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Why is Research on Herbal Medicinal Products Important and How Can We Improve Its Quality?

ABSTRACT: Research on herbal medicinal products is increasingly published in "Western" scientific journals dedicated primarily to conventional medicines. Publications are concerned mainly not only on the issues of safety and interactions, but also on efficacy. In reviews, a recurring complaint has been a lack of quality studies. In this opinion article, we present the case of Chinese herbal medicines as an example, as they have been extensively used in the global market and increasingly studied worldwide. We analyze the potential reasons for problems and propose some ways forward. As in the case of any drug, clinical trials for safety, efficacy, and/or effectiveness are the ultimate demonstration of therapeutic usefulness of herbal products. These will only make scientific sense when the tested herbal products are authentic, standardized, and quality controlled, if good practice guidelines of evidence-based medicine are followed, and if relevant controls and outcome measures are scientifically defined. Herbal products are complex mixtures, and for such complexity, an obvious approach for mechanistic studies is network pharmacology based on omic tools and approaches, which has already begun to revolutionize the study of conventional drugs, emphasizing networks, interactions, and polypharmacological features behind the action of many drugs.

SUBMITTER: Pelkonen O

PROVIDER: S-EPMC4032837 | biostudies-other | 2014 Jan

REPOSITORIES: biostudies-other

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Why is Research on Herbal Medicinal Products Important and How Can We Improve Its Quality?

Pelkonen Olavi O Xu Qihe Q Fan Tai-Ping TP

Journal of traditional and complementary medicine 20140101 1

Research on herbal medicinal products is increasingly published in "Western" scientific journals dedicated primarily to conventional medicines. Publications are concerned mainly not only on the issues of safety and interactions, but also on efficacy. In reviews, a recurring complaint has been a lack of quality studies. In this opinion article, we present the case of Chinese herbal medicines as an example, as they have been extensively used in the global market and increasingly studied worldwide. ...[more]

PMID: 24872927

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Project description:Oleuropein (OE) is a secoiridoid glycoside, which occurs mostly in the Oleaceae family presenting several pharmacological properties, including antioxidant, cardio-protective, anti-atherogenic effects etc. Based on these findings OE is commercially available, as Herbal Medicinal Product (HMP), claimed for its antioxidant effects. As there are general provisions of the medicine regulating bodies e.g. European Medicines Agency, the quality of the HMP's must always be demonstrated. Therefore, a novel LC-MS methodology was developed and validated for the simultaneous quantification of OE and its main degradation product, hydroxytyrosol (HT), for the relevant OE claimed HMP's. The internal standard (IS) methodology was employed and separation of OE, HT and IS was achieved on a C18 Fused Core column with 3.1 min overall run time employing the SIM method for the analytical signal acquisition. The method was validated according to the International Conference on Harmonisation requirements and the results show adequate linearity (r(2) > 0.99) over a wide concentration range [0.1-15 ?g/mL (n=12)] and a LLOQ value of 0.1 ?g/mL, for both OE and HT. Furthermore, as it would be beneficial to control the quality taking into account all the substances of the OE claimed HMP's; a metabolomics-like approach has been developed and applied for the total quality control of the different preparations employing UHPLC-HRMS-multivariate analysis (MVA). Four OE-claimed commercial HMP's have been randomly selected and MVA similarity-based measurements were performed. The results showed that the examined samples could also be differentiated as evidenced according to their scores plot. Batch to batch reproducibility between the samples of the same brand has also been determined and found to be acceptable. Overall, the developed combined methodology has been found to be an efficient tool for the monitoring of the HMP's total quality. Only one OE HMP has been found to be consistent to its label claim.

Project description:BackgroundThe use of herbal medicinal products (HMPs) is common among older adults; however, little is known about concurrent use with prescription drugs, as well as potential interactions associated with such combinations.ObjectiveThe aim of this systematic review was to identify and evaluate the literature on concurrent prescription and HMP use among older adults to assess prevalence, patterns, potential interactions and factors associated with this use.MethodsSystematic searches were conducted in the MEDLINE, PsycINFO, EMBASE, CINAHL, AMED, Web of Science and Cochrane databases from inception to May 2017 for studies reporting concurrent use of prescription medicines with HMPs in adults ? 65 years of age. Quality was assessed using the Joanna Briggs Institute checklists. And the Evidence for Policy and Practice Information and Co-ordinating Centre (EPPI-Centre) three-stage approach to mixed method research was used to synthesise data.ResultsTwenty-two studies were included. A definition of HMPs or what was considered an HMP was frequently missing. Prevalence of concurrent use by older adults varied widely between 5.3 and 88.3%. Prescription medicines most combined with HMPs were antihypertensive drugs, ?-blockers, diuretics, antihyperlipidemic agents, anticoagulants, analgesics, antihistamines, antidiabetics, antidepressants and statins. The HMPs most frequently used were Ginkgo biloba, garlic, ginseng, St John's wort, Echinacea, saw palmetto, evening primrose oil and ginger. Potential risks of bleeding due to the use of Ginkgo biloba, garlic or ginseng with aspirin or warfarin was the most reported herb-drug interaction. Some data suggest being female, and having a lower household income and less than a high-school education were associated with concurrent use.ConclusionThe prevalence of concurrent prescription drugs and HMP use among older adults is substantial and potential interactions have been reported. Knowledge of the extent and manner in which older adults combine prescription drugs will aid healthcare professionals in appropriately identifying and managing patients at risk. Systematic Review Registration Number: PROSPERO 2014:CRD42014009091.

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Why is Research on Herbal Medicinal Products Important and How Can We Improve Its Quality?

Publications

Why is Research on Herbal Medicinal Products Important and How Can We Improve Its Quality?

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