Randomised clinical trial: The burden of illness of uninvestigated dyspepsia before and after treatment with esomeprazole - Results from the STARS II study

Alimentary Pharmacology and Therapeutics

Volumn 34, Issue 7, 2011, Pages 714-723

  Veldhuyzen Van Zanten, S ^a   Wahlqvist, P ^b   Talley, N J ^c,d   Halling, K ^e   Vakil, N ^f   Lauritsen, K ^g   Flook, N ^a   Persson, T ^b   Bolling Sternevald, E ^b,h  

^a UNIVERSITY OF ALBERTA   (Canada)

^b ASTRAZENECA R AND D   (Sweden)

^c MAYO CLINIC   (United States)

^d UNIVERSITY OF SYDNEY   (Australia)

^e PRO Consulting   (Sweden)

^f UNIVERSITY OF WISCONSIN SCHOOL OF MEDICINE AND PUBLIC HEALTH   (United States)

^g ODENSE UNIVERSITY HOSPITAL   (Denmark)

^h KAROLINSKA INSTITUTE   (Sweden)

Author keywords

[No Author keywords available]

Indexed keywords

ESOMEPRAZOLE; PLACEBO;

ABDOMINAL PAIN; ADULT; ANXIETY; ARTICLE; CONSTIPATION; CONTROLLED STUDY; DAILY LIFE ACTIVITY; DEPRESSION; DIARRHEA; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DYSPEPSIA; EMOTIONAL STRESS; ENDOSCOPY; FEMALE; FOOD INTAKE; FUNCTIONAL STATUS; GASTROESOPHAGEAL REFLUX; HEARTBURN; HOSPITAL ANXIETY AND DEPRESSION SCALE; HUMAN; INDIGESTION; MAJOR CLINICAL STUDY; MALE; MENTAL HEALTH; PHYSICAL FUNCTION; PRIORITY JOURNAL; PRODUCTIVITY; QUALITY OF LIFE; QUALITY OF LIFE IN REFLUX AND DYSPEPSIA; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; REFLUX DISEASE QUESTIONNAIRE; SLEEP DISORDER; SOCIAL STATUS; STOMACH ACID; STOMACH ACID REGURGITATION; SYMPTOM; TREATMENT DURATION; VITALITY; WORK PRODUCTIVITY; WORK PRODUCTIVITY AND ACTIVITY IMPAIRMENT;

ADOLESCENT; ADULT; ANTI-ULCER AGENTS; COST OF ILLNESS; DOUBLE-BLIND METHOD; DYSPEPSIA; HUMANS; MIDDLE AGED; OMEPRAZOLE; QUALITY OF LIFE; QUESTIONNAIRES; REGRESSION ANALYSIS; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME; YOUNG ADULT;

EID: 80052509592     PISSN: 02692813     EISSN: 13652036     Source Type: Journal    
DOI: 10.1111/j.1365-2036.2011.04789.x     Document Type: Article

References (48)

