Review article: Endpoints used in functional dyspepsia drug therapy trials

Alimentary Pharmacology and Therapeutics

Volumn 33, Issue 6, 2011, Pages 634-649

  Ang, D ^a   Talley, N J ^b   Simren, M ^c   Janssen, P ^a   Boeckxstaens, G ^a   Tack, J ^a  

^a UNIVERSITY HOSPITALS LEUVEN   (Belgium)

^b MAYO CLINIC   (United States)

^c SAHLGRENSKA UNIVERSITY HOSPITAL   (Sweden)

Author keywords

[No Author keywords available]

Indexed keywords

ACOTIAMIDE; ALOSETRON; GASTROINTESTINAL AGENT; ITOPRIDE; OMEPRAZOLE; PLACEBO; TEGASEROD;

ARTICLE; CLINICAL ASSESSMENT TOOL; CLINICAL DYSPEPSIA QUESTIONNAIRE; CLINICAL FEATURE; CONSTRUCT VALIDITY; CONTENT VALIDITY; DISEASE SEVERITY; DRUG EFFICACY; DYSPEPSIA; DYSPEPSIA SYMPTOM SEVERITY INDEX; FUNCTIONAL DYSPEPSIA; GASTROINTESTINAL SYMPTOM; GASTROINTESTINAL SYMPTOM RATING SCALE; GASTROINTESTINAL SYMPTOM SCORE; GLASGOW DYSPEPSIA SEVERITY SCORE; GLOBAL OVERALL SYMPTOM SCALE; HONG KONG DYSPEPSIA INDEX; HUMAN; LEEDS DYSPEPSIA QUESTIONNAIRE; LIKERT SCALE; MEDLINE; MULTIDIMENSIONAL QUESTIONNAIRE; OUTCOME ASSESSMENT; PAGI QOL QUESTIONNAIRE; PAGI SYM QUESTIONNAIRE; PATIENT ASSESSMENT; PORTO ALEGRE DYSPEPTIC SYMPTOMS QUESTIONNAIRE; PRACTICE GUIDELINE; PRIORITY JOURNAL; QUALITY OF LIFE; QUALITY OF LIFE IN REFLUX AND DYSPEPSIA; QUALITY OF LIFE QUESTIONNAIRE; QUESTIONNAIRE; RATING SCALE; REFLUX DISEASE QUESTIONNAIRE; SCORING SYSTEM; SEVERITY OF DYSPEPSIA ASSESSMENT; SHORT FORM 36; SHORT FORM NEPEAN DYSPEPSIA INDEX; TREATMENT OUTCOME; TREATMENT RESPONSE;

DYSPEPSIA; GASTROINTESTINAL AGENTS; HUMANS; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME;

EID: 79951665389     PISSN: 02692813     EISSN: 13652036     Source Type: Journal    
DOI: 10.1111/j.1365-2036.2010.04566.x     Document Type: Article

References (153)

