. pylori Study Group. Current European concepts on the management of Helicobacter pylori infection. The Maastricht Consensus report. Gut 1997; 41: Lassen A, Pedersen FM, Bytzer P, de Muckadell O. Helicobacter pylori test and eradicate versus prompt endoscopy for management of dyspeptic patients: a randomized trial. Lancet 2; 356: Kravitz RL, Callahan EJ, Paterniti D, Antonius D, Dunham M, Lewis CE. Prevalence and sources of patients unmet expectations for care. Ann Intern Med 1996; 125(9): Hood HM, Wark C, Burgess PA, Nicewander D, Scott MW. Screening for Helicobacter pylori and nonsteroidal antiinflammatory drug use in Medicare patients hospitalized with peptic ulcer disease. Arch Intern Med 1999; 159(2): Schwartz L, Woloshin S, Welch G. Trends in diagnostic testing following a national guideline for evaluation of dyspepsia. Arch Intern Med 1996; 156:

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