Application of BRAFO-tiered approach for health benefit-risk assessment of dark tea consumption in China.

Dark tea, a unique tea fermented primarily in China, has numerous potential beneficial effects. However, harmful substances present in dark tea have provoked significant concern. To conduct a quantitative benefit-risk assessment of dark tea for Chinese residents and provide guidance on rational consumption, a framework of Benefit-Risk Analysis for Foods (BRAFO) and meta-analysis was applied to construct a disability-adjusted life year (DALY). Based on the BRAFO-tiered approach, a reference scenario (no intake) and an alternative scenario (intake of 3 cups/day) were determined. The overall health impacts of dark tea were simulated by comparing the risks of fluoride and AF with benefits of reduced-risk to coronary heart disease (CHD) and diabetes in different scenarios. Three cups of fermented tea consumed per day decreased risks of CHD and diabetes by 8.16% and 12.77% respectively. After quantitative integration of information, the ultimate net health effect was found to be -1958.827 illustrating that the benefits of drinking three cups of dark tea per day outweigh the risks. However, considering the uncertainties in the process, decision-makers should proceed with caution, consulting additional well-conducted studies and further managing harmful substances in dark tea.

Assessment of Passiflora incarnata L for conscious sedation of patients during the extraction of mandibular third molars: a randomized, split-mouth, double-blind, crossover study.

OBJECTIVE: The aim of the present study was to evaluate the efficacy of Passiflora incarnata L for the control of anxiety during third mandibular molar extraction and compare it to midazolam, the most used benzodiazepine in dentistry. METHOD AND MATERIALS: The investigators implemented a prospective, randomized, double-blind, split-mouth study. The degree of anxiety of the patients was assessed before the surgical procedure. The surgeries took place in two sessions: one on each side of the hemi-mandible and, on each of them, the patient received one of the drugs, crosswise. Anxiety control was measured through physical parameters, at the following periods during the surgery: (1) immediately administration of anxiolytic medication, (2) 30 minutes after anxiolytic medication, (3) after extraoral antisepsis, (4) after local anesthesia, (5) during incision, (6) during osteotomy, (7) between osteotomy and odontosection, (8) during odontosection, (9) during surgical store curettage, (10) during suture, and (11) immediately after postoperative care guidelines. Lastly, the volunteers received a self-assessment form in order to report their experience. Statistical analysis was performed using the Wilcoxon test. RESULTS: The final sample was composed of 20 patients, with a mean age of 22.5 years. The results of the physical parameters showed statistically significant differences (P < .05) for certain times and physical parameters, especially heart rate (P = .036), which showed the highest control for Passiflora at time point (3). The undesirable effects reported by patients such as drowsiness, muscle relaxation, and dizziness were greater with benzodiazepine. CONCLUSION: The results of this study suggest that Passiflora may be considered as an alternative to midazolam in controlling anxiety in dentistry. Future studies will focus on other benzodiazepines and herbal medicines.

International policies and challenges on the legalization of traditional medicine/herbal medicines in the fight against COVID-19.

The coronavirus disease 2019 (COVID-19) has now rapidly spread around the world, causing an outbreak of acute infectious pneumonia. To develop effective and safe therapies for the prevention and treatment of COVID-19 has become the major global public health concern. Traditional medicine (TM)/herbal medicines (HMs) have been used to treat multiple epidemics in human history, which brings hope for the fight against COVID-19 in some areas. For example, in China, India, and South Korea with traditional medication history and theory, the governments issued a series of guidelines to support TM/HMs in the medication of COVID-19. In contrast, other countries e.g. North American and European governments are typically silent on these practices, unless to warn of possible harm and overselling. Such difference is due to the discrepancy in culture, history and philosophical views of health care and medication, as well as unharmonized policies and standards in the regulation and legalization of TM/HMs among different areas. Herein, we reviewed the responses and scientific researches from seven selected countries on the policies and legalization of TM/HMs to treat COVID-19, and also analyzed the major challenges and concerns to utilize the traditional knowledge and resource.

Cost-Effectiveness of Passion Fruit Albedo versus Turmeric in the Glycemic and Lipaemic Control of People with Type 2 Diabetes: Randomized Clinical Trial.

