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Article Dans Une Revue Phytomedicine Année : 2019

Comment on "Effect of Artemisia annua and Artemisia afra tea infusions on schistosomiasis in a large clinical trial"

Résumé

We read the article entitled "Effect of Artemisia annua and Artemisia afra tea infusions on schistosomiasis in a large clinical trial" by Munyangi et al. with great interest. This trial was presumably designed as a phase III clinical trial with a randomized, controlled, double-blind study that aimed to demonstrate the superiority of A. annua and A. afra plant-based infusions over praziquantel for the treatment of schistoso-miasis. We would like to offer a critical analysis of this trial, as we believe there are several crucial issues regarding its scientific background, design , and statistical methods. These concerns question the scientific validity of the results while raising critical issues regarding ethical aspects. At first, backgrounds should be précised. We agree with the authors that the use of artemisinin-based combination therapies is a promising alternative for treating schistosomiasis as already suggested in a meta-analysis of 24 randomized trials where the cure rate of oral artesunate (alone or combined with various anti-parasitic agents) was compared with that of praziquantel for schistosomiasis (Villar et al., 2012). Nevertheless, in a sub-analysis of this meta-analysis, artesunate alone (4 mg/kg/day for 3 days) was clearly less effective than praziquantel (40 mg/kg once) (odds ratio = 0.27, 95% confidence interval (CI): 0.13-0.53). The crude cure rates were 33% and 61.5% in the artesunate and praziquantel groups, respectively. On another hand, artemisinin derivatives are reportedly efficient against the juvenile form of the parasite (schistosomulae), but not against adults or eggs as reported in experimental models (Sabah et al., 1986). This may explain the pro-phylactic effect of artemisinin derivatives on the disease, but the effect on adults or eggs is less convincing. Indeed, the efficacy of artemether on worm reduction was above 70% for schistosomulae aged 14-28 days, but decreased for older parasites. Taken together these experimental and clinical data do not seem sufficient to support such an approach. Moreover A. afra does not contain significant artemisinin, and A. annua contains a very low and variable level of this molecule as detailed by the authors in their article. Thus, the use of an Artemisia-based infusion in a phase III clinical trial does not seem to be supported by sufficient data to be considered as a valid alternative to praziquantel. Secondly, regarding the study protocol, the motivations for the exclusion criteria are unclear. Patients over 60 years-old and pregnant women were excluded. The authors did include school-aged children over the age of six years but did not explain how Artemisia infusion was given. Did the children receive the same treatment as the adults? Was the quantity of the infusion reduced? Praziquantel was prescribed at an unusual dosage of 60 mg/kg/day for 3 days. Most guidelines, including those from the WHO, recommend 40 mg/kg in a single dose, even for preschool-aged children (Colley et al., 2014; Coulibaly et al., 2017).
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hal-02148369 , version 1 (05-06-2019)

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Xavier Argemi, Yves Hansmann, Jean Gaudart, André Gillibert, Eric Caumes, et al.. Comment on "Effect of Artemisia annua and Artemisia afra tea infusions on schistosomiasis in a large clinical trial". Phytomedicine, 2019, 62, pp.152943. ⟨10.1016/j.phymed.2019.152943⟩. ⟨hal-02148369⟩
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