A double blind, randomized, placebo-controlled trial of proton pump inhibitor therapy in patients with uninvestigated dyspepsia

Research output: Contribution to journalArticle

Linda Rabeneck, Julianne Souchek, Kimberly Wristers, Terri Menke, Eunice Ambriz, Iris Huang, Nelda Wray

OBJECTIVES: In patients with uninvestigated dyspepsia, a common initial management strategy in primary care is to prescribe a course of empiric antisecretory therapy and to refer those patients who do not respond for endoscopy. The objective of this research was to evaluate the effects of an empiric course of antisecretory therapy on dyspepsia-related health in patients with uninvestigated dyspepsia. METHODS: We conducted a double blind, randomized, placebo-controlled trial in which patients with uninvestigated dyspepsia were randomized to a 6-wk course of omeprazole 20 mg p.o. b.i.d. versus placebo capsules p.o. b.i.d. and followed over 1 yr. The patients were at least 18 yr old with at least a 1-wk history of dyspepsia without alarm features. Dyspepsia-related health was measured using the Severity of Dyspepsia Assessment (SODA), a valid, reliable, disease-specific outcome measure. The primary outcome was treatment failure, defined by a SODA Pain Intensity score ≥29 (scores, 2-47) during follow-up. Patients who were treatment failures underwent endoscopy. RESULTS: We enrolled 140 patients. The mean age was 51 yr, and seven (5%) were women. At 2 wk there were fewer treatment failures in the omeprazole group: 12 of 71 patients (17%) in the omeprazole group failed compared with 24 of 69 (35%) in the placebo group (p = 0.037, log rank test). Also, at 6 wk there were fewer failures in the omeprazole group: 21 of 71 patients (30%) in the omeprazole group failed compared with 31 of 69 (45%) in the placebo group (p = 0.067, log rank test). However, at the 1-yr follow-up, there was no significant difference in treatment failure rates in the two groups: 37 of 71 patients (52%) in the omeprazole group failed compared with 41 of 69 (59%) in the placebo group (p = 0.28, log rank test). CONCLUSIONS: In patients with uninvestigated dyspepsia, as compared with a strategy that would entail prompt endoscopy for all patients, an initial 6-wk course of either placebo or omeprazole reduces the need for endoscopy over a 1-yr follow-up. Compared with placebo, an initial 6-wk course of omeprazole delays, but does not reduce, the need for endoscopy. For proton pump inhibitor therapy to reduce the need for endoscopy, it may need to be given continuously.

Original languageEnglish (US)
Pages (from-to)3045-3051
Number of pages7
JournalAmerican Journal of Gastroenterology
Volume97
Issue number12
DOIs
StatePublished - Dec 1 2002

PMID: 12492188

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A double blind, randomized, placebo-controlled trial of proton pump inhibitor therapy in patients with uninvestigated dyspepsia. / Rabeneck, Linda; Souchek, Julianne; Wristers, Kimberly; Menke, Terri; Ambriz, Eunice; Huang, Iris; Wray, Nelda.

In: American Journal of Gastroenterology, Vol. 97, No. 12, 01.12.2002, p. 3045-3051.

Research output: Contribution to journalArticle

Harvard

Rabeneck, L, Souchek, J, Wristers, K, Menke, T, Ambriz, E, Huang, I & Wray, N 2002, 'A double blind, randomized, placebo-controlled trial of proton pump inhibitor therapy in patients with uninvestigated dyspepsia' American Journal of Gastroenterology, vol. 97, no. 12, pp. 3045-3051. https://doi.org/10.1016/S0002-9270(02)05540-5

APA

Rabeneck, L., Souchek, J., Wristers, K., Menke, T., Ambriz, E., Huang, I., & Wray, N. (2002). A double blind, randomized, placebo-controlled trial of proton pump inhibitor therapy in patients with uninvestigated dyspepsia. American Journal of Gastroenterology, 97(12), 3045-3051. https://doi.org/10.1016/S0002-9270(02)05540-5

Vancouver

Rabeneck L, Souchek J, Wristers K, Menke T, Ambriz E, Huang I et al. A double blind, randomized, placebo-controlled trial of proton pump inhibitor therapy in patients with uninvestigated dyspepsia. American Journal of Gastroenterology. 2002 Dec 1;97(12):3045-3051. https://doi.org/10.1016/S0002-9270(02)05540-5

Author

Rabeneck, Linda ; Souchek, Julianne ; Wristers, Kimberly ; Menke, Terri ; Ambriz, Eunice ; Huang, Iris ; Wray, Nelda. / A double blind, randomized, placebo-controlled trial of proton pump inhibitor therapy in patients with uninvestigated dyspepsia. In: American Journal of Gastroenterology. 2002 ; Vol. 97, No. 12. pp. 3045-3051.

