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Komplementär- und Alternativmethoden
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The integration of herbal medicine into modern medical practices including cancer treatments must take into account the interrelated issues of quality, safety, and efficacy. Quality is the paramount issue because it can affect the efficacy and/or safety of the herbal products being used. Current product quality ranges from very high to very low due to intrinsic, extrinsic, and regulatory factors. Intrinsically, species differences, organ specificity, diurnal and seasonal variations can affect the qualitative and quantitative accumulation of active chemical constituents in the source medicinal plants. Extrinsically, environmental factors; field collection methods such as cultivation, harvest, post-harvest transport and storage; manufacturing practices; inadvertent contamination and substitution; and intentional adulteration are contributing factors to the quality of herbal medicinal products. Source plant materials that are contaminated with microbes, microbial toxins, environmental pollutants, or heavy metals; or finished products that are adulterated with foreign toxic plants or synthetic pharmaceutical agents can lead to adverse events. Substandard source materials or finished products will yield therapeutically less effective agents. Herbal medicine quality can also be attributed to regulatory practices. In a number of countries, herbal medicines are unregulated, which has led to product quality differences. Product quality improvement may be achieved by implementing control measures from the point of medicinal plant procurement under good agricultural practices (GAPs) and the manufacture of the finished botanical products under good manufacturing practices (GMPs), plus post-marketing quality assurance surveillance. The lack of pharmacological and clinical data on the majority of herbal medicinal products is a major impediment to the integration of herbal medicines into conventional medical practices. For valid integration, pharmacological and especially, clinical studies, must be conducted on those plants lacking such data. Adverse events, including drug-herb interaction must also be monitored to promote a safe integration of efficacious herbal medicine into conventional medical practices.
Summary Use and Acceptance of Classical Natural and Alternative Medicine in Germany - Findings of a Representative Population-Based Survey Background: The use of classical natural therapies and alternative medicine is becoming increasingly popular in Germany and other European countries. Only few population-based studies in Germany have investigated the use and acceptance of a variety of classical and alternative methods, including their possible determinants. Methods: Cross-sectional survey of a nationally representative sample of men and women aged 18 to 69 years, applying a standardized self-administered questionnaire, that included questions on 21 different healing methods, on personal reasons for use, on individual attitudes to natural therapies, and on the socioeconomic background. Results: Overall, 70% of women and 54% of men had used at least one classical natural or alternative healing method (including homeopathic and anthroposophic medicine) during the 12 months preceding the study. The most frequently used methods were classical therapies such as exercise therapy (32% of women, 26% of men), herbal medicine (33% of women, 20% of men), hydrotherapy (24% of women, 17% of men), and medical massage (22% of women, 15% of men). About 20% of women and 10% of men had applied homeopathic therapies, and about 9% (11% women, 6% men) had used acupuncture. In multivariate logistic regression analyses gender and education were the best predictors of classical and alternative medicine use. Women and persons with at least high-school education used these methods significantly more often than men and persons with lower education. Age-stratified analyses revealed that the age-group of the 40-49-year-old people used classical and alternative methods significantly more often than younger or older age-groups. The most frequently reported health problems for which natural therapies had been applied were back pain (57%), cold (29%), headaches (19%), strain (15%) and gastrointestinal ailments (12%). Overall, the efficacy and usefulness of natural healing methods was evaluated positive by the majority of the study population. 58% would appreciate it if physicians would more often prescribe such therapies, and 48% would like to have more information about the benefit of natural healing methods. Conclusions: The prevalence of use of natural medicine varies substantially across different types of healing methods. The observed overall acceptance together with the marked need for more information should be used more intensively for the development of health promotion strategies and underpins the necessity of reinforced research activities in this field.
In a way similar to synthetic antidepressants, extracts of
St. John’s wort inhibit the uptake of neurotransmitters such as
serotonin and noradrenaline into the nerve cells of the CNS. The
results of 37 controlled, doubleblind trials demonstrated the
therapeutic efficacy in patients with mild or moderate
depression. Results of the trials showed that the threshold dose
for efficacy of these extracts in terms of individual symptoms
and complaints occurring in the depressive disorder is
approximately 300–500 mg of extract per day. In a dose of
approximately 500–1000 mg per day, these preparations showed an
efficacy in physician-supported therapy of mild to moderately
severe depressive episodes comparable to some synthetic
antidepressants. However, compared with the latter, the
incidence of adverse events during treatment with St. John’s
wort extract is at least ten times lower. Serious risks can
arise from interactions with drugs such as cyclosporin,
phenprocoumon derivatives, or indinavir.
The increasing number of approved efficacious therapies for various indications raises the question of whether the inclusion of a placebo group is still justified. In addition, pharmaceutical companies and regulatory agencies acknowledge that it may be sufficient to prove that a new therapy is comparable to an approved reference therapy regarding efficacy and safety in some situations. This becomes especially striking for the approval to market a generic drug. Another, perhaps even more important example is the increasing resistance of bacteria which calls for new antibiotics based on new therapeutic principles without having the claim for better efficacy. In these situations, a comparable efficacy would constitute progress. In the present paper, we discuss the numerous methodological challenges and approaches to overcome these problems that occur when it is not possible or even not wanted to use the classic approach of a randomized placebo-controlled superiority trial. Here, the field of medical biometry, which has proved in the last 25 years to be an integral part of the development of new drugs, demonstrates its suitability as a flexible and scientifically based means to fulfil the requirements resulting from clinical practice. Starting from the fact that statistical methods are not able to prove “equality” of two treatments, “shifted” hypotheses are considered and their importance for the different study designs is discussed. We show how the classic hypotheses known from placebo-controlled clinical trials can be embedded in this concept. The implications of this approach for the analysis and interpretation of study results is further discussed. The relevant guidelines of the European and US regulatory agencies are taken into account.
