Comparison the cost-efficacy of furazolidone-based versus clarithromycin-based quadruple therapy in initial treatment of Helicobacter pylori infection in a variable clarithromycin drug-resistant region, a single-center, prospective, randomized, open-label study.

Helicobacter pylori (Hp) drug resistant rate to clarithromycin (CLA) has increased to 20% to 50%, which cause concerns regarding its effectiveness in eradicating Hp, we aim to evaluate the cost-effectiveness of CLA-based versus furazolidone (FZD)-based quadruple therapy, and assess factors that affect anti-Hp efficacy.One hundred eighty-five patients were enrolled in this single-center, prospective, randomized, open-label study. In FZD group, 92 patients were treated with FZD plus esomeprazole, bismuth potassium citrate, and amoxicillin for 14 days. In CLA group, 93 patients were treated with the same regimen except FZD was replaced by CLA. Patients were tested 4 weeks post-treatment to confirm eradication.Of the 185 enrolled patients, 180 completed the study. On intention-to-treat analysis, Hp eradication rates in FZD and CLA groups were 90.22% and 86.02% (P = .378); in per-protocol analysis, their eradication rates were 93.26% and 87.91%, respectively (P = .220). Overall incidence of total side effects in FZD and CLA groups was 19.57% and 13.98%, and their severe side effects were 3.26% and 2.15%, respectively (P > .05). Cost-effectiveness ratios of FZD and CLA groups were 0.75 and 1.02, and incremental cost-effectiveness ratio of FZD group over CLA group was -3.62. Eradication failures were not associated with factors including gender, age, body mass index, smoking, alcohol consumption, educational level, and urban-rural distribution in this observation (P > .05).Despite increasing drug resistance to CLA, Hp eradication rates in FZD and CLA groups have no significant difference at present; as FZD-based quadruple therapy is more cost-effective, we recommend this regimen be a first-line choice for Hp eradication.

Furazolidone, tetracycline and omeprazole: a low-cost alternative for Helicobacter pylori eradication in children.

OBJECTIVES: To evaluate furazolidone, tetracycline and omeprazole as first line therapy for Helicobacter pylori in children with digestive symptoms. METHODS: Prospective and consecutive open trial. The study included patients older than 8 years old with functional dyspepsia, functional abdominal pain, severe histological abnormalities (intestinal metaplasia, gastric atrophy or mucosa-associated lymphoid tissue lymphoma) or peptic ulcer. H. pylori status was defined based both upon histology and rapid urease test. Drug regimen was a 7-day course of omeprazol, tetracycline (or doxycycline) and furazolidone twice daily. Eradication was assessed by upper endoscopy 2 months after treatment (histology and rapid urease test). Further clinical evaluation was done 7 days and 2 months after treatment. RESULTS: Thirty-six patients (21 female/15 male) were included. Age ranged from 8 to 19 years (mean 12.94+/-2.89 years). On intention-to-treat analysis (n = 36), eradication rate was 83.3% (95%CI 77.1-89.5) whereas in per-protocol analysis (n = 29), it was 89.7% (95%CI 84.6-94.7). Compliance was better when doxycycline was used, but the success rates were similar for the two tetracyclines. There was no variable associated with treatment failure. Side effects were reported in 17 patients (47.2%), mainly abdominal pain (11/30.5%), nausea (seven/19.4%) and vomiting (five/13.9%). CONCLUSION: Triple therapy with furazolidone and tetracycline is a low-cost alternative regimen to treat H. pylori infection.

Furazolidona, tetraciclina e omeprazol: uma alternativa de baixo custo para erradicação de Helicobacter pylori em crianças / Furazolidone, tetracycline and omeprazole: a low-cost alternative for Helicobacter pylori eradication in children

OBJETIVOS: Avaliar furazolidona, tetraciclina e omeprazol como tratamento de primeira linha para Helicobacter pylori em crianças com sintomas digestivos. MÉTODOS: Ensaio clínico aberto, prospectivo e consecutivo. O estudo incluiu pacientes acima de 8 anos com dispepsia funcional, dor abdominal funcional, anormalidades histológicas graves (metaplasia intestinal, atrofia gástrica ou linfoma do tecido linfóide associado às mucosas) ou úlcera péptica. A presença de H. pylori foi definida com base em exame histológico e teste da urease. O regime medicamentoso consistiu de um tratamento de 7 dias com omeprazol, tetraciclina (ou doxiciclina) e furazolidona duas vezes por dia. A erradicação foi avaliada através de endoscopia digestiva alta 2 meses após o tratamento (exame histológico e teste da urease). Avaliações clínicas posteriores foram realizadas 7 dias e 2 meses após o tratamento. RESULTADOS: Foram incluídos 36 pacientes (21 meninas/15 meninos). A idade variou de 8 a 19 anos (média de 12,94+2,89 anos). Na análise por intenção de tratar (n = 36), a taxa de erradicação foi de 83,3 por cento (IC95 por cento 77,1-89,5), ao passo que na análise por protocolo (n = 29), foi de 89,7 por cento (IC95 por cento 84,6-94,7). A adesão foi melhor quando se utilizou doxiciclina, mas as taxas de sucesso foram semelhantes para as duas tetraciclinas. Não houve nenhuma variável associada à falha no tratamento. Foram relatados efeitos colaterais em 17 pacientes (47,2 por cento), principalmente dor abdominal (11/30,5 por cento), náusea (sete/19,4 por cento) e vômitos (cinco/13,9 por cento). CONCLUSÃO: A terapia tripla com furazolidona e tetraciclina é uma alternativa de baixo custo para o tratamento da infecção pelo H. pylori.

OBJECTIVE: To evaluate furazolidone, tetracycline and omeprazole as first line therapy for Helicobacter pylori in children with digestive symptoms. METHODS: Prospective and consecutive open trial. The study included patients older than 8 years old with functional dyspepsia, functional abdominal pain, severe histological abnormalities (intestinal metaplasia, gastric atrophy or mucosa-associated lymphoid tissue lymphoma) or peptic ulcer. H. pylori status was defined based both upon histology and rapid urease test. Drug regimen was a 7-day course of omeprazol, tetracycline (or doxycycline) and furazolidone twice daily. Eradication was assessed by upper endoscopy 2 months after treatment (histology and rapid urease test). Further clinical evaluation was done 7 days and 2 months after treatment. RESULTS: Thirty-six patients (21 female/15 male) were included. Age ranged from 8 to 19 years (mean 12.94+2.89 years). On intention-to-treat analysis (n = 36), eradication rate was 83.3 percent (95 percentCI 77.1-89.5) whereas in per-protocol analysis (n = 29), it was 89.7 percent (95 percentCI 84.6-94.7). Compliance was better when doxycycline was used, but the success rates were similar for the two tetracyclines. There was no variable associated with treatment failure. Side effects were reported in 17 patients (47.2 percent), mainly abdominal pain (11/30.5 percent), nausea (seven/19.4 percent) and vomiting (five/13.9 percent). CONCLUSION: Triple therapy with furazolidone and tetracycline is a low-cost alternative regimen to treat H. pylori infection.