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, MD1, Chanpiwat K, MD1, Bunchorntavakul C, MD1
Affiliation : 1 Division of Gastroenterology and Hepatology, Rajavithi Hospital, Bangkok, Thailand
Background : A 10-day standard concomitant therapy (SCT) is a first-line Helicobacter 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 standard concomitant
therapy (SCT).
Materials and Methods : This open label, randomized study was conducted at Rajavithi 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 bid., amoxicillin 1,000 mg bid., clarithromycin 500 mg bid. and metronidazole 400 mg tid. for 7 days) or 10-
day SCT (omeprazole 20 mg bid., amoxicillin 1,000 mg bid., 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.
Conclusion : 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.
Keywords : Concomitant therapy, Helicobacter pylori, Eradication, Thailand