1. Colin-Jones DG, Bloom B, Bodemar G, et al. Management of dyspepsia: report of a working party. Lancet 1988; 1: 576-9. (Pubitemid 18060490)
2. Talley NJ, Koch KL, Koch M, et al. Functional dyspepsia: a classification with guidelines for diagnosis and management. Gastrointest Int 1991; 4: 145-60.
3. Talley NJ, Stanghellini V, Heading RC, Koch KL, Malagelada JR, Tytgat GNJ,. Functional gastroduodenal disorders. Gut 1999; 45 (Suppl. II): 37-42.
4. Tack J, Talley NJ, Camilleri M, et al. Functional gastroduodenal disorders. Gastroenterology 2006; 130: 1466-79.
5. Drossman DA, Thompson G, Talley NJ, et al. Identification of subgroups of functional gastrointestinal disorders. Gastroenterol Int 1991; 4: 145-60.
6. Talley NJ, Phillips SF,. Non-ulcer dyspepsia: potential causes and pathophysiology. Ann Intern Med 1988; 108: 965-79.
7. Talley NJ, Weaver AL, Zinsmeister AR, et al. Onset and disappearance of gastrointestinal symptoms and functional gastrointestinal disorders. Am J Epidemiol 1992; 136: 165-77.
8. Shaib Y, El-Serag HB,. The prevalence and risk factors of functional dyspepsia in a multiethnic population in the United States. Am J Gastroenterol 2004; 99: 2210-6. (Pubitemid 39524713)
9. US Food and Drug Administration (FDA). Guidance for Industry. Patient reported outcome measures: use in medical product development to support labeling claims. 2006.
10. Design of Treatment Trials Committee, Irvine EJ, Whitehead WE, et al. Design of treatment trials for functional gastrointestinal disorders. Gastroenterology 2006; 130: 1538-51.
11. Veldhuyzen van Zanten SJ,. A systematic overview (meta-analysis) of outcome measures in Helicobacter pylori gastritis trials and functional dyspepsia. Scan J Gastroenterol 1993; 28 (Suppl. 199): 40-3.
12. Talley NJ,. A critique of therapeutic trials in Helicobacter pylori-positive functional dyspepsia. Gastroenterology 1994; 106: 1174-83. (Pubitemid 24129232)
13. Veldhuyzen van Zanten SJ, Cleary C, Talley NJ, et al. Drug treatment of functional dyspepsia: a systematic analysis of trial methodology with recommendations for design of future trials. Am J Gastroenterol 1996; 91: 660-73. (Pubitemid 26117940)
14. Veldhuyzen van Zanten SJO,. Assessment of outcome in dyspepsia: has progress been made? Gut 2002; 50 (Suppl. IV): 23-5.
15. Tack J, Bisschops R, Sarnelli G,. Pathophysiology and treatment of functional dyspepsia. Gastroenterology 2004; 127: 1239-55. (Pubitemid 39345892)
16. Guyatt GH, Veldhuyzen van Zanten SJO, Feeney DH, et al. Measuring quality of life in clinical trials: a taxonomy and review. Can Med J Assoc 1989; 140: 1441-8. (Pubitemid 19155833)
17. Talley NJ, Nyren O, Drossman DA, et al. The irritable bowel syndrome: toward optimal design of controlled treatment trials. Gastroenterol Int 1993; 6: 189-211. (Pubitemid 24053949)
18. Guyatt GH, Townsend M, Berman LB, Keller JL,. A comparison of Likert and Visual Analogue Scales for measuring change in function. Chron Dis 1987; 40: 1129-33. (Pubitemid 17158144)
19. Jaeschke R, Singer J, Guyatt GH,. Measurement of health status: ascertaining the minimal clinically important difference. Control Clin Trials 1989; 10: 407-15. (Pubitemid 20025670)
20. Guyatt G, Deyo RA, Charlson M, Levine MN, Mitchell A,. Responsiveness and validity in health status measurement: a clarification. J Clin Epidemiol 1989; 42: 403-8. (Pubitemid 19165904)
21. Veldhuyzen van Zanten SJ, Talley NJ, Bytzer P, Klein KB, Whorwell PJ, Zinsmeister AR,. Design of treatment trials for functionalgastrointestinal disorders. Gut 1999; 45 (Suppl. 2): 1169-77.
22. Hays RD, Hadorn D,. Responsiveness to change: an aspect of validity, not a separate dimension. Qual Life Res 1992; 1: 73-5.
23. Kirshner B, Guyatt GH,. A methodological framework for assessing health indices. J Chron Dis 1985; 38: 27-36. (Pubitemid 15136767)
24. Cook KF, Rabeneck L, Campbell CJM, Wray NP,. Evaluation of a multidimensional measure of dyspepsia related health for use in a randomized clinical trial. J Clin Epidemiol 1999; 52: 381-92. (Pubitemid 29305342)
25. Farup PG, Hovde O, Torp R, Wetterhus S,. Patients with functional dyspepsia responding to omeprazole have a characteristic gastro-oesophageal reflux pattern. Scan J Gastroenterol 1999; 34: 575-9. (Pubitemid 29339210)
26. Camilleri M, Mayer EA, Drossman DA, et al. Improvement in pain and bowel function in female irritable bowel patients with alosetron, a 5-HT3 receptor antagonist. Aliment Pharmacol Ther 1999; 13: 1149-59. (Pubitemid 29445893)
