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阿育吠陀草药制剂玛哈瑞诗·阿姆里特·卡拉斯的疗效与安全性:随机对照试验的系统评价

Efficacy and safety of the Ayurvedic herbal preparation Maharishi Amrit Kalash: a systematic review of randomized controlled trials.

作者信息

Koch Anna K, Patel Manish, Gupta Shivenarain, Wullenkord Ricarda, Jeitler Michael, Kessler Christian S

机构信息

Department of Internal Medicine and Nature-Based Therapies, Immanuel Hospital Berlin, Berlin, Germany.

Division of Oncology and Hematology, Department of Pediatrics, Charité Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.

出版信息

Front Med (Lausanne). 2024 Apr 16;11:1325037. doi: 10.3389/fmed.2024.1325037. eCollection 2024.

DOI:10.3389/fmed.2024.1325037
PMID:38690176
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11058942/
Abstract

BACKGROUND

Maharishi Amrit Kalash (MAK) 4 and 5 are Ayurvedic herbal nutritional supplements that are believed to have beneficial effects on overall health and wellbeing. This study aimed to systematically review all available randomized controlled trials (RCTs) investigating the clinical effects and safety of MAK.

METHODS

We included RCTs on therapy, health promotion, and prevention for patients and healthy volunteers of all ages. We systematically searched MEDLINE (via PubMed), EMBASE (via Ovid), the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library), DHARA, Clinicaltrials.gov, the World Health Organization (WHO) International Clinical Trials Registry Platform, and Google Scholar from inception through 7 May 2023, with no time or language restrictions. The risk of bias was assessed using the Cochrane Risk of Bias Tool version 1. The protocol was registered with PROSPERO before conducting the review (CRD42023421655).

RESULTS

Three RCTs with 418 study participants were included. Two studies were on breast cancer patients and one on healthy adults. The two studies on cancer evaluated the efficacy of MAK in reducing the side effects of chemotherapy in women with breast cancer. The study on healthy adults evaluated whether MAK has an effect on an age-related alertness task as an indicator of cognitive aging. Both studies on breast cancer patients found beneficial effects on performance status, anorexia, vomiting, and body weight. One study reported positive effects regarding stomatitis. Regarding visual alertness, results showed that individuals who received MAK improved in performance. None of the three included studies reported adverse events. The risk of bias was mixed. Due to the small number and heterogeneity of the RCTs, no meta-analysis could be performed.

CONCLUSION

There is evidence that MAK may have supportive effects in chemotherapeutic treatments for breast cancer patients and for healthy individuals regarding visual discrimination. However, it is difficult to verify treatment effects due to the small number of RCTs and the mixed risk of bias. Furthermore, none of the included studies recorded adverse events. Therefore, further high-quality studies are warranted to confirm the potential health benefits of MAK and to determine its optimal dosage and duration of use.

SYSTEMATIC REVIEW REGISTRATION

PROSPERO, CRD42023421655.

摘要

背景

玛赫西·阿姆里特·卡拉什(MAK)4和5是阿育吠陀草药营养补充剂,被认为对整体健康有益。本研究旨在系统评价所有关于MAK临床疗效和安全性的随机对照试验(RCT)。

方法

我们纳入了针对所有年龄段患者和健康志愿者的治疗、健康促进及预防方面的RCT。我们系统检索了MEDLINE(通过PubMed)、EMBASE(通过Ovid)、Cochrane对照试验中心注册库(CENTRAL,Cochrane图书馆)、DHARA、Clinicaltrials.gov、世界卫生组织(WHO)国际临床试验注册平台以及谷歌学术,检索时间从建库至2023年5月7日,无时间或语言限制。使用Cochrane偏倚风险工具第1版评估偏倚风险。在进行综述之前,该方案已在PROSPERO注册(CRD42023421655)。

结果

纳入了3项RCT,共418名研究参与者。两项研究针对乳腺癌患者,一项针对健康成年人。两项关于癌症的研究评估了MAK减轻乳腺癌女性化疗副作用的疗效。关于健康成年人的研究评估了MAK作为认知衰老指标对与年龄相关的警觉任务是否有影响。两项针对乳腺癌患者的研究均发现对身体状况、厌食、呕吐和体重有有益影响。一项研究报告了对口腔炎的积极作用。关于视觉警觉性,结果显示接受MAK的个体表现有所改善。三项纳入研究均未报告不良事件。偏倚风险参差不齐。由于RCT数量少且存在异质性,无法进行荟萃分析。

结论

有证据表明,MAK可能对乳腺癌患者的化疗治疗以及对健康个体的视觉辨别有支持作用。然而,由于RCT数量少且偏倚风险参差不齐,难以验证治疗效果。此外,纳入研究均未记录不良事件。因此,需要进一步开展高质量研究,以证实MAK的潜在健康益处,并确定其最佳剂量和使用时长。

系统评价注册

PROSPERO,CRD42023421655。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c426/11058942/416adc22dd03/fmed-11-1325037-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c426/11058942/c5c34b06b888/fmed-11-1325037-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c426/11058942/416adc22dd03/fmed-11-1325037-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c426/11058942/c5c34b06b888/fmed-11-1325037-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c426/11058942/416adc22dd03/fmed-11-1325037-g002.jpg

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