Acupressure for Chemotherapy Induced Nausea and Vomiting in Breast-Cancer Patients: A Randomized, Placebo-Controlled Clinical Trial

Introduction: Chemotherapy is an important treatment in cancer (CA) care and is associated with numerous side effects. Early studies reported that patients cited nausea and vomiting as the most distressing symptoms when receiving chemotherapy. Despite continuing improvements in antiemetic therapies, nausea and vomiting following chemotherapy treatment for CA remains a significant clinical problem for many patients and there is correlation between the intensity of anticipatory nausea in the clinic prior to their treatment infusion and subsequent post treatment of nausea and vomiting. Since pharmacological treatments have failed to completely manage nausea and vomiting, exploring the complementary, non-pharmacological, approaches that can be used in addition to pharmacological approaches becomes paramount. Acupressure at the P6 point is a value-added technique in addition to pharmaceutics; management for women undergoing treatment for breast cancer to reduce the incidence and intensity of delayed chemotherapy induced nausea and vomiting (CINV), since up to 60% of patients had been reported nausea despite the use of antiemetics Aims: The first aim is to examine the efficacy of P6-acupressure in preventing chemotherapy induced nausea and emesis associated with highly emetogenic chemotherapy (i.e. doxorubicin as adjuncts to standard 5-HT3 antiemetics (granisetron) and dexamethasone antiemetic given as part of routine care in reducing acute nausea (during the day of treatment) and delayed nausea (2-5 days) following the day of chemotherapy. The second aim is to examine the efficacy of the acupressure bands in reducing vomiting and in maintaining Quality of Life (QOL). Patients and methods: A randomised, double-blind, placebo controlled trial. One group received acupressure with bilateral stimulation of P6 (n=42), a second group received bilateral placebo stimulation, (n=42) and a third group received no acupressure wrist band and served as a control group, (n=42). Acupressure was applied using a Sea-Band (Sea- Band UK Ltd., Leicestershire, England) which had to wear for the 5 days following the chemotherapy administration. Assessments of acute and delayed nausea and emesis, OOL, patients' satisfaction, recommendation of treatment and requirement of rescue antiemetic were obtained. Results: No significant differences were found in the incidence of acute nausea or emesis 24- h following chemotherapy by treatment groups. Significant difference was found in the severity of early nausea (0-6 scale) in the acupressure group M (SD) 1.62 (2.04) as compared to placebo group 2.17 (2.09), p=, 0006. The acupressure group had a statistically significant reduction in the incidence of delayed nausea 40% (17/42) as compared to the control group 62% (26/42) (p= ,0495). Further analyses indicated that significant difference existed in the intensity of delayed nausea by acupressure group mean (SD) 1.45 (1.73), p=, 0002 as compared to control 2.03 (1.91). Significant difference also existed in the intensity of delayed nausea by placebo group 1.33 (1.66), p=, 0010 as compared to control 2.03 (1.91). Here we noted a placebo effect. The percentage of the patients who had delayed moderate to very severe nausea day 2-5 (≥3 on 0-6 scale) in the acupressure group is 55% (23/42 (p= 0206), in the placebo group 52% (22/42) (p= 0116), a statistically significant reduction existed as compared to control 79% (33/42). Here we noted a placebo effect. The incidence of delayed vomiting episodes day 2-5 was 48% (20/42), 64% (27/42), and 57% (24/42) in the acupressure, placebo and control group respectively. No significant differences were found between the groups. The mean of number of delayed emetic episodes day 2-5 was significantly less in the acupressure group 2.7 (1.87) as compared to placebo 3.3 (1.91), p=,0022 and control groups 2.07(1.20), P= ,0005. Requirement of rescue antiemetic was significantly lower in P6-acupressure (55%, 23/42), as compared to control group (76%, 32/42) (p= 0389). 81% (35/42)) of the patients in acupressure group were significantly satisfied with P6-acupressure as compared to placebo group 64% (27/42), p= 0.0471. 79% (34/42)) of the patients in acupressure group would recommend P6-acupressure to another patients as compared to placebo group 62% (26/42), p= 0,0533 . No statistically significant differences between groups were observed for the overall items response rate of the FACT-Scale which were 74/108, 67/108, 69/108 in the acupressure, placebo and control group respectively. Conclusion: P-6 Acupressure is efficacious for control of delayed chemotherapy related nausea and emesis and is a value-added method in addition to pharmaceutical management for women undergoing treatment for breast cancer. Placebo effect of acupressure decreased severity of delayed nausea day 2-5 but the mean of number of delayed emetic episodes and need of rescue antiemetics were reduced only by acupressure with the correct P6 point stimulation. Keywords: breast cancer, chemotherapy, nausea, vomiting, acupressure.