Head Karen, Snidvongs Kornkiat, Glew Simon, Scadding Glenis, Schilder Anne Gm, Philpott Carl, Hopkins Claire
Cochrane ENT, Nuffield Department of Surgical Sciences, University of Oxford, UK Cochrane Centre, Summertown Pavilion, 18 - 24 Middle Way, Oxford, UK.
Cochrane Database Syst Rev. 2018 Jun 22;6(6):CD012597. doi: 10.1002/14651858.CD012597.pub2.
Allergic rhinitis is a common condition affecting both adults and children. Patients experience symptoms of nasal obstruction, rhinorrhoea, sneezing and nasal itching, which may affect their quality of life.Nasal irrigation with saline (salty water), also known as nasal douching, washing or lavage, is a procedure that rinses the nasal cavity with isotonic or hypertonic saline solutions. It can be performed with low positive pressure from a spray, pump or squirt bottle, with a nebuliser or with gravity-based pressure in which the person instils saline into one nostril and allows it to drain out of the other. Saline solutions are available over the counter and can be used alone or as an adjunct to other therapies.
To evaluate the effects of nasal saline irrigation in people with allergic rhinitis.
The Cochrane ENT Information Specialist searched the ENT Trials Register; CENTRAL; Ovid MEDLINE; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 23 November 2017.
Randomised controlled trials (RCTs) comparing nasal saline irrigation, delivered by any means and with any volume, tonicity and alkalinity, with (a) no nasal saline irrigation or (b) other pharmacological treatments in adults and children with allergic rhinitis. We included studies comparing nasal saline versus no saline, where all participants also received pharmacological treatment (intranasal corticosteroids or oral antihistamines).
We used the standard methodological procedures expected by Cochrane. Primary outcomes were patient-reported disease severity and a common adverse effect - epistaxis. Secondary outcomes were disease-specific health-related quality of life (HRQL), individual symptom scores, general HRQL, the adverse effects of local irritation or discomfort, ear symptoms (pain or pressure) and nasal endoscopy scores. We used GRADE to assess the quality of the evidence for each outcome; this is indicated in italics.
We included 14 studies (747 participants). The studies included children (seven studies, 499 participants) and adults (seven studies, 248 participants). No studies reported outcomes beyond three months follow-up. Saline volumes ranged from 'very low' to 'high' volume. Where stated, studies used either hypertonic or isotonic saline solution.Nasal saline versus no saline treatmentAll seven studies (112 adults; 332 children) evaluating this comparison used different scoring systems for patient-reported disease severity, so we pooled the data using the standardised mean difference (SMD). Saline irrigation may improve patient-reported disease severity compared with no saline at up to four weeks (SMD -1.32, 95% confidence interval (CI) -1.84 to -0.81; 407 participants; 