Grommets (ventilation tubes) for recurrent acute otitis media in children

 

Abstract

Background

This is an update of a Cochrane Review first published in The Cochrane Library in Issue 4, 2008.

Acute suppurative otitis media is one of the most common infectious diseases in childhood. Recurrent acute otitis media is defined for the purposes of this review as either three or more acute infections of the middle ear cleft in a six-month period, or at least four episodes in a year. Strategies for managing the condition include the assessment and modification of risk factors where possible, repeated courses of antibiotics for each new infection, antibiotic prophylaxis and the insertion of ventilation tubes (grommets).

Objectives

To establish whether grommet insertion reduces the frequency of episodes of recurrent acute otitis media and the proportion of children with symptoms of ear disease.

Search methods

We searched the Cochrane Ear, Nose and Throat Disorders Group Trials Register; the Cochrane Central Register of Controlled Trials (CENTRAL); PubMed; EMBASE; CINAHL; Web of Science; BIOSIS Previews; Cambridge Scientific Abstracts; ICTRP and additional sources for published and unpublished trials. The date of the most recent search was 11 January 2011.

Selection criteria

Randomised controlled trials comparing grommet insertion versus control (antibiotics/other treatments/no treatment) for recurrent acute otitis media in children aged from 0 to 16 years.

Data collection and analysis

Two authors independently selected studies; three authors independently assessed study quality and extracted data. We synthesised data descriptively.

Main results

Two studies involving 148 children were included in the review. One of these studies, involving 95 children, showed that grommet insertion leads to a mean reduction of 1.5 episodes of acute otitis media in the first six months after treatment. This study also showed a significant increase in the proportion of children with no episodes of acute otitis media (P < 0.001) in the grommet group. The other included study also found a higher proportion of patients in the grommet group had no episodes of acute otitis media in the six months after intervention, but the difference did not reach statistical significance (P = 0.16).

Authors' conclusions

Grommets have a significant role in maintaining a 'disease-free' state in the first six months after insertion. Further research is required to investigate the effect beyond six months. Clinicians should consider the possible adverse effects of grommet insertion before surgery is undertaken.

 

Plain language summary

Grommets (ventilation tubes) for recurrent acute otitis media in children

Acute otitis media is a common disease of childhood, involving inflammation of the space behind the eardrum (the middle ear cleft). Episodes typically involve a fever and a build up of pus that stretches the eardrum causing severe pain. The drum may then rupture, relieving the pain, and a discharge of pus enters the ear canal. A small proportion of children suffer with recurrent acute otitis media, which is defined as either three or more acute infections of the middle ear cleft in a six-month period, or at least four episodes in a year.

One of the strategies used to treat this condition is the insertion of a miniature plastic ventilation tube (or grommet) into the eardrum, which prevents the painful accumulation of pus in the middle ear. This review aims to assess the evidence for the effectiveness of this treatment in reducing recurrent acute otitis media.

We searched for scientific studies which compared treating children with recurrent acute otitis media with either grommets or a non-surgical treatment such as antibiotics (or no treatment). In these studies, children with grommets in place were considered to have suffered an episode of acute otitis media if they had a discharge of pus from the ear.

Two suitable studies were found to be suitable for further analysis. The combined results from these two studies suggested that more children treated with grommets are rendered symptom-free in the six months following surgery compared to those who receive other treatments or no treatment. One of the two included studies, involving 95 children, showed that grommets reduce the number of episodes of acute otitis media in the first six months after surgery, by an average of 1.5 episodes per child.

When considering the size of this effect, it is important to bear in mind that the studies were not perfect in their design and execution. To be confident in these findings further high-quality research is required.

