Rationalising Optimal Dosing of Phytotherapeutics For Use In Children: Current Status - Potential Solutions - Actions Needed.

"Children are not small adults with respect to the treatment with medicinal products." This statement of the WHO was the basis for the initiative of the European Commission for the establishment of a paediatric regulation in 2007 to improve the health of children by facilitating the development of medicines for children and adolescents. Seventeen years later, in the field of herbal medicinal products, results are still sobering. Therefore, the Foundation Plants for Health, Society for Medicinal Plants and Natural Products Research, and German Society for Phytotherapy organised a symposium to assess the status quo for the paediatric use of herbal medicinal products (HMPs), to analyse the causes of the current situation, and to discuss strategies for establishing the proof of safe and efficacious HMPs for children.The current situation for HMPs and their use in children is not fulfilling the requirements of legislation. HMPs in paediatrics are effective and safe, but considering the needs of children is necessary. In European countries, the use, registration, and marketing of HMPs are different, depending on the respective national regulations and specific traditions. EU herbal monographs are the best common denominator for such procedures. Emerging safety discussions must be considered. New approaches with real-world data might be a solution. The regulatory framework is to be adapted. Defining rationalised dosing for HMPs can be achieved by the extrapolation of data from adults, by using existing clinical data for children, and by using RWD. Therefore, a strong need for revising restrictions for the use of HMPs in children and rationalising defined dosage regimes is obvious.

Quality variation of maidong (Ophiopogon japonicus and Liriope spicata) - A HPTLC-based approach.

The tuberous roots of Ophiopogon japonicus and Liriope spicata are used for the same therapeutic purpose in traditional Chinese medicine and are collectively referred to as maidong medicine. Interestingly, it was observed that the price of tuberous roots varies depending on their location on the plant, and fibrous roots are usually discarded post-harvest. Mislabeling might be of concern due to similarities in morphological features between the two species. Moreover, paclobutrazol has been observed to be heavily applied during the production, and therefore might be of health concern. Overall, maidong might suffer from quality inconsistencies while its metabolomic complexity is influenced by growing region and cultivation practices, botanical species, and plant parts. To address these challenges, this study employed High-Performance Thin Layer Chromatography (HPTLC) approach, in which sample preparation and derivatization procedure were optimized to enable to capture more detailed and comprehensive metabolomic fingerprints. By integrating with rTLC algorithm and Multivariate Data Analysis (MVDA), an improved quality assessment was achieved. Samples were collected from four production regions and supplemented with commercial products from markets. The optimized HPTLC analysis recognized species- and region-specific metabolomic patterns of maidong, uncovering a 4% of mislabelled cases. Moreover, findings highlight the underexplored therapeutic potential of fibrous roots, and comparable therapeutic efficacy between different root types. Additionally, complemented by Liquid Chromatography-Mass Spectrometry (LC-MS) for paclobutrazol residue evaluation, 24.66% of the commercial maidong samples surpassed maximum residue limits of paclobutrazol, raising safety concerns. This research represents a significant analytical advancement, offering a robust, cost-effective, and comprehensive method for maidong quality control, and paving the way for more strict residue regulation and updates to herbal pharmacopoeias and monographs.

From the CONSORT to the ConPhyMP statement and beyond-how to ascertain best practice.

With the implementation of the ConPhyMP reporting tool as an element of peer review in Frontiers in Pharmacology, Section Ethnopharmacology and in other journals, this short perspective paper highlights the use of a new tool available via the website of the Society for Medicinal Plant and Natural Product Research (https://ga-online.org/best-practice/) and how to use it. The ConPhyMP guidelines and the tool cover the relevant aspects which need to be reported when studying a plant extract using pharmacological, toxicological microbiological, clinical and other approaches. In our vision, science will only remain impactful if it is based on a drive for best practice, i.e., on a sound conceptual and methodological basis.

Uso de plantas medicinales por la comunidad boliviana en el área metropolitana de Barcelona / Uso de plantas medicinais pela comunidade boliviana na área metropolitana de Barcelona / Use of medicinal plants by the Bolivian community in the Metropolitan Region of Barcelona

