Efficacy of two-week therapy with doxycycline-based quadruple regimen versus levofloxacin concomitant regimen for helicobacter pylori infection: a prospective single-center randomized controlled trial

Abstract

Background Antibiotic-resistance reduces the efficacy of conventional triple therapy for Helicobacter Pylori infections worldwide, which necessitates using various treatment protocols. We used two protocols, doxycycline-based quadruple regimen and concomitant levofloxacin regimen. The aim was to assess the effectiveness of doxycycline-based quadruple regimen for treating Helicobacter Pylori infections compared with levofloxacin concomitant regimen as empirical first-line therapy based on intention-to-treat (ITT) and per-protocol analyses (PPA) in Syrian population. Settings and design An open-label, randomised, parallel, superiority clinical trial. Methods We randomly assigned 78 naïve patients who tested positive for Helicobacter Pylori gastric infection, with a 1:1 ratio to (D-group) which received (bismuth subsalicylate 524 mg four times daily, doxycycline 100 mg, tinidazole 500 mg, and esomeprazole 20 mg, each twice per day for 2 weeks), or (L-group) which received (levofloxacin 500 mg daily, tinidazole 500 mg, amoxicillin 1000 mg, and esomeprazole 20 mg each twice per day for two weeks). We confirmed Helicobacter Pylori eradication by stool antigen test 8 weeks after completing the treatment. Results Thirty-nine patients were allocated in each group. In the D-group, 38 patients completed the follow-up, 30 patients were cured. While in the L-group, 39 completed the follow-up, 32patients were cured. According to ITT, the eradication rates were 76.92%, and 82.05%, for the D-group and L-group respectively. Odds ratio with 95% confidence interval was 1.371 [0.454–4.146]. According to PPA, the eradication rates were 78.9%, and 82.05% for the D-group and L-group respectively. The odds ratio with 95% confidence interval was 1.219 [0.394–3.774]. We didn’t report serious adverse effects. Conclusions Levofloxacin concomitant therapy wasn’t superior to doxycycline based quadruple therapy. Further researches are required to identify the optimal first-line treatment for Helicobacter-Pylori Infection in the Syrian population. Trial registration We registered this study as a standard randomized clinical trial (Clinicaltrial.gov, identifier-NCT04348786, date:29-January-2020).

Mortality and risk factors associated with peptic ulcer bleeding among adult inpatients of Damascus Hospital, Syria: A cross-sectional study

“…[35] While the doxycycline-based quadruple regimen and levofloxacin concomitant regimen was effective in 82% of cases. [36] When reviewing patient charts, it was found that there is a significant flaw in documenting the H. pylori infection status, treatment protocol, and treatment result. Although there is a clear policy regarding the medical file, including the results of tests and biopsies, this policy is not always followed because the Syrian health sector is facing severe challenges due to doctor emigration, a shortage of nursing staff, and imposed sanctions.…”

Advanced diffuse gastric adenocarcinoma in young Syrian woman. A case report

“…Other risk factors are genetic and family history of cancers such as hereditary nonpolyposis colorectal cancer (Lynch syndromes I & II) and familial adenomatous polyposis (FAP) [ 7 ], and none of them appear to be true in our case based on the history. Helicobacter Pylori infection is the most potently recognized risk factor for gastric adenocarcinoma; however, even after decades of infection, the only an insignificant proportion of infected subjects develop adenocarcinoma [ 8 ], and there is insufficient evidence to suggest the optimal age to begin eradication therapy [ 9 , 10 ], knowing that Helicobacter pylori infection eradication is difficult in Syria [ 11 , 12 ]. Early detection of a gastric tumor is critical in determining prognosis, and each of the following indicates metastatic gastric cancer: weight loss, anemia, Virchow nodes (left supraclavicular), Irish node (anterior axillary), and periumbilical (Sister Mary Joseph nodule).…”

Efficacy of a 2-week therapy with levofloxacin concomitant versus a levofloxacin sequential regimen for Helicobacter pylori infection in the Syrian population: a study protocol for randomized controlled trial

“…For two weeks, patients on the concomitant levofloxacin regimen will receive levofloxacin 500 mg once daily, amoxicillin 1000 mg, tinidazole 500 mg, and esomeprazole 20 mg twice daily. When applied as a first-line treatment, the previous regimen had the highest eradication rate for Syrian patients naive to HP treatment [ 36 , 37 ]. A rescue regimen of high-dose dual therapy consisting of esomeprazole (40 mg twice daily) and amoxicillin (1000 mg three times daily) for 2 weeks will be used after first-line treatment fails [ 22 , 39 ].…”

“…However, the increasing antibiotic resistance of HP has become a major global problem [ 24 – 35 ]. In Syria, the eradication rate of traditional triple therapy with clarithromycin or levofloxacin was less than 30% [ 36 ], whereas the eradication rate with the levofloxacin concomitant regimen and the doxycycline-bismuth-based quadruple regiment was 82.05% and 78.9%, respectively [ 37 ]. As a result, there is a need to look for more effective therapeutic regimens as well as the best therapeutic regimens for follow-up when the first line of treatment fails.…”