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      Herbal medicines for the treatment of otitis media with effusion: a systematic review of randomised controlled trials

      systematic-review

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          Abstract

          Objectives

          This systematic review aimed to assess the clinical evidence supporting the use of herbal medicines (HMs) for the treatment of otitis media with effusion (OME).

          Design

          Systematic review and meta-analysis.

          Data sources

          MEDLINE, EMBASE, Cochrane Library, AMED, CINAHL and three trial registries were searched up to January 2015. We also searched five Korean medical databases (KoreaMed, RISS, OASIS, DBPIA and KISS) and three Chinese databases (CNKI, Wanfang and VIP).

          Study eligibility criteria

          This study included randomised clinical trials that reported the effects of HM for OME. The primary outcome was the complete resolution of OME at 2 or 3 months post randomisation. Secondary outcomes included the partial or complete resolution at all possible time points and hearing test. Three authors independently screened the titles and abstracts, selected studies and extracted the data relating to trial quality, characteristics and results.

          Results

          A total of 2141 potentially relevant studies were identified, of which 17 randomised clinical trials met our inclusion criteria. Most were evaluated as having a high or unclear risk of bias. Tongqiao tablets, Tongqiao huoxue decoctions and Tsumura-Saireito were associated with a lower complete or partial resolution rate when compared with conventional medicines (CMs) (p=0.02, p=0.0001, and p=0.04, respectively), and similar outcomes were observed with Huanglong tonger pills, Erzhang decoctions and Shenling baizhu powder when combined with CM versus CM alone (p<0.00001, p=0.02, and p=0.05, respectively). Tongqiao huoxue decoction plus CM appeared to be more effective than CM in terms of improving the pure tone threshold levels (p=0.0007). Tsumura-Saireito was found to affect the proportion of patients with normalised tympanometry (p=0.03).

          Conclusions

          Despite some indications of potential symptom improvement, the evidence regarding the effectiveness and efficacy of HMs for OME is of poor quality and therefore inconclusive.

          Protocol registration number

          CRD42013005430.

          Related collections

          Most cited references12

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          Natural history of untreated otitis media.

          Richard Rosenfeld, David Kay (2003)
          Data from cohort studies and untreated groups in randomized controlled trials can be identified through systematic literature review and synthesized with meta-analysis to estimate natural history of acute otitis media (AOM) and otitis media with effusion (OME). Systematic literature review and meta-analysis. Source articles were identified by MEDLINE search through August 2002 plus manual crosschecks of bibliographies and published meta-analyses. Data were abstracted independently by two investigators and combined with random effects meta-analysis to estimate spontaneous resolution, 95% confidence intervals (CI), and heterogeneity. Sensitivity analysis was performed. Sixty-three articles met inclusion criteria. AOM symptoms improved within 24 hours without antibiotics in 61% of children (95% CI, 50-72%), rising to 80% by 2 to 3 days (95% CI, 69-90%). Suppurative complications were comparable if antibiotics were withheld (0.12%) or provided (0.24%). Children entered recurrent AOM trials with a mean rate of 5.5 or more annual episodes but averaged only 2.8 annual episodes while on placebo (95% CI, 2.2-3.4). No AOM episodes occurred in 41%, and only 17% remained otitis prone (3 or more episodes). OME after untreated AOM had 59% resolution by 1 month (95% CI, 50-68%) and 74% resolution by 3 months (95% CI, 68-80%). OME of unknown duration had 28% spontaneous resolution by 3 months (95%, CI 14-41%), rising to 42% by 6 months (95% CI, 35-49%). In contrast, chronic OME had only 26% resolution by 6 months and 33% resolution by 1 year. The natural history of otitis media is very favorable. Combined estimates of spontaneous resolution provide a benchmark against which to judge new or established interventions. The need for surgery in children with recurrent AOM or chronic OME should be balanced against the likelihood of timely spontaneous resolution and the potential risk of learning, language, or other adverse sequelae from persistent middle ear effusion. Further research is needed to identify prognostic factors that can target children unlikely to improve spontaneously for earlier intervention.
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            The aetiology of otitis media with effusion: a review.

            John Birchall, Aislinn Pearson, H Kubba (2000)
            Otitis media with effusion (OME) is the most common cause of deafness in children in the developed world. In this article we aim to present an overview of current research developments on the aetiology of OME and the resulting implications for treatment. In the model we describe, the primary event is inflammation of the middle ear mucosa, usually due to the presence of bacteria. This leads to the release of inflammatory mediators, which cause secretion of a mucin-rich effusion by up-regulating mucin genes. Prolonged stimulation of the inflammatory response and poor mucociliary clearance lead to persistence of the middle ear fluid, giving rise to the clinical presentation of OME. We describe OME in the following sequence: the initial production of the effusion, the composition of the effusion produced, and factors impairing clearance of the effusion.
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              Clinical practice guideline: Otitis media with effusion (update)

              R.M. Rosenfeld, J.‐J. Shin, S.R. Schwartz … (2016)
              Article 0 comments Cited 33 times – based on 0 reviews     Review now
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                Author and article information

                Journal
                Journal ID (nlm-ta): BMJ Open
                Journal ID (iso-abbrev): BMJ Open
                Journal ID (hwp): bmjopen
                Journal ID (publisher-id): bmjopen
                Title: BMJ Open
                Publisher: BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                ISSN (Electronic): 2044-6055
                Publication date Collection: 2016
                Publication date (Electronic): 24 November 2016
                Volume: 6
                Issue: 11
                Electronic Location Identifier: e011250
                Affiliations
                [1 ]Clinical Research Division, Korea Institute of Oriental Medicine , Daejeon, Republic of Korea
                [2 ]K-herb Research Center, Korea Institute of Oriental Medicine , Daejeon, Republic of Korea
                [3 ]Mibyeong Research Center, Korea Institute of Oriental Medicine , Daejeon, Republic of Korea
                [4 ]KM Convergence Research Division, Korea Institute of Oriental Medicine , Daejeon, Republic of Korea
                Author notes
                [Correspondence to ] Dr Yun Hee Kim; ddyunee@ 123456kiom.re.kr
                Author information
                http://orcid.org/0000-0003-1701-9122
                Article
                Publisher ID: bmjopen-2016-011250
                DOI: 10.1136/bmjopen-2016-011250
                PMC ID: 5168523
                PubMed ID: 27884841
                SO-VID: d92d4763-f56e-4ad9-b0d9-8cb209323796
                Copyright © Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/
                License:

                This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

                History
                Date received : 24 January 2016
                Date revision received : 6 September 2016
                Date accepted : 3 November 2016
                Funding
                Funded by: Korea Institute of Oriental Medicine, http://dx.doi.org/10.13039/501100003718;
                Award ID: K16124
                Categories
                Subject: Ear, Nose and Throat/Otolaryngology
                Subject: Research
                Subject: 1506
                Subject: 1690
                Subject: 1685

                ScienceOpen disciplines: Medicine
                Keywords: otitis media with effusion,systematic review
                Data availability:
                ScienceOpen disciplines: Medicine
                Keywords: otitis media with effusion, systematic review

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