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Herbal remedies are multicomponent mixtures by their nature as well as by pharmaceutical definition. Being a multicomponent mixture is not only a crucial property of herbal remedies, it also represents a precondition for interactions such as synergism or antagonism. Until now, only a few phytomedicines are accurately described concerning the interactions of their active components. The aim of this study was to search for interactions within such a naturally given multi-component mixture and to discuss the pharmaceutical and clinical impacts. The thyme oil chosen for the examination belongs to the essential oils with the most pronounced antimicrobial activity. Antibiotic activity of thyme oil and single active components were tested against six different strains of microorganisms. The checkerboard assay was used to search for interactions. The time-kill assay was used to verify the observed effects and to get information about the temporal resolution of the antimicrobial activity. The degree of the detected interactions corresponded with the demarcating FICI measure of 0.5, which separates the additive from the over-additive (synergistic) effects. Therefore, the observed effect was called a "borderline case of synergism" or, respectively, "partial synergism". Partial synergism was observed only in the presence of Klebsiella pneumoniae. Additive antimicrobial activity was observed for the combination of the two monosubstances carvacrol plus linalool and thymol plus linalool as well as with the combination of the two essential oils of the carvacrol and linalool chemotypes. An increase of the carvacrol oil concentration from one to two times the MIC resulted in a considerable acceleration of the kill-rate. Thyme oil is composed of several different components that show antimicrobial activity (at least: carvacrol, thymol and linalool). The antimicrobial activity of thyme oil is partly based on additive effects, which might especially enhance the rapidity of the antimicrobial action. In addition, a mixture of several active ingredients that varies in its composition from year to year and from lot to lot as is the case with herbal remedies may be more stable concerning the antimicrobial activity than mixtures containing just a single active component.

Background: Mistletoe is often used as a complementary approach in oncology. Despite experimental anti-tumour effects and several reviews there remains controversy about its clinical role. Patients and Methods: Potentially relevant trials were identified to perform a systematic review (databases: e.g. EMBASE, MEDLINE; hand search: e.g. bibliographies; search terms: e.g. mistletoe). To be included, randomised or comparative clinical trials at least had to examine mistletoe preparations standardized according to manufacturing process and to describe interventions explicitly. Additionally, cohort studies were included for reasons of external validity. Results were summarised in tables. Results: 18 clinical trials (>6,800 participants) were included. Their internal quality was mostly low. Due to heterogeneity between trials a meta-analysis was impossible. Regarding efficacy, findings were inconsistent regarding life expectancy, relation to tumour entity, dosing and treatment duration. Yet, studies indicate that quality of life (QoL) is improved. As these findings do not seem to be limited to one of the different parenteral mistletoe preparations reviewed the treatment may be summarised under the umbrella term ‘mistletoe therapy’. Regarding safety, 1 serious adverse event (AE) related to mistletoe was described; non-serious AEs were local reactions at injection site. Allergic reactions were rare. Conclusion: Supportive ‘mistletoe therapy’ seems safe and beneficial for QoL in adult patients with solid tumours. But there is an urgent need to confirm its efficacy in patient-centred care in a complex oncological setting. This has to be evaluated systematically in prospective observational trials with validated, multidimensional patient-rated QoL questionnaires and comparisons of different preparations and dosages.

