[Scepticism about a Chinese herbal mixture for sepsis]

While on the one hand the field yearns for an effective treatment for sepsis, on the other hand a there is a sceptical attitude towards positive results. The EXIT-SEP trial showed that treatment with Xuebijing (XBJ), a mixture of 5 Chinese herbs with 162 different components, significantly reduced mortality. This was a multicentric, double-blinded placebo-controlled, adequately powered trial. However, there were also relevant limitations: in view of the uncertainty about the mechanism of action of XBJ, it is disappointing that the secondary endpoints do not provide further insight into this. Also, it remains unclear if an organ-specific effect may be present, and to what extent the survival benefit may be explained from this. For registration in the Western world, an adequately powered positive confirmation trial would be necessary and for this botanical product, manufacturing and quality control issues might represent relevant hurdles for XBJ to become available outside of China.