Dataset Information

PC6 acupoint stimulation for the prevention of postcardiac surgery nausea and vomiting: a protocol for a two-group, parallel, superiority randomised clinical trial.

ABSTRACT:

Introduction

Postoperative nausea and vomiting (PONV) are frequent but unwanted complications for patients following anaesthesia and cardiac surgery, affecting at least a third of patients, despite pharmacological treatment. The primary aim of the proposed research is to test the efficacy of PC6 acupoint stimulation versus placebo for reducing PONV in cardiac surgery patients. In conjunction with this we aim to develop an understanding of intervention fidelity and factors that support, or impede, the use of PC6 acupoint stimulation, a knowledge translation approach.

Methods and analysis

712 postcardiac surgery participants will be recruited to take part in a two-group, parallel, superiority, randomised controlled trial. Participants will be randomised to receive a wrist band on each wrist providing acupressure to PC six using acupoint stimulation or a placebo. Randomisation will be computer generated, use randomly varied block sizes, and be concealed prior to the enrolment of each patient. The wristbands will remain in place for 36?h. PONV will be evaluated by the assessment of both nausea and vomiting, use of rescue antiemetics, quality of recovery and cost. Patient satisfaction with PONV care will be measured and clinical staff interviewed about the clinical use, feasibility, acceptability and challenges of using acupressure wristbands for PONV.

Ethics and dissemination

Ethics approval will be sought from appropriate Human Research Ethics Committee/s before start of the study. A systematic review of the use of wrist acupressure for PC6 acupoint stimulation reported minor side effects only. Study progress will be reviewed by a Data Safety Monitoring Committee (DSMC) for nausea and vomiting outcomes at n=350. Dissemination of results will include conference presentations at national and international scientific meetings and publications in peer-reviewed journals. Study participants will receive a one-page lay-summary of results.

Trial registration number

Australian New Zealand Clinical Trials Registry--ACTRN12614000589684.

SUBMITTER: Cooke M

PROVIDER: S-EPMC4244418 | biostudies-literature | 2014 Nov

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

PC6 acupoint stimulation for the prevention of postcardiac surgery nausea and vomiting: a protocol for a two-group, parallel, superiority randomised clinical trial.

Cooke Marie M Rickard Claire C Rapchuk Ivan I Shekar Kiran K Marshall Andrea P AP Comans Tracy T Doi Suhail S McDonald John J Spooner Amy A

BMJ open 20141113 11

<h4>Introduction</h4>Postoperative nausea and vomiting (PONV) are frequent but unwanted complications for patients following anaesthesia and cardiac surgery, affecting at least a third of patients, despite pharmacological treatment. The primary aim of the proposed research is to test the efficacy of PC6 acupoint stimulation versus placebo for reducing PONV in cardiac surgery patients. In conjunction with this we aim to develop an understanding of intervention fidelity and factors that support, o ...[more]

PMID: 25394818

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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:ImportancePostoperative nausea and vomiting (PONV) gives patients a bad experience and negates their good recovery from surgery.ObjectiveThis trial aims to assess the preventive effectiveness of transcutaneous electrical acupoint stimulation (TEAS) on the incidence of PONV in high-risk surgical patients.DesignThe large sample size, multicenter, evaluator-blinded, and randomized controlled study was conducted between September 3, 2019 to February 6, 2021.SettingThe 12 hospitals were from different Chinese provinces.ParticipantsAfter obtaining ethics approval and written informed consent, 1,655 patients with Apfel score ≥ 3 points were enrolled for selective laparoscopic non-gastrointestinal surgery under general anesthesia.InterventionsPatients were randomly allocated into the TEAS and Sham group with a 1:1 ratio. The TEAS group was stimulated on bilateral Neiguan and Zusanli acupoints after recovery from anesthesia on the surgical day and the next morning for 30 min, while the Sham group received an identical setting as TEAS but without currents delivered. Electronic patient self-reported scale was used to evaluate and record the occurrence of PONV.Main outcomes and measuresPrimary clinical end point is the incidence of PONV which was defined as at least one incidence of nausea, retching, or vomiting after operation within postoperative 24 h.ResultsCompared with the Sham treatment, the TEAS lowered the PONV incidence by 4.8% (29.4 vs. 34.2%, P = 0.036) and vomiting incidence by 7.4% (10.4 vs. 17.8%, P < 0.001). TEAS also lowered persistent nausea incidence and PONV scores and decreased PONV related complications and Quality of Recovery-40 scores (P < 0.05). TEAS lowered the 24 h PONV risk by 20% (OR, 0.80, 95% CI, 0.65 -0.98; P = 0.032), and lowered hazard ratio by 17% (HR, 0.83, 95% CI, 0.70-0.99; P = 0.035). Both TEAS and palonosetron were the independent PONV risk protective factors for 24 h PONV incidence and cumulative PONV incidence. The combination of TEAS and palonosetron was the most effective strategy to reduce the PONV incidence (P < 0.001).Conclusions and relevanceTEAS attenuated the PONV incidence and severity in high-risk surgical patients and may be applied clinically as a complement therapy to prevent PONV.Clinical trial registrationhttps://clinicaltrials.gov/ct2/show/NCT04043247, identifier: NCT04043247.