Echinacea spp. are native to North America and were traditionally used by the Indian tribes for a variety of ailments, including mouth sores, colds and snakebites. The three most commonly used Echinacea spp. are E. angustifolia, E. pallida and E. purpurea. Systematic literature searches were conducted in six electronic databases and the reference lists of all of the papers located were checked for further relevant publications. Information was also sought from the spontaneous reporting programmes of the WHO and national drug safety bodies. Twenty-three manufacturers of echinacea were contacted and asked for data held on file. Finally our own departmental files were searched. No language restrictions were imposed. Combination products and homeopathic preparations were excluded.
Data from clinical studies and spontaneous reporting programmes suggest that adverse events with echinacea are not commonly reported. Gastrointestinal upsets and rashes occur most frequently. However, in rare cases, echinacea can be associated with allergic reactions that may be severe. Although there is a large amount of data that investigates the efficacy of echinacea, safety issues and the monitoring of adverse events have not been focused on.
Short-term use of echinacea is associated with a relatively good safety profile, with a slight risk of transient, reversible, adverse events. The association of echinacea with allergic reactions is supported by the present evaluation. While these reactions are likely to be rare, patients with allergy or asthma should carefully consider their use of echinacea. The use of echinacea products during pregnancy and lactation would appear to be ill-advised in light of the paucity of data in this area.
Ephedra is a botanical product widely used to enhance alertness, as a weight loss aide, and as a decongestant. Its reported adverse effects led the Food and Drug Administration (FDA) to ban ephedra-containing products in the United States in 2004. This study's purpose was to compare toxicity from botanical products containing ephedra to nonephedra products.
The Toxic Exposure Surveillance System (TESS), a national poison center database, was utilized to determine the number and outcomes of cases involving botanical products reported from 1993-2002. Cases listing both a botanical product and any other drugs or chemicals were excluded a priori. Ten-year hazard rates (moderate outcomes + major outcomes + deaths per 1000 exposures) were used to compare botanical product categories.
There were 21,533 toxic exposures with definitive medical outcomes reported over the 10 yrs where a botanical product was the only substance involved. Of these, 4306 (19.9%) had moderate or major medical outcomes and there were two deaths, for an overall hazard score of 200 per 1000 exposures. The number of ephedra reports to poison centers increased 150-fold over the 10-yr period. The hazard rate for products that contained only ephedra was 250 per 1000 exposures and 267 per 1000 exposures for products that contained ephedra and additional ingredients; whereas the hazard score for only nonephedra botanical products was 96 per 1000 exposures. The rate ratios for multibotanical products with ephedra (RR 1.33; 95% C.I. 1.27-1.40) and for single-ingredient ephedra products (RR 1.25; 95% C.I. 1.11-1.40) were both two to six times higher than those of other common botanical products. Yohimbe-containing products had the highest hazard score (417) and rate ratio (2.08; 95% C.I. 1.59-2.80).
Ephedra-containing botanical products accounted for a significant number of toxic exposures with severe medical outcomes reported to poison centers. Hazard rate analysis suggests poison center-reported events involving ephedra-containing botanical products were much more likely to result in severe medical outcomes than those involving nonephedra-containing botanical products. These data support recommendations by policymakers that the sale of ephedra should be prohibited to protect consumers. Our data suggest that the botanical product, yohimbe, may also be associated with unacceptably high risks of toxicity and should receive close scrutiny from health policymakers.
In the treatment of minor blunt injuries several topical drugs are known to have anti-inflammatory and analgesic properties. They represent, however, two fundamentally different major pharmacological therapy approaches: the "chemical-synthetical" and the "phytotherapeutical" approach. The main objective of this trial (CODEC_2004) was to compare the efficacy and tolerability of an ointment of Comfrey extract (Extr. Rad. Symphyti) with that of a Diclofenac gel in the treatment of acute unilateral ankle sprain (distortion). In a single-blind, controlled, randomized, parallel-group, multicenter and confirmatory clinical trial outpatients with acute unilateral ankle sprains (n=164, mean age 29.0 years, 47.6% female) received either a 6 cm long ointment layer of Kytta-Salbe f (Comfrey extract) (n=82) or of Diclofenac gel containing 1.16 g of diclofenac diethylamine salt (n=82) for 7 +/- 1 days, four times a day. Primary variable was the area-under-the-curve (AUC) of the pain reaction to pressure on the injured area measured by a calibrated caliper (tonometer). Secondary variables were the circumference of the joint (swelling; figure-of-eight method), the individual spontaneous pain sensation at rest and at movement according to a Visual Analogue Scale (VAS), the judgment of impaired movements of the injured joint by the method of "neutral-zero", consumption of rescue medication (paracetamol), as well as the global efficacy evaluation and the global assessment of tolerability (both by physician and patient, 4 ranks). In this study the primary variable was also to be validated prospectively. It was confirmatorily shown that Comfrey extract is non-inferior to diclofenac. The 95% confidence interval for the AUC (Comfrey extract minus Diclofenac gel) was 19.01-103.09h*N/cm2 and was completely above the margin of non-inferiority. Moreover, the results of the primary and secondary variables indicate that Comfrey extract may be superior to Diclofenac gel.
Neue Therapien mit ätherischen Ölen und Edelsteinen, Ansata-Verlag, München bzw
- Dietmar Krämer
Side effects of Drugs
- E Ernst