FOLFIRINOX or gemcitabine/nab-paclitaxel in advanced pancreatic adenocarcinoma: A novel validated prognostic score to facilitate treatment decision-making in real-world.

There is no prospective, randomised head-to-head trial comparing first-line FOLFIRINOX and gemcitabine/nab-paclitaxel in advanced pancreatic cancer. We assess real-world effectiveness and quality of life (QoL) of both regimens using a new prognostic score. This analysis includes 1540 patients with advanced pancreatic cancer from the prospective, clinical cohort study Tumour Registry Pancreatic Cancer separated into learning (n = 1027) and validation sample (n = 513). The Pancreatic Cancer Score (PCS) was developed using multivariate Cox regression. We compared overall survival (OS) and time to deterioration (TTD) for longitudinal QoL between first-line FOLFIRINOX (n = 407) and gemcitabine/nab-paclitaxel (n = 655) according to patients' prognostic risk, after inverse probability of treatment weighting (IPTW) by propensity score analysis. The PCS includes nine independent prognostic factors for survival: female sex, BMI ≥24/unknown, ECOG performance status ≥1, Charlson comorbidity index ≥1, tumour staging IV/unknown at primary diagnosis, liver metastases, bilirubin >1.5× upper limit of normal (ULN), leukocytes >ULN and neutrophil-to-lymphocyte ratio ≥4. Median OS of the validation sample was 11.4 (95% confidence interval [CI]: 10.4-14.4), 8.5 (95% CI: 6.8-9.6) and 5.9 months (95% CI: 4.0-7.4) for favourable- (0-3 risk factors), intermediate- (4-5 factors) and poor-risk group (6-9 factors), respectively. After IPTW, only poor-risk patients had significantly longer median OS and TTD of overall QoL with FOLFIRINOX (OS: 6.9 months, 95% CI: 3.9-13.3; TTD: 10.6 months, 95% CI: 2.0-14.1) vs gemcitabine/nab-paclitaxel (OS: 4.0 months, 95% CI: 2.8-4.8; TTD: 4.1 months, 95% CI: 2.4-4.5). Our novel PCS may facilitate treatment decisions in clinical routine of advanced pancreatic cancer, since only poor-risk, but not favourable-risk patients, seem to benefit from intensified treatment with FOLFIRINOX.

An Unusual Case of Iron-Deficiency Anemia: The Culprit Hides in the Aorta.

In a 72-year-old patient with anemia (Hb 7 g/dl), duodenoscopy exhibited an area of polypous irregular-looking mucosa. Histology revealed duodenal infiltration by epithelioid tumor cells, immunhistochemically positive for endothelial cell markers (CD34, CD31, ERG). Ultrasonography showed thrombotic material in the otherwise unremarkable abdominal aorta with some uptake of contrast bubbles on CEUS. Histological and clinical diagnosis assumed an epithelioid angiosarcoma of the thoraco-abdominal aorta at the level of the visceral and renal arteries with duodenal metastases.To prevent further shedding of tumor cells and aortic rupture, a branched stent-graft was placed into the thoraco-abdominal aorta. Palliative chemotherapy with gemcitabine and docetaxel was started, leading to a partial remission after 6 cycles. Three months later, however, there was a progress of the duodenal masses with new pulmonal and osseous metastases. Thirteen months after the initial diagnosis, death occured due to a hemorrhagic shock caused by a hematothorax.Aortic tumors are exceedingly rare, with only slightly more than 220 cases reported so far. In most cases, diagnosis is made either at autopsy or after an emergency operation for embolic complications like embolic intestinal ischemia. With an overall median survival of 8 months, prognosis is very poor.This case sensitizes for the correct sonographic interpretation of aortic "thrombi" in an otherwise normally appearing aorta, possibly with the aid of CEUS. Besides, it demonstrates the relatively early and uncommon diagnosis of an aortic angiosarcoma by the combination of endoscopy, immunohistochemistry, and ultrasonography.

The power of touch: external applications from whole medical systems in the care of cancer patients (literature review).

PURPOSE: In the context of whole medical systems (WMSs), external applications are manual treatments that stem from complementary medicine and are performed by practitioners, nurses and caregivers through the application of interpersonal touch. These applications work via physiological, psychological and social processes and are intended for holistic healing. In integrative oncology, these applications are used to improve patients' wellbeing. The purpose of the review is to collect and compare research results concerning external applications from WMSs applied to patients with cancer. METHODS: We conducted a literature review to explore the effects of external applications on patients undergoing cancer treatment. Inclusion criteria were external applications from Anthroposophic Medicine, Traditional Chinese Medicine (TCM) and Ayurvedic Medicine, examined detached from the effect interdependencies of their respective WMSs. RESULTS: Searches identified 111 publications. Final inclusions were four Shiatsu studies (from TCM), supplemented by two case reports exploring anthroposophic external applications. The literature review suggests that external applications may improve patients' wellbeing during cancer treatment and are associated with physical and psychological effects that potentially enhance supportive cancer care. The number and quality of published studies in the field is limited. CONCLUSIONS: Future empirical investigations should assess the effectiveness and underlying effects in patients with cancer