Las condiciones de vida que los inmigrantes de Sudamérica encuentran en España influye en sus prácticas para el cuidado de la salud. Los objetivos de este estudio fueron documentar la etnofarmacopea de los inmigrantes bolivianos en Barcelona y comprender sus pautas de comportamiento en relación con la necesidad de atención sanitaria. Para recabar información, tanto cualitativa como cuantitativa, se utilizaron cuestionarios y listados libres, asi como entrevistas semi-estructuradas y no estructuradas. Adicionalmente, se recogieron y documentaron todas las plantas medicinales y productos citados disponibles. A partir de entrevistas con 51 informantes, se registró un total de 60 remedios vegetales (115 citas de uso), con un total de 77 usos. Es común el pluralismo medicinal: los informantes utilizaban tanto los remedios vegetales en automedicación como la consultas con médicos de familia del sistema nacional de salud español. Los remedios vegetales culturalmente más relevantes incluyen infusiones de manzanilla (Matricaria recutita L.) y de hoja de coca (Erythroxylum coca Lam.) y Mentisan©, un ungiiento mentolado. A pesar de ser una muestra relativamente pequeña, este primer estudio sobre el uso de plantas medicinales por inmigrantes en España claramente indica que la comunidad boliviana sigue siendo fiel a sus tradiciones médicas (AU)

As condicoes de vida que os imigrantes da América do Sul encontram em Espanha influencia as suas práticas de cuidados de saúdo. Os objetivos deste estudo foram documentar a etnofarmacopeia do imigrantos bolivianos em Barcelona o entender sous padroes do comportamento em rolaçáo a necessidade de cuidados de saúdo. Para rocolhor informacoes, tanto qualitativas como quantitativas, foram utilizados questionários o listas livros, o entrevistas semi-estruturadas e nao estruturadas. Alem disso, recolhoram-se o documentaram-so todas as plantas medicinais o produtos citados disponíveis. A partir de entrevistas com 51 participantes, foram registados um total de 60 romádios vegetais (115 citacoes de uso), com um total de 77 usos. O pluralismo médico e comum: os informantes tanto usam remédios a base de plantas na auto-modicaçáo como consultas com médicos de familia do sistema nacional de saúde espanhol. Osremédios a base de plantas culturalmente mais relevantes incluem infusoes do camomila (Matricaria recutita L.) o de coca (Erythroxylum coca Lam.) o Mentisan©, um unguento mentolado. A pesar de ser uma amostra relativamente pequena, este primeiro estudo sobre o uso de plantas medicinais por imigrantes em Espanha indica claramente que a comunidade boliviana permanece fiel as suas tradicoes médicas (AU)

Living conditions that South American migrant communities encounter in Spain have an influence on their health care practices. The aims of this study are both to determine Bolivian migrants' ethnopharmacopeia in Barcelona and to understand the health-seeking strategies. Questionnaires and free-listings as well as semi-structured and unstructured interviews were used to gather both quantitative and qualitative data during the field work. Moreover, all accessible medicinal plants and herbal products mentioned were both collected and documented. As a result and on the basis of interviews with 51 informants, a total of sixty herbal remedies (115 use reports) were recorded used to treat with a total of 77 uses. Medical pluralism is common: informants used both plant remedies in self—medication and consultations with family doctors of the Spanish health care system. The most culturally salient plant remedies included chamomile (Matricaria recutita L.) infusion, infusion of coca leaf (Erythroxylum coca Lam.) and Mentisan©, a mentholated ointment. Despite of a relatively small sample size, this first study on immigrant medicinal plant use in Spain clearly shows that the Bolivian community in Barcelona remains loyal to their medical traditions (AU)

La palmera datilera y la palmera canaria en la medicina tradicional de España / The date palm and canary islands date palm in the traditional herbal medicine of Spain

En la actualidad son muy pocos los usos vigentes. Aunque los dátiles son la materia utilizada con mayor frecuencia, también se han empleado la savia, el polen y el cogollo tierno o palmito. Los dátiles de Phoenix dactylifera se utilizaron como analgésico y para tratar la anemia y trastornos digestivos, o para fortalecer las encías, en el tratamiento de la disfunción eréctil y como afrodisiacos, para facilitar el parto y calmar los dolores postparto, y tratar el prolapso de la matriz o para el exceso de flujo menstrual. También se utilizaron como diuréticos, para la disuria y en trastornos de la vejiga. El uso que más claramente ha persistido es el tratamiento de diversos problemas respiratorios. En uso externo se utilizaron para tratar problemas de la piel, heridas, hemorragias y hemorroides. De la palmera de Canarias (Phoenix canariensis), especialmente en la isla de la Gomera, la savia cruda o guarapo, su concentrado o miel de palma y los resultantes de su fermentación (vino de palma) se consumen como alimento y también se utilizan como diurético, remedio de trastornos génitourinarios, digestivo, para infecciones de la cavidad bucal, expectorante, antitusígeno y para las irritaciones de garganta. En el Toledo de Al-Andalus las espatas de P. dactylifera se utilizaron, hace casi mil años, en el tratamiento de la debilidad, los dolores, nefritis, las enfermedades de la vejiga, trastornos hepáticos (también como preventivo), diarrea, trastornos digestivos, dolores en el abdomen y en el estómago, excesivo sangrado menstrual, úlceras en la piel y sarna, dolores articulares y trastornos cardiacos. La fitoterapia racional debería prestar atención a este recurso, considerar la evidencia científica disponible (farmacológica e incluso clínica) e incorporarlo a nuestro repertorio terapéutico (AU)

