Electro-acupuncture versus sham electro-acupuncture versus standard care for acute and delayed chemotherapy-induced nausea and vomiting : a feasibility pilot study and acupuncture service evaluation in the day oncology unit

Abstract

The purpose of this study was to examine: the feasibility of conducting an efficacy trial of electro-acupuncture (EA) for chemotherapy-induced nausea and vomiting (CINV); the role of an acupuncture service in the day oncology unit on patients' wellbeing; and evaluate participants' perceptions of the service. CINV is managed by new state-of-the-art anti-emetics; however, 30 per cent of patients continue to experience CINV. These symptoms have a significant impact on their quality of life. A Cochrane Systematic Review 2006, identified the need for further study with acupuncture for CINV, particularly EA. Offering complementary medicine as supportive care for cancer patients who are undergoing conventional treatment is an emerging field; there is a need to establish a research basis for the benefits and risks, particularly from a patient-centred perspective.1-4 Patients attending for their first cycle of chemotherapy were randomised to one of three arms: EA plus standard care; sham EA plus standard care; or standard care alone. Treatment arms received acupuncture on the first day of chemotherapy, ten minutes prior to chemotherapy, and for total 30 minutes, returning in two days for another treatment. Acupuncture points used ST36, PC6, LV3 and LI4 bilaterally. The primary outcome was feasibility, time to recruit, percentage of follow up treatment, blinding effectiveness, and secondary endpoints with change in 'Functional Living Index Emesis' (FLIE) scores between Day one, four and seven, and nausea and vomiting scores. The sample size was 60 participants. An intention to treat analysis using the Kruskal-Wallis test (for non-parametric data) was done on the FLIE, nausea and vomiting scores. Patients using the acupuncture service were asked to participate in the evaluation. The evaluation was a pre- and post-test observational study, using the tool, MYCaW (Measure Yourself Concern and Wellness); a researcher developed the questionnaire. Questionnaires and MYCaW were completed prior to, and redone in four to six weeks after, at least two treatments. Sixty patients were recruited from 153, screened from April 2009 to May 2011. Feasibility was shown with some changes to recruitment timeframes, inclusion criteria and outcome measures for objectivity. The incidence of CINV was low in the first cycle chemotherapy and the number recruited was not large enough to show significant benefit. The change in the Functional Living Index Emesis (FLIE) score Day 1 to 7: standard care -1.02 (19.4), sham acupuncture -1.05 (21.6) and true acupuncture -3.36 (20.8) (median (interquartile range) p= 0.589), with no significant difference between groups. One-hundred-and-twelve patients were recruited from October 2011 to October 2012. Evaluation of the acupuncture service identified a positive response from patients in relation to the benefit, helpfulness and usefulness of the service. The majority of patients (73%) found the service worthwhile and would have liked the service to continue. The pre- and post-test observational tool, Measure Yourself Concerns and Wellness (MYCaW) showed a clinical and statistical significant improvement of patients' symptoms or concerns scores, 1.75 (p=

Date of Award	2014
Original language	English