Furazolidone, tetracycline and omeprazole: a low-cost alternative for <i>Helicobacter pylori</i> eradication in children

Abstract

ResumoObjetivos: 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% (IC95% 77,1-89,5), ao passo que na análise por protocolo (n = 29), foi de 89,7% (IC95% 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%), principalmente dor abdominal (11/ 30,5%), náusea (sete/19,4%) e vômitos (cinco/13,9%). Conclusão:A terapia tripla com furazolidona e tetraciclina é uma alternativa de baixo custo para o tratamento da infecção pelo H. 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.J Pediatr (Rio J). 2008;84(2):160-165

Helicobacter Pylori Treatment with Alternative Drugs: Good and Cheap for Developing Countries Furazolidone-Based Treatment- Omeprazole, Furazolidone and Tetracycline Open-Label Trial in A Developing Country: Why Not?

“…In Brazil other studies were done with the same antibiotics. Our study presented a side effects rate of 49%, compatible with the scientific literature, which advocates between 34-59.7% [9,10]. In Silva et al [10] the rate of reported side effects for the same therapeutic scheme was 34% 10, while in Machado et al [9] it was 47.2%.…”

“…The low complexity of the therapeutic scheme favors patients adherence to the treatment and, consequently, success which can be seen in the high eradication rates obtained (96%). Furthermore, this therapeutic scheme had its efficacy proved by two other studies: Silva et al found an intention-to-treat efficacy of 69% and in Machado et al [9] H. pylori eradication rates were 83.3% patients in intentionto-treat analysis and 89.7% in per-protocol analysis [9,10].…”

“…The occurrence of side effects, nonetheless, was not the determinant factor for discontinuing the treatment, and able to consider that the proposed therapeutic scheme was welltolerated [9,10]. The therapy proposed for this study avoids using clarithromycin, due to high antibiotic resistance and advocates the use of furazolidone, a drug which has proven to be efficient in fighting infection by H. pylori in Brazil.…”

“…This drug present low bacterial resistance and it is effective against the strains of H. pylori and have a reduced cost [2,[7][8][9]. In 2002, Eisig et al [7] proposed a 7-day treatment based on furazolidone and tetracycline combined to a pump inhibitor (Omeprazole) in patients that had been previously treated.…”

3rd BRAZILIAN CONSENSUS ON Helicobacter pylori

“…The treatment is performed for 7 days, the doses of furazolidone used range from 100 mg (children) to 400 mg/day, with frequent adverse effects, particularly gastrointestinal (28,35,63,107,128) . A systematic review and meta-analysis of the effects of furazolidone and nitrofurantoinic derivatives in eradicating H pylori showed that schemes using such drugs had more frequent adverse effects and slightly less effective eradication rates when compared with the classic triple therapy (12) .…”