BACKGROUND: Robust evidence has related yellow passion fruit albedo and long turmeric to the metabolic and glycemic control of diabetes. AIM: To analyze the incremental cost-effectiveness of the flour made from yellow passion fruit albedo versus long turmeric merged with piperine in the glycemic and lipid control of individuals with type 2 diabetes. METHOD: Eighty-nine patients were enrolled in this randomized, placebo-controlled, clinical trial for 120 days. The first group was prescribed 500 mg capsules, three times a day, of yellow passion fruit albedo flour (FAMA). The second group was prescribed long turmeric capsules (500 mg), merged with piperine (5 mg) (CURPI), at fasting. The third group followed the standard advice recommendations, and ingested a placebo of carboxymethyl cellulose (500 mg) at fasting. RESULTS: The group using FAMA showed a higher reduction (-5.9%) of glycemia after fasting, compared to placebo (+9%), and CURPI (-3.2%) (p < 0.05). Regarding HbA1c, the study observed a significant and similar statistical reduction (-0.8%) in the intervention groups, in contrast with the placebo group (p < 0.05). The reduction in HOMA-IR in the CURPI group (-9.4%) was higher than the other groups (p < 0.05). The CURPI group also showed a higher reduction of serum triglyceride levels (-20.8%) compared to the placebo (-0.09%) and FAMA (+1.8%) (p < 0.05) groups. CONCLUSION: It was concluded that turmeric is the most cost-effective in comparison with yellow passion fruit albedo, because of its decrease in the levels of triglycerides and HOMA-IR, even when adjusted for confounding variables. On the other hand, HbA1c cost-effectiveness relation was similar.

An evidence based efficacy and safety assessment of the ethnobiologicals against poisonous and non-poisonous bites used by the tribals of three westernmost districts of West Bengal, India: Anti-phospholipase A2 and genotoxic effects.

INTRODUCTION: To explore the ethnobiological wisdom of the tribals of three western districts of West Bengal, India against poisonous and non-poisonous bites and stings, a quantitative approach was adopted. These age-old yet unexplored knowledge can be utilized in finding lead-molecules against poisonous and non-poisonous animal-bites. Further, an evidence-based approach is needed to assess the venom-neutralization ability of plants by experimental studies. MATERIALS AND METHODS: During 2008-2009 and 2012-2017, 11 ethnomedicinal surveys were carried out to explore the use of medicinal flora and fauna via conducting open semi-structured interviews with 47 traditional healers (THs) or informants. The retrieved dataset was statistically evaluated using seven quantitative-indexes: use-value (UV), informants'-consensus-factor (ICF), fidelity-level (FL), relative-importance (RI), cultural importance-index (CI), index of agreement on remedies (IAR) and cultural agreement-index (CAI). Anti-phospholipaseA2 (PLA2) properties of selected plant extracts were also examined. In addition, the cytotoxicity and genotoxicity of the water extract of the plants showing high FL as well as significant PLA2 inhibitory potential were investigated using Allium cepa root tip assay. RESULTS: A total of 41 traditional-formulations (TFs) containing 40 plant species (of 39 genera from 28 families) and 3 animal species were prescribed by the THs. Fabaceae exhibited most number of medicinal plants. Piper nigrum (1.78) and Apis cerana indica and Crossopriza lyoni (both 0.21) exhibited the highest UV among the plants and the animals respectively. Stinging of centipede and dog/cat/hyena bite displayed highest ICF (1.00 each). Among the plants, the maximum RI (0.91) and CI (4.98) values were observed for Aristolochia indica. IAR (1.00) was recorded maximum for Achyranthes aspera, Gloriosa superba, Lycopodium cernuum, Smilax zeylanica and Streblus asper. Maximum CAI value was noted for Piper nigrum (5.5096). Among the animals, Apis cerana indica (0.31) and Crossopriza lyoni (1.52) displayed the highest RI and CI values respectively. Crossopriza lyoni (0.99) and Apis cerana indica (1.3871) exhibited maximum IAR and CAI values respectively. Plants showing higher FL exhibited higher anti-PLA2 activity via selective inhibition of human-group PLA2. In addition, Allium cepa root tip assay has indicated the safety and/or toxicity of the plant parts prescribed by the THs. Root water extracts of Aristolochia indica and Gloriosa superba exhibited significant genotoxicity and cytotoxicity. CONCLUSIONS: Three western districts of West Bengal is the natural abode for many tribal and non-tribal communities. A noteworthy correlation was established between the plants used against poisonous-bites and their anti-PLA2 activity. A few plant parts used by the THs also exhibited high toxicity. Such alternative medical practices serve as the only option in these underprivileged and backward areas during medical-exigencies.

