A Pragmatic Historical Assessment Tool: A New Systematic Framework for the Collation and Evaluation of Documented Empirical Effectiveness and Safety of Traditional Plant Medicines in the European Materia Medica.

INTRODUCTION: Traditional plant medicines (TPMs) are plant-derived therapeutic products prepared and applied according to longstanding medical customs. Around the world they are widely used in primary and preventative health care. The World Health Organization (WHO) calls in its Traditional Medicine Strategy 2014-2023 for Member States to provide a regulatory framework so that the formal contribution of traditional therapeutics can be advanced in national systems of health care. Evidence of effectiveness and safety is paramount for the regulatory integration of TPMs; however, a presumed lack of such "evidence" is one obstacle for full integration. The consequential health policy question is how to systematically evaluate therapeutic claims relating to herbal remedies when the extant evidence is predominantly based on historical and contemporary clinical usage, i.e., is empiricist in nature. This paper introduces a new method along with several illustrative examples. METHOD: Our research design employs a longitudinal, comparative textual analysis of standard textbooks of the professional European medical literature from the early modern period (1588/1664) onwards to today. It then triangulated these intergenerationally documented clinical observations on two exemplars (Arnica and St. John's Wort) with corresponding listings in multiple qualitative and quantitative sources. A Pragmatic Historical Assessment (PHA) tool was developed and tested as a method to systematically collate the large amount of pharmacological data recorded in these judiciously selected sources. The evidential validity of longstanding professional clinical knowledge could thus be compared with therapeutic indications approved in official and authoritative sources (pharmacopoeias, monographs) and with those supported by contemporary scientific research (randomised-controlled trials [RCTs], experimental research). RESULTS: There was high congruency between therapeutic indications that are based on repeated empirical observations from professional patient care (empirical evidence), those approved in pharmacopoeias and monographs, and modern scientific evidence based on RCTs. The extensive herbal triangulation confirmed parallel records of all main therapeutic indications of the exemplars across all qualitative and quantitative sources over the past 400 years. CONCLUSIONS: Historical clinical medical textbooks and contemporary phytotherapeutic equivalents are the key repository of repeatedly evaluated therapeutic plant knowledge. The professional clinical literature proved to be a reliable and verifiable body of empirical evidence that harmonised with contemporary scientific assessments. The newly developed PHA tool provides a coding framework for the systematic collation and evaluation of empirical data on the effectiveness and safety of TPMs. It is suggested as a feasible and efficient tool to extend evidence typologies that substantiate therapeutic claims for TPMs as part of an evidence-based regulatory framework that formally integrates these medically and culturally important therapeutics.Traditionelle pflanzliche Arzneimittel sind aus Pflanzen gewonnene Heilmittel, die gemäß langjähriger medizinischer Praxis zubereitet und angewendet werden. Weltweit sind sie in der primären und präventiven Gesundheitsversorgung weit verbreitet. Die Weltgesundheitsorganisation (WHO) ruft in ihrer Traditional Medicine Strategy 2014­2023 die Mitgliedstaaten dazu auf, regulatorische Rahmenbedingungen zu schaffen, welche den formellen Beitrag traditioneller Therapeutika in den nationalen Gesundheitssystemen fördern. Der Nachweis von Wirksamkeit und Sicherheit ist von zentraler Bedeutung für die regulatorische Integration traditioneller pflanzlicher Arzneimittel, doch das angebliche Fehlen solcher "Nachweise" ist eine der Hürden für die vollständige Integration. Daraus ergibt sich die gesundheitspolitische Frage, wie man therapeutische Anwendungsgebiete pflanzlicher Heilmittel systematisch evaluieren kann, wenn die vorliegende Evidenz überwiegend auf deren historischer und aktueller klinischen Verwendung beruht, also empirischer Natur ist. In dieser Arbeit wird eine neue Methode mitsamt veranschaulichenden Beispielen vorgestellt.Unser Forschungsansatz beruhte auf einer longitudinalen, vergleichenden Textanalyse von Standard-Lehrwerken der europäischen medizinischen Fachliteratur ausgehend von der frühen Neuzeit (1588/1664) bis heute. Die über Generationen dokumentierten klinischen Beobachtungen wurden anhand von zwei Beispielen (Arnika and Johanniskraut) mit den diesbezüglichen Angaben in unterschiedlichen qualitativen und quantitativen Quellen trianguliert. Ein Pragmatisch­Historisches Auswertungstool (PHA) wurde als Methode entwickelt und getestet, um die großen Mengen der in diesen kritisch ausgewählten Quellen enthaltenen pharmakologischen Daten systematisch zu erfassen. Die Evidenzvalidität des langjährigen klinischen Fachwissens konnte so mit den therapeutischen Anwendungsgebieten verglichen werden, die in offiziellen und autoritativen Quellen (Pharmakopöen, Monografien) zugelassen sind, sowie mit denjenigen, die durch zeitgenössische wissenschaftliche Forschung gestützt werden (randomisierte kontrollierte Studien [RCTs], experimentelle Forschung).Es bestand ein hohes Maß an Kongruenz zwischen den therapeutischen Anwendungsgebieten, welche auf wiederholte empirische Beobachtung aus der professionellen Patientenversorgung beruhen (empirische Evidenz), den zugelassenen Indikationen in Pharmakopöen und Monographien sowie der aktuellen wissenschaftlichen Evidenz basierend auf klinischen Studien. Die umfassende pflanzenbezogene Triangulation bestätigte parallele Aufzeichnungen aller wesentlichen Anwendungsgebiete der untersuchten Beispiele in allen qualitativen und quantitativen Quellen über die letzten 400 Jahre hinweg.Historische Lehrbücher für klinische Medizin und zeitgenössische phytotherapeutische Äquivalente sind die wichtigsten Quellen von wiederholt evaluiertem therapeutischem Wissen zu Heilpflanzen. Die klinische Fachliteratur erwies sich als zuverlässiger und verifizierbarer Korpus empirischer Evidenz, der mit aktuellen wissenschaftlichen Untersuchungen übereinstimmte. Das neu entwickelte PHA-Verfahren bietet ein Kodierungs­Instrument für das systematische Erfassen und Auswerten empirischer Daten zur Wirksamkeit und Sicherheit von traditionellen pflanzlichen Arzneimitteln. Das PHA­Verfahren wird als praktikables und effizientes Instrument zur Erweiterung der Evidenz­Typologien empfohlen, indem es therapeutische Indikationen für traditionelle pflanzliche Arzneimittel untermauern kann, so dass diese medizinisch und kulturell wichtigen Therapeutika in einen evidenz-basierten regulatorischen Rahmen integriert werden können.

