Engelstraat 16, 8211 Aartrijke, Belgium, Rohrbach, Germany.
Evid Based Complement Alternat Med. 2009 Dec;6(4):507-15. doi: 10.1093/ecam/nem144. Epub 2007 Oct 25.
In an open-label, prospective non-randomized cohort study, we compared the effectiveness and tolerability profiles of the homeopathic remedy Nervoheel N with those of the benzodiazepine, lorazepam, in 248 patients with insomnia, distress, anxieties, restlessness or burnout and similar nervous conditions ('mild nervous disorders'). Patients were treated with Nervoheel N or lorazepam at the recommended doses for a maximum of 4 weeks. Dose variations were allowed if in the patient's best interest. Treatment effects were evaluated by the practitioner in a dialogue with the patient at the start of treatment, after 2 weeks and after maximally 4 weeks of treatment. Tolerability data were recorded as adverse events. At baseline, lorazepam patients were on average slightly older and there was a somewhat greater percentage of men in this group than in the Nervoheel group. Both treatment groups reported significant symptomatic improvements of similar magnitude during the course of the study. The sum of symptom scores improved by 4.4 points with Nervoheel N and by 4.2 points with lorazepam. The differences between the treatment groups were not significant. All differences between treatments were within 10% of the maximum score ranges, demonstrating non-inferiority of Nervoheel N. Both treatments were well tolerated, with few adverse events and very good self-assessed tolerability ratings by the patients. Thus, in patients who opt for a homeopathic treatment regimen for the short-term relief of mild nervous disorders, the effects of Nervoheel N are non-inferior to those of lorazepam.
在一项开放标签、前瞻性非随机队列研究中,我们比较了顺势疗法制剂 Nervoheel N 与苯二氮䓬类药物劳拉西泮在 248 例失眠、痛苦、焦虑、不安或倦怠和类似神经症患者(“轻度神经障碍”)中的疗效和耐受性特征。患者以推荐剂量接受 Nervoheel N 或劳拉西泮治疗,最长 4 周。如果符合患者最佳利益,可以进行剂量调整。治疗效果由医生在治疗开始时与患者对话、治疗 2 周后和最长 4 周后进行评估。耐受性数据作为不良事件记录。在基线时,劳拉西泮组患者的年龄略大,且该组男性比例略高于 Nervoheel 组。两组患者在研究过程中均报告了相似程度的显著症状改善。Nervoheel N 组的症状评分总和改善了 4.4 分,劳拉西泮组改善了 4.2 分。治疗组之间的差异无统计学意义。所有治疗差异均在最大评分范围的 10%以内,表明 Nervoheel N 具有非劣效性。两种治疗方法均耐受良好,不良事件少,患者自我评估的耐受性良好。因此,对于选择短期缓解轻度神经障碍的顺势疗法治疗方案的患者,Nervoheel N 的疗效不劣于劳拉西泮。