Background: Agitation poses a significant challenge in the treatment of schizophrenia. Electroconvulsive therapy (ECT) is a fast, effective and safe treatment for a variety of psychiatric disorders, but no meta-analysis of ECT treatment for agitation in schizophrenia has yet been reported.
Aims: To systematically evaluate the efficacy and safety of ECT alone or ECT-antipsychotics (APs) combination for agitation in schizophrenia.
Methods: Systematic literature search of randomized controlled trials (RCTs) was performed. Two independent evaluators selected studies, extracted data about outcomes and safety with available data, conducted quality assessment and data synthesis. The Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) was used to judge the level of the overall evidence of main outcomes.
Results: Seven RCTs from China, including ECT alone (4 RCTs with 5 treatment arms, n=240) and ECT-APs combination (3 RCTs, n=240), were identified. Participants in the studies were on average 34.3(4.5) years of age and lasted an average of 4.3(3.1) weeks of treatment duration. All 7 RCTs were non-blinded, and were rated as low quality based on Jadad scale. Meta-analysis of the pooled sample found no significant difference in the improvement of the agitation sub-score of the Positive and Negative Syndrome Scale (PANSS) when ECT alone (weighted mean difference=-0.90, (95% confidence interval (CI): -2.91, 1.11), p=0.38) or ECT-APs combination (WMD=-1.34, (95%CI: -4.07, 1.39), p=0.33) compared with APs monotherapy. However, ECT alone was superior to APs monotherapy regarding PANSS total score (WMD=-7.13, I2=0%, p=0.004) and its excitement sub-score (WMD=-1.97, p<0.0001) as well as the PANSS total score at 14 days (WMD=-7.13, I2 =0%, p=0.004) and its excitement sub-score at 7 and 14 days (WMD=-1.97 to -1.92, p=0.002 to 0.0001) after ECT. The ECT-APs combination was superior to APs monotherapy with respect to the PANSS total score at treatment endpoint (WMD=-10.40, p=0.03) and 7 days (WMD=-5.01, p=0.02). Headache (number-needed-to-harm (NNH)=3, 95%CI=2-4) was more frequent in the ECT alone group compared to AP monotherapy. According to the GRADE approach, the evidence levels of main outcomes were rated as ''very low'' (37.5%) and "low" (50%).
Conclusion: Pooling of the data based on 7 RCTs from China found no advantage of ECT alone or ECT-APs combination in the treatment of agitation related outcomes in schizophrenia patients. However, ECT alone or ECT-APs combination were associated with significant reduction in the PANSS total score. High-quality RCTs are needed to confirm the current interpretations.
背景: 躁动在精神分裂症治疗中是一个重大挑战。电 休克疗法（ECT）对各种精神疾病是一种快速、有效、 和安全的治疗，但ECT 对精神分裂症的躁动治疗的相 关meta 分析还尚未报道。.
目标: 系统地评估单一使用ECT 或ECT 合并使用其他 抗精神病药物（APs）的对精神分裂症的躁动治疗的有 效性和安全性。.
方法: 进行随机对照试验（RCT）的系统文献搜索。 两名独立评估者筛选研究、提取结果数据与现有数据 的安全性、进行质量评估和数据合成。采用建议、评估、 开发、和评价的工作组等级（GRADE）来判断主要成 果的证据的总体水平。.
结果: 一共确定了中国有七个RCTs，包括ECT 单一 使用（4 个RCTs 有5 个治疗组，n = 240）和ECT-APs 合并使用（3 个RCTs，n = 240）。研究对象平均年龄 34.3（4.5）岁，平均治疗时间为4.3（3.1）周。所有7 个RCTs 非盲法，并且根据Jadad 量表7 项RCTs 均被评 为低质量。样本的Meta 分析发现与APs 单一治疗相比， 单一使用ECT 或ECT-APs 合并使用阳性和阴性症状量 表（PANSS）的躁动子因子评分改善均无显著性差异（ECT 单一使用: weighted mean difference（WMD）=-0.90, 95% confidence interval (CI): (-2.91, 1.11), p=0.38; ECT-APs 合并使用：WMD=-1.34, (95%CI: -4.07, 1.39), p=0.33）。 然而，PANSS 总分（WMD=-7.13, I2=0%, p=0.004）和 兴奋子因子评分（WMD=-1.97, p<0.0001）、ECT 治疗 14 天后的PANSS 总分（WMD=-7.13, I2=0%, p=0.004） 和第7 天和第14 天的兴奋子因子评分（WMD=-1.97 to -1.92, p=0.002 to 0.0001）均显示单一使用ECT 优 于APs 单一治疗。ECT-APs 合并治疗结束时（WMD=- 10.40, p=0.03）和治疗后7 天（WMD=-5.01, p=0.02）的 PANSS 总分显示均优于APs 单药治疗。头痛（p=0.0001, number-needed-to-harm (NNH)=3, 95%CI=2-4）是唯一 的ECT 单一治疗后不良反应，并且ECT 单一治疗组比 APs 单药治疗发生的更频繁。根据GRADE 方法，主要 结果的证据水平被评为“ 非常低”（37.5%）和“ 低” （50%）.
结论: 基于中国7 个RCTs 合并的数据发现ECT 单一治 疗或ECT-APs 合并治疗在精神分裂症患者的躁动治疗 中并没有优势。然而，ECT 单一治疗或ECT-APs 合并治 疗均与PANSS 总分减低显著有关。需要高质量的RCTs 验证目前的解释。.
Keywords: Electroconvulsive therapy; agitation; headache; meta-analysis; schizophrenia.