O uso medicinal da tamareira e seus produtos foi relativamente comum em Espanha, tendo alcançado o topo da diversidade e importância durante a Idade Média, tanto no Al-Andalus como nos territórios cristãos da fronteira norte, mas foram-se perdendo progressivamente. Estudou-se a evolução histórica dos usos medicinais da tamareira e da tamareira das Ilhas Canárias, tanto na Península Ibérica como nas ilhas Canárias e Baleares .Actualmente, são muito poucos os usos que se mantêm. Relativamente à parte utilizada, as tâmaras são as mais referiadas, mas também existem registos para a seiva, pólen e palmito. As tâmaras de Phoenix dactylifera foram usados como analgésicos, e para o tratamento de anemia e distúrbios digestivos, ou para fortalecer as gengivas, no tratamento da disfunção eréctil e como afrodisíacos, para facilitar o parto e acalmar as dores pós-parto, para tratamento do prolapso uterino ou do fluxo menstrual excessivo. As tâmaras também foram utilizados como diuréticos em disúria e distúrbios da bexiga e são ainda utilizados para o tratamento de vários problemas respiratórios. Externamente foram usados para tratar problemas de pele, feridas, hemorragias e hemorróidas. Da tamareira das Ilhas Canárias (Phoenix canariensis), especialmente na ilha de La Gomera, a seiva (localmente conhecida por guarapo), o seu concentrado (mel de palma), e os produtos resultantes da sua fermentação (vinho de palma) consomem-se como alimentos mas também se utilizam como diuréticos, para tratamento de problemas genito-urinários e digestivos, para infecções orais, como expectorante, antitússico e para tratar irritações da garganta. Há quase mil anos, em Toledo, usavam-se as espatas de P. dactylifera no tratamento de fraqueza, dores, nefrites, doenças da bexiga, doenças do fígado (também em prevenção), diarreia, distúrbios digestivos, dores no abdômen e estômago, fluxo menstrual excessivo, úlceras de pele e sarna, dores articulares e problemas cardíacos.A fitoterapia racional deveria prestar atenção a este recurso, considerar a evidencia científica disponível (farmacológica e mesmo clínica) e incorporá-lo no nosso repertório terapêutico

In Spain the medicinal use of date palm and its products has been relatively common, reaching the highest level of diversity and importance during the Middle Ages, both in Al Andalus and the Christian territories of the northern border. However, uses have become less common since then. Here the historical evolution of medicinal uses of date palm and Canary Island palm in both the Iberian Peninsula and the Canary and Balearic islands are reviewed. At present there are very few reported uses. The dates are the most commonly used product, but the sap, pollen and tender bud of palm (palmito) are also used. The dates of Phoenix dactylifera were used as analgesic, and to treat anaemia and digestive disorders, to strengthen the gums, and in the treatment of erectile dysfunction and as an aphrodisiac, to facilitate childbirth and soothing postpartum pains and treating matrix prolapse or excessive menstrual flow. Dates were also used as diuretics in dysuria and bladder disorders and are still used for the treatment of various respiratory problems. Externally they were used to treat skin problems, wounds, bleeding and haemorrhoids. Canary Palm (Phoenix canariensis) raw juice or sap, or concentrated palm juice, or fermented juice (palm wine) are consumed, especially on the island of La Gomera, as food and are also used as diuretic, as a remedy for genitourinary, digestive, for oral infections, as an expectorant, antitussive and to treat cavity and throat irritations disorders. Almost a thousand years ago in Al-Andalus' Toledo, spathes of P. dactylifera were used, in the treatment of weakness, pain, nephritis, bladder diseases, liver disorders, diarrhea, digestive disorders, pain in the abdomen and stomach, excessive menstrual bleeding, skin ulcers and scabies , joint pain and heart disorders. Modern rational Phytotherapy should pay closer attention to this resource and its potential, considering the available scientific evidence (pharmacological and even clinical) and incorporate it into our modern therapeutic repertoire (AU)

