Perry Rachel, Huntley Alyson L, Lai Nai Ming, Teut Michael, Martin David D, van der Werf Esther T
The National Institute for Health and Care Research Applied Research Collaboration West (NIHR ARC West) at University Hospitals Bristol and Weston NHS Foundation Trust, UK.
Centre for Academic Primary Care, Bristol Medical School, University of Bristol, Bristol, UK.
Heliyon. 2024 Oct 15;10(20):e39174. doi: 10.1016/j.heliyon.2024.e39174. eCollection 2024 Oct 30.
This systematic review of clinical trial evidence aims to determine whether homeopathy can effectively relieve symptoms and reduce antibiotic use in patients diagnosed with otitis media (OM).
Seven databases and four trial registries were searched. Eligible studies included randomised- and non-randomised-controlled-trials in patients diagnosed with OM. Studies on Individualised- and non-Individualised-Homeopathy (IH, non-IH) were included, and controls were inactive and/or active treatment. Primary outcomes were clinical-improvement and antibiotic-use. Data extraction, Risk of Bias and certainty of evidence (GRADE) were performed using established methodology.
Nine studies (IH = 4, non-IH = 5) comprising seven Randomised Clinical Trials (RCTs) and two non-RCTs (nRCTS) compared homeopathy with placebo (n = 2) or standard care (n = 7). 4/7 included RCTs reported statistically significant individual outcomes at relevant time points (symptom score, MEE, and antibiotic use) favouring homeopathy. However, heterogeneity of study designs, homeopathic interventions and outcome measures hindered the pooling of data for most outcomes, except for antibiotic use (non-IH). Add-on non-IH reduced filled antibiotic prescriptions by 46 % (RR = 0.54 [95%CI: 0.28, 1.06], P = 0.07, I = 12 %), but this did not reach statistical significance. Most studies demonstrated that the homeopathy group had less adverse events than the control group.
The evidence base for the effectiveness of homeopathy and OM treatment is modest in study number, size, and risk of bias assessment. Individual RCTs report positive effects on clinical improvement and/or antibiotic use at relevant time points with homeopathy with no safety issues. Due to heterogeneity, the current evidence is insufficient to satisfactorily answer whether homeopathy is effective for clinical improvement and reducing antibiotic use in patients with OM. A Core Outcome Set for OM for future research is warranted to improve the potential for meta-analyses and strengthen the evidence base.
本系统评价临床试验证据旨在确定顺势疗法是否能有效缓解确诊为中耳炎（OM）患者的症状并减少抗生素使用。
检索了七个数据库和四个试验注册库。符合条件的研究包括针对确诊为OM患者的随机对照试验和非随机对照试验。纳入了个体化顺势疗法和非个体化顺势疗法（IH，非IH）的研究，对照为无活性和/或活性治疗。主要结局为临床改善和抗生素使用。使用既定方法进行数据提取、偏倚风险和证据确定性（GRADE）评估。
九项研究（IH = 4，非IH = 5），包括七项随机临床试验（RCT）和两项非随机对照试验（nRCT），将顺势疗法与安慰剂（n = 2）或标准治疗（n = 7）进行了比较。7项纳入的RCT中有4项在相关时间点报告了统计学上显著的个体结局（症状评分、中耳积液和抗生素使用），支持顺势疗法。然而，研究设计、顺势疗法干预措施和结局测量的异质性阻碍了大多数结局的数据合并，抗生素使用（非IH）除外。附加非IH使已开具的抗生素处方减少了46%（RR = 0.54 [95%CI：0.28，1.06]，P = 0.07，I = 12%），但未达到统计学显著性。大多数研究表明，顺势疗法组的不良事件少于对照组。
顺势疗法治疗OM有效性的证据基础在研究数量、规模和偏倚风险评估方面较为有限。个别RCT报告顺势疗法在相关时间点对临床改善和/或抗生素使用有积极影响，且无安全问题。由于异质性，目前的证据不足以令人满意地回答顺势疗法对OM患者的临床改善和减少抗生素使用是否有效。有必要为未来的OM研究制定一个核心结局集，以提高荟萃分析的可能性并加强证据基础。
