RESUMO
PURPOSE: Nausea and vomiting complicating chemotherapy (CINV) remain side effects despite preventive and curative treatments. We hypothesize that acupuncture (ACU), auriculotherapy (AUR), and their combination (ACU-AUR), could decrease, compared to usual treatment (UT), the intensity of acute nausea in patients already treated according to the antiemetic guidelines and presenting nausea with or without vomiting in the earlier cycle. METHODS: In this multicenter study, patients were treated just before chemotherapy according to randomization. ACU consisted of implanting bilaterally on each forearm, one semi-permanent needle at point P6. AUR consisted of implanting bilaterally on each pavilion of the ear, one semi-permanent needle at point O. All patients received systematic preventive drug treatment according to antiemetic guidelines. Main outcome was intensity of nausea at 24 h after chemotherapy using a numeric scale ranging from 0 (no nausea) to 10 (maximum symptoms). RESULTS: One hundred and fifteen patients were included. Baseline characteristics were similar between groups at inclusion. Intensity of nausea at 24 h after chemotherapy, was statistically different between the groups (covariance intergroup analysis, p = 0.005) and was significantly lower for the all-treatment groups vs UT group (p = 0.007 for AUR, p = 0.008 for ACU, and p = 0.0009 for AUR-ACU). AUR-ACU also decreased intensity of delayed nausea when compared to UT (p = 0.023). AUR, ACU and AUR-ACU had no effect on acute and delayed vomiting episodes. No serious adverse event due to the studied treatments was reported in our study. CONCLUSION: AUR or ACU reduce intensity of acute and delayed nausea in patients treated by optimal antiemetic treatment. CLINICALTRIALS: gov identifier NCT02767791, registered on May 10, 2016.