A meta-analysis for Kuanxiong Aerosol on the treatment of angina pectoris.

BACKGROUND: Kuanxiong Aerosol (KA) has been used in patients with angina pectoris (AP) attacks for many years, this systematic review and meta-analysis aims to evaluate the clinical efficacy and safety of KA versus nitrates in the treatment of AP. METHODS: Seven databases (PubMed, EMBASE, CENTRAL, CNKI, VIP, CBM and Wanfang) were searched from inception to November 2019 to include randomized controlled trials (RCTs) that compare the efficacy and safety of KA with nitrates on the treatment of AP. And two reviewers independently assessed the risk of bias. RESULT: A total of 12 RCTs were eventually included, involving 2001 patients. Compared with the Nitrates group, the KA group showed great significant improvement on the 3-min [relative risk (RR) = 1.12, 95% confidence interval (CI) (1.03,1.23), P < .05;11 studies,1875 patients] and 5-min [RR = 1.05, 95%CI (1.01,1.08), P < 0.05; 11 studies,1875 patients] angina remission rates, the incidence of adverse reactions [RR = 0.42,95% CI (0.33,0.54), P < 0.00001; 8 studies, 1350 patients], endothelin(ET) [SMD = -0.40, 95%CI (-0.74,-0.07), P < 0.05; 2 studies, 143 patients] and c-reactive protein (CRP) [SMD = -0.58, 95%CI (-0.87,-0.30), P < 0.00001;2 studies, 200 patients],but no significant improvement on electrocardiogram efficacy [RR = 1.03, 95%CI (0.98,1.10), P = 0.26;11 studies, 1549 patients], nitric oxide (NO) [SMD = -0.08, 95%CI (-0.61,0.45), P = 0.76;2 studies, 143 patients]. CONCLUSION: The clinical use of KA is effective and safe on the treatment of AP, which appears to be better than nitrates in terms of efficiency, adverse reactions, endothelial function and inflammatory response. Nevertheless, due to some limitations in the sample size and quality of the included studies, more high-quality RCTs were still needed for further verification.

Quality Standards for Herbal Drugs and Herbal Drug Preparations - Appropriate or Improvements Necessary?

Standards for quality control as defined in the European Pharmacopoeia contribute significantly to a consistent and high quality of herbal drugs, herbal drug preparations, and herbal medicinal products. The minimum content of single plant constituents is considered of high relevance. Therefore, nearly all monographs on herbal drugs or herbal drug preparations contain an obligatory assay.However, a critical evaluation of the data published for such assayed constituents reveals that in most cases these constituents have to be considered as purely analytical markers without correlation to quality or efficacy. Examples where the assay does not meet its objective support the need to adapt current quality standards. Moreover, the trend to increase the content of certain constituents may lead to significant modifications to traditional manufacturing processes.In order to initiate a scientific discussion, the role of the assay in the context of quality requirements, quality documentation in the manufacturing process, safety, and efficacy is discussed and possible alternatives to the single marker assay are examined.

Quality assessment of medicinal herbs and their extracts: Criteria and prerequisites for consistent safety and efficacy of herbal medicines.

Ingredients of commercial herbal medicines are assessed for quality primarily to ensure their safety. However, as complex mixtures of different groups of plant secondary metabolites, retention of overall phytochemical consistency of herbal medicines is pivotal to their efficacy. Authenticity and homogeneity of the herbs and strict regimes of physical processing and extract manufacturing are critical factors to maintain phytochemical consistency in commercial products. To ensure both safety and efficacy of herbal medicines, implementation of and adherence to good agricultural and collection practice (GACP), good plant authentication and identification practice (GPAIP), good manufacturing practice (GMP) before and during the manufacturing process, and good laboratory practice (GLP) in analysis are necessary. Establishment and application of harmonized multilaboratory-validated analytical methods and transparency in the supply (value) chain through vendor audits are additional requirements in quality assurance. In this article, we outline steps of a comprehensive quality assurance paradigm aimed at achieving and maintaining safety, consistent phytochemical composition, and clinical efficacy of ingredients of herbal medicines. This article is part of a Special Issue entitled Botanicals for Epilepsy.

Legislation relating to nutraceuticals in the European Union with a particular focus on botanical-sourced products.

Nutraceuticals are food or food ingredients that have defined physiological effects. They do not easily fall into the legal categories of food or drug and often inhabit a grey area between the two. These products in general terms cover health promotion, "optimal nutrition" the concept of enhanced performance--both physically and mentally--and reduction of disease risk factors. In this paper the focus is mainly on legislation governing botanical-sourced nutraceuticals in the European Union (EU). Nutraceutical concept in general has been defined. Different pieces of legislation influencing botanical nutraceuticals are described. The issue of the borderline between food and drug is discussed. The regulatory status of botanical nutraceuticals as food supplement, food ingredient, functional and fortified food, novel foods and foods for particular nutritional use in the diversified, complex and ever-changing European regulatory environment is described. Botanical nutraceuticals present additional problems because of their complex nature and composition particularly with respect to the quality aspects, which in turn affect safety parameters and overall efficacy of the products. Quality issues relating to botanical sources, growth conditions, end products, their specifications and other technical criteria are highlighted. Guiding principles to be observed for conducting in vitro, in vivo studies in animals and their impact on clinical safety data are discussed. Finally, health claims, their types and criteria of substantiation in light of ongoing discussions with regard to the EU frame work of regulation on nutrition and health claims and role of process for the assessment of scientific support for claims (PASSCLAIM) initiative is discussed. The concept of grading of evidence to substantiate different claims and to establish standards, which should not be revoked or reversed by emerging science at a later stage has been considered. These issues are crucial and are being discussed at EU Parliament and Commission level during the development of the health claim regulations.

