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Pharmacovigilance of herbal medicines: Concerns and future prospects
Abstract
Abstract
Ethnopharmacological relevance
The use of herbal medicines for prophylaxis, prevention, and treatment of various ailments is rising throughout the world because they are thought to be safer than allopathic treatments, which they are. However, several investigations have documented the toxicity and adverse drug reactions (ADR) of certain formulations and botanicals if not consumed wisely.
Aim of the study
The goal of the current study is to address herbal medication pharmacovigilance (PV) modeling and related considerations for improved patient safety. Also, focus is laid on the comprehensive and critical analysis of the current state of PV for herbal medications at the national and international levels.
Materials and methods
Targeted review also known as focused literature review methodology was utilized for exploring the data from various scientific platforms such as Science Direct, Wiley Online Library, Springer, PubMed, Google Scholar using “pharmacovigilance, herbal medicine, traditional medicine, ADR, under reporting, herb toxicity, herb interactions” as keywords along with standard literature pertaining to herbal medicines that is published by the WHO and other international and national organizations etc. The botanical names mentioned in the present article were authenticated using World Flora Online database. Results: The historical developments paving the way for PV in regulatory setup were also discussed, along with various criteria's for monitoring herbal medicine, ADR of herbs, phytoconstituents, and traditional medicines, herb-drug interactions, modes of reporting ADR, databases for reporting ADR's, provisions of PV in regulatory framework of different nations, challenges and way forward in PV are discussed in detail advocating a robust drug safety ecosystem for herbal medicines.
Conclusion
Despite recent efforts to encourage the reporting of suspected ADRs linked to herbal medicines, such as expanding the programme and adding community pharmacists as recognized reporters, the number of herbal ADR reports received by the regulatory bodies remains comparatively low. Since users often do not seek professional advice or report if they have side effects, under-reporting, is anticipated to be significant for herbal medications. There are inadequate quality control methods, poor regulatory oversight considering herbs used in food and botanicals, and unregulated distribution channels. In addition, botanical identity, traceability of herbs, ecological concerns, over-the-counter (OTC) herbal medicines, patient-physicians barriers requires special focus by the regulatory bodies for improved global safety of herbal medicines.
... ADR data must be collected, analyzed, and appropriate action must be taken to ensure the safety of patients. Since post-marketing safety monitoring standards for herbal drugs were published in the latter part of the twentieth century, pharmacovigilance for herbal therapies has developed and grown (Choudhury et al. 2023). Herbal treatments are being used more frequently due to an increase in the percentage of individuals who decide to turn to these remedies for their primary healthcare needs. ...
... Herbovigilance is required while utilizing herbal remedies to ensure the safety of conventional medicines at both the national and international levels (Choudhury et al. 2023). The goal is to improve patient safety by detecting and minimizing risks related to herbal medication use. ...
... Growing acceptance of herbal medicines: Due to the assumption that herbal medications are safer than traditional allopathic therapies, their use is expanding globally. Despite this impression, specific herbal formulations have been linked to documented toxicity incidents and unfavorable medication interactions if administered improperly (Choudhury et al. 2023). ...
Herbal medicines have been used for treating a wide variety of diseases and illnesses since ancient times. There are still issues concerning the use of herbal treatments and the adverse pharmacological responses that can occur because of them. Herbovigilance is the practice of monitoring herbal treatments for safety. It is critical to analyze safety and discover potential threats and eliminate the instances resulting from inferior-quality products and improper consumption. In territories where herbal medicine is widely utilized, integrating herbovigilance into contemporary healthcare systems and gaining collaboration between practitioners and regulatory bodies can be challenging. Harmonizing these processes can make it easier to monitor the safety of herbal medications. A lack of detailed evidence and information regarding the effectiveness and safety of herbal drugs hinders herbovigilance programs. Substantial evidence is needed to identify and evaluate adverse effects, pharmacological interactions, and potential risks associated with herbal treatments. It is crucial to remember that these potential difficulties are not all-inclusive and that herbovigilance is a field that is continually changing. Regulatory agencies, healthcare practitioners, scientists, and herbal medicines must work together to address these difficulties to ensure herbal remedies’ long-term safety and efficacy.
This Chapter Contains: Introduction, Concept of Herbovigilance in PV, Sources of Reporting ADRs, Reporting of ADRs related to Herbal medicines, Regulatory aspects of herbal medicines, WHO Guidelines for Safety Monitoring in Herbovigilance, Current Scenario of Herbovigilance in India, Herbovigilance Overview Worldwide, Future Prospects, Future Obstacles and Conclusion.
... The resolutions acknowledge this local decision and seek to influence nations that have decided to establish national systems that do not discriminate against traditional healing. They also recommend that nations collaborate to improve the contribution of traditional healing to health systems [20,21,22,23,24,25]. Additionally, models of closer integration and cooperation of practitioners of traditional, complementary, and alternative medicines with the biomedical health care sector have evolved sporadically in response to practical health care needs in a variety of situations and societies. ...
... Integration and partnerships between traditional, complementary, and alternative medicine users/providers with biological resource research, development, and protection as a means to further the future potential of traditional, complementary, and alternative medicine. In some countries, traditional, complementary, and alternative medicine pharmacopoeias are integrated into national health policy [22,23,24,25]. ...
Traditional healers play a significant role in healthcare, particularly in rural sub-Saharan Africa, where access to biomedical treatments is often limited. This paper examines the impact of traditional healing practices on managing diarrheal diseases, one of the leading causes of morbidity and mortality, especially among children and women. By examining historical and cultural significance, epidemiological factors, traditional treatment methods, and empirical evidence on healer efficacy, this study highlights both the strengths and limitations of traditional healing. While biomedical approaches remain the dominant treatment method, there is growing recognition of the potential benefits of integrating traditional healers into mainstream healthcare systems. The findings suggest that a combined approach could enhance healthcare accessibility and effectiveness, particularly in underserved areas. Keywords: Traditional healers, diarrheal diseases, sub-Saharan Africa, alternative medicine, biomedical integration, public health.
... Understanding specific botanical ingredients helps HCPs and researchers analyze adverse reactions more effectively. Identifying these components also aids in assessing interactions between herbs and medications, improving comprehension of AE mechanisms [15,55]. This knowledge supports creating clearer guidelines and warnings, enhancing transparency and reliability in reporting AEs, and promoting safer use and informed decision-making in the herbal product industry [6]. ...
... HCPs, consumers/patients, manufacturers, complementary practitioners, and sellers/distributors, is crucial for the effective engagement of the system in actively monitoring and reporting AEs [6,55]. ...
Background
Herbal medicines (HMs) are extensively used by consumers/patients worldwide. However, their safety profiles are often poorly reported and characterized. Previous studies have documented adverse events (AEs) associated with HMs, such as hepatotoxicity, renal failure, and allergic reactions. However, the prevalence rate of AEs related to HMs has been reported to be low. To date, no systematic review and meta-analysis has comprehensively analyzed the AEs of HMs using published data acquired from pharmacovigilance (PV) databases.
Objective
This study aimed to (1) estimate the reporting rate of the AEs of HMs using PV databases and (2) assess the detailed data provided in AE reports.
Methods
In this systematic review and meta-analysis, MEDLINE/PubMed, SCOPUS, EMBASE, and CINAHL were systematically searched for relevant studies (until December 2023). The DerSimonian-Laird random effects model was used for pooling the data, and subgroup analyses, the meta-regression model, and sensitivity analysis were used to explore the source of heterogeneity. Crombie’s checklist was used to evaluate the risk of bias (ROB) of the included studies.
Results
In total, 26 studies met the eligibility criteria. The reporting rate of the AEs of HMs ranged considerably, from 0.03% to 29.84%, with a median overall pooled estimate of 1.42% (IQR 1.12%-1.72%). Subgroup analyses combined with the meta-regression model revealed that the reporting rate of the AEs of HMs was associated with the source of the reporter (P=.01). None of the included studies provided full details of suspected herbal products, only the main ingredients were disclosed, and other potentially harmful components were not listed.
Conclusions
This systematic review and meta-analysis highlighted risks related to HMs, with a wide range of reporting rates, depending on the source of the reporter. Continuous efforts are necessary to standardize consumer reporting systems in terms of the reporting form, education, and follow-up strategy to improve data quality assurance, aiming to enhance the reliability and utility of PV data for monitoring the safety of HMs. Achieving effective monitoring and reporting of these AEs necessitates collaborative efforts from diverse stakeholders, including patients/consumers, manufacturers, physicians, complementary practitioners, sellers/distributors, and health authorities.
Trial Registration
PROSPERO (Prospective International Register of Systematic Reviews) CRD42021276492
... Medicines and supplements of plant origin are a major element in various types of traditional medicine such as Ayurveda, homeopathy, traditional oriental medicine, and Indian medicine. It is also estimated that among plant-derived medical devices, approximately 74% are used in modern medicine in a way that correlates directly with their traditional use in folk medicine [2][3][4][5][6]. About one-fourth of annually prescribed drugs and about 7000 different medical devices contain ingredients of plant origin or their derivatives, with a market value of about USD 40 billion. ...
... About one-fourth of annually prescribed drugs and about 7000 different medical devices contain ingredients of plant origin or their derivatives, with a market value of about USD 40 billion. Nearly 33% of medicines produced in highly developed countries are preparations obtained from plants [3][4][5][6]. One such commonly used medicinal plant is lemongrass (Cymbopogon citratus (DC.) ...
The importance of natural plant materials in modern medicine is considerable, and raw materials with antiviral, antibacterial, antifungal, and anticancer properties are still sought because of microbe resistance and difficulties in anticancer therapy. This review focuses on the lemongrass Cymbopogon citratus (DC.) Stapf. and on the lemongrass oil properties and applications. Multiple applications of this plant were described in different latitudes and cultures, including cases of digestive disorders and anti-inflammatory, antipyretic, diaphoretic, stimulating, and antispasmodic conditions. Data from the literature on the composition of essential oil and extracts from C. citratus were analyzed, and the results of research on the antifungal, antibacterial, and antiviral effects were quoted. Essential oil inhibits the growth of fungi (Aspergillus niger, A. fumigatus, Candida spp.) and has an antibacterial effect (Staphylococcus aureus, Bacillus subtilis, Pseudomonas aeruginosa). It also shows antiviral activity and deters insects. Lemongrass contains active substances with potential anticancer effects. This plant has apoptosis-stimulating properties, mainly through the activity of apigenin, which is the main active flavonoid in this plant. This active substance helps inhibit cell proliferation by stopping the cell cycle and directing cancer cells toward apoptosis.
... Herbal remedies are available in bulk as unrefined extracts or as pharmaceutical dosage forms, such as tablets, capsules, tinctures, teas, and decoctions. The perception that herbal medicines are intrinsically safe, patients' disenchantment with the effectiveness and/or safety of allopathic conventional drugs, and their satisfaction with the therapeutic outcome have all had an impact on the use of herbal medicines in the management of both minor and major illnesses [6][7][8]. Some more intricate explanations for the inclination toward herbal remedies include philosophical perspectives on life and health [6], cultural and personal beliefs, and patient comparisons of the experiences of complementary medicine practitioners and conventional healthcare providers [11]. ...
... The perception that herbal medicines are intrinsically safe, patients' disenchantment with the effectiveness and/or safety of allopathic conventional drugs, and their satisfaction with the therapeutic outcome have all had an impact on the use of herbal medicines in the management of both minor and major illnesses [6][7][8]. Some more intricate explanations for the inclination toward herbal remedies include philosophical perspectives on life and health [6], cultural and personal beliefs, and patient comparisons of the experiences of complementary medicine practitioners and conventional healthcare providers [11]. In many affluent as well as emerging nations, the use of herbal therapy has increased [12,13]. ...
The purpose of this study was to examine Pakistani community pharmacists' expertise and approach regarding the safety and effectiveness of both allopathic and herbal medicines during pregnancy. During the three months of 1 st November 2023 to 30 th January 2024, an online questionnaire was used to conduct a cross-sectional study in multi-setting of Pakistan. SPSS version 26 was used to analyze the data. The relationship between approach scores and other continuous factors, such as age and years of experience, was examined using the Mann-Whitney U Test. There were total 185 participants. Among them, 69.1% females and 30.9% were males. In overall, 82.15 populations were having post-graduation and only 17.9% have only graduation. Data were collected from both community pharmacists and obstetrician & gynecologists. Moreover, 74.6% were having professional experience of >5 years. Most of the respondents reported inquire about the pregnancy status always (60.6%), sometimes (31.9%), and 1.1% never inquire for status. When faced with uncertainty about drug safety, 74.6% indicated that they would refer to authentic sources, and 54.1% would advise pregnant women to consult their physicians when requesting a potentially contraindicated drug. Nearly half (51.2%) of the participants contacted the prescribing physician to explore safer options. As per study approach, 74.50% allopathic mediation and 44.60% herbs are Community safe to use throughout pregnancy while 17.30% allopathic mediation and 22.40% herbs are unsafe to use throughout pregnancy. A higher knowledge score was significantly associated with receiving a post-graduation degree (p= 0.002). In conclusion, the study's findings demonstrated that community pharmacists adhere to safe practices and possess expertise in utilizing drugs safely while pregnant. Higher knowledge scores were linked to post-graduation. Consequently, the survey participants felt strongly that there was a need for seminars, sessions, and educational programs focused on herbal medicines.
... The toxicity associated with herbal remedies continues to present a significant hurdle, imposing constraints on their utilization despite the prevailing public perception of their safety and lack of potential harm. Among the prevalent toxicities are hepatotoxicity, nephrotoxicity, neurotoxicity, pulmonary toxicity, cardiac toxicity, adult respiratory distress syndrome, and seizures, among others 6,7 . Consequently, the World Health Organization (WHO) advocates for the thorough scientific evaluation of herbal remedies, encompassing both effectiveness and safety assessments. ...
... Consequently, the World Health Organization (WHO) advocates for the thorough scientific evaluation of herbal remedies, encompassing both effectiveness and safety assessments. This proactive approach is crucial to safeguarding the public from potential exposure to harmful plant-derived compounds 2,6 Blighia unijugata Baker is a shade-producing tree commonly found in tropical Africa 8,9 . It is used indigenously to treat boils, vertigo, and post-partum hemorrhage, and also as a purgative, sedative, anti-emetic, and anthelminthic remedy 10,11 . ...
