Safety Of Herbal Medicines Research Articles

Herbal Medicines for Hepatitis C Virus Infection: The Exploratory Journey from Bench to Bedside Still Has a Long Way to Go

Hepatitis C virus (HCV) infects at least 150 million people chronically worldwide. It is a major risk factor for cirrhosis, hepatocellular carcinoma, and death. Direct-acting antiviral therapy is very efficacious in treating HCV infection but it is inaccessible and unavailable in some developing countries. Therefore, searching for more effective and easily accessible regimens remains an urgent need. The aim of this article is to review the anti-HCV effects of herbal medicines from experimental to clinical evidence, and discuss current issues, hurdles and future perspectives for their application from bench to bedside. Numerous in vitro studies have indicated that many herbs work effectively in exerting anti-HCV activities. Yet, only a few animal experiments have been conducted that demonstrate the anti-HCV effects of these medicines; in addition, these results do not show an ability to eliminate the virus completely from the infected animals. Thus far, clinical trials have produced inconclusive anti-HCV results in terms of efficacy and safety, presumably due to the lack of the quality of methodologies used in the trials. In conclusion, despite apparent anti-HCV activities in vitro, clinical efficacy and safety of herbal medicines for the treatment of HCV infection have not been revealed convincingly. More animal studies using ideal models and more well-designed clinical trials with a larger sample sizes and longer treatment periods, taking the body habitus into consideration, are required to further assess the efficacy and safety of herbal medicines for HCV infection.

Safety of medicines-Pharmacists' knowledge, practice, and attitudes toward pharmacovigilance and adverse drug reactions reporting process.

Patients' safety is a public concern in healthcare systems across the world and should be ensured, among others, by pharmacovigilance based on spontaneous reports of adverse drug reactions (ADRs). Spontaneous ADRs reporting is an important component of the pharmacovigilance system. The role of pharmacists in spontaneous ADRs reporting is crucial in the pharmacovigilance system since it helps to monitor the patients' treatment in real-life conditions. The aim of the study was to evaluate the pharmacists' attitudes to and knowledge on spontaneous ADRs reporting in Poland and to identify the reasons for underreporting of ADRs. The study was conducted between January 2016 and January 2018. A self-administered questionnaire was designed and distributed to pharmacists. The pharmacists were randomly selected from the official database kept by the chief pharmaceutical inspectorate in Poland. Only 16% (n=84) of the respondents have ever attended a training on pharmacovigilance. Eighty-one percent (N=422) of pharmacists believe that not all synthetic drugs available on the market were safe. Twenty-eight percent (n=146) of the respondents were certain about safety of drugs of natural origin, and 16% (n=84) were of an opinion that adverse reactions following administration of such drugs should not be reported at all. To conclude, there is an increasing awareness of the need to develop pharmacovigilance practices. The current (not fully adhered to in practice) model of pharmacovigilance and its associated tools have been developed for synthetic drugs, and applying these methods to monitor safety of herbal medicines presents unique challenges.

Analysis of spontaneous adverse drug reactions to echinacea, valerian, black cohosh and ginkgo in Australia from 2000 to 2015

ObjectiveAssessing adverse drug reactions (ADRs) is a proven method to estimate the safety of medicines. The ADRs to herbal medicines in Australia (and by inference, the safety of herbal medicines in Australia) remain unknown. This study examines spontaneous ADR cases to four of the most popular herbs in Australia from 2000 to 2015: echinacea (Echinacea purpurea), valerian (Valeriana officinalis), black cohosh (Actaea racemosa) and ginkgo (Ginkgo biloba). MethodsADRs of echinacea, valerian, black cohosh and ginkgo reported to the Australian Therapeutic Goods Administration (TGA) between 2000 and 2015 were obtained from the TGA database. Data were collated and analysed according to age, sex, severity, type of ADR and body system affected. Statistics were calculated using GraphPad Prism software. ResultsMost ADRs were mild or moderate. However, every herbal medicine was associated with life-threatening ADRs. In each life-threatening case, the herbal medicine was taken concomitantly with prescription medications. Black cohosh was associated with a significant number of severe ADRs (30.3% of the total), with 39.4% of these ADRs being associated with abnormal hepatic function, hepatitis or hepatotoxicity. ConclusionThis study highlights the lack of public awareness with regard to herb–drug interactions, since most of the severe ADRs involved a herb–drug interaction.