Trends of Medicinal Plant Use over the Last 2000 Years in Central Europe.

Medicinal plant knowledge in Central Europe can be traced back from the present to antiquity, through written sources. Approximately 100 medicinal plant taxa have a history of continuous use. In this paper, we focus on use patterns over time and the link between historical and traditional uses with the current scientific evidence. We discuss our findings against the backdrop of changing eras and medicinal concepts. Based on use-records from totally 16 historical, popular and scientific herbals, we analyze how use categories of 102 medicinal plant taxa developed over time. Overall, 56 of the 102 taxa maintained continuous use throughout all time periods. For approximately 30% of the continuous uses, scientific evidence supporting their use exists, compared to 11% for recently added uses and 6% for discontinuous uses. Dermatology and gastroenterology are use categories that are relevant across all time periods. They are associated with a high diversity of medicinal taxa and continuously used medicinal species with scientific evidence. Antidotes, apotropaic (protective) magic, and humoral detoxification were important use categories in the past. New applications reflecting biomedical progress and epidemiological challenges are cardiovascular and tonic uses. Changes in medicinal concepts are mirrored in plant use and specifically in changes in the importance of use categories. Our finding supports the concept of social validation of plant uses, i.e., the assumption that longstanding use practice and tradition may suggest efficacy and safety.