Introduction: While the efficacy of Blighia unijugata against various conditions has been scientifically validated, very little is known of its safety in normal rats. This study aimed to assess the toxic effects of the ethanolic stem bark extract of Blighia unijugata (EBU) on body and organ weight, biochemistry, and hematology of Sprague Dawley rats following repeated oral administration. Method: Twenty (20) male Sprague-Dawley rats were randomly selected into four groups (n = 5) and administered distilled water or EBU at doses of 50, 100, or 200 mg/kg respectively for 28 days. For each group, percentage changes in body and organ weight, serum lipid profile, fasting blood glucose levels, liver, and kidney functions, and the various hematological variables were determined. Results: EBU treatment (50-200 mg/kg body weight) caused no significant changes (p>0.05) in the body weight and the relative organ weight of the heart, kidney, and spleen. Similarly, no significant changes (p>0.05) were observed in the lipid profile (Total Cholesterol, Triglycerides, High-Density Lipoproteins, Low-Density Lipoproteins, and Very Low-Density Lipoproteins), fasting blood glucose, serum urea, creatinine, albumin, globulin, total protein, total bilirubin, alanine aminotransferase, aspartate aminotransferase, and the hematological measures, except for a significant reduction (p ≤ 0.05) in Alkaline Phosphatase after treatment with 200 mg/kg EBU. Conclusion: Overall, this investigation underscores that EBU administration did not cause significant effects on the evaluated parameters, suggesting relative safety within the experimental conditions. However, for potential clinical trials and human use, additional studies such as chronic toxicity assessments across diverse animal models and dosage ranges are recommended. Keywords: Blighia unijugata; biochemistry, hematology, body weight, organ weight
... Herbs should be bought in places that are subject to health inspections. All of these will contribute to patients receiving a quality herbal product and a good health benefit from traditional medical treatment [13,14,15]. ...
Herbal medicine has long played a significant role in managing various diseases, including diabetes, across different cultures. The integration of traditional medicine with modern healthcare is a growing area of interest, as cultural beliefs strongly influence treatment choices. This study examines the cultural perspectives on the use of herbal medicine in diabetic care, analyzing its benefits, risks, and integration with conventional treatments. While herbal remedies are widely used for their perceived effectiveness and affordability, concerns regarding their safety, regulation, and potential interactions with pharmaceutical treatments remain. By examining traditional practices from different regions and the cultural beliefs that shape them, this study highlights the need for a balanced approach that integrates herbal medicine with conventional diabetes management. The findings suggest that healthcare providers should engage with patients to understand their cultural preferences, promote safe practices, and ensure informed decision-making regarding herbal remedies.
... Even despite the recent efforts to encourage the reporting of adverse drug reactions, the number of reports remains relatively low. Therefore, there is a need for global regulatory harmonization of herbs [275]. ...
The incidence of anxiety and depression disorders is increasing worldwide. There is an increasing incidence of hard-to-treat depression with various aspects of origin. Almost 80% of people prefer to use natural remedies and supplements as their primary healthcare solution. Not surprisingly, around one-third of drugs were inspired by nature. Over the past three decades, the use of such remedies has increased significantly. Synthetic antidepressants may cause various negative side effects, whereas herbal medicines are favored because of their ability to relieve symptoms with minimal to no side effects and lower financial burden. This review provides an overview of herbs and biologically active compounds used to treat depression.
... The term 'complementary' now refers to nonmainstream therapies used in conjunction with conventional medicine (integrative) in Europe and 'alternative' to those therapies that are used in place of conventional medicine in the US. The developing multi-centered international studies on integrative health care may have a far-reaching impact on how care can be improved today [5,6,7,8,9]. It has not been the tool of questioning this combined approach, but rather the unique experience of care for the patient. ...
Integrative medicine is an evolving healthcare paradigm that blends conventional medical practices with complementary and alternative medicine (CAM) to provide holistic, patient-centered care. This approach emphasizes treating the whole person mind, body, and spirit rather than merely addressing symptoms. Conventional medicine, grounded in scientific rigor, excels in acute care and emergency interventions, while alternative therapies offer personalized, preventive, and lifestyle-based solutions. The effectiveness of integrative medicine lies in evidence-based practices, interdisciplinary collaboration, and patient empowerment. Despite its potential, challenges such as skepticism, lack of regulation, and standardization issues remain. This paper explores the principles, strengths, limitations, and real-world applications of integrative medicine, advocating for a balanced, research-driven approach that enhances healthcare outcomes.
... The term 'complementary' now refers to nonmainstream therapies used in conjunction with conventional medicine (integrative) in Europe and 'alternative' to those therapies that are used in place of conventional medicine in the US. The developing multi-centered international studies on integrative health care may have a far-reaching impact on how care can be improved today [5,6,7,8,9]. It has not been the tool of questioning this combined approach, but rather the unique experience of care for the patient. ...
Integrative medicine is an evolving healthcare paradigm that blends conventional medical practices with complementary and alternative medicine (CAM) to provide holistic, patient-centered care. This approach emphasizes treating the whole person mind, body, and spirit rather than merely addressing symptoms. Conventional medicine, grounded in scientific rigor, excels in acute care and emergency interventions, while alternative therapies offer personalized, preventive, and lifestyle-based solutions. The effectiveness of integrative medicine lies in evidence-based practices, interdisciplinary collaboration, and patient empowerment. Despite its potential, challenges such as skepticism, lack of regulation, and standardization issues remain. This paper explores the principles, strengths, limitations, and real-world applications of integrative medicine, advocating for a balanced, research-driven approach that enhances healthcare outcomes.
... Herbal medicinal plants have been increasingly employed in primary health care globally (Amanpour et al. 2023;Ferreira, Arcanjo, and Peron 2023;Patricio et al. 2022). Plant specimens were used since antiquity and are considered the origin of modern medicine (Batista et al. 2022;Choudhury et al. 2023;Salmerón-Manzano, Garrido-Cardenas, and Manzano-Agugliaro 2020;Sen andSamanta 2015, Viana et al. 2023). Initially, the methods employed were trial and error to treat diseases or simply to feel better, thus distinguishing which plants were beneficial (Kunle, Egharevba, and Ahmadu 2012). ...
... The demand for herbal drugs is growing, as they are perceived as natural, safe, and associated with fewer side effects compared to prescription medications (Choudhury et al., 2023). Plants may offer a novel source for synthesizing antiepileptic drugs due to their biological activity (Ohanme et al., 2024). ...
Epilepsy, a neurological disorder, is characterized by recurrent, uncontrolled seizures due to an imbalance between inhibitory and excitatory neuronal interactions in the central nervous system (CNS). This study explores the neuroprotective effects of an alcoholic extract from Selaginella bryopteris leaves in experimental epilepsy models. Swiss albino mice (25–30 g) were used, and epilepsy was induced via pentylenetetrazol (PTZ, 60 mg/kg) and maximal electric shock (MES). The extract was administered orally at varying doses and compared with conventional antiepileptic drugs, phenytoin and diazepam. LC-MS analysis identified amentoflavone as a key bioactive compound with antiepileptic properties. The extract demonstrated significant dose-dependent protection in both PTZ and MES models, delaying convulsions in the PTZ model at 500 mg/kg, comparable to diazepam, and providing convulsion protection in the MES model similar to phenytoin. Additionally, the extract increased gamma-aminobutyric acid (GABA) and glutathione (GSH) levels while reducing lipid peroxidation (LPO) levels, indicating its neuroprotective properties. These findings suggest that S. bryopteris leaves possess significant antiepileptic properties and may serve as a promising treatment for epilepsy.
... The Phyto vigilance of drug-plant interactions is complicated due to numerous factors like the patient's comorbid conditions, pharmacogenomic variations, and polypharmacy [11]. On the other hand, Phyto vigilance studies have elaborated on several causes of drug-plant interactions, such as multiple botanical constituents, misidentification of therapeutic dose, mislabelling, and contamination [17,18]. Thus, information regarding herb-drug interactions is potentially problematic, especially in critical cases such as cardiovascular illness, breast cancer and patients with kidney diseases [19][20][21]. ...
Background
The lack of regulation of herbal products in Lebanon, and potential risks associated with herbal-drug interactions potentiates the need for increasing awareness and understanding of herbal-drug interactions among patients and athletes in Lebanon. This study highlights the need for increased awareness and understanding of herbal-drug interactions among healthcare professionals and patients in Lebanon.
Objective
The study aims to investigate the level of knowledge and understanding of herbal interactions and conventional medications among Lebanese patients. Moreover, the study will examine the Lebanese patients’ awareness, perception towards Herbal Drug Interactions (HDIs) and the role of pharmacists in patient education and information provided about herbal medicine.
Methods
A cross-sectional, descriptive study was performed from March to May 2023 consisting of Lebanese outpatients (General Population and Athletes) aged 20 years and older at Lebanese community pharmacies who agreed to respond to the survey questionnaire from medications, sociodemographic and clinical characteristics were collected from patients via face-to-face Interviews, and a well-structured survey questionnaire administered to a representative sample of Lebanese patients to gather data via Online Google Platform Surveys. All these calculations are performed using Statistical Package for the Social Sciences Software (SAS), SAS Institute. Descriptive statistics are used to describe independent variables. One-Way ANOVA analysis followed by a t-test (binary logistic regression) was performed to identify factors associated with HDI(s).
Results
The results of this study provide valuable insights into the current state of awareness and highlight areas for improving patient education regarding herbal-drug interactions, which included 501 patients, with a mean age of 50.248 years, 53.1% of them being female 58.9% and males 41.1%. The category of Lebanese patients who consumed Herbal medications during the last 12 months accounted for 46.7% and advising others to take herbal medication, 47.9%, versus patients who don’t consume herbal medications 53.3%. Lebanese patients get their recommendation for herbal medication use from mass media such as TV, ads, social media (32.3%), pharmacist (21.6%), family members with friends and neighbours (19%), personal reading/ Internet search (13.6%), didn’t get any recommendation (10.8%), Herbalist (9.8%), and Physician (7.4%).
Conclusion
The study provides valuable insights into the awareness of herbal-drug interactions and the need for understanding these interactions among professionals and patients where various factors affect negatively the unauthorized use of herbal products such as the economic crisis in Lebanon which negatively affected the purchasing power of Lebanese patients to buy their conventional medications, the affordable prices of herbal medications, and the reputation of folk medicine practiced by ancestors.
... This interaction can lead to decreased drug efficacy or increased risk of adverse events. Consequently, regulatory agencies issued safety communications and label updates, warning about the potential for reduced therapeutic effects when St. John's Wort is taken with medications like oral contraceptives, antiretrovirals, or certain cancer therapies [53,54]. ...
Pharmacovigilance involves detecting, assessing, understanding, and preventing adverse drug effects. The field aims to systematically monitor medicines and promote their safe, effective use. However, pharmacovigilance faces challenges such as fragmented systems and passive reporting. As the discipline advances, priorities now include centralizing data analysis, applying technologies like AI for safety signals, leveraging real-world data, implementing proactive risk planning, and increasing patient engagement. Recent advancements have emphasized the role of machine learning in identifying adverse drug reactions (ADRs), predicting drug-drug interactions, and enhancing personalized care. Big Data and cloud computing also play critical roles in facilitating the efficient analysis of massive healthcare datasets, contributing to earlier safety signal detection. Moreover, the emerging application of blockchain technology promises to revolutionize drug traceability, data security, and real-time reporting, thus improving drug safety monitoring. The COVID-19 pandemic revealed the need for robust systems that can enable rapid responses to emerging safety issues around epidemic treatments and vaccines. The next era of pharmacovigilance seeks to transform monitoring to improve patient outcomes worldwide. However, thoughtful implementation, focused on ethics, validity, and equity, is critical. The aim of this chapter is to provide perspectives on optimizing pharmacovigilance practices in an evolving landscape, integrating cutting-edge technologies to better safeguard patients.
... This includes any unexpected reactions during the use of AYUSH medications, especially given the distinct formulations and components often used in these systems (Pharmacovigilance Programme of India, PvPI). 3,5,7 HERBAL PHARMACOVIGILANCE: WHO highlights that traditional medicine pharmacovigilance-often called herbal pharmacovigilance-is essential due to the unique risks associated with herbal products, including batch variations and plant misidentification. This is particularly relevant for AYUSH, where botanical sources are often used and variability in sourcing can lead to differing safety profiles (WHO, 2013). ...
Abstract
Background: AYUSH systems, including Ayurveda, Siddha, Sowga rigpa, Unani, Yoga, and Naturopathy, have gained significant popularity worldwide. However, there is a growing concern about adverse drug reactions (ADRs) associated with AYUSH formulations.
Objective: This review aims to provide a comprehensive overview of ADRs reported in AYUSH systems, highlighting the challenges in ADR reporting and prevention.
Methods: A systematic review of literature was conducted using electronic databases to identify studies reporting ADRs in AYUSH. Relevant data on ADR types, frequency, severity, and associated factors were extracted.
Results: The review revealed a limited number of studies reporting ADRs in AYUSH systems. Common ADRs included gastrointestinal disturbances, skin reactions, and neurological symptoms. However, the underreporting of ADRs in AYUSH remains a significant challenge due to various factors, such as cultural beliefs, lack of awareness, and limited healthcare infrastructure.
Conclusion: While AYUSH systems offer potential benefits, it is essential to address the issue of ADRs to ensure their safe and effective use. Improved ADR reporting mechanisms, standardized pharmacovigilance practices, Increasing global acceptance and usage of AYUSH treatments and further research are necessary to enhance the understanding of ADRs in AYUSH and to develop strategies for their prevention.
Keywords: AYUSH, adverse drug reactions, pharmacovigilance, traditional medicine, safety
... In the context of phytopreparation studies, Choudhury et al. 6 emphasise the significance of careful control and monitoring of such products. This is to ensure their safety and efficacy, considering potential risks and side effects. ...
The purpose of this study was to investigate the therapeutic potential and safety of the use of Al Hayat black cumin seed oil. Descriptive and discrete statistical methods and frequency analysis were applied. There were 20 participants in total aged between 11 and 67 years, both men and women. The participants were divided into three subgroups, each receiving different doses of black cumin oil: 10 mg/kg, 20 mg/kg, and 30 mg/kg, respectively. Such parameters as general blood count, liver enzyme activities (aspartate aminotransferase and alanine aminotransferase), creatinine, and serum iron levels were analysed. A dose of 10 mg/kg was found to have no significant therapeutic or adverse effect. A dosage of 20 mg/kg demonstrated positive effects on platelet, immune cell, and creatinine values with no significant side effects. A dose of 30 mg/kg is not recommended for use due to the high risk of adverse reactions. The author also found no significant differences in the therapeutic effects and adverse reactions to black cumin oil that could be related to the gender or age of the participants.