Der Echte Thymian (Thymus vulgaris) wurde vom WUrzburger Studienkreis ‘Entwicklungsgeschichte der Arzneipflanzenkunde’ zur Arzneipflanze des Jahres 2006 erkoren. Was verschafft dem Thymian diese Ehre? Neben der langen Tradition als Arzneipflanze mit Indikationen, die sich zum Teil bis heute gehalten haben (z.B.: Keuchhusten und Bronchitis), fOrderte die jUngste Forschung eine ganze Reihe neuer viel versprechender Eigenschaften des Thymians zu Tage, die die Wahl zur Arzneipflanze 2006 zweifellos rechtfertigen. Thymol und Carvacrol, die beiden Hauptwirkstoffe des Atherischen Ols, aber auch das Atherische Ol selbst sowie Extrakte des Thymians, zeichnen sich durch eine hohe antimikrobielle AktivitAt und ein breites Wirkspektrum aus. Die antiseptischen Eigenschaften des Thymians kommen bei den unterschiedlichsten Anwendungen zum Tragen: bei Bronchitis, zum Gurgeln bei entzUndeten SchleimhAuten in Mund- und Rachenbereich, bei infizierten Wunden und Ausserlichen Pilzinfektionen aber auch bei der BekAmpfung Akarizid-resistenter Varroa-Milben oder als Konservierungsmittel in der Nahrungsmitteltechnologie. Weitere Eigenschaften, die durch experimentelle Daten gestUtzt werden, sind die antiphlogistische, die antioxidative, die spasmolytische, die sekretolytische und die tonisiernde Wirkung. Die aktuelle Forschung zeigt, dass das Potential des Vielstoffgemisches Thymian noch lange nicht ausgeschOpft ist. Ein Bereich, der zunehmend von der experimentellen Forschung entdeckt wird, sind Vielstoffgemische und deren Fraktionen, die mitunter Eigenschaften aufweisen, die den isolierten Wirkstoffen fehlen. Auf weitere Ergebnisse der noch jungen Thymianforschung darf man gespannt sein.

Fennel Tea: Risk Assessment of the Phytogenic Monosubstance Estragole in Comparison to the Natural Multicomponent Mixture For centuries, fennel fruits have been used as traditional

A systematic review referring to efficacy and tolerability of the herbal combination Iberogast (Iberis amara planta totalis, Chelidonii herba, Cardui mariae fructus, Melissae folium, Carvi fructus, Liquiritiae radix, Angelicae radix, Matricariae flos, Menthae piperitae folium) was performed in patients with functional dyspepsia. Three placebo-controlled trials and a reference-controlled trial showed a statistical significant and therapeutical relevant reduction of the gastrointestinal symptom-scores in 595 patients. The therapeutic efficacy was also found in one observational study (2267 patients). In accordance with the available evidence Iberogast seems to be an effective phytotherapeutic preparation to reduce the symptoms of dyspepsia yet, without central nervous side effects.

Die markant gestiegenen Umsatzzahlen, die viele pflanzliche Arzneimittel in den letzten Jahren erzielten, zeugen vom Vertrauen, das ein großer Teil der Bevölkerung pflanzlichen Arzneidrogen entgegenbringt. Dafür verantwortlich ist in erster Linie die weit verbreitete Ansicht, pflanzliche Heilmittel seien frei von Nebenwirkungen. Die lange Tradition und die «natürliche» Herkunft allein, auf die man sich in diesem Zusammenhang gerne beruft, sind jedoch keine Garanten für Sicherheit im Umgang mit pflanzlichen Arzneimitteln. Wenn auch ein großer Teil der ernsthaften unerwünschten Ereignisse auf Verfälschungen, Verunreinigungen und mangelnde Qualitätskontrollen zurückzuführen sind, so dürfen auch qualitätsgeprüfte pflanzliche Arzneidrogen nicht generell als harmlos eingestuft werden. Wirkstoffe mit toxischen und kanzerogenen Eigenschaften konnten mittlerweile in verschiedenen Phytotherapeutika nachgewiesen werden. Inzwischen liegen auch Hinweise über Wechselwirkungen mit anderen Arzneimitteln vor, bei denen Phytopharmaka vermutlich durch Aktivierung bzw. Hemmung des Cytochrom-P450-Systems, den Blutplasmaspiegel unterschiedlicher Arzneimittel beeinflussen können. Unterrepräsentiert sind zur Zeit vor allem Daten zur Frage von unerwünschten Wirkungen bei langfristiger Anwendung pflanzlicher Arzneimittel. Gerade ihrer Unbedenklichkeit wegen werden sie häufig bei chronischen Erkrankungen verschrieben und dann über längere Zeit eingenommen. Die Quoten unerwünschter Wirkungen von Phytopharmaka sind jedoch, selbst unter Berücksichtigung des derzeitigen Mangels an Daten zu Nebenwirkungen, bemerkenswert niedrig.

