Comparative evaluation of two Helicobacter pylori eradication schemes (with and without bismuth tripotassium dicitrate)
A.V. Belkovets (1), S.A. Kurilovich (1, 2), T.A. Yurkova (1), N.Yu. Tolkacheva (1), L.V. Scherbakova (1)
1) Scientific Research Institute of Therapy and Preventive Medicine – Affiliated Branch of the Federal Research Center for the Institute of Cytology and Genetics of Siberian Branch of the Russian Academy of Sciences, Novosibirsk, Russia;
2) Novosibirsk State Medical University, Novosibirsk, Russia
Objective. Comparison of the efficacy and tolerability of the two Helicobacter pylori infection eradication regimens (classical triple and classical with the addition of bismuth tripotassium dicitrate [BTD] preparation – Ulcavis).
Methods. The study included 138 patients aged from 19 to 78 years with H. pylori-associated diseases requiring eradication therapy and randomized into two groups. Diagnosis of H. pylori infection was performed using a urease test during video gastroscopy. Group 1 received the classic triple regimen: esomeprazole (Emanera) 40 mg twice a day+amoxicillin (Flemoxin) 1000 mg twice a day+clarithromycin (Fromilid) 500 mg twice a day. The group 2 received similar preparations+BTD (Ulcavis) 240 mg twice a day. The duration of both treatment regimens was 10 days. Patients daily filled out a questionnaire on the tolerability of treatment and medication. The result of eradication therapy was evaluated after 8 weeks.
Results. The study protocol was completed in 121 patients, and not completed in 17 patients for various reasons. The treatment efficacy among those who completed the protocol (PP – per protocol) was 95% in total (93.7% with classical triple therapy and 96.6% with addition of BTD; p=0.5). When calculated for all patients included in the protocol (ITT– intention to treat), treatment efficacy was 83.3% in the total group, 80.8% in group 1, and 86.3% in group 2, i.e. advantages of the scheme with the addition of BTD were revealed. This treatment regimen had an advantage in tolerability: bitter taste in the mouth was less common (p<0.04), and the duration of diarrhea was shortened by 2–3 days (p<0.04).
Conclusion. The classical triple scheme using a double dose of a generic proton pump inhibitor (Emanera) and enhanced with a generic drug (Ulcavis), in case of high compliance, demonstrates high efficiency with a lower frequency of some side effects and can be recommended for widespread use in practice.
About the Autors
Corresponding author: Anna V. Belkovets, PhD in Medical Scineces, Head of the Clinic, Senior Researcher at the Laboratory of Gastroenterology, Head of the Gastroenterological Department of Scientific Research Institute of Therapy and Preventive Medicine – Affiliated Branch of the Federal Research Center for the Institute of Cytology and Genetics of Siberian Branch of the Russian Academy of Sciences, Novosibirsk, Russia; tel. +7 (383) 224-02-47, e-mail: firstname.lastname@example.org
Address: 175/1, Boris Bogatkov Street, Novosibirsk 630089, Russian Federation