OBJECTIVE: To compare the efficacy of a single dose mebendazole 500 mg from the original manufacturer and a formulation locally produced by State Pharmaceuticals Manufacturing Corporation of Sri Lanka and albendazole400 mg in mass treatment of soil-transmitted nematode infections. DESIGN: Randomised trial. SETTING: Government owned plantations in low-country regions of Sri Lanka with poor sanitary facilities. SUBJECTS:399 children 3 to 15 years of age infected with at least one type soil-transmitted nematode. INTERVENTION: Mebendazole 500 mg or albendazole 400 mg given as single dose treatment. MEASUREMENTS: Cure rates and egg reduction rates calculated from egg counts of pre- and post-treatment stool samples using the quantitative Kato-Katz technique. RESULTS: All three drugs were effective against Ascaris infection with cure rates above 95%. The efficacy against Trichuris trichuria was uniformly poor. For hookworm infection albendazole appeared to be more effective in a single dose with cure rates of 77.9% compared with 28.7% and 35.8% for the two mebendazole formulations; corresponding egg reduction rates were 95.4% compared with 72.0% and 74.5%. CONCLUSION:Albendazole is the drug of choice for mass deworming where hookworm disease is prominent. There was no statistically significant difference between the original and locally produced mebendazole.
RCT Entities:
OBJECTIVE: To compare the efficacy of a single dose mebendazole 500 mg from the original manufacturer and a formulation locally produced by State Pharmaceuticals Manufacturing Corporation of Sri Lanka and albendazole 400 mg in mass treatment of soil-transmitted nematode infections. DESIGN: Randomised trial. SETTING: Government owned plantations in low-country regions of Sri Lanka with poor sanitary facilities. SUBJECTS: 399 children 3 to 15 years of age infected with at least one type soil-transmitted nematode. INTERVENTION: Mebendazole 500 mg or albendazole 400 mg given as single dose treatment. MEASUREMENTS: Cure rates and egg reduction rates calculated from egg counts of pre- and post-treatment stool samples using the quantitative Kato-Katz technique. RESULTS: All three drugs were effective against Ascaris infection with cure rates above 95%. The efficacy against Trichuris trichuria was uniformly poor. For hookworm infection albendazole appeared to be more effective in a single dose with cure rates of 77.9% compared with 28.7% and 35.8% for the two mebendazole formulations; corresponding egg reduction rates were 95.4% compared with 72.0% and 74.5%. CONCLUSION:Albendazole is the drug of choice for mass deworming where hookworm disease is prominent. There was no statistically significant difference between the original and locally produced mebendazole.