Iberogast(r): A Modern Phytotherapeutic Combined Herbal Drug for the Treatment of Functional Disorders of the Gastrointestinal Tract (Dyspepsia, Irritable Bowel Syndrome) – from Phytomedicin

Efficacy of Herbal Teas in the Treatment of Dyspeptic Disorders Background: Medicinal teas present one of the oldest galenic preparations of herbal remedies. Their use is primarily determined by tradition and empirics. One of their traditional domains are gastrointestinal disorders, which belong to the most frequent wellness disorders. While the effectiveness and compatibility of essential oils, modern drug extracts, and alcoholic extracts from bitters and etheric-oil drugs in the treatment of dyspeptic disorders have been documented in placebo-controlled clinical trials, little attention has so far been given to aqueous extracts from bitters and etheric-oil drugs, which are equivalent to the standard method of preparing herbal teas. Purpose: The presented application observation in clinical practice tried to give evidence for effectiveness and tolerability of medicinal teas in the treatment of dyspeptic disorders and to quantify their extent. Material and Methods: We collected information about effectiveness, compatibility, and side effects of herbal teas from 89 patients (w = 56; m = 33) suffering from dyspeptic disorders. The data were reported with a questionnaire that was sent to physicians and pharmacists experienced in phytotherapy. Results: It could be shown that complaints in patients with primary dyspeptic symptoms (n = 79) decreased by an average of 74%. Final overall assessment revealed that the physicians as well as the patients estimated an effectiveness of 2.9 points as good (3 = good). Compatibility was considered as good to very good (4 = very good), with an average rating of 3.3 points. Two patients stopped therapy because of an extreme aversion to the bitter taste of the teas. No other serious side effects were reported. Conclusion: The herbal teas can be considered effective, very well tolerable and to a large extent free from serious side effects. However, due to the limited observation time, no final conclusion could be given concerning long-term compatibility.

Dyspepsia and Phytotherapy - A Review of Traditional and Modern Herbal Drugs Gastrointestinal complaints rank among the most frequently reasons why people asking for medical advice

Plant extracts with a high content of proteolytic enzymes have been used in traditional medicine for a long time. Besides herbal proteinases, 'modern' enzyme therapy includes pancreatic enzymes. The therapeutic use of proteolytic enzymes is empirically based, but is also supported by scientific studies. This review provides an overview of preclinical and clinical trials of systemic enzyme therapy in rheumatic disorders. Studies of the use of proteolytic enzymes in rheumatic disorders have mostly been carried out on enzyme preparations consisting of combinations of bromelain, papain, trypsin and chymotrypsin. The precise mechanism of action of systemic enzyme therapy remains unresolved. The ratio of proteinases to antiproteinases, which is affected by rheumatic diseases, appears to be influenced by the oral administration of proteolytic enzymes, probably via induction of the synthesis of antiproteinases or a signal transduction of the proteinase-antiproteinase complex via specific receptors. Furthermore, there are numerous alterations of cytokine composition during therapy with orally administered enzymes resulting from immunomodulatory effects, which might be an indication of the efficacy of enzyme therapy. The results of various studies (placebo-controlled and comparisons with nonsteroidal anti-inflammatory drugs) in patients with rheumatic diseases suggest that oral therapy with proteolytic enzymes produces certain analgesic and anti-inflammatory effects. However, the results are often inconsistent. Nevertheless, in the light of preclinical and experimental data as well as therapeutic experience, the application of enzyme therapy seems plausible in carefully chosen patients with rheumatic disorders.