6 studies; low quality) and between four weeks and three months (SMD -1.44, 95% CI -2.39 to -0.48; 167 participants; 5 studies; low quality). Although the evidence was low quality the SMD values at both time points are considered large effect sizes. Subgroup analysis showed the improvement in both adults and children. Subgroup analyses for volume and tonicity were inconclusive due to heterogeneity.Two studies reported methods for recording adverse effects and five studies mentioned them. Two studies (240 children) reported no adverse effects (epistaxis or local discomfort) in either group and three only reported no adverse effects in the saline group.One study (48 children) reported disease-specific HRQL using a modified RCQ-36 scale. It was uncertain whether there was a difference between the groups at any of the specified time points (very low quality). No other secondary outcomes were reported.Nasal saline versus no saline with adjuvant use of intranasal steroids or oral antihistamines Three studies (40 adults; 79 children) compared saline with intranasal steroids versus intranasal steroids alone; one study (14 adults) compared saline with oral antihistamines versus oral antihistamines alone. It is uncertain if there is a difference in patient-reported disease severity at up to four weeks (SMD -0.60, 95% CI -1.34 to 0.15; 32 participants; 2 studies; very low quality) or from four weeks to three months (SMD -0.32, 95% CI -0.85 to 0.21; 58 participants; 2 studies; very low quality). Although none of the studies reported methods for recording adverse effects, three mentioned them: one study (40 adults; adjuvant intranasal steroids) reported no adverse effects (epistaxis or local discomfort) in either group; the other two only reported no adverse effects in the saline group.It is uncertain if saline irrigation in addition to pharmacological treatment improved disease-specific HRQL at four weeks to three months, compared with pharmacological treatment alone (SMD -1.26, 95% CI -2.47 to -0.05; 54 participants; 2 studies; very low quality). No other secondary outcomes were reported.Nasal saline versus intranasal steroidsIt is uncertain if there was a difference in patient-reported disease severity between nasal saline and intranasal steroids at up to four weeks (MD 1.06, 95% CI -1.65 to 3.77; 14 participants; 1 study), or between four weeks and three months (SMD 1.26, 95% CI -0.92 to 3.43; 97 participants; 3 studies), or indisease-specific HRQL between four weeks and three months (SMD 0.01, 95% CI -0.73 to 0.75; 83 participants; 2 studies). Only one study reported methods for recording adverse effects although three studies mentioned them. One (21 participants) reported two withdrawals due to adverse effects but did not describe these or state which group. Three studies reported no adverse effects (epistaxis or local discomfort) with saline, although one study reported that 27% of participants experienced local discomfort with steroid use. No other secondary outcomes were reported.
