When investigating the work of Dr. Yoshitaka Fujii, Toho University noted that 8/9 studies did not have appropriate ethics committee approval. A subsequent analysis by the Japanese Society of Anesthesiologists found that 172/212 studies were fabricated. Earlier this year in an editorial published in Anesthesia & Analgesia, Drs. Ashraf S. Habib and Tong J. Gan summarized the effect of Dr. Fujii’s work on the knowledge and management of postoperative nausea and vomiting. They concluded that though he did publish quite a bit, “the effect of his fraud on the management of PONV has been minimal. The lack of inclusion of his data in the current commonly used guidelines should minimize the effect of these retractions on the practice of PONV management, particularly in North America, where the SAMBA guidelines have been widely adopted.” In their article “Re-Evaluation of the Effectiveness of Ramosetron for Preventing Postoperative Nausea and Vomiting: A Systematic Review and Meta-Analysis” published in this month’s edition of Anesthesia & Analgesia, Dr. Takahiro Mihara, Department of Anesthesiology and Critical Care Medicine, Yokohama City University Graduate School of Medicine, Yokohama, Japan, and coauthors re-evaluated the effect of ramosetron without using Fujii’s data.
Fifteen trials written by Fujii were excluded. Ultimately, 12 studies met inclusion criteria for the meta-analysis. Based on 7 studies comparing the effectiveness of ramosetron with a placebo, ramosetron resulted in a significant reduction of both early and late postoperative nausea and postoperative vomiting. Based on 6 studies in which ramosetron was compared with a placebo, ramosetron resulted in a significant reduction in the need for both early and late rescue. Side effects after ramosetron were not different from the placebo group. When compared with ondansetron, ramosetron did not have a significant effect in reducing early or late postoperative nausea, though early and late postoperative vomiting were both significantly less. Need for rescue drug and side effects were both no different when ramosetron was compared with ondansetron.
Should ramosetron replace ondansetron? The answer is probably not. Both drugs are 5-HT3 receptor antagonists. Though vomiting is less with ramosetron, the clinical significance is questionable due to the large number needed to treat. Furthermore, without Fujii’s data, though differences are significant, they are less significant than if his data would have been included. Fortunately, Fujii’s fabrication was uncovered. Fuji, interestingly, holds the record for number of retractions by a single author.
OpenAnesthesia has a discussion on PONV.