A sub-chronic Xysmalobium undulatum hepatotoxicity investigation in HepG2/C3A spheroid cultures compared to an in vivo model

Ethnopharmacology relevanceTraditional herbal medicines are utilized by 27 million South Africans. Xysmalobium undulatum (Uzara) is one of the most widely used traditional medicinal plants in Southern Africa. A false belief in the safety of herbal medicine may result in liver injury. Herb-induced liver injury (HILI) range from asymptomatic elevation of liver enzymes, to cirrhosis and in certain instances even acute liver failure. Various in vitro and in vivo models are available for the pre-clinical assessment of drug and herbal hepatotoxicity. However, more reliable and readily available in vitro models are needed, which are capable of bridging the gap between existing models and real human exposure. Three-dimensional (3D) spheroid cultures offer higher physiological relevance, overcoming many of the shortcomings of traditional two-dimensional cell cultures. Aims of this studyThis study investigated the hepatotoxic and anti-prolific effects of the crude X. undulatum aqueous extract during a sub-chronic study (21 days), in both a 3D HepG2/C3A spheroid model and the Sprague Dawley rat model. MethodsHepG2/C3A spheroids were treated with a known hepatotoxin, valproic acid, and crude X. undulatum aqueous extract for 21 days with continuous evaluation of cell viability and proliferation. This was done by evaluating cell spheroid growth, intracellular adenosine triphosphate (ATP) levels and extracellular adenylate kinase (AK). Sprague Dawley rats were treated with the same compounds over 21 days, with evaluation of in vivo toxicity effects on serum chemistry. ResultsThe results from the in vitro study clearly indicated hepatotoxic effects and possible liver damage following treatment with valproic acid, with associated growth inhibition, loss of cell viability and increased cytotoxicity as indicated by reduced intracellular ATP levels and increased AK levels. These results were supported by the increased in vivo levels of AST, ALT and LDH following treatment of the Sprague Dawley rats with valproic acid, indicative of hepatic cellular damage that may result in hepatotoxicity. The in vitro 3D spheroid model was also able to predict the potential concentration dependant hepatotoxicity of the crude X. undulatum aqueous extract. Similarly, the results obtained from the in vivo Sprague Dawley model indicated moderate hepatotoxic potential. ConclusionThe data from both the 3D spheroid model and the Sprague Dawley model were able to indicate the potential concentration dependant hepatotoxicity of the crude X. undulatum aqueous extract. The results obtained from this study also confirmed the ability of the 3D spheroid model to effectively and reliably predict the long-term outcomes of possible hepatotoxicity.

Current perspectives on safety of herbal medicine: summary of the evidence from basic to clinical domains

Current perspectives on safety of herbal medicine: summary of the evidence from basic to clinical domains

Thirteen-Week Oral Toxicity Study of HVC1 in Rats.

Studies on the safety of herbal medicine are essential for the development of new drugs. The aim of this study was to evaluate the no-observed-adverse-effect-level (NOAEL) of HVC1 (Gamisamhwangsasim-tang, a 30% ethanol extract of a mixture of Pruni Cortex, Scutellariae Radix, Coptidis Rhizoma, and Rhei Rhizoma) and identify its target organs after oral administration to Sprague-Dawley (SD) rats repeatedly for 13 weeks. Three test groups were treated with HVC1 at a dose of either 500 (low-dose), 1,000 (middle-dose), or 2,000 (high-dose) mg/kg/day. Another group received high-dose HVC1 and was observed for 4 weeks following treatment to examine recovery from the effects of the extract. All treatment groups were compared to a vehicle control group. During the study, mortality, clinical signs, body weight changes, food consumption, abnormal lesions in the eye, urinary parameters, hematological parameters, blood coagulation time, blood biochemical parameters, changes in organ weight, gross findings, and histopathological changes were examined. No systemic toxicity related to HVC1 was observed in any group, and it was concluded that the NOAEL of HVC1 was 2,000 mg/kg/day. No target organ was identified.