27. Camilleri M, Northcutt SR, Kong S, Dukes GE, McSorley D, Mangel AW,. Efficacy and safety of alosetron in women with irritable bowel syndrome: a randomized, placebo-controlled trial. Lancet 2000; 355: 1035-40. (Pubitemid 30162805)
28. Camilleri M, Chey WY, Mayer EA, et al. A randomized controlled clinical trial of the serotonin type 3 receptor antagonist alosetron in women with diarrhoea-predominant irritable bowel syndrome. Arch Intern Med 2001; 161: 1733-40. (Pubitemid 32679548)
29. Miner P, Stanton DB, Carter F, et al. Cilansetron in irritable bowel syndrome with diarrhoea predominance (IBS-D); efficacy and safety in a 3 month US study. Am J Gastroenterol 2004; 99: S277.
30. Leventer SM, Kucharik RF, Keogh JC, et al. The potential dextofisopam for treatment of irritable bowel syndrome and the irritable bowel syndrome. Am J Gastroenterol 2004; 99: S279.
31. Bradette M, Moennikes H, Carter F, Krause G, Caras S, Steinborn C,. Cilansetron in irritable bowel syndrome with diarrhoea predominance (IBS-D): efficacy and safety in a 6 month global study. Gastroenterology 2004; 126 (Suppl. 2): A42.
32. Coremans G, Clouse RE, Carter F, et al. Cilansetron, a novel 5-HT3 antagonist demonstrated efficacy in males with irritable bowel syndrome with diarrhoea-predominance (IBS-D). Gastroenterology 2004; 126 (4 Suppl. 2): A643.
33. Leventer S, Raudibaugh K, Frissora C, et al. The safety and efficacy of dextofisopam in patients with diarrhoea-predominant or alternating irritable bowel syndrome. Gastroenterology 2005; 128 (4 Suppl. 2): A94.
34. Kellow J, Lee OY, Chang FY, et al. An Asia-Pacific, double-blind, placebo controlled, randomized study to evaluate the efficacy, safety, and tolerability of tegaserod on patients with irritable bowel syndrome. Gut 2003; 52: 671-6. (Pubitemid 36528868)
35. Nyhlin H, Bang C, Elsborg L, et al. A double-blind, placebo-controlled, randomized study to evaluate the efficacy, safety and tolerability of tegaserod in patients with irritable bowel syndrome. Scand J Gastroenterol 2004; 39: 119-26. (Pubitemid 38253623)
36. Muller-Lissner S, Holtmann G, Rueegg P, Weidinger G, Loffler H,. Tegaserod is effective in the initial and re-treatment of irritable bowel syndrome with constipation. Aliment Pharmacol Ther 2005; 21: 11-20. (Pubitemid 40175339)
37. Tack J, Muller-Lissner S, Bytzer P, et al. A randomized controlled trial assessing the efficacy and safety of repeated tegaserod therapy in women with irritable bowel syndrome with constipation. Gut 2005; 54: 1707-13. (Pubitemid 41697668)
38. Mangel AW,. Personal view: adequate relief as a primary endpoint in irritable bowel syndrome. Aliment Pharm Ther 2006; 23: 879-81.
39. Camilleri M, Drossman DA, Fehnel S, Mangel A, Mayer EA, Talley NJ,. Primary endpoints for FGID trials: a review of binary and integrated symptom assessments. Clin Gastro Hepatol 2007; 5: 534-40.
40. Talley NJ, Van Zanten SV, Saez LR, et al. A dose ranging placebo controlled randomized trial of alosetron in patients with functional dyspepsia. Aliment Pharmacol Ther 2001; 15: 525-37. (Pubitemid 32242779)
41. Matsueda K, Hongo M, Sasaki D, et al. Therapeutic efficacy of novel agent (Z-338) in functional dyspepsia (FD). Gastroenterology 2006; 130: A467.
42. Talley NJ, Tack J, Kowalski D, Borton MA, Barve A,. A Novel Acetylcholine Esterase Inhibitor Acotiamide Hydrochloride (YM443) in Functional Dyspepsia: efficacy in a randomized, double-blind, placebo-controlled dose ranging trial. Gastroenterology 2008; 134 (Suppl. 1): A-157.
43. Vakil N, Talley NJ, Zakko S, Laine L, Chey W, Tack J,. Tegaserod treatment for functional dyspepsia dysmotility symptoms: results of two randomized, controlled trials. Am J Gastroenterol 2008; 103: 1906-19.
44. Jian R, Ducrot F, Ruskone A, et al. Symptomatic, radionuclide and therapeutic assessment of chronic idiopathic dyspepsia. A double-blind placebo-controlled evaluation of cisapride. Dig Dis Sci 1989; 34: 657-64. (Pubitemid 19139346)
45. Tatsuta M, Iishi H, Nakaizumi A, Okuda S,. Effect of treatment with cisapride alone or in combination with domperidone on gastric emptying and gastrointestinal symptoms in dyspeptic patients. Aliment Pharmacol Ther 1992; 6: 221-8.
46. Sarin SK, Sharma P, Chawla YK, et al. Clinical trial on the effect of domperidone on non-ulcer dyspepsia. Indian J Med Res 1986; 83: 623-8. (Pubitemid 16002809)