Chronic Pain: How Challenging Are DDIs in the Analgesic Treatment of Inpatients with Multiple Chronic Conditions?

BACKGROUND: Chronic pain is common in multimorbid patients. However, little is known about the implications of chronic pain and analgesic treatment on multimorbid patients. This study aimed to assess chronic pain therapy with regard to the interaction potential in a sample of inpatients with multiple chronic conditions. METHODS AND FINDINGS: We conducted a retrospective study with all multimorbid inpatients aged ≥18 years admitted to the Department of Internal Medicine of University Hospital Zurich in 2011 (n = 1,039 patients). Data were extracted from the electronic health records and reviewed. We identified 433 hospitalizations of patients with chronic pain and analyzed their combinations of chronic conditions (multimorbidity). We then classified all analgesic prescriptions according to the World Health Organization (WHO) analgesic ladder. Furthermore, we used a Swiss drug-drug interactions knowledge base to identify potential interactions between opioids and other drug classes, in particular coanalgesics and other concomitant drugs. Chronic pain was present in 38% of patients with multimorbidity. On average, patients with chronic pain were aged 65.7 years and had a mean number of 6.6 diagnoses. Hypertension was the most common chronic condition. Chronic back pain was the most common painful condition. Almost 90% of patients were exposed to polypharmacotherapy. Of the chronic pain patients, 71.1% received opioids for moderate to severe pain, 43.4% received coanalgesics. We identified 3,186 potential drug-drug interactions, with 17% classified between analgesics (without coanalgesics). CONCLUSIONS: Analgesic drugs-related DDIs, in particular opioids, in multimorbid patients are often complex and difficult to assess by using DDI knowledge bases alone. Drug-multimorbidity interactions are not sufficiently investigated and understood. Today, the scientific literature is scarce for chronic pain in combination with multiple coexisting medical conditions and medication regimens. Our work may provide useful information to enable further investigations in multimorbidity research within the scope of potential interactions and chronic pain.

Herbalists of Today's Switzerland and Their Plant Knowledge. A Preliminary Analysis from an Ethnobotanical Perspective.

BACKGROUND: Herbal medicine is a popular part of primary health care in Switzerland. Following an ethnobotanical approach, in this study we seek to identify Swiss herbalists with broad, empirical medicinal plant knowledge and use. We aim to consider different areas of the medicinal landscape including biomedicine, complementary and alternative medicine, and self-medication. MATERIAL AND METHODS: A total of 61 expert interviews were conducted from February 2010 to November 2011. The transfer of knowledge was analyzed according to a Switzerland-related selection of historical and recent popular as well as scientific herbal books. RESULTS: A total of 254 medicinal plant species, belonging to 218 genera and 87 families, were recorded in 934 use reports. Predominantly leaves and flowers are used for the treatment of dermatological, respiratory, nervous, and gastrointestinal problems. Recent to historical herbal books are an important source of plant knowledge. CONCLUSIONS: Medicinal plants are used for self-medication and professional health care and despite different underlying medicinal concepts and philosophies, herbalists largely agree on the most important medicinal plant species.

Alteration of anti-inflammatory activity of Harpagophytum procumbens (devil's claw) extract after external metabolic activation with S9 mix.

