Despite effective therapies such as the 5-HT3 receptor antagonists (e.g., ondansetron) and NK1 receptor antagonists (e.g., aprepitant), chemotherapy-induced nausea and vomiting (CINV) can often be difficult to manage. Therapies such as auricular acupressure (AA) may have a complementary role and may add to the beneficial effect of pharmacologic therapy. However, evidence on the effects of AA is inconclusive since many of these trials are plagued by methodological issues.
Investigators developed and evaluated an evidence-based program to assess the effect of AA in managing CINV and on quality of life (QOL) of patients undergoing chemotherapy.
Using a three-arm, sham-controlled randomized, controlled trial, researchers conducted a pilot study comparing true AA, sham AA, and a standard-care group. Female patients with BC in stages I through III without distant metastases were eligible for inclusion in this study if they were chemotherapy-and auricular therapy–naïve; if they spoke Mandarin Chinese; if they could tolerate standard antiemetics, including the 5-HT3 receptor antagonists and/or dexamethasone; and if they were scheduled to receive their first cycle of chemotherapy with a moderately high or highly emetogenic therapy. Patients were excluded if they were immunocompromised or frail; unable to follow directions; were undergoing radiation or other chemotherapy; had other health problems that may interfere with their CINV symptoms, such as gastrointestinal conditions, migraines, or tinnitus; or if they had ear problems and could not undergo AA. All patients received 5-HT3 receptor antagonists and/or dexamethasone antiemetic therapy prior to starting chemotherapy.
There was partial blinding between true AA and sham AA. True AA was conducted on seven recognized acupressure points based on established protocols. It was performed on Days 1 through 21 of the first chemotherapy cycle and consisted of positioning vaccaria seeds taped to the acupoints. Participants would press on the taped seeds to achieve a sensation of heaviness, soreness, distention, or tingling—also known as the deqi sensation. In the case of sham AA, the same acupoints were utilized but no pressure was applied, and the seeds were replaced with softer ones. In the true AA, patients were provided with a log to record their daily AA practice and to report any adverse events. The sham AA group only had to report adverse events in their log.
Assessment tools included the MASCC Antiemesis Tool (MAT) to evaluate acute and delayed CINV symptoms, the Functional Asssessment of Cancer Therapy-Breast to assess patients' QOL, and the Index of Nausea, Vomiting and Retching to determine the presence of anticipatory nausea and vomiting.
One-hundred and ten BC patients completed the study over a 15-month period. The retention rate was 96.5%. The average age of the group was 47.5 years. The investigators found that the true and sham AA groups had higher rates of complete response than the standard-care group, but the complete response rates between the true and sham AA groups were similar. Only the difference between the true AA group and the standard-care group for complete response of acute CINV achieved statistical significance following posthoc comparisons; this was marked by a medium-effect size (P = .01).
The occurrence of acute vomiting in the true AA was associated with a lower incidence than in the sham AA group, which was lower than in the standard group; however, the posthoc analysis showed only a statistically significant difference between the true AA group and the standard-care group (P = .01) Similarly, the mean score for the severity of acute nausea was much lower in the true AA group than in the sham AA group and the standard-care group; however, following the posthoc analysis, only the difference between the true AA and the standard-care group were significantly different.
The occurrence of delayed nausea was similar between the three groups. Both the true AA and the sham AA demonstrated significant differences in the occurrence of acute nausea, acute vomiting, and delayed vomiting compared with the standard-care group. Differences in the occurrence of delayed nausea were significant between the true AA group and the standard-care group.
Significant differences were observed in the MAT between the true AA and standard-care groups only. The occurrence of anticipatory nausea could not be adequately assessed due to too few patients who experienced this adverse event. There was no difference in QOL between the groups, although, there was evidence that QOL deteriorated after the first chemotherapy cycle. No serious adverse events occurred in any group.
The authors concluded that AA plus standard antiemetic therapy was more beneficial than the use of standard antiemetic treatment and care alone in managing CINV. AA was more effective in relieving acute CINV, especially acute nausea, compared with delayed CINV. However, the authors caution that there was a very large placebo effect, which actually reached clinical significance.
Pharmacists are frequently asked to advise on complementary interventions when pharmacologic therapy is not completely adequate. Despite its limitations, this paper helps pharmacist distinguish between the benefits of AA, the placebo effect, and the limitations of traditional methods of treating CINV.
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