A placebo-controlled trial of 10-day bismuth-based quadruple therapy to eradicate Helicobacter pylori infection; A pilot study for the large Linqu County trial Journal Article
| Authors: | Ma, J.; Liu, W.; Zhang, L.; Pan, K.; Zhao, H.; Zhou, T.; Winawer, S.; Zauber, A.; Classen, M.; You, W. |
| Article Title: | A placebo-controlled trial of 10-day bismuth-based quadruple therapy to eradicate Helicobacter pylori infection; A pilot study for the large Linqu County trial |
| Abstract: | AIM: To explore a low-cost and highly-effective therapy for eradication of Helicobacter pylori (H. pylori), a placebo-controlled trial of quadruple therapy was conducted in a population at high risk of gastric cancer in Linqu County of Shandong Province, China. Methods: Two hundred and seventy-seven adults aged 35-54 years with H. pylori infection in three villages were assigned to two groups: treatment (n=189 in two villages) and placebo (n=88 in one village). Participants received either a 10-day oral quadruple therapy regimen with omeprazole (20 mg, twice daily); tetracycline (750 mg, three times daily); metronidazole (500 mg, three times daily) and bismuth potassium citrate (300 mg, twice daily), or a similar lookalike placebo regimen. The status of H. pylori infection in each trial participant before and after six weeks of treatment was determined by a C-urea breath test. Results: One hundred and seventy-four of 189 participants completed the quadruple therapy (92.1%) and 84 participants completed the placebo therapy (95.5%). The H. pylori eradication rate by intention-to-treat analysis was 76.7% (145 of 189) in the treatment group and 1.1% (1 of 88) in the placebo group, respectively; by per-protocol analysis it was 83.3% (145 of 174) in the treatment group and 1.2% (1 of 84) in the placebo group, respectively. Conclusion: In a high-risk area of gastric cancer, we conducted a high compliance, tolerable, low side-effect and lowcost therapy of anti-H. pylori. The eradication rate of the 10-day quadruple treatment was more than 80% and significantly higher than the triple therapy regimen used in this population in an earlier trial. © 2010 Wolters Kluwer Health | Lippincott Williams & Wilkins. |
| Keywords: | adult; controlled study; treatment outcome; middle aged; major clinical study; clinical trial; fatigue; placebo; drug efficacy; drug withdrawal; prospective study; anorexia; controlled clinical trial; nausea; abdominal pain; dizziness; drug induced headache; rural population; anti-bacterial agents; statistical analysis; drug therapy, combination; pilot projects; patient compliance; stomach cancer; high risk population; melena; tetracycline; metronidazole; helicobacter infections; helicobacter pylori; placebos; omeprazole; china; carbon isotopes; urea; bloating; anti-infective agents; 10-day quadruple therapy; h. pylori infection; population-based study; bismuth citrate; eradication therapy; helicobacter infection; urea breath test; antacids; anti-ulcer agents; bismuth; breath tests |
| Journal Title: | European Journal of Gastroenterology and Hepatology |
| Volume: | 22 |
| Issue: | 5 |
| ISSN: | 0954-691X |
| Publisher: | Lippincott Williams & Wilkins |
| Date Published: | 2010-05-01 |
| Start Page: | 597 |
| End Page: | 601 |
| Language: | English |
| DOI: | 10.1097/MEG.0b013e3283337146 |
| PUBMED: | 19996977 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | --- - "Export Date: 20 April 2011" - "CODEN: EJGHE" - "Source: Scopus" |
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