OBJECTIVES: Extracts of the tubers of Harpagophytum procumbens (devil's claw, DC) inhibit different proinflammatory mediators important in the pathophysiology of osteoarthritis. Many plant-derived preparations interfere with cytochrome P450 liver enzymes, which influence their different biological activities. Therefore, the present study was designed to investigate the influence of an external metabolic activation of a DC extract on the cytotoxicity and the release of proinflammatory cytokines. METHODS: A screening experiment with a panel of 12 inflammatory cytokines identified three as suitable for the study: tumour necrosis factor-α (TNF-α), interleukin (IL) IL-6 and IL-8. They were determined using enzyme-linked immunosorbent assays in lipopolysaccharide (LPS)-stimulated monocytic THP-1 cells, which were treated with rat liver S9 mix metabolically activated DC extract (DCm). For the cytotoxity experiments, a WST-1 assay was used. KEY FINDINGS: DC dose-dependently suppressed the release of TNF-α, IL-6 and IL-8 in LPS-stimulated monocytic THP-1 cells at non-cytotoxic concentrations (50-250 µg/ml). The metabolic activation of the DC extract by S9 mix did not alternate its cytotoxicity and did not diminish its inhibitory effect. This effect was improved in the case of TNF-α inhibition as reflected by their EC50 values of 116 ± 8.2 µg/ml and 49 ± 3.5 µg/ml for DC and DCm (P < 0.01). CONCLUSIONS: Cytokines inhibitory activity of DC was not affected after its external metabolic activation. However, the amount of harpagoside and caffeic acid derivates was decreased. Other components of the extract might have contributed to its anti-inflammatory effect.

Medical online consultation service in CAM at the University Hospital Zurich.

BACKGROUND: The University Hospital Zurich offers medical online consultation services in individual health concerns. We examined the need for users' information in the field of CAM. For this purpose, the content of the questions, the users' profiles, and the online responses of the physicians were analyzed. METHODS: The retrospective study analyzed 154 (1.3%) out of 11,827 questions and responses, selected by a literature-based keyword list between 2006 and 2007. They were evaluated by means of an inductive category system described by Mayring using a professional text analysis program (MAXQDA). Frequencies and mean values of the categories were statistically determined. RESULTS: Users (aged 39.2 ± 16, females 61%) asked questions, which were in 73% allocated to herbal medicine, 7% to homeopathy, and 2% to acupuncture. The questions referred to medical fields, such as gynecology (18%), dermatology (13%), psychiatry (11%), and oncology (8%). One third of the responses provided detailed information about herbal treatment options. CONCLUSIONS: The email-based online consultation service was used as a source of medical information in order to get more professional consultation in the field of CAM. Future scientific evaluation should investigate if online consultation services which are embedded in an environment of highly qualified health professionals may contribute to a better health literacy and empowerment of the patients.

The use of the local flora in Switzerland: a comparison of past and recent medicinal plant knowledge.

ETHNOPHARMACOLOGICAL RELEVANCE: This analysis of documented medicinal plants of the Swiss Flora over the last two millennia provides a rich source of knowledge on earlier uses of plants and use patterns of the local flora. We ask which local plant species were used during different time periods of the last 2000 years and how the numbers of species and the use intensity of specific plant families, growth forms and habitats changed over time. MATERIALS AND METHODS: Totally 25 herbals from the antiquity, monastic medicine, Renaissance, early modern era and the contemporary time as well as five recent ethnobotanical studies were considered. Use patterns were analysed with the Bayesian approach. RESULTS: A total of 768 species, i.e. 32% of the vascular plants of the Swiss Flora have been documented as medicinal plants. Numbers increase until the monastic period (366 spp.) and the Renaissance (476) and remain relatively stable since then (modern and contemporary era: 477). But, 465 formerly documented species do not occur in the ethnobotanical studies and thus seem not to be used any more. Overall, 104 species are documented through all time periods. Archeophytes, trees and forest plants are generally overrepresented in herbals from all time periods while plants from above the timberline are generally underrepresented. Most widely used are the Lamiaceae and Apiaceae. CONCLUSION: A constant body of medicinal plant knowledge in Switzerland exists since ancient time. This knowledge was always influenced by knowledge from neighboring countries and no "typical Swiss specialties" seem to exist. Medicinal plants are not randomly chosen from the available flora. Certain species are deliberately introduced others are neglected. This process, which is still ongoing, can be traced back with the help of herbals to the antiquity.