Chlorophyllin (Chlin), the Mg-chlorin obtained from chlorophyll (Chl) was employed as substrate of Mg-dechelatase. The release of Mg 2+ was associated with a shift of absorption from 644 to 687 nm. Changes of absorption at 687 nm were taken as a measure of Mg-dechelatase activity present in preparations of oilseed rape thylakoids. Absorption changes were correlated linearly with enzyme dose. The pH optimum of Mg release from Chlin was ca 9 with a broad flank down to pH 7. The reaction showed saturation kinetics with an apparent k m value of ca 17 nM. The activity was inhibited in the presence of cysteamine or reduced glutathion. There was no effect of the thiol reagent N-ethyl maleimide. The bulk of dechelatase activity was associated with the chloroplast membranes. The enzyme is partially latent and the appearance of full activity requires the solubilization of thylakoids with detergent. The highest activities were detected in mature green rape cotyledons. During dark-induced senescence the activity declined at roughly the same rate as Chl was lost in the leaf tissue

Eine Reihe von pflanzlichen Arzneimitteln lassen sich bei den verschiedenen gastrointestinalen Beschwerden und Symptomen von tumorkranken Menschen (Halitosis, Ubelkeit, Erbrechen, dyspeptische Beschwerden, Reizdarmsymptome, Obstipation, Diarrhoe) sinnvoll einsetzen als palliative und supportive Behandlung. Die Basis fUr die Anwendung bilden einerseits therapeutische Empirie und andererseits wissenschaftlich erhobene Daten und klinische Studien, wobei derzeit nur ein kleinerer Teil mit Tumorpatienten durchgefUhrt wurde. Unter diesen Gesichtspunkten stehen vielfAltige Arzneidrogen, phytotherapeutische Zubereitungen und Kombinationen zur VerfUgung: Atherische Ole (z.B. Pfefferminze, Salbei, australischer Teebaum), Bitterstoff-Drogen (z.B. Wermut, Enzian, Artischocke, Iberis), Teezubereitungen und Tinkturen (z.B. Kamille, Brombeere, Frauenmantel, GAnsefinger, Tormentill, Uzara, Szygium, Heidelbeere, Schwarztee), Laxanzien (z.B. Rhabarber, Faulbaum, Senna, Aloe, Leinsamen, Flohsamen) und Fertigarzneimittel wie z.B. Padmed Laxan und Iberogast. Die vorhandenen Erfahrungen und die bisherigen klinischen Studien lassen die mOglichen Vorteile, die geringe HAufigkeit unerwUnschter Wirkungen, aber auch die EinschrAnkungen der phytotherapeutischen Therapien deutlich hervortreten. Insgesamt scheint es, dass das Potential der symptomorientierten Therapie mit pflanzlichen Arzneimitteln in der Behandlung gastrointestinaler Beschwerden bei Patienten mit Tumorerkrankungen unterschAtzt wird.

A systematic review referring to efficacy and tolerability of the herbal combination Iberogast (Iberis amara planta totalis, Chelidonii herba, Cardui mariae fructus, Melissae folium, Carvi fructus, Liquiritiae radix, Angelicae radix, Matricariae flos, Menthae piperitae folium) was performed in patients with functional dyspepsia. Three placebo-controlled trials and a reference-controlled trial showed a statistical significant and therapeutical relevant reduction of the gastrointestinal symptom-scores in 595 patients. The therapeutic efficacy was also found in one observational study (2267 patients). In accordance with the available evidence Iberogast seems to be an effective phytotherapeutic preparation to reduce the symptoms of dyspepsia yet, without central nervous side effects.

