Mental Health Program, The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia.
Division of Psychological and Social Medicine, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.
Cochrane Database Syst Rev. 2022 Nov 17;11(11):CD003690. doi: 10.1002/14651858.CD003690.pub5.
Antidepressants may be useful in the treatment of abnormal crying associated with stroke. This is an update of a Cochrane Review first published in 2004 and last updated in 2019.
To evaluate the benefits and harms of pharmaceutical treatment in people with emotionalism after stroke.
We searched the Cochrane Stroke Group Register, CENTRAL, MEDLINE, Embase, four other databases, and three trials registers (May 2022).
We included randomised controlled trials (RCTs) and quasi-RCTs comparing psychotropic medication to placebo in people with stroke and emotionalism (also known as emotional lability, pathological crying or laughing, emotional incontinence, involuntary emotional expression disorder, and pseudobulbar affect).
Two review authors independently selected trials, assessed risk of bias, extracted data from all included trials, and used GRADE to assess the certainty of the body of evidence. We calculated the mean difference (MD) or standardised mean difference (SMD) for continuous data and the risk ratio (RR) for dichotomous data, with 95% confidence intervals (CIs). We assessed heterogeneity using the I statistic. The primary emotionalism measures were the proportion of participants achieving at least a 50% reduction in abnormal emotional behaviour at the end of treatment, improved score on the Center for Neurologic Study - Lability Scale (CNS-LS) or Clinician Interview-Based Impression of Change (CIBIC), or diminished tearfulness.
We did not identify any new trials for this update. We included seven trials with a total of 239 participants. Two trials had a cross-over design, but outcome data were not available from the first phase (precross-over) in an appropriate format for inclusion as a parallel randomised controlled trial (RCT). Thus, the results of the review are based on five trials with a total of 213 participants. It is uncertain whether fluoxetine increases the number of people who have a 50% reduction in emotionalism when compared to placebo (risk ratio (RR) 0.26, 95% CI 0.09 to 0.77; P = 0.02; 1 trial, 19 participants) because the certainty of evidence is very low. Sertraline may lead to little to no difference in Center for Neurologic Study - Lability Scale (CNS-LS) scores and Clinician Interview-Based Impression of Change (CIBIC) scores when compared to placebo (RR 0.20, 95% CI 0.03 to 1.50; P = 0.12; 1 trial, 28 participants; low-certainty evidence). Antidepressants probably increase the number of people who experience a reduction in tearfulness (RR 0.32, 95% CI 0.12 to 0.86; P = 0.02; 3 trials, 164 participants; moderate-certainty evidence). No trials were found that evaluated the impact of other pharmaceutical interventions. Only two trial authors systematically recorded and reported adverse events, resulting in limited data on the potential harms of treatment. Six trials reported death as an adverse event and found no difference between the groups (antidepressants versus placebo) in the number of deaths reported (RR 0.59, 95% CI 0.08 to 4.50; P = 0.61; 172 participants; moderate-certainty evidence). This review provides very low- to moderate-certainty evidence that antidepressants may reduce the frequency and severity of emotionalism. The included trials were small and had some degree of bias.
AUTHORS' CONCLUSIONS: Antidepressants may reduce the frequency and severity of crying or laughing episodes when compared to placebo, based on very low-certainty evidence. Our conclusions must be qualified by several methodological deficiencies in the trials and interpreted with caution despite the effect being very large. The effect does not seem specific to one drug or class of drugs. More reliable data are required before appropriate conclusions can be made about the treatment of post-stroke emotionalism. Future trialists investigating the effect of antidepressants in people with emotionalism after stroke should consider developing and using a standardised method to diagnose emotionalism, determine severity, and assess change over time; provide treatment for a sufficient duration and follow-up to better assess rates of relapse or maintenance; and include careful assessment and complete reporting of adverse events.
抗抑郁药可能对中风后异常哭泣有治疗作用。这是 2004 年首次发表并于 2019 年最后更新的 Cochrane 综述的更新内容。
评估药物治疗对中风后情感障碍患者的益处和危害。
我们检索了 Cochrane 卒中组注册库、CENTRAL、MEDLINE、Embase、另外四个数据库以及三个试验注册库（2022 年 5 月）。
我们纳入了随机对照试验（RCT）和准随机对照试验，比较了在中风后出现情感障碍（也称为情感不稳定、病理性哭笑、情感失禁、不随意情感表达障碍和假性延髓性情感障碍）的患者中使用精神药物与安慰剂的效果。
两名综述作者独立选择试验、评估偏倚风险、从所有纳入的试验中提取数据，并使用 GRADE 评估证据体的确定性。我们计算了连续数据的均数差（MD）或标准化均数差（SMD），二分类数据的风险比（RR），置信区间（CI）为 95%。我们使用 I ²统计量评估异质性。主要的情感障碍指标是在治疗结束时至少有 50%的异常情感行为得到改善的参与者比例、中心神经功能研究-不稳定性量表（CNS-LS）或临床医生访谈基于变化印象量表（CIBIC）评分的改善，或减少流泪。
我们没有为本次更新确定任何新的试验。我们纳入了 7 项试验，共 239 名参与者。两项试验采用交叉设计，但结果数据无法以适当的格式从第一阶段（交叉前）获得，无法作为平行随机对照试验（RCT）纳入。因此，本综述的结果基于 5 项试验，共 213 名参与者。尚不确定氟西汀是否能比安慰剂增加情感障碍减少 50%的人数（RR 0.26，95%CI 0.09 至 0.77；P = 0.02；1 项试验，19 名参与者），因为证据的确定性非常低。与安慰剂相比，舍曲林可能对 CNS-LS 评分和临床医生访谈基于变化印象量表（CIBIC）评分没有差异或仅有轻微差异（RR 0.20，95%CI 0.03 至 1.50；P = 0.12；1 项试验，28 名参与者；低质量证据）。抗抑郁药可能会增加流泪减少的人数（RR 0.32，95%CI 0.12 至 0.86；P = 0.02；3 项试验，164 名参与者；中等质量证据）。没有发现评估其他药物干预影响的试验。只有两位试验作者系统地记录和报告了不良事件，因此治疗潜在危害的数据有限。6 项试验报告了死亡作为不良事件，且两组（抗抑郁药与安慰剂）之间的死亡人数无差异（RR 0.59，95%CI 0.08 至 4.50；P = 0.61；172 名参与者；中等质量证据）。本综述提供了非常低至中等质量的证据，表明抗抑郁药可能会减轻情感障碍的频率和严重程度。纳入的试验规模较小，存在一定程度的偏倚。
基于非常低质量的证据，抗抑郁药可能会减少与安慰剂相比中风后哭泣或大笑发作的频率和严重程度。我们的结论必须受到试验方法学缺陷的限制，并谨慎解释，尽管效果非常大。这种效果似乎并不特定于一种药物或一类药物。在对中风后情感障碍患者的治疗做出适当结论之前，需要更可靠的数据。未来研究情感障碍的抗抑郁药治疗效果的试验人员应考虑制定和使用标准化方法来诊断情感障碍、确定严重程度以及评估随时间的变化；提供足够的治疗时间和随访，以更好地评估复发或维持的比率；并包括仔细评估和完整报告不良事件。
