Lee Anna, Chan Simon K C, Fan Lawrence T Y
Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, New Territories, Hong Kong.
Cochrane Database Syst Rev. 2015 Nov 2;2015(11):CD003281. doi: 10.1002/14651858.CD003281.pub4.
Postoperative nausea and vomiting (PONV) are common complications following surgery and anaesthesia. Antiemetic drugs are only partially effective in preventing PONV. An alternative approach is to stimulate the PC6 acupoint on the wrist. This is an update of a Cochrane review first published in 2004, updated in 2009 and now in 2015.
To determine the effectiveness and safety of PC6 acupoint stimulation with or without antiemetic drug versus sham or antiemetic drug for the prevention of PONV in people undergoing surgery.
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (Cochrane Library, Issue 12, 2014), MEDLINE (January 2008 to December 2014), EMBASE (January 2008 to December 2014), ISI Web of Science (January 2008 to December 2014), World Health Organization Clinical Trials Registry, ClinicalTrials.gov, and reference lists of articles to identify additional studies. We applied no language restrictions.
All randomized trials of techniques that stimulated the PC6 acupoint compared with sham treatment or drug therapy, or combined PC6 acupoint and drug therapy compared to drug therapy, for the prevention of PONV. Interventions used in these trials included acupuncture, electro-acupuncture, transcutaneous electrical acupoint stimulation, transcutaneous nerve stimulation, laser stimulation, capsicum plaster, acu-stimulation device, and acupressure in people undergoing surgery. Primary outcomes were the incidences of nausea and vomiting after surgery. Secondary outcomes were the need for rescue antiemetic therapy and adverse effects.
Two review authors independently extracted the data and assessed the risk of bias domains for each trial. We used a random-effects model and reported risk ratio (RR) with associated 95% confidence interval (95% CI). We used trial sequential analyses to help provide information on when we had reached firm evidence in cumulative meta-analyses of the primary outcomes, based on a 30% risk ratio reduction in PONV.
We included 59 trials involving 7667 participants. We rated two trials at low risk of bias in all domains (selection, attrition, reporting, blinding and other). We rated 25 trials at high risk in one or more risk-of-bias domains. Compared with sham treatment, PC6 acupoint stimulation significantly reduced the incidence of nausea (RR 0.68, 95% CI 0.60 to 0.77; 40 trials, 4742 participants), vomiting (RR 0.60, 95% CI 0.51 to 0.71; 45 trials, 5147 participants) and the need for rescue antiemetics (RR 0.64, 95% CI 0.55 to 0.73; 39 trials, 4622 participants). As heterogeneity among trials was substantial and there were study limitations, we rated the quality of evidence as low. Using trial sequential analysis, the required information size and boundary for benefit were reached for both primary outcomes.PC6 acupoint stimulation was compared with six different types of antiemetic drugs (metoclopramide, cyclizine, prochlorperazine, droperidol. ondansetron and dexamethasone). There was no difference between PC6 acupoint stimulation and antiemetic drugs in the incidence of nausea (RR 0.91, 95% CI 0.75 to 1.10; 14 trials, 1332 participants), vomiting (RR 0.93, 95% CI 0.74 to 1.17; 19 trials, 1708 participants), or the need for rescue antiemetics (RR 0.87, 95% CI 0.65 to 1.16; 9 trials, 895 participants). We rated the quality of evidence as moderate, due to the study limitations. Using trial sequential analyses, the futility boundary was crossed before the required information size was surpassed for both primary outcomes.Compared to antiemetic drugs, the combination of PC6 acupoint stimulation and antiemetic therapy reduced the incidence of vomiting (RR 0.56, 95% CI 0.35 to 0.91; 9 trials, 687 participants) but not nausea (RR 0.79, 95% CI 0.55 to 1.13; 8 trials, 642 participants). We rated the quality of evidence as very low, due to substantial heterogeneity among trials, study limitations and imprecision. Using trial sequential analysis, none of the boundaries for benefit, harm or futility were crossed for PONV. The need for rescue antiemetic was lower in the combination PC6 acupoint stimulation and antiemetic group than the antiemetic group (RR 0.61, 95% CI 0.44 to 0.86; 5 trials, 419 participants).The side effects associated with PC6 acupoint stimulation were minor, transient and self-limiting (e.g. skin irritation, blistering, redness and pain) in 14 trials. Publication bias was not apparent in the contour-enhanced funnel plots.
AUTHORS' CONCLUSIONS: There is low-quality evidence supporting the use of PC6 acupoint stimulation over sham. Compared to the last update in 2009, no further sham comparison trials are needed. We found that there is moderate-quality evidence showing no difference between PC6 acupoint stimulation and antiemetic drugs to prevent PONV. Further PC6 acupoint stimulation versus antiemetic trials are futile in showing a significant difference, which is a new finding in this update. There is inconclusive evidence supporting the use of a combined strategy of PC6 acupoint stimulation and antiemetic drug over drug prophylaxis, and further high-quality trials are needed.