Combined extracts of Moringa oleifera, Murraya koeingii leaves, and Curcuma longa rhizome increases energy expenditure and controls obesity in high-fat diet-fed rats.

BACKGROUND: LI85008F is a proprietary combination of leaf extracts of Moringa oleifera, Murraya koeingii, and extract of Curcuma longa rhizome. This herbal extract combination is an effective weight loss supplement for overweight and obese subjects. The present study aimed to investigate the thermogenic potential of the LI85008F in high-fat diet (HFD)-induced obese Sprague Dawley rats. METHODS: Seven rats received a regular diet (RD), and twenty-one rats received a high-fat diet (HFD) for 56 days. On day 28, the HFD-fed rats were randomized into three groups (n = 7). Starting from day 29 through day 56, one HFD-fed group received daily oral gavage of 0.5% Carboxymethylcellulose Sodium (CMC) alone (HFD), and the remaining two groups received 100 and 250 mg/kg LI85008F (LI85008F-100 and LI85008F-250, respectively). Body weight, fat mass, fat cell size, liver weight, liver triglyceride were measured. The energy metabolism parameters were measured using indirect calorimetry. In serum, the metabolic and endocrine markers were analyzed. The adipogenic and thermoregulatory proteins expression in the white adipose tissue (WAT) were analyzed using an immunoblot assay. RESULTS: Supplementation with both doses of LI85008F significantly increased resting energy expenditure (REE) in the obese rats. The LI85008F-250 rats showed significant up-regulation of uncoupling protein-1 (UCP-1) expression, as compared with the HFD rats. LI85008F significantly reduced body weight gain, fat mass, fat cell size, liver weight, and hepatic triglycerides. Serum triglyceride, total cholesterol, glucose, leptin, and fat cell markers were significantly reduced in LI85008F-supplemented rats compared to the HFD rats. CONCLUSION: The present data suggest that LI85008F reduces body fat mass and controls body weight gain via increasing energy metabolism in combination with reduced lipogenesis in diet-fed obese rats.

Natural Health Product-Drug Interaction Causality Assessment in Pediatric Adverse Event Reports Associated with Attention-Deficit/Hyperactivity Disorder Medication.

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.

Assessment of the effect of sachet formulation of almond (Amygdalus dulcis L.) on diarrhea prominent irritable bowel syndrome (IBS-D) symptoms: A clinical trial.

OBJECTIVES: Almond has been listed in the low FODMAPs (Fermentable Oligo-, Di-, Mono saccharides And Polyols) and is recommended for infant diarrhea and gastrointestinal problem in Iranian folk medicine. In this work, sachet of almond has been designed, formulated and is studied on the clinical symptoms of diarrhea prominent irritable bowel syndrome (IBS-D). DESIGN: almond was standardized on the basis of total protein and carbohydrate content. A sachet of almond and wheat flour (placebo) was formulated and their physicochemical characteristics were investigated. INTERVENTION: In a double blind randomized trial, fifty IBS-D patients were randomly enrolled into the almond and placebo groups, ranked in respect to the severity of symptoms to mild-moderate and severe disease. The patients received almond or placebo sachet (40 g/day,20 days) respectively. MAIN OUTCOME MEASURE: Patients were assessed for bowel habit, pain severity and frequency and bloating and data was recorded in a data collecting form. RESULTS: The results showed that none of the primary outcomes of the disease is improved in the patients treated with almond. The bowel movement and severity of the pain was significantly increased in the almond treated patients compared to the placebo and baseline (p < 0.05). CONCLUSION: Almond contains high content of oligo-fructan which in high intake might result in a large amount of fermentable carbohydrates that can exacerbate the symptoms of the disease. So, despite the almond inclusion in the low-FODMAPs, the amount of almond intake is a determining factor and here we have controversial results for almond intake in patients with IBS. Mental health and physical activity of patients are also involved in the disease.

Ethnobotany of medicinal plants used by the Zeliangrong ethnic group of Manipur, northeast India.

