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Efficacy of omeprazole for the treatment of symptomatic acid reflux disease without esophagitis.
Arch Intern Med. 2000 Jun 26; 160(12):1810-6.AI

Abstract

BACKGROUND

Up to three quarters of patients with gastroesophageal reflux disease (GERD) have symptoms, such as heartburn, but no macroscopic evidence of erosive esophagitis, making symptomatic GERD a common clinical problem in the primary care setting.

OBJECTIVE

To compare the efficacy and safety of omeprazole, 20 mg once daily; omeprazole, 10 mg once daily; and placebo in the treatment of symptomatic GERD without erosive esophagitis.

METHODS

Patients with a history of heartburn (> or =12 months) and episodes of moderate to severe heartburn on 4 or more of the 7 days before endoscopy were eligible to participate in this 4-week, randomized, double-blind, placebo-controlled trial. The absence of erosive esophagitis was established through endoscopy. Eligible patients were randomized to 1 of 3 treatment groups: omeprazole, 20 mg once daily; omeprazole, 10 mg once daily; or placebo. Patients were assessed at weeks 2 and 4. The efficacy of omeprazole for the treatment of heartburn was determined mainly through the following diary card data: daily resolution of heartburn and complete resolution of heartburn every day during 1 week of treatment. The efficacy of omeprazole for the treatment of acid regurgitation, dysphagia, epigastric pain, and nausea was also assessed.

RESULTS

Of 359 randomized patients, 355 were included in the statistical analysis (intention-to-treat population). Daily proportions of patients with no heartburn were consistently greater in the 20-mg omeprazole group (62%, day 7; 74%, day 27) than in the 10-mg omeprazole group (41%, day 7; 49%, day 27) or the placebo group (14%, day 7; 23%; day 27). Complete resolution of heartburn every day during the last treatment week was significantly (P< or =.002) higher in the 20-mg omeprazole group (48%) than in the 10-mg omeprazole (27%) or placebo (5%) group. Omeprazole was significantly (P< or =.003) more effective than placebo for the treatment of acid regurgitation, dysphagia, epigastric pain, and nausea.

CONCLUSIONS

Patients with symptomatic GERD require profound acid suppression to achieve symptomatic relief. Omeprazole, 20 mg once daily, was superior to omeprazole, 10 mg once daily, and to placebo in providing early and sustained resolution of heartburn, as well as treatment of other troublesome GERD symptoms.

Authors+Show Affiliations

Department of Gastroenterology, Cleveland Clinic Foundation, Ohio 44195, USA.No 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

10871975

Citation

Richter, J E., et al. "Efficacy of Omeprazole for the Treatment of Symptomatic Acid Reflux Disease Without Esophagitis." Archives of Internal Medicine, vol. 160, no. 12, 2000, pp. 1810-6.
Richter JE, Peura D, Benjamin SB, et al. Efficacy of omeprazole for the treatment of symptomatic acid reflux disease without esophagitis. Arch Intern Med. 2000;160(12):1810-6.
Richter, J. E., Peura, D., Benjamin, S. B., Joelsson, B., & Whipple, J. (2000). Efficacy of omeprazole for the treatment of symptomatic acid reflux disease without esophagitis. Archives of Internal Medicine, 160(12), 1810-6.
Richter JE, et al. Efficacy of Omeprazole for the Treatment of Symptomatic Acid Reflux Disease Without Esophagitis. Arch Intern Med. 2000 Jun 26;160(12):1810-6. PubMed PMID: 10871975.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy of omeprazole for the treatment of symptomatic acid reflux disease without esophagitis. AU - Richter,J E, AU - Peura,D, AU - Benjamin,S B, AU - Joelsson,B, AU - Whipple,J, PY - 2000/6/29/pubmed PY - 2000/7/25/medline PY - 2000/6/29/entrez SP - 1810 EP - 6 JF - Archives of internal medicine JO - Arch. Intern. Med. VL - 160 IS - 12 N2 - BACKGROUND: Up to three quarters of patients with gastroesophageal reflux disease (GERD) have symptoms, such as heartburn, but no macroscopic evidence of erosive esophagitis, making symptomatic GERD a common clinical problem in the primary care setting. OBJECTIVE: To compare the efficacy and safety of omeprazole, 20 mg once daily; omeprazole, 10 mg once daily; and placebo in the treatment of symptomatic GERD without erosive esophagitis. METHODS: Patients with a history of heartburn (> or =12 months) and episodes of moderate to severe heartburn on 4 or more of the 7 days before endoscopy were eligible to participate in this 4-week, randomized, double-blind, placebo-controlled trial. The absence of erosive esophagitis was established through endoscopy. Eligible patients were randomized to 1 of 3 treatment groups: omeprazole, 20 mg once daily; omeprazole, 10 mg once daily; or placebo. Patients were assessed at weeks 2 and 4. The efficacy of omeprazole for the treatment of heartburn was determined mainly through the following diary card data: daily resolution of heartburn and complete resolution of heartburn every day during 1 week of treatment. The efficacy of omeprazole for the treatment of acid regurgitation, dysphagia, epigastric pain, and nausea was also assessed. RESULTS: Of 359 randomized patients, 355 were included in the statistical analysis (intention-to-treat population). Daily proportions of patients with no heartburn were consistently greater in the 20-mg omeprazole group (62%, day 7; 74%, day 27) than in the 10-mg omeprazole group (41%, day 7; 49%, day 27) or the placebo group (14%, day 7; 23%; day 27). Complete resolution of heartburn every day during the last treatment week was significantly (P< or =.002) higher in the 20-mg omeprazole group (48%) than in the 10-mg omeprazole (27%) or placebo (5%) group. Omeprazole was significantly (P< or =.003) more effective than placebo for the treatment of acid regurgitation, dysphagia, epigastric pain, and nausea. CONCLUSIONS: Patients with symptomatic GERD require profound acid suppression to achieve symptomatic relief. Omeprazole, 20 mg once daily, was superior to omeprazole, 10 mg once daily, and to placebo in providing early and sustained resolution of heartburn, as well as treatment of other troublesome GERD symptoms. SN - 0003-9926 UR - https://www.unboundmedicine.com/medline/citation/10871975/Efficacy_of_omeprazole_for_the_treatment_of_symptomatic_acid_reflux_disease_without_esophagitis_ L2 - https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/vol/160/pg/1810 DB - PRIME DP - Unbound Medicine ER -