Ernst A, Schlattmann P, Waldfahrer F, Westhofen M
HNO-Klinik im ukb.
Hals-Nasen-Ohren-Klinik, Kopf- und Halschirurgie, Universitätsklinikum Erlangen.
Laryngorhinootologie. 2017 Aug;96(8):519-521. doi: 10.1055/s-0043-113690. Epub 2017 Aug 29.
The BEMED study (BMJ 2016; 352: DOI 10.1136) was designed as multi-centric, double-blind, plaebo-controlled study in patients with Menière's disease. It should compare a low-level (2 × 24 mg/d) vs. high-level (3 × 48 mg/d) betahstine intake vs. placebo. The primary endpoint was the "number of vertigo attacks lasting longer than 20 min as documented in a patient's diary". The main finding of the study was that betahistine did not significantly better reduced the number of vertigo attacks than placebo. Therefore, the BEMED study should be critically discussed in the present paper.
BEMED研究(《英国医学杂志》2016年;352卷:DOI 10.1136)设计为一项针对梅尼埃病患者的多中心、双盲、安慰剂对照研究。该研究比较低剂量(2×24毫克/天)与高剂量(3×48毫克/天)倍他司汀摄入量与安慰剂的效果。主要终点是“患者日记中记录的持续超过20分钟的眩晕发作次数”。该研究的主要发现是,倍他司汀在减少眩晕发作次数方面并不比安慰剂有显著更好的效果。因此,本文应对BEMED研究进行批判性讨论。