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This case report indicates a complication of a footbath with herbs, self-applied by a patient at home. A 60 year old female patient presented herself at the TCM (Traditional Chinese Medicine) hospital, Bad Kötzting, Germany with the main symptoms of persistent coughing fits and disturbing smells especially during meals. At admission, she was administered a high dose Chinese herbal therapy complementary to her already prescribed pharmaceuticals. During her sojourn in the hospital she started suffering from numbness in both feet, preferred on the dorsum, and up to and including the toes, accompanied with a sensation of cold. Therefore TCM herbal footbaths containing 5g Psoraleae fructus semen (Buguzhi) were administered, twice a day, for 2 weeks, during the hospital stay without any complications. One week after discharge from the hospital she went on with her footbaths, prescribed for outpatient treatment. Buguzhi is suspected to cause phototoxic reactions under sunlight. Unfortunately, the patient applied the prescription-based footbath under a parasol in her garden. This seems to be the reason, why the patient developed an erythema bullosa grade three. She was treated with antibiotics for 10 days and ointment bandages until remission. To avoid similar adverse events in future, patients have to be informed to not expose their skin to solar irradiation during or after footbaths containing Buguzhi. Alternatively it has to be considered to omit Buguzhi for the use of footbaths applied as outpatient treatment.

Background: The use of drugs derived from plants is a cornerstone of Traditional Chinese Medicine (TCM). Yet, too little is known about risk and safety of Chinese medicinal drugs (CMD). Therefore, the TCM hospital Bad Kötzting has developed a quality control and complication screening programme in order to ensure a safe administration of TCM drugs to their patients. Methods: All Chinese medicinal drugs delivered to the hospital between September 1, 2012 and December 31, 2013 entered the quality control program and were screened for microbial contamination, aflatoxin, pesticides and heavy metals. A routinely applied complication screening programme monitored liver enzymes in all patients. Case causality assessment by CIOMS scale and identification of admitted herbs were conducted. Additionally, side effects of patients were identified by a routinely performed web-based documentation system. Results: In 5 of 23 investigated samples (21.7%) the initial testing showed microbial contamination (2), pesticide (2) and heavy metals (1). The drugs were tested for authenticity and adulterations, respectively. All 994 patients (mean age 52.6 years; 72.6% female) admitted were available for analysis. 448 (45.1%) of all patients reported having perceived at least one side effect of treatment. They experienced mainly gastrointestinal symptoms (13.6%), neurovegetative symptoms (10.8 %), temporary deteriorations of pain (8.8%), diarrhoea (5.9%), nausea (1.6%) and vomiting (0.5%). Further, 6 patients with a more than 2-fold elevation (compared to maximum normal value or elevated admission values) of ALT were found in the systematic laboratory control with a non-conclusive causality assessment for TCM-drugs. Conclusion: Approximate incidence rates and analysed drugs associated with liver damage revealed a low rate of liver injury. Patients should be informed of the gastrointestinal symptoms caused by and potential hepatotoxicity of TCM herbs.

International audience; Background: Traditional Chinese Medicine (TCM) with its focus on herbal use is popular and appreciated worldwide with increased tendency, although its therapeutic efficacy is poorly established for most herbal TCM products. Treatment was perceived as fairly safe but discussions emerged more recently as to whether herb induced liver injury (HILI) from herbal TCM is a major issue; Methods: To analyze clinical and case characteristics of HILI caused by herbal TCM, we undertook a selective literature search in the PubMed database with the search items Traditional Chinese Medicine, TCM, alone and combined with the terms herbal hepatotoxicity or herb induced liver injury; Results: HILI caused by herbal TCM is rare and similarly to drugs can be caused by an unpredictable idiosyncratic or a predictable intrinsic reaction. Clinical features of liver injury from herbal TCM products are variable, and specific diagnostic biomarkers such as microsomal epoxide hydrolase, pyrrole-protein adducts, metabolomics, and microRNAs are available for only a few TCM herbs. The diagnosis is ascertained if alternative causes are validly excluded and causality levels of probable or highly probable are achieved applying the liver specific RUCAM (Roussel Uclaf Causality Assessment Method) as the most commonly used diagnostic tool worldwide. Case evaluation may be confounded by inappropriate or lacking causality assessment, poor herbal product quality, insufficiently documented cases, and failing to exclude alternative causes such as infections by hepatotropic viruses including hepatitis E virus infections; Conclusion: Suspected cases of liver injury from herbal TCM represent major challenges that deserve special clinical and regulatory attention to improve the quality of case evaluations and ascertain patients' safety and benefit.