Ethnopharmacology: quo vadis? Challenges for the future

It is well-known that humans have used medicinal plants for millennia, but as a defined field of scientific research called ethnopharmacology, it has a relatively short history. It is linked to the development of pharmacology in the 19th century (as exemplified in the work of Claude Bernard linking the explorers' observations on traditional uses of medicines and toxins) and to fascination with psychoactive drugs in the 1960s. This fascination gave rise to what we now call ethnopharmacology, a term first used as recently as 1967. With thousands of ethnopharmacological articles published each year now, the field has expanded greatly. It nowadays covers a wide range of topics based on the anthropological, historical and other socio-cultural studies of local and traditional plants, fungi and animals; as well as the biological and clinical studies of resources used as medicines, toxins, foods, among other applications. It is one of the few fields in science truly transdisciplinary and it is a key bridge between socio-cultural and the natural/medical sciences. More importantly, ethnopharmacological research is crucial for the improvement of livelihood, health and wellbeing of humans.

El fruto de sabal mejora los síntomas de la hiperplasia benigna de próstata y la disfunción sexual. Resultados de un estudio piloto / Saw palmetto Berry improves BHP symptoms and sexual dysfunctions. Results from a pilot trial

La hyperplasia prostática benigna (HPB) es un importante factor de riesgo para la disfunción sexual. Además, el tratamiento estándar, los bloqueadores alpha-adrenérgicos y los inhibidores de la 5alpha-reductasa pueden causar a su vez disfunción sexual. Los preparados del fruto de sabal (Serenoa repens (W. Bartram) Samall son un tratamiento eficaz y bien tolerado para la HPB leve o moderada y se han utilizado tradicionalmente para tratar disfunciones sexuales. Se ha llevado a cabo un estudio clínico piloto, abierto, multicéntrico para investigar si el preparado de fruto de sabal Prostasan (comercializado en España como Sabalsan) influye en los síntomas de la HPB y las disfunciones sexuales. Ochenta y dos pacientes participaron en el estudio, de 8 semanas de duración, tomando una cápsula diaria (320mg) de un extracto lipofílico de fruto de sabal. Al final del tratamiento, la puntuación en la escala internacional de síntomas prostáticos (IPSS) se redujo de 14,4 a 6,9 (p<0,0001); las disfunciones sexuales, medidas con el inventario breve de la función sexual mejoraron de 22,4 a 31,4 (p<0,0001); la puntuación del componente de la vida sexual del cuestionario de calidad de vida para la HPB (Urolife BHP QoL-9 sex), mejoró de 137,3 a 195 (p<0,0001). Las evaluaciones de los investigadores y pacientes confirmaron la eficacia, tolerabilidad y aceptación por los pacientes. Los análisis de correlación confirmaron la vinculación entre la mejoría de los síntomas de la HPB y la reducción de la disfunción sexual. Este es el primer estudio que demuestra una mejoría simultánea en los síntomas de la HPB y las disfunciones sexuales con extracto de fruto de sabal (AU)

The benign prostate hiperplasia (BPH) is a major risk factor for sexual dysfunctions. Additionally, the standard treatments for BPH symptoms, alpha-blockers and 5alpha-reductase inhibitors, cause sexual dysfunction themselves. Preparations from saw palmetto (Serenoa repens (W. Bartram) Small) fruit have shown efficacy and good tolerability been used to treat sexual dysfunctions. We conducted an open, multicentric, clinical pilot trial to investigate wheter Prostasan (marketed in Spian as Sabalsan), a preparation of saw palmetto fruit, influenced BPH symptoms and sexual dysfunctions. Eighty two patients participated in a 8-week trial, taking one capsule (320mg) of the saw palmetto lipophilic extract daily. At the end of the treatment, the International Prostate Symptom Score (IPSS) was reduced from 14.4 to 6.9 (p<0.0001). Sexual dysfunctions measured with the brief Sexual Function Inventory improved from 22.4 to 31.4 (p<0.0001), and the score of the component regarding sexual life of the life quality questionnaire for benign prostatic syperplasia (Urolife BPH QoL-9 sex) improved from 13.7 to 195 (p<0.0001). Investigators, and patients' assessments confirmed the efficacy, tolerability and acceptance by the patients. Correlation analyses confirmed the relationship between improved BPH symptoms and reduced sexual dysfunction. This is the first trial with Sabal serrulata showing improvement in BPH symptoms and in sexual dysfunction as well (AU)