Prevention of duodenal ulcer relapse with omeprazole 20 mg daily: a randomized double-blind, placebo-controlled study
| Autor: | Shiu Kum Lam, Kang Jy, Rin Chang, Boonyapisit S, Goh Kl, Lai Kh |
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| Rok vydání: | 1995 |
| Předmět: |
Male
medicine.medical_specialty Placebo-controlled study Administration Oral Placebo Placebo group Gastroenterology Drug Administration Schedule Double blind Maintenance therapy Double-Blind Method Recurrence Internal medicine Medicine Humans Omeprazole Hepatology medicine.diagnostic_test business.industry Middle Aged Surgery Endoscopy Duodenal ulcer Treatment Outcome Duodenal Ulcer Female business medicine.drug |
| Zdroj: | Journal of gastroenterology and hepatology. 10(1) |
| ISSN: | 0815-9319 |
| Popis: | We report the first double-blind, placebo-controlled study that assesses the efficacy and safety of omeprazole 20 mg daily in the maintenance treatment of duodenal ulcer. For the healing phase, 128 patients with endoscopically proven active duodenal ulcer and a history of three or more relapses during the 2 years prior to the study were treated until healing with omeprazole 40 mg daily for 2 and up to 8 weeks. One hundred and twenty-three patients whose ulcers were healed were randomized to receive omeprazole 20 mg daily (n = 60) or placebo (n = 63) for 12 months as maintenance treatment. Patients were interviewed at 3, 6, 9 and 12 months, and endoscopy was performed at 3, 6 and 12 months and whenever symptoms recurred. The healing rates of the 124 patients completing the healing phase were 84, 98 and 100% at 2, 4 and 8 weeks, respectively. During the maintenance phase, eight and four patients discontinued treatment from the omeprazole and placebo groups, respectively. The proportion of patients in remission in the omeprazole group and placebo group after 12 months were 94 and 9% respectively (life table estimates, P < 0.0001). No significant clinical or laboratory changes were observed in patients on therapy with omeprazole. Patients with a history of frequent relapses thus continued to have a very high relapse rate without prophylactic treatment. Omeprazole 20 mg daily was effective and safe in maintaining such patients in remission. |
| Databáze: | OpenAIRE |
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