47. Champion MC, MacCannell Kl, Thomson AB, et al. A double-blind randomized study of cisapride in the treatment of non-ulcer dyspepsia. The Canadian Cisapride Nud Study Group. Can J Gastroenterol 1997; 11: 127-34. (Pubitemid 27146011)
48. De Groot GH, De Both PSM,. Cisapride in functional dyspepsia in general practice. A placebo-controlled, randomized, double-blind study. Aliment Pharmacol Ther 1997; 11: 193-9. (Pubitemid 27067353)
49. Tack J, Masclee A, Heading R, et al. A dose-ranging, placebo-controlled, pilot trial of acotiamide in patients with functional dyspepsia. Neurogastroenterol Motil 2009; 21: 272-80.
50. Gotthard R, Bodemar G, Brodin U, Jonsson KA,. Treatment with cimetidine, antacid or placebo in patients with dyspepsia of unknown origin. Scand J Gastroenterol 1988; 23: 7-18. (Pubitemid 18067021)
51. Bekhti A, Rutgeerts L,. Domperidone in the treatment of functional dyspepsia in patients with delayed gastric emptying. Postgrad Med 1979; 55 (Suppl. 1): 30-2. (Pubitemid 9167376)
52. Van de Mierop L, Rutgeerts L, Van den Langenbergh B, Staessen A,. Oral domperidone in chronic postprandial dyspepsia. Digestion 1979; 19: 244-50.
53. Haarmann K, Lebkuchner F, Widmann A, Kief W, Esslinger M,. A double-blind study of domperidone in the symptomatic treatment of chronic post-prandial upper gastrointestinal distress. Postgrad Med J 1979; 55 (Suppl. 1): 24-7. (Pubitemid 9167374)
54. Lance P, Wastell C, Schiller KFR,. A controlled trial of cimetidine for the treatment of non-ulcer dyspepsia. J Clin Gastroenterol 1986; 8: 414-8. (Pubitemid 16025414)
55. Smith PM, Troughton AH, Gleeson F, Walters J, McCarthy CF,. Pirenzepine in non-ulcer dyspepsia: a double-blind multicentre trial. J Int Med Res 1990; 18: 16-20. (Pubitemid 20052133)
56. Deruyttere M, Lepoutre L, Heylen H, Samain H, Pennoit H,. Cisapride in the management of chronic functional dyspepsia: a multicentre, double-blind, placebo-controlled study. Clin Ther 1987; 10: 44-51. (Pubitemid 18085042)
57. Rosch W,. Cisapride in non ulcer dyspepsia. Results of a placebo-controlled trial. Scand J Gastroenterol 1987; 22: 161-4. (Pubitemid 17024399)
58. Hannon R,. Efficacy of cisapride in patients with nonulcer dyspepsia. A placebo-controlled study. Curr Ther Res Clin Exp 1987; 42: 814-22. (Pubitemid 18011116)
59. Goethals C, Van De Mierop L,. Cisapride in the treatment of chronic functional dyspepsia. Results of a double-blind, placebo-controlled, crossover study. Curr Ther Res 1987; 42: 261-7. (Pubitemid 17139053)
60. Francois I, De Nutte N,. Nonulcer dyspepsia: effect of the gastrointestinal prokinetic drug cisapride. Curr Ther Res 1987; 41: 891-8. (Pubitemid 17089786)
61. De Nutte N, Van Ganse W, Witterhulghe M, Defrance P,. Relief of epigastric pain in nonulcer dyspepsia: controlled trial of the promotility drug cisapride. Clin Ther 1989; 11: 62-8. (Pubitemid 19112877)
62. Wood SF, Penney SC, Cochran KM,. Cisapride in functional dyspepsia: a double-blind placebo-controlled randomized trial in general practice patients. Scand J Gastroenterol 1993; 28 (Suppl. 195): 5-10. (Pubitemid 23135136)
63. Chung JM,. Cisapride in chronic dyspepsia: results of a double-blind, placebo-controlled trial. Scand J Gastroenterol 1993; 195 (Suppl.): 11-4. (Pubitemid 23135137)
64. Van Outryve M, De Nutte N, Van Eeghem P, Gooris JP,. Efficacy of cisapride in functional dyspepsia resistant to domperidone or metoclopramide: a double-blind placebo-controlled study. Scand J Gastroenterol 1993; 28 (Suppl. 195): 47-53. (Pubitemid 23135142)
65. Fumagalli I, Hammer B,. Cisapride versus metoclopramide in the treatment of functional dyspepsia. A double-blind comparative trial. Scand J Gastroenterol 1994; 29: 33-7. (Pubitemid 24027419)
66. Al-Quorain A, Larbi EB, Al-Shedoki F,. A double-blind, randomized, placebo-controlled trial of cisapride in Saudi Arabs with functional dyspepsia. Scand J Gastroenterol 1995; 30: 531-4.
67. Kellow JE, Cowan H, Shuter B, et al. Efficacy of cisapride therapy in functional dyspepsia. Aliment Pharmacol Ther 1995; 9: 153-60.
68. Carvalhinhos A, Fidalgo P, Freire A, Matos L,. Cisapride compared with ranitidine in the treatment of functional dyspepsia. Euro J Gastroenterol and Hepatol 1995; 7: 411-7.
