Is homeopathic ‘immunotherapy’ effective? A double-blind, placebo-controlled trial with the isopathic remedy Betula 30c for patients with birch pollen allergy

S Aabel , E Laerum , S Dølvik , P Djupesland
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引用次数: 40

Abstract

The objective of the study was to examine the effect of the homeopathic remedy Betula 30c vs placebo for patients with birch pollen allergy. A double-blind, randomized, placebo-controlled trial was carried out. Tablets were given for 4 weeks during the birch pollen season. The setting was Oslo, Norway, May 1995.

Patients were aged between 18 and 50 y; 32 patients received Betula 30c tablets and 34 patients received placebo tablets.

The main outcome measure was the total score of 17 different allergy symptoms. Daily total scores were calculated, as well as differences and ratios between the run-in and the following time periods. Point estimates of the median difference between the experimental and placebo groups, with their 95% confidence intervals, were the main measure of effect.

No statistically significant difference between the groups was found during the first and last period of May. However, from 8 to 18 May, a clinically interesting difference was revealed between the groups, those receiving Betula 30c having fewer and less serious symptoms. For some days these differences were statistically significant. Surprisingly, this group reported more aggravation from the tablets than did the placebo group.

With a statistical power of 70% for a defined clinically interesting difference (25%), the present results indicate that treatment with Betula 30c during the pollen season deserves further attention.

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顺势“免疫疗法”有效吗?一项双盲、安慰剂对照试验,用同种疗法桦30c治疗桦树花粉过敏患者
该研究的目的是检查顺势疗法桦30c与安慰剂对桦树花粉过敏患者的效果。进行了一项双盲、随机、安慰剂对照试验。在桦树花粉季节给药4周。地点是1995年5月挪威奥斯陆。患者年龄在18 - 50岁之间;32例患者服用桦30c片,34例患者服用安慰剂片。主要结果测量是17种不同过敏症状的总分。计算每日总分,以及磨合期和磨合期之间的差异和比率。试验组和安慰剂组之间的中位数差的点估计,其95%的置信区间,是效果的主要衡量标准。5月上旬和5月下旬两组间无统计学差异。然而,从5月8日到18日,两组之间出现了临床有趣的差异,接受桦30c的患者症状较少,也不那么严重。在一些日子里,这些差异在统计上是显著的。令人惊讶的是,与安慰剂组相比,这一组的病情加重程度更高。对于定义的临床有趣差异(25%),统计力为70%,本研究结果表明,在花粉季节使用桦木30c治疗值得进一步关注。
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