Use of herbal medicines in a Nigerian community and their reported adverse effects: A pilot study

Purpose: To evaluate the use of herbal medicines in Nsukka community and determine the adverse reactions associated with this practice.Methods: A cross-sectional survey of 120 persons was conducted in Ogige market, Nsukka using selfadministered questionnaires. Outcomes measured included proportion of respondents who use herbal medicines and their reasons, their perception on the safety and effectiveness of the medicines, their purchasing habits of the medicines, those who recommend the medicines, and adverse reactions to them. Frequency analysis and Pearson’s correlation test were conducted with statistical significance set at p < 0.05.Results: Less than half of the respondents (43.2%) took herbal medicines without consulting a health professional, and more than 60 % of them believed that herbal medicines are safe and effective. Only 47.4 % of the respondents claimed to have ever experienced mild adverse effects following the use of the medicines which were resolved with advice sought from health professionals. Stooling and vomiting were the major reported adverse effects. Older respondents had a better perception on the safety of herbal medicines (p = 0.005) and are less likely to tell their health professionals that they are already taking herbal medicines when orthodox medicines are prescribed/recommended for them. High-income earners spent more on herbal medicines (p = 0.029) than others.Conclusion: Many respondents use herbal medicines without consulting a health professional. However, most of them seek advice from health professionals when adverse effects result from these medicines during use.Keywords: Adverse effects, health professionals, herbal medicines use, Nsukka community

Herbal medicine for benign prostatic hyperplasia: A protocol for a systematic review of controlled trials.

Background:Herbal medicine has been used to manage benign prostatic hyperplasia (BPH) and the associated lower urinary tract symptoms, but its effects are not yet fully understood. The purpose of this review is to assess the efficacy and safety of herbal medicine as a treatment for BPH.Methods and analysis:Thirteen databases will be searched for relevant studies from inception to the present date. We will include randomized controlled trials assessing herbal medicine for the treatment of BPH. The methodological qualities, including the risk of bias, will be evaluated using the Cochrane risk of bias assessment tool, while confidence in the cumulative evidence will be evaluated using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.Ethics and dissemination:Ethical approval is not required, as this study is based on the review of published research. This review will be published in a peer-reviewed journal and disseminated both electronically and in print.

Herbal medicine for acute management and rehabilitation of traumatic brain injury: A protocol for a systematic review.

This systematic review protocol describes the methods that will be used to evaluate the efficacy and safety of herbal medicine in treating traumatic brain injury. The following electronic databases will be searched up to December 2018 without language or publication status restrictions: Medline, EMBASE, the Cochrane Central Register of Controlled Trials, Allied and Complementary Medicine Database, and Cumulative Index to Nursing and Allied Health Literature. We will also search Korean, Chinese, and Japanese databases. Any randomized controlled trials related to herbal medicine for traumatic brain injury will be included. The functional outcome, consciousness state, morbidity, and mortality will be assessed as primary outcomes. The quality of life, adverse events, and total effective rate will be evaluated as secondary outcomes. Two researchers will independently perform the study selection, data extraction, assessment of study quality, and evaluation of the quality of evidence for the main findings. Data synthesis and analysis will be performed using RevMan version 5.3. The results will be expressed as a risk ratio for the binary outcome and as the mean difference or standardized mean difference for a continuous outcome. We will synthesize the data by either fixed effects or random effects model according to a heterogeneity test or the number of studies included in the meta-analysis. The methodological quality of the included studies will be evaluated using the Cochrane Collaboration's risk of bias tool. The quality of evidence for each main outcome will be evaluated using the Grading of Recommendations Assessment, Development, and Evaluation approach. Ethical approval is not required because individual patient data are not included. The findings of this systematic review will be disseminated through a peer-reviewed publication or conference presentations. CRD42018116559.

