采用标准化的睡茄（印度人参）提取物辅助治疗精神分裂症症状恶化：一项随机、双盲、安慰剂对照研究。

Adjunctive Use of a Standardized Extract of Withania somnifera (Ashwagandha) to Treat Symptom Exacerbation in Schizophrenia: A Randomized, Double-Blind, Placebo-Controlled Study.

机构信息

Comprehensive Recovery Services, Western Psychiatric Institute and Clinic, University of Pittsburgh Medical Center, 3811 O'Hara St, Pittsburgh, PA 15213-2593.

Western Psychiatric Institute and Clinic, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.

出版信息

J Clin Psychiatry. 2018 Jul 10;79(5):17m11826. doi: 10.4088/JCP.17m11826.

DOI:10.4088/JCP.17m11826

PMID:29995356

Abstract

OBJECTIVE

To determine if adjunctive treatment with a standardized extract of Withania somnifera (WSE), with known anti-inflammatory and immunomodulating properties, improves psychopathology and stress in patients with schizophrenia or schizoaffective disorder (DSM-IV-TR).

METHODS

Patients experiencing an exacerbation of symptoms were assigned to WSE (1,000 mg/d) or placebo for 12 weeks, added to their antipsychotic medication, in a random-assignment, double-blind, placebo-controlled study conducted from April 2013 to July 2016. Primary outcomes were change from baseline to end of treatment on the Positive and Negative Syndrome Scale (PANSS total, positive, negative, and general symptoms) between treatment groups. Secondary outcomes evaluated stress and inflammatory indices using the Perceived Stress Scale (PSS), S100 calcium-binding protein B (S100B), and C-reactive protein (CRP).

RESULTS

Sixty-six randomized patients (n = 33 per group) provided efficacy data. Beginning at 4 weeks and continuing to the end of treatment, WSE produced significantly greater reductions in PANSS negative, general, and total symptoms (Cohen d: 0.83, 0.76, 0.83), but not positive symptoms, when compared to placebo. PSS scores improved significantly with WSE treatment compared to placebo (Cohen d: 0.58). CRP and S100B declined more in the WSE group but were not significantly different from placebo. Adverse events were mild to moderate and transient; somnolence, epigastric discomfort, and loose stools were more common with WSE. No significant between-treatment differences were noted in body weight, vital signs, or laboratory measures, which remained stable.

CONCLUSIONS

This early study suggests that adjunctive treatment with a standardized extract of Withania somnifera provides significant benefits, with minimal side effects, for negative, general, and total symptoms and stress in patients with recent exacerbation of schizophrenia.

TRIAL REGISTRATION

ClinicalTrials.gov identifier: NCT01793935.

摘要

目的

确定具有已知抗炎和免疫调节特性的茄属植物标准化提取物（WSE）辅助治疗是否能改善精神分裂症或分裂情感障碍（DSM-IV-TR）患者的精神病理学和应激。

方法

在 2013 年 4 月至 2016 年 7 月进行的一项随机分组、双盲、安慰剂对照研究中，将处于症状恶化期的患者随机分配至 WSE（1000mg/d）或安慰剂组，同时添加到他们的抗精神病药物治疗中。主要结局是治疗组从基线到治疗结束时阳性和阴性综合征量表（PANSS 总分、阳性、阴性和一般症状）的变化。次要结局是使用压力感知量表（PSS）、S100 钙结合蛋白 B（S100B）和 C 反应蛋白（CRP）评估应激和炎症指标。

结果

66 名随机患者（每组 33 名）提供了疗效数据。从第 4 周开始，WSE 治疗组的 PANSS 阴性、一般和总分症状显著减轻（Cohen d：0.83、0.76、0.83），但阳性症状没有改善，与安慰剂相比。与安慰剂相比，WSE 治疗组的 PSS 评分显著改善（Cohen d：0.58）。WSE 组的 CRP 和 S100B 下降更明显，但与安慰剂相比无显著差异。不良反应为轻度至中度且短暂；WSE 组更常见的不良反应是嗜睡、上腹部不适和稀便。体重、生命体征或实验室指标无显著组间差异，且保持稳定。