Efficacy and safety of electroacupuncture with different acupoints for chemotherapy-induced nausea and vomiting: study protocol for a randomized controlled trial

Abstract

Background: Many patients experience nausea and vomiting during chemotherapy treatment. Evidence demonstrates that electroacupuncture is beneficial for controlling chemotherapy-induced nausea and vomiting (CINV). However, the acupoint or matching acupoint with the best efficacy for controlling CINV still remains unidentified.

Methods/design: This study consists of a randomized controlled trial (RCT) with four parallel arms: a control group and three electroacupuncture groups (one with Neiguan (PC6), one with Zhongwan (CV12), and one with both PC6 and CV12). The control group received standard antiemetic only, while the other three groups received electroacupuncture stimulation with different acupoints besides the standard antiemetic. The intervention is done once daily from the first day (day 1) to the fourth day (day 4) during chemotherapy treatment. The primary outcome measures include frequency of nausea, vomiting and retching. The secondary outcome measures are the grade of constipation and diarrhea, electrogastrogram, assessment of quality of life, assessment of anxiety and depression, and other adverse effects during the chemotherapy. Assessments are scheduled from one day pre-chemotherapy (day 0) to the fifth day of chemotherapy (day 5). Follow-ups are done from day 6 to day 21.

Discussion: The aim of this study is to evaluate the efficacy and safety of electro-acupuncture with different acupoints in the management of CINV.

Trial registration: The register number of randomized controlled trial is NCT02195908 . The date of registration was 21 July 2014.

Figures

Figure 1

Flow diagram and schedule of enrollment, interventions, and assessments. Assessed for eligibility with eligibility criteria during enrollment, the participants will be randomly divided among four arms: the control group is supplied with a pharmaceutical antiemetic, and the other three arms consist of the antiemetic drug and one type of acupuncture (Neiguan (PC6) in one arm or Zhongwan (CV12) in another arm), and the antiemetic drug and both types of acupuncture in the remaining arm. The treatment is scheduled to occur within 30 to 60 min before chemotherapy infusion for 4 days. All assessments will be scheduled from the day before chemotherapy to the fifth day of chemotherapy, with follow-up in the next 15 days, followed by data collection and analysis.