RESUMO
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.
RESUMO
ABSTRACT Background This multicenter multinational RCT designed to compare the efficacy of suppository indomethacin and NAC for prevention of PEP. Methods: During a 6-month period, all of the ERCP cases in seven referral centers were randomly assigned to receive either 1200 mg oral NAC, indomethacin suppository 100 mg, 1200 mg oral NAC plus indomethacin suppository 100 mg or placebo 2 hours before ERCP. The primary outcomes were the rate and severity of any PEP. Results: A total of 432 patients included (41.4% male). They were originally citizens of 6 countries (60.87% Caucasian). They were randomly allocated to receive either NAC (group A, 84 cases), rectal indomethacin (group B, 138 cases), NAC + rectal indomethacin (group C, 115 cases) or placebo (group D, 95 cases). The rate of PEP in groups A, B and C in comparison with placebo were 10.7%, 17.4%, 7.8% vs 20% (P=0.08, 0.614 & 0.01 respectively). The NNT for NAC, indomethacin and NAC + indomethacin was 11, 38 and 8 respectively. Conclusion: Oral NAC is more effective than rectal indomethacin when compared to placebo for prevention of PEP and the combination of NAC and Indomethacin had the lowest incidence of PEP and may have synergistic effect in preventing of PEP (IRCT20201222049798N1; 29/12/2020).
RESUMO Contexto: Este estudo randomizado, controlado multicêntrico e multinacional foi projetado para comparar a eficácia da indometacina supositório e N-acetil cisteína (NAC) para prevenção de pancreatite pós colangiografia endoscópica. Métodos: Durante um período de 6 meses, todos os pacientes submetidos à CPRE em sete centros de referência foram aleatoriamente atribuídos para receber 1200 mg de NAC oral, supositório de indometacina 100 mg, 1200 mg de NAC oral mais supositório de indometacina 100 mg ou placebo 2 horas antes do procedimento. Os resultados primários foram a taxa e a gravidade de qualquer pancreatite pós procedimento (PPP). Resultados: Um total de 432 pacientes foram incluídos (41,4% do sexo masculino). Eram originalmente cidadãos de seis países (60,87% caucasianos). Foram alocados aleatoriamente para receber NAC (grupo A, 84 casos), indometacina retal (grupo B, 138 casos), NAC + indometacina retal (grupo C, 115 casos) ou placebo (grupo D, 95 casos). A taxa de PPP nos grupos A, B e C em comparação com o placebo foi de 10,7%, 17,4%, 7,8% vs 20% (P=0,08, 0,614 e 0,01, respectivamente). Conclusão A NAC oral é mais eficaz do que a indometacina retal quando comparado ao placebo para prevenção de PPP e a combinação de NAC e indometacina teve a menor incidência de PPP e pode ter efeito sinérgico na sua prevenção de PPP. (IRCT20201222049798N1; 29/12/2020).
RESUMO
BACKGROUND: This multicenter multinational RCT designed to compare the efficacy of suppository indomethacin and NAC for prevention of PEP. METHODS: During a 6-month period, all of the ERCP cases in seven referral centers were randomly assigned to receive either 1200 mg oral NAC, indomethacin suppository 100 mg, 1200 mg oral NAC plus indomethacin suppository 100 mg or placebo 2 hours before ERCP. The primary outcomes were the rate and severity of any PEP. RESULTS: A total of 432 patients included (41.4% male). They were originally citizens of 6 countries (60.87% Caucasian). They were randomly allocated to receive either NAC (group A, 84 cases), rectal indomethacin (group B, 138 cases), NAC + rectal indomethacin (group C, 115 cases) or placebo (group D, 95 cases). The rate of PEP in groups A, B and C in comparison with placebo were 10.7%, 17.4%, 7.8% vs 20% (P=0.08, 0.614 & 0.01 respectively). The NNT for NAC, indomethacin and NAC + indomethacin was 11, 38 and 8 respectively. CONCLUSION: Oral NAC is more effective than rectal indomethacin when compared to placebo for prevention of PEP and the combination of NAC and Indomethacin had the lowest incidence of PEP and may have synergistic effect in preventing of PEP (IRCT20201222049798N1; 29/12/2020).