Pesticides in Herbal Medicines, the Insidious Public Health Hazard: Multi-Residue Pesticide Analysis and Risk Assessments Based on 1771 Samples

Background: Focus on the safety of herbal medicines has mainly been directed towards the presence of intrinsic toxicity, as found in the reported cases of renal and hepatic dysfunction caused by aristolochic acids. However, contamination from extrinsic hazards may have the potential to impart an even greater reduction in their safety and efficacy. Methods: Currently available herbal medicine samples from large-scale cultivation areas in major herbal medicines markets in China were collected for analysis of pesticides by LC/MS-MS or GC/MS-MS. Additionally, dietary exposure assessment, risk-ranking score and comparative health impact analysis were employed to estimate the hazard potential of pesticide residue exposure in herbal medicines. Findings: This study reveals that pesticides were present in the majority (88%) of a large, comprehensive cross-section (n=1771) of herbal medicine samples. Alarmingly, more than half (59%) contained pesticides over the European Pharmacopoeia (EP) limit, and 43% contained 35 varieties of banned, extremely toxic pesticides, eight of which were detected at levels over 500 times higher than the default Maximum Residue Limit (MRL). DDTs, carbofuran, and mevinphos were confirmed as being among the most risk-inducing pesticides by three different risk assessments methods, reported to produce carcinogenic, genotoxic, reproductive, and developmental effects, in addition to carrying nephrotoxicity and hepatotoxicity. Interpretation: Herbal medicines are severely contaminated with risk-inducing pesticides, therefore the authors strongly recommend the application of quality-control measures to safeguard public health. Funding Statement: This study was funded by the Study on the Key Safety Validation Elements of Chinese Medicine in International Trade, International Science & Technology Cooperation Program, PR China (2015DFM30030) and the OLCA-Pest Project, financially supported by ADEME, Denmark (17-03-C0025). Declaration of Interests: All authors declare no competing interests. Ethics Approval Statement: Not required.

Efficacy and safety of herbal medicine (Bailemian capsule) for treating insomnia: Protocol for a systematic review and meta-analysis.

Insomnia has become a universal subhealth disease, affecting more and more modern people's health and quality of life. At present, western medicine is only symptomatic treatment for insomnia. Bailemian Capsule (BLMC) is a proprietary Chinese medicine for treating insomnia. It has been widely used in China, but lacks evidence for evidence-based medicine. At the same time, the clinical efficacy and safety of BLMC are controversial. Therefore, the effectiveness and safety of BLMC in the treatment of insomnia are studied and systematically evaluated in this study. It provides reliable theoretical support for the treatment of insomnia with Traditional Chinese Medicine and the combination of traditional Chinese and Western medicine. The information was retrieved from electronic databases, Cochrane, PubMed, EMBASE, SinoMed, China National Knowledge Infrastructure, VIP Data, and WangFang Data. Randomized controlled trials on the BLMC in the treatment of insomnia were conducted. There was no limitation on the literature language. RevMan 5.3 software and STATA 12.0 software were used to perform the meta-analysis. This review will be to assess the efficacy and safety of BLMC for insomnia. Our systematic evaluation will provide evidence for the clinical efficacy and safety of BLMC in the treatment of insomnia, and will be published in the form of academic papers in the future to provide new ideas for clinicians in the treatment of insomnia.

Toxicity of Antidiarrheal and Spasmolytic Herbal Mixtures Used in Neonates and Infants less than Six Months of Age in Young Rodents

Background: Leaves of Alstonia boonei De Wild. (Apocynaceae), Aristolochia ringens Vahl. (Aristlochiaceae) [Anti-diarrhoea], Allium ascalonicum L. (Amaryllidaceae) and Calliandra haematocephala Haask. (Fabaceae) [Spasmolytic] are components of anti-diarrhoea and spasmolytic herbal mixtures commonly used to treat diarrhoea and abdominal colics in neonates and infants less than 6 months of age in Lagos, Nigeria. Objective: This study was done to evaluate the acute and sub-acute toxicity of the anti-diarrhoea (aqueous leaf extracts of A. boonei and A. ringens) and spasmolytic (aqueous leaf extracts of A. ascalonicum and C. haematocephala) herbal mixtures in young experimental rodents. Materials and Methods: Each herbal mixture contained dried leaves of the two plants in equal amounts and was extracted as used traditionally by herbal practitioners. The acute toxicity test was done using young albino mice of both sexes (average weight 15 g) and the 28 day sub-acute toxicity test was done using young albino rats (average weight 120 g) of both sexes to evaluate the safety of the herbal mixtures. Results: No mortality occurred during the oral acute toxicity study for both the anti-diarrhoea and spasmolytic herbal mixtures. The intraperitoneal acute toxicity study showed mortality at higher doses for both anti-diarrhoea (LD50:1318 mg/kg) and spasmolytic (LD50: 1175 mg/kg) herbal mixtures. In the 28 day sub-acute toxicity study, both the anti-diarrhoea and spasmolytic herbal mixtures produced no significant increase in the weight of rats, dose-dependent elevations of total cholesterol and low density lipoprotein, significant dose-dependent reductions in platelet counts (p&lt;0.05). The histopathological analysis done after 28 days showed that unlike the spasmolytic herbal mixture, the anti-diarrhoea herbal mixture had dose-dependent fluid congestions of the liver, kidney and brain, and tubular necrosis in the kidneys. Conclusion: The results of this study show that when administered through the intraperitoneal route in the acute toxicity study, mortality occurred at the higher doses for both the anti-diarrhoea and spasmolytic herbal mixtures. After 28 days, the antidiarrhoea herbal mixture containing Alstonia boonei and Aristolochia ringens was toxic when administered to young rodents in high doses. The results of this study show evidence of toxicity and these are important safety signals. Therefore, parents, health care providers and regulatory authorities should be aware of the potential toxicity of these herbal mixtures, especially when used in the young child without scientific dose finding studies. Pharmacovigilance is essential to detect and document safety of herbal medicines.

