Respiratory Medicine Unit, The Queen Elizabeth Hospital, Central Adelaide Local Health Network, Adelaide, Australia.
School of Medicine, The University of Adelaide, Adelaide, Australia.
Cochrane Database Syst Rev. 2021 May 17;5(5):CD001496. doi: 10.1002/14651858.CD001496.pub2.
Asthma and gastro-oesophageal reflux disease (GORD) are common medical conditions that frequently co-exist. GORD has been postulated as a trigger for asthma; however, evidence remains conflicting. Proposed mechanisms by which GORD causes asthma include direct airway irritation from micro-aspiration and vagally mediated oesophagobronchial reflux. Furthermore, asthma might precipitate GORD. Thus a temporal association between the two does not establish that GORD triggers asthma.
To evaluate the effectiveness of GORD treatment in adults and children with asthma, in terms of its benefits for asthma.
The Cochrane Airways Group Specialised Register, CENTRAL, MEDLINE, Embase, reference lists of articles, and online clinical trial databases were searched. The most recent search was conducted on 23 June 2020.
We included randomised controlled trials comparing treatment of GORD in adults and children with a diagnosis of both asthma and GORD versus no treatment or placebo.
A combination of two independent review authors extracted study data and assessed trial quality. The primary outcome of interest for this review was acute asthma exacerbation as reported by trialists.
The systematic search yielded a total of 3354 citations; 23 studies (n = 2872 participants) were suitable for inclusion. Included studies reported data from participants in 25 different countries across Europe, North and South America, Asia, Australia, and the Middle East. Participants included in this review had moderate to severe asthma and a diagnosis of GORD and were predominantly adults presenting to a clinic for treatment. Only two studies assessed effects of intervention on children, and two assessed the impact of surgical intervention. The remainder were concerned with medical intervention using a variety of dosing protocols. There was an uncertain reduction in the number of participants experiencing one or more moderate/severe asthma exacerbations with medical treatment for GORD (odds ratio 0.53, 95% confidence interval (CI) 0.17 to 1.63; 1168 participants, 2 studies; low-certainty evidence). None of the included studies reported data related to the other primary outcomes for this review: hospital admissions, emergency department visits, and unscheduled doctor visits. Medical treatment for GORD probably improved forced expiratory volume in one second (FEV₁) by a small amount (mean difference (MD) 0.10 L, 95% CI 0.05 to 0.15; 1333 participants, 7 studies; moderate-certainty evidence) as well as use of rescue medications (MD -0.71 puffs per day, 95% CI -1.20 to -0.22; 239 participants, 2 studies; moderate-certainty evidence). However, the benefit of GORD treatment for morning peak expiratory flow rate was uncertain (MD 6.02 L/min, 95% CI 0.56 to 11.47; 1262 participants, 5 studies). It is important to note that these mean improvements did not reach clinical importance. The benefit of GORD treatment for outcomes synthesised narratively including benefits of treatment for asthma symptoms, quality of life, and treatment preference was likewise uncertain. Data related to adverse events with intervention were generally underreported by the included studies, and those that were available indicated similar rates regardless of allocation to treatment or placebo.
AUTHORS' CONCLUSIONS: Effects of GORD treatment on the primary outcomes of number of people experiencing one or more exacerbations and hospital utilisation remain uncertain. Medical treatment for GORD in people with asthma may provide small benefit for a number of secondary outcomes related to asthma management. This review determined with moderate certainty that with treatment, lung function measures improved slightly, and use of rescue medications for asthma control was reduced. Further, evidence is insufficient to assess results in children, or to compare surgery versus medical therapy.
哮喘和胃食管反流病(GORD)是常见的医学病症,常同时存在。GORD 被认为是哮喘的诱因;然而,证据仍然存在争议。GORD 引起哮喘的机制包括微吸入引起的直接气道刺激和迷走神经介导的食管支气管反流。此外,哮喘也可能引发 GORD。因此,两者之间的时间关联并不能确定 GORD 引发哮喘。
评估 GORD 治疗对哮喘患者的有效性,即 GORD 治疗对哮喘的益处。
检索了 Cochrane Airways 组专业注册库、CENTRAL、MEDLINE、Embase、文章参考文献列表和在线临床试验数据库。最近一次检索是在 2020 年 6 月 23 日。
我们纳入了比较成人和儿童哮喘合并 GORD 诊断患者的 GORD 治疗与无治疗或安慰剂治疗的随机对照试验。
两名独立的综述作者结合提取了研究数据并评估了试验质量。本综述的主要结局是由试验人员报告的急性哮喘加重。
系统搜索共产生了 3354 条引用;23 项研究(n = 2872 名参与者)适合纳入。纳入的研究报告了来自 25 个不同国家/地区的参与者的数据,这些国家/地区分布在欧洲、北美和南美、亚洲、澳大利亚和中东。本综述纳入的参与者患有中重度哮喘和 GORD 诊断,主要是因治疗而到诊所就诊的成年人。只有两项研究评估了干预对儿童的影响,两项研究评估了手术干预的影响。其余研究均关注使用各种剂量方案的医学干预。与 GORD 的医学治疗相比,接受 GORD 治疗的参与者发生一次或多次中重度哮喘加重的人数减少,但这种减少的程度不确定(比值比 0.53,95%置信区间 0.17 至 1.63;1168 名参与者,2 项研究;低质量证据)。纳入的研究均未报告本综述其他主要结局的数据:住院、急诊就诊和非计划就诊。GORD 的医学治疗可能会略微改善用力呼气量(FEV₁)(平均差值 0.10 L,95%置信区间 0.05 至 0.15;1333 名参与者,7 项研究;中等质量证据)以及缓解药物的使用(平均差值 -0.71 吸/天,95%置信区间 -1.20 至 -0.22;239 名参与者,2 项研究;中等质量证据)。然而,GORD 治疗对清晨呼气峰值流速的获益不确定(平均差值 6.02 L/min,95%置信区间 0.56 至 11.47;1262 名参与者,5 项研究)。需要注意的是,这些平均改善程度没有达到临床意义。治疗对哮喘症状、生活质量和治疗偏好等综合结局的获益也不确定。纳入的研究一般未充分报告与干预相关的不良事件数据,而提供的数据表明,无论分配到治疗组还是安慰剂组,不良事件的发生率相似。
GORD 治疗对主要结局(即发生一次或多次加重的人数和住院使用率)的影响仍不确定。哮喘患者的 GORD 治疗可能对一些与哮喘管理相关的次要结局有一定益处。本综述确定,GORD 治疗可略微改善肺功能指标,减少哮喘控制的急救药物使用,且具有中等确定性证据。但仍不足以评估在儿童中的结果,或比较手术与药物治疗。