BibTeX

@article{b0748b8f3b0f42958596760c3b887d83,
title = "A double blind, randomized, placebo-controlled trial of proton pump inhibitor therapy in patients with uninvestigated dyspepsia",
abstract = "OBJECTIVES: In patients with uninvestigated dyspepsia, a common initial management strategy in primary care is to prescribe a course of empiric antisecretory therapy and to refer those patients who do not respond for endoscopy. The objective of this research was to evaluate the effects of an empiric course of antisecretory therapy on dyspepsia-related health in patients with uninvestigated dyspepsia. METHODS: We conducted a double blind, randomized, placebo-controlled trial in which patients with uninvestigated dyspepsia were randomized to a 6-wk course of omeprazole 20 mg p.o. b.i.d. versus placebo capsules p.o. b.i.d. and followed over 1 yr. The patients were at least 18 yr old with at least a 1-wk history of dyspepsia without alarm features. Dyspepsia-related health was measured using the Severity of Dyspepsia Assessment (SODA), a valid, reliable, disease-specific outcome measure. The primary outcome was treatment failure, defined by a SODA Pain Intensity score ≥29 (scores, 2-47) during follow-up. Patients who were treatment failures underwent endoscopy. RESULTS: We enrolled 140 patients. The mean age was 51 yr, and seven (5{\%}) were women. At 2 wk there were fewer treatment failures in the omeprazole group: 12 of 71 patients (17{\%}) in the omeprazole group failed compared with 24 of 69 (35{\%}) in the placebo group (p = 0.037, log rank test). Also, at 6 wk there were fewer failures in the omeprazole group: 21 of 71 patients (30{\%}) in the omeprazole group failed compared with 31 of 69 (45{\%}) in the placebo group (p = 0.067, log rank test). However, at the 1-yr follow-up, there was no significant difference in treatment failure rates in the two groups: 37 of 71 patients (52{\%}) in the omeprazole group failed compared with 41 of 69 (59{\%}) in the placebo group (p = 0.28, log rank test). CONCLUSIONS: In patients with uninvestigated dyspepsia, as compared with a strategy that would entail prompt endoscopy for all patients, an initial 6-wk course of either placebo or omeprazole reduces the need for endoscopy over a 1-yr follow-up. Compared with placebo, an initial 6-wk course of omeprazole delays, but does not reduce, the need for endoscopy. For proton pump inhibitor therapy to reduce the need for endoscopy, it may need to be given continuously.",
author = "Linda Rabeneck and Julianne Souchek and Kimberly Wristers and Terri Menke and Eunice Ambriz and Iris Huang and Nelda Wray",
year = "2002",
month = "12",
day = "1",
doi = "10.1016/S0002-9270(02)05540-5",
language = "English (US)",
volume = "97",
pages = "3045--3051",
journal = "American Journal of Gastroenterology",
issn = "0002-9270",
publisher = "Nature Publishing Group",
number = "12",

}

RIS

TY - JOUR

T1 - A double blind, randomized, placebo-controlled trial of proton pump inhibitor therapy in patients with uninvestigated dyspepsia

AU - Rabeneck, Linda

AU - Souchek, Julianne

AU - Wristers, Kimberly

AU - Menke, Terri

AU - Ambriz, Eunice

AU - Huang, Iris

AU - Wray, Nelda

PY - 2002/12/1

Y1 - 2002/12/1

N2 - OBJECTIVES: In patients with uninvestigated dyspepsia, a common initial management strategy in primary care is to prescribe a course of empiric antisecretory therapy and to refer those patients who do not respond for endoscopy. The objective of this research was to evaluate the effects of an empiric course of antisecretory therapy on dyspepsia-related health in patients with uninvestigated dyspepsia. METHODS: We conducted a double blind, randomized, placebo-controlled trial in which patients with uninvestigated dyspepsia were randomized to a 6-wk course of omeprazole 20 mg p.o. b.i.d. versus placebo capsules p.o. b.i.d. and followed over 1 yr. The patients were at least 18 yr old with at least a 1-wk history of dyspepsia without alarm features. Dyspepsia-related health was measured using the Severity of Dyspepsia Assessment (SODA), a valid, reliable, disease-specific outcome measure. The primary outcome was treatment failure, defined by a SODA Pain Intensity score ≥29 (scores, 2-47) during follow-up. Patients who were treatment failures underwent endoscopy. RESULTS: We enrolled 140 patients. The mean age was 51 yr, and seven (5%) were women. At 2 wk there were fewer treatment failures in the omeprazole group: 12 of 71 patients (17%) in the omeprazole group failed compared with 24 of 69 (35%) in the placebo group (p = 0.037, log rank test). Also, at 6 wk there were fewer failures in the omeprazole group: 21 of 71 patients (30%) in the omeprazole group failed compared with 31 of 69 (45%) in the placebo group (p = 0.067, log rank test). However, at the 1-yr follow-up, there was no significant difference in treatment failure rates in the two groups: 37 of 71 patients (52%) in the omeprazole group failed compared with 41 of 69 (59%) in the placebo group (p = 0.28, log rank test). CONCLUSIONS: In patients with uninvestigated dyspepsia, as compared with a strategy that would entail prompt endoscopy for all patients, an initial 6-wk course of either placebo or omeprazole reduces the need for endoscopy over a 1-yr follow-up. Compared with placebo, an initial 6-wk course of omeprazole delays, but does not reduce, the need for endoscopy. For proton pump inhibitor therapy to reduce the need for endoscopy, it may need to be given continuously.

AB - OBJECTIVES: In patients with uninvestigated dyspepsia, a common initial management strategy in primary care is to prescribe a course of empiric antisecretory therapy and to refer those patients who do not respond for endoscopy. The objective of this research was to evaluate the effects of an empiric course of antisecretory therapy on dyspepsia-related health in patients with uninvestigated dyspepsia. METHODS: We conducted a double blind, randomized, placebo-controlled trial in which patients with uninvestigated dyspepsia were randomized to a 6-wk course of omeprazole 20 mg p.o. b.i.d. versus placebo capsules p.o. b.i.d. and followed over 1 yr. The patients were at least 18 yr old with at least a 1-wk history of dyspepsia without alarm features. Dyspepsia-related health was measured using the Severity of Dyspepsia Assessment (SODA), a valid, reliable, disease-specific outcome measure. The primary outcome was treatment failure, defined by a SODA Pain Intensity score ≥29 (scores, 2-47) during follow-up. Patients who were treatment failures underwent endoscopy. RESULTS: We enrolled 140 patients. The mean age was 51 yr, and seven (5%) were women. At 2 wk there were fewer treatment failures in the omeprazole group: 12 of 71 patients (17%) in the omeprazole group failed compared with 24 of 69 (35%) in the placebo group (p = 0.037, log rank test). Also, at 6 wk there were fewer failures in the omeprazole group: 21 of 71 patients (30%) in the omeprazole group failed compared with 31 of 69 (45%) in the placebo group (p = 0.067, log rank test). However, at the 1-yr follow-up, there was no significant difference in treatment failure rates in the two groups: 37 of 71 patients (52%) in the omeprazole group failed compared with 41 of 69 (59%) in the placebo group (p = 0.28, log rank test). CONCLUSIONS: In patients with uninvestigated dyspepsia, as compared with a strategy that would entail prompt endoscopy for all patients, an initial 6-wk course of either placebo or omeprazole reduces the need for endoscopy over a 1-yr follow-up. Compared with placebo, an initial 6-wk course of omeprazole delays, but does not reduce, the need for endoscopy. For proton pump inhibitor therapy to reduce the need for endoscopy, it may need to be given continuously.

UR - http://www.scopus.com/inward/record.url?scp=0036897287&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0036897287&partnerID=8YFLogxK

U2 - 10.1016/S0002-9270(02)05540-5

DO - 10.1016/S0002-9270(02)05540-5

M3 - Article

VL - 97

SP - 3045

EP - 3051

JO - American Journal of Gastroenterology

T2 - American Journal of Gastroenterology

JF - American Journal of Gastroenterology

SN - 0002-9270

IS - 12

ER -

ID: 3326358