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.

A homeopathic remedy from arnica, marigold, St. John's wort and comfrey accelerates in vitro wound scratch closure of NIH 3T3 fibroblasts.

BACKGROUND: Drugs of plant origin such as Arnica montana, Calendula officinalis or Hypericum perforatum have been frequently used to promote wound healing. While their effect on wound healing using preparations at pharmacological concentrations was supported by several in vitro and clinical studies, investigations of herbal homeopathic remedies on wound healing process are rare. The objective of this study was to investigate the effect of a commercial low potency homeopathic remedy Similasan® Arnica plus Spray on wound closure in a controlled, blind trial in vitro. METHODS: We investigated the effect of an ethanolic preparation composed of equal parts of Arnica montana 4x, Calendula officinalis 4x, Hypericum perforatum 4x and Symphytum officinale 6x (0712-2), its succussed hydroalcoholic solvent (0712-1) and unsuccussed solvent (0712-3) on NIH 3T3 fibroblasts. Cell viability was determined by WST-1 assay, cell growth using BrdU uptake, cell migration by chemotaxis assay and wound closure by CytoSelect ™Wound Healing Assay Kit which generated a defined "wound field". All assays were performed in three independent controlled experiments. RESULTS: None of the three substances affected cell viability and none showed a stimulating effect on cell proliferation. Preparation (0712-2) exerted a stimulating effect on fibroblast migration (31.9%) vs 14.7% with succussed solvent (0712-1) at 1:100 dilutions (p < 0.001). Unsuccussed solvent (0712-3) had no influence on cell migration (6.3%; p > 0.05). Preparation (0712-2) at a dilution of 1:100 promoted in vitro wound closure by 59.5% and differed significantly (p < 0.001) from succussed solvent (0712-1), which caused 22.1% wound closure. CONCLUSION: Results of this study showed that the low potency homeopathic remedy (0712-2) exerted in vitro wound closure potential in NIH 3T3 fibroblasts. This effect resulted from stimulation of fibroblasts motility rather than of their mitosis.

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.

Test of a homeopathic dilution of Aconitum napellus. A clinical, randomized, double-blind, controlled crossover study in healthy volunteers.

BACKGROUND: Although healthy persons often report on reactions to homeopathically diluted substances, the mechanism behind such reactions remains unclear. This study examines whether a distinction can be made between the short-term reactions of healthy volunteers to a homeopathically diluted substance - Aconitum napellus C30 - and to a placebo. PARTICIPANTS AND METHODS: From the 33 subjects randomized for this double-blind, placebo-controlled crossover study, 27 could be included in the analysis. The study comprised two 7-day-long treatment periods, each including the intake of a study preparation for 3 days and a wash-out period of 4 days. One group was first treated with Aconitum napellus C30 and then with placebo; the other group received the two study preparations in the reverse order. The signs and symptoms before the first treatment and after each treatment were collected, evaluated, weighted and repertorized. Based on this classification the blinded physician assessed these signs and symptoms as study outcome parameter to represent the responses to each of the study preparations. Statistical analysis of the data was performed using the Wilcoxon-Mann-Whitney rank test. RESULTS: Crossover differences yielded statistical significance between the classified reactions towards Aconitum napellus C30 and to placebo (p = 0.004). CONCLUSIONS: A clear difference between the reported short-term reactions of healthy subjects towards Aconitum napellus C30 and towards placebo was shown. The crossover design with intra-individual comparisons proved to be adequate to recognize the study preparations and for the statistical analysis of a small population sample.