J Med Assoc Thai 2019; 102 (12):12

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7-day High-dose Proton Pump Inhibitor Versus 10-day Standard Concomitant Therapy for Helicobacter pylori Eradication in Thai Patients: A Randomized Controlled Trial
Rojsanga W , Chanpiwat K , Bunchorntavakul C Mail

Background: A 10-day standard concomitant therapy (SCT) is a first-line H. pylori treatment option with slightly higher eradication rates as compared to a standard triple therapy. More aggressive acid suppression by high-dose proton pump inhibitor (PPI) may allow shortening treatment duration without compromising eradication rates. This study was aimed to compare the H. pylori eradication rates between a 7-day high-dose PPI (modified) concomitant therapy (MCT) and a 10-day SCT.

Materials and Methods: This open label, randomized study was conducted at Rajvithi Hospital, Bangkok, Thailand between November 2016 and November 2017. Patients with active H. pylori infection (n=240) were included and randomized (1:1) into either 7-day MCT (omeprazole 40 mg b.i.d., amoxicillin 1000 mg b.i.d., clarithromycin 500 mg b.i.d. and metronidazole 400 mg t.i.d. for 7 days) or 10-day SCT (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d., clarithromycin 500 mg b.i.d. and metronidazole 400 mg t.i.d. for 10 days).  H. pylori eradication was evaluated by 14C-urea breath test at 4-6 weeks after the completion of treatment.

Results: A total of 120 patients were randomized into each treatment group. In intention-to-treat analysis, H. pylori eradication rate was 88.3% (106/120) and 88.3% (106/120) in the 7-day MCT and 10-day SCT groups, respectively (p>0.99). In per-protocol analysis, H. pylori eradication rate was 94.6% (106/112) and 95.5% (106/111) in the 7-day MCT and 10-day SCT groups, respectively (p=0.769). Treatment-related adverse events were mostly mild and well tolerated, which occurred in a similar frequency in both groups

Conclusions: 7-day MCT was safe and able to achieve similar eradication rate as compared with a 10-day SCT. This novel shorter MCT may be a practical alternative first-line treatment option for H. pylori eradication in Thailand since shorter treatment is associated with lesser cost and better tolerability.


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