Effect of an electronic antiemetic device (EAD) stimulating the Neiguan acupoint (PC6) on chemotherapy-induced nausea and vomiting in cancer patients: A randomised controlled trial.

OBJECTIVE

To assess the effectiveness of an electronic antiemetic device (EAD) stimulating the Neiguan acupoint (PC6) in preventing and alleviating chemotherapy-induced nausea and vomiting (CINV) in cancer patients, with a particular focus on delayed-phase CINV. The safety of the device was also assessed.

METHODS

126 cancer patients who were scheduled to undergo chemotherapy that was either moderately or highly emetogenic were enrolled in this single-centre, randomised controlled experiment. Block randomisation was used to allocate participants in a 1:1 ratio to either the control group (ondansetron alone) or the experimental group (EAD plus ondansetron). The experimental group received EAD stimulation at the PC6 prior to chemotherapy and continued its use throughout the entire chemotherapy cycle, in addition to ondansetron, whereas the control group received only ondansetron. The complete response rate (CRR) and no emesis rate of acute and delayed CINV, symptom severity, quality of life (QoL), and the incidence of adverse events were assessed.

RESULTS

In the intention-to-treat population (n = 126), no significant differences were observed for acute nausea (CRR: ARR = 9.5%, 95% CI -1.0 to 20.0, P = 0.076; no emesis rate: ARR = 11.1%, 95% CI -0.5 to 22.7, P = 0.061). However, the experimental group had significantly higher delayed nausea CRR (ARR = 44.4%, 95% CI 29.8 to 59.1, P < 0.001) and delayed vomiting no emesis rate (ARR = 12.7%, 95% CI 1.2 to 24.2, P = 0.031). FLIE scores were higher in the experimental group during both acute (MD = 10.0, 95% CI -3.5 to 23.5, P = 0.146) and delayed phases (MD = 30.1, 95% CI 18.5 to 41.5, P < 0.001). The incidence of several gastrointestinal and systemic adverse events (CTCAE Grade≥2) was also lower in the experimental group (all P < 0.05).

CONCLUSION

Stimulation of the PC6 with an EAD significantly alleviates delayed CINV and lowers the incidence of adverse events, although its efficacy on acute CINV is less pronounced. These findings require validation in blinded, multicentre trials.