Does blinding of readers affect the results of meta-analyses?

Does blinding of readers affect the results of meta-analyses?
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DOI:
10.1016/s0140-6736(05)62352-5
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发表时间:
1997-07-19
期刊:
影响因子:
168.9
通讯作者:
Berlin, JA
Berlin, JA
中科院分区:
医学1区
文献类型:
--
作者:
Berlin, JA

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虽然夜惊很少见,但它很难治疗,也是一个主要的管理问题,尤其是当伴有梦游或其他无意识行为时。据报道,起床后意识混乱期间会发生严重伤害(有时甚至死亡),1 和更频繁的发作会导致严重的睡眠中断,这可能会损害随后的白天功能并导致精神合并症。因此,夜惊会导致严重的残疾,有效的治疗将对患者及其家人有益。有报道称使用苯二氮卓类药物 1 丙咪嗪 2 和长期心理治疗 3 但只有苯二氮卓类药物取得了显着的成功。选择性血清素再摄取抑制剂(SSRI)具有抗惊恐作用,并且夜间惊恐发作和夜惊的症状有一些重叠。我们报告了一系列六名患有夜惊的患者,由于令人痛苦或危险的伴随行为或睡眠中断而转诊接受药物治疗。所有六名患者均接受了临床评估和家庭多导睡眠图(medilog)评估。所有患者均对 SSRI 帕罗西汀治疗有反应(表)。在这些患者中,帕罗西汀对于治疗长期的、致残性的夜惊是有效的,并且可能与苯二氮卓类药物一样有效,尽管正式的比较是必要的。我们的两名患者在服用苯二氮卓类药物时感到恐惧,可能是因为帕罗西汀不会产生耐受性。与苯二氮卓类药物相比,帕罗西汀的其他优点是它可以治疗共病或继发性抑郁症,并且不是滥用药物。我们认为帕罗西汀的恐怖抑制作用是其通过阻断再摄取来增加脑干中 5-羟色胺 (5-HT) 浓度的能力的直接作用。刺激导水管周围灰质很容易引发动物和人类的恐怖行为,4, 5,而动物的这种行为可以通过急性施用 SSRI 和直接作用的 5HT2c 受体激动剂来抑制。 4 5HT2c 激动剂正在临床开发中,用于治疗焦虑和抑郁,测试它们对夜惊的功效将会很有趣。帕罗西汀对睡眠的影响是已知的,但可能不会影响其对夜惊的影响。帕罗西汀的治疗作用可能是直接的,而不是通过神经适应性机制(被认为是抗惊恐作用的基础)的进一步证据来自停止治疗后复发的患者。随着帕罗西汀的血浆和大脑浓度下降,夜惊迅速复发,重新开始治疗很快又再次抑制了夜惊。在一名患者中,治疗效果似乎与剂量相关。先前报道的对丙咪嗪有反应的两个病例也迅速反应,表明抗抑郁作用的作用方式不同。丙咪嗪还具有 5-HT 摄取阻断作用。我们发现帕罗西汀是一种安全有效的治疗方法,可以治疗一小部分患者的夜惊症状。帕罗西汀这样的选择性药物的有效性也可能表明中枢 5-HT 功能下降在夜惊的病因学中发挥了作用。
Although rare, night terrors are difficult to treat and a major management problem, especially when accompanied by sleepwalking or other automatic behaviours. Severe injury (sometimes death) during the period of confusion following the rise from bed has been reported, 1 and more frequent attacks lead to serious disruption of sleep, which may impair subsequent daytime functioning and result in psychiatric comorbidity. Night terrors can thus cause severe disability, and effective therapy would be of benefit to patients and their families. There have been reports of treatment with benzodiazepines, 1 imipramine, 2 and longterm psychotherapy, 3 but only benzodiazepines have shown any notable success. Selective serotonin reuptake inhibitors (SSRIs) have antipanic actions and there is some overlap in symptoms of nocturnal panic attacks and night terrors. We report a series of six patients with night terrors, referred for drug treatment because of distressing or dangerous accompanying behaviours, or sleep disruption. All six patients were assessed clinically and by home polysomnography (medilog). All responded to treatment with the SSRI paroxetine (table). In these patients paroxetine was effective in the treatment of longstanding and disabling night terrors and may be as effective as benzodiazepines, although formal comparison is necessary. Two of our patients were having terrors while on benzodiazepines, possibly because of the development of tolerance which does not occur with paroxetine. Other advantages of paroxetine over benzodiazepines is that it treats comorbid or secondary depression and is not a drug of abuse. We suggest that the terror-suppressing action of paroxetine is a direct effect of its ability to increase 5-hydroxytryptamine (5-HT) concentrations in the brainstem by blocking reuptake. Terror-like behaviour in animals and man can be readily provoked by stimulation of the periaqueductal grey matter, 4, 5 and this behaviour in animals is suppressed by acute administration of SSRIs and direct-acting 5HT2c receptor agonists. 4 5HT2c agonists are in clinical development for the treatment of anxiety and depression and it would be interesting to test their efficacy in night terrors. The effects of paroxetine on sleep are known and probably do not contribute to its effect on night terrors. Further evidence that the therapeutic action of paroxetine may be direct rather than through a neuroadaptive mechanism (thought to underlie the antipanic action) comes from the patients who had relapse after stopping treatment. Night terrors recurred rapidly as plasma and brain concentrations of paroxetine fell, and restarting treatment quickly suppressed them again. In one patient the treatment effect seemed dose related. The two cases previously reported to have responded to imipramine also responded rapidly, suggesting a different mode of action to the antidepressant effect. Imipramine also has5-HT-uptake blocking effects. We found paroxetine to be a safe and effective treatment for disabling night terrors in a small group of patients. The effectiveness of such a selective agent as paroxetine may also suggest a role for decreased central 5-HT function in the aetiology of night terrors.