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*Division of Gastroenterology, Department of Medicine, Rajavithi Hospital, 2 Phyathai Road, Ratchathewi, Bangkok 10400, Thailand; Phone: +66-2-3548108 ext. 5101; Email: dnchalermrat@gmail.com
บทคัดย่อ
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.
ที่มา
วารสารจดหมายเหตุทางการแพทย์ ปี 2562, October
ปีที่: 102 ฉบับที่ Suppl 10 หน้า 12-17
คำสำคัญ
Thailand, Eradication, Helicobacter pylori, Concomitant therapy