术后恶心呕吐(PONV)是手术和麻醉后常见的并发症。止吐药物在预防PONV方面仅部分有效。另一种方法是刺激手腕上的内关穴(PC6)。这是Cochrane系统评价的更新版,该评价首次发表于2004年,2009年进行了更新,现于2015年再次更新。
确定在接受手术的患者中,单独或联合使用止吐药物刺激PC6穴位与假刺激或止吐药物相比,预防PONV的有效性和安全性。
我们检索了Cochrane对照试验中央注册库(CENTRAL)(Cochrane图书馆,2014年第12期)、MEDLINE(2008年1月至2014年12月)、EMBASE(2008年1月至2014年12月)、ISI科学网(2008年1月至2014年12月)、世界卫生组织临床试验注册库、ClinicalTrials.gov以及文章的参考文献列表,以识别其他研究。我们未设语言限制。
所有将刺激PC6穴位的技术与假治疗或药物治疗进行比较,或PC6穴位与药物联合治疗与药物治疗进行比较以预防PONV的随机试验。这些试验中使用的干预措施包括针灸、电针、经皮穴位电刺激、经皮神经刺激、激光刺激、辣椒贴剂、穴位刺激装置以及对接受手术患者的指压按摩。主要结局是术后恶心和呕吐的发生率。次要结局是急救止吐治疗的需求和不良反应。
两位综述作者独立提取数据,并评估每个试验的偏倚风险领域。我们使用随机效应模型,并报告风险比(RR)及相关的95%置信区间(95%CI)。我们使用试验序贯分析来帮助提供信息,说明在主要结局的累积Meta分析中何时获得了确凿证据,基于PONV风险比降低30%。
我们纳入了59项试验,涉及7667名参与者。我们将两项试验在所有领域(选择、失访、报告、盲法和其他)的偏倚风险评为低。我们将25项试验在一个或多个偏倚风险领域评为高。与假治疗相比,刺激PC6穴位显著降低了恶心发生率(RR 0.68,95%CI 0.60至0.77;40项试验,4742名参与者)、呕吐发生率(RR 0.60,95%CI 0.51至0.71;45项试验,5147名参与者)以及急救止吐药物的需求(RR 0.64,95%CI 0.55至0.73;39项试验,4622名参与者)。由于试验间异质性较大且存在研究局限性,我们将证据质量评为低。使用试验序贯分析,两个主要结局均达到了所需的信息量和获益边界。将刺激PC6穴位与六种不同类型的止吐药物(胃复安、赛克利嗪、异丙嗪、氟哌利多、昂丹司琼和地塞米松)进行比较。刺激PC6穴位与止吐药物在恶心发生率(RR 0.91,95%CI 0.75至1.10;14项试验,1332名参与者)、呕吐发生率(RR 0.93,95%CI 0.74至1.17;19项试验,1708名参与者)或急救止吐药物需求(RR 0.87,95%CI 0.65至1.16;9项试验,895名参与者)方面没有差异。由于研究局限性,我们将证据质量评为中等。使用试验序贯分析,在两个主要结局超过所需信息量之前,已越过无效边界。与止吐药物相比,PC6穴位刺激与止吐治疗联合使用降低了呕吐发生率(RR 0.56,95%CI 0.35至0.91;9项试验,687名参与者),但未降低恶心发生率(RR 0.79,95%CI 0.55至1.13;8项试验,642名参与者)。由于试验间异质性大、研究局限性和不精确性,我们将证据质量评为非常低。使用试验序贯分析,PONV的获益、危害或无效边界均未越过。PC6穴位刺激与止吐药物联合组的急救止吐药物需求低于止吐药物组(RR 0.61,95%CI 0.44至0.86;5项试验,419名参与者)。在14项试验中,与PC6穴位刺激相关的副作用轻微、短暂且为自限性(如皮肤刺激、水疱、发红和疼痛)。在轮廓增强漏斗图中未显示明显的发表偏倚。
有低质量证据支持使用PC6穴位刺激而非假刺激。与2009年的上次更新相比,无需进一步进行与假刺激的比较试验。我们发现有中等质量证据表明,在预防PONV方面,PC6穴位刺激与止吐药物之间没有差异。进一步比较PC6穴位刺激与止吐药物的试验显示出显著差异是徒劳的,这是本次更新中的一个新发现。对于支持使用PC6穴位刺激与止吐药物联合策略而非药物预防,证据尚无定论,需要进一步的高质量试验。