ETHNOPHARMACOLOGICAL RELEVANCE: The Zeliangrong people with their yearlong experiences still depend on the medicinal plants for primary healthcare. Some of the medicinal plants used by the community exhibits established pharmacological activities which signify the importance of the traditional knowledge of the tribes. Besides, many other species traditionally used by the tribes assume to have pharmacological potentiality. AIM OF THE STUDY: The study aimed to identify the medicinally and pharmacologically important species with understanding the traditional healing practices and to compare medicinal plant knowledge among the informants of the three tribes under Zeliangrong group. MATERIAL AND METHODS: Data were collected by interviewing selected 27 herbal healers using modified semi-structured questionnaires. Identification and documentation of all the species have been made using standard taxonomic procedure. Ethnomedicinal uses of all the recorded species was analyzed with computation of the use reports for each species and Informant Consensus Factor. RESULTS: The study recorded 145 medicinal plants used in healing practices by the Zeliangrong tribes. Except 2 species, all are Angiospermic plants found mostly in wild condition. These medicinal plants are used for treating about 59 different health ailments categorized under 13 ICPC disease categories. Highest ICF (0.75) was found in Digestive disorder with 174 use reports for 44 plant species. Besides the established medicinal plants in the Indian System of medicine like Acorus calamus, Centella asiatica, Oroxylum indicum and Phyllanthus emblica, a number of other species like Ageratum conizoides, Blumeopsis flava, Clerodendrum glandulosum, Gynura cusimbua, Hedyotis scandens and Paederia foetida also has maximum use reports. Among the species with higher use reports, 2 species namely Clerodendrum glandulosum and Paederia foetida are exclusively used for the treatment of hypertension, and bone fracture and sprain respectively indicating their remarkable medicinal values and acceptability. Out of the total 145 species, only 24 are shared by all the three tribes with 11 species used for similar diseases. CONCLUSION: The medicinal plants with higher use reports can be evaluated for validation of pharmacological activities and their toxicity. The Indigenous Knowledge System of Zeliangrong community for herbal remedies may be of immense value in pharmacological experimentation particularly for the uses like malaria, health tonic, cancer, jaundice, hypertension and diabetes.

The relationship between women's characteristics and herbal medicines use during pregnancy.

The use of herbal medicines (HM) has been increasing worldwide. This cross-sectional study investigated the prevalence of and characteristics related to use of HM among 320 pregnant women. Participants were admitted to Mazandaran-based hospitals' postnatal wards from March to June 2015. Data were collected via a self-report questionnaire, including herbs used during pregnancy and demographic, socioeconomic, and pregnancy-related factors. Nearly half (48.4%) of the women reported taking one or more HM during pregnancy. The most frequently used herbs were sour orange (30.97%), peppermint (19.81%), and Borage (19.46%). Most women (29.20%) were advised by their relatives to take these and did not disclose this use to their health care providers (50%) because they perceived their use as safe (39.7%). The use of herbs was greater among pregnant women with upper secondary level education, living in their own house and from higher socioeconomic classes. Most of the information sources for women were informal, indicating they were not knowledgeable about the herbs' safety and efficacy during pregnancy. Health care providers should be informed about HM and question pregnant women about their use of HM during pregnancy so that they can advise them about potential side effects and drug interactions.

Zanthoxylum armatum DC.: Current knowledge, gaps and opportunities in Nepal.

ETHNOPHARMACOLOGICAL RELEVANCE: Zanthoxylum armatum DC. possesses several medicinal properties and has been commonly used in different indigenous medicinal practices to cure several diseases because of its stomachic, carminative and anthelmintic properties. AIM: This review paper aims to provide an update on and analysis of information about the ecology, uses, phytochemistry, pharmacology, trade opportunities, policy gaps for the commercialization of this species forming a basis for further scientific innovations MATERIALS AND METHODS: Information was gathered through a search of different books, journals, articles, annual reports, proceedings and web-based materials. RESULT: Alkaloids, sterols, phenolics, lignins coumarins, terpenoids and flavonoids have been identified from leaves, fruits, stem, bark and seeds. Its trade value is also very high with its manifold applications in Ayurveda, allopathy, general pharmacy, and other industries. Antimicrobial, antiviral, antioxidant, anti-inflammatory, cytotoxic, hepato-protective, insecticidal/larvicidal effects are of particular relevance. CONCLUSION: It is one of the prioritized medicinal plants for economic development in Nepal. Owing to its diverse applications, the species can be developed as an important commodity for alleviation of poverty in rural areas. The various ethno-pharmacological applications of Zanthoxylum armatum have been verified by several related researches. More extensive study on the individual specific phyto-component can lead to novel innovations for the well-being of mankind.

