Effect of Poloxamer 188 vs Placebo on Painful Vaso-Occlusive Episodes in Children and Adults With Sickle Cell Disease: A Randomized Clinical Trial

SPS commentary:

A related editorial reviews the evidence for this nonionic linear copolymer which reduces blood viscosity, and refers to a previous study performed in 2001 which found a statistically significant reduction in the duration of the vaso-occlusive episodes with poloxamer 188 vs placebo.

The editorial highlights that the study published here was completed 5 years ago and is much older than the randomised clinical trials that this journal usually publishes, and goes on to describe why it decided to report it.  The company that had rights to the trial were not interested in publishing the results and the data were no longer available to the investigators. Although it took several years, ultimately one of the investigators reported that he was able to use his own resources to allow completion of the analysis, an important and noteworthy commitment to the scientific process.  The editorial notes that results of studies, especially clinical trials that are time and resource intensive, should be published in a peer-reviewed journal, regardless of whether the outcomes were positive or negative. The results of clinical trials should not be discarded because of financial interests, disinterest, or shift in priorities on the part of the funders. Not publishing negative results can lead to research duplication, as well as waste of the resources committed to the trial. In addition, individuals participate in research expecting that their efforts will contribute to the base of knowledge, and it is unfair and perhaps unethical to disregard the data and findings based on their participation in studies