An approach to the concept of tonic: suggested definitions and historical aspects.

In traditional medicine, especially CAM, the concept of (herbal) tonics has a long history in the different medical systems (TEN -- Traditional European Naturopathy; TCM - Traditional Chinese Medicine). Nevertheless, the ideas concerning the function of a tonic differ, e.g., stimulation of body functions, strengthening of organ function, enhancement of adaption, and well-being. Although no exact pharmacodynamic or pharmacokinetic properties of tonics can be given, the following general definition, even in the transcultural comparison between European and Chinese concepts, seems meaningful: A tonic is an agent that has the capability to restore and/or maintain the physiological functioning of an organ system, leading to the subjective feeling of well-being of the patient treated with it.

[Clinical studies in peripheral arterial occlusive disease: update from the aspects of a meta-narrative review]. / Klinische Studien bei peripherer arterieller Verschlusskrankheit: Update unter den Aspekten eines meta-narrativen Reviews.

BACKGROUND: Atherosclerosis is a systemic disease. Its association with the metabolic syndrome requires a multimodal therapy setting, to alleviate symptoms and for primary and secondary prevention. In the planning of the therapy, information about evidence of the interventions and a rationale for reasonable combinations are important. METHOD: For compiling a meta-narrative review (MNR) on the evidence of complementary and conventional pharmaco-therapy in peripheral arterial occlusive disease (PAOD), the literature was searched for meta-analyses of randomized controlled trials (RCTs). These were evaluated taking into account network-pharmacological aspects and research parameters. RESULTS: 4 suitable meta-analyses were found. In comparison to placebo, treatments with verum showed a significant improvement of the maximum walking distance of 63.5 m (95% confidence interval (CI) 27.11-99.91 m; Padma 28, Tibetan Formula), 41.3 m (95% CI -7.1-89.7 m; cilostazol, phosphodiesterase IIl inhibitor), 43.8 m (95% CI 14.1-73.6 m; pentoxifylline, rheological drug), and 71.2 m (95% CI 13.3-129.0 m; naftidrofuryl, rheological drug). Only for Padma 28, clinical relevance, defined as an increase of the maximum walking distance by >100 m, was analyzed and reached by 18.2% of the verum and 2.1% of the placebo patients (odds ratio 10; 95% CI 3.03-33.33). 1 conventional and 1 complementary drug additionally showed to have significant pleiotropic effects (Padma 28 and cilostazol (e.g. reduction of triglycerides)). CONCLUSIONS: According to meta-analytic evidence, naftidrofuryl and Padma 28 show clinically relevant efficacy for the treatment of early stages of PAOD. The extent to which the theoretically possible combination of different drugs contributes to improve the systemic disease under a network-pharmacological rationale remains to be shown in a multi-armed RCT.

Clinical studies on the efficacy and safety of Padma 28, a complex herbal formulation from Tibetan medicine: an overview.

BACKGROUND: Padma 28 is an herbal formula from Tibetan Medicine, which since 35 years has been registered in Switzerland as a drug for the symptoms of circulatory disorders. Over this time, a large body of scientific literature has accumulated. The aim of this article was to give an overview of the clinical studies. METHODS: A systematic literature search was done in PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials (CCRCT). The clinical trials found were assessed regarding fields of application, efficacy, and safety, as well as methodological quality and level of evidence. RESULTS: 29 trials (1 meta-analysis, 21 controlled trials, 7 open trials) and 3 retrospective case studies were found. They deal with different indications and include a total of 1,704 verum (of these, 697 children), 333 placebo, and 394 untreated or healthy patients. Dropouts and withdrawals were 2.5 and 3.5 times higher in the placebo than in the verum group, respectively. The highest level of evidence for the use of Padma 28 was found in the indication of intermittent claudication (11 trials). Indications of efficacy were also found in other vascular (6 trials) and different inflammatory diseases (12 trials). CONCLUSIONS: The results suggest a favorable safety profile for Padma 28, also in the children examined (41% of the study population). Furthermore, the results show a broad field of applications. According to clinical evidence, Padma 28 has shown to be a safe and effective symptomatic treatment option for atherosclerosis-related diseases such as intermittent claudication. It also seems to have a potential for application in certain chronic inflammatory diseases such as recurrent respiratory tract infections, viral hepatitis, and multiple sclerosis. However, further randomized controlled trials (RCT) are needed to confirm these findings.

