Hajak Göran, Vetter Céline, Wehling Martin
Clinic for Psychiatry, Psychosomatic Medicine and Psychotherapy, Sozialstiftung Social Foundation Bamberg, Teaching Hospital of the University of Erlangen, 96049 Bamberg, Germany.
IQVIA Commercial GmbH & Co. KG, 60549 Frankfurt am Main, Germany.
Healthcare (Basel). 2024 Jul 16;12(14):1413. doi: 10.3390/healthcare12141413.
Real-world evidence on the association between natural medicinal products and the recurrence of sleep disorders is currently limited, particularly when compared to the evidence reported for prescription hypnotics. In a retrospective cohort analysis, we investigated patients with sleep disorders prescribed either the natural medicinal product Neurexan (Nx4), benzodiazepines, or nonbenzodiazepines (Z-drugs) using the IQVIA Disease Analyzer database, which encompasses electronic medical records nationwide in Germany. A 1:1 matching procedure based on age, sex, prevalent depression, anxiety or adjustment disorder, and the number of medical consultations in the past 12 months resulted in four cohorts: patients prescribed Nx4 were matched with those prescribed Z-drugs (two cohorts with 8594 matched patients each), and another cohort of patients prescribed Nx4 were matched with those prescribed benzodiazepines (7779 matched pairs). Results from multivariable-adjusted Cox regression models demonstrated that Nx4 was associated with a significantly lower risk of recurrent sleep disorder diagnosis within 30-365 days after prescription compared to both Z-drugs (HR = 0.65, 95%CI = 0.60-0.70, < 0.001) and benzodiazepines (HR = 0.85, 95%CI = 0.79-0.93, < 0.001). Additionally, Nx4 was associated with a lower prevalence of depression compared to Z-drugs (HR = 0.90, 95%CI = 0.83-0.98, = 0.020) and benzodiazepines (HR = 0.89, 95%CI = 0.82-0.97, = 0.009). These findings suggest an association between Nx4 and improved sleep and mental health outcomes. However, due to inherent limitations in the study design, the causality of this relationship cannot be stated.
目前,关于天然药用产品与睡眠障碍复发之间关联的真实世界证据有限,尤其是与处方催眠药的相关证据相比。在一项回顾性队列分析中,我们使用IQVIA疾病分析数据库调查了被处方天然药用产品Neurexan(Nx4)、苯二氮䓬类药物或非苯二氮䓬类药物(Z类药物)的睡眠障碍患者,该数据库涵盖了德国全国的电子病历。基于年龄、性别、既往抑郁症、焦虑症或适应障碍以及过去12个月内的医疗咨询次数进行1:1匹配程序,得到了四个队列:被处方Nx4的患者与被处方Z类药物的患者匹配(两个队列,每个队列有8594名匹配患者),另一组被处方Nx4的患者与被处方苯二氮䓬类药物的患者匹配(7779对匹配患者)。多变量调整后的Cox回归模型结果表明,与Z类药物(HR = 0.65,95%CI = 0.60 - 0.70,P < 0.001)和苯二氮䓬类药物(HR = 0.85,95%CI = 0.79 - 0.93,P < 0.001)相比,Nx4与处方后30 - 365天内睡眠障碍复发诊断风险显著降低相关。此外,与Z类药物(HR = 0.90,95%CI = 0.83 - 0.98,P = 0.020)和苯二氮䓬类药物(HR = 0.89,95%CI = 0.82 - 0.97,P = 0.009)相比,Nx4与抑郁症患病率较低相关。这些发现表明Nx4与改善睡眠和心理健康结果之间存在关联。然而,由于研究设计存在固有局限性,无法确定这种关系的因果性。