Sequential therapy versus standard triple-drug therapy for Helicobacter pylori eradication: a prospective randomized study

• Published in: European journal of clinical pharmacology 2013-09, Vol.69 (9), p.1709-1715
• Main Authors: Seddik, Hassan, Ahid, Samir, El Adioui, Tarek, El Hamdi, Fatim-Zohra, Hassar, Mohammed, Abouqal, Redouane, Cherrah, Yahia, Benkirane, Ahmed
• Format: Article
• Language: English
• Subjects: Adult; Amoxicillin - administration & dosage; Amoxicillin - adverse effects; Anti-Bacterial Agents - administration & dosage; Anti-Bacterial Agents - adverse effects; Anti-Ulcer Agents - administration & dosage; Anti-Ulcer Agents - adverse effects; Bacterial diseases; Bacterial diseases of the digestive system and abdomen; Bacterial infections; Biological and medical sciences; Biomedical and Life Sciences; Biomedicine; Clarithromycin - administration & dosage; Clarithromycin - adverse effects; Drug therapy; Drug Therapy, Combination; Female; Helicobacter Infections - drug therapy; Helicobacter pylori; Human bacterial diseases; Humans; Infectious diseases; Male; Medical sciences; Middle Aged; Omeprazole - administration & dosage; Omeprazole - adverse effects; Pharmacoepidemiology and Prescription; Pharmacology; Pharmacology. Drug treatments; Pharmacology/Toxicology; Prospective Studies
• ISSN: 0031-6970; 1432-1041
• DOI: 10.1007/s00228-013-1524-6

Purpose Eradication rates following standard triple therapy for Helicobacter pylori infection are declining. Recent studies, conducted in a number of countries, have shown that sequential therapy for H . pylori infection yields high cure rates. Aim To compare the efficacy and tolerability of a sequential regimen as a first-line treatment of H . pylori infection with a standard triple treatment regime in Morocco. Methods A total of 281 naive H. pylori -infected patients, confirmed by histological examination, were assigned randomly to one of two treatment groups: standard triple therapy [omeprazole (20 mg bid) + amoxicillin (1 g bid) + clarithromycin (500 mg bid) for 7 days] or sequential therapy [omeprazole (20 mg bid) + amoxicillin (1 g bid) for 5 days, followed by omeprazole (20 mg bid) + tinidazole (500 mg bid) + clarithromycin (500 mg bid) for an additional 5 days]. H. pylori eradication was checked 4–6 weeks after treatment initiation by using a 13 C-urea breath test. Compliance and adverse events were assessed. Results The two groups did not differ significantly in gender, age, previous disease history, endoscopic and histological features and smoking. The intention-to-treat and per-protocol eradication rates were 65.9 and 71 % in the standard triple therapy group, and 82.8 and 89.9 % in the sequential therapy group, respectively. The eradication rate was significantly higher in the sequential therapy group than in the standard triple therapy group ( p