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婆罗米丸治疗广泛性焦虑症的疗效——随机双盲对照临床试验

Efficacy of Brahmi vati in generalised anxiety disorder - Randomized double blind comparative clinical trial.

作者信息

Khot Siddhi G, Tubaki Basavaraj R, Gonugade Varsha B

机构信息

Department of Kayachikitsa, Dr. N. A. Magadum Ayurvedic Medical College, Hospital & Research Centre, Ankali, Taluk-Chikodi, District-Belagavi, Karnataka, 591213, India.

Department of Kayachikitsa, Shri BMK Ayurveda Mahavidyalaya, A Constituent Unit of KLE Academy of Higher Education & Research, Belagavi, Karnataka, 590003, India.

出版信息

J Ayurveda Integr Med. 2022 Apr-Jun;13(2):100552. doi: 10.1016/j.jaim.2022.100552. Epub 2022 Mar 21.

Abstract

BACKGROUND

Generalized Anxiety Disorder (GAD) is the most common anxiety disorder. GAD has high comorbidities and it can affect social, professional and personal life. Ayurvedic medicine, Brahmi vati is explored for the possible role in management of GAD and is compared to Manasmitra vataka.

AIM

To evaluate the efficacy of B. vati on Generalized Anxiety Disorder.

METHODS

A randomized double blind controlled trial, with total 56 patients meeting the DSM V criteria of GAD between 20-60 years of age and either sex participated in the study. Participants were randomly divided into two groups, Brahmi group received capsule B. vati 500 mg and Manasmitra group received capsule M. vataka 500 mg thrice a day with water for 45 days. Assessments were conducted through various clinical parameters such as Hamilton Anxiety Rating Scale (HARS), GAD 7 scale (GAD 7), Beck Depression Inventory scale (BDI), Epworth sleepiness scale (ESS), Pittsburgh Sleep Quality Index (PSQI), WHO Quality of Life- BREF (WHOQOL-BREF), Clinical Global Improvement scale (CGI). Blood variables including Haemoglobin, Erythrocyte Sedimentation Rate (ESR), Liver Function Test (LFT) and serum creatinine were assessed before and after the study. Assessments during intervention were conducted on every 15th day.

RESULTS

Study results indicate that both B. vati and M. vataka were comparable and each produced significant improvement (p < 0.001) in HARS, GAD-7, BDI, ESS, PSQI, WHOQOL-BREF and CGI. Brahmi vati also produced significant decrease in systolic (p = 0.002) and diastolic (p < 0.001) blood pressure. Both groups showed good safety profile evaluated through the assessment of serum creatinine levels and LFT.

CONCLUSION

B. vati and M. vataka were effective, safe and comparable in the management of GAD. Warrants further studies.

摘要

背景

广泛性焦虑障碍(GAD)是最常见的焦虑症。GAD共病率高,会影响社交、职业和个人生活。人们探索了印度草药疗法中的婆罗米丸在GAD管理中的可能作用,并将其与心智平衡丸进行比较。

目的

评估婆罗米丸对广泛性焦虑障碍的疗效。

方法

一项随机双盲对照试验,共有56名年龄在20至60岁之间、符合GAD的DSM-V标准的男女患者参与研究。参与者被随机分为两组,婆罗米组服用500毫克婆罗米丸胶囊,心智平衡组服用500毫克心智平衡丸胶囊,每天三次,用水送服,持续45天。通过各种临床参数进行评估,如汉密尔顿焦虑量表(HARS)、GAD-7量表(GAD-7)、贝克抑郁量表(BDI)、爱泼沃斯嗜睡量表(ESS)、匹兹堡睡眠质量指数(PSQI)、世界卫生组织生活质量简表(WHOQOL-BREF)、临床总体改善量表(CGI)。在研究前后评估包括血红蛋白、红细胞沉降率(ESR)、肝功能检查(LFT)和血清肌酐在内的血液变量。干预期间每15天进行一次评估。

结果

研究结果表明,婆罗米丸和心智平衡丸具有可比性,二者在HARS、GAD-7、BDI、ESS、PSQI、WHOQOL-BREF和CGI方面均产生了显著改善(p < 0.001)。婆罗米丸还使收缩压(p = 0.002)和舒张压(p < 0.001)显著降低。通过血清肌酐水平和LFT评估,两组均显示出良好的安全性。

结论

婆罗米丸和心智平衡丸在GAD的管理中有效、安全且具有可比性。值得进一步研究。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/19c2/8943402/45fadc52f86d/gr1.jpg

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