M F Yanze1, C Duru, M Jacob, J M Bastide, M Lankeuh. 1. Laboratoire de Galénique, Pharmacotechnie et Biopharmacie, UFR de sciences pharmaceutiques, Université de Montpellier I, France. fmyanze@libertysurf.fr
Abstract
OBJECTIVE: To compare the efficiency, safety and taste of two pharmaceutical forms of chloroquine phosphate 300 mg: effervescent tablets against uncoated tablets. METHOD: An open randomized study with 60 adults who suffered from acute uncomplicated Plasmodium falciparum malaria in three health centres in Nkongsamba health district, Cameroon. RESULTS:Mean times to fever clearance, symptoms clearance and asexual parasites clearance were longer in the uncoated tablets group: 36 h (range 24-48 h, SD = 16.8) vs. 60 h (range 24-96 h, SD = 31.2, P = 0.001) for fever clearance, 36 h (24-48 h, SD = 16.8) vs. 48 h (24-72, SD = 24, P = 0.001) for symptoms clearance and 48 h (24-72, SD = 1) vs. 72 h (48-96, SD = 24, P = 0.001) for parasitaemia clearance. Uncoated tablets took significantly longer to achieve 50% reduction of the initial asexual parasite density: (mean/SD) 19.2 h/7 vs. 52.8 h/16.8, P < 0.00001. The adverse effects in the two groups were similar, P > 0.05. The cure rate at day 7 in the two groups was similar, P > 0.05. There was no chloroquine resistance in the effervescent tablets group but one RI and one RII resistance in the uncoated tablets group. The taste of the two pharmaceutical forms was significantly different, P < 0.00001. Effervescent tablets tasted sweet (score = 7.93), whereas uncoated tablets were bitter (score = 2.07). CONCLUSION: Effervescent tablets of chloroquine phosphate 300 mg work faster than uncoated tablets and because of their safe use and sweet taste achieve good therapeutic compliance.
RCT Entities:
OBJECTIVE: To compare the efficiency, safety and taste of two pharmaceutical forms of chloroquine phosphate 300 mg: effervescent tablets against uncoated tablets. METHOD: An open randomized study with 60 adults who suffered from acute uncomplicated Plasmodium falciparum malaria in three health centres in Nkongsamba health district, Cameroon. RESULTS: Mean times to fever clearance, symptoms clearance and asexual parasites clearance were longer in the uncoated tablets group: 36 h (range 24-48 h, SD = 16.8) vs. 60 h (range 24-96 h, SD = 31.2, P = 0.001) for fever clearance, 36 h (24-48 h, SD = 16.8) vs. 48 h (24-72, SD = 24, P = 0.001) for symptoms clearance and 48 h (24-72, SD = 1) vs. 72 h (48-96, SD = 24, P = 0.001) for parasitaemia clearance. Uncoated tablets took significantly longer to achieve 50% reduction of the initial asexual parasite density: (mean/SD) 19.2 h/7 vs. 52.8 h/16.8, P < 0.00001. The adverse effects in the two groups were similar, P > 0.05. The cure rate at day 7 in the two groups was similar, P > 0.05. There was no chloroquine resistance in the effervescent tablets group but one RI and one RII resistance in the uncoated tablets group. The taste of the two pharmaceutical forms was significantly different, P < 0.00001. Effervescent tablets tasted sweet (score = 7.93), whereas uncoated tablets were bitter (score = 2.07). CONCLUSION: Effervescent tablets of chloroquine phosphate 300 mg work faster than uncoated tablets and because of their safe use and sweet taste achieve good therapeutic compliance.