SummaryWhile the effectiveness of Hypericum extracts in the treatment of mild and moderately severe depressive disorders seems to be well-established, the mechanism of action is still unl

SummaryDie Akupunktur scheint derzeit dabei zu sein, sich aus dem Reigen der alternativen bzw. komplementaren Verfahren zu verabschieden. Eine «offizielle» Konsensuskonferenz gibt fur def

This article describes and discusses five placebo-controlled randomized studies investigating the immunomodulatory activity of preparations containing extracts of Echinacea in healthy volunteers. A total of 134 (18 female and 116 male) healthy volunteers between 18 and 40 years of age were studied. Two studies tested intravenous homeopathic complex preparations containing Echinacea angustifolia D1 (study 1) and D4 (study 5). Two studies (2 and 3a) tested oral alcoholic extracts of roots of E. purpurea, one study an extract of E. pallida roots (study 3b), and one study an extract of E. purpurea herb (study 4). Test and placebo preparations were applied for four (study 5) or five (studies 1-4) consecutive days. The primary outcome measure for immunomodulatory activity was the relative phagocytic activity of polymorphonuclear neutrophil granulocytes (PNG), measured in studies 1 and 2 with a microscopic method and in studies 3, 4, and 5 with two different cytometric methods. The secondary outcome measure was the number of leukocytes in peripheral venous blood. Safety was assessed by a screening program of blood and other objective parameters as well as by documentation of all subjective side effects. In studies 1 and 2 the phagocytic activity of PNG was significantly enhanced compared with placebo [maximal stimulation 22.7% (95% confidence interval 17.5-27.9%) and 54.0% (8.4-99.6%), respectively], while in the other studies no significant effects were observed. Analysis of intragroup differences revealed significant changes in phagocytic activity during the observation periods in five test and three control groups. Leukocyte number was not influenced significantly in any study. Side effects due to the test preparations could not be detected. Our studies provide evidence for immunomodulatory activity of the homeopathic combination tested in study 1 and the E. purpureae radix extract tested in study 2. The negative results of the other three studies are difficult to interpret due to the different methods for measuring phagocytosis, the relevant changes in phagocytic activity within most placebo and treatment groups during the observation period, and the small sample sizes. Future studies should be performed on patients rather than healthy volunteers and use standardized or chemically defined monopreparations of Echinacea.

The TLC-chromatograms of Sophora flavescens root extract samples except of some quantitative deviation show a rather uniform zone pattern when detected with vanillin-sulphuric acid reagent. The Sophora tonkinensis sample did not contain the characteristic flavanones, chalcones and pterocarpan but showed only a small amount of the alkaloid Oxymatrine. Glycyrrhiza pallidiflora was devoid of both classes of compounds. In the HPLC-fingerprints of all Sophora flavescens extract samples 1–6 the characteristic flavanones, chalcones and pterocarpan were detectable at 210 and 365 nm. Neither Sophora tonkinensis nor Glycyrrhiza pallidiflora extract showed any relevant peaks which could be used for the authentity proof. For the HPLC-analysis of the alkaloids of Sophora flavescens another extraction procedure and HPLC-system has to be used.

The fingerprints of Pericarpium Citri reticulatae can be very well authenticated by TLC and especially by HPLC. The “European” fruits of Pericarpium Citri limonis and Pericarpium Citri aurantii as falsifications or adulterations can be easily distinguished from each other in TLC as well as in HPLC.

The TLC- and HPLC-fingerprint analysis has confirmed that in both processed Aconitum roots the extremely toxic alkaloid Aconitine was strongly degraded. Therefore the demand of the Chinese Pharmacopoeia seems to be fulfilled. However, since neither the processing methods used are standardized nor safe limits were stipulated for the toxic Aconitine, Mesaconitine and the other main alkaloids, it is compulsory to work out reliable, quantitative HPLC-methods to guarantee the safety of processed Aconitum species for prescription and the preparations of decoctions. It is also compulsory to perform toxicity studies to asses how safety limits(3) can be achieved without simultaneous loss of the medicinal potential. If this aim cannot be guaranteed all unprocessed and processed Aconitum drugs should be banned from the Pharmacopoeias and excluded from the market.