Aaron Ksenia, Cooper Tess E, Warner Laura, Burton Martin J
Department of Otolaryngology - Head and Neck Surgery, Keck School of Medicine of the University of Southern California, Los Angeles, CA, USA.
Cochrane Database Syst Rev. 2018 Jul 25;7(7):CD012171. doi: 10.1002/14651858.CD012171.pub2.
BACKGROUND: Ear wax (cerumen) is a normal bodily secretion that can become a problem when it obstructs the ear canal. Symptoms attributed to wax (such as deafness and pain) are among the commonest reasons for patients to present to primary care with ear trouble.Wax is part of the ear's self-cleaning mechanism and is usually naturally expelled from the ear canal without causing problems. When this mechanism fails, wax is retained in the canal and may become impacted; interventions to encourage its removal may then be needed. Application of ear drops is one of these methods. Liquids used to remove and soften wax are of several kinds: oil-based compounds (e.g. olive or almond oil); water-based compounds (e.g. sodium bicarbonate or water itself); a combination of the above or non-water, non-oil-based solutions, such as carbamide peroxide (a hydrogen peroxide-urea compound) and glycerol. OBJECTIVES: To assess the effects of ear drops (or sprays) to remove or aid the removal of ear wax in adults and children. SEARCH METHODS: We searched the Cochrane ENT Trials Register; Cochrane Register of Studies; PubMed; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the most recent search was 23 March 2018. SELECTION CRITERIA: Randomised controlled trials (RCTs) in which a 'cerumenolytic' was compared with no treatment, water or saline, an alternative liquid treatment (oil or almond oil) or another 'cerumenolytic' in adults or children with obstructing or impacted ear wax. DATA COLLECTION AND ANALYSIS: We used the standard methodological procedures expected by Cochrane. The primary outcomes were 1) the proportion of patients (or ears) with complete clearance of ear wax and 2) adverse effects (discomfort, irritation or pain). Secondary outcomes were: extent of wax clearance; proportion of people (or ears) with relief of symptoms due to wax; proportion of people (or ears) requiring further intervention to remove wax; success of mechanical removal of residual wax following treatment; any other adverse effects recorded and cost. We used GRADE to assess the quality of the evidence for each outcome; this is indicated in italics. MAIN RESULTS: We included 10 studies, with 623 participants (900 ears). Interventions included: oil-based treatments (triethanolamine polypeptide, almond oil, benzocaine, chlorobutanol), water-based treatments (docusate sodium, carbamide peroxide, phenazone, choline salicylate, urea peroxide, potassium carbonate), other active comparators (e.g. saline or water alone) and no treatment. Nine of the studies were more than 15 years old.The overall risk of bias across the 10 included studies was low or unclear. PRIMARY OUTCOME: proportion of patients (or ears) with complete clearance of ear waxSix studies (360 participants; 491 ears) contributed quantitative data and were included in our meta-analyses.Active treatment versus no treatmentOnly one study addressed this comparison. The proportion of ears with complete clearance of ear wax was higher in the active treatment group (22%) compared with the no treatment group (5%) after five days of treatment (risk ratio (RR) 4.09, 95% confidence interval (CI) 1.00 to 16.80); one study; 117 ears; NNTB = 8) (low-quality evidence).Active treatment versus water or salineWe found no evidence of a difference in the proportion of patients (or ears) with complete clearance of ear wax when the active treatment group was compared to the water or saline group (RR 1.47, 95% CI 0.79 to 2.75; three studies; 213 participants; 257 ears) (low-quality evidence). Two studies applied drops for five days, but one study only applied the drops for 15 minutes. When we excluded this study in a sensitivity analysis it did not change the result.Water or saline versus no treatmentThis comparison was only addressed in the single study cited above (active versus no treatment) and there was no evidence of a difference in the proportion of ears with complete wax clearance when comparing water or saline with no treatment after five days of treatment (RR 4.00, 95% CI 0.91 to 17.62; one study; 76 ears) (low-quality evidence).Active treatment A versus active treatment BSeveral single studies evaluated 'head-to-head' comparisons between two active treatments. We found no evidence to show that one was superior to any other.Subgroup analysis of oil-based active treatments versus non-oil based active treatmentsWe found no evidence of a difference in this outcome when oil-based treatments were compared with non-oil-based active treatments. PRIMARY OUTCOME: adverse effects: discomfort, irritation or painOnly seven studies planned to measure and did report this outcome. Only two (141 participants;176 ears) provided useable data. There was no evidence of a significant difference in the number of adverse effects between the types of ear drops in these two studies. We summarised the remaining five studies narratively. All events were mild and reported in fewer than 30 participants across the seven studies (low-quality evidence).Secondary outcomesThree studies reported 'other' adverse effects (how many studies planned to report these is unclear). The available information was limited and included occasional reports of dizziness, unpleasant smell, tinnitus and hearing loss. No significant differences between groups were reported. There were no emergencies or serious adverse effects reported in any of the 10 studies.There was very limited or no information available on our remaining secondary outcomes. AUTHORS' CONCLUSIONS: Although a number of studies aimed to evaluate whether or not one type of cerumenolytic is more effective than another, there is no high-quality evidence to allow a firm conclusion to be drawn and the answer remains uncertain.A single study suggests that applying ear drops for five days may result in a greater likelihood of complete wax clearance than no treatment at all. However, we cannot conclude whether one type of active treatment is more effective than another and there was no evidence of a difference in efficacy between oil-based and water-based active treatments.There is no evidence to show that using saline or water alone is better or worse than commercially produced cerumenolytics. Equally, there is also no evidence to show that using saline or water alone is better than no treatment.