1. Drossman DA, Corazziari E, Delvaux M,. Rome III: The Functional Gastrointestinal Disorders, 3rd edn. McLean: Degnon Associates, 2006.
2. Drossman DA, Corazziari E, Talley NJ, Thomson WG, Whitehead WE,. Rome II: The Functional Gastrointestinal Disorders, 2nd edn. McLean: Degnon Associates, 2000.
3. El-Serag HB, Talley NJ,. Health-related quality of life in functional dyspepsia. Aliment Pharmacol Ther 2003; 18: 387-93. (Pubitemid 37070236)
4. Halling K, Kulich K, Carlsson J, Wiklund I,. An international comparison of the burden of illness in patients with dyspepsia. Dig Dis 2008; 26: 264-73. (Pubitemid 351667811)
5. Moayyedi P, Mason J,. Clinical and economic consequences of dyspepsia in the community. Gut 2002; 50 (Suppl 4): iv10-2. (Pubitemid 34407461)
6. North of England Dyspepsia Guideline Development Group. Dyspepsia: Managing Dyspepsia in Adults in Primary Care. Newcastle upon Tyne: Centre for Health Services Research, 2004.
7. Talley NJ, Stanghellini V, Heading RC, Koch KL, Malagelada JR, Tytgat GN,. Functional gastroduodenal disorders. Gut 1999; 45 (Suppl 2): II37-42. (Pubitemid 29434811)
8. Talley NJ, Vakil N,. Guidelines for the management of dyspepsia. Am J Gastroenterol 2005; 100: 2324-37.
9. Talley NJ, Vakil NB, Moayyedi P,. American Gastroenterological Association technical review on the evaluation of dyspepsia. Gastroenterology 2005; 129: 1756-80. (Pubitemid 41597412)
10. Veldhuyzen van Zanten SJ, Bradette M, Chiba N, et al. Evidence-based recommendations for short- and long-term management of uninvestigated dyspepsia in primary care: an update of the Canadian Dyspepsia Working Group (CanDys) clinical management tool. Can J Gastroenterol 2005; 19: 285-303. (Pubitemid 40812614)
11. van Zanten SV, Flook N, Talley NJ, et al. One-week acid suppression trial in uninvestigated dyspepsia patients with epigastric pain or burning to predict response to 8 weeks' treatment with esomeprazole: a randomized, placebo-controlled study. Aliment Pharmacol Ther 2007; 26: 665-72. (Pubitemid 47246198)
12. Talley NJ, Meineche-Schmidt V, Pare P, et al. Efficacy of omeprazole in functional dyspepsia: double-blind, randomized, placebo-controlled trials (the Bond and Opera studies). Aliment Pharmacol Ther 1998; 12: 1055-65. (Pubitemid 28508719)
13. Svedlund J, Sjodin I, Dotevall G,. GSRS-a clinical rating scale for gastrointestinal symptoms in patients with irritable bowel syndrome and peptic ulcer disease. Dig Dis Sci 1988; 33: 129-34. (Pubitemid 18054672)
14. Ware JE Jr, Sherbourne CD,. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992; 30: 473-83.
15. Snaith RP,. The hospital anxiety and depression scale. Health Qual Life Outcomes 2003; 1: 29.
16. Shaw MJ, Talley NJ, Beebe TJ, et al. Initial validation of a diagnostic questionnaire for gastroesophageal reflux disease. Am J Gastroenterol 2001; 96: 52-7. (Pubitemid 32104807)
17. Wiklund IK, 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; 583: 41-9. (Pubitemid 29054907)
18. Prasad M, Wahlqvist P, Shikiar R, Shih YC,. A review of self-report instruments measuring health-related work productivity: a patient-reported outcomes perspective. Pharmacoeconomics 2004; 22: 225-44. (Pubitemid 38393392)
19. Reilly MC, Zbrozek AS, Dukes EM,. The validity and reproducibility of a work productivity and activity impairment instrument. Pharmacoeconomics 1993; 4: 353-65.
20. Shaw M, Dent J, Beebe T, et al. The Reflux Disease Questionnaire: a measure for assessment of treatment response in clinical trials. Health Qual Life Outcomes 2008; 6: 31.
21. van Zanten SV, Armstrong D, Barkun A, Junghard O, White RJ, Wiklund IK,. Symptom overlap in patients with upper gastrointestinal complaints in the Canadian confirmatory acid suppression test (CAST) study: further psychometric validation of the reflux disease questionnaire. Aliment Pharmacol Ther 2007; 25: 1087-97. (Pubitemid 46587686)
22. Revicki DA, Wood M, Wiklund I, Crawley J,. Reliability and validity of the gastrointestinal symptom rating scale in patients with gastroesophageal reflux disease. Qual Life Res 1998; 7: 75-83. (Pubitemid 28113967)
23. Zigmond AS, Snaith RP,. The hospital anxiety and depression scale. Acta Psychiatr Scand 1983; 67: 361-70. (Pubitemid 13098606)
24. Reilly Associates Inc. WPAI Scoring. New York: Reilly Associates Inc, 2002.
25. Ware JE Jr, Snow KK, Kosinski M, Gandek B,. SF-36 Health Survey: Manual and Interpretation Guide. Boston: The Health Institute, 1993.
26. Turner JR, Thayer JF,. Introduction to Analysis of Variance: Design, Analysis, and Interpretation. Thousand Oaks: Sage Publications, 2001.
27. Welen K, Faresjo A, Faresjo T,. Functional dyspepsia affects women more than men in daily life: a case-control study in primary care. Gend Med 2008; 5: 62-73. (Pubitemid 351506547)