Medicines in the forest: Ethnobotany of wild medicinal plants in the pharmacopeia of the Wichí people of Salta province (Argentina).

ETHNOPHARMACOLOGICAL RELEVANCE: This article presents the results of a study on wild plant pharmacopeia and medical ethnobotany of the Wichí people of the South American Gran Chaco region, where native forest still persist. Few previous works on the former subjects exist, with only partial information. Traditionally, shamans are in charge of healing serious diseases and wild plants are used for treating minor problems. Some ethnobotanists believe that much of the present pharmacopeia of native peoples of the Gran Chaco comes from the Criollos (local non-native people) and that medicinal plants and uses would have been much fewer in the past. AIMS OF THE STUDY: The study aims to: a) document the wild medicinal plants used by the Wichís and the associated ethnobotanical knowledge, b) discuss the use of medicinal plants in the current sanitary, epidemiological and ethnomedical context of the Wichís, and c) analyse the similarities between the medicinal plants and uses of the Wichís and those reported for the Criollos of the study area, for the We'enhayek (Wichís of Bolivia) and for other indigenous peoples of the Gran Chaco. All of them will help to answer a general research question: are medicinal wild plants of the Wichís present pharmacopoeia long-dated or are they relatively new adquisitions? MATERIALS AND METHODS: Original data were obtained between 2005 and 2017 from 51 informants through open and semi-structured interviews, participant observation, "walks-through-the-forest" technique and gathering of plant vouchers. Consensus of Use (CU) per species, use, ailment and use-category were calculated. Species and uses of the Wichís and those reported for other groups of the region were compared confronting the data, a similarity index (Sorensen) was calculated and a cluster analysis was carried out. An interpretative analysis of the results was performed. RESULTS: Original data consist of 408 applications for which 115 plants of 48 botanical families are used for treating 68 ailments or symptoms. Species are mainly used for treating prevalent health disorders in Wichí epidemiological context (skin and digestive disorders, fever, respiratory affections) and feminine issues. CONCLUSIONS: The similarity of the current Wichí pharmacopoeia with the other ethnic groups of the region seem to respond more to a geographical proximity than to cultural affinity. Much (but not all) of their pharmacopoeia seem to be novel, resulting from a permanent seek for solutions to both old and new health problems in the native forests. Many medicinal plants, but not specific uses, seem to come from the neighbouring Criollos, whilst traditional remedies seem to be simultaneously preserved. Hence, I propose that the ethnobotanical "diversification hypothesis", slightly modified, applies in the case of wild medicinal plants of the Wichís, as new wild medicines are being added to the old ones to fill therapeutic vacancies that for several sociocultural and historical reasons appear in their traditional pharmacopoeia. Altogether, results provide novel information of interest for ethnopharmacology, medical ethnobotany and related disciplines, expand the knowledge of Wichí pharmacopoeia and constitute a baseline for future diachronic and cross-cultural studies in the Gran Chaco region.

Father's roles and perspectives on healthcare seeking for children with pneumonia: findings of a qualitative study in a rural community of the Philippines.

OBJECTIVES: Pneumonia remains a primary cause of death for under-five children. It is possible to reduce the mortality impact from childhood pneumonia if caregivers recognise the danger signs of pneumonia and obtain appropriate healthcare. Among caregivers, research on fathers' healthcare-seeking behaviours and perceptions are limited, whereas research on mothers is available. This study aims to reveal fathers' roles and perspectives with respect to the selection of care and treatment for children with pneumonia in a remote island of the Philippines. DESIGN: A qualitative research was carried out using semistructured interviews. SETTING AND PARTICIPANTS: The interviews were conducted with 12 fathers whose children had pneumonia-like episodes in the 6 months prior to the interview. Data analysis was performed using the concept analysis method to identify codes which were merged into subcategories and categories. Finally, the themes were identified. RESULTS: Three themes were identified as part of fathers' roles, and two were identified as fathers' perspectives on various treatment options. Fathers took care of their sick children by not entrusting care only to mothers because they considered this as part of their role. Notably, fathers considered that arranging money for the child's treatment was a matter of prime importance. They selected a particular treatment based on their experiences and beliefs, including herbal medicine, home treatment, and visiting traditional healers and health facilities. Their decision was influenced by not only their perception of the severity of illness but also cultural beliefs on the cause of illness. Visiting health facilities, particularly during hospital admissions, causes significant financial burden for the family which was the main concern of fathers. CONCLUSION: It is crucial to consider the cultural background and also imperative to address issues related to medical cost and the credibility of health facilities to improve fathers' healthcare-seeking behaviour.