 

摘要

背景

Grommets(通氣管)用於兒童反覆發作的急性中耳炎

急性化膿性中耳炎是兒童最常見之感染性疾病之一。為了本文獻回顧的目的，將反覆發作的急性中耳炎定義為：六個月內三次或更多次的急性中耳感染；或一年內至少四次發作。針對此疾病的處置策略，包括：疾病風險評估及可能的風險調整；每次新感染時皆重複給予一次抗生素療程；預防性抗生素的使用；及通氣管(grommets)的置入。

目標

為了解通氣管的置入，能否降低兒童反覆發作急性中耳炎的頻率，及耳疾症狀的比率。

搜尋策略

我們蒐集了the Cochrane Ear, Nose and Throat Disorders Group Trials Register、the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, Issue 1 2008)、MEDLINE (1950 to 2008)、EMBASE (1974 to 2008)、CINAHL、mRCT (the metaRegister of Controlled Trials for ongoing/unpublished trials)、NRR (National Research Register)、LILACs、KoreaMed、IndMed、PakMediNet、Zetoc、ISI Proceedings and Cambridge Scientific Abstracts。 由上述電子資料庫搜尋而得的文獻，瀏覽其參考文獻是否有適合的可用文獻。搜尋其他系統性回顧及統合分析的文章，並瀏覽其參考文獻。本文作者也和所搜尋到文獻的原作者或此領域的專家聯繫。最後資料蒐集時間為2008年3月。

選擇標準

選擇符合選入要件且包含治療組及控制對照組的臨床試驗。取得其文獻摘要及全文後，由兩位評論者獨立地評估，是否符合選入要件。回顧中的所有文獻，皆依據考科藍有關治療之系統性回顧手冊中的方法，由所有作者獨立地評讀文獻品質。

資料收集與分析

文獻資料由評論者獨立地摘錄出來並整合。 找到五篇隨機分配控制試驗，其中兩篇符合選入要件。

主要結論

選入之試驗包含148名兒童。其中一篇包含95名兒童的研究顯示，通氣管的置入可使治療後六個月內，平均減少1.5次的急性中耳炎再發作。同時可以顯著地增加沒有發生急性中耳炎的人數比例(p<0.001)。另一篇文獻也發現，通氣管的置入可以增加沒有發生急性中耳炎的人數比例，但沒有達到統計學上的差異(p = 0.16)。

作者結論

通氣管的置入，在最初六個月內，對於維持“無病”的情形有明顯的重要性。但超過六個月之後的效果，需要更多的研究來評估。臨床醫師應該在為病患施行通氣管置入前，審慎評估其副作用。

翻譯人

本摘要由臺北榮民總醫院楊漢儒翻譯。

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

Grommets(通氣管)用於兒童反覆發作的急性中耳炎：急性中耳炎是兒童常見的疾病，造成耳膜後的發炎(中耳裂區域)。典型症狀為發燒，化膿並因膿液的增加擠壓耳膜，進而造成耳痛。耳膜可能因而破裂後，膿液流出至外耳道而減緩了疼痛感。部分兒童會有反覆發生的現象，定義為半年至少三次或一年至少四次的急性中耳炎發作。治療上有些會採取將一塑膠材質的通氣管置放於耳膜上，以避免因蓄膿造成的耳痛感。這篇文章主要是探討通氣管置入是否能預防疾病的反覆發作。我們搜尋科學上的證據，去比較治療反覆發作的急性中耳炎兒童，使用通氣管置入或使用非手術治療例如使用抗生素(或未施行任何治療)的差異。在這些研究當中，有施行通氣管置入術的兒童，如果有膿從耳朵內流出，就當作有急性中耳炎發作。總共找到五篇合適的文獻。經由評估其研究品質，只有兩篇適合進一步分析。這兩篇文章綜合分析後顯示，使用通氣管治療者，較使用其他治療或未使用任何治療者，前六個月較不會有任何症狀復發。當中一篇包含95位兒童的研究顯示，使用通氣管能使六個月內復發平均次數下降1.5次。在考量這樣的治療效果之下，很重要的是，必須銘記此研究在設計及執行並非完美。這樣的治療效果想要有公信力，需要進一步更高品質的研究。