Pratibha Singhi1, Devi Dayal, N Khandelwal. 1. Department of Pediatrics, Post Graduate Institute of Medical Education and Research, Chandigarh, India. drsinghi@glide.net.in
Abstract
BACKGROUND: The appropriate duration of albendazole therapy in neurocysticercosis remains to be determined. Observations in small, uncontrolled clinical trials that short course therapy is as effective as longer regimens must be tested by proper trials. OBJECTIVE: To compare efficacy of 1 and 4 weeks of albendazole therapy in children with neurocysticercosis. STUDY DESIGN AND SETTING: A randomized, placebo-controlled, double blind clinical trial at the Pediatric Neurocysticercosis Clinic of Advanced Pediatric Centre, a tertiary care teaching hospital. SUBJECTS: We observed 122 consecutive children with seizures and either a single small enhancing computerized tomographic lesion or up to 3 lesions on head computerized tomography (CT) examination. INTERVENTION: All children received albendazole (15 mg/kg/day) for 7 days followed by either albendazole or placebo for the following 21 days according to their random number allocation. CT scans were repeated at 1 and 3 months after completion of therapy. Codes opened at the completion of study revealed that 60 children had received albendazole for 28 days (Group A) and 62 received albendazole for 7 days (Group B). All children were followed for at least 2 years. RESULTS:Complete resolution of lesions was similar in the two therapy groups on the first (42% vs. 39%) and second (77% vs. 79%) follow-up CT. Reduction in total number and size was also similar. Also the proportion of lesions that calcified (5% vs. 10%) did not differ significantly. Seizure control at 2 years was similar in the 2 groups. CONCLUSIONS: In this clinical trial 1 week of albendazole therapy was as effective as 4 weeks of therapy in children with neurocysticercosis having one to three lesions.
RCT Entities:
BACKGROUND: The appropriate duration of albendazole therapy in neurocysticercosis remains to be determined. Observations in small, uncontrolled clinical trials that short course therapy is as effective as longer regimens must be tested by proper trials. OBJECTIVE: To compare efficacy of 1 and 4 weeks of albendazole therapy in children with neurocysticercosis. STUDY DESIGN AND SETTING: A randomized, placebo-controlled, double blind clinical trial at the Pediatric Neurocysticercosis Clinic of Advanced Pediatric Centre, a tertiary care teaching hospital. SUBJECTS: We observed 122 consecutive children with seizures and either a single small enhancing computerized tomographic lesion or up to 3 lesions on head computerized tomography (CT) examination. INTERVENTION: All children received albendazole (15 mg/kg/day) for 7 days followed by either albendazole or placebo for the following 21 days according to their random number allocation. CT scans were repeated at 1 and 3 months after completion of therapy. Codes opened at the completion of study revealed that 60 children had received albendazole for 28 days (Group A) and 62 received albendazole for 7 days (Group B). All children were followed for at least 2 years. RESULTS: Complete resolution of lesions was similar in the two therapy groups on the first (42% vs. 39%) and second (77% vs. 79%) follow-up CT. Reduction in total number and size was also similar. Also the proportion of lesions that calcified (5% vs. 10%) did not differ significantly. Seizure control at 2 years was similar in the 2 groups. CONCLUSIONS: In this clinical trial 1 week of albendazole therapy was as effective as 4 weeks of therapy in children with neurocysticercosis having one to three lesions.