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Artemisinin-based combination therapy
Are child-friendly, easily soluble tablets or child syrups as effective, safe and tolerable as conventional tablets for malaria therapy? This question was investigated by the Clinical Research Department at the Bernhard Nocht Institute for Tropical Medicine (BNITM) in an elaborate, systematic analysis of available study data, which was published in the Cochrane database this month.
In Africa, the infectious disease malaria mainly affects small children under five years. For the treatment of uncomplicated malaria cases, the World Health Organisation (WHO) recommends oral therapy with combination preparations containing the active ingredient artemisinin (Artemisinin-based Combination Therapy, ACT for short). Scientists have already developed several special child-friendly dosage forms of ACTs to facilitate malaria therapy for children. In individual studies, these dosage forms show similar efficacy compared to standard therapy with crushed tablets. However, an advantage in tolerability due to the improved administration could not yet be shown in the individual studies due to low case numbers.
Prof. Michael Ramharter, Dr. Florian Kurth and the team of the Clinical Research Department have therefore carried out an elaborate, systematic meta-analysis according to the "Cochrane standard". "We analysed and summarised several existing study data to investigate whether there is a difference in the efficacy or tolerability of child-specific ACTs compared to standard therapy," explains Kurth.
For this purpose, the authors evaluated all published studies that doctors had conducted between 2006 and 2015 in sub-Saharan Africa with more than 1,300 children aged between six months and eleven years with uncomplicated malaria. In the studies, they compared crushed conventional ACT tablets with child-friendly ACT formulations, such as easy-dissolve tablets or a syrup.
"Both the crushed conventional ACT tablets and the child-friendly formulations showed good efficacy in the trials," Kurth emphasises. After 28 days, no malaria parasites were detectable in around 94 percent of the children in either treatment group. However, children who took child-friendly, light-soluble tablets had fewer adverse effects (such as vomiting) than children who received crushed tablets.
"In summary, special child-friendly ACT formulations for the treatment of children with uncomplicated malaria are just as effective as crushed conventional tablets, but cause fewer side effects," clarifies Kurth. The acceptance of antimalarial drugs for the treatment of young children in Africa could thus increase significantly, he predicts.
Bélard S, Ramharter M, Kurth F. Paediatric formulations of artemisinin-based combination therapies for treating uncomplicated malaria in children. Cochrane Database Syst Rev. 2020 Dec 8;12:CD009568.
Priv.-Doz. Dr. Florian Kurth
Abt. Klinische Forschung
Tel.: +49 40 42818-369