69. Yeoh KG, Kang JY, Tay HH, et al. Effect of cisapride on functional dyspepsia in patients with and without histological gastritis: a double-blind placebo controlled trial. J Gastroenterol Hepatol 1997; 12: 13-8. (Pubitemid 27100159)
70. Hansen JM, Bytzer P, Schaffalitzky de Muckadell O,. Placebo-controlled trial of cisapride and nizatidine in unselected patients with functional dyspepsia. Am J Gastroenterol 1998; 93: 368-74. (Pubitemid 29068339)
71. Creytens G,. Effect of the non-antidopaminergic drug cisapride on postprandial nausea. Curr Ther Res 1999; 36: 1063-70.
72. Chen JD, Ke MY, Lin XM, Wang Z, Zhang M,. Cisapride provides symptomatic relief in functional dyspepsia associated with gastric myoelectrical abnormality. Aliment Pharmacol Ther 2000; 14: 1041-7. (Pubitemid 30618165)
73. Fraitag B, Homerin M, Hecketsweiler P,. Double-blind dose-response multicenter comparison of fedotozine and placebo in treatment of nonulcer dyspepsia. Dig Dis Sci 1994; 39: 1072-7. (Pubitemid 24188852)
74. Read NW, Abitol Jl, Bardhan KD, Whorwell PJ, Fraitag B,. Efficacy and safety of the peripheral kappa agonist fedotozine versus placebo in the treatment of functional dyspepsia. Gut 1997; 41: 664-8.
75. Delattre M, Malesky M, Prinzie A,. Symptomatic treatment of non-ulcer dyspepsia with cimetidine. Curr Ther Res 1985; 37: 980-1.
76. Kelbaek H, Linde J, Eriksen J, et al. Controlled clinical trial of treatment with cimetidine for non-ulcer dyspepsia. Acta Med Scand 1985; 217: 281-7. (Pubitemid 15056811)
77. Singal AK, Kumar A, Broor SL,. Cimetidine in the treatment of non-ulcer dyspepsia: results of a randomized double-blind, placebo-controlled study. Curr Med Res Opin 1989; 11: 390-7. (Pubitemid 19086260)
78. Kairaluoma MI, Hentilae R, Alavaikko M, et al. Sucralfate versus placebo in treatment of non-ulcer dyspepsia. Am J Med 1987; 83: 51-5.
79. Loffeld RJ, Potters HV, Stobberingh E, Flendrig JA, van Spreeuwel JP, Arends JW,. Campylobacter associated gastritis in patients with non-ulcer dyspepsia: a double blind placebo controlled trial with colloidal bismuth subcitrate. Gut 1989; 30: 1206-12. (Pubitemid 19255428)
80. Vaira D, Holton J, Ainley C, et al. Double blind trial of colloidal bismuth subcitrate versus placebo in Helicobacter pylori positive patients with non-ulcer dyspepsia. Italian J Gastroenterol 1992; 24: 400-4.
81. Hausken T, Stene-Larsen G, Lange O, et al. Misoprostol treatment exacerbates abdominal discomfort in patients with non-ulcer dyspepsia and erosive pyloric changes. A double-blind, placebo-controlled multicentre study. Scand J Gastroenterol 1990; 25: 1028-33. (Pubitemid 20363198)
82. Bolling-Sternevald E, Lauritsen K, Aalykke C, et al. Effect of profound acid suppression in functional dyspepsia: a double-blind, randomized, placebo-controlled trial. Scand J Gastroenterol 2002; 37: 1395-402. (Pubitemid 36054199)
83. Peura DA, Kovacs TO, Metz D, Siepman N, Pilmer BL, Talley NJ,. Lansoprazole in the treatment of functional dyspepsia: two double-blind, randomized, placebo-controlled trials. Am J Med 2004; 116: 740-8. (Pubitemid 38622310)
84. Blum AL, Arnold R, Stolte M, Fischer M, Koelz HR, the Frosch Study Group. Short course acid suppressive treatment for patients with functional dyspepsia: results depend on Helicobacter pylori status. Gut 2000; 47: 473-80.
85. Talley NJ, Verlinden M, Snape W, et al. Failure of a motilin receptor agonist (ABT-229) to relieve the symptoms of functional dyspepsia in patients with and without delayed gastric emptying: a randomized double-blind placebo-controlled trial. Aliment Pharmacol Ther 2000; 14: 1653-61. (Pubitemid 32011739)
86. Hallerback BI, Bommelaer G, Bredberg E, et al. Dose finding study of mosapride in functional dyspepsia: a placebo-controlled, randomized study. Aliment Pharmacol Ther 2002; 16: 959-67. (Pubitemid 34461766)
87. Holtmann G, Adam B, Haag S, Collet W, Grunewald E, Windeck T,. Efficacy of artichoke leaf extract in the treatment of patients with functional dyspepsia: a six-week placebo-controlled, double-blind multicentre trial. Aliment Pharmacol Ther 2003; 18: 1099-105. (Pubitemid 38021595)
88. 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)
89. Blum AL, Talley NJ, OMorain C, et al. Lack of effect of treating Helicobacter pylori infection in patients with nonulcer dyspepsia. Omeprazole plus Clarithromycin and Amoxicillin Effect One Year after Treatment (OCAY) Study Group. N Engl J Med 1998; 339: 1875-81.