Project description:BACKGROUND:Postoperative nausea and vomiting (PONV) are common complications following surgery and anaesthesia. Drugs to prevent PONV are only partially effective. An alternative approach is to stimulate the P6 acupoint on the wrist. This is an update of a Cochrane review first published in 2004. OBJECTIVES:To determine the efficacy and safety of P6 acupoint stimulation in preventing PONV. SEARCH STRATEGY:We searched CENTRAL (The Cochrane Library, Issue 3, 2008), MEDLINE (January 1966 to September 2008), EMBASE (January 1988 to September 2008), ISI Web of Science (January 1965 to September 2008), the National Library of Medicine publication list of acupuncture studies, and reference lists of articles. SELECTION CRITERIA:All randomized trials of techniques that stimulated the P6 acupoint compared with sham treatment or drug therapy for the prevention of PONV. Interventions used in these trials included acupuncture, electro-acupuncture, transcutaneous nerve stimulation, laser stimulation, capsicum plaster, an acu-stimulation device, and acupressure in patients undergoing surgery. Primary outcomes were the risks of nausea and vomiting. Secondary outcomes were the need for rescue antiemetic therapy and adverse effects. DATA COLLECTION AND ANALYSIS:Two review authors independently assessed trial quality and extracted the data. We collected adverse effect information from the trials. We used a random-effects model and reported relative risk (RR) with associated 95% confidence intervals (95% CI). MAIN RESULTS:We included 40 trials involving 4858 participants; four trials reported adequate allocation concealment. Twelve trials did not report all outcomes. Compared with sham treatment P6 acupoint stimulation significantly reduced: nausea (RR 0.71, 95% CI 0.61 to 0.83); vomiting (RR 0.70, 95% CI 0.59 to 0.83), and the need for rescue antiemetics (RR 0.69, 95% CI 0.57 to 0.83). Heterogeneity among trials was moderate. There was no clear difference in the effectiveness of P6 acupoint stimulation for adults and children; or for invasive and noninvasive acupoint stimulation. There was no evidence of difference between P6 acupoint stimulation and antiemetic drugs in the risk of nausea (RR 0.82, 95% CI 0.60 to 1.13), vomiting (RR 1.01, 95% CI 0.77 to 1.31), or the need for rescue antiemetics (RR 0.82, 95% CI 0.59 to 1.13). The side effects associated with P6 acupoint stimulation were minor. There was no evidence of publication bias from contour-enhanced funnel plots. AUTHORS' CONCLUSIONS:P6 acupoint stimulation prevented PONV. There was no reliable evidence for differences in risks of postoperative nausea or vomiting after P6 acupoint stimulation compared to antiemetic drugs.

Dataset Information

PC6 acupoint stimulation for the prevention of postcardiac surgery nausea and vomiting: a protocol for a two-group, parallel, superiority randomised clinical trial.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

PC6 acupoint stimulation for the prevention of postcardiac surgery nausea and vomiting: a protocol for a two-group, parallel, superiority randomised clinical trial.

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