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Hanno et al.ǀ Journal of Clinical and Translational Research 2024; 10(6): 317-324 319
2. Methods two patients from the vonoprazan group did not complete the
study, and 14 patients from the PPI group voluntarily stopped
2.1. Study design the drug regimen and did not complete the study.
This was a prospective, controlled, multicenter, parallel- The final sample size was 1184 patients, and they were
assignment, and open-label study involving patients selected divided accordingly in the study: 701 naïve patients received
from the gastroenterology and/or tropical medicine departments, first-line therapy (355 patients received a triple vonoprazan-
as well as inpatient and outpatient clinics, from 12 university based regimen, and 346 patients received a triple PPI-based
centers across Egypt (i.e., Faculty of Medicine of Alexandria regimen), and 483 experienced patients received the second-
University, Al-Azhar University, Ain Shams University, Cairo line therapy (243 patients received quadrable vonoprazan-
University, Assiut University, Mansoura University, based regimen, and 240 patients received quadrable PPI-based
Tanta University, Minia University, South Valley University, regimen). After recruitment and allocation, all patients were
Zagazig University, Benha University; Faculty of Medicine and subjected to the following:
National Liver Institute of Menoufia University). The study was (i) Full history and complete clinical examination: stool
conducted from January 1, 2022, to June 30, 2022. analysis, urine, complete blood count, H. pylori antigen
The inclusion criteria were patients (i) above 18 years (Ag) in stool (quantitative assay), and serum creatinine.
of matched age and sex, and (ii) provided written informed (ii) The presence of H. pylori was confirmed by the H. pylori
consent before study participation. The exclusion criteria were SAT before study treatment administration and 4 weeks after
patients (i) with known allergy to any of the treatment drugs; the treatment regimen; antibiotics and acid-suppressive
(ii) refused to sign an informed consent; (iii) had surgery therapies were discontinued 2 weeks before doing the test.
that might affect gastric acid secretion (upper GI resection During follow-ups, the patients were contacted by telephone
or vagotomy), Zollinger–Ellison syndrome, or other gastric after 1 week of starting the regimen to check compliance. The
acid hypersecretion disorders; (iv) had serious neurological, first follow-up visit was after completing 2 weeks of treatment
cardiovascular, pulmonary, hepatic, renal, metabolic, GI, to register any adverse events. The second follow-up visit was
urological, endocrinological, or hematological disorders; after completing 4 weeks of the treatment regimen to register
(v) need surgery, history of drug (including alcohol) abuse, the eradication results.
history of malignancy, and female subjects who are pregnant The primary purpose of the trial was to increase the rate of first-
or lactating; (vi) pregnancy or planning for pregnancy during line H. pylori elimination. The second endpoint was the rate of H.
the study period; and (vii) on PPIs, P-CABs, and/or antibiotics pylori elimination in those who failed the first line of therapy.
within 1 month before inclusion in the study. The incidence of treatment-emergent adverse events was
Patients who fulfilled the study inclusion criteria were recorded. The principal investigator supervised the assessment
allocated to one group of study as follows: of the safety of triple and quadrable therapy for H. pylori
(i) Group-I: Naïve patients (patients who did not receive any eradication in the local population.
prior H. pylori eradication regimens)
• Arm 1: Patients received vonoprazan triple therapy: 2.3. Statistical analysis
CLA 500 mg twice daily (bis in die [BID]) + AMO 1 g The sample size was calculated using Power Analysis and
BID + vonoprazan 20 mg BID for 14 days Sample Size software (PASS 2020; ncss.com/software/pass;
• Arm 2: Patients received the classic triple therapy: NCSS, LLC., USA). The minimal total hypothesized sample
CLA 500 mg BID + AMO 1 g BID + PPI “omeprazole size of 800 eligible patients (400 per group) is required to
40 mg” BID for 14 days compare the efficacy of vonoprazan and PPI in Egypt’s first- and
(ii) Group-II: Non-responders (patients who did not respond to second-line H. pylori eradication regimens. This calculation
the previous first-line eradication regimen): assumes a 25% effect size (i.e., a minimally clinically important
• Arm 1: Patients received vonoprazan-based non- difference), a 95% confidence level, a 1:1 compliance ratio, and
bismuth quadruple therapy: levofloxacin 500 mg once 80% power, using the Chi-square test [25,26]. The sample size
daily (OD) + vonoprazan 20 mg BID + nitazoxanide was estimated based on the formula:
500 mg BID + doxycycline 100 mg OD for 14 days
× − p)
• Arm 2: Patients received the classic non-bismuth [ Z2 × p (1 ]
quadruple therapy: Levofloxacin 500 mg OD + PPI Sample size n () = N × e2 (I)
p
“omeprazole 40 mg” BID + nitazoxanide 500 mg BID N 1 Z2 ××(1 − ) p ]
−+[
+ doxycycline 100 mg OD) for 14 days. e2
2.2. Data collection Where N is the population size, Z is the critical value of the
normal distribution at the required confidence level, p is the
A total of 1200 patients were enrolled at the beginning of the sample proportion, and e is the margin of error.
study and were further divided into two equal-sized groups, each Data were fed to the computer and analyzed using IBM
containing 600 subjects. The subjects were blindly allocated to Statistical Package for the Social Sciences software version 20.0
vonoprazan and traditional PPI therapies. At the end of the study, (IBM Corp., USA). A Chi-square test was applied to compare

DOI: http://doi.org/10.36922/jctr.24.00043