Chris McKeon1, Caroline A Smith2, Kristen Gibbons3, Janet Hardy4. 1. Mater Health Services, Mater Cancer Care Centre, South Brisbane, Queensland, Australia. 2. National Institute of Complementary Medicine, University of Western Sydney, Campbelltown, Australia. 3. Data Management and Analysis Team, Mater Research Office, South Brisbane, Australia. 4. Palliative and Supportive Care, Mater Health Services, South Brisbane, Australia.
Abstract
OBJECTIVE: To assess the feasibility of undertaking a high-quality randomised controlled study to determine whether EA gives better control of delayed chemotherapy-induced nausea and vomiting (CINV) than sham EA or standard antiemetic treatment alone. METHODS:Patients having their first cycle of moderately or highly emetogenic chemotherapy were randomised to EA, sham EA or standard care. EA was given for 30 min on day 1 at the time of chemotherapy and on day 3 using standard acupuncture points bilaterally. Sham EA was given to points adjacent to true EA points. All patients received usual care, comprising antiemetics, according to hospital guidelines. The primary outcomes related to study feasibility, and the clinical outcome measure was the change in Functional Living Index Emesis (FLIE) score captured on days 1 and 7. RESULTS:153 participants were screened between April 2009 and May 2011. Eighteen patients did not meet the inclusion criteria, 37 declined to participate and the absence of an acupuncturist or lack of consent from the treating oncologist excluded a further 38 patients; 60 patients were recruited. The FLIE was completed on day 7 by 49 participants; 33 of 40 patients returned on day 3 for treatment. The nausea and vomiting scores were low in all three arms. Adverse events were generally mild and infrequent. CONCLUSIONS: It was feasible to undertake a randomised EA trial on a busy day oncology unit. As few patients experienced nausea with their first cycle of chemotherapy, it was not possible to determine whether EA improves CINV over standard care. An enriched enrolment strategy is indicated for future studies. A simple numerical rating scale may prove a better objective nausea measure than the FLIE. TRIAL REGISTRATION NUMBER: ACTRN12609001054202. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
RCT Entities:
OBJECTIVE: To assess the feasibility of undertaking a high-quality randomised controlled study to determine whether EA gives better control of delayed chemotherapy-induced nausea and vomiting (CINV) than sham EA or standard antiemetic treatment alone. METHODS:Patients having their first cycle of moderately or highly emetogenic chemotherapy were randomised to EA, sham EA or standard care. EA was given for 30 min on day 1 at the time of chemotherapy and on day 3 using standard acupuncture points bilaterally. Sham EA was given to points adjacent to true EA points. All patients received usual care, comprising antiemetics, according to hospital guidelines. The primary outcomes related to study feasibility, and the clinical outcome measure was the change in Functional Living Index Emesis (FLIE) score captured on days 1 and 7. RESULTS: 153 participants were screened between April 2009 and May 2011. Eighteen patients did not meet the inclusion criteria, 37 declined to participate and the absence of an acupuncturist or lack of consent from the treating oncologist excluded a further 38 patients; 60 patients were recruited. The FLIE was completed on day 7 by 49 participants; 33 of 40 patients returned on day 3 for treatment. The nausea and vomiting scores were low in all three arms. Adverse events were generally mild and infrequent. CONCLUSIONS: It was feasible to undertake a randomised EA trial on a busy day oncology unit. As few patients experienced nausea with their first cycle of chemotherapy, it was not possible to determine whether EA improves CINV over standard care. An enriched enrolment strategy is indicated for future studies. A simple numerical rating scale may prove a better objective nausea measure than the FLIE. TRIAL REGISTRATION NUMBER: ACTRN12609001054202. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
Authors: Chi Hoon Maeng; Seunghoon Lee; Jae Joon Han; Hong Jun Kim; Dongwoo Nam; Junhee Lee; Sun Kyung Baek Journal: Evid Based Complement Alternat Med Date: 2022-04-05 Impact factor: 2.629
Authors: Gabriel Tavares Garcia; Robson Fonseca Ribeiro; Isabella Boechat Faria Santos; Fabiana de Campos Gomes; João Simão de Melo-Neto Journal: Med Acupunct Date: 2021-02-16