The Quality of Randomized Controlled Trials on <i>DanShen</i> in the Treatment of Ischemic Vascular Disease

Shicheng, Yu; Zhong, Bao‐Liang; Zheng, Ming‐Hua; Xiao, Fangyi; Dong, Zhibing; Zhang, Huaiqing

doi:10.1089/acm.2008.0436

Cited by 15 publications

(8 citation statements)

References 25 publications

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“…The quality of the RCTs is a major issue. Previous sampled surveys [86][87][88][89][90] on the RCTs on traditional Chinese medicine conducted in China showed poor quality of RCT conduct and reporting. This systematic review found that most of retrieved RCTs are of low to medium quality.…”

Section: Discussionmentioning

confidence: 99%

Is danshen (Salvia miltiorrhiza) dripping pill more effective than isosorbide dinitrate in treating angina pectoris? A systematic review of randomized controlled trials

Jia

Huang

Zhang

et al. 2012

International Journal of Cardiology

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Section: Discussionmentioning

confidence: 99%

Is danshen (Salvia miltiorrhiza) dripping pill more effective than isosorbide dinitrate in treating angina pectoris? A systematic review of randomized controlled trials

Jia

Huang

Zhang

et al. 2012

International Journal of Cardiology

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“…Preclinical studies have shown that tanshinone IIA and its sodium sulfonate have a wide spectrum of pharmacological activities, including cardioprotective, neuro-protective, anticancer, immuno-modulating, anti-osteoporotic, cytotoxic and apoptosis-inducing, anti-atherosclerotic, and anti-oxidative and radicalscavenging effects. However, although there have been 150 randomized clinical trials for danshen in the treatment of ischemic vascular diseases which are all conducted in mainland China, only 6.7% (10/150) of these studies are considered with high quality (Jadad score 4) [81]. A recent Cochrane systematic review claimed that the evidence to support use of danshen preparations is too weak to make any judgement about its clinical efficacy [82].…”

Section: Salvia Miltiorrhiza (Danshen)mentioning

confidence: 99%

Disposition Pathways and Pharmacokinetics of Herbal Medicines in Humans

He¹,

Li²,

Liu³

et al. 2012

CMC

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Pharmacokinetic studies have become an integral part of modern drug development, but these studies are not regulatory needs for herbal remedies. This paper updates our current knowledge on the disposition pathways and pharmacokinetic properties of commonly used herbal medicines in humans. To retrieve relevant data, the authors have searched through computer-based literatures by full text search in Medline (via Pubmed), ScienceDirect, Current Contents Connect (ISI), Cochrance Library, CINAHL (EBSCO), CrossRef Search and Embase (all from inception to May 2010). Many herbal compounds undergo Phase I and/or Phase II metabolism in vivo, with cytochrome P450s (CYPs) and uridine diphosphate glucuronosyltransferases (UGTs) playing a major role. Some herbal ingredients are substrates of P-glycoprotein (P-gp) which is highly expressed in the intestine, liver, brain and kidney. As such, the activities of these drug metabolizing enzymes and drug transporters are determining factors for the in vivo bioavailability, disposition and distribution of herbal remedies. There are increasing pharmacokinetic studies of herbal remedies, but these studies are mainly focused on a small number of herbal remedies including St John's wort, milk thistle, sculcap, curcumin, echinacea, ginseng, ginkgo, and ginger. The pharmacokinetic data of a small number of purified herbal ingredients, including anthocyanins, berberine, catechins, curcumin, lutein and quercetin, are available. For the majority of herbal remedies used in folk medicines, data on their disposition and biological fate in humans are lacking or in paucity. For a herbal medicine, the pharmacological effect is achieved when the bioactive agents or the metabolites reach and sustain proper levels at their sites of action. Both the dose levels and fates of active components in the body govern their target-site concentrations after administration of an herbal remedy. In this regard, a safe and optimal use of herbal medicines requires a full understanding of their pharmacokinetic profiles. To optimize the use of herbal remedies, further clinical studies to explore their biological fate including the disposition pathways and kinetics in the human body are certainly needed.

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“…However, the methodological quality of many studies has been criticized. 110 A 2010 Cochrane Review of traditional Chinese herbal products for stable angina identified 242 potentially relevant publications, which were reduced to 127 RCTs. 108 Of these, only three finally met the inclusion criteria, but even these suffered from methodological flaws.…”

Section: Clinical Evidence Of Chm's Efficacy In Treating Anginamentioning

confidence: 99%

The potential role of herbal medicines in the treatment of chronic stable angina pectoris: a review of key herbs, and as illustration, exploration of the Chinese herbal medicine approach

O’Brien

Vitetta²

2012

BTAT

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Herbal medicines have been used for centuries within different cultures to treat cardiovascular disease, including stable angina pectoris. However, the use of herbs varies within traditions of natural medicine, and how they are understood to work in systems such as Chinese medicine, for example, is vastly different from the pharmaceutical model that seeks to reduce herbs to their active constituents. This review first discusses, individually, key herbs used within Western, Indian, and Chinese herbalism to treat stable angina pectoris and their main active constituents and pharmacological actions. The second part of the paper then specifically explores how angina is treated traditionally with Chinese herbal medicine, a unique approach to the understanding of health and illness underpinned by philosophies and theories that describe the physiological functioning and pathological changes in the body in terms very different from those of biomedicine. A foundational account of the guiding theories of Chinese medicine is followed by a description of the cardiovascular system and the etiology and pathogenesis of angina from the Chinese medical perspective. This forms the basis for understanding the rationale for construction of Chinese herbal medicinal formulae for treating angina pectoris. The scientific evidence of the efficacy of some Chinese herbal formulae is discussed.

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The Quality of Randomized Controlled Trials on DanShen in the Treatment of Ischemic Vascular Disease

Abstract: The quality of DanShen RCTs in mainland China has not been improved significantly over recent years, and the overall quality of DanShen RCTs is still poor.

Cited by 15 publications

References 25 publications

Is danshen (Salvia miltiorrhiza) dripping pill more effective than isosorbide dinitrate in treating angina pectoris? A systematic review of randomized controlled trials

Is danshen (Salvia miltiorrhiza) dripping pill more effective than isosorbide dinitrate in treating angina pectoris? A systematic review of randomized controlled trials

Disposition Pathways and Pharmacokinetics of Herbal Medicines in Humans

The potential role of herbal medicines in the treatment of chronic stable angina pectoris: a review of key herbs, and as illustration, exploration of the Chinese herbal medicine approach

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