Homeopathy in severe sepsis
30 December 2017 (online)
For several reasons, I was puzzled by the re-publication of the study by Frass et al..[ 1 ] I believe it raises several questions.
If real, the findings reported are of ground-breaking importance and could save many lives. Did Frass et al. not feel a responsibility to conduct a more definitive, appropriately powered study during the 6 years since the first publication of their trial? Is such a study in progress? If yes, why re-publish this preliminary report?
Can the authors confirm that the two study endpoints were the only ones evaluated according to the protocol approved by their ethical committee?
If there were other endpoints (which their phrase “the evaluated endpoint was death…” seems to imply), do the authors agree that the p-values should have been corrected and are therefore misleading?
Do the authors agree that the endpoint at 180 days is likely to be entirely unrelated to sepsis?
Could they provide the sites of sepsis by treatment group, as this is an important determinant of prognosis?
Could the authors provide causes of deaths?
Could they also provide the details of the concomitant therapies administered to both patient groups?
Could the authors explain the figure of 67.7% as it seems to imply that 21 of 31 patients survived at day 30? If that is correct, what happened to the other three patients in the control group?
One of the most puzzling features of this study is the fact that 70 patients “were assessed eligibility, all were included in the study”. How do the authors explain that not the usual percentage of patients declined to participate?
As this small study was conducted in Vienna, what were the roles and contributions of the co-authors many of which did not work in Vienna? What were their conflicts of interest? Who financed this study?
I suggest that, in future, clinical trials of this nature are published in accordance with CONSORT guidelines. The re-publication of this trial makes it essential that all of these questions receive a full answer, if not, the reputation of the journal and its editorial board would suffer.
- 1 Frass M., Linkesch M., Resch G., Dielacher C., Löbl T., Endler C. et al. Adjunctive homeopathic treatment in patients with sever sepsis: a randomized, double-blind, placebo-controlled trial in an intensive care unit. Homeopathy 2011; 100: 95-100.