Abstract
Gastro-oesophageal reflux disease (GORD) is common in the general population and is diagnosed based on patient-reported symptoms and clinical tests. Although clinical tests are available, significant percentages of patients report symptoms of heartburn and reflux despite negative endoscopies, and 24-hour pH tests are not often used by primary-care physicians in diagnosis. Consequently, patient-reported symptoms and health-related QOL (HR-QOL) are important in assessing treatment outcome.
HR-QOL is significantly impaired in patients with GORD, and HR-QOL is associated with symptom severity and changes in GORD-related symptoms. The objective of this literature review is to examine the impact of pharmacological treatment on HR-QOL in patients with GORD.
Generic and disease-specific HR-QOL measures have been used in clinical trials to evaluate the impact of GORD on patient functioning and well-being. The Psychological General Well-Being (PGWB) Index and the 36-Item Short-Form Health Survey (SF-36) have been used in several clinical trials of treatment for GORD and have consistently shown that HR-QOL improves with successful therapy. These trials have been conducted primarily with two pharmacological agents, omeprazole and ranitidine. On the Heartburn-specific Quality of Life questionnaire, patients treated with ranitidine reported better HR-QOL after treatment compared with placebo therapy. In two clinical trials where omeprazole and ranitidine were compared, patients treated with omeprazole reported significantly better HR-QOL (based on the PGWB Index) than those treated with ranitidine; however, 2 other trials did not detect significant differences between the treatments. Results from clinical trials using disease-specific measures (Gastrointestinal Quality of Life Index [GIQLI] and Heartburn-specific Quality of Life questionnaire) demonstrate similar findings, supporting the association between treatment-related symptom resolution and improvements in HR-QOL. The GIQLI was used in a trial comparing pantoprazole and ranitidine, where results favoured pantoprazole therapy.
Several studies have demonstrated that resolution of GORD symptoms is associated with improvement in HR-QOL. Although there is evidence that treatment for GORD does improve symptoms and HR-QOL outcomes, further research is needed to more completely understand the value of medical therapy for GORD.
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References
Goyal RK. Diseases of the esophagus. In: Isselbacher KJ, Braunwald E, Wilson JD, et al., editors. Principles of internal medicine. New York (NY): McGraw Hill, 1994: 1355–62
Wiener GJ, Koufman JA, Wu WC, et al. Chronic hoarseness secondary to gastroesophageal reflux disease: documentation with 24-hour ambulatory pH monitoring. Am J Gastroenterol 1989; 84: 1503–8
Sontag SJ, O’Connell S, Khandelwal S, et al. Most asthmatics have gastroesophageal reflux with or without bronchodilator therapy. Gastroenterology 1990; 99: 613–90
Modlin IM, Sachs R. Acid-related diseases. Munich: Schnetztor-Verlag GmbH D-Konstantz, 1998
Nebel OT, Fornes MF, Castell DO. Symptomatic gastro-sophageal reflux: incidence and precipitating factors. Am J Dig Dis 1976; 21: 953–6
van Pinxteren B, Numans ME, Bonis PA, et al. Short-term treatment with proton pump inhibitors, H2-receptor antagon-ists and prokinetics for gastro-oesophageal reflux disease-like symptoms and endoscopy negative reflux disease (Cochrane Review). Available in the Cochrane Library [database on disk and CD ROM]. Updated quarterly. The Cochrane Collaboration; issue 4. Oxford: Update Software, 2001
Beers MH, Berkow R, editors. Gastrointestinal disorders: the Merck manual. 17th ed. Whitehouse Station (NJ): Merck Re-search Laboratories, 1999
Wolfe MM. An overview of gastroesophageal reflux disease. Am J Manag Care 2000; 6 Suppl.: S461–6
An evidence-based appraisal of reflux disease management: the Genval Workshop Report. Gut 1999; 44 Suppl. 2: S1–16