背景:耳垢是一种正常的身体分泌物,当它阻塞耳道时就会成为问题。因耳垢导致的症状(如耳聋和疼痛)是患者因耳部问题就诊于初级医疗保健机构的最常见原因之一。耳垢是耳部自我清洁机制的一部分,通常会自然地从耳道排出而不会引发问题。当这种机制失效时,耳垢会滞留在耳道内并可能形成耵聍栓塞;此时可能就需要采取干预措施来促使其排出。滴耳液的应用就是其中一种方法。用于清除和软化耳垢的液体有几种:油基化合物(如橄榄油或杏仁油);水基化合物(如碳酸氢钠或水本身);上述两者的组合或非水、非油基溶液,如过氧化脲(一种过氧化氢 - 尿素化合物)和甘油。 目的:评估滴耳液(或喷雾剂)在成人和儿童中清除或辅助清除耳垢的效果。 检索方法:我们检索了Cochrane耳鼻喉科试验注册库、Cochrane研究注册库、PubMed、Ovid Embase、CINAHL、科学引文索引、ClinicalTrials.gov、国际临床试验注册平台以及其他已发表和未发表试验的来源。最近一次检索日期为2018年3月23日。 选择标准:随机对照试验,其中将“耵聍溶解剂”与未治疗、水或生理盐水、另一种液体治疗(油或杏仁油)或另一种“耵聍溶解剂”在患有阻塞性或耵聍栓塞性耳垢的成人或儿童中进行比较。 数据收集与分析:我们采用了Cochrane期望的标准方法程序。主要结局为:1)耳垢完全清除的患者(或耳朵)比例;2)不良反应(不适、刺激或疼痛)。次要结局包括:耳垢清除程度;因耳垢导致症状缓解的人群(或耳朵)比例;需要进一步干预以清除耳垢的人群(或耳朵)比例;治疗后机械清除残留耳垢的成功率;记录的任何其他不良反应以及成本。我们使用GRADE评估每个结局的证据质量;这在文中用斜体表示。 主要结果:我们纳入了10项研究,共623名参与者(900只耳朵)。干预措施包括:油基治疗(三乙醇胺多肽、杏仁油、苯佐卡因、氯丁醇)、水基治疗(多库酯钠、过氧化脲、非那宗、水杨酸胆碱、过氧化尿素、碳酸钾)、其他活性对照(如单独的生理盐水或水)以及未治疗。其中9项研究已有15年以上历史。纳入的10项研究的总体偏倚风险较低或不明确。 主要结局:耳垢完全清除的患者(或耳朵)比例 六项研究(360名参与者;491只耳朵)提供了定量数据并纳入我们的荟萃分析。 活性治疗与未治疗 仅有一项研究涉及此比较。治疗五天后,活性治疗组耳垢完全清除的耳朵比例(22%)高于未治疗组(5%)(风险比(RR)4.09,95%置信区间(CI)1.00至16.80);一项研究;117只耳朵;需治疗人数(NNTB) = 8)(低质量证据)。 活性治疗与水或生理盐水 当将活性治疗组与水或生理盐水组进行比较时,我们未发现耳垢完全清除的患者(或耳朵)比例存在差异的证据(RR 1.47,95% CI 0.79至2.75;三项研究;213名参与者;257只耳朵)(低质量证据)。两项研究滴药五天,但一项研究仅滴药15分钟。在敏感性分析中排除该研究时,结果未改变。 水或生理盐水与未治疗 此比较仅在上述引用的单一研究(活性治疗与未治疗)中涉及,治疗五天后,将水或生理盐水与未治疗进行比较时,未发现耳垢完全清除的耳朵比例存在差异的证据(RR 4.00,95% CI 0.91至17.62;一项研究;76只耳朵)(低质量证据)。 活性治疗A与活性治疗B 多项单一研究评估了两种活性治疗之间的“直接”比较。我们未发现证据表明一种比另一种更优。 油基活性治疗与非油基活性治疗的亚组分析 当将油基治疗与非油基活性治疗进行比较时,我们未发现此结局存在差异的证据。 主要结局:不良反应:不适、刺激或疼痛 仅有七项研究计划测量并报告了此结局。仅有两项研究(141名参与者;176只耳朵)提供了可用数据。在这两项研究中,不同类型滴耳液之间的不良反应数量没有显著差异的证据。我们对其余五项研究进行了叙述性总结。所有事件均为轻度,七项研究中报告的参与者均少于30人(低质量证据)。 次要结局 三项研究报告了“其他”不良反应(不清楚有多少研究计划报告这些不良反应)。可用信息有限,包括偶尔出现的头晕、难闻气味、耳鸣和听力损失报告。未报告组间存在显著差异。10项研究中均未报告紧急情况或严重不良反应。 关于我们其余的次要结局,可用信息非常有限或没有。 作者结论:尽管有多项研究旨在评估一种耵聍溶解剂是否比另一种更有效,但没有高质量证据得出确切结论,答案仍然不确定。一项单一研究表明,滴耳液应用五天可能比完全不治疗更有可能实现耳垢的完全清除。然而,我们无法得出一种活性治疗是否比另一种更有效的结论,并且没有证据表明油基和水基活性治疗在疗效上存在差异。没有证据表明单独使用生理盐水或水比市售耵聍溶解剂更好或更差。同样,也没有证据表明单独使用生理盐水或水比不治疗更好。
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