[Tibetan formulas as pleiotropic signatures--application of network medicines in multimorbidity]. / Tibetische Rezepturen als pleiotrope Signaturen--Einsatz von Netzwerk-Arzneien bei Multimorbidität.

In the context of the network model of the organism, multimorbid states (≥ 2 chronic diseases at the same time) can be considered as a complex disease pattern which can be mapped as characteristic signatures. From the perspective of system theory, living systems such as the human body are viewed as networks of interacting parts. These in turn can themselves be subnetworks assigned to different complexity levels. They range, e.g., from the gene to the transcriptome, proteome, metabolome, and epigenome up to the network of the entire molecular interactions, the so-called interactome. In multimorbidity, the disease signature affects different networks at all levels, e.g., cell systems, organs, and functional systems. Based on this semiotics, certain signatures of effectiveness and profiles of action can be assigned to each drug. A drug signature represents the physicochemical stimuli that cause a reaction by the system, as well as the cross-links by which the entire connected system is affected at all levels. Phytotherapeutics, which chemically represent multi-component mixtures, have especially complex signatures. As multi-target medicines with a pleiotropic effect profile, they therapeutically affect different levels of the network, which is why they are also referred to as network medicines. Herbal formulas from traditional medicine systems such as Tibetan Medicine are an example for phytotherapeutics with a particularly complex pleiotropic signature. Also from the traditional point of view, a disease signature is set in relation with a corresponding drug signature. However, in this case, it is based on the traditional energetic understanding of diseases. Modern research results clearly indicate a widely diversified signature range of Tibetan Medicines and thus provide a rationale for their use in integrative treatment approaches for diseases with complex signatures, e.g. in multimorbidity. The system-theoretical approach discussed here represents a method to enable a connectivity of traditional methods from complementary and alternative medicine to the other disciplines of modern medicine.

Improving BPH symptoms and sexual dysfunctions with a saw palmetto preparation? Results from a pilot trial.

In elderly men, benign prostatic hyperplasia (BPH) is a major risk factor for sexual dysfunctions (SDys). Additionally, the standard treatments for BPH symptoms, alpha blockers and 5-alpha-reductase inhibitors, cause SDys themselves. Preparations from saw palmetto berries are an efficacious and well-tolerated symptomatic treatment for mild to moderate BPH and have traditionally been used to treat SDys. We conducted an open multicentric clinical pilot trial to investigate whether the saw palmetto berry preparation Prostasan® influenced BPH symptoms and SDys. Eighty-two patients participated in the 8-week trial, taking one capsule of 320 mg saw palmetto extract daily. At the end of the treatment, the International Prostate Symptom Score was reduced from 14.4 ± 4.7 to 6.9 ± 5.2 (p < 0.0001); SDys measured with the brief Sexual Function Inventory improved from 22.4 ± 7.2 to 31.4 ± 9.2 (p < 0.0001), and the Urolife BPH QoL-9 sex total improved from 137.3 ± 47.9 to 195.0 ± 56.3 (p < 0.0001). Investigators' and patients' assessments confirmed the good efficacy, and treatment was very well tolerated and accepted by the patients. Correlation analyses confirmed the relationship between improved BPH symptoms and reduced SDys. This was the first trial with saw palmetto to show improvement in BPH symptoms and SDys as well. [Corrections made here after initial online publication.]

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)