90. Talley NJ, Janssens J, Lauritsen K, et al. Eradication of Helicobacter pylori in functional dyspepsia: randomised double blind placebo controlled trial with 12 months follow up. The Optimal Regimen Cures Helicobacter Induced Dyspepsia (ORCHID) Study group. BMJ 1999; 318: 833-7. (Pubitemid 29191958)
91. Holtmann G, Talley NJ, Liebregts T, Adam B, Parow C,. A placebo-controlled trial of itopride in functional dyspepsia. N Eng J Med 2006; 354: 832-40. (Pubitemid 43290921)
92. Talley NJ, Tack J, Ptak T, Gupta R, Giguere M,. Itopride in Functional Dyspepsia: results of two phase III multicenter, randomized, double-blind, placebo-controlled trials. Gut 2008; 57: 740-6. (Pubitemid 351716964)
93. Veldhuyzen van Zanten SJO, Tytgat KMAJ, Pollak PT, et al. Can severity of symptoms be used as outcome measures in trials of non-ulcer dyspepsia and Helicobacter pylori associated gastritis? J Clin Epidemiol 1993; 46: 273-9. (Pubitemid 23107075)
94. Veldhuyzen van Zanten SJO, 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)
95. Chiba N, Veldhuyzen van Zanten SJO, Sinclair P, et al. Treating Helicobacter pylori infection in primary care patients with uninvestigated dyspepsia: the Canadian adult dyspepsia empiric treatment-Helicobacter pylori positive (CADET-HP) randomised controlled trial. BMJ 2002; 324: 1012-6. (Pubitemid 34457514)
96. Armstrong D, Veldhuyzen van Zanten SJO, Barkun A, et al., the CADET-HR Study Group. 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)
97. Veldhuyzen van Zanten S, Armstrong D, Chiba N, et al. Esomeprazole 40 mg once a day in patients with functional dyspepsia: the Randomized, Placebo-Controlled "ENTER" Trial. Am J Gastroenterol 2006; 101: 2096-106. (Pubitemid 44337636)
98. Matsueda K, Hongo M, Sasaki D, et al. Clinical trial: dose-dependent therapeutic efficacy of acotiamide hydrochloride (Z-338) in patients with functional dyspepsia-100 mg t.i.d. is an optimal. Neurogastroenterol Motil 2010; 22: 618-e173.
99. Weberg R, Berstad A,. Low dose antacids and pirenzipine in the treatment of patients with nonulcer dyspepsia and erosive prepyloric changes. A randomized, double-blind, placebo-controlled trial. Scand J Gastroenterol 1988; 23: 237-43. (Pubitemid 18096839)
100. Johannessen T, Fjosne U, Kleveland PM, et al. Cimetidine responders in non-ulcer dyspepsia. Scan J Gastroenterol 1988; 23: 327-36.
101. Seno H, Nakase H, Chiba T,. Usefulness of famotidine in functional dyspepsia patient treatment: comparison among prokinetic, acid suppression and antianxiety therapies. Aliment Pharmacol Ther 2005; 21 (Suppl. 2): 32-6. (Pubitemid 40806578)
102. Hausken T, Berstad A,. Cisapride treatment of patients with non-ulcer dyspepsia and erosive prepyloric changes. A double-blind, placebo-controlled trial. Scan J Gastroenterol 1992; 27: 213-7.
103. May B, Kohler S, Schneider B,. Efficacy and tolerability of a fixed combination of peppermint oil and caraway oil in patients suffering from functional dyspepsia. Aliment Pharmacol Ther 2000; 14: 1671-7. (Pubitemid 32011740)
104. Holtmann G, Gschossmann J, Mayr P, Talley NJ,. A randomized placebo-controlled trial of simethicone and cisapride for the treatment of patients with functional dyspepsia. Aliment Pharmacol Ther 2002; 16: 1641-8.
105. Veldhuyzen van Zanten SJO, Chiba N, Armstrong D, et al. Validation of a 7-point global overall symptom (GOS) scale to measure the severity of dyspepsia symptoms in clinical trials. Aliment Pharmacol Ther 2006; 23: 521-9. (Pubitemid 43382007)
106. Armstrong D, Veldhuyzen van Zanten SJO, Barkun AN, et al. Symptom response at 1-week predicts responders at 4-weeks with esomeprazole (40 mg bid and od) in patients with uninvestigated dyspepsia. Am J Gastroenterol 2003; 98 (9 Suppl. 1): S48-9.
107. 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 1998; 583: 41-9. (Pubitemid 29054907)
108. 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)
109. 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)
110. Dimenas E, Glise H, Hallerback B, et al. Quality of life in patients with upper gastrointestinal symptoms. An improved evaluation of treatment regimens? Scand J Gastroenterol 1993; 28: 681-7. (Pubitemid 23231987)
111. 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. (Pubitemid 28113967)
112. Talley NJ, Riff DS, Schwartz H, Marcuard SP,. Double-blind placebo-controlled multicentre studies of rebamipide, a gastroprotective drug, in the treatment of functional dyspepsia with or without Helicobacter pylori infection. Aliment Pharmacol Ther 2001; 15: 1603-11. (Pubitemid 32912403)