Ethnomedicinal plants and traditional knowledge among three Chin indigenous groups in Natma Taung National Park (Myanmar).

ETHNOPHARMACOLOGICAL RELEVANCE: This research describes the ethnomedicinal plants as used by three Chin indigenous groups inhabiting areas at Natma Taung National Park (NTNP) in bio-culturally diverse Myanmar. The aim of this study was (1) to identify wild medicinal species and evaluate their local importance in local peoples' healthcare as well as in protected area conservation; and (2) to compare traditional medicinal plant knowledge among the informants. MATERIALS AND METHODS: A total of 206 Müün, Ng'gah and Daai informants from 20 villages were interviewed using semi-structured questionnaires. Species use-reports were computed to determine plant local importance and the informant consensus factor. Descriptive and the inferential statistics Mann-Whitney U and Kruskal-Wallis tests were employed to evaluate and compare the informants' traditional medicinal knowledge. RESULTS: A total of 75 wild ethnomedicinal taxa in 40 plant families across 16 ICPC-based disease categories were recorded. Species which recorded the highest number of use-reports appeared to play an important role not only in informants' primary healthcare and in park conservation, but also in local livelihood. CONCLUSION: This study presents the diversity of ethnomedicinal plants and their local importance in Chin indigenous peoples' healthcare. This paper also recognizes the value of these plants and the local traditional knowledge for the conservation and management of NTNP.

International consensus statement on allergy and rhinology: allergic rhinitis-executive summary.

BACKGROUND: The available allergic rhinitis (AR) literature continues to grow. Critical evaluation and understanding of this literature is important to appropriately utilize this knowledge in the care of AR patients. The International Consensus statement on Allergy and Rhinology: Allergic Rhinitis (ICAR:AR) has been produced as a multidisciplinary international effort. This Executive Summary highlights and summarizes the findings of the comprehensive ICAR:AR document. METHODS: The ICAR:AR document was produced using previously described methodology. Specific topics were developed relating to AR. Each topic was assigned a literature review, evidence-based review (EBR), or evidence-based review with recommendations (EBRR) format as dictated by available evidence and purpose within the ICAR:AR document. Following iterative reviews of each topic, the ICAR:AR document was synthesized and reviewed by all authors for consensus. RESULTS: Over 100 individual topics related to AR diagnosis, pathophysiology, epidemiology, disease burden, risk factors, allergy testing modalities, treatment, and other conditions/comorbidities associated with AR were addressed in the comprehensive ICAR:AR document. Herein, the Executive Summary provides a synopsis of these findings. CONCLUSION: In the ICAR:AR critical review of the literature, several strengths were identified. In addition, significant knowledge gaps exist in the AR literature where current practice is not based on the best quality evidence; these should be seen as opportunities for additional research. The ICAR:AR document evaluates the strengths and weaknesses of the AR literature. This Executive Summary condenses these findings into a short summary. The reader is also encouraged to consult the comprehensive ICAR:AR document for a thorough description of this work.

A Quantitative Assessment of the Reporting Quality of Herbal Medicine Research: The Road to Improvement.

OBJECTIVES: To quantify different aspects of the quality of reporting of herbal medicine clinical trials, to determine how that quality is affecting the conclusions of meta-analyses, and to target areas for improvement in future herbal medicine research reporting. STUDY DESIGN: The Electronic databases PubMed, Academic Search Premier, ScienceDirect, and Alt HealthWatch were searched for meta-analyses of herbal medicines in refereed journals and Cochrane Reviews in the years 2000-2004 and 2010-2014. The search was limited to meta-analyses of randomized controlled trials involving humans and published in English. Judgments and descriptions within the meta-analyses were used to report on risks of bias in the included clinical trials and the meta-analyses themselves. RESULTS: Out of 3264 citations, 9 journal-published meta-analyses were selected from 2000 to 2004, 116 from 2010 to 2014, and 44 Cochrane Reviews from 2010 to 2014. Across both time frames and categories of publication, <42% of the trials included in the meta-analyses described adequate randomization; <19% described concealment methods; <26% described double blinding; <29% described outcome assessment blinding, ≤53% discussed incomplete data, and <36% were nonselective in their reporting. Less than 54% of trials reported on adverse events and 64% of meta-analyses did not include a single trial with a low risk of bias. Taxonomic verification and chemical characterization of test products were infrequent in trials. Only 40% of meta-analyses considered publication bias and, of those that did, 90% found evidence for it. Cochrane Reviews were more likely than other sources to make negative conclusions of efficacy or to defer conclusions because of the absence of high quality trials. CONCLUSIONS: Meta-analyses of herbal medicines include a significant number of clinical trials that do not meet the recommended standards for clinical trial reporting. This quantitative assessment identified significant publication bias and other bias risks that may be due to inadequate trial design or incomplete reporting of outcomes. Suggested improvements to herbal medicine clinical trial reporting are discussed.