DeVault KR, Castell DO, on behalf of The Practice Parameters Committee of the American College of Gastroenterology. Updated guidelines for the diagnosis and treatment of gastro esophageal reflux disease. Am J Gastroenterol 1999; 94 (6): 1434–42
Flynn CA. The evaluation and treatment of adults with gastroesophageal reflux disease. J Fam Pract 2001; 50: 57–63
SAGES (Society of American Gastrointestinal Endoscopic Sur-geons). Guidelines for surgical treatment of gastroesophageal reflux disease (GERD). Surg Endosc 1998; 12: 186–8
Wiklund I. Quality of life in patients with gastroesophageal reflux disease. Am J Gastroenterol 2001; 96 (8 Suppl.): S46–53
Rentz AM, Battista C, Trudeau E, et al. Symptom and health-related quality of life measures for selected gastrointestinal disease studies: a review and synthesis of the literature. Pharmacoeconomics 2001; 19 (4): 349–63
DeVault KR, Castell DO. Current diagnosis and treatment of gastroesophageal reflux disease. Mayo Clin Proc 1994; 69: 867–76
Ramirez B, Richter JE. Promotility drugs and the treatment of gastroesophageal reflux disease. Aliment Pharmacol Ther 1993; 7: 5–20
Iskedjian M, Einarson TR. Meta-analyses of cisapride, omeprazole, and ranitidine in the treatment of GORD: implications for treating patient subgroups. Clin Drug Invest 1998; 16: 9–18
Fennerty MB, Castell D, Fendrick AM, et al. The diagnosis and treatment of gastroesophageal reflux disease in a managed care environment. Arch Intern Med 1996; 156: 477–82
Humphries TJ, Merritt GJ. Drug interactions with agents used to treat acid-related diseases. Aliment Pharmacol Ther 1999; 13: 18–26
Bardhan KD. The role of proton pump inhibitors in the treatment of gastroesophageal reflux disease. Aliment Pharmacol Ther 1995; 9: 15–25
Sontag SJ, Kogut DG, Fleischmann R, et al. Lansoprazole heals erosive reflux esophagitis resistant to histamine-2 receptor antagonist therapy. Am J Gastroenterol 1997; 92: 429–37
Lansoprazole [package insert]. TAP Pharmaceuticals Inc., 2002
Omeprazole [package insert]. AstraZeneca, 2002
Moyer CA, Fendrick AM. Measuring health-related quality of life in patients with gastrointestinal disease. Dig Dis 1998; 16: 315–24
Revicki DA, Wood M, Wiklund I, et al. Reliability and validity of the gastrointestinal symptom rating scale in patients with gastroesophageal reflux disease. Qual Life Res 1998; 7: 75–83
Revicki DA, Wood M, Maton P, et al. The impact of gastroesophageal reflux disease on health-related quality of life. Am J Med 1998; 104: 252–8
Carlsson R, Dent J, Watts R, et al. Gastro-oesophageal reflux disease in primary care: an international study of different treatment strategies with omeprazole. Eur J Gastroenterol Hepatol 1998; 10: 119–24
Wiklund I, Glise H, Jerndal P, et al. Does endoscopy have a positive impact on quality of life in dyspepsia? Gastrointest Endosc 1998; 47: 449–54
Havelund T, Lind T, Wiklund I, et al. Quality of life in patients with heartburn but without esophagitis: effects of treatment with omeprazole. Am J Gastroenterol 1999; 94 (7): 1783–90
Kaplan-Machlis B, Spiegler G, Zodet MW, et al. Effectiveness and costs of omeprazole vs ranitidine for treatment of Symptomatic gastroesophageal reflux disease in primary care clinics in West Virginia. Arch Fam Med 2000; 9: 624–30
Lundell L, Miettinen P, Myrvold HE, et al. Long-term management of gastro-oesophageal reflux disease with omeprazole or open antireflux surgery: results of a prospective, randomized clinical trial. The Nordic GORD Study Group. Eur J Gastroenterol Hepatol 2000; 12 (8): 879–87
Revicki DA, Ehreth JL. Health-related quality of life assessment and planning for the pharmaceutical industry. Clin Ther 1997; 19: 1101–15
Kaplan-Machlis B, Spiegler G, Revicki DA. Health-related quality of life in primary care patients with gastroesophageal reflux disease. Ann Pharmacother 1999; 33: 1032–6
Young TL, Krichdoerfer LJ, Osterhaus JT. A development and validation process for a disease-specific quality of life instrument. Drug Inform J 1996; 30: 185–93
Revicki DA, Sorensen S, Maton P, et al. Health-related quality of life outcomes of omeprazole versus ranitidine in poorly responsive symptomatic gastroesophageal reflux disease. Dig Dis 1998; 16: 284–91
