Son Mi Ju, Choi Songie, Kim Young-Eun, Kim Yun Hee
Clinical Research Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.
K-herb Research Center, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.
BMJ Open. 2016 Nov 24;6(11):e011250. doi: 10.1136/bmjopen-2016-011250.
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).
Systematic review and meta-analysis.
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).
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.
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).
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.
CRD42013005430.
本系统评价旨在评估支持使用草药治疗分泌性中耳炎（OME）的临床证据。
系统评价和荟萃分析。
检索截至2015年1月的MEDLINE、EMBASE、Cochrane图书馆、AMED、CINAHL以及三个试验注册库。我们还检索了五个韩国医学数据库（KoreaMed、RISS、OASIS、DBPIA和KISS）和三个中国数据库（CNKI、万方和维普）。
本研究纳入报告草药对OME疗效的随机临床试验。主要结局是随机分组后2或3个月时OME的完全缓解。次要结局包括所有可能时间点的部分或完全缓解以及听力测试。三位作者独立筛选标题和摘要、选择研究并提取与试验质量、特征和结果相关的数据。
共识别出2141项潜在相关研究，其中17项随机临床试验符合我们的纳入标准。大多数研究被评估为具有高或不明确的偏倚风险。与传统药物（CMs）相比，通窍片、通窍活血汤和津村柴胡汤的完全或部分缓解率较低（分别为p = 0.02、p = 0.0001和p = 0.04），黄龙通耳丸、二陈汤和参苓白术散与CM联合使用时与单独使用CM相比观察到相似结果（分别为p < 0.00001、p = 0.02和p = 0.05）。通窍活血汤加CM在改善纯音阈值水平方面似乎比CM更有效（p = 0.0007）。发现津村柴胡汤会影响鼓室导抗图正常化患者的比例（p = 0.03）。
尽管有一些潜在症状改善的迹象，但关于草药治疗OME有效性和疗效的证据质量较差，因此尚无定论。
CRD42013005430。
