Silymarin has long been used as a hepatoprotective remedy. Chronic toxicity studies in rodents have confirmed that silymarin has a very low toxicity. These data support its history as a safe medication in hepatic diseases. In the last years, several studies expanded our understanding of the pharmacology of silymarin and its molecular mechanisms of action. These new insights may affect the handling of silymarin in clinical studies and daily practice. Additionally, scientific knowledge in hepatology is constantly evolving with, particularly, an increase in the field of non-alcoholic fatty liver disease which is considered today as the most frequent liver disease worldwide. In this review, we will describe scientific evidence for the effectiveness of silymarin in hepatic disorders. We will focus on silymarin’s pharmacological effects in non-alcoholic fatty liver disease and on its well described effects in alcoholic liver disease and acute intoxications, e.g. with Amanita species. We will discuss the relevance of pharmacological data as a function of doses or concentrations required for a given effect and of concentrations achieved in the target tissues. Many pharmacological effects of silymarin can be attributed to effects downstream or upstream of its antioxidative and membrane-stabilizing properties. However, despite promising new experimental and clinical data further clinical studies are required including long-term observations and the application of hard clinical endpoints such as survival rates, to further support silymarin’s use for the treatment of hepatic diseases.
Background: The etiology of functional dyspepsia (FD) is multi-factorial. Its prevalence is high and it considerably impairs the patients' quality of life. The treatment options are limited. Padma Digestin, a multi-herbal formula from Tibetan Medicine, is traditionally used in malabsorption and dyspeptic symptoms as they do occur in FD, but as yet no clinical data exist on the formula. The aim of this study was to evaluate the safety, tolerability, and efficacy of Padma Digestin in patients with FD in a prospective, open, clinical phase III trial. Patients and Methods: Patients were recruited by general practitioners, internists, and gastroenterologists and treated with 2 × 3 capsules of Padma Digestin daily for 6 weeks. Dyspeptic symptoms were analyzed using the Domestic/International Gastroenterology Surveillance Study (DIGEST) questionnaire extended by the 2 symptoms stomach cramps and lack of appetite. The quality of life was assessed using the Psychological General Well-Being Index (PGWBI-S) questionnaire (short version). Results: 37 patients were admitted and efficacy could be assessed in 31. In the overall efficacy assessment, the Padma Digestin treatment led to a statistically highly significant reduction of the respective most bothersome symptom scores regarding frequency, severity, and impairment of daily activities (p < 0.01). The treatment also led to significant improvements of the individual symptoms of postprandial fullness, nausea, localized and diffuse epigastric pain, stomach cramps, and lack of appetite. The onset of improvement was after a median of 7 days; time until disappearance of the symptoms was after a median of 22 days. The global efficacy and tolerability were rated as good or very good by the doctors and the patients in 84% and 78%, respectively. The PGWBI-S increased from 55 ± 19.5% to 70.5 ± 15.5%, which is nearly the normal value (73.5 ± 15.4%). As for safety, 11 patients reported a total of 17 adverse events (AE), 1 of which was serious but unrelated to the study medication. The AE were mild or moderate. The safety laboratory data showed no statistically significant or otherwise relevant changes. Conclusions: The results show that the formula Padma Digestin has a high tolerability and efficacy in FD symptoms and positively influences psychological well-being and thus quality of life. It therefore represents a much needed extension of the therapeutic repertoire in FD.
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Background: In outpatient settings diagnostic classification of depressive symptoms is mostly descriptive based on ICD-10. Depending on clinical experience and consultation time, diagnosis can be verified by validated scales. However, physicians working in primary care are familiar with ICD-10 criteria. Therefore, the aim of the present study was to examine the feasibility of the validation of an ICD-10-derived symptom scale for depression. Methods: For this preliminary trial we generated a symptom scale derived 1:1 from the diagnostic criteria for depression given in the ICD-10 with 10 items. The Hamilton Rating Scale for Depression (HAMD-17) was used as reference in a population of 226 outpatients suffering from depressive symptoms. Correlation between scales as well as sensitivity and specificity of the ICD-10 scale were calculated. Results: The generated ICD-10 symptom scale for depression could be analyzed in 219 patients and showed a significant and strong correlation with the HAMD-17 (p < 0.0001; ρ = 0.75). The best tradeoffs between specificity and sensitivity of the ICD-10 score were found at 10 points for the lower and 14 points for the upper cut-off. Overall sensitivity and specificity was 76.7 and 88.6%. Almost two thirds (i.e. 65.3%) of the patients were correctly classified by the ICD-10 scale. Conclusion: The ICD-10 symptom scale examined in the current population was found to have fair correlation with the HAMD-17 as well as, in face of the limited variance of the patients’ condition, acceptable sensitivity and specificity. Therefore, this preliminary study showed that the ICD-10-derived symptom scale seems appropriate to be investigated in a thorough validation trial.
