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

ABSTRACT: 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.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.The aim of this study is to evaluate the efficacy and safety of electro-acupuncture with different acupoints in the management of CINV.The register number of randomized controlled trial is NCT02195908 . The date of registration was 21 July 2014.

SUBMITTER: Chen B

PROVIDER: S-EPMC4445984 | biostudies-literature | 2015 May

REPOSITORIES: biostudies-literature

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

Chen Bo B Hu Shu-xiang SX Liu Bao-hu BH Zhao Tian-yi TY Li Bo B Liu Yan Y Li Ming-yue MY Pan Xing-fang XF Guo Yong-ming YM Chen Ze-lin ZL Guo Yi Y

Trials 20150512

<h4>Background</h4>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.<h4>Methods/design</h4>This study consists of a randomized controlled trial (RCT) with four parallel arms: a control group and three electroacupuncture groups (one wi ...[more]

PMID: 25963295

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Project description:BackgroundPatients suffering from chemotherapy-induced nausea and vomiting (CINV) might have negative adherence of treatment. Acupoint therapies, including acupuncture, acupressure, acupoints injection, massage, and moxibustion, are safe medical procedures with minimal side effects for CINV, but studies about overall safety and effectiveness of acupoint therapies have not been scientifically and methodically evaluated in recent years. Evaluating the overall safety and effectiveness of acupoint therapies in patients with CINV is the purpose of this review.Methods and analysisRelevant randomized controlled trials (RCTSs) are being searched in the following electronic databases: PubMed, Cochrane Library, Web of Science, EMBASE, China National Knowledge Infrastructure (CNKI), Chinese Scientific Journal Database (VIP database), Wanfang Data Knowledge Service Platform, and Chinese Biomedical Literature Database (CBM). We will also attempt to obtain the unpublished academic data by contacting the colleague, professor, or Institute of Traditional Chinese Medicine. The RCTs of the acupoint therapies for CINV patients will be searched in the databases from inception to July 2019. The primary outcomes are defined as severity, duration and frequency of nausea or vomiting, or both. The secondary outcomes are defined as any adverse events and quality of life. Performing the meta-analysis by using RevMan version 5 software. Mean difference (MD) or standardized mean difference (SMD) will express the continuous variables, while relative risk (RR) will express the categorical variables.ResultsThe results of this review will provide a high-quality synthesis to evaluate the effectiveness and safety of acupoint therapies for CINV.ConclusionThis review will provide evidence to estimate whether acupoint therapies are effective interventions for CINV.DisseminationEvidence whether acupoint therapies are effective interventions for CINV will be provided by this systematic review. This knowledge will recommend better acupoint therapies and selections of acupoints which might be helpful in treating CINV. The findings of this systematic review will be disseminated via various forms of presentation and publication of the data in a journal or electronic databases.Prospero registration numberCRD42019125538.

Project description:BackgroundDue to the worldwide rise in cancer incidence, and therefore the rise in the need for antineoplastic chemotherapy, it is important for both healthcare professionals and patients alike that the side effects of chemotherapy, such as chemotherapy-induced nausea and vomiting (CINV), are treated and prevented. Auriculotherapy is a type of acupuncture and may be a low-cost and safe antiemetic measure to control the side effects of chemotherapy. The goal of this systematic review is to synthesize the available evidence in the literature regarding the auriculotherapy effects to treat CINV in people with cancer.MethodsThe review will only include randomized controlled trials (RCTs) that compare the clinical effects of the auriculotherapy intervention (used alone or as an add-on), with sham auriculotherapy, routine treatment with antiemetic drugs, or other non-pharmacological interventions in patients with cancer with CINV who are undergoing chemotherapy. The outcomes to be evaluated are nausea and vomiting: in acute, delayed, or anticipated stages, when induced by chemotherapy. A comprehensive search for studies will be carried out in these databases: MEDLINE via PubMed, EMBASE, CINAHL, Cochrane Central Register of Controlled Trials, ICTRP, LILACS, CUMED, IBECS, BVS MTCI Americas, Web of Science, Scopus, PEDro, CNKI, and CBMdisc up until December 31, 2018. Only articles in English, Portuguese, and Spanish will be selected. Two independent reviewers will evaluate full texts, extract data, and assess the risk of bias of eligible articles. The quality of evidence will be assessed using Grading of Recommendations, Assessment, Development and Evaluation (GRADE). A meta-analysis will be undertaken to assess the interventions and outcomes' homogeneity, assessing statistical heterogeneity using the Cochran's Q test and quantified using Higgins' inconsistency index. If there is insufficient data for a meta-analysis, a narrative synthesis will be presented. This protocol has been prepared according to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) guidelines.DiscussionThe results of this systematic review will summarize the strength of evidence for the use of auriculotherapy in the control of CINV of patients with cancer and will be used to identify evidence gaps.Systematic review registrationPROSPERO CRD42018117513.

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

Publications

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

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