Comment on “A. annua and A. afra infusions vs. Artesunate-amodiaquine (ASAQ) in treating Plasmodium falciparum malaria in a large scale, double blind, randomized clinical trial” Munyangi et al., 2019

We read with great interest the article entitled “A. annua and A. afra infusions vs. Artesunate-amodiaquine (ASAQ) in treating Plasmodium falciparum malaria in a large scale, double blind, randomized clinical trial“ We have noticed some issues and inconsistencies in the background, methods and results, and would like to provide a critical analysis of this study. The scientific validity of the results is affected as well as the ethical integrity given the lethal risk of malaria for infected patients. Critic of Ethics: A large-scale randomized controlled trial for Artemisia (phase III) should not have been conducted without prior evidence of efficacy in smaller randomized trials. The ethics committee authorization number seems to be shared with another clinical trial and seems to have been obtained in 2016, after the clinical trial was conducted. Critic of Methods: Unclear or unadequate randomization. The primary outcome was not mentioned in methods and there is no hypothesis test on any efficacy outcome. No PCR adjustment for reinfection. Critic of Results: Many inconsistencies in sample sizes and efficacy results. Major imbalance of randomized group sizes in some centers. Response rate of ASAQ (34%) far lower than anything described in this region (> 90%). Efficacy varying from 0% to 100% from center to center. Frequencies of adverse effects are almost all multiples of five, which can hardly be explained by random fluctuations (p<0.0001).