RESUMEN
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.
Asunto(s)
Anisoles/efectos adversos , Foeniculum/química , Fitoterapia , Derivados de Alilbenceno , Animales , Anisoles/uso terapéutico , Antioxidantes/efectos adversos , Antioxidantes/uso terapéutico , Bebidas/efectos adversos , Carcinógenos/efectos adversos , Carcinógenos/uso terapéutico , Humanos , Ratones , Extractos Vegetales/efectos adversos , Extractos Vegetales/uso terapéutico , Medición de RiesgoRESUMEN
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.
Asunto(s)
Dispepsia/tratamiento farmacológico , Fitoterapia , Extractos Vegetales , Humanos , Estudios Multicéntricos como Asunto , Satisfacción del Paciente , Ensayos Clínicos Controlados Aleatorios como Asunto , Proyectos de Investigación , Seguridad , Resultado del TratamientoRESUMEN
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.
Asunto(s)
Bebidas , Dispepsia/tratamiento farmacológico , Fitoterapia , Extractos Vegetales/uso terapéutico , Humanos , Extractos Vegetales/efectos adversos , Encuestas y Cuestionarios , Resultado del TratamientoRESUMEN
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.
Asunto(s)
Interacciones Farmacológicas , Fitoterapia/efectos adversos , Extractos Vegetales/efectos adversos , Contaminación de Medicamentos , Hipersensibilidad a las Drogas/etiología , Interacciones de Hierba-Droga , Humanos , Extractos Vegetales/uso terapéutico , SuizaRESUMEN
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.
Asunto(s)
Brassicaceae , Enfermedades Gastrointestinales/tratamiento farmacológico , Fitoterapia , Extractos Vegetales/uso terapéutico , Medicina Basada en la Evidencia , Humanos , Extractos Vegetales/efectos adversos , Seguridad , Resultado del TratamientoRESUMEN
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.
Asunto(s)
Medicamentos Herbarios Chinos/uso terapéutico , Dispepsia/tratamiento farmacológico , Medicina Tradicional , Fitoterapia , Salud Holística , Humanos , Humoralismo , Medicina Ayurvédica , Medicina Tradicional China , Plantas MedicinalesRESUMEN
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.