一种复方顺势疗法药物（Sinfrontal）治疗急性上颌窦炎患者的疗效：一项前瞻性、随机、双盲、安慰剂对照、多中心临床试验。

Efficacy of a complex homeopathic medication (Sinfrontal) in patients with acute maxillary sinusitis: a prospective, randomized, double-blind, placebo-controlled, multicenter clinical trial.

作者信息

Zabolotnyi Dmitriy I, Kneis Kyra C, Richardson Andy, Rettenberger Reinhard, Heger Marianne, Kaszkin-Bettag Marietta, Heger Peter W

机构信息

Research Institute for Ear, Nose, and Throat Diseases, Kiev, Ukraine.

出版信息

Explore (NY). 2007 Mar-Apr;3(2):98-109. doi: 10.1016/j.explore.2006.12.007.

DOI:10.1016/j.explore.2006.12.007

PMID:17362845

Abstract

BACKGROUND

There is a demand for clinical trials that demonstrate homeopathic medications to be effective and safe in the treatment of acute maxillary sinusitis (AMS).

OBJECTIVE

The objective of this clinical trial was to demonstrate the efficacy of a complex homeopathic medication (Sinfrontal) compared with placebo in patients with AMS confirmed by sinus radiography.

DESIGN

A prospective, randomized, double-blind, placebo-controlled, phase III clinical trial was conducted for a treatment period of 22 days, followed by an eight-week posttreatment observational phase.

SETTING

The clinical trial was conducted at six trial sites in the Ukraine.

PARTICIPANTS

One hundred thirteen patients with radiography-confirmed AMS participated in the trial.

INTERVENTIONS

Fifty-seven patients received Sinfrontal and 56 patients received placebo. Additionally, patients were allowed saline inhalations, paracetamol, and over-the-counter medications, but treatment with antibiotics or other treatment for sinusitis was not permitted.

MAIN OUTCOME MEASURES

Primary outcome criterion was change of the sinusitis severity score (SSS) from day zero to day seven. Other efficacy assessments included radiographic and clinical cure, improvement in health state, ability to work or to follow usual activities, and treatment outcome.

RESULTS

From day zero to day seven, Sinfrontal caused a significant reduction in the SSS total score compared with placebo (5.8 +/- 2.3 [6.0] points vs 2.3 +/- 1.8 [2.0] points; P < .0001). On day 21, 39 (68.4%) patients on active medication had a complete remission of AMS symptoms compared with five (8.9%) placebo patients. All secondary outcome criteria displayed similar trends. Eight adverse events were reported that were assessed as being mild or moderate in intensity. No recurrence of AMS symptoms occurred by the end of the eight-week posttreatment observational phase.

CONCLUSION

This complex homeopathic medication is safe and appears to be an effective treatment for acute maxillary sinusitis.

摘要

背景

需要开展临床试验来证明顺势疗法药物在治疗急性上颌窦炎（AMS）方面的有效性和安全性。

目的

本临床试验的目的是证明一种复方顺势疗法药物（Sinfrontal）与安慰剂相比，对经鼻窦造影证实患有AMS的患者的疗效。

设计

进行了一项前瞻性、随机、双盲、安慰剂对照的III期临床试验，治疗期为22天，随后是为期八周的治疗后观察期。

地点

该临床试验在乌克兰的六个试验地点进行。

参与者

113名经造影证实患有AMS的患者参与了试验。

干预措施

57名患者接受Sinfrontal治疗，56名患者接受安慰剂治疗。此外，患者可进行盐水吸入、服用扑热息痛和非处方药物，但不允许使用抗生素或其他鼻窦炎治疗方法。

主要观察指标

主要观察标准是从第0天到第7天鼻窦炎严重程度评分（SSS）的变化。其他疗效评估包括影像学和临床治愈、健康状况改善、工作或进行日常活动的能力以及治疗结果。

结果

从第0天到第7天，与安慰剂相比，Sinfrontal使SSS总分显著降低（5.8±2.3[6.0]分对2.3±1.8[2.0]分；P<.0001）。在第21天，39名（68.4%）接受活性药物治疗的患者AMS症状完全缓解，而接受安慰剂治疗的患者为5名（8.9%）。所有次要观察标准均显示出类似趋势。报告了8起不良事件，强度评估为轻度或中度。在为期八周的治疗后观察期结束时，未出现AMS症状复发。