Comprehensive Recovery Services, Western Psychiatric Institute and Clinic, University of Pittsburgh Medical Center, 3811 O'Hara St, Pittsburgh, PA
J Clin Psychiatry. 2013 Nov;74(11):1076-83. doi: 10.4088/JCP.13m08413.
Cognitive impairments contribute significantly to inadequate functional recovery following illness episodes in bipolar disorder, yet data on treatment interventions are sparse. We assessed the cognitive effects of a standardized extract of the medicinal herb Withania somnifera (WSE) in bipolar disorder.
Sixty euthymic subjects with DSM-IV bipolar disorder were enrolled in an 8-week, double-blind, placebo-controlled, randomized study of WSE (500 mg/d) as a procognitive agent added adjunctively to the medications being used as maintenance treatment for bipolar disorder. Study enrollment and data analyses were completed between December 2008 and September 2012. Cognitive testing at baseline and 8 weeks assessed primary efficacy outcomes. Psychopathology and adverse events were monitored at scheduled visits.
Fifty-three patients completed the study (WSE, n = 24; placebo, n = 29), and the 2 groups were matched in terms of demographic, illness, and treatment characteristics. Compared to placebo, WSE provided significant benefits for 3 cognitive tasks: digit span backward (P = .035), Flanker neutral response time (P = .033), and the social cognition response rating of the Penn Emotional Acuity Test (P = .045). The size of the WSE treatment effect for digit span backward was in the medium range (Cohen d = 0.51; 95% CI, 0.25-0.77). None of the other cognitive tasks showed significant between-group differences. Mood and anxiety scale scores remained stable, and adverse events were minor.
Although results are preliminary, WSE appears to improve auditory-verbal working memory (digit span backward), a measure of reaction time, and a measure of social cognition in bipolar disorder. Given the paucity of data for improving cognitive capacity in bipolar disorder, WSE offers promise, appears to have a benign side-effects profile, and merits further study.
ClinicalTrials.gov identifier: NCT00761761.
认知障碍会显著影响双相情感障碍患者在疾病发作后的功能恢复，但目前关于治疗干预的数据还很缺乏。我们评估了药用植物南非醉茄（WSE）提取物治疗双相情感障碍的认知效应。
60 名符合 DSM-IV 双相情感障碍诊断的缓解期患者参与了一项为期 8 周的、双盲、安慰剂对照、随机研究，研究将 WSE（500mg/d）作为一种认知促进剂添加到维持双相情感障碍治疗的药物中。研究招募和数据分析于 2008 年 12 月至 2012 年 9 月之间完成。在基线和 8 周时进行认知测试，以评估主要疗效结果。在预定访视时监测精神病理学和不良事件。
53 名患者完成了研究（WSE 组，n=24；安慰剂组，n=29），两组在人口统计学、疾病和治疗特征方面相匹配。与安慰剂相比，WSE 在 3 项认知任务上提供了显著的益处：数字跨度后向（P=0.035）、Flanker 中性反应时间（P=0.033）和宾夕法尼亚情感敏锐度测试的社会认知反应评分（P=0.045）。WSE 对数字跨度后向的治疗效果大小处于中等范围（Cohen d=0.51；95%CI，0.25-0.77）。其他认知任务均未显示出显著的组间差异。情绪和焦虑量表评分保持稳定，不良事件轻微。
尽管结果尚属初步，但 WSE 似乎可以改善双相情感障碍患者的听觉言语工作记忆（数字跨度后向）、反应时间和社会认知。鉴于改善双相情感障碍认知能力的数据很少，WSE 具有一定的前景，且具有良性的副作用特征，值得进一步研究。
ClinicalTrials.gov 标识符：NCT00761761。