Effectiveness and safety of herbal medicines for induction of labour: a systematic review and meta-analysis

ObjectiveThe use of herbal medicines for induction of labour (IOL) is common globally and yet its effects are not well understood. We assessed the efficacy and safety of herbal medicines...

Adjunctive herbal medicine treatment for patients with acute ischemic stroke: A systematic review and meta-analysis

Background and purposeIn the East-Asian countries, the combined treatment of Western medicine and herbal medicine has been widely administered. The purpose of this study was to evaluate the efficacy and safety of herbal medicine in the treatment of acute ischemic stroke. MethodsWe searched the PubMed, Cochrane Central Register of Controlled Trials, EMBASE, and CNKI up to January 2017. Randomized Controlled Trials evaluating the effect of adjunctive herbal medicine on acute ischemic stroke were included. ResultsA total of 80 studies (8057 patients) were collected. The overall methodological quality was low. In the herbal group, meta-analysis indicated a statistically significant improvement in the neurologic deficits and activity of daily living compared with the non-herbal group. Furthermore, herbal treatments were relatively safe. ConclusionThe treatment can induce neurological improvements without side effects. However, concrete conclusions cannot be made due to the methodological problems of the included studies.

Simultaneous determination of fourteen compounds of Hedyotis diffusa Willd extract in rats by UHPLC–MS/MS method: Application to pharmacokinetics and tissue distribution study

A rapid, sensitive and selective ultra high-performance liquid chromatography-tandem mass spectrometry UHPLC–MS/MS method has been developed and validated for the simultaneous determination of fourteen bioactive ingredients (gallic acid, geniposidic acid, protocatechuic acid, caffeic acid, ferulic acid, scopoletin, apigenin-7-o-glucuronide, daidzein, apigenin, ursolic acid, oleanolic acid, β-sitosterol, coniferin, and stigmasterol) in the plasma and tissues of rats. Danshensu and icariin were used as internal standards (IS1 and IS2). The chromatographic separation was achieved by using an Agilent ZORBAX RRHD Eclipse Plus C18 column (2.1 mm × 50 mm, 1.8 μm) with gradient elution using mobile phase, which consisted of 0.1% acetic acid water (solvent A) and methanol (solvent B) and pumped at a flow rate of 0.3 mL/min. Mass spectrometric detection was performed in multiple reaction monitoring (MRM) mode utilizing electrospray ionization (ESI) in positive and negative mode. The plasma samples were pretreated via protein precipitation with 300 μL of methanol containing 0.1% (v/v) formic acid and organ homogenates were processed by solid-phase extraction (SPE) with Waters Oasis HLB 3 cc (60 mg), respectively. The intra- and inter- day precisions (RSD%) were less than 10.3%, while the accuracy was ranged from –7.34% to 9.10%. Extraction recovery ranged from 85.02 to 112.0% and the matrix effects ranged from 85.12% to 109.6%. The present method exhibited excellent linearity and the lower limits of quantification (LLOQ) were 30.0 ng/mL, 15.0 ng/mL, 80.0 ng/mL, 30.0 ng/mL, 10.0 ng/mL, 3.0 ng/mL, 2.5 ng/mL, 2.5 ng/mL, 1.5 ng/mL, 15.0 ng/mL, 75.0 ng/mL, 15.0 ng/mL, 30.0 ng/mL, and 20.0 ng/mL for gallic acid, protocatechuic acid, geniposidic acid, caffeic acid, ferulic acid, scopoletin, apigenin-7-o-glucuronide, daidzein, apigenin, ursolic acid, oleanolic acid, β-sitosterol, coniferin, and stigmasterol, respectively. This analytical method was verified by the FDA guidelines for bioanalytical method validation and applied to investigate the pharmacokinetics and biodistribution of fourteen constituents of Hedyotis diffusa Willd extract in rats. These results provide useful information for improving the pharmacokinetics and biodistribution of fourteen bioactive ingredients of Hedyotis diffusa Willd extract in SD rats, supporting additional clinical application and Chinese herbal medicine safety evaluations.