For centuries, fennel fruits have been used as traditional herbal medicine in Europe and China. For the treatment of infants and sucklings suffering from dyspeptic disorders, fennel tea is the drug of first choice. Its administration as a carminativum is practiced in infant care in private homes and in maternity clinics as well where it is highly appreciated for its mild flavor and good tolerance. The long standing positive experience is astonishingly contrasted by a recent statement of the German 'Bundesinstitut für gesundheitlichen Verbraucherschutz und Veterinärmedizin' (BgVV, May 11, 2001), where consumers are advised to reduce their intake of foods containing estragole and methyleugenol, e.g. tarragon, basil, anis, star anis, jamaica pepper, nutmeg, lemon grass as well as bitter and sweet fennel fruits for reasons of health. These warnings are based on experiments with rats and mice where estragole, a natural ingredient of fennel fruits, proved to be carcinogenic. Meanwhile, criticism arose amongst experts concerning the interpretation of these studies. The crucial points of criticism concern the transfer of data obtained in animal models to the human situation as well as the high doses of the applied monosubstance, which do not at all represent the amounts humans are exposed to as consumers of estragole-containing foods and phytopharmaceuticals. Furthermore, studies on estragole metabolism revealed at least quantitative differences between the estragole metabolism of mice and men. In addition, it has been shown that an agent when administered in its isolated form may have significantly different effects and side effects than the same agent applied as a constituent in naturally occurring multicomponent mixtures. Thus, a multicomponent mixture such as fennel tea contains various antioxidants known to be protective against cancer. These differences were not considered in the risk assessment. A well done risk assessment should be based on appropriate data collected in humans. Considering the long traditional use of fennel tea and the total lack of epidemiological and clinical studies indicating a well founded cancerogenic potential, the probability of a serious risk connected with the consumption of fennel tea seems to be negligibly small.

Iberogast is a complex herbal preparation. As a fixed drug combination (9 constituents) it is composed of a fresh plant extract of Iberis amara and of extracts of 8 other dried herbal drugs ( Chelidonii herba, Cardui mariae fructus, Melissae folium, Carvi fructus, Liquiritiae radix, Angelicae radix, Matricariae flos, Menthae piperitae folium). The pharmacological effects as well as the therapeutic effectiveness, tolerability, and toxicity of Iberogast were experimentally and clinically recorded and documented using modern investigation tools. Both the experimental as well as the clinical studies indicated a regulatory influence of Iberogast on the whole gastrointestinal tract by a special dual action. While the included extracts of the dried herbal drugs have mainly spasmolytic properties, the fresh plant extract of Iberis amara has a tonic effect on the gastrointestinal tract. Depending on the predistension of the gastric or intestinal wall, the tonic or the spasmolytic effects of Iberogast prevail. Both the fresh plant extract of Iberis amara and the combined preparation of Iberogast were found to be toxicologically safe in therapeutically effective doses. For the estimation of the clinical effectiveness a systematic review was performed (data research: January 1970 to September 2002). As shown in controlled (according GCP standard) as well as supportive and uncontrolled clinical studies, the symptoms of functional dyspepsia and of irritable bowel syndrome (one controlled study and one observational study) could be significantly reduced by these herbal preparation in comparison to placebo. Two trials comparing Iberogast with the prokinetics metoclopramide and cisapride demonstrated a comparable therapeutic effectiveness of the herbal preparation and the prokinetics in the treatment of dyspepsia. Adverse events were rare and, with respect to frequency and spectrum, partly the same as found with placebo. Another advantage of Iberogast is that it targets only the gastrointestinal tract and the enteral nervous system, but not the central nervous system. Because of its special dual action, its clinically proven effectiveness, and its good tolerability, Iberogast may be a drug of first choice in the treatment of functional gastrointestinal diseases and their corresponding symptoms.

