Effectiveness Not Established

Electronic Antinausea Device (ELANI)

for Chemotherapy-Induced Nausea and Vomiting—Adult

An electronic antinausea instrument is an apparatus that provides low-frequency electric stimulation percutaneously through a pulse generator that looks similar to a wristwatch. The pulse generated is transferred to the brain cortex via the median nerve in the wrist. The electric pulse is supposed to adjust a number of activities, including the central stimulation of nausea and vomiting in the brain. This type of device was studied in patients with cancer for its effect on chemotherapy-induced nausea and vomiting.

Research Evidence Summaries

Xiao, Y., Liu, J., Liu, Y.C., Huang, X.E., Guo, J.X., & Wei, W. (2014). Phase II study on EANI combined with hydrochloride palonosetron for prevention of chemotherapy-induced nausea and vomiting following highly emetogenic chemotherapy. Asian Pacific Journal of Cancer Prevention, 15, 3951–3954.

Study Purpose

To evaluate the effects of an electronic antinausea instrument (EANI) combined with hydrochloride palonosetron versus hydrochloride palonosetron alone on nausea and vomiting during the administration of highly emetogenic chemotherapy

Intervention Characteristics/Basic Study Process

The treatment group received 0.25 mg of hydrochloride palonosetron injected five minutes before chemotherapy while wearing an EANI (no report of how long the patients wore the instrument). The control group received 0.25 mg of hydrochloride palonosetron injected five minutes before chemotherapy alone.

Sample Characteristics

  • N = 120 (60 in control, 60 in treatment)
  • AGE RANGE = 23–74 years (no sample characteristics provided)
  • MALES: Not reported, FEMALES: Not reported
  • KEY DISEASE CHARACTERISTICS: Not reported
  • OTHER KEY SAMPLE CHARACTERISTICS: No sample characteristics were reported, but eligibility criteria included patients being treated with highly emetogenic chemotherapy (adriamycin, cisplatin, and epirubicin) with no nausea or vomiting 24 hours before chemotherapy.

Setting

  • SITE: Not stated
  • SETTING TYPE: Not specified    
  • LOCATION: People’s Hospital of Taixing City, China

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

Randomized, controlled trial

Measurement Instruments/Methods

  • Vomiting degree was measured and reported as 0 (no vomiting), 1 (one to two emesis events per day), 2 (three to five emesis events per day), or 3 (greater than five emesis events per day).
  • Nausea level was measured and reported as 0 (no change), 1 (no change in eating), 2 (obvious reduction in food intake), or 3 (couldn't eat and needed IV nutritional support).  
  • Response rate was defined as the degree of vomiting plus the level of nausea divided by the total number of cases.
  • There was no report of who recorded nausea and vomiting or how often.

Results

There was a significant difference in the response rate for nausea (90% response in treatment group and 76.7% response in control group, p < 0.05), and there was a significant difference in the response rate for vomiting (95% response in treatment group and 78.3% response in control group, p < 0.05). No significant differences in adverse reactions between the groups and no severe adverse reactions were reported.

Conclusions

The use of an electronic antinausea instrument along with hydrochloride palonosetron appeared to be more effective than hydrochloride palonosetron alone for the treatment of acute nausea and vomiting associated with highly emetogenic chemotherapy.

Limitations

  • Risk of bias (no blinding)
  • Risk of bias (no appropriate attentional control condition)
  • Measurement/methods not well described
  • Measurement validity/reliability questionable
  • Other limitations/explanation: The study lacked a great deal of information, which calls into question its validity. There was no information how the randomization was performed, no information on sample characteristics was provided, no information on the EANI device was given, vomiting and nausea classifications were not validated, who determined the vomiting and nausea classifications for each patient was not stated, and there was no report of a statistical analysis. Adverse reactions were reported in the results but were not part of the purpose statement, and it was not described how the information was obtained.

Nursing Implications

Electronic antinausea instruments may be effective for treating chemotherapy-induced nausea and vomiting, but additional studies are needed to confirm these findings.

Print