113. Miwa H, Nagahara A, Tominaga K, et al. Efficacy of the 5-HT1A agonist tandospirone citrate in improving symptoms of patients with functional dyspepsia: a randomized controlled trial. Am J Gastroenterol 2009; 104: 2779-87.
114. Moayyedi P, Duffett S, Braunholtz D, et al. The Leeds Dyspepsia Questionnaire: a valid tool for measuring the presence and severity of dyspepsia. Aliment Pharmacol Ther 1998; 12: 1257-62. (Pubitemid 28565967)
115. Fraser A, Delaney BC, Ford AC, Qume M, Moayyedi P,. The Short-Form Leeds Dyspepsia Questionnaire validation study. Aliment Pharmacol Ther 2007; 25: 477-86. (Pubitemid 46184462)
116. Leidy NK, Farup C, Rentz AM, et al. Patient-based assessment in dyspepsia: development and validation of Dyspepsia Symptom Severity Index (DSSI). Dig Dis Sci 2000; 45: 1172-9. (Pubitemid 30409463)
117. Hu WM, Lam KF, Wong YH, et al. The Hong Kong index of dyspepsia: a validated symptom severity questionnaire for patients with dyspepsia. J Gastroenterol Hepatol 2002; 17: 545-51. (Pubitemid 34748175)
118. Wong WM, Wong BCY, Hung WK, et al. Double blind, randomised placebo controlled study of four weeks of lansoprazole for the treatment of functional dyspepsia in Chinese patients. Gut 2002; 51: 502-6.
119. Sander GB, Mazzoleni LE, Francesconi CF, et al. Development and validation of a cross-cultural questionnaire to evaluate nonulcer dyspepsia: The Porto Alegre Dyspeptic Symptoms Questionnaire (PADYQ). Dig Dis Sci 2004; 49: 1822-9. (Pubitemid 40228546)
120. Talley NJ, Haque M, Wyeth JW, et al. Development of a new dyspepsia impact scale: the Nepean Dyspepsia Index. Aliment Pharmacol Ther 1999; 13: 225-35. (Pubitemid 29090019)
121. Talley NJ, Verlinden M, Jones MP,. Validity of a new quality of life scale for functional dyspepsia: a United States multicentre trial of the Nepean Dyspepsia Index (NDI). Am J Gastroenterol 1999; 94: 2390-7. (Pubitemid 29420662)
122. Talley NJ, Locke GR III, Lahr BD, et al. Functional dyspepsia, delayed gastric emptying, and impaired quality of life. Gut 2006; 55: 933-9. (Pubitemid 43962602)
123. Talley NJ, Verlinden M, Jones M,. Validity of a new quality of life scale for functional dyspepsia: a United States multicenter trial of the Nepean Dyspepsia Index. Am J Gastroenterol 1999; 94: 2390-7. (Pubitemid 29420662)
124. Khalil MS, Wahass SH, Al-Qourain AA, Yassawy MI,. Initial linguistic and psychometric validation of the Arabic version of Nepean Dyspepsia Index. Saudi Med J 2006; 27: 1554-60. (Pubitemid 351833169)
125. Talley NJ, Verlinden M, Jones M,. Quality of life in functional dyspepsia: responsiveness of the Nepean Dyspepsia Index and development of a new 10-item short form. Aliment Pharmacol Ther 2001; 15: 207-16. (Pubitemid 32142498)
126. Rabeneck L, Cook KR, Wristers K, Souchek J, Menke T, Wray NP,. SODA (Severity of Dyspepsia Assessment): a new effective outcome measure for dyspepsia-related health. J Clin Epi 2001; 54: 755-65. (Pubitemid 32722178)
127. Rabeneck L, Wristers K, Goldstein JL, et al. Reliability, validity, and responsiveness of severity of dyspepsia assessment (SODA) in a randomized clinical trial of a COX-2-specific inhibitor and traditional NSAID therapy. Am J Gastroenterol 2002; 97: 32-9. (Pubitemid 34059761)
128. Rentz AM, Kahrilas P, Stanghellini V, et al. Development and psychometric evaluation of the patient assessment of upper gastrointestinal symptom severity index (PAGI-SYM) in patients with upper gastrointestinal disorders. Qual Life Res 2004; 13: 1737-49. (Pubitemid 41215253)
129. Revicki DA, Rentz AM, Tack J, et al. Responsiveness and interpretation of a symptom severity index specific to upper gastrointestinal disorders. Clin Gastroenterol Hepatol 2004; 2: 769-77. (Pubitemid 39200715)
130. Tack J, Van Elzen B, Tytgat G, et al. A placebo-controlled trial of the 5-HT1A agonist R-137696 on symptoms, visceral hypersensitivity and on impaired accommodation in functional dyspepsia. Neurogastroenterol Motil 2009; 21: 619-26, e23-4.
131. De La Loge C, Trudeau E, Marquis P, et al. Responsiveness and interpretation of a quality of life questionnaire specific to upper gastrointestinal disorders. Clin Gastroenterol Hepatol 2004; 2: 778-86. (Pubitemid 39200716)
