Moazen-Zadeh Ehsan, Abbasi Seyed Hesameddin, Safi-Aghdam Hamideh, Shahmansouri Nazila, Arjmandi-Beglar Akram, Hajhosseinn Talasaz Azita, Salehiomran Abbas, Forghani Saeedeh, Akhondzadeh Shahin
1 Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences , Tehran, Iran .
2 Tehran Heart Center, Tehran University of Medical Sciences , Tehran, Iran .
J Altern Complement Med. 2018 Apr;24(4):361-368. doi: 10.1089/acm.2017.0173. Epub 2017 Nov 29.
Cognitive decline, depression, and anxiety are among the major concerns in patients undergoing coronary artery bypass grafting (CABG). Crocus sativus L. (saffron) seems to be a promising candidate for treatment of these conditions.
In this 12-week, randomized, double-blind, placebo-controlled clinical trial, men and women with on-pump CABG, who had Wechsler Memory Scale (WMS) score >70 and age <70 years, received either saffron capsules (15 mg/twice daily) or placebo. Patients were excluded if they had history of treatment with saffron or acetylcholinesterase inhibitors, comorbid neuropsychiatric disorders, serious medical conditions other than cardiovascular diseases, and hypersensitivity to herbal compounds. The primary outcome was defined as the difference in mean total score changes for WMS-Revised from the baseline to week 12 between the saffron and placebo groups. Secondary outcomes included difference in mean score changes from baseline to endpoint between the two treatment groups for Mini Mental Status Examination and subscales of Hospital Anxiety and Depression Scale ( www.irct.ir ; IRCT201408071556N63).
No significant difference was detected in primary or secondary outcomes between the saffron and placebo groups. Also, no significant time × treatment interaction effect was found for any of the scales.
The results of this trial do not support the hypothesis of potential benefits of saffron in treatment of CABG-related neuropsychiatric conditions.
认知功能减退、抑郁和焦虑是接受冠状动脉搭桥术(CABG)患者的主要担忧问题。藏红花似乎是治疗这些病症的一个有前景的候选药物。
在这项为期12周的随机、双盲、安慰剂对照临床试验中,接受体外循环CABG且韦氏记忆量表(WMS)得分>70分、年龄<70岁的男性和女性,接受藏红花胶囊(15毫克/每日两次)或安慰剂治疗。如果患者有藏红花或乙酰胆碱酯酶抑制剂治疗史、合并神经精神疾病、除心血管疾病外的严重疾病以及对草药化合物过敏,则被排除。主要结局定义为藏红花组和安慰剂组从基线到第12周WMS修订版平均总分变化的差异。次要结局包括两个治疗组在简易精神状态检查表以及医院焦虑抑郁量表各子量表(www.irct.ir;IRCT201408071556N63)上从基线到终点的平均得分变化差异。
藏红花组和安慰剂组在主要或次要结局方面均未检测到显著差异。此外,在任何量表上均未发现显著的时间×治疗交互效应。
该试验结果不支持藏红花对治疗CABG相关神经精神疾病有潜在益处的假设。