Medicinal teas present one of the oldest galenic preparations of herbal remedies. Their use is primarily determined by tradition and empirics. One of their traditional domains are gastrointestinal disorders, which belong to the most frequent wellness disorders. While the effectiveness and compatibility of essential oils, modern drug extracts, and alcoholic extracts from bitters and etheric-oil drugs in the treatment of dyspeptic disorders have been documented in placebo-controlled clinical trials, little attention has so far been given to aqueous extracts from bitters and etheric-oil drugs, which are equivalent to the standard method of preparing herbal teas.The presented application observation in clinical practice tried to give evidence for effectiveness and tolerability of medicinal teas in the treatment of dyspeptic disorders and to quantify their extent.We collected information about effectiveness, compatibility, and side effects of herbal teas from 89 patients (w = 56; m = 33) suffering from dyspeptic disorders. The data were reported with a questionnaire that was sent to physicians and pharmacists experienced in phytotherapy.It could be shown that complaints in patients with primary dyspeptic symptoms (n = 79) decreased by an average of 74%. Final overall assessment revealed that the physicians as well as the patients estimated an effectiveness of 2.9 points as good (3 = good). Compatibility was considered as good to very good (4 = very good), with an average rating of 3.3 points. Two patients stopped therapy because of an extreme aversion to the bitter taste of the teas. No other serious side effects were reported.The herbal teas can be considered effective, very well tolerable and to a large extent free from serious side effects. However, due to the limited observation time, no final conclusion could be given concerning long-term compatibility.

The significantly increased sales figures many phytopharmaceuticals have achieved during the last years prove the confidence that a great part of the population has in herbal remedies. This is primarily due to the wide-spread opinion that herbal remedies are free from side-effects. The long tradition and presumed 'natural' origin are no guarantee for safety in the treatment with herbal remedies. Even if a large proportion of the undesirable events is traceable to falsifications, impurities and lacking quality controls, herbal drugs with controlled quality should not be generally classified as harmless. In the meantime it has been possible to prove the presence of active substances with toxic and cancerogenic properties in various phytopharmaceuticals. Interactions with other drugs have been documented in a number of notes, where phytopharmaceuticals could influence the blood plasma level of various drugs, presumably by activating or inhibiting the cytochrom-P450-system. At present, especially data about adverse effects during long-term administration of herbal remedies are under-represented. Particularly because of their presumed harmlessness they often are prescribed in the case of chronic diseases and then taken over a longer period of time. The frequency of undesirable effects of phytopharmaceuticals is remarkably low, even if the present lack of data about side-effects is considered.

Gastrointestinal complaints rank among the most frequently reasons why people asking for medical advice. About 15-30% of the adult patients suffer from different various functional dyspeptic conditions. The therapy of functional gastrointestinal disorders is one of the domains of phytotherapeutic treatments. From ancient times on, bitter herbal drugs played a very important role in the therapy of patients with dyspeptic symptoms. The mechanisms of action of the bitters are not completely understood. But there are indications that they sensorially stimulate at even very small concentrations sensorially the secretion of the stomach as well as the digestive glands and strengthen the smooth musculature of the digestive tract (via the gustatory system, N. vagus and the enteric nervous system). Across the enteral nervous system the strengthened digestive tract seems to stimulate the CNS, leading to a general tonification. At higher dosages bitters probably directly affect the mucous membranes of the stomach and the bowel. Bitters often are combined with essential oils (some volatile oils as aromatic bitters, drug combinations of a volatile oil with a bitter). Essential oils act primarily as spasmolytics, carminatives and local anesthetics. In the last years several controlled studies were carried out with phytotherapeutic combinations (e.g. with Iberis amara, caraway oil, peppermint oil, curcuma extract, ginger extract) in which the herbal drugs proved to be superior compared to placebo and were as effective as prokinetics (studies according to evidence-based medicine). The traditional phytotherapeutic approach is based upon the illness- as well as the patient-related investigations referring to the effectiveness of bitter, acrid- and essential-oil drugs. Such a treatment is supported by a rich amount of various of kinds of individual empirical experience (experience-based phytotherapy). Important traditional medical systems like the Traditional Chinese Medicine, the Ayurvedic Medicine as well as the European 'Humoral Medicine' consider different aspects of the sick human being, like the constitution of the patient (holistic approach), and take qualities of herbal drugs, vegetarian food, and spices into account for therapeutic purposes.