Matthews Anne, Haas David M, O'Mathúna Dónal P, Dowswell Therese
School of Nursing and Human Sciences, Dublin City University, Collins Avenue, Dublin, Ireland, 9.
Cochrane Database Syst Rev. 2015 Sep 8;2015(9):CD007575. doi: 10.1002/14651858.CD007575.pub4.
Nausea, retching and vomiting are very commonly experienced by women in early pregnancy. There are considerable physical, social and psychological effects on women who experience these symptoms. This is an update of a review of interventions for nausea and vomiting in early pregnancy last published in 2014.
To assess the effectiveness and safety of all interventions for nausea, vomiting and retching in early pregnancy, up to 20 weeks' gestation.
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register, the Cochrane Complementary Medicine Field's Trials Register (19 January 2015) and reference lists of retrieved studies.
All randomised controlled trials of any intervention for nausea, vomiting and retching in early pregnancy. We excluded trials of interventions for hyperemesis gravidarum, which are covered by another Cochrane review. We also excluded quasi-randomised trials and trials using a cross-over design.
Four review authors, in pairs, reviewed the eligibility of trials and independently evaluated the risk of bias and extracted the data for included trials.
Forty-one trials involving 5449 women, met the inclusion criteria. These trials covered many interventions, including acupressure, acustimulation, acupuncture, ginger, chamomile, lemon oil, mint oil, vitamin B6 and several antiemetic drugs. There were no included studies of dietary and other lifestyle interventions. Evidence regarding the effectiveness of P6 acupressure, auricular (ear) acupressure and acustimulation of the P6 point was limited. Acupuncture (P6 or traditional) showed no significant benefit to women in pregnancy. The use of ginger products may be helpful to women, but the evidence of effectiveness was limited and not consistent, though three recent studies support ginger over placebo. There was only limited evidence from trials to support the use of pharmacological agents including vitamin B6, Doxylamine-pyridoxoine and other anti-emetic drugs to relieve mild or moderate nausea and vomiting. There was little information on maternal and fetal adverse outcomes and on psychological, social or economic outcomes.We were unable to pool findings from studies for most outcomes due to heterogeneity in study participants, interventions, comparison groups, and outcomes measured or reported. The methodological quality of the included studies was mixed. Risk of bias was low related to performance bias, detection bias and attrition bias for most studies. Selection bias risk was unclear for many studies and almost half of the studies did not fully or clearly report all pre-specified outcomes.
AUTHORS' CONCLUSIONS: Given the high prevalence of nausea and vomiting in early pregnancy, women and health professionals need clear guidance about effective and safe interventions, based on systematically reviewed evidence. There is a lack of high-quality evidence to support any particular intervention. This is not the same as saying that the interventions studied are ineffective, but that there is insufficient strong evidence for any one intervention. The difficulties in interpreting and pooling the results of the studies included in this review highlight the need for specific, consistent and clearly justified outcomes and approaches to measurement in research studies.
恶心、干呕和呕吐是孕期女性早期常见的症状。这些症状会对女性产生相当大的身体、社会和心理影响。这是对2014年最后一次发表的关于孕期恶心和呕吐干预措施综述的更新。
评估孕期20周内所有针对恶心、呕吐和干呕干预措施的有效性和安全性。
我们检索了Cochrane妊娠与分娩组试验注册库、Cochrane补充医学领域试验注册库(2015年1月19日)以及检索到的研究的参考文献列表。
所有关于孕期恶心、呕吐和干呕任何干预措施的随机对照试验。我们排除了妊娠剧吐干预措施的试验,该内容由另一篇Cochrane综述涵盖。我们还排除了半随机试验和采用交叉设计的试验。
四位综述作者两两一组,审查试验的纳入资格,并独立评估偏倚风险,提取纳入试验的数据。
41项试验涉及5449名女性,符合纳入标准。这些试验涵盖了许多干预措施,包括指压、声刺激、针灸、生姜、洋甘菊、柠檬油、薄荷油、维生素B6以及几种止吐药物。没有关于饮食和其他生活方式干预措施的纳入研究。关于内关穴指压、耳穴(耳部)指压和声刺激内关穴有效性的证据有限。针灸(内关穴或传统针灸)对孕期女性无显著益处。使用生姜制品可能对女性有帮助,但有效性证据有限且不一致,不过最近三项研究表明生姜优于安慰剂。试验中仅有有限证据支持使用包括维生素B6、多西拉敏 - 吡哆醇和其他止吐药物在内的药物来缓解轻度或中度恶心和呕吐。关于母婴不良结局以及心理、社会或经济结局的信息很少。由于研究参与者、干预措施、对照组以及测量或报告的结局存在异质性,我们无法对大多数结局进行研究结果合并。纳入研究的方法学质量参差不齐。大多数研究在执行偏倚、检测偏倚和失访偏倚方面的偏倚风险较低。许多研究的选择偏倚风险不明确,几乎一半的研究未完整或清晰报告所有预先设定的结局。
鉴于孕期恶心和呕吐的高发生率,女性和健康专业人员需要基于系统综述的证据,获得关于有效和安全干预措施的明确指导。缺乏高质量证据支持任何特定干预措施。这并非意味着所研究的干预措施无效,而是没有足够有力的证据支持任何一种干预措施。解释和合并本综述中纳入研究结果的困难凸显了研究中需要特定、一致且理由充分的结局及测量方法。