AUTHORS' CONCLUSIONS: Saline irrigation may reduce patient-reported disease severity compared with no saline irrigation at up to three months in both adults and children with allergic rhinitis, with no reported adverse effects. No data were available for any outcomes beyond three months. The overall quality of evidence was low or very low. The included studies were generally small and used a range of different outcome measures to report disease severity scores, with unclear validation. This review did not include direct comparisons of saline types (e.g. different volume, tonicity).Since saline irrigation could provide a cheap, safe and acceptable alternative to intranasal steroids and antihistamines further high-quality, adequately powered research in this area is warranted.
过敏性鼻炎是一种影响成人和儿童的常见疾病。患者会出现鼻塞、流涕、打喷嚏和鼻痒等症状,这些症状可能会影响他们的生活质量。用盐水(咸水)进行鼻腔冲洗,也称为鼻腔灌洗、清洗或冲洗,是一种用等渗或高渗盐溶液冲洗鼻腔的操作。可以通过喷雾器、泵或喷瓶产生的低正压、雾化器或重力压力来进行,即让患者将盐水滴入一侧鼻孔,使其从另一侧流出。盐溶液可以在柜台购买,可单独使用或作为其他治疗的辅助手段。
评估鼻腔盐水冲洗对过敏性鼻炎患者的影响。
Cochrane耳鼻喉科信息专家检索了耳鼻喉科试验注册库、CENTRAL、Ovid MEDLINE、Ovid Embase、CINAHL、Web of Science、ClinicalTrials.gov、ICTRP以及其他来源,以查找已发表和未发表的试验。检索日期为2017年11月23日。
随机对照试验(RCT),比较通过任何方式、使用任何体积、张力和碱度的盐水进行鼻腔冲洗与(a)不进行鼻腔盐水冲洗或(b)对过敏性鼻炎成人和儿童使用其他药物治疗的效果。我们纳入了比较鼻腔盐水与不使用盐水的研究,其中所有参与者也接受了药物治疗(鼻内皮质类固醇或口服抗组胺药)。
我们采用了Cochrane预期的标准方法程序。主要结局是患者报告的疾病严重程度和一种常见的不良反应——鼻出血。次要结局包括疾病特异性健康相关生活质量(HRQL)、个体症状评分、总体HRQL、局部刺激或不适的不良反应、耳部症状(疼痛或压力)和鼻内镜评分。我们使用GRADE来评估每个结局的证据质量;这在文中用斜体表示。
我们纳入了14项研究(747名参与者)。这些研究包括儿童(7项研究,499名参与者)和成人(7项研究,248名参与者)。没有研究报告超过三个月随访的结局。盐水体积范围从“非常低”到“高”。如有说明,研究使用的是高渗或等渗盐溶液。
鼻腔盐水与不使用盐水治疗
所有7项评估此比较的研究(112名成人;332名儿童)对患者报告的疾病严重程度使用了不同的评分系统,因此我们使用标准化均值差(SMD)汇总数据。与不使用盐水相比,在长达四周时,盐水冲洗可能改善患者报告的疾病严重程度(SMD -1.32,95%置信区间(CI)-1.84至-0.81;407名参与者;6项研究;低质量),在四周至三个月时也是如此(SMD -1.44,95%CI -2.39至-0.48;167名参与者;5项研究;低质量)。尽管证据质量低,但两个时间点的SMD值都被认为是大效应量。亚组分析显示成人和儿童均有改善。由于异质性,关于体积和张力的亚组分析尚无定论。
两项研究报告了记录不良反应的方法,五项研究提及了不良反应。两项研究(240名儿童)报告两组均无不良反应(鼻出血或局部不适),三项研究仅报告盐水组无不良反应。
一项研究(48名儿童)使用改良的RCQ - 36量表报告了疾病特异性HRQL。在任何指定时间点两组之间是否存在差异尚不确定(质量非常低)。没有报告其他次要结局。
鼻腔盐水与联合使用鼻内类固醇或口服抗组胺药的不使用盐水治疗
三项研究(40名成人;79名儿童)比较了盐水与鼻内类固醇联合使用与单独使用鼻内类固醇的效果;一项研究(14名成人)比较了盐水与口服抗组胺药联合使用与单独使用口服抗组胺药的效果。在长达四周时(SMD -0.60,95%CI -1.34至0.15;32名参与者;2项研究;质量非常低)或四周至三个月时(SMD -0.32,95%CI -0.85至0.21;58名参与者;2项研究;质量非常低),患者报告的疾病严重程度是否存在差异尚不确定。尽管没有研究报告记录不良反应的方法,但有三项研究提及了不良反应:一项研究(40名成人;辅助使用鼻内类固醇)报告两组均无不良反应(鼻出血或局部不适);另外两项研究仅报告盐水组无不良反应。
与单独使用药物治疗相比,在四周至三个月时,除药物治疗外使用盐水冲洗是否改善疾病特异性HRQL尚不确定(SMD -1.26,95%CI -2.47至-0.05;54名参与者;2项研究;质量非常低)。没有报告其他次要结局。
鼻腔盐水与鼻内类固醇治疗
在长达四周时(MD 1.06,95%CI -1.65至3.77;14名参与者;1项研究),鼻腔盐水与鼻内类固醇在患者报告的疾病严重程度上是否存在差异尚不确定,在四周至三个月时(SMD 1.26,95%CI -0.92至3.43;97名参与者;3项研究)以及在四周至三个月时疾病特异性HRQL方面(SMD 0.01,95%CI -0.73至0.75;83名参与者;2项研究)也是如此。只有一项研究报告了记录不良反应的方法,尽管有三项研究提及了不良反应。一项研究(21名参与者)报告因不良反应有两名患者退出,但未描述这些不良反应或说明是哪一组。三项研究报告盐水无不良反应(鼻出血或局部不适),尽管一项研究报告27%的参与者使用类固醇时有局部不适。没有报告其他次要结局。
与不进行盐水冲洗相比,在长达三个月的时间里,盐水冲洗可能会降低过敏性鼻炎成人和儿童患者报告的疾病严重程度,且未报告不良反应。超过三个月的任何结局均无数据。证据的总体质量低或非常低。纳入的研究一般规模较小,使用了一系列不同的结局测量方法来报告疾病严重程度评分,且验证不明确。本综述未包括盐水类型的直接比较(例如不同体积、张力)。由于盐水冲洗可以为鼻内类固醇和抗组胺药提供一种廉价、安全且可接受的替代方法,因此有必要在该领域进行进一步高质量、有足够样本量的研究。