28. Aro P, Ronkainen J, Storskrubb T, Bolling-Sternevald E, Talley NJ, Agreus L,. Quality of life impairment in community subjects with functional dyspepsia defined according to the ROME III criteria. Gastroenterology 2009; 136 (5 Supplement 1): A-215.
29. Talley NJ, Locke GR 3rd, Lahr BD, et al. Functional dyspepsia, delayed gastric emptying, and impaired quality of life. Gut 2006; 55: 933-9. (Pubitemid 43962602)
30. Halder SL, Locke GR 3rd, Talley NJ, Fett SL, Zinsmeister AR, Melton LJ 3rd,. Impact of functional gastrointestinal disorders on health-related quality of life: a population-based case-control study. Aliment Pharmacol Ther 2004; 19: 233-42. (Pubitemid 38174892)
31. Aro P, Talley NJ, Ronkainen J, et al. Anxiety is associated with uninvestigated and functional dyspepsia (Rome III criteria) in a Swedish population-based study. Gastroenterology 2009; 137: 94-100.
32. 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: 881-6. (Pubitemid 29389521)
33. Wiklund I, Carlsson R, Carlsson J, Glise H,. Psychological factors as a predictor of treatment response in patients with heartburn: a pooled analysis of clinical trials. Scand J Gastroenterol 2006; 41: 288-93.
34. Pare P, Gray J, Lam S, et al. Health-related quality of life, work productivity, and health care resource utilization of subjects with irritable bowel syndrome: baseline results from LOGIC (Longitudinal Outcomes Study of Gastrointestinal Symptoms in Canada), a naturalistic study. Clin Ther 2006; 28: 1726-35. (Pubitemid 44841981)
35. Wahlqvist P, Guyatt GH, Armstrong D, et al. The Work Productivity and Activity Impairment Questionnaire for patients with gastroesophageal reflux disease (WPAI-GERD): responsiveness to change and English language validation. Pharmacoeconomics 2007; 25: 385-96. (Pubitemid 46744469)
36. Wahlqvist P, Reilly MC, Barkun A,. Systematic review: the impact of gastro-oesophageal reflux disease on work productivity. Aliment Pharmacol Ther 2006; 24: 259-72. (Pubitemid 43972894)
37. Dean BB, Aguilar D, Barghout V, et al. Impairment in work productivity and health-related quality of life in patients with IBS. Am J Manag Care 2005; 11 (1 Suppl): S17-26.
38. Gisbert JP, Cooper A, Karagiannis D, et al. Impact of gastroesophageal reflux disease on work absenteeism, presenteeism and productivity in daily life: a European observational study. Health Qual Life Outcomes 2009; 7: 90.
39. Armstrong D, Veldhuyzen van Zanten SJ, Barkun AN, et al. Heartburn-dominant, uninvestigated dyspepsia: a comparison of 'PPI-start' and 'H2-RA-start' management strategies in primary care-the CADET-HR Study. Aliment Pharmacol Ther 2005; 21: 1189-202. (Pubitemid 40733484)
40. Meineche-Schmidt V, Talley NJ, Pap A, et al. Impact of functional dyspepsia on quality of life and health care consumption after cessation of antisecretory treatment. A multicentre 3-month follow-up study. Scand J Gastroenterol 1999; 34: 566-74. (Pubitemid 29339209)
41. Blum AL, Arnold R, Stolte M, Fischer M, Koelz HR,. Short course acid suppressive treatment for patients with functional dyspepsia: results depend on Helicobacter pylori status. The Frosch Study Group. Gut 2000; 47: 473-80.
42. Veldhuyzen van Zanten SJ, Chiba N, Armstrong D, et al. A randomized trial comparing omeprazole, ranitidine, cisapride, or placebo in Helicobacter pylori negative, primary care patients with dyspepsia: the CADET-HN Study. Am J Gastroenterol 2005; 100: 1477-88. (Pubitemid 41032350)
43. Juniper EF, Guyatt GH, Willan A, Griffith LE,. Determining a minimal important change in a disease-specific quality of life questionnaire. J Clin Epidemiol 1994; 47: 81-7. (Pubitemid 24034293)
44. Veldhuyzen van Zanten SJ, Talley NJ, Bytzer P, Klein KB, Whorwell PJ, Zinsmeister AR,. Design of treatment trials for functional gastrointestinal disorders. Gut 1999; 45 (Suppl 2): II69-77. (Pubitemid 29434816)
45. Lauritsen K, Degl' Innocenti A, Hendel L, et al. Symptom recording in a randomised clinical trial: paper diaries vs. electronic or telephone data capture. Control Clin Trials 2004; 25: 585-97. (Pubitemid 39592863)
46. Shiffman S, Stone AA, Hufford MR,. Ecological momentary assessment. Annu Rev Clin Psychol 2008; 4: 1-32. (Pubitemid 351688514)
47. Hunfeld NG, Geus WP, Kuipers EJ,. Systematic review: rebound acid hypersecretion after therapy with proton pump inhibitors. Aliment Pharmacol Ther 2007; 25: 39-46. (Pubitemid 44902862)
48. Niklasson A, Lindström L, Simrén M, Lindberg G, Björnsson E,. Dyspeptic symptom development after discontinuation of a proton pump inhibitor: a double-blind placebo-controlled trial. Am J Gastroenterol 2010; 105: 1531-7.