Background: Treatment of rheumatic or musculoskeletal disorders (MD) is multi-disciplinary and includes herbal analgesics. Although already reviewed, no quantitative evaluation of efficacy and safety of the herbal combination Phytodolor® (STW1) is available. Methods: We searched in databases and contacted authors and the manufacturer to identify randomized controlled trials (RCTs) examining STW1 in patients with MD. We made a reanalysis of raw data of eligible published and unpublished RCTs and pooled the results for meta-analysis according to Cochrane guidelines and intention-to-treat. Primary outcome measure was patient global assessment of efficacy, secondary outcome measure was pain at rest and on movement. Results were stratified according to treatment groups. Results: Patient data of 11 RCTs were eligible for pooling. In the entire population, STW1 was significantly superior compared to placebo in patients' global assessment of efficacy (group difference for rating very good/good: 20%; placebo 48.9% and STW1 69.1%; p < 0.001; OR 0.43; 95% CI 0.28–0.65) and in the subpopulation 'other rheumatic diseases' (placebo 45.4%; STW1 72.3%; p < 0.001; OR 0.32; 95% CI 0.2–0.52), but not in the subpopulation 'gonarthrosis'. STW1 did not differ significantly compared to non-steroidal anti-inflammatory drugs (NSAIDs), neither in the entire population nor the subpopulations. Similar results were found for pain at rest and on movement. No serious adverse events (AE) but minor AE were reported (placebo 8.1%; STW1 14.2%; NSAIDs 18.9%). Conclusion: According to the analysed data, STW1 showed a better pain reduction than placebo in patients with pain due to MD, probably equivalent to NSAIDs, and was well tolerated.
Background: Extracts of Hypericum perforatum have demonstrated in randomized trials (RCTs) to be effective in mild to moderate depressive episodes. However, as their use in daily practice may differ from that in RCTs we have conducted a study to achieve a better estimate of the range and frequency of adverse drug reactions (ADR) and the efficacy. Patients and Methods: In an observational study in Germany, adult outpatients with depressive syndrome were treated with an extract of St. John's Wort. Study duration was 12 weeks, with control visits every 4 weeks. Besides anamnestic data, the variables assessed were: evolution of ICD-10 derived symptom score, Global Clinical Impression scale (GCI), and tolerability. Results: 1,778 patients from 304 centers participated in the study (mean duration of disorder 7.3 ± 18.9 months), and 1,541 patients completed it. At the last control visit the ICD-10 sum score had dropped by 63.1% and the proportion of patients described as 'normal to mildly ill' (GCI-s) had increased from 21.6% at admission to 72.4%. Regarding the GCI-i, 77% of the patients had improved 'very much' or 'much' at the last visit. This was consistent with their self-assessment (76%). Lower age and shorter duration of the disorder were associated with significantly better outcomes. The incidence of ADRs was 3.54% and had been decreasing continuously from the first control visit onwards; serious ADRs did not occure. Conclusions: The herbal drug was well tolerated, and no new or serious ADR were identified. In view of the limitations inherent to the study design, it can be concluded that extracts of St. John's Wort are effective as an antidepressant in the management of depression in daily practice.
Hintergrund: Viele Menschen bewegen sich heute zu wenig und ernÄhren sich unausgewogen. Dies hat negative Auswirkungen auf das Wohlbefinden, die kÖrperliche LeistungsfÄhigkeit und ganz allgemein auf die Gesundheit. Zielsetzung: Erstellung eines systematischen Review zur Bedeutung von Sport und ErnÄhrung fÜr die Gesundheit. Methoden: Systematische Analyse und Bewertung von Humanstudien (prospektive Doppelblindstudien, epidemiologische und retrospektive Studien, kurzfristige biochemische/hÄmatologische Studien («Surrogate Markers»)) der letzten 10 Jahre aus den gÄngigen elektronischen Datenbanken sowie der Angaben von Standardwerken und publizierten Monographien. Ergebnisse und Schlussfolgerungen: SportfÖrderung stellt eine wichtige prÄventiv-medizinische Massnahme dar. Grundlage fÜr die benÖtigte kÖrperliche Bewegung ist beispielsweise die Bewegungspyramide. Zur Verbesserung sportlicher Leistung muss ein Training nach dem Prinzip der schrittweise steigenden Belastung aufgebaut sein. Die ErnÄhrung von SportlerInnen sollte – wie die ErnÄhrung von Personen, die keinen Sport betreiben – grundsÄtzlich auf der Lebensmittelpyramide basieren. Manche SportlerInnen benÖtigen zusÄtzliche NÄhrstoffe. KÖrperliche LeistungsfÄhigkeit nimmt zwar mit dem Alter ab, die LeistungsfÄhigkeit kann aber im Alter durch Training erhalten und verbessert werden. Die positive Wirkung des Trainings auf Blutfettwerte und besonders auf Herz und Kreislauf ist abhÄngig von der TrainingsintensitÄt. Schwitzen ist ein zentraler Regulationsmechanismus der durch Training oder Sport erhÖhten KÖrpertemperatur. Mit Schweiss und Verdunstung werden ausser Wasser auch Elektrolyte ausgeschieden, die wieder zu ersetzen sind. Viele SportlerInnen fragen sich, ob sie mit NahrungsergÄnzungsmitteln oder anderen – legalen! – Wirkstoffen ihre Leistung verbessern kÖnnen. Zurzeit gibt es wenige Daten Über dazu geeignete Substanzen.