Revicki DA, Crawley JA, Zodet MW, et al. Complete resolution of heartburn symptoms and health-related quality of life in patients with gastro-oesophageal reflux disease. Aliment Pharmacol Ther 1999; 13: 1621–30
Dimenas E. Methodological aspects of evaluation of quality of life in upper gastrointestinal diseases. Scand J Gastroenterol 1993; 28: 18–21
Ware J. SF-36 Health survey manual and interpretation guide. Boston (MA): The Health Institute, New England Medical Center, 1993
Dupuy HJ. The psychological general well-being (PGWB) index. In: Wender NK, Mattson ME, Furberg CD, et al., editors. Assessment of quality of life in clinical trials of cardiovascular therapies. New York (NY): Le Jacq, 1984: 170–83
Eypasch E, Williams JI, Wood-Dauphinee S, et al. Gastrointestinal quality of life index: development, validation, and application of a new instrument. Br J Surg 1995; 82: 216–22
Wiklund I, Junghard O, Grace E, et al. Quality of life in reflux and dyspepsia patients: psychometric documentation of a new disease-specific questionnaire (QOLRAD). Eur J Surg Suppl 1998; 164: 41–9
Raymond JM, Marquis P, Bechade D, et al. Assessment of quality of life of patients with gastroesophageal reflux: elaboration and validation of a specific questionnaire [in French]. Gastroenterol Clin Biol 1999; 23 (1): 32–9
Marquis P, Sapede C, Bechade D, et al. Development and psychometric validation of a disease-specific quality of life questionnaire in gastro-oesophageal reflux. Qual Life Res 1995; 4: 457–8
Colwell HH, Mathias SD, Pasta DJ, et al. Development of a health-related quality-of-life questionnaire for individuals with gastroesophageal reflux disease: a validation study. Dig Dis Sci 1999 Jul; 44 (7): 1376–83
Rush DR, Stelmach WJ, Young TL, et al. Clinical effectiveness and quality of life with ranitidine vs placebo in gastro-esophageal reflux disease patients: a clinical experience network (CEN) study. J Fam Pract 1995; 41 (2): 126–36
Chat KL, Stacey JH, Sacks GE. The effect of ranitidine on symptom relief and quality of life of patients with gastrooesophageal reflux disease. Br J Clin Pract 1995; 49 (2): 73–7
Kaspari S, Biedermann A, Mey J. Comparison of pantoprazole 20mg to ranitidine 150mg BID in the treatment of mild gastro-esophageal reflux disease. Digestion 2001; 63: 163–70
Stacey JH, Miocevich ML, Sacks GE. The effect of ranitidine (as effervescent tablets) on the quality of life of GORD patients. Br J Clin Pract 1996; 50 (4): 190–4, 196
Watson RGP, Tham TCK, Johnston BT, et al. Double-blind cross-over placebo-controlled study of omeprazole in the treatment of patients with reflux symptoms and physiological levels of acid reflux: the “sensitive oesophagus”. Gut 1997; 40: 587–90
Oster G, Thompson D, Kaatz S, et al. The GORD outcomes trial: a randomized study to assess outcomes and costs in primary care practice [abstract]. Gastroenterology 1998; 114: A32
Wiklund I, Bardhan KD, Müller-Lissner S, et al. Quality of life during acute and intermittent treatment of gastro-oesophageal reflux disease with omeprazole compared with ranitidine: re sults from a multicentre clinical trial. Ital J Gastroenterol Hepatol 1998; 30: 19–27
Lauritsen K, Junghard O, Eklund S, et al. Effect of esomeprazole 40 mg on healing, reflux symptoms, and quality of life in patients with reflux esophagitis [abstract]. Presented at the Annual Meeting for Digestive Disease Week, American Gastroenterological Association; 2002 May 19–22; San Francisco (CA)
Schipper H, Clinch JJ, Olweny CLM. Quality of life studies: definition and conceptual issues. In: Spiler B, editor. Quality of life and pharmacoeconomics in clinical trials. 2nd ed. Philadelphia: Lippincott-Raven Press, 1996
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Prasad, M., Rentz, A.M. & Revicki, D.A. The Impact of Treatment for Gastro-Oesophageal Reflux Disease on Health-Related Quality of Life. Pharmacoeconomics 21, 769–790 (2003). https://doi.org/10.2165/00019053-200321110-00002
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DOI: https://doi.org/10.2165/00019053-200321110-00002