N Padilla1, R Díaz, M Muñoz. 1. Research Unit, Nursing and Obstetrics School of Celaya, University of Guanajuato, Guanajuato, Mexico, padilla@celaya.podernet.com.mx.
Abstract
OBJECTIVE: To compare the efficacy and safety of single doses of quinfamide and secnidazole in the treatment of amoebic non-dysenteric colitis in children. DESIGN: This was a prospective, longitudinal, double-blind, randomised, comparative study. SETTING: The participants were students or relatives of students at two urban elementary schools in Celaya, Guanajuato, Mexico. PARTICIPANTS: Patients aged between 2 and 15 years of age with cysts of Entamoeba histolytica in stool samples for 3 consecutive days as detected by Faust's concentration method were enrolled in this study. INTERVENTIONS AND OUTCOME MEASURES: Single doses of quinfamide 4.3 mg/kg or secnidazole 30 mg/kg were administered. Patients were asked about the acceptability of the flavour of the drugs. Efficacy was evaluated by the presence or absence of E. histolytica cysts in stool samples on the fifth, sixth and seventh days after administration of the drugs. Adverse events were evaluated by direct questioning of patients. RESULTS:734 patients were evaluated by coproparasitoscopy, of whom 239 (32.6%) had E. histolytica cysts. 112 patients were randomised to receive quinfamide and 127 to receive secnidazole. Differences in age, bodyweight, size and gender distribution were not statistically significant between the groups. 108 patients (96%) in thequinfamide group and 15 patients (12%) in the secnidazole group reported the flavour as good (p < 0.0001). 95 patients (85%) in the quinfamide group and 93 patients (73%) in the secnidazole group had negative stool samples at the end of treatment (p = 0.04). Nausea (p < 0.0001), abdominal pain (p < 0.05) and unpleasant taste (i.e. metallic taste 3 to 5 days after administration of secnidazole) in mouth (p < 0.0001) were more common in the secnidazole group than in the quinfamide group. CONCLUSIONS:Quinfamide is an excellent option for amoebic non-dysenteric colitis because of its high parasitoscopic efficacy, minimum adverse effects and good acceptance by children. The single-dose schedule guarantees completion of treatment.
RCT Entities:
OBJECTIVE: To compare the efficacy and safety of single doses of quinfamide and secnidazole in the treatment of amoebic non-dysenteric colitis in children. DESIGN: This was a prospective, longitudinal, double-blind, randomised, comparative study. SETTING: The participants were students or relatives of students at two urban elementary schools in Celaya, Guanajuato, Mexico. PARTICIPANTS: Patients aged between 2 and 15 years of age with cysts of Entamoeba histolytica in stool samples for 3 consecutive days as detected by Faust's concentration method were enrolled in this study. INTERVENTIONS AND OUTCOME MEASURES: Single doses of quinfamide 4.3 mg/kg or secnidazole 30 mg/kg were administered. Patients were asked about the acceptability of the flavour of the drugs. Efficacy was evaluated by the presence or absence of E. histolytica cysts in stool samples on the fifth, sixth and seventh days after administration of the drugs. Adverse events were evaluated by direct questioning of patients. RESULTS: 734 patients were evaluated by coproparasitoscopy, of whom 239 (32.6%) had E. histolytica cysts. 112 patients were randomised to receive quinfamide and 127 to receive secnidazole. Differences in age, bodyweight, size and gender distribution were not statistically significant between the groups. 108 patients (96%) in the quinfamide group and 15 patients (12%) in the secnidazole group reported the flavour as good (p < 0.0001). 95 patients (85%) in the quinfamide group and 93 patients (73%) in the secnidazole group had negative stool samples at the end of treatment (p = 0.04). Nausea (p < 0.0001), abdominal pain (p < 0.05) and unpleasant taste (i.e. metallic taste 3 to 5 days after administration of secnidazole) in mouth (p < 0.0001) were more common in the secnidazole group than in the quinfamide group. CONCLUSIONS:Quinfamide is an excellent option for amoebic non-dysenteric colitis because of its high parasitoscopic efficacy, minimum adverse effects and good acceptance by children. The single-dose schedule guarantees completion of treatment.