Patient-centered developments in colon- and rectal cancer with a multidisciplinary international team: From translational research to national guidelines.

Rarely, scientific developments centered around the patient as a whole are published. Our multidisciplinary group, headed by gastrointestinal surgeons, applied this research philosophy considering the most important aspects of the diseases "colon- and rectal cancer" in the long-term developments. Good expert cooperation/knowledge at the Comprehensive Cancer Center Ulm (CCCU) were applied in several phase III trials for multimodal treatments of primary tumors (MMT) and metastatic diseases (involving nearly 2000 patients and 64 centers), for treatment individualization of MMT and of metastatic disease, for psycho-oncology/quality of life involving the patients' wishes, and for disease prevention.

[Traditional Chinese Pharmacotherapy in Patients with Chronic Rhinosinusitis - an Observational Trial Considering the Origin of Medicinal Drugs].

Background: The use of Chinese medicinal drugs is becoming more common in Germany. However, the import from China results in aggravated quality controls and potentially jeopardized therapeutic safety. Therefore, in 1999 the Bavarian Department for Agriculture has initiated an interdisciplinary research project to cultivate and analyze important Chinese herbal plants.

Cross matching observations on toxicological and clinical data for the assessment of tolerability and safety of Ginkgo biloba leaf extract.

Ginkgo biloba is one of the most widely used herbal remedies in Europe and the US. It may be purchased in different types of formulations, but most of the clinical studies have been performed with the controlled G. biloba extract EGb761(®).

Safety aspects of Chinese herbal medicine in pregnancy-re-evaluation of experimental data of two animal studies and the clinical experience.

Introduction: Chinese herbal medicine is an increasingly popular worldwide medical therapy which also has an impact in pregnancy. However, the question of its drug safety during pregnancy remains unresolved. Potential problems include teratogenicity, abortion, perinatal toxicity, pre- and postnatal developmental abnormalities, and eventually an increased risk for carcinomas in the offspring.

Which level of evidence does the US National Toxicology Program provide? Statistical considerations using the Technical Report 578 on Ginkgo biloba as an example.

The US National Toxicology Program (NTP) is assessed by a statistician. In the NTP-program groups of rodents are fed for a certain period of time with different doses of the substance that is being investigated. Then the animals are sacrificed and all organs are examined pathologically.

Double blockade of CD14 and complement C5 abolishes the cytokine storm and improves morbidity and survival in polymicrobial sepsis in mice.

Sepsis and septic shock, caused by an excessive systemic host-inflammatory response, are associated with high morbidity and mortality. The complement system and TLRs provide important pattern recognition receptors initiating the cytokine storm by extensive cross-talk. We hypothesized that double blockade of complement C5 and the TLR coreceptor CD14 could improve survival of experimental polymicrobial sepsis.

Is a controlled randomised trial the non-plus-ultra design? A contribution to discussion on comparative, controlled, non-randomised trials.

Background: Clinical studies provide formalised experience for evidence-based medicine (EBM). Many people consider a controlled randomised trial (CRT, identical to a randomised controlled trial RCT) to be the non-plus-ultra design. However, CRTs also have limitations.

[Evaluation of methods of traditional chinese medicine at the clinic at Steigerwald Part 2: therapy success and sustainability].

Introduction: in 2008, we described the documentation system of the ‘Klinik am Steigerwald’. Now, we report on the results gained with this system, especially on the therapeutic success and its sustainability.

Patients And Methods: we evaluated 1,972 in-patients treated between 1999 and 2007.

The efficacy and safety of Crataegus extract WS 1442 in patients with heart failure: the SPICE trial.

Background: Crataegus preparations have been used for centuries especially in Europe. To date, no proper data on their efficacy and safety as an add-on-treatment are available. Therefore a large morbidity/mortality trial was performed.

[Evaluating traditional Chinese medicine as applied in the Clinic at Steigerwald. Part 1: Methods of assessment].

Background: In the 'Klinik am Steigerwald' (Gerolzhofen, Germany), founded in 1996 and providing accommodation for 44 patients, European physicians apply methods of traditional Chinese medicine (TCM).

Objective: To develop an assessment system which is suitable for the evaluation of therapies, can be integrated into daily routine, takes into account the particular therapeutic approach of the hospital, and promotes quality management.

Patients And Methods: The hospital admits all kinds of patients with chronic and often therapy-resistant diseases.

Benfotiamine in diabetic polyneuropathy (BENDIP): results of a randomised, double blind, placebo-controlled clinical study.

Aim: Efficacy and safety of benfotiamine in treatment of diabetic polyneuropathy.