Associations between the use of herbal medicines and adverse pregnancy outcomes in rural Malawi: a secondary analysis of randomised controlled trial data

BackgroundThe use of herbal medicines during pregnancy is very high globally and previous studies have pointed out possible associations with adverse pregnancy outcomes. Nevertheless, the safety of herbal medicines in pregnancy is under-explored in low-income countries experiencing high maternal and neonatal complications. We investigated the associations between self-reported use of Mwanamphepo (a group of herbal medicines commonly used to induce or hasten labour) and adverse maternal and neonatal outcomes in rural Malawi.MethodsWe conducted a cross-sectional analysis of secondary household data relating to 8219 births that occurred between 2005 and 2010 in Mchinji district, Malawi. The data were collected as part of a cluster-randomised controlled trial (RCT) that evaluated community interventions designed to reduce maternal and neonatal mortality. Data were gathered on maternity history, demographic characteristics, pregnancy outcomes and exposure to Mwanamphepo. Associations between self-reported use of Mwanamphepo and maternal morbidity as well as neonatal death or morbidity were examined using mixed-effects models, adjusted for relevant covariates. All analyses were also adjusted for the clustered nature of the survey.ResultsOf the 8219 births, Mwanamphepo was used in 2113 pregnancies, representing an estimated prevalence of 25.7%. The self-reported use of Mwanamphepo was significantly associated with increased occurrence of maternal morbidity and neonatal death or morbidity. Specifically, the odds of maternal morbidity were 28% higher among self-reported users than non-users of Mwanamphepo (AOR = 1.28; 95% CI = 1.09–1.50) and the probabilities of neonatal death or morbidity were 22% higher (AOR =1.22; 95% CI = 1.06–1.40) among neonates whose mother reportedly used Mwanamphepo than those who did not.ConclusionThe use of Mwanamphepo was associated with adverse pregnancy outcomes in rural Malawi. Thus, herbal medicines may not be safe in pregnancy. Where possible, pregnant women should be discouraged from using herbal medicines of unconfirmed safety and those who report to have used should be closely monitored by health professionals. The study was limited by the self-report of exposure and unavailability of data relating to some possible confounders.

Herbal Medicine as an Alternative Treatment in Autism Spectrum Disorder: A Systematic Review.

This review focuses on the efficacy and safety of herbal medicines in the management of autism spectrum disorder (ASD) in humans and animals. PubMed, Scopus, Google Scholar, Web of Science, and Science Direct databases were searched up to October 30, 2016. The key terms used were "ASD", "Asperger", "autism", "healing plants", "herbal medicine", and "medicinal plants". In each database, the searches consisted of each of three key terms describing the disorder and subtypes plus each of the terms describing the therapy. All human and animal studies on the effects of herbs with the key outcome of change in autism symptoms were included. In vitro studies were excluded. From the publications perused in the initial database, 3157 results were identified, reviewed and a total of 23 studies were included. Preclinical studies using critically validated models were conducted, with some promising preliminary results. Data availability on controlled clinical studies is currently very limited. The use of different methodologies and the very small number of patients raise doubts about the effects of these preparations. Available data do not yet allow us to suggest the effectiveness of herbal medicines as an add-on in the treatment of ASD symptoms.

Herbal Medicine in Ischemic Stroke: Challenges and Prospective.

