ABSTRACT
Background: The ideal combination regimen for Helicobacter pylori (HP) eradication has not yet been determined and the success rate of HP eradication has been extensively reduced worldwide due to increasing antibiotic resistance. So this multinational multi-center randomized controlled trial was designed to evaluate the efficacy of tetracycline +levofloxacin for HP eradication. Methods: During a 6-month period, all of the cases with HP infection in eight referral tertiary centers of three countries were included and randomly allocated to receive either tetracycline + levofloxacin or clarithromycin plus amoxicillin quadruple regimen for two weeks. For all of the participants, pantoprazole was continued for 4 more weeks and after one to two weeks of off-therapy, they underwent urea breath test C13 to prove eradication. Results: Overall 788 patients were included (358 male (45.4%), average age 44.2 years). They were diagnosed as having non-ulcer dyspepsia (516 cases, 65.5%), peptic ulcer disease (PUD) (234 cases, 29.69%), and intestinal metaplasia (38 cases, 4.8%). Racially 63.1% were Caucasian, 14.5% Arab, 15.6% African, and 6.1% Asian. The participants were randomly allocated to groups A and B to receive either tetracycline + levofloxacin or clarithromycin. Among groups A and B in intention to treat (ITT) and per protocol (PP) analysis, 75.2% & 82.1% (285 cases) and 67.5% & 70.1% (276 cases) of participants achieved eradication, respectively (P = 0.0001). The complete compliance rate in groups A and B were 84.4% and 83.6%, respectively. During the study, 33.5% of the participants in group A (127 cases) reported side effects while the complication rate among group B was 27.9% (114 cases, P = 0.041). The most common complaints among groups A and B were nausea and vomiting (12.6% & 9.3%) and abdominal pain (4.48% & 2.68%), respectively. The rate of severe complications that caused discontinuation of medication in groups A and B were 2.1% and 1.46%, respectively (P = 679). In subgroup analysis, the eradication rates of tetracycline+levofloxacin among patients with non-ulcer dyspepsia, PUD, and intestinal metaplasia were 79.4%, 88.1%, and 73.9%, respectively. These figures in group B (clarithromycin base) were 71.3%, 67.6%, and 61.5% respectively (P = 0.0001, 0.0001, and 0.043). Conclusion: Overall, the combination of tetracycline+levofloxacin is more efficient for HP eradication in comparison with clarithromycin+amoxicillin despite more complication rate. In areas with a high rate of resistance to clarithromycin, this therapeutic regimen could be an ideal choice for HP eradication, especially among those who were diagnosed with PUD.
ABSTRACT
BACKGROUND: Irritable bowel syndrome (IBS) is the most frequent functional gastrointestinal (GI) disorder. In this study, we aimed to evaluate the different aspects of IBS among Middle Eastern residents. METHODS: During the study period, patients attending gastroenterology clinics of nine tertiary referral centers in four Middle Eastern couturiers (Iran, Egypt, Kuwait, and Turkey) were evaluated by Rome IV diagnostic criteria, and those who fulfilled the diagnostic criteria of IBS were asked to fill in a questionnaire covering different demographics and clinical aspects. RESULTS: Overall, during a 6-month period, 509 patients with IBS were included. 41.3% of the participants were male (210 patients), and 37.4% of them had academic education. 50% of the participants were Caucasian, and 34% were Arab, and originally, they were citizens of 18 countries. 77.4% of the participants were residents of subtropical areas, while 22.2% were living in temperate regions. The average age of the participants during the first presentation in subtropical and temperate areas were 38.4 ± 12.19 and 38.06 ± 12.18 years, respectively (P = 0.726). The most common subtypes of IBS in subtropical areas were unclassified (IBS-U, 44.4%), constipation dominant (IBS-C, 27.6%), mixed pattern (IBS-M, 21%), and diarrhea dominant (IBS-D, 6.8%) in descending order while in temperate areas the most common subtypes were IBS-U (43.3%), and IBS-D (22.1%), respectively (P < 0.001). Besides abdominal pain, the most common symptom of patients in each region was bloating (62.2% and 68.1%, respectively, P = 0.246). The rate of depression and anxiety were significantly higher among the residents of temperate areas in comparison with subtropical regions (41.6% vs. 16.5% and 80.5% vs. 58.4%, respectively, P < 0.001). CONCLUSION: Although the average age of IBS presentation is the same in subtropical and temperate areas, it seems that in temperate areas, the rate of IBS-D is more prevalent than in subtropical regions. The rate of anxiety and depression are significantly higher among those who searched social media and the internet to get information about their problems.