Methods: Double blind, placebo-controlled, phase-III-study. 181 patients were screened.

Riluzole in Huntington's disease: a 3-year, randomized controlled study.

Objective: We conducted a randomized double-blind trial of riluzole in Huntington's disease to investigate the efficacy of this antiexcitotoxic drug in slowing disease progression.

Methods: The study included 537 adult patients with a clinical diagnosis of Huntington's disease confirmed by genotyping. Patients were randomized (2:1) to treatment with riluzole (50mg twice daily) or placebo for 3 years.

[Evaluation of a modular out-patient education program for adult asthmatics with office-based specialists--results of a controlled, randomized multicenter trial].

The efficacy of a modular education program for adult asthmatics was evaluated in a controlled, randomized multicenter trial under outpatient conditions for six months. The education was performed with material (patient handout and PowerPoint slides) of the MASA Program (i.e.

Identification of adverse drug reactions by evaluation of a prescription database, demonstrated for "risk of bleeding".

Objective: Information about adverse drug reactions plays an important role when assessing the benefit/risk profile of a drug. Identifying rare adverse drug reactions, however, is a difficult task. This paper illustrates the advantages of using a prescription database for this purpose.

A randomized trial of Korodin Herz-Kreislauf-Tropfen as add-on treatment in older patients with orthostatic hypotension.

In a randomized, double-blind, placebo-controlled, parallel group, phase III clinical trial efficacy and safety of Korodin, a combination of natural D-camphor and an extract from fresh crataegus berries, was investigated in patients 50 years and older with orthostatic hypotension. At visit 1 eligibility of patients was checked and a placebo medication was given to all patients. At visit 2 orthostatic hypotension had to be reconfirmed, then the patient was randomized either to Korodin or placebo, study medication (25 drops) was applied once and then outcome was measured.

Meta-analysis of the efficacy of the acetonic kava-kava extract WS1490 in patients with non-psychotic anxiety disorders.

Introduction: The herbal medicinal product kava-kava, used for treating anxiety disorders, was assessed positively by the Cochrane Review. However, it was withdrawn from the market in Switzerland and Germany due to cases of liver failure and 'unproven' efficacy.

Methods: A protocol for the meta-analysis based on patient source data was written, a literature search was done, and six placebo-controlled, randomized trials with the kava extract WS1490 were identified.

Risk factors for alveolar echinococcosis in humans.

We conducted a case-control study to investigate risk factors for acquiring autochthonous alveolar echinococcosis in Germany. Forty cases and 120 controls matched by age and residence were interviewed. Patients were more likely than controls to have owned dogs that killed game (odds ratio [OR] = 18.

Pharmacokinetic herb-drug interactions: are preventive screenings necessary and appropriate?

Pharmacokinetic interactions often occur as a result of activity changes of drug-metabolizing and transporting proteins, especially cytochrome P450 (CYP) isoenzymes and P-glycoprotein (P-gp). The activity of these enzymes and drug transporters can be enhanced or inhibited by synthetic drugs as well as by natural products. Since the number of herb-drug interactions has increased in recent years, systematic in vitro screenings and more clinical studies to identify such interactions were proposed for herbal medicinal products.

Guidelines for reporting non-randomised studies.

Non-randomised studies (NRSs) are useful because they allow interventions to be evaluated that are difficult to investigate by randomised controlled trials (RCTs). However, NRSs are more susceptible to bias. The Consolidated Standards of Reporting Trials (CONSORT) statement was established to ensure that researchers report features of RCTs that must be considered when appraising their quality.

Randomised trials versus observational studies: is the comparative observational study a poor compromise or a perfect synthesis?

Overview of some fundamental designs for clinical trials and studies. Some tentative definitions are given in order to stimulate questions and perspectives for further research.

Colostrinin (a naturally occurring, proline-rich, polypeptide mixture) in the treatment of Alzheimer's disease.

This study was designed to confirm or negate findings from earlier trials demonstrating that Colostrinin, a novel compound derived from ewes' colostrum, has potential in the treatment of mild or moderate Alzheimer's Disease (AD). 105 patients were recruited from six psychiatric centres in Poland. The trial consisted of a 15 week double-blind phase comparing Colostrinin with placebo, followed by a second 15 week open labelled phase when all patients received Colostrinin.

Applying evidence to support ethical decisions: is the placebo really powerless?

Using placebos in day-to-day practice is an ethical problem. This paper summarises the available epidemiological evidence to support this difficult decision. Based on these data we propose to differentiate between placebo and "knowledge framing".