The Medicinal Chemistry of Natural and Semisynthetic Compounds against Parkinson's and Huntington's Diseases.

Among the diseases affecting the central nervous system (CNS), neurodegenerations attract the interest of both the clinician and the medicinal chemist. The increasing average age of population, the growing number of patients, and the lack of long-term effective remedies push ahead the quest for novel tools against this class of pathologies. We present a review on the state of the art of the molecules (or combination of molecules) of natural origin that are currently under study against two well-defined pathologies: Parkinson's disease (PD) and Huntington's disease (HD). Nowadays, very few tools are available for preventing or counteracting the progression of such diseases. Two major parameters were considered for the preparation of this review: particular attention was reserved to these research works presenting well-defined molecular mechanisms for the studied compounds, and where available, papers reporting in vivo data were preferred. A literature search for peer-reviewed articles using PubMed, Scopus, and Reaxys databases was performed, exploiting different keywords and logical operators: 91 papers were considered (preferentially published after 2015). The review presents a brief overview on the etiology of the studied neurodegenerations and the current treatments, followed by a detailed discussion of the natural and semisynthetic compounds dividing them in different paragraphs considering their several mechanisms of action.

The Brazilian phytotherapics industry: challenges and opportunities. / A indústria de fitoterápicos brasileira: desafios e oportunidades.

The purpose of this article is to discuss and analyze the development challenges of the medicinal plants and phytotherapics industry in Brazil. This industry represents an excellent alternative to face the paradox of abundance that exists in the health area. The methodology adopted was a field research, using semi-structured questionnaires with companies, researchers and public managers to evaluate their development between 2009 and 2015 and to point out the most serious problems faced. The results observed indicate that the main challenges found were the regulation of law on the access to the genetic patrimony in the research area, and to bring into harmony the rules in the entire chain of medicinal plants and phytotherapics production area. The slow implementation pace of public policies for the industry shows a setback regarding both productive and research activities with medicinal plants and phytotherapics in the period.

A indústria de fitoterápicos brasileira: desafios e oportunidades / The Brazilian phytotherapics industry: challenges and opportunities

Resumo O objetivo deste artigo é discutir e analisar os desafios do desenvolvimento da indústria de plantas medicinais e de fitoterápicos no Brasil. Esta indústria representa uma excelente alternativa para responder ao paradoxo da abundância na área de saúde. A metodologia adotada foi uma pesquisa de campo, utilizando-se questionários semiestruturados, com empresas, pesquisadores e gestores públicos para avaliar seu desenvolvimento entre 2009 e 2015 e apontar seus principais problemas. Os resultados observados indicam que os principais desafios são, na pesquisa, a regulamentação da lei de acesso ao patrimônio genético e, na produção, a harmonização da regulamentação em toda a cadeia produtiva da indústria de plantas medicinais e fitoterápicos. A morosidade da implantação das políticas públicas voltadas para a indústria mostra um retrocesso tanto das atividades produtivas com fitoterápicos, quanto das atividades de pesquisa com plantas medicinais no período.

Abstract The purpose of this article is to discuss and analyze the development challenges of the medicinal plants and phytotherapics industry in Brazil. This industry represents an excellent alternative to face the paradox of abundance that exists in the health area. The methodology adopted was a field research, using semi-structured questionnaires with companies, researchers and public managers to evaluate their development between 2009 and 2015 and to point out the most serious problems faced. The results observed indicate that the main challenges found were the regulation of law on the access to the genetic patrimony in the research area, and to bring into harmony the rules in the entire chain of medicinal plants and phytotherapics production area. The slow implementation pace of public policies for the industry shows a setback regarding both productive and research activities with medicinal plants and phytotherapics in the period.