Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Academic Medical Center, Amsterdam, The Netherlands.
Europace. 2011 Nov;13(11):1639-47. doi: 10.1093/europace/eur200. Epub 2011 Jul 13.
Initial treatment of vasovagal syncope (VVS) consists of advising adequate fluid and salt intake, regular exercise, and physical counterpressure manoeuvres. Despite this treatment, up to 30% of patients continue to experience regular episodes of VVS. We investigated whether additional Midodrine treatment is effective in these patients.
In our study, patients with at least three syncopal and/or severe pre-syncopal recurrences during non-pharmacological treatment were eligible to receive double-blind cross-over treatment starting either with Midodrine or placebo. Treatment periods lasted for 3 months with a wash-out period of 1 week in-between. At baseline and after each treatment period, we collected data about the recurrence of syncope and pre-syncope, side effects, and quality of life (QoL). Twenty-three patients (17% male, mean age 32) included in the cross-over trial received both Midodrine and placebo treatment. The proportion of patients who experienced syncopal and pre-syncopal recurrences did not differ significantly between Midodrine and placebo treatment (syncope: 48 vs. 65%, P= 0.22; pre-syncope: 74 vs. 78%, P> 0.99). The median number of syncopes and pre-syncopes per 3 months were also not significantly different during Midodrine and placebo treatment (0 vs. 1; P= 0.57; and 6 vs. 8; P= 0.90). The occurrence of side effects was similar during Midodrine and placebo treatment (48 vs. 57%; P= 0.75). Also, QoL did not differ significantly.
Our findings indicate that additional Midodrine treatment is less effective in patients with VVS not responding to non-pharmacological treatment than reported as first-line treatment.
血管迷走性晕厥（VVS）的初始治疗包括建议充分的液体和盐摄入、规律运动以及身体对抗压力动作。尽管进行了这种治疗，仍有多达 30%的患者继续经历常规的 VVS 发作。我们研究了在这些患者中是否添加米多君治疗更为有效。
在我们的研究中，至少有三次非药物治疗期间出现晕厥和/或严重先兆晕厥发作的患者有资格接受米多君或安慰剂的双盲交叉治疗。治疗期持续 3 个月，期间有 1 周的洗脱期。在基线和每个治疗期结束时，我们收集了晕厥和先兆晕厥复发、副作用和生活质量（QoL）的数据。23 名患者（43%为男性，平均年龄 32 岁）参与了交叉试验，接受了米多君和安慰剂治疗。米多君和安慰剂治疗之间晕厥和先兆晕厥复发的患者比例无显著差异（晕厥：48% vs. 65%，P=0.22；先兆晕厥：74% vs. 78%，P>0.99）。米多君和安慰剂治疗期间每 3 个月的晕厥和先兆晕厥中位数也无显著差异（0 次 vs. 1 次；P=0.57；6 次 vs. 8 次；P=0.90）。米多君和安慰剂治疗期间副作用的发生也相似（48% vs. 57%；P=0.75）。此外，QoL 也无显著差异。
我们的研究结果表明，在对非药物治疗无反应的 VVS 患者中，添加米多君治疗不如作为一线治疗报告的那样有效。