Herbal medicines, mainly of plant source, are invaluable source for the discovery of new therapeutic agents for all sorts of human ailments. The complex pathogenesis of stroke and multifactorial effect of herbal medicine and their active constituents may suggest the promising future of natural medicine for stroke treatment. Anti-oxidant, anti-inflammatory, anti-apoptotic, neuroprotective and vascular protective effect of herbal medicines are believed to be efficacious in stroke treatment. Herbs typically have fewer reported side effects than allopathic medicine, and may be safer to use over longer period of time. Herbal medicines are believed to be more effective for the longstanding health complaints, such as stroke. Several medicinal plants and their active constituents show the promising results in laboratory research. However failure in transformation of laboratory animal research to the clinical trials has created huge challenge for the use of herbal medicine in stroke. Until and unless scientifically comprehensive evidence of the efficacy and safety of herbal medicine in ischemic stroke patients is available, efforts should be made to continue implementing treatment strategies of proven effectiveness. More consideration should be paid to natural compounds that can have extensive therapeutic time windows, perfect pharmacological targets with few side effects. Herbal medicine has excellent prospective for the treatment of ischemic stroke, but a lot of effort should be invested to transform the success of animal research to human use.

Utility of alkaloids as chemical and biomarkers for quality, efficacy, and safety assessment of botanical ingredients

BackgroundSelecting the appropriate chemical and bio-markers for monitoring the quality, efficacy, and safety is critical for efficient and reliable assessment of traditional medicines derived from botanical sources. Chemical markers have been implicated primarily in establishing the analytical methodologies aiming at verification of the botanical sources of the raw materials, the extracts, and the finished products such as botanical dietary supplements and nutraceuticals. In addition, they have been employed in differentiation between crude or raw (unprocessed) and processed plant extracts, and identification as well as determination of potential toxicants and adulterants in herbal medicines. Additionally, these chemical markers are utilized for selection of efficient methods for extraction of plants. Further, biomarkers have been exploited in determination of the pharmacokinetic properties of bioactive herbal constituents. Alkaloids, unlike other plant constituents, are uniquely characterized by having basic properties, and possessing substantial and diverse pharmacological effects. These features make alkaloids attractive components for functioning as chemical and biomarkers in determining the quality of botanical ingredients where this class of phytochemicals prevail or is responsible for lending biological effects. PurposeThe aim of the review is to exhibit the function of alkaloids as biomarkers and chemical markers in the evaluation of quality, efficacy, and safety of medicinal herbs and their commercial products. MethodsLiterature acquisition was accomplished using the most commonly accessed scholarly search engines including SciFinder, PubMed, and Google Scholar. Secondly, the full-texts which are relevant to the topic were included in this review. This was followed by a thorough and detailed analysis of the collected information. ResultsThe literature search with main emphasis on the roles of alkaloids in the evaluation of quality, efficacy and safety of herbal medicines was evaluated to provide all succinct information in one place. Compilation of such critical information is expected to help the reader to appreciate alkaloids as important markers in the quality control of herbal drugs and products. ConclusionThe current review article covers the fundamental roles played by alkaloids as chemical and biomarkers in assessing the essential parameters of the quality of botanical ingredients, as briefly described earlier. The utilization of alkaloids as biomarkers to determine the efficacy-linked pharmacokinetic parameters is limited to reviewing studies on human subjects.

Novel Approaches of Herbal Drug Delivery

From ancient times, herbal medicines are in use to cure the diseases due to their potential and less side effects. But difficulties in identification, processing, standardizing, extracting of herbal drugs, it rarely attracts scientists towards the development of novel delivery systems for herbal drugs. The reduced efficacy of herbal drugs is due to the traditional and out of date approach of administration to patients. To minimize these problems various novel drug delivery systems (NDDS) such as phytosomes, ethosomes, transfersomes, herbal transdermal patches, nanoparticles and biphasic emulsions are used nowadays. Novel approach of delivering herbal drugs will increase the efficacy and safety of herbal medicines along with the increased stability of the drug product. These techniques provide improved patient compliance, sustained release and targeted action of plant actives and extracts. This review summarizes the information of various novel techniques used for improving safety and efficacy of phytomedicines, type of active ingredients, biological activity and application of novel formulation of herbal drugs to achieve better therapeutic response.