132. El-Omar EM, Banerjee S, Wirz A, McColl KEL,. The Glasgow dyspepsia severity score-a tool for the global measurement of dyspepsia. Eur J Gastroenterol Hepatol 1996; 8: 967-71. (Pubitemid 26356598)
133. McColl K, Murray L, El-Omar E, et al. Symptomatic benefit from eradicating Helicobacter pylori infection in patients with nonulcer dyspepsia. N Eng J Med 1998; 339: 1869-74. (Pubitemid 29013929)
134. Calvet X, Bustamante E, Montserrat A, et al. Validation of phone interview for follow-up in clinical trials on dyspepsia: evaluation of the Glasgow Dyspepsia Severity Score and a Likert-scale symptoms test. Eur J Gasatroenterol Hepatol 2000; 12: 949-53. (Pubitemid 30663909)
135. Garratt AM, Ruta DA, Russel I, et al. Developing a condition-specific measure of health for patients with dyspepsia and ulcer-related symptoms. J Clin Epidemiol 1996; 49: 565-71. (Pubitemid 26195612)
136. Adam B, Liebregts T, Saadat-Gilani K, Vinson B, Holtmann G,. Validation of the gastrointestinal symptom score for the assessment of symptoms in patients with functional dyspepsia. Aliment Pharmacol Ther 2005; 22: 357-63. (Pubitemid 41207466)
137. Madisch A, Holtmann G, Mayr G, Vinson B, Hotz J,. Treatment of functional dyspepsia with a herbal preparation. A doubleblind, randomized, placebo-controlled, multicenter trial. Digestion 2004; 69: 45-52. (Pubitemid 38332924)
138. Rosch W, Vinson B, Sassin I,. A randomised clinical trial comparing the efficacy of a herbal preparation STW 5 with the prokinetic drug cisapride in patients with dysmotility type of functional dyspepsia. Z Gastroenterol 2002; 40: 401-8. (Pubitemid 34650774)
139. Madisch A, Melderis H, Mayr G, Sassin I, Hotz J,. A plant extract and its modified preparation in functional dyspepsia. Results of a double-blind placebo controlled comparative study. Z Gastroenterol 2001; 39: 511-7.
140. Stewart AL, Hays RD, Ware JE Jr,. The MOS short-form general health survey. Reliability and validity in a patient population. Med Care 1988; 26: 724-35.
141. Patrick Dl, Drossman DA, Frederick HO, et al. Quality of life in persons with irritable bowel syndrome. Development and validation of a new measure. Dig Dis Sci 1998; 43: 400-11. (Pubitemid 28124621)
142. Laine L, Tack J, Howden C, et al. Work productivity and daily activity impairment in patients with functional dyspepsia: double-blind comparison of tegaserod vs placebo. Gastroenterology 2007; 132 (Suppl. 2): A94.
143. Locke GR III,. Prevalence, incidence and natural history of dyspepsia and
144. Lindell GH, Celebioglu F, Graffner HO,. Non ulcer dyspepsia in the long term perspective. Eur J Gastroenterol Hepatol 1995; 7: 829-33.
145. Finney JS, Kinnersley N, Hughes M, et al. Meta analysis of antisecretory and gastrokinetic compounds in functional dyspepsia. J Clin Gastroenterol 1998; 26: 312-20. (Pubitemid 28272513)
146. Klein KB,. Controlled treatment trials in the irritable bowel syndrome: A critique. Gastroenterology 1988; 95: 232-41.
147. Moayyedi P, Soo S, Deeks J, Delaney B, Innes M, Forman D,. Pharmacological interventions for non-ulcer dyspepsia. Coch Datab Syst Rev 2006; 4: 1-22.
148. Pappa KA, Williams BO, Payne JE, Buaron KS, Mussari KL, Ciociola AA,. A double-blind, placebo-controlled study of the efficacy and safety of non-prescription ranitidine 75 mg in the prevention of meal-induced heartburn. Aliment Pharmacol Ther 1999; 13: 467-73. (Pubitemid 29176869)
149. FDA Gastrointestinal Drugs Advisory Committee. Transcript from FDA Gastrointestinal Drugs Advisory Committee. Lotronex 1999; November: 119.
150. Mangel AW, Hahn BA, Heath AT, et al. Adequate relief as an endpoint in clinical trials in irritable bowel syndrome. J Int Med Res 1998; 26: 76-81. (Pubitemid 28211930)
151. Mangel AW, Northcutt AR,. Review article: safety and efficacy of alosetron, a 5-HT3 receptor antagonist, in female irritable bowel syndrome patients. Aliment Pharmacol Ther 1999; 13 (Suppl. 2): 77-82. (Pubitemid 29219285)
152. Whitehead WE, Palasson OS, Levy RL, Feld AD, VonKorff M, Turner M,. Reports of "satisfactory relief" by IBS patients receiving usual medical care are confounded by baseline symptom severity and do not accurately reflect symptom improvement. Am J Gastroenterol 2006; 101: 1057-65. (Pubitemid 43725320)
153. Corazziari E, Bytzer P, Delvaux M, et al. Clinical trial guidelines for pharmacological treatment of irritable bowel syndrome. Aliment Pharmacol Ther 2003; 18: 569-80. (Pubitemid 37186606)