Dataset Information

Oral administration of herbal medicines for the treatment of otitis media with effusion: protocol for a systematic review.

ABSTRACT:

Introduction

The purpose of this systematic review is to investigate the efficacy of the oral administration of herbal medicines for otitis media with effusion through analysing trial data.

Methods and analysis

Electronic searches of the following 11 databases will be performed: MEDLINE, CINAHL, EMBASE, AMED, the Cochrane CENTRAL, 3 Chinese databases (CNKI, Wangfang Data and VIP Information) and 5 Korean databases (KoreaMed, Research Information Service System, Korea Studies Information System, Oriental Medicine Advanced Searching Integrated System (OASIS) and DBpia). The selection of the studies, data abstraction and validations will be performed independently by two researchers.

Dissemination

The systematic review will be published in a peer-reviewed journal. The review will also be disseminated electronically and in print. The review will be updated to inform and guide healthcare practice and policy.

Trial registration number

PROSPERO 2013: CRD42013005430.

SUBMITTER: Kim YH

PROVIDER: S-EPMC3939645 | biostudies-literature | 2014 Feb

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Oral administration of herbal medicines for the treatment of otitis media with effusion: protocol for a systematic review.

Kim Yun Hee YH Son Mi Ju MJ Kim Young-Eun YE Lee Hye Won HW Lee Myeong Soo MS

BMJ open 20140227 2

<h4>Introduction</h4>The purpose of this systematic review is to investigate the efficacy of the oral administration of herbal medicines for otitis media with effusion through analysing trial data.<h4>Methods and analysis</h4>Electronic searches of the following 11 databases will be performed: MEDLINE, CINAHL, EMBASE, AMED, the Cochrane CENTRAL, 3 Chinese databases (CNKI, Wangfang Data and VIP Information) and 5 Korean databases (KoreaMed, Research Information Service System, Korea Studies Infor ...[more]

PMID: 24578537

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Project description:BACKGROUND:Radiation pneumonitis is a common and serious complication of radiotherapy. Many published randomized controlled studies (RCTs) reveal a growing trend of using herbal medicines as adjuvant therapy to prevent radiation pneumonitis; however, their efficacy and safety remain unexplored. OBJECTIVE:The aim of this systematic review is to evaluate the efficacy and safety of herbal medicines as adjunctive therapy for the prevention of radiation pneumonitis in patients with lung cancer who undergo radiotherapy. METHODS:We searched the following 11 databases: three English medical databases [MEDLINE (PubMed), EMBASE, The Cochrane Central Register of Controlled Trials (CENTRAL)], five Korean medical databases (Korean Studies Information, Research information Service System, KoreaMed, DBPIA, National Digital Science Library), and three Chinese medical databases [the China National Knowledge Database (CNKI), Journal Integration Platform (VIP), and WanFang Database]. The primary outcome was the incidence of radiation pneumonitis. The risk of bias was assessed using the Cochrane risk-of-bias tool. RESULTS:Twenty-two RCTs involving 1819 participants were included. The methodological quality was poor for most of the studies. Meta-analysis showed that herbal medicines combined with radiotherapy significantly reduced the incidence of radiation pneumonitis (n = 1819; RR 0.53, 95% CI 0.45-0.63, I2 = 8%) and the incidence of severe radiation pneumonitis (n = 903; RR 0.22, 95% CI 0.11-0.41, I2 = 0%). Combined therapy also improved the Karnofsky performance score (n = 420; WMD 4.62, 95% CI 1.05-8.18, I2 = 82%). CONCLUSION:There is some encouraging evidence that oral administration of herbal medicines combined with radiotherapy may benefit patients with lung cancer by preventing or minimizing radiation pneumonitis. However, due to the poor methodological quality of the identified studies, definitive conclusion could not be drawn. To confirm the merits of this approach, further rigorously designed large scale trials are warranted.

Project description:BackgroundChildren with persistent hearing loss due to otitis media with effusion are commonly managed by surgical intervention. A safe, cheap, and effective medical treatment would enhance treatment options. Underpowered, poor-quality trials have found short-term benefit from oral steroids. We aimed to investigate whether a short course of oral steroids would achieve acceptable hearing in children with persistent otitis media with effusion and hearing loss.MethodsIn this individually randomised, parallel, double-blinded, placebo-controlled trial we recruited children aged 2-8 years with symptoms attributable to otitis media with effusion for at least 3 months and with confirmed bilateral hearing loss. Participants were recruited from 20 ear, nose, and throat (ENT), paediatric audiology, and audiovestibular medicine outpatient departments in England and Wales. Participants were randomly allocated (1:1) to sequentially numbered identical prednisolone (oral steroid) or placebo packs by use of computer-generated random permuted block sizes stratified by site and child's age. The primary outcome was audiometry-confirmed acceptable hearing at 5 weeks. All analyses were by intention to treat. This trial is registered with the ISRCTN Registry, number ISRCTN49798431.FindingsBetween March 20, 2014, and April 5, 2016, 1018 children were screened, of whom 389 were randomised. 200 were assigned to receive oral steroids and 189 to receive placebo. Hearing at 5 weeks was assessed in 183 children in the oral steroid group and in 180 in the placebo group. Acceptable hearing was observed in 73 (40%) children in the oral steroid group and in 59 (33%) in the placebo group (absolute difference 7% [95% CI -3 to 17], number needed to treat 14; adjusted odds ratio 1·36 [95% CI 0·88-2·11]; p=0·16). There was no evidence of any significant differences in adverse events or quality-of-life measures between the groups.InterpretationOtitis media with effusion in children with documented hearing loss and attributable symptoms for at least 3 months has a high rate of spontaneous resolution. A short course of oral prednisolone is not an effective treatment for most children aged 2-8 years with persistent otitis media with effusion, but is well tolerated. One in 14 children might achieve improved hearing but not quality of life. Discussions about watchful waiting and other interventions will be supported by this evidence.FundingNational Institute for Health Research (NIHR) Health Technology Assessment programme.

Dataset Information

Oral administration of herbal medicines for the treatment of otitis media with effusion: protocol for a systematic review.

Introduction

Methods and analysis

Dissemination

Trial registration number

Publications

Oral administration of herbal medicines for the treatment of otitis media with effusion: protocol for a systematic review.

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