Utility of nutraceutical products marketed for cognitive and memory enhancement.

This article identifies a convenience sample of 14 memory-enhancing herbal products that were found to be available commercially, examines their active ingredients, states their claims, and evaluates the available evidence to determine their efficacy. The analyses identified four problematic areas. First, a majority of the products use cognitive terminology, which leads consumers to anticipate an intended cognitive benefit. Second, some ingredients are completely homeopathic and contain components not known outside of the homeopathic field. Third, the evidence of treatment efficacy is often contradictory, because products are recommended for purposes other than cognitive or memory loss. Finally, the manufacturers of the product have usually conducted the research on individual products. Until more research is available, it is suggested that holistic nursing professionals exercise caution in recommending nutraceuticals to their patients/clients for the use of cognitive improvement or memory enhancement.

Kava hepatotoxicity solution: A six-point plan for new kava standardization.

Kava-induced liver injury has been demonstrated in a few patients worldwide and appears to be caused by inappropriate quality of the kava raw material. When cases of liver disease in connection with the use of kava emerged, this was an unexpected and challenging event considering the long tradition of safe kava use. In order to prevent kava hepatotoxicity in future, a set of quality specifications as standard is essential for the preparation not only of kava drugs and kava dietary supplements in the Western world but also for traditional kava drinks in the South Pacific Islands. For all these purposes a uniform approach is required, using water based extracts from the peeled rhizomes and roots of a noble cultivar such as Borogu with at least 5 years of age at the time of harvest. Cultivated in Vanuatu for centuries, noble varieties (as defined in the Vanuatu Kava Act of December 2002) are well tolerated traditional cultivars with a good safety record. At present, Vanuatu kava legislation is inadequately enforced to meet quality issues for kava, and further efforts are required in Vanuatu, in addition to similar legislation in other kava producing South Pacific Islands. Future regulatory and commercial strategies should focus not only on the standardization of kava drugs, kava dietary supplements, and traditional kava extracts, but also on thorough surveillance during the manufacturing process to improve kava quality for safe human use. The efficacy of kava extracts to treat patients with anxiety disorders is well supported, but further clinical trials with aqueous kava extracts are necessary. We thereby propose a six-point kava solution plan: (1) use of a noble kava cultivar such as Borogu, at least 5 years old at time of harvest, (2) use of peeled and dried rhizomes and roots, (3) aqueous extraction, (4) dosage recommendation of ≤250mg kavalactones per day (for medicinal use), (5) systematic rigorous future research, and (6) a Pan Pacific quality control system enforced by strict policing. In conclusion, at different levels of responsibility, new mandatory approaches are now required to implement quality specification for international acceptance of kava as a safe and effective anxiolytic herb.

Summary consensus statement of the Review Board of the Swiss Complementary Medicine Evaluation Programme, (Programme Evaluation Komplementärmedizin, PEK) regarding the PEK process and products.

The international review board was set up as the scientific advisory body of the Swiss Complementary Medicine Evaluation Programme (PEK) in 2002. It has met several times and has given advice with respect to the most important aspects of the programme. It would have been the normal procedure for the review board to have had the opportunity to comment on the drafts of the final scientific products as well as the draft of the summary report, in order to advise on them, before the documents became publicly available and formed the basis for political decision making. But the responsible authorities changed this process. In the following, the review board comments both on this process and on the products.

State of complementary and alternative medicine in cardiovascular, lung, and blood research: executive summary of a workshop.

The National Heart, Lung, and Blood Institute and the National Center for Complementary and Alternative Medicine recently cosponsored a workshop on the use of complementary and alternative medicine (CAM) in cardiovascular, lung, and blood research. In view of the increasing use of CAM by the general public, it is imperative to promote credible research by the established biomedical community. The goal of this workshop was to enhance the exchange of information and ideas between alternative medicine practitioners and scientists in cardiovascular, lung, and blood research and to foster collaborative research among these researchers. The workshop focused on 5 areas of research, including a historical and cultural perspective of CAM, methodological issues in clinical trials, herbal medicine, chelation therapy, mind/body (meditation) therapy, and acupuncture. CAM has become widely used without rigorously proven efficacy and safety. To protect the public, it was recommended that the fundamental mechanistic research for these CAM approaches be vigorously pursued and that any large-scale clinical trial be carefully executed to avoid any waste of resources and any unnecessary risk. It was felt that standardization of botanical products and procedure-based CAM intervention, such as acupuncture and meditation, is essential for meaningful basic and clinical research. Although botanical products properly consumed are perceived as generally safe, potential herb-drug interactions are a major safety concern. Clearly, many challenges need to be addressed by the scientific community before the public can be assured of the proper use of CAM.