BACKGROUND:Triple therapy is recommended for Helicobacter pylori eradication, yet consensus on the duration of treatment is lacking. AIM: To compare the efficacy and safety of 1- and 2-week regimens of omeprazole, amoxicillin and clarithromycin in a large, multicentre, double-blind and randomised study. METHODS: A total of 909 H pylori-positive patients with duodenal ulcer, enrolled in 81 endoscopy units in Italy, were randomised to receive omeprazole, amoxicillin and clarithromycin for either 1 week (OAC1W) or 2 weeks (OAC2W) or omeprazole and amoxicillin for 2 weeks. H pylori eradication was assessed by histological examination and carbon-13 urea breath test 4 weeks after treatment. RESULTS: Both the intention-to-treat (ITT; n = 907) and per protocol (PP; n = 661) analyses showed no significant differences between the eradication rates of OAC1W (ITT 79.7%; PP 83.6%) and OAC2W (ITT 81.7%; PP 84.9%; ITT p = 0.53; PP p = 0.71). Both triple omeprazole, amoxicillin and clarithromycin regimens gave significantly higher eradication rates compared with omeprazole and amoxicillin treatment (ITT 44.6%; PP 42.8%; p<0.001). Poor compliance was reported in 18.6%, 17.3% and 15.1% (p = 0.51) of patients for OAC2W, OAC1W and omeprazole and amoxicillin, respectively. Adverse events occurred in 9.9% and 9.6% (p = 0.88) of patients for OAC2W and OAC1W, respectively, and in 5.9% for omeprazole and amoxicillin (p = 0.11). CONCLUSIONS: 1-week and 2-week triple treatments for H pylori eradication are similar in terms of efficacy, safety and patient compliance.
RCT Entities:
BACKGROUND: Triple therapy is recommended for Helicobacter pylori eradication, yet consensus on the duration of treatment is lacking. AIM: To compare the efficacy and safety of 1- and 2-week regimens of omeprazole, amoxicillin and clarithromycin in a large, multicentre, double-blind and randomised study. METHODS: A total of 909 H pylori-positive patients with duodenal ulcer, enrolled in 81 endoscopy units in Italy, were randomised to receive omeprazole, amoxicillin and clarithromycin for either 1 week (OAC1W) or 2 weeks (OAC2W) or omeprazole and amoxicillin for 2 weeks. H pylori eradication was assessed by histological examination and carbon-13 urea breath test 4 weeks after treatment. RESULTS: Both the intention-to-treat (ITT; n = 907) and per protocol (PP; n = 661) analyses showed no significant differences between the eradication rates of OAC1W (ITT 79.7%; PP 83.6%) and OAC2W (ITT 81.7%; PP 84.9%; ITT p = 0.53; PP p = 0.71). Both triple omeprazole, amoxicillin and clarithromycin regimens gave significantly higher eradication rates compared with omeprazole and amoxicillin treatment (ITT 44.6%; PP 42.8%; p<0.001). Poor compliance was reported in 18.6%, 17.3% and 15.1% (p = 0.51) of patients for OAC2W, OAC1W and omeprazole and amoxicillin, respectively. Adverse events occurred in 9.9% and 9.6% (p = 0.88) of patients for OAC2W and OAC1W, respectively, and in 5.9% for omeprazole and amoxicillin (p = 0.11). CONCLUSIONS: 1-week and 2-week triple treatments for H pylori eradication are similar in terms of efficacy, safety and patient compliance.
Authors: N Dal Bo'; F Di Mario; G Battaglia; A Buda; G Leandro; F Vianello; S Kusstatscher; S Salandin; A Pilotto; M Cassaro; S Vigneri; M Rugge Journal: J Gastroenterol Hepatol Date: 1998-03 Impact factor: 4.029
Authors: P Malfertheiner; E Bayerdörffer; U Diete; J Gil; T Lind; P Misiuna; C O'Morain; P Sipponen; R C Spiller; J Stasiewicz; H Treichel; L Ujszászy; P Unge; S J Zanten; L Zeijlon Journal: Aliment Pharmacol Ther Date: 1999-06 Impact factor: 8.171
Authors: S J Zanten; M Bradette; A Farley; D Leddin; T Lind; P Unge; E Bayerdörffer; R C Spiller; C O'Morain; P Sipponen; M Wrangstadh; L Zeijlon; P Sinclair Journal: Aliment Pharmacol Ther Date: 1999-03 Impact factor: 8.171
Authors: P Moayyedi; H Langworthy; K Shanahan; D S Tompkins; M F Dixon; D M Chalmers; A T Axon Journal: Helicobacter Date: 1996-06 Impact factor: 5.753
Authors: T Lind; S Veldhuyzen van Zanten; P Unge; R Spiller; E Bayerdörffer; C O'Morain; K D Bardhan; M Bradette; N Chiba; M Wrangstadh; C Cederberg; J P Idström Journal: Helicobacter Date: 1996-09 Impact factor: 5.753
Authors: T Lind; F Mégraud; P Unge; E Bayerdörffer; C O'morain; R Spiller; S Veldhuyzen Van Zanten; K D Bardhan; M Hellblom; M Wrangstadh; L Zeijlon; C Cederberg Journal: Gastroenterology Date: 1999-02 Impact factor: 22.682
Authors: F Bazzoli; M Zagari; P Pozzato; O Varoli; S Fossi; L Ricciardiello; G Alampi; G Nicolini; S Sottili; P Simoni; A Roda; E Roda Journal: Aliment Pharmacol Ther Date: 1998-05 Impact factor: 8.171
Authors: Jai Hoon Yoon; Gwang Ho Baik; Kyoung Min Sohn; Dae Yong Kim; Yeon Soo Kim; Ki Tae Suk; Jin Bong Kim; Dong Joon Kim; Jin Bae Kim; Woon Geon Shin; Hak Yang Kim; Il Hyun Baik; Hyun Joo Jang Journal: World J Gastroenterol Date: 2012-12-07 Impact factor: 5.742