... Presently, it has been shown that around 65% of the drugs licensed for use in medical sectors have been derived from natural sources. The natural products database has a vast collection of about 210,000 physiologically active molecules, exhibiting a significant degree of chemical variety [2]. Natural products have gained considerable recognition within scientific communities due to their superior therapeutic potential compared to synthetic products [3]. ...
Background
Bacillus strains are well recognized for their inherent production of bioactive compounds that exhibit antibacterial and anticancer properties. This study aims to evaluate the antimicrobial and anticancer effects of the secondary metabolite isolated from Bacillus licheniformis and Bacillus siamensis strain.
Material and method
We developed and purified a new soil-derived Bacillus strain to study its metabolites on cancer cells and bacteria. After evaluating the antimicrobial effects of the selected strains’ secondary metabolites by well diffusion, growth conditions and temperature optimised using liquid-liquid extraction, secondary metabolites isolated, and active compounds identified using GC-MS. Evaluation of PC-3 and HPrEpC cytotoxicity. AV/PI staining and comet assay assessed necrosis and apoptosis. Real-time PCR measured apoptotic gene expression. Finally, the scratch test measured cell movement.
Results
Bacillus strain metabolites exhibit dual-purpose antimicrobial and anticancer properties. Bacillus licheniformis isolate 56 and S2-G12 isolate 60 demonstrated the greatest antibacterial activity. Among all Bacillus isolates, isolates 56 (Bacillus licheniformis) and 60 (Bacillus siamensis strain) had the highest antibacterial activity. Crude extracts obtained from strains 56 and 60 decreased PC-3 cell viability in a dose-dependent manner. At 200 µg/mL, the survival rate of cells treated with strain 56 and 60 crude extract was 23% and 25%, respectively (p < 0.001). The treatment of PC-3 cells with strains 56 and 60 crude extract led to considerable apoptosis (46.2% and 50.09%, respectively) compared to the control group. After treatment with the crude extract from strains 56 and 60 at an IC50 concentration, a significant number of PC-3 cells showed comet formation, indicating DNA fragmentation. Metabolites extracted from strain 56 and 60 enhanced caspase 3, caspase 8, and Bax genes expression and reduced Bcl-2 expression (p < 0.001). Cell migration was also prevented.
Conclusion
Our findings show that the secondary metabolites of B. licheniformis and B. siamensis have antibiotic and anticancer properties. However in vivo studies are necessary to confirm these findings.
... Herbal medicine has been utilized since ancient times (Choudhury et al. 2023). Complementary treatments are becoming increasingly popular among patients. ...
... For example, in Malawi, the market is replete with unregulated herbal medicines of questionable quality [40]. Other articles have also stressed the importance of herbal pharmacovigilance and improving awareness and regulatory oversight [41,42]. Several authors have described herbal pharmacovigilance systems in their country [7,38,43]. ...
The use of herbal products globally is substantial, but varying definitions and regulatory frameworks have led to differences in their status as medicinal products and in approaches to monitoring their safety. This article explores the current landscape of herbal pharmacovigilance, drawing insights from interviews with global experts in the field, and offers recommendations for best practices to enhance the safety and benefit-to-harm balance of herbal products.
This study comprised semi-structured interviews with members of the International Society of Pharmacovigilance-Herbal and Traditional Medicines Special Interest Group and the Nutrivigilance Information Exchange Network, recruited using purposive sampling. Data were stored and coded using NVIVO® and analysed thematically using a qualitative inductive approach.
Sixteen participants from 11 countries were interviewed, revealing diverse regulatory approaches and challenges in herbal pharmacovigilance. Key themes included legal status, awareness, identification and coding of herbal products, pre-/post-marketing product control, reporting of adverse drug reactions, causality assessment and signals of herbal products. This study yielded five general recommendations to further improve herbal pharmacovigilance worldwide.
This study offers an overview of the global landscape of herbal pharmacovigilance, highlighting challenges in monitoring herbal products and presenting universal recommendations. These recommendations encompass increasing awareness, enhancing education and improving legislative frameworks. Given the growing use of herbal products, the implementation of strong pharmacovigilance practices is crucial to ensure consumer safety.
... This process is essential as it allows for the monitoring of medication safety in real-use scenarios, thereby ensuring that the benefit-risk ratio remains favorable throughout the drug lifecycle. This activity involves rigorous control of biomedical and pharmacological risks, which is vital for public health protection (Bihan et al., 2020;Choudhury et al., 2023). ...
Anticonvulsants are crucial for treating neurological diseases, necessitating close pharmacovigilance due to their potential risks. For this reason, a prospective descriptive study was conducted to characterize drug-related adverse reactions associated with the use of carbamazepine in the health area of the "Ramon Lopez Peña" Polyclinic, covering the period from July to December 2022. The sample consisted of 35 patients, characterized based on demographic, clinical, and pharmacotherapeutic variables. The detected drug-related adverse events were classified according to causality, severity, and frequency of occurrence. The results showed that the age group of 40-75 years (45.7%) predominated, along with female gender, mixed ethnicity, pre-university education level, and 54.2% did not have any unhealthy habits. The most common diagnosis was epilepsy (68.4%) and among the associated diseases, hypertension was prevalent. The most consumed medications were captopril, hydrochlorothiazide, paracetamol, and metamizole (dipirona). Drug interactions were detected, and 73 adverse reactions occurred, with the nervous system being the most affected at 56.0%. Possible adverse reactions (42.5%), frequent (49.4%), and mild (58.9%) predominated. This study underscores the importance of continuous and effective monitoring in pharmacovigilance to enhance patient safety under carbamazepine treatment, thereby promoting a more rational use of this medication.
... It can lead to the transfer of contaminated herbs from an unregulated market in Pakistan to Norway and can pose severe adverse effects for the users. So, research on herbal toxicology [81], standardization [82], and pharmacovigilance [83] of herbal medicines is essential and warranted. In our study, most participants believed that TM is always safe because of its natural origin [84]. ...
Background
Pakistani immigrants are the largest non-Western ethnic minority group in Norway. Traditional medicines (TM) are extensively used in Pakistan, and studies show that ethnic minorities also use them to recover from illness after migration to the Western world. This study aims to explore Pakistani immigrants’ experiences and perceptions of risk regarding the use of TM to treat illnesses.
Methods
A qualitative study was conducted through in-depth interviews (n = 24) with Pakistani immigrants in Norway from February to March 2023. Participants were recruited through purposive and snowball sampling methods. The data was analyzed using Braun & Clarke’s reflexive thematic analysis (RTA) using Nvivo.
Results
RTA revealed three main themes and six sub-themes. The main themes were: (a) House of knowledge, (b) Choosing the best possible approach for health restoration, and (c) Adverse effects of TM used. A total of 96 different TM were identified, including herbs, food items, animal products, minerals, herbal products, and ritual remedies. All participants used TM to restore health in acute and chronic diseases, and many used TM along with conventional medicines. The participants’ mothers were the primary source of knowledge about TM, and they passed it on to the next generation. They also frequently used religious knowledge to recover from illness. Although TM is considered safe because of its natural origin, some participants experienced adverse effects of TM, but none of them reported it to the health authorities.
Conclusion
The study helps to understand the experiences and perceptions of risk of Pakistani immigrants in Norway regarding traditional practices for treating health complaints. Public health policies to improve the health of these immigrants should consider the importance of TM in their lives. Further research is necessary to explore the safety and toxicity of those TM that are common in Pakistani households in Norway.
... Outcomes and Impact: Along with increased public awareness over safety of medicines, there is an increasing public stare on the performance of the health professions, industry and regulators. A major focus must be to empower health practitioners and patients themselves with useful information that improves individual therapy, aids the diagnosis and management of medicine-induced disease, and generally leads to a reduction of iatrogenic diseases [22][23][24] . ...
... Dalam memasuki pasar internasional, perlu diperhatikan segala persyaratan dan prosedur yang ditetapkan, memperhatikan kebutuhan, kebiasaan pengobatan, dan kebutuhan farmasi pada pasar negara tujuan serta dapat menjalin kerjasama dengan organisasi lokal (Xiong et al., 2022). Selain itu penting untuk memberikan informasi mengenai efek samping produk karena penggunaan jamu olahan sering tidak mencari referensi atau nasihat dari profesional (Choudhury et al., 2023). Inovasi produk jamu juga harus terus dilakukan agar dapat mengikuti perkembangan zaman, namun dengan tetap mempertahankan ciri utamanya sebagai minuman tradisional dan menyehatkan (Setyowati et al., 2023). ...
The development of the herbal industry, especially in the sector of herbal medicine, is increasingly gaining momentum. The COVID-19 pandemic has heightened the demand for a healthy life. Consequently, many institutions are involved in the marketing and distribution of herbal products. This study aimed to analyze the institutions involved, marketing patterns, and marketing strategies for industrially processed herbal medicine products. A qualitative approach with descriptive analysis was employed in this study. Data collection methods included observation, literature study, and interviews with informants. The key informants in this research included herbal medicine business actors and market managers. These business actors consist of herbal medicine processors and marketers. This research was conducted in Sukoharjo Regency. The results show that the institutions involved in the marketing chain of herbal medicine products comprise raw material suppliers, manufacturers functioning as distributors, retailers, and consumers. The marketing chain for processed herbal medicine products can be categorized into 6 marketing channels. The marketing strategies for industrially processed herbal medicine products that can be implemented include promotion via social media; employing a super value strategy; adding distribution agents; developing research on standardization and market opportunities; and innovation in industrially processed herbal medicine products.
... Additionally, the importance of maintaining quality control and the authenticity of pharmaceutical products that are marketed through e-pharmacies could be another challenge [15]. Germany set up a rigorous system to check the quality of medications sold on the market and their distribution in order to make sure everything is in line with safety standards [16]. Digital pharmacies need to conform to these regulations for these reasons, and they have to gain the necessary approval and certification to be allowed to sell pharmaceutical products online. ...
The digitalization of retail pharmacy services in Germany has led to a profound change in the pharmaceutical market that is propelled by factors like an aging population, a need to obtain prescription medications, and government regulations that are meant to make the market more efficient. Online pharmacies are quickly expanding, and major players like Doc Morris and Shop-Apotheke Europe are taking their businesses online. The German regulatory system guarantees quality and patient safety, which are managed through the regulation of licensing and operations defined in accordance with given standards. Digital pharmacies have several advantages like accessibility, convenience, and cost savings, but they also have some issues, such as data protection and regulatory compliance. They are creating new realities for conventional pharmacies and forcing them to adopt to the changing environment by having an online presence and adopting technological advancements. The future of digital pharmacies is driven by advanced technology like artificial intelligence and the application of blockchain, and the cooperation of digital and traditional pharmacies can improve patient care. Policy interventions must be in place to facilitate innovation and training in the digital pharmacy sphere to make it a contributing force to healthcare sector development.
... This misconception leads to a high usage of herbal products in the EU. Unfortunately, this increase has also led to a significant rise in the number of reported adverse reactions caused by these products (1). As a result, herbal products are now being regulated to address these quality, safety, and efficacy concerns. ...
The regulation and use of herbal medicines is a topic of debate due to concerns about their quality, safety, and efficacy. EU Directive 2004/24/EC on Herbal Medicinal Products was a significant step towards establishing a regulatory framework for herbal medicinal products in the EU, and bridging the gap between conventional and herbal medicines. This Directive allows herbal medicinal products to be marketed in the EU through full marketing authorisation, well-established use, and traditional use of herbal medicinal products. The framework relies on the correlation between the therapeutic claims of herbal medicine and the scientific evidence backing them up: the greater the claims made regarding medicinal benefits, the more evidence is required to substantiate its efficacy and safety. This regulatory framework acknowledges and incorporates traditional knowledge when evaluating herbal medicines, showcasing a balanced approach that values cultural traditions while mandating monographs for traditional herbal medicinal products. Excluding herbal medicines completely limits access to affordable treatment, particularly when they serve as the only alternative for some, and protects consumer autonomy. This EU framework could therefore serve as a practical guidance for the use and regulation of herbal medicines, even outside the EU. In conclusion, it is argued that the same moral imagination and courage shown by regulators in the case of herbal medicines could perhaps be used in the regulatory frameworks of other healthcare products.
... 1 20 23-25 For instance, IHM use could result in heartburn, increased blood flow, miscarriage, premature labour and allergic reactions. 27 They also have herb-drug interactions, 28 are associated with induced liver injury 29 , and complicate the care of pregnant women who have pre-existing conditions such as epilepsy or asthma. 21 Moreover, intrauterine death and intrauterine growth restriction, uterine rupture, stillbirth, birth defects of the eye, ear and heart, and other risks have also been linked to the use of IHMs by pregnant women. ...
... 1 20 23-25 For instance, IHM use could result in heartburn, increased blood flow, miscarriage, premature labour and allergic reactions. 27 They also have herb-drug interactions, 28 are associated with induced liver injury 29 , and complicate the care of pregnant women who have pre-existing conditions such as epilepsy or asthma. 21 Moreover, intrauterine death and intrauterine growth restriction, uterine rupture, stillbirth, birth defects of the eye, ear and heart, and other risks have also been linked to the use of IHMs by pregnant women. ...
Objective
The aim of this study was to investigate the prevalence of indigenous herbal medicine use and its associated factors among pregnant women attending antenatal care (ANC) at public health facilities in Dire Dawa, Ethiopia.
Design
A facility-based cross-sectional study design.
Setting
The study was conducted in seven public health facilities (one referral hospital, three urban and three rural health centres) in Dire Dawa, Ethiopia, from October to November 2022.
Participants
628 pregnant women of any gestational age who had been on ANC follow-up at selected public health facilities were included.
Main outcome measures
Prevalence of indigenous herbal medicine (users vs non-users) and associated factors.
Results
The study revealed that 47.8% (95% CI 43.8% to 51.6%) of pregnant women used herbal medicines. Lack of formal education (adjusted OR, AOR 5.47, 95% CI 2.40 to 12.46), primary level (AOR 4.74, 95% CI 2.15 to 10.44), housewives (AOR 4.15, 95% CI 1.83 to 9.37), number of ANC visits (AOR 2.58, 95% CI 1.27 to 5.25), insufficient knowledge (AOR 4.58, 95% CI 3.02 to 6.77) and favourable perception (AOR 2.54, 95% CI 1.71 to 3.77) were factors significantly associated with herbal medicine use. The most commonly used herbs were garden cress ( Lepidium sativum ) (32%), bitter leaf ( Vernonia amygdalina ) (25.2%), moringa ( Moringa oleifera ) (24. 5 %). Common indications were related to gastrointestinal problems, blood pressure and sugar.
