顺势疗法药物 SilAtro-5-90 附加治疗复发性扁桃体炎的疗效：一项国际、实用、随机、对照临床试验。

Effectiveness of an add-on treatment with the homeopathic medication SilAtro-5-90 in recurrent tonsillitis: An international, pragmatic, randomized, controlled clinical trial.

机构信息

ENT Practice, Röthenbach an der Pegnitz, Germany.

ENT Department, Vinnytsia Regional Clinical Hospital Named after M.I. Pirogov, Vinnytsia, Ukraine.

出版信息

Complement Ther Clin Pract. 2017 Aug;28:181-191. doi: 10.1016/j.ctcp.2017.05.005. Epub 2017 May 22.

DOI:10.1016/j.ctcp.2017.05.005

PMID:28779928

Abstract

OBJECTIVE

To investigate the effectiveness and safety of the homeopathic product SilAtro-5-90 in recurrent tonsillitis.

METHODS

In this international, pragmatic, controlled clinical trial, 256 patients (6-60 years) with moderate recurrent tonsillitis were randomized to receive either SilAtro-5-90 in addition to standard symptomatic treatment, or to receive standard treatment only. The primary outcome was the mean time period between consecutive acute throat infections (ATI) within 1 year (analyzed via repeated events analysis).

RESULTS

During the evaluation year, the risk of getting an ATI was significantly lower (hazard ratio: 0.45, proportional means model, p = 0.0002, ITT) with SilAtro-5-90 compared to control. Tonsillitis-specific symptoms were significantly reduced (p < 0.0001, ITT) and the need of antibiotics to treat acute throat infections (p = 0.0008; ITT) decreased. 3 non-serious adverse drug reactions were reported for SilAtro-5-90.

CONCLUSIONS

An integrative treatment approach where SilAtro-5-90 is given alongside mainstream symptomatic treatment may bring therapeutic benefit to patients suffering from recurrent tonsillitis.

TRIAL REGISTRATION

ISRCTN registry: Registration number ISRCTN19016626, registered 23 January 2013.

摘要

目的

研究顺势疗法产品 SilAtro-5-90 治疗复发性扁桃体炎的有效性和安全性。

方法

本国际、实用、对照临床试验纳入 256 例（6-60 岁）中度复发性扁桃体炎患者，随机分为 SilAtro-5-90 联合标准对症治疗组或仅接受标准治疗组。主要结局为 1 年内连续急性咽炎（ATI）之间的平均时间间隔（通过重复事件分析进行分析）。

结果

在评估年度，与对照组相比，SilAtro-5-90 组的 ATI 风险显著降低（风险比：0.45，比例均数模型，p=0.0002，ITT）。扁桃体炎特异性症状显著减轻（p<0.0001，ITT），急性喉咽感染治疗所需的抗生素也减少（p=0.0008；ITT）。SilAtro-5-90 组报告了 3 例非严重药物不良反应。