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Lansoprazole in the treatment of functional dyspepsia: two double-blind, randomized, placebo-controlled trials.
Am J Med. 2004 Jun 01; 116(11):740-8.AJ

Abstract

PURPOSE

The efficacy of proton pump inhibitor therapy for symptom resolution in patients with functional dyspepsia remains controversial. This study was designed to compare the efficacy of lansoprazole with placebo in relieving upper abdominal discomfort in patients with functional dyspepsia.

METHODS

We enrolled 921 patients with functional dyspepsia (defined as persistent or recurrent upper abdominal discomfort during the prior 3 months) and moderate upper abdominal discomfort on at least 30% of screening days; none of the patients had predominant symptoms suggestive of gastroesophageal reflux or endoscopic evidence of erosive or ulcerative esophagitis, or gastric or duodenal ulcer or erosion. Patients were assigned randomly to receive lansoprazole 15 mg (n = 305), lansoprazole 30 mg (n = 308), or placebo (n = 308) daily for 8 weeks. Patients recorded the frequency and severity of symptoms in daily diaries.

RESULTS

At week 8, significantly (P <0.001) greater mean reductions in the percentage of days with upper abdominal discomfort were reported in patients treated with lansoprazole 15 mg (35%) or 30 mg (34%) compared with those treated with placebo (19%). Similarly, more patients treated with lansoprazole 15 mg (44%) or 30 mg (44%) reported complete symptom resolution (defined as no episodes of upper abdominal discomfort in the 3 days before the study visit) at 8 weeks than did placebo-treated patients (29%, P <0.001). Improvement of upper abdominal discomfort, however, was seen only in patients who had at least some symptoms of heartburn at enrollment.

CONCLUSION

Lansoprazole, at a daily dose of 15 mg or 30 mg, is significantly better than placebo in reducing symptoms of persistent or recurrent upper abdominal discomfort accompanied by at least some symptoms of heartburn.

Authors+Show Affiliations

University of Virginia, Charlottesville, Virginia, USA. DAP8V@hscmail.mcc.virginia.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15144910

Citation

Peura, David A., et al. "Lansoprazole in the Treatment of Functional Dyspepsia: Two Double-blind, Randomized, Placebo-controlled Trials." The American Journal of Medicine, vol. 116, no. 11, 2004, pp. 740-8.
Peura DA, Kovacs TO, Metz DC, et al. Lansoprazole in the treatment of functional dyspepsia: two double-blind, randomized, placebo-controlled trials. Am J Med. 2004;116(11):740-8.
Peura, D. A., Kovacs, T. O., Metz, D. C., Siepman, N., Pilmer, B. L., & Talley, N. J. (2004). Lansoprazole in the treatment of functional dyspepsia: two double-blind, randomized, placebo-controlled trials. The American Journal of Medicine, 116(11), 740-8.
Peura DA, et al. Lansoprazole in the Treatment of Functional Dyspepsia: Two Double-blind, Randomized, Placebo-controlled Trials. Am J Med. 2004 Jun 1;116(11):740-8. PubMed PMID: 15144910.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Lansoprazole in the treatment of functional dyspepsia: two double-blind, randomized, placebo-controlled trials. AU - Peura,David A, AU - Kovacs,Thomas O G, AU - Metz,David C, AU - Siepman,Nancy, AU - Pilmer,Betsy L, AU - Talley,Nicholas J, PY - 2002/10/28/received PY - 2004/01/15/revised PY - 2004/01/15/accepted PY - 2004/5/18/pubmed PY - 2004/6/18/medline PY - 2004/5/18/entrez SP - 740 EP - 8 JF - The American journal of medicine JO - Am J Med VL - 116 IS - 11 N2 - PURPOSE: The efficacy of proton pump inhibitor therapy for symptom resolution in patients with functional dyspepsia remains controversial. This study was designed to compare the efficacy of lansoprazole with placebo in relieving upper abdominal discomfort in patients with functional dyspepsia. METHODS: We enrolled 921 patients with functional dyspepsia (defined as persistent or recurrent upper abdominal discomfort during the prior 3 months) and moderate upper abdominal discomfort on at least 30% of screening days; none of the patients had predominant symptoms suggestive of gastroesophageal reflux or endoscopic evidence of erosive or ulcerative esophagitis, or gastric or duodenal ulcer or erosion. Patients were assigned randomly to receive lansoprazole 15 mg (n = 305), lansoprazole 30 mg (n = 308), or placebo (n = 308) daily for 8 weeks. Patients recorded the frequency and severity of symptoms in daily diaries. RESULTS: At week 8, significantly (P <0.001) greater mean reductions in the percentage of days with upper abdominal discomfort were reported in patients treated with lansoprazole 15 mg (35%) or 30 mg (34%) compared with those treated with placebo (19%). Similarly, more patients treated with lansoprazole 15 mg (44%) or 30 mg (44%) reported complete symptom resolution (defined as no episodes of upper abdominal discomfort in the 3 days before the study visit) at 8 weeks than did placebo-treated patients (29%, P <0.001). Improvement of upper abdominal discomfort, however, was seen only in patients who had at least some symptoms of heartburn at enrollment. CONCLUSION: Lansoprazole, at a daily dose of 15 mg or 30 mg, is significantly better than placebo in reducing symptoms of persistent or recurrent upper abdominal discomfort accompanied by at least some symptoms of heartburn. SN - 0002-9343 UR - https://www.unboundmedicine.com/medline/citation/15144910/Lansoprazole_in_the_treatment_of_functional_dyspepsia:_two_double_blind_randomized_placebo_controlled_trials_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0002934304001068 DB - PRIME DP - Unbound Medicine ER -