Conclusion
The prevalence of herbal medicine use is high (one in two pregnant women) and significantly associated with education level, occupation, ANC visits, knowledge and perceptions. The study’s findings are helpful in advancing comprehension of herbal medicines using status, types and enforcing factors. It is essential that health facilities provide herbal counselling during ANC visits, and health regulatory bodies ought to raise awareness and implement interventions to lower the risks from over-the-counter herbal medicine use by pregnant women.
... .4(Choudhury et al. 2023;Kalaiselvan et al. 2019). Although non-genetic variables (such as age, gender, nutritional status, other diseases, and the presence of comorbidities) used to dominate pharmacokinetic and pharmacodynamic variability(Castillo-Carniglia et al. 2019;Bonevski et al. 2014). ...
Pharmacovigilance information is most important and has been involved in the summary of product characteristics (SPC) of medications since the turn of the century. Both newly launched medications and those that have a strong market presence rely on pharmacovigilance to help assure patient safety. Adverse events occur after post-marketing if pharmacovigilance reporting is not implemented or enforced for clinical studies. Precisely, it is estimated that between 90% and 100% of adverse events associated with currently available drugs are not reported. As a result, identifying drug safety issues in people with severe comorbidities and complicated conditions is very difficult. Because conventional doses of pharmacological drugs are utilised to treat each patient in populations without these concerns, a complete awareness of potential difficulties and contraindications associated with genome in the population is inadequate. Therefore, pharmacogenetics is a cutting-edge technology that can help to solve these challenges. This chapter discusses pharmacovigilance science, pharmacogenetics, and the importance of pharmacogenetics in adverse drug reactions (ADRs), patient care, and clinical trials. Furthermore, this chapter discusses current pharmacogenetics issues.
... Individual variations in metabolism and health status also play a role in these interactions, so it is important to monitor adverse drug reactions (ADRs) because dietary supplements, often derived from plants and other natural sources, may contain active compounds that can interact with prescription medications. These interactions can lead to a range of ADRs, including reduced drug efficacy, increased drug toxicity, or even life-threatening conditions [5]. Understanding these interactions can help healthcare providers and patients make informed decisions about the use of supplements alongside medications. ...
Flavonoids, a diverse group of polyphenolic compounds found abundantly in fruits, vegetables, and beverages like tea and wine, offer a plethora of health benefits. However, they have a potential interaction with drug metabolism, particularly through the inhibition of the cytochrome P450 3A4 enzyme, the most versatile and abundant enzyme in the liver. CYP3A4 is responsible for metabolizing approximately 50% of clinically prescribed drugs across diverse therapeutic classes, so these interactions have raised concerns about potential adverse effects. This review delves into the scientific evidence surrounding flavonoid-mediated CYP3A4 inhibition, exploring the inhibitory potential of investigated flavonoids and future implications. Kusehnol I, chrysin, leachianone A, and sophoraflavone G showed the largest inhibitory potentials and lowest IC50 values. While the clinical significance of flavonoid-mediated CYP3A4 inhibition in dietary contexts is generally considered low due to moderate intake and complex interactions, it poses a potential concern for individuals consuming high doses of flavonoid supplements or concurrently taking medications metabolized by CYP3A4. This can lead to increased drug exposure, potentially triggering adverse reactions or reduced efficacy.
... Our findings reveal instances where batches contained Grubs from multiple biological origins. Detailed biochemical and pharmacological studies are needed for such instances to provide safe and high-quality drugs to patients (Choudhury et al., 2023;Hassen et al., 2022). Therefore, further biochemical and pharmacological studies are essential to gain insights into the clinical significance of this combination of multiple biological sources. ...
... Due to the growing use of herbal products including treatments worldwide, it is becoming increasingly essential to include herbal products and therapies in pharmacovigilance procedures. The major problem with implementation of pharmacovigilance in herbal medicines involves the following reasons [80] ( Fig. 2). Due to their extensive use worldwide, herbal medicines and products have been integrated into pharmacovigilance systems for quite some time. ...
... Thus, adverse reactions associated with herbal preparations are likely to be underreported (Henderson et al., 2002). Thus, there is a need to monitor and to report suspected adverse reactions linked to herbal medicines (Choudhury et al., 2023). ...
Male fertility is increasingly recognized as a critical aspect of overall male health and is influenced by genetic, lifestyle, and environmental factors. It is a biological marker for various health conditions including oncological, cardiovascular, and autoimmune diseases. Understanding male fertility can provide insights into broader health issues, emphasizing the need for a multidisciplinary approach to healthcare. This review aimed to analyze the existing evidence on the mechanisms and effects of herbal treatments on male fertility. This underscores the importance of rigorous clinical trials and quality control to ensure the safe application of these remedies. This narrative review concentrated on English-language literature encompassing research studies, case reports, systematic reviews, and meta-analyses. Comprehensive searches were conducted across databases such as PubMed, Scopus, and Google Scholar, employing keywords including "Male Fertility, Herbal Medicine, Reproductive Health, Plant Extracts, and Complementary Therapies". To ensure the inclusion of the most recent findings, filters were applied to select studies published in English between 1995 and December 2024. This review highlights that lifestyle choices, such as diet and substance use, significantly impact male fertility, while environmental pollutants and medications also pose risks. Male infertility treatments, including in vitro fertilization (IVF) and hormonal therapies, often face challenges related to cost, complexity, and side effects. Many conventional therapies lack robust scientific support, which necessitates ongoing research. Herbal medicines, which have a long history in various cultures, are gaining popularity as complementary options to enhance male fertility. Herbs such as maca and ginseng have shown the potential to improve sperm quality and count, primarily due to their antioxidant properties. However, the efficacy and safety of these treatments requires further validation. Overall, while herbal treatments offer promising benefits, they should be used cautiously and in conjunction with conventional therapies to provide a holistic approach to addressing male infertility. The ultimate goal is to empower couples with informed choices regarding infertility treatments.
Pharmacovigilance, which is often connected with monitoring the safety of conventional pharmaceuticals, has expanded to include herbal medications. The usage of herbal medications has significantly increased worldwide due to their increasing popularity, which is fuelled by people's perceptions of their natural origin and perceived safety. Nonetheless, there are a number of hazards associated with the absence of strict regulatory frameworks and uniform quality controls, including as adulteration, contamination, and variation in active ingredients. The evaluation of adverse reactions and the identification of causative linkages are made more difficult by these considerations. This review explores the many approaches used in the pharmacovigilance of herbal products, such as post-marketing research, active surveillance, and spontaneous reporting systems. Examined is the blending of classical knowledge with contemporary pharmacovigilance techniques, emphasizing the value of multidisciplinary approaches and the part played by medical professionals in identifying and disclosing adverse events. The review also addresses the difficulties in gathering and interpreting data because of the complexity of herbal remedies and the impact of cultural and ethnopharmacological variables. In order to improve the safety profile of herbal medicines, the assessment ends by recommending increased international cooperation, the creation of strong regulatory frameworks, and the promotion of public awareness.
This research is focused on assessing the antibacterial properties of Pogostemon benghalensis stem bark and inflorescence extracts, as well as their inhibitory effects on xanthine oxidase, antioxidant potential, overall phenolic content, and flavonoid concentration. The cold maceration technique was used to obtain extracts using water, methanol, and ethyl acetate solvents. The disk diffusion method demonstrated the significant antibac- terial efficacy of the methanol stem bark extract against Staphylococcus epidermidis, with a zone of inhibition (ZOI) of 13 mm, and the inflorescence methanol extract against Kleb- siella pneumonia (ZOI: 12.9 mm). Moreover, the methanol stem bark extract exhibited the minimum bactericidal concentration (MBC) at 1.56 mg/mL and the minimum inhibitory concentration (MIC) at 0.78 mg/mL against S. epidermidis. The ethyl acetate inflorescence extract displayed noteworthy xanthine oxidase inhibition (IC50: 29.1 μg/mL) comparable to allopurinol (IC50: 12.7 μg/mL). Furthermore, the methanol stem bark extract exhibited a remarkable DPPH free radical inhibitory effect, showing an IC50 value of 42.5 μg/mL. The total polyphenol content ranged from 29.9 μg to 161.3 μg GAE per mg of dried extract weight in the methanol inflorescence extract, while the total flavonoid content ranged from 38.4 μg to 96.8 μg QE per mg of dried extract weight within the water-derived extract. Overall, these findings demonstrate the potent antibacterial properties, xanthine oxidase inhibition, and antioxidant activity of P. benghalensis extracts..
Introduction
Systematic collection of diverse adverse events during herbal medicine administration is crucial. The Korea Adverse Event Reporting System (KAERS) compiles spontaneously reported adverse event data for medicinal products including herbal medicines. This study focused on extracting and analyzing adverse event data specifically related to herbal medicine products from the KAERS database.
Methods
Individual case safety reports (ICSRs) encompassing 84 types of herbal medicine products, identified by item codes from 2012 to 2021, were extracted from the KAERS database. Descriptive statistics were employed to analyze the characteristics of the extracted reports, and adverse event information was systematically categorized and analyzed based on the MedDRA System Organ Class and preferred term classification.
Results
In total, 1,054 ICSRs were extracted, with some documenting multiple adverse events in a single ICSR, resulting in 1,629 extracted adverse events. When categorized by the MedDRA System Organ Class, gastrointestinal disorders were the most prevalent (28.7%), followed by skin and subcutaneous tissue disorders (20.1%). Based on the preferred terms, the most frequently reported adverse events were diarrhea (5.8%), urticaria (5.3%), pruritus (4.7%), rash (4.4%), and abdominal discomfort (4.2%). The most frequently reported herbal medicines were Bangpungtongseong-san (297 cases), Kyeongok-go (144 cases), and Eunkyo-san (108 cases).
Conclusion
Spontaneously reported adverse events associated with herbal medicine products were systematically documented using the KAERS database. This study, which focused on voluntarily reported adverse reactions, underscores the need for additional research to estimate the incidence rate of adverse events and assess causality.
Network pharmacology is an emerging interdisciplinary research method. The application of network pharmacology to reveal the nutritional effects and mechanisms of active ingredients in food is of great significance in promoting the development of functional food, facilitating personalized nutrition, and exploring the mechanisms of food health effects. This article systematically reviews the application of network pharmacology in the field of food science using a literature review method. The application progress of network pharmacology in food science is discussed, and the mechanisms of functional factors in food on the basis of network pharmacology are explored. Additionally, the limitations and challenges of network pharmacology are discussed, and future directions and application prospects are proposed. Network pharmacology serves as an important tool to reveal the mechanisms of action and health benefits of functional factors in food. It helps to conduct in‐depth research on the biological activities of individual ingredients, composite foods, and compounds in food, and assessment of the potential health effects of food components. Moreover, it can help to control and enhance their functionality through relevant information during the production and processing of samples to guarantee food safety. The application of network pharmacology in exploring the mechanisms of functional factors in food is further analyzed and summarized. Combining machine learning, artificial intelligence, clinical experiments, and in vitro validation, the achievement transformation of functional factor in food driven by network pharmacology is of great significance for the future development of network pharmacology research.
In remote Himalayan regions, ethnic communities living near protected areas are dependent on medicinal plants for their healthcare. Although several studies related to ethnomedicine are available from Kashmir Himalaya, however studies focusing on protected areas in this region are largely overlooked. In this study, we aimed to document the ethnomedicinal plant species of the Hirpora Wildlife Sanctuary in Kashmir Himalaya. We conducted systematic field surveys in the study area to collect primary data from 60 participants through face-to-face interviews using a semi-structured questionnaire approach. We recorded 56 medicinal plant species used against different human diseases. The most frequent plant species were used for the treatment of gastro-intestinal disorders. Asteraceae followed by Lamiaceae and Polygonaceae were the most dominant families. The most commonly used plant parts were the leaves, and the main method of preparation was decoction. The present study provides an empirical documentation of valuable ethnic knowledge of medicinal plant species and their respective uses to treat various diseases that will be useful to the pharmaceutical industries for various drug formulations through bioprospection.
The worldwide HIV cases were 39.0 million (33.1-45.7 million) in 2022. Due to genetic variations, HIV-1 is more easily transmitted than HIV-2 and favours CD4 + T cells and macrophages, producing AIDS. Conventional HIV drug therapy has many drawbacks, including adherence issues leading to resistance, side effects that lower life quality, drug interactions, high costs limiting global access, inability to eliminate viral reservoirs, chronicity requiring lifelong treatment, emerging toxicities, and a focus on managing infections. Conventional dosage forms have bioavailability issues due to intestinal P-glycoprotein (P-gp) efflux, which can reduce anti-retroviral drug efficacy and lead to resistance. Use of phyto-constituents with P-gp regulating actions has great benefits for semi-synthetic modification to create formulations with greater bioavailability and reduced toxicity, which improves drug effectiveness. Lipid-based nanocarriers, solid lipid nanoparticles, nanostructured lipid carriers, polymer-based nanocarriers, and inorganic nanoparticles may inhibit P-gp efflux. Employing potent P-gp inhibitors within nanocarriers as a Trojan horse approach can enhance the intracellular accumulation of anti-retroviral drugs (ARDs), which are substrates for efflux transporters. This technique increases oral bioavailability and offers lower-dose options, boosting HIV patient compliance and lowering costs. Molecular docking of the inhibitor with P-gp may anticipate optimum binding and function, allowing drug efflux to be minimised.
A quality control strategy for herbal materials, taking into account the alignment between process characteristics and material quality attributes. The application of this approach holds significant potential for ornamental the building of quality herbal products. The concept of Quality by Design (QbD) has emerged as a dominant framework in the pharmaceutical industry to ensure the quality, safety, and efficacy of herbal products, as well as optimization of product development, manufacturing, and process control to elevate overall quality. In recent years, QbD principles have found application in the development and manufacturing of herbal formulations due to its emerging popularity and demand for natural remedies. This chapter explores the implementation of QbD for herbal products, highlighting its importance in surmounting the challenges posed by the inherent variability of natural ingredients. A profound comprehension of the identification of critical quality attributes (CQAs), which represent measurable characteristics influencing its performance, and the critical process parameters (CPPs) specific to herbal products, encompassing the variables affecting the manufacturing process, is indispensable for the effective implementation of QbD principles. Numerous examples showcase the successful application of QbD in optimizing the manufacturing process of herbal formulations. Furthermore, this chapter presents regulatory aspects and guidelines related to QbD for the herbal formulation, advancements, and future directions in QbD for herbal products, shedding light on potential areas for further research and improvement. Overall, this chapter serves as a comprehensive guide for researchers, formulators, and industry professionals interested in leveraging QbD principles to enhance the quality and reliability of herbal formulations.
Introduction: Phytopharmaceutical products are successfully used for acute respiratory infections and may therefore be promising candidates for adjuvant symptomatic treatment of COVID-19. In vitro and clinical studies suggest that the proprietary Pelargonium sidoides DC. root extract EPs 7630 has antiviral and immunomodulatory properties, and effects on SARS-CoV-2 propagation have been shown in vitro. Medicinal products containing the extract have been approved for the symptomatic treatment of acute viral respiratory tract infections.
Methods: We present a retrospective review of case reports submitted spontaneously to the pharmacovigilance database of the manufacturer of EPs 7630 and containing information on the off-label use of the extract for the treatment and prophylaxis of COVID-19 and of post-COVID-19 syndrome. Eligible case reports were identified by automated database searches.
Results: Forty-four case reports filed between December 2019 and February 2023 were eligible for analysis. More than ¾ described the use of EPs 7630 for treatment of COVID-19 while the remaining reports referred to the treatment of post-COVID-19 syndrome or to COVID-19 prophylaxis. 15/22 cases which reported on treatment duration indicated an intake of EPs 7630 for up to 7 days. Five case reports indicated the use of EPs 7630 as COVID-19 monotherapy while 14 indicated a combination treatment with other drugs. All 28 cases that reported on treatment outcome characterized the patients as improved. Thirty case reports (68%) did not indicate any complications. The most frequent suspected adverse reactions were gastrointestinal complaints and hypersensitivity reactions, both of which may occur as known adverse effects of EPs 7630. No unexpected adverse reactions were observed.
Conclusion: Reported cases confirm that there was a certain off-label use of EPs 7630 for COVID-19 in the market. Even though no formal conclusions about the efficacy of EPs 7630 in COVID-19 can be drawn, a beneficial effect would be explainable by the pharmacological profile of the extract. Further assessment of the effects of EPs 7630 in COVID-19-related indications therefore appears to be both justified and promising, particularly as the available case reports did not give rise to any safety concerns also in this patient group.
Herbal medicines contain chemical compounds which can potentially forestall illnesses and afflictions. Unfortunately, the increasing popularity of herbal drugs worldwide led to the most pervasive misconception that they are perfectly safe and are recommended by patients as self-medication, which frequently brings about unfavourable outcomes and adverse effects. To combat and create awareness of these adverse events, establishing pharmacovigilance (PV) procedures for herbal medications is becoming more widely recognized on several levels. Different ways of using herbal treatments, which might present unique toxicological issues, whether taken separately or in conjunction with other pharmaceuticals, might represent contributing factors to the unpleasant drug response in lifestyle disorders. The chapter contributes to delivering basic knowledge of PV and adverse drug reactions, along with the safe dosage range of phytochemicals in lifestyle diseases, viz. obesity, diabetes, and atherosclerosis. The discussed toxicity and phytovigilance profile of multitudinous natural remedies in enormous lifestyle disorders makes the work unique.
The geranium genus consists of about 400 species, which have been utilized for a long time in ancient medical practices throughout the world. As a result, herbal medications based on species are commonly utilized to treat a range of illnesses. This investigation aims to provide an extensive assessment of the literature on the phytochemistry, ethnomedicinal and pharmacological importance of the genus Geranium. Data were collected through systemic computer searches among the most reputable scientific databases, Web of Science, Google Scholar, and Scopus. Occasionally, information published as peer-reviewed literature was added to data from sources that these databases do not include. This review includes all published works through the end of 2022. The assessment of the biological characteristics of medicinal plant species in the genus Geranium has received a great deal of attention, primarily in the last 20 years, in tandem with the growing interest in herbal remedies in general. The detailed and systematic comparative analysis presented here provides valuable information on the current Geranium species. It paves the way for other beneficial species of Geranium to be studied in the fields of ethnobotany, phytochemistry, and new drug discovery.
Amlapitta is one of the most common disorder of the Annavaha Srotas (digestive System). Improper food intake, changed diet pattern and mental stress are the main contributing factors for disease manifestation. Among two types of Amlapitta, Urdwaga Amlapitta is most common in clinical practice. Amlodgara (sour belching), Urodaha (burning sensation), Hrillasa (nausea) are the major symptoms of it. The disease can be co-related with the hyperacidity, hyperchlorhydria or gastritis. Complications caused by the regular use of Modern medicine for the disease encouraged the current study. Clinical trial of Khanadamalaki Rasayana and Gudakushmandaka Rasayana is conducted on 40 subjects of Urdwaga Amlapitta in two divided groups i.e., Group A and Group B. Single Blind Study Design was applied for the study. Patients were selected from OPD of DGM Ayurvedic Medical College and Hospital for respective trial. Criteria of assessment are set aside on the basis of relief in the signs and symptoms of subjective parameter of Urdwaga Amlapitta. Among 40 patients 8 patients got moderate relief and 32 patients got complete relief from the Symptoms by the treatment. Conclusively the treatment was satisfactorily effective in the patients. The criteria of the assessment and Statistical analysis reveal that Gudakushmandaka Rasayana is more effective than Khandamalaki Rasayana in treating the Urdwaga Amlapitta. The drugs used in this study are having the properties of Pittashamana and Rasayana, So these are helpful in curing the disease along with correcting the Agni and general condition of the patient.
Right from the inception of Ayurveda, through its development across the ages, the fundamental principles of Ayurveda have been influenced and enriched by the thoughts and logics from different Indian philosophical schools. Among the many branches of Indian philosophical schools, Nyaya, Vaisheshika, Samkhya, Vedanta and certain Buddhist schools had a great influence in building up the basic fundamental principles of Ayurveda. The theory of causality behind every action i.e. Karya Karana Vada has been adopted by the majority of Indian philosophical schools with their own unique explanation, which gives the distinct identity to each of the doctrines related to the theory of cause and effect. Charaka Samhita, one of the most fundamental treatise of Ayurveda has adopted many of them and explains different biological as well as universal phenomenon on the basis of these theories. A number of doctrines and concepts those are described both in different philosophical schools and Charaka Samhita, among which Paramanu Vada (doctrine of atom), Pilu Paka Vada (doctrine of molecular change), Pithara Paka Vada (doctrine of physical change), Sat Karya Vada (doctrine of causation), Asat Karya Vada (doctrine of non - existence), Arambhavada (doctrine of commencement), Parinama Vada (doctrine of transformation), Vivarta Vada (doctrine of appearances), Kshanabhangura Vada (doctrine of momentariness), and Swabhavoparama Vada (doctrine of self-destruction) are some of the theories which are discussed in this present study with descriptions & examples available in Charaka Samhita.
Background: Kasa is an independent disease of Pranvaha Strotas. Kasa is an independent disease and it is not life threatening but it interferes with the quality of routine activity of an individual. Prevalence of Vataja kasa is remarkable. Vataja Kasa is one of the type of Shuskakasa dominated by Vata and Pran Vayu Dusthi. Congested Vayu causes the production of abnormal sound, which may be dry or productive. Aim - Comparative efficacy of Duhsparshadi Leha and Kantakari Avaleha in Vataja Kasa. Material and method –In this study, 40 patients of Vataja Kasa will randomly divided into two groups (20 in each) having typical signs and symptoms of Vataja Kasa were treated. In Group A (Experimental)-10 gms Duhsparshadi Leha will administered twice a day with lukewarm water before meal and Group B (Control) will given 10 gms Kantakari Avaleha twice a day with lukewarm water before meal for 15 days. Subjective criteria like Kasavega, Uraha-parshwashool, Shirshool, Swarbheda TLC (Total Leukocyte Count), Neutrophils, and Absolute Eosinophil Count (AEC) are examples of laboratory measures were assessed before and after treatment. Assessment will be recorded in every week (7th day and 15th day). After treatment, there was a significant improvement in all indicators.
Obesity is a major health problem that is caused by body fat accumulation and that can lead to metabolic diseases. Owing to several side effects of the currently used antiobesity drugs, natural plants have risen as safe and potential candidates to alleviate obesity. We have previously reported the antiobesity effect of Hydrangea serrata (Thunb.) Ser. leaves extract (WHS) and its underlying mechanisms. As an extension of our preclinical studies, this study aimed to investigate the effect of WHS on body weight and body fat reduction in overweight or obese humans. A total of 93 healthy overweight or obese males and females, aged 19–65 years, with body mass indexes (BMIs) ≥ 25 and <32 kg/m2, were recruited and received either an oral administration of 600 mg of WHS, or placebo tablets for 12 weeks. Daily supplementation with WHS decreased body weights, body fat masses, and BMIs compared with the placebo-treated group. The hip circumferences, visceral fat areas, abdominal fat areas, and visceral-to-subcutaneous ratios decreased after WHS supplementation. No significant side effects were observed during or after the 12 weeks of WHS intake. In conclusion, WHS, which has beneficial effects on body weight and body fat reduction, could be a promising antiobesity supplement that does not produce any side effects.
Although research has long established that interaction with the natural environment is associated with better overall health and well-being outcomes, the Western model mainly focuses on treating symptoms. In Aotearoa/New Zealand, the Indigenous Māori have long demonstrated significantly more negative health outcomes than non-Māori. Little research has examined the causes compared to Western populations or the role of the natural environment in health outcomes for Māori. An exploration of rongoā Māori (traditional healing system) was conducted to ascertain the importance of landscape in the process of healing. Eight rongoā healers or practitioners took part in semi-structured narrative interviews from June to November 2020. Transcribed interviews were analysed using an interpretative phenomenological analysis and Kaupapa Māori techniques. The findings show how rongoā is underpinned by a complex set of cultural values and beliefs, drawing from the connection to wairua (spirit), tinana (body), tikanga and whakaora (customs and healing), rākau (plants), whenua (landscape) and whānau (family). Incorporating such constructs into the landscape can foster our understanding of health and well-being and its implications for conceptualising therapeutic environments and a culturally appropriate model of care for Māori and non-Māori communities.
Amlapitta is the most typical illness in the present era. In a rapidly growing civilization, Amlapitta is the outer- most common disorder within the current society, because of indulgence in incompatible food habits and activi- ties. Materialistic lifestyle provokes people to run behind a busy, tremendous stressful life which is the least con- cern towards proper food habits. "Hurry", “Worry” & “Curry” are the main causes of Amlapitta disease. The us- age of synthetic drugs like H2 receptor blockers & proton pump inhibitors has decreased due to their side effects. The signs and symptoms of Amlapitta are very comparable to Gastritis or Hyperacidity. The ruling features of Amlapitta are Avipaka (indigestion), Urodaha (Burning in the chest), Utklesha (Nausea) Aruchi (Anorexia) and Tikta-Amlodgara (sour and bitter belching) have been described in Ayurvedic classical texts. A 42-year-old male patient came in OPD with the following complaints Tikta-Amlodgara, Urodaha, Utklesha, Aruchi, Praseka. Dur- ing Examination, the vitals are normal. The patient was treated with Sutshekar rasa 1 tab. BD, Avipattikar chura- na 3gm BD, Drakshavaleha 5gm BD on the basis. The patient was advised to follow up every 15th day. Along with medication, the patient was also advised to follow diet and lifestyle restrictions. Keywords: Agni, Amlapitta, Annavahasrotas, Hyperacidity.
Saraca asoca is an IUCN red-listed tree species that extensively famous in the Ayurvedic medicine field. Saraca asoca (Roxb.) de Wilde belongs to the family Fabaceae, has been used to treat various gynecological disorders, bacterial infections, worm infestations, haemmorhagic dysentery, uterine pain, skin diseases, cancer, circulatory, cardiovascular disorders, and many others. All parts of the Saraca asoca have medicinal values. Numerous antioxidant compounds like flavonoids, catechin, beta-sitosterol, lignin glycosides are present in the bark, leaf, and flower of Saraca asoca plant, which help to stabilize free radicals molecules that are associated with the development of cancer conditions. Currently in the cancer research study field new and more effective modes of natural therapies are recently being analyzed. Traditional medicines have been used for their preventative role against various diseases in the human population. Plant based therapy for cancer prevention is becoming more demanding due to its various unique properties such as natural chemical composition, less expensiveness, naturally available., easily orally administrable, significant chemo-protective activities, nontoxic to normal cells in the body, less side effects compared to other synthetic chemotherapeutic drugs. The chemotherapeutic drugs will be harmful to both cancer and normal cells. Additionally, some common side effects or health consequences like vomiting, nausea, bleeding, hair fall, alopecia, hyperuricemia, thrombocytopenia, bone marrow depression, mucositis are very common after chemotherapeutic drug treatment in cancer. This review paper summarizes the evidences which agree with the fact that flavonoids and other phenolic compounds in Saraca asoca plant possess significant antioxidant activity and an efficient chemopreventive characteristic against different types of cancer. This paper reviews the anticancer activities of Saraca asoca bark and flower and discusses the potential preventive roles of phenolic and flavonoids compounds, present in bark and flower of Saraca asoca in the cancer treatment process.
Aim: To investigate the different antileishmanial activities of extracts of Cassia Fistula L., Morus Nigra L. and Ziziphus Jujuba Mill. Methodology: In this method, three (03) plants having concentrations between 500-2000 µg/mL were subjected to KWH23 strains of L. tropica in which Standard drug was Amphotericin B and have negative control for 24-48 hours. To check the in-vivo studies, plant extract was tested on BALB/c mice (Iqbal et al., 2016). Results: It showed that inhibition (mean) of KWH23 strains at 500, 1000, 1500, 2000 µg/mL after 48 hours were 92.1 ± 0.02, 95.00 ± 0.05, 97.09 ± 0.07 and 98.05 ± 0.05 % respectively. It decreased the lesion size (mean) from 0.8 ± 0.1 mm to 0.40 ± 0.2 mm having significance value p < 0.01 after 8 th week, and cure at 200 mg/Kg against intracellular amastigotes in BALB/c mice was 90.00% (95% Cl = 80.05-97.00). Conclusion: The result shows that Ziziphus jujuba Mill. leaves possess significant antileishmanial activity. Original Research Article Iqbal et al.; JPRI, 33(46B): 466-471, 2021; Article no.JPRI.75329 467
Hyperlipidemia is a disorder of lipid metabolism, which is a major cause of coronary heart disease. Although there has been considerable progress in hyperlipidemia treatment, morbidity and risk associated with the condition continue to rise. The first-line treatment for hyperlipidemia, statins, has multiple side effects; therefore, development of safe and effective drugs from natural products to prevent and treat hyperlipidemia is necessary. Diosgenin is primarily derived from fenugreek (Trigonella foenum graecum) seeds, and is also abundant in medicinal herbs such as Dioscorea rhizome, Dioscorea septemloba, and Rhizoma polygonati, is a well-known steroidal sapogenin and the active ingredient in many drugs to treat cardiovascular conditions. There is abundant evidence that diosgenin has potential for application in correcting lipid metabolism disorders. In this review, we evaluated the latest evidence related to diosgenin and hyperlipidemia from clinical and animal studies. Additionally, we elaborate the pharmacological mechanism underlying the activity of diosgenin in treating hyperlipidemia in detail, including its role in inhibition of intestinal absorption of lipids, regulation of cholesterol transport, promotion of cholesterol conversion into bile acid and its excretion, inhibition of endogenous lipid biosynthesis, antioxidation and lipoprotein lipase activity, and regulation of transcription factors related to lipid metabolism. This review provides a deep exploration of the pharmacological mechanisms involved in diosgenin-hyperlipidemia interactions and suggests potential routes for the development of novel drug therapies for hyperlipidemia.
Many different types of medicinal herbs and their formulation have been used since time immemorial. Practical experience and several modern research works have clearly shown that therapy using medicinal plants is more esteemed than using synthetic chemicals. The world is rich in medicinal plants growing wild or cultivated, forming a huge natural and economical health which must be protected, increased for the development of economy, wealth of nation and health of people. The identification of purely active moiety is an important requirement for Quality control and dose determination of plant related dugs. Standardization of herbal drugs means confirmation of its identity, Quality, and purity. Therefore, it is necessary to improve the safety of herbs and develop a certain quality control along with following WHO guidelines for herbal medicines
Background
Cardamom ( Elettaria cardamomum ) is a spice and exhibits potent antioxidant and biological activities through distinct molecular mechanisms. However, the anticancer effect of cardamom was not explored yet in Ehrlich solid tumor (EST)-bearing mice.
Objectives
This investigation was aimed to evaluate the anti-cancer effects of green cardamom (GCar) alone or combined with the anti-cancer drug cyclophosphamide in an in vivo model to explore its mechanistic role in tumor cell death in EST-bearing mice.
Methods
Ehrlich ascites tumor cells were injected in the mice and 5 days later the animals treated with GCar and/or cyclophosphamide for 10 days. Twenty-four hours from the last treatment, animals were sacrificed for the different measurements.
Results
Data recorded for tumor size, percentage of tumor growth inhibition, tumor growth delay and mean survival time of EST-bearing mice demonstrated the effective role of GCar alone or combined with CPO as a promising anti-cancer agent because it reduced tumor size. GCar elevated the mean survival time of EST-bearing mice compared to that of untreated EST and EST + CPO groups. Analysis of qPCR mRNA gene and protein expression revealed that GCar alone or combined with CPO were promising anticancer agents. After the treatment of EST with GCar, the apoptotic-related genes and proteins were significantly modulated. GCar induced markedly significant decreases in oxidative stress biomarkers and a significant increment in glutathione levels and that of antioxidant enzymes. With a marked diminish in liver and kidney function biomarkers.
Conclusion
The results revealed that GCar could serve as an apoptotic stimulator agent, presenting a novel and potentially curative approach for cancer treatment, inducing fewer side effects than those of the commercially used anti-cancer drugs, such as CPO.
The causative agent of tuberculosis (TB) is Mycobacterium tuberculosis, which mainly infects lungs and causes severe, fever, weight loss, chest pain, etc. It is an extremely transmittable disease spreaded throughout the world as per the WHO. It has emerged as new threat and drug resistance strains of Mycobacterium are emerging throws a challenge to human’s health like Covid-19 in current scenario. TB is now come in the form of bone TB, which is very difficult to diagnosis due to very slow-growing characteristics of Mycobacterium. This review highlights the history, drug development, current treatment both allopathic and Ayurvedic, as well as novel drugs available for the treatment of drug resistance Mycobacterium.
The term retained products of conception (RPOC) refers to intrauterine tissue that develops after conception and persists after medical and surgical pregnancy termination, miscarriage, and vaginal or cesarean delivery. Approximately half of the conceptions are not even recognized 10- 15% is lost during 1st trimester and additional 2-3% is lost in later pregnancy. The word abortion means expulsion from the uterus of the product of conception before the fetus is viable. This period of viability is different in different views. In modern medicine the period of viability is taken as 7 months. In Ayurveda this abortion is mentioned with the name of Garbhasrava or Garbhapata. A 30 yr old female patient came to NIA opd with a complaint of heavy bleed continously since 1 month. On examination it was found, she has taken MTP pill from local clinic. D and C was done though she was getting her bleed continously. Then, she came to NIA opd for futher management and was given Dashmool Kwatha, Ajmodadi Churna, Triphala Guggulu and Prataplankeshwar ras for 7 days. Then the patient was advised for USG which revealed no retained product of conception.
Aqueous leaf extract of Ziziphus mauritiana Lam. was successfully used to synthesize zinc oxide (ZnO) and magnesium-doped ZnO (Mg-doped ZnO) particles and acted as capping and stabilizing agent. UV–Vis diffuse reflectance spectra showed that optical band gap energy of ZnO has narrowed from 3.11 to 3.08 eV and 3.03 eV when doped with 1% Mg and 5% Mg, respectively. Powder X-ray diffraction and X-ray photoelectron spectroscopy studies confirmed the purity and crystalline nature of the synthesized materials. FT-IR spectroscopy revealed the presence of phytochemicals coated on the surface of synthesized materials. The synthesized materials were found to effectively scavenge DPPH radicals in the presence of visible light in comparison to the dark. The antibacterial properties of the synthesized materials were evaluated against Staphylococcus aureus and Escherichia coli. The obtained results revealed that Staphylococcus aureus seemed to be more sensitive to the green synthesized ZnO and Mg-doped ZnO than Escherichia coli.
Premenstrual syndrome (PMS) is a common disorder of young and middle-aged women characterized by cyclic occurrence in the luteal phase of the menstrual cycle of a combination of distressing physical, psychological and behavioral changes of sufficient severity to result in deterioration of inter- personal relationships; which remit upon onset or immediately after menstruation. PMS is due to doshic imbalance and impairment of satwa. Objective of study is to find out the effect of Punarnavadi kashayam and Aswagandha choornam in Premenstrual syndrome. Study design was interventional, pre and posttest with a sample size of 20. Females of age group 20-35 years with PMS fulfilling the American College of Obstetrics and Gynecology criteria of PMS was selected. Punarnavadi Kashayam in the dose of 48 ml bid, 30 minutes before food and Aswagandha choorna in the dose of 3 gm. bid along with kashaya. Administration of drug started 14 days before menstruation and was continued till fourth day of menstruation for three consecutive cycles. Follow up was done for next two consecutive cycles. Patient was assessed on fifth day of menstruation during study period and follow up period. The research drug had shown effectiveness in the treatment of depressive effect, anxiety, fatigue, irritation, depressive thoughts, pain, appetite changes, sleep changes, bloating assessed by premenstrual scale. Both drugs showed effectiveness in normalizing serum sodium and serum potassium levels. Associated premenstrual complaints also subsided. Study concluded that Punarnavadi kashaya and Aswagandha choorna is very much effective in treating Premenstrual syndrome.
Objective
Barriers to healthcare in Ghana are multifaceted. Many people, including patients and providers, face them at different levels. To address these barriers, there is a need to explore the role of an intercultural healthcare system. This paper explores and provides the first evidence on ways through which an intercultural healthcare system can reduce the sociocultural and economic barriers to healthcare in Ghana.
Methods
Focus group discussions with 35 participants comprising 17 healthcare users, 11 formal healthcare providers and 7 alternative healthcare providers were conducted to gather data. Thematic analyses were performed on the transcribed data and presented based on a posteriori inductive reduction approach.
Results
Findings reveal that an intercultural healthcare system in Ghana can help reduce barriers to healthcare, especially cultural, social and economic barriers, by fostering an enhanced relationship between culture and healthcare, promoting affordable healthcare and promoting effective communication between healthcare providers and users. Weak institutional support, lack of strong political will and commitment, lack of training to meet standards of practice, poor registration and regulatory measures, and lack of universal acceptance inhibit implementation of an intercultural healthcare system in Ghana.
Conclusion
The support for intercultural healthcare system and the agreement on its perceived ability to reduce social, cultural and economic healthcare barriers for service users offer an opportunity for policymakers to demonstrate a stronger political will and improved commitment for effective education and training, enforcement of regulatory measures, inclusion of intercultural healthcare in medical school curricula across the country, and community engagement.
The Unani System of Medicine pioneered in Greece and was developed by Arabs into an elaborate medical science based on the frame work of the teaching of Buqrat (Hippocrates) and Jalinoos (Galen). Since that time Unani Medicine has been khown as Greco-Arab Medicine. This system is based on Hippocatic theory of four humours viz. blood, phlegm, yellow bile and black bile, and the four qualities of states of living human body like hot, cold, moist and dry. They are represented as earth, water, fire and air, the Greek ideas were put by Arabian physician as seven principles (Umoor-e-Tabbiya) and included, element (Arkan), temperament (Mizaj), humours (Akhlat), organs (Aaza), sprit (Arwah), faculties (Qowa) and functions (Afaal). In this system is it believed that, these principles are responsible for the body constitution and its health, as well as, diseased
conditions (1).
The World Health Organization (WHO) has recognized the Unani System of Medicine (USM) as an alternative system to cater the health care needs of human population. Alternative medicine is being practiced worldwide.
Keywords: Unani system of medicine
The widely used cancer treatment, chemotherapy, causes severe long-term neuropathic pain in 30–40% cases, the condition clinically known as chemotherapy-induced peripheral neuropathy (CIPN). Approved conventional analgesics are sometimes ineffective, while others like opioids have undesirable side effects like addiction, seizures, and respiratory malfunctioning. Tricyclic antidepressants and anticonvulsants, although exhibit anti-allodynic effects in neuropathy, also have unpleasant side effects. Thus, alternative medicines are being explored for CIPN treatment. Despite scattered reports on different extracts from different plants having potential anti-allodynic effects against CIPN, no established medicine or formulation of herbal origin exists. In this study, efficacy of an herbal decoction, formulated based on ancient medicinal principles and protocols for treating neuropathic pain, Divya-Peedantak-Kwath (DPK), has been evaluated in a paclitaxel (PTX)-induced peripheral neuropathic mouse model. We observed that DPK has prominent anti-allodynic and anti-hyperalgesic effects and acts as a nociceptive modulator for CIPN. With exhibited antioxidative effects, DPK restored the redox potential of the sciatic nerves to the normal. On histopathological evaluation, DPK prevented the PTX-induced lesions in the sciatic nerve, in a dose-dependent manner. It also prevented inflammation by modulating the levels of pro-inflammatory cytokines involved in CIPN pathogenesis. Our observations evinced that DPK can alleviate CIPN by attenuating oxidative stress and concomitant neuroinflammation through immune modulation.
Ashwagandhadi Lehya is a multi-component herbal formulation, an official in the Ayurvedic Formulary of India. It is indicated as aphrodisiac and spermatogenic, containing Withania somnifera as one of major constituents. The objectives of the present studies were evaluation of aphrodisiac and spermatogenic potential and evolving probable mechanism. The spermatogenic potential was evaluated in vivo by estimating serum testosterone and serum cholesterol content, histological assessment of seminiferous tubules, and performing spermatozoa count from cauda fluid. Testosterone content secreted by isolated Leydig cells was evaluated in vitro. The effect of AL on the expression of mRNA, corresponding to 3-β-Hydroxyl Steroid Dehydrogenase and Steroidogenic Acute Regulatory Protein, using TM3 cell line was studied. The aphrodisiac potential was evaluated by performing sexual behavior studies in rats. The serum concentration of cholesterol and testosterone was increased by 2.29 and 0.9 fold, respectively in treated animals. Sperm concentration was increased by 57.9 fold in treated animals compared to control. The amount of testosterone was increased by 20.6 fold in Leydig cells. TM3 cells cultured with Ashwagandhadi Lehya, Withania somnifera, as well as Withaferin-A, showed enhanced expression of selected mRNA. Studies suggested that Ashwagandhadi Lehya could act on Leydig cells, stimulating steroidogenesis, and up-regulated testosterone synthesis. Elevated testosterone levels might influence spermatogenesis in vivo. The elevated serum concentration of testosterone might be attributed to the aphrodisiac potential of the Ashwagandhadi Lehya.
This study was undertaken to assess the nutritive value and mineral contents from Vitex negundo and Adhatoda vasica. These two plant species are fairly used as medicine throughout the greater part of India. Adhatoda vasica is used to control pain, inflammation and other related diseases. Leaves of Adhatoda vasica are used for treatment of cold, cough, chronic bronchitis and asthma. It was also used by traditional midwives at the time of delivery. The leaves of Adhatoda vasica are extensively used in indigenous medicines remedies. Both the plants contained important macro and micro elements: K, Ca, Fe, Cu, Zn and Cr. These elements were found in more quantity in Vitex negundo than in Adhatoda vasica. The leaves of both the plants were analyzed for ash content, moisture, crude fat, crude fibre, crude carbohydrate and crude protein content. The results for percentage of ash content, moisture content, crude fat, crude fiber, carbohydrate and protein were 5.4 ± 0.35, 16.50 ± 1.2, 7 ± 0.7, 28.02 +1.03, 8.5 ± 0.45, 13.7 ± 1.04 % respectively for Vitex negundo; and 5.2 ± 1.23, 15.3 ± 0.5, 1.6 ± 0.3, 6.4 ± 0.45, 16.4 ± 0.8, 6.5 ± 0.3 respectively for Adhatoda vasica. The leaves were also assessed for nutritional value. Nutritional value of Vitex negundo was 151.80 Cal/100g and that of Adhatoda vasica was 106.00 Cal/100.g.
Kasa is an independent disease of Pranvaha Strotas.Vataja Kasa is one of the type of Shuska Kasa which is not life threatening but it can indulge day to day activity. Prevalence of Vataja kasa is remarkable. Hetu Sevana such as Ruksha,Sheeta and Kashaya Pradhan Aahar, Alpabhojana, Upavasa, Mala-Mutra Vegavidharan, Ati-shrama, Ati-maithuna etc. result in Vataja kasa which having symptoms of Kasa Vega, Uraha-Parshwashool, Shirshool, Swarbheda and Daurbalya. Aim-Effectiveness of Duhsparshadi Leha and Kantakari Avaleha in Vataja Kasa. Material and Methods – Study contain 40 patients of Vataja Kasa will divided at way into two groups (each group contain 20). In Group A (Control)-10 gms Kantakari Avaleha will administered two times a day before meal with warm water and Experimental group will given 10 gms Duhsparshadi Leha two times a day before meal with warm water for 15 days. Assessment will be recorded in every week (7th day and 15th day). Result – Subjective and Objectives outcomes will be assess. Conclusion – Duhsparshadi Avaleha will further effectual than Kantakari Avaleha in Vataja Kasa.
Context
Off-label and unlicensed use of drugs is a widespread practice in pediatric care due to the lack of specific efficacy and safety data and the absence of formulations adapted to the needs of these individuals. Pediatric patients with a life-limiting illness frequently receive drugs under these conditions, though no studies have established the prevalence of this practice.
Aim
To describe the prevalence, indications, and most common uses of off-label and unlicensed drugs in a pediatric palliative care unit.
Methods
A prospective, cross-sectional observational study carried out between January and October 2019.
Setting/participants: The study included all patients admitted to the pediatric palliative care unit for home hospitalization and with at least one prescribed drug treatment.
Results
Eighty-five patients involving 1198 prescriptions were analyzed. A total of 39.6% were off-label and 12.9% were unlicensed. All received at least one off-label drug, with a median of 5 per patient (IQR = 3–7), and 81.2% received at least one unlicensed drug. A total of 36.1% of the prescriptions were considered off-label due to indication, 33.8% due to dosage, and 26.6% due to age. The main drugs used off-label were oral morphine, oral levetiracetam, inhaled albuterol, sublingual ondansetron, oral tizanidine, sublingual fentanyl, and oral diazepam. The main symptoms treated with off-label drugs were dyspnea, pain, and nausea/vomiting.
Conclusions
Over half of the prescriptions in this PPCU were off-label or unlicensed. Treatment indication was one of the main reasons for off-label use. Administration of compounded preparations was common in patients with a life-limiting illness.
Research in medicinal plants has gained a renewed focus recently. The prime reason is that other system of medicine although effective come with a number of side effects that often lead to serious complications. Plant based system of medicine being natural does not pose any serious problems. Aonla is one of the oldest oriental medicines mentioned in Ayurveda as potential remedy for various ailments. The fruit is rich in quercetin, phyllaemblic compounds, gallic acid, tannins, flavonoids, pectin, and vitamin C and also contains various polyphenolic compounds. A wide range of phytochemical components including terpenoids, alkaloids, flavonoids, and tannins have been shown to possess useful biological activities. In this review, we have focused our interest on phytochemistry, traditional uses, cancer chemo-preventive, anti-microbial and antimutagenicity activities activity of aonla. It is having a strong memory enhancing property, in lowering cholesterol level applicable in ophthalmic disorder, antimicrobial action and in neutralizing snake venom.
Background
Little is known about the epidemiology of medication errors and medication-related harm following transition from secondary to primary care. This systematic review aims to identify and critically evaluate the available evidence on the prevalence and nature of medication errors and medication-related harm following hospital discharge.Methods
Studies published between January 1990 and March 2019 were searched across ten electronic databases and the grey literature. No restrictions were applied with publication language or patient population studied. Studies were included if they contained data concerning the rate of medication errors, unintentional medication discrepancies, or adverse drug events. Two authors independently extracted study data.ResultsFifty-four studies were included, most of which were rated as moderate (39/54) or high (7/54) quality. For adult patients, the median rate of medication errors and unintentional medication discrepancies following discharge was 53% [interquartile range 33–60.5] (n = 5 studies) and 50% [interquartile range 39–76] (n = 11), respectively. Five studies reported adverse drug reaction rates with a median of 27% [interquartile range 18–40.5] and seven studies reported adverse drug event rates with a median of 19% [interquartile range 16–24]. For paediatric patients, one study reported a medication error rate of 66.3% and another an adverse drug event rate of 9%. Almost a quarter of studies (13/54, 24%) utilised a follow-up period post-discharge of 1 month (range 2–180 days). Drug classes most commonly implicated with adverse drug events were antibiotics, antidiabetics, analgesics and cardiovascular drugs.Conclusions
This is the first systematic review to explore the prevalence and nature of medication errors and adverse drug events following hospital discharge. Targets for future work have been identified.
The study aimed to determine the effectiveness of Bermuda grass
(Cynodon dactylon) topical cream on induced second-degree burns in male albino mice by utilizing a randomized controlled trial experimental research design. The research subjects were assigned randomly into three (3) groups and each containing six (6) mice. Silver sulfadiazine was applied on Group 1 while Base cream was applied on Group 2, and five percent (5%) Bermuda grass topical cream was applied on the Group 3. All treatments were applied every twenty-four (24) hours thereafter while measurement of wound contraction began twenty-four (24) hours after the induction of the burn and every forty-eight (48) hours thereafter until the seventeenth day where complete wound con- traction was observed. The study supported the potential of Bermuda grass as a possible alternative for Silver sulfadiazine in the treatment of burn injuries. This was demonstrated by a higher mean (%) wound contraction – 93.14±4.59, effect of five percent (5%) Bermuda grass topical cream against the mean percent (%) wound contraction effect of Silver sulfadiazine and Base cream – 78.77±8.98 and 89.38±4.24 respectively.
Ayurvedic medicine, a traditional system of medicine practiced in the Indian subcontinent is considered to be devoid of adverse events. We report three cases which highlight the possibility of adverse events related with the use of ayurvedic products. A 35 year old woman with hepatitis took ayurvedic powder medicine and swarnabhasma (gold salt) and had her liver injury worsened, possibly due to alkaloids, and developed nephrotic syndrome, possibly due to gold salt. A 57 year old hypertensive man was taking ayurvedic medicine containing reserpine which had long been withdrawn from the allopathic system of medicine due to wide range of side effects. A 47 year old woman with rheumatoid arthritis was taking an unknown tablet containing steroid as an adulterant for 2 years and developed side effects typical of steroid excess. We would like to highlight the fact that ayurvedic medicines do have propensity to cause adverse events due to adulteration or inherent constituents like alkaloids, and hence may not always be completely safe.
Background: Pain affects millions of people worldwide, opioid
analgesics have been used for chronic painful conditions. Due
to their adverse effects, safer alternatives would be beneficial.
Terminalia chebula, with proven analgesic action has been
evaluated in the hot air pain model for its analgesic activity.
Aim: To evaluate analgesic activity and safety of single oral
dose of Terminalia chebula using hot air pain model in healthy
human participants.
Setting and Design: Randomized, Double blind, Placebo
controlled, Cross over study.
Materials and Methods: After taking written informed consent
to IEC approved protocol, 12 healthy human participants were
randomized to receive either single oral dose of two capsules of
Terminalia chebula 500 mg each or identical placebo capsules
in a double blinded manner. Thermal pain was assessed using
hot air analgesiometer, to deliver thermal pain stimulus. Mean
Pain Threshold time and Mean Pain Tolerance time measured
in seconds at baseline and 180 minutes post drug. A washout
period of two weeks was given for cross-over between the two
treatments.
Results: Terminalia chebula significantly increased mean pain
threshold and tolerance time compared to baseline and placebo.
Mean pain threshold time increased from 34.06±2.63 seconds
to 41.00±2.99 seconds (p
There are many synthetic dyes used to stain leishmania parasite for the purpose of diagnosis and the most famous are geimsa stain and leishman stain. Due to the damage caused by the use of synthetic dyes, including large environmental pollution and harmful toxic side effects this study came for the purpose of obtaining alternative dyes for the staining of the parasite from natural sources available, cheap and easy to obtain. The water extract of kujarat flowers Hibiscus sabdariffa and the alcoholic extract of Damask rose Rosadamascena and China rose Hibiscus rosa sinensis were prepared and used in staining the Leishmania donovani promastigotes and compared with geimsa stain. The three natural flower extracts gave a good capability in staining the promastigote of Leishmania donovani.
Objective:
Medical expulsive therapy is an important non-invasive treatment modality that facilitates the passage of ureteral stones. The aim of the present study was to evaluate the efficacy of Gilaburu (Viburnum opulus) extract in the treatment of distal ureteral stones <10 mm.
Material and methods:
Data of 103 patients were retrospectively analyzed. Patients were divided into two groups: those given V. opulus 1000 mg peroral 3×2 and diclofenac 50 mg peroral on-demand (n=53) and those given only diclofenac sodium 50 mg peroral on-demand (n=50). Comparisons of stone expulsion rates and the elapsed time until the expulsion between the groups were determined as primary outcome measures. The comparison of the need for additional treatment [ureteroscopy (URS) or extracorporeal shock wave lithotripsy (ESWL)], the need for emergency admission, analgesic requirement, and the complication rates in additional treatment were determined as secondary outcome measures.
Results:
The mean age of the patients was 45.8±14.5 years. The rate of stone expulsion was significantly higher (82% vs. 66%, p=0.026), and elapsed time to stone expulsion was significantly shorter (9±1.8 vs. 14±2.3 day, p=0.018) in the V. opulus group. The need for additional treatment (URS and ESWL) and analgesic requirement was less in the V. opulus group (9.4% vs. 20%, p=0.038 and 24.5% vs. 44%, p=0.042, respectively).
Conclusion:
V. opulus is an herbal treatment alternative that facilitates the passage of ureteral stones <10 mm. Prospective, randomized studies are needed to support these results.
The paradigm of cutaneous adverse drug reactions (CADRs) due to the resurgence of Dushi-visha (~cumulative poison) is less reported. Clinical evidence of Dushi-visha is not commonly diagnosed in the clinics. This is the era of polypharmacy; the long duration of medication along with a multi-therapeutic approach causes drug intolerance and complicates with reduced assimilation. Improper elimination causes an increased concentration of these medicines in the plasma and produces toxic side effects. These cumulative endotoxins are termed as Dushi-visha in Ayurveda. A 60-year-old male diagnosed with abdominal tuberculosis had undergone anti-tubercular treatment and suffered from pyogenic abscess over back, and rectal area, around the umbilical area. Pus culture isolated coagulase-negative Staphylococcus . In due course of time, the patient took treatment but abscess continued to develop over different parts of the body. This is a suspected case of tuberculous gumma based on clinical presentation and history of the disease, and according to Ayurveda, this is a case of Dushi-visha . The classical treatment of an abscess is focussed on incision and drainage, but this case was handled with Vishaghna chikitsa (~anti-toxin treatment) and other potential treatments considering the resurgence of Dushi-visha without any surgical intervention. Many conditions, which generally seem idiopathic due to lack of proper history, may be due to reactivation of Dushi-visha . This case report opens up the way to clinically identify and potentially treat the condition with Ayurveda.
This study aimed to investigate the chemical composition and antibacterial potential of Terminalia arjuna (Roxb. ex DC.) Wight Arn. commonly called Arjun leaves essential oil and its major compound i.e., α-terpineol against phytopathogenic bacteria of rice and potato i.e., Xanthomonas oryzae pv. oryzae, Dickeya zeae and Streptomyces scabies. The essential oil was extracted from the leaves by hydro-distillation method using Clevenger apparatus. The essential oil was characterized by Gas Chromatography-Mass Spectrometry analysis which revealed the presence of 34 compounds having α-terpineol as a major compound. It was isolated from the essential oil by column chromatography and its purity was confirmed by ¹H-NMR and IR studies. Both the essential oil and α-terpineol were tested for antibacterial activity against X. oryzae pv. oryzae, D. zeae and S. scabies using agar disc diffusion method. Arjun leaves essential oil was found ineffective against D. zeae but exhibited minimum inhibitory concentrations (MIC) of 38.5 and 40.0 ppm against X. oryzae pv. oryzae and S. scabies respectively. The major compound i.e., α-terpineol was found more effective than the essential oil against all the three tested bacteria with MIC values of 31.5, 29.5 and 27.0 ppm against X. oryzae pv. oryzae, D. zeae and S. scabies respectively. Hence it can be concluded that α-terpineol, a major compound in Arjun leaves essential oil may be used as a natural eco-friendly antibacterial agent against the above said phytopathogenic bacteria
Medicinal plants have regained popularity in recent years as a result of growing trust in traditional medicine, and the worldwide supply of medicinal plants sourced from the wild is resulting in a dwindling natural resource base. It is necessary to pursue a broad trend toward medicinal plant production, as well as vertical integration of commodities by downstream enterprises ensuring them consistent supply of high-quality herbs. The first step towards achieving a successful farming model is suggesting the right crops in the right location. Our major objectives therefore, were to encompass agro-ecological studies permitting identification of potential growing regions of medicinal plants taking into account their climatological characters for successful cultivation using Geographical Information System (GIS). For safe and sustainable medicinal plant production for both growers and consumers, the article included studies pertaining to the historical advents of Good Agricultural Practices (GAP) in different countries and agro-practices of medicinal plants. Subsequently, this has urged us to document critical alignment approach to comprehend quality of medicinal produce by identifying critical materials and process parameters including phyto-remediation techniques. The Indian state of Punjab was studied to better understand the challenges and opportunities in the medicinal plants sector, as well as to make recommendations based on current knowledge for the establishment and smooth operation of the sector. Before beginning commercial cultivation of medicinal plants, the review indicates that understanding of agro-ecological zoning, GAP, quality target, and agro-economics are required. It also emphasises the importance of more comprehensive legal and policy control in the herbal industry. This article will serve as a guide for farmers and policymakers working in the medicinal plant industry.
Tribulus terrestris, L. (puncture vine) have been used as a folk medicine for five thousands of years, but its targets, effects, their mechanisms and application requires further studies. This paper reviews the provenance, constituents and properties of Tribulus terrestris, L., its general physiological and health effects, as well as the currently available knowledge concerning its influence on male and female reproductive processes and their dysfunctions. Analysis of the available publications demonstrated the influence of Tribulus terrestris on a wide spectrum of targets and physiological processe and disorders. In particular, Tribulus terrestris can be a stimulator of male and female reproductive processes at the level of central nervous system, sexual behaviour, pituitary and gonadal hormones and their receptors, gonadal functions (including ovarian follicullogenesis and spermatogenesis), improvement of the quality and quantity of gametes (at least of sperm) and fecundity. This ability of puncture vine is applicable for the improvement of man’s sexual desire and sperm quality in vivo and in vitro, as well as of women’s libido, activation of women’s reproductive organs, fecundity, and treatment of infertility, especially that related to the polycystic ovarian syndrome.
Tribulus terrestris, L. (puncture vine) have been used as a folk medicine for five thousands of years, but its targets, effects, their mechanisms and application requires further studies. This paper reviews the provenance, constituents and properties of Tribulus terrestris, L., its general physiological and health effects, as well as the currently available knowledge concerning its influence on male and female reproductive processes and their dysfunctions. Analysis of the available publications demonstrated the influence of Tribulus terrestris on a wide spectrum of targets and physiological processe and disorders. In particular, Tribulus terrestris can be a stimulator of male and female reproductive processes at the level of central nervous system, sexual behaviour, pituitary and gonadal hormones and their receptors, gonadal functions (including ovarian follicullogenesis and spermatogenesis), improvement of the quality and quantity of gametes (at least of sperm) and fecundity. This ability of puncture vine is applicable for the improvement of man’s sexual desire and sperm quality in vivo and in vitro, as well as of women’s libido, activation of women’s reproductive organs, fecundity, and treatment of infertility, especially that related to the polycystic ovarian syndrome.
Embelia ribes Burm F. is large scandent shrub, disturbed throughout India and belongs to the family Myrsinacae. It is commonly known as false black pepper or Vidanga. E. ribes grows in semi-evergreen and deciduous forests at an altitude of 1,500m found in central and lower Himalayas, Arunachal Pradesh, Assam, Bengal, Orissa, Andhra Pradesh and Madhya Pradesh throughout India. Embelia ribes has been proven to have great pharmacological potential with a great utility and usage as folklore medicine. The root, berries and leaves of Embelia ribes is used in herbal formulas. It is used as antibacterial, antifertility activities, antiprotozoal, abdominal disorders, lung diseases, constipation, indigestion, fungus infections, mouth ulcer, sore throat, pneumonia, heart disease and obesity, analgesic, anti-inflammatory, antioxidant and formulations of Embelia ribes are Ardrakakhandavaleha, Eranda paka, Krimighna kashaya churna, Vidangadi churna, Taramandura guda, Guduchi lauha, Abhayarishta, Kumari asava, Manibhadra yoga, Pippalyasava, Kaishore guggulu, Vyoshadi guggulu, Saptavishantika guggulu, Eladi ghrita, Kasisadi ghrita, Chandraprabha vati, Wdangadi lauha, Vidanga taila.
Mucositis is a very painful unavoidable and common side effect in head and neck cancer patients undergoing curative radiotherapy and can affect the planned treatment. In this study, attempt is made at understanding the efficacy of Emblica officinalis Linn (amla) when combined with providone iodine in mitigating radiation-induced mucositis, weight loss and tumor control. This was a retrospective chart based study and was carried out by extracting the data from the files of patients with cancer of head and neck who used amla in combination with iodine or iodine alone during the course of the curative radiotherapy (> 60 Gy). The data was entered in to Microsoft excel and subjected to statistical analysis using SPSS 17 software. The results indicate that when compared with iodine alone, the group where iodine and amla gargling were used was very effective in delaying mucositis, reduced incidence of intolerable mucositis (P = 0.027), quantitative grade of weight loss (P = 0.016), incidence of severe weight loss (P = 0.03) without affecting tumor response. The results suggest that when compared with iodine alone, amla when combined with iodine was more effective in mitigating radiation mucositis and by not interfering with the tumor cell kill. As far as the authors are aware of this is the first study that shows the usefulness of combining iodine with Amla in mitigating radiation-induced mucositis.
According to the European Union regulation, some countries have established a pre-market notification system for food supplements while others have not. As this regulation is unfulfilled, a notified and marketed food supplement ingredient in one country may be forbidden in another. Even though food supplements shall not be placed on the market if unsafe, some products may still expose the consumers to risks. The risk is increased by easier access due to worldwide dissemination fostered by the internet and free movement of goods in the European Union. The Rapid Alert System for Food and Feed and the Emerging Risks Exchange Network are described. To date, the European Union legislation does not include a provision to establish a dedicated vigilance system for food supplements (Nutrivigilance). Six European Union countries have nevertheless set up national systems, which are presented. The present lack of European Union data collection harmonization, does not allow easy cooperation between countries. This article advocates for creating a coordinated European Nutrivigilance System to detect and scrutinize adverse effects of food supplements. This, to help in directing science-based risk assessments and reinforce the science-based decision of policy makers to improve public health safety.
The covid -19 pandemic has wreaked havoc on the global healthcare system and the economy. At present, no specific antiviral vaccine is available to combat this contagious virus. Traditional medicine has a long history of playing a significant role in managing several infectious diseases. In this context, scientists around the globe are also exploring various traditional medical interventions to prevent the covid -19 pandemic. In the present work, we summarize available scientific data advocating the use of traditional medicine for preventing covid -19. A robust literature review was conducted using scientific platforms such as Science Direct, National Center for Biotechnology Information ( ncbi ), Pubmed, Google Scholar, and online database like The Plant List (The Plant List 2013) version 1.1. Special emphasis was given to potential natural antiviral, immuno-modulator plants, and traditional medicines to highlight their possible roles in reducing the disease burden. Immuno-modulator such as Withania somnifera and other natural compounds especially glycyrrhizin, kaempferol, ginsenoside, and lycorine can be leading candidates against sars -CoV-2. Besides the need for rigorous scientific validation of potential herbs and related formulations, their use can be beneficial for the preventive as well as symptomatic treatment of covid -19 infected patients. This work provides a run-through of the experimental therapeutics, preventive and treatment options for covid -19.
The experiments were conducted at CCS HAU, Hisar (Haryana) to study the morpho physico-chemical components of resistance to pod borer, Helicoverpa armigera in pigeonpea with different sowing dates. In different four sowing dates, the minimum pod infestation (1.70%) was recorded in (D4) 3rd week of July sown crop, whereas, it was observed maximum (4.54%) in (D2) 1st week of July sown crop. In different pigeonpea varieties, the minimum mean pod infestation (2.45%) was recorded in AL-201, whereas, the maximum mean pod infestation (3.72%) was recorded in Pusa-992. The glandular (type A) and non-glandular (type B) trichomes on pods of top and middle canopy of the plant and pod wall thickness were associated with resistance to H. armigera, whereas, the non-glandular lengthy (type C) trichomes and pod length were associated with susceptibility to this insect. The expression of resistance to H. armigera was also associated with the high amount of fat, phenol and tannin content. Crude protein and total soluble sugar content were responsible for higher pod infestation.
Background
Over the last decade, there has been a sudden rise in the demand of herbal as well as Information and Technology (IT) industry around the world. Identification of plant species has become useful and relevant to all the members of the society including farmers, traders and hikers etc. Conventional authentication techniques such as morphological characterization, histological methods, and optical microscopy require multiple skills which are tedious, time-consuming and difficult to learn for non-experts. This creates hurdle for individuals interested in acquiring knowledge of species. Relying on rapid, economical and computerized approaches to identify and authenticate medicinal plants has become a recent development.
Objective
The purpose of this review is to summarize artificial intelligence-based technologies for wider dissemination of common plant-based knowledge such as identification and authentication to common people earlier limited to only experts.
Methods
A robust plant identification design enabling automated plant-organ and feature-based identification utilizing pattern recognition and image processing techniques resulting in image retrieval and recognition have been highlighted in this review for all the concerned stakeholders. Attempts have been made to compare conventional authentication methods with advanced computerized techniques to emphasize the advantages and future applications of an automated identification system in countering adulteration and providing fair trade opportunities to farmers.
Results
Major findings suggested that identification of microscopical features such as shape and size of calcium oxalate crystals, trichomes, scleriods, stone cells, fibers etc. are the essential descriptors for identification and authentication of herbal raw drugs. Conclusion: This computational design can be successfully employed to address quality issues of medicinal plants. Therefore, computational techniques proved as a milestone in the growth of agriculture and medicinal plant industries.
Background:
Some pediatric patients with attention-deficit/hyperactivity disorder (ADHD) use natural health products (NHPs) such as herbal remedies. Although herbal remedies are generally considered to be safe when they are used appropriately, they may contain active components that can interact with medications being used concurrently, with potential for NHP-drug interactions leading to adverse events.
Objectives:
The objectives of this study were (1) to identify adverse event reports (AERs) involving commonly used herbal remedies and ADHD prescription medicines in children and adolescents; (2) to evaluate the quality of collected AERs; and (3) to assess whether NHP-drug interactions can be causally linked to reported adverse events.
Methods:
We systematically searched the FDAble database (FDAble.com) for herbal remedies commonly used by patients (4-18 years old) also taking ADHD drugs from 1997 to 2015. We assessed the completeness of the AERs and used three causality assessment tools modified for NHPs (Naranjo Adverse Drug Reaction Probability Scale, HORN Drug Interaction Probability Scale, and World Health Organization Uppsala Monitoring Centre Scale).
Results:
Of the 23 identified AERs involving both an herbal remedy and an ADHD prescription medication, most involved multiple (>3) substances with inadequate detail to assess multiple potential interactions. Following data extraction and evaluation of completeness, five AERs involving only one herbal remedy and one ADHD medication were evaluated for causality. An NHP-drug interaction was assessed to be probable in one case and to be possible in another. Both these reports involved a methylphenidate formulation and St. John's wort.
Conclusions:
Eighteen of the 23 identified AERs involving both an herbal remedy and an ADHD drug also involved other multiple ingredient products. The reporting quality was poor for the five AERs examined. Further research is needed to study the interaction between St. John's wort and methylphenidate.
Purpose:
In 2011, France and Germany banned pioglitazone due to a concomitant risk for bladder cancer. There has been continued debate about this topic. Therefore, we present a detailed analysis of data from individual case safety reports of pioglitazone use (PG-ICSRs) associated with bladder cancer reported worldwide and in India.
Methods:
Data from PG-ICSRs reported by the National Coordination Centre's Pharmacovigilance Programme of India, as well as over 131 World Health Organization member countries in the Uppsala Monitoring Centre's VigiLyze pharmacovigilance database system, from January 1, 1967, to March 4, 2018, were collected. Comparisons between data from global and Indian PG-ICSRs were made by applying filters such as country, bladder cancer, age group, gender, time period, information component, and data mining.
Findings:
Among the adverse drug reactions (ADRs) reported with pioglitazone use worldwide, bladder cancer and related terms were the most highly reported (43%). The most frequently co-reported concurrently used drug was metformin, which was included in 25% and 40% of overall and bladder cancer-specific PG-ICSRs, respectively. Suspected bladder cancer-specific pioglitazone-related reactions were reported in 27 countries, with 8548 serious and 1858 fatal cases and an information components value of 9.15. The Americas had the highest relative percentage of suspected bladder cancer in PG-ICSRs (53%), while the prevalence was much lower in India (2%). In both cohorts, men over the age of 45 years constituted the most highly reported population.
Implications:
India has a very low prevalence of reported overall and bladder cancer-specific pioglitazone-related ADRs compared to Europe and the Americas. Possible explanations for the difference in reporting rates include variance in genetic makeup, low BC risk factor, pioglitazone prescription at a lower therapeutic dose, greater use of chemopreventive spices in the diet, higher frequency of metformin as a concurrent drug, and under-reporting of ADRs.
Pancreatic cancer (PC) is a disease of insidious onset and late clinical presentation with an annual incidence of 100 per million population. Itis the sixth most common cause of mortality from cancer and records a median survival of about 3–6 months without treatment. Quality of life (QOL) is the major consideration in the management of advanced cancer. PC adversely affects QOL of sufferers and mostly presents with abdominal pain from intra- and extra-pancreatic origins. Opioids are the “Gold-standard” treatment in severe cancer pain management. However, its use may be challenged by debilitating side effects such as drowsiness, respiratory depression, constipation, nausea/vomiting, or opioid toxicity which further worsens QOL of patients burdened with cancer. Neurolytic coeliac plexus block (NCPB) is indicated in PC pain that is resistant or refractive to conventional analgesic methods. Such potent analgesic technique could ease the suffering of cancer patients and provides an improved QOL. Reports indicate that NCPB provides effective analgesia in advanced PC but might be associated with minor and transient side effects such as hypotension, diarrhea, and retroperitoneal hemorrhage. Reports from studies analyzed in this review show that NCPB provides superior analgesia in PC pain management than opioid-based therapies. However, there is no satisfactory evidence that NCPB improved QOL in these patients. This shows that QOL of advanced cancer patients is not synonymous with pain relief. Improvement in QOL will be difficult without management of the “total pain” felt by the patients.
Drug-induced liver injury (DILI) is an adverse reaction to drugs or other xenobiotics that occurs either as a predictable event when an individual is exposed to toxic doses of some compounds or as an unpredictable event with many drugs in common use. Drugs can be harmful to the liver in susceptible individuals owing to genetic and environmental risk factors. These risk factors modify hepatic metabolism and excretion of the DILI-causative agent leading to cellular stress, cell death, activation of an adaptive immune response and a failure to adapt, with progression to overt liver injury. Idiosyncratic DILI is a relative rare hepatic disorder but can be severe and, in some cases, fatal, presenting with a variety of phenotypes, which mimic other hepatic diseases. The diagnosis of DILI relies on the exclusion of other aetiologies of liver disease as specific biomarkers are still lacking. Clinical scales such as CIOMS/RUCAM can support the diagnostic process but need refinement. A number of clinical variables, validated in prospective cohorts, can be used to predict a more severe DILI outcome. Although no pharmacological therapy has been adequately tested in randomized clinical trials, corticosteroids can be useful, particularly in the emergent form of DILI related to immune-checkpoint inhibitors in patients with cancer. This Primer discusses the cause, mechanisms, diagnosis and treatment of drug-induced liver injury — an adverse reaction to supplements, herbal medicines and commonly used pharmaceuticals.
Background:
The European Pharmacopoeia as well as further legal provisions contain rules for the assessment of potential residues and contaminants in herbal substances and preparations used for the production of herbal medicinal products, e.g. for the assessment of pesticide residues, heavy metals and other elemental impurities, mycotoxins and microorganisms. As a potential contamination caused by weeds, the occurrence of pyrrolizidine alkaloids is being discussed for several years which lead to measures of health authorities limiting the PA content in herbal medicinal products and to measures of industry consisting of reducing the probability of PA occurrence in medicinal plants and the respective products.
Conclusion:
In this context and with regard to all kinds of potential residues or contaminants, collection and evaluation of data from daily analytical practice of manufacturers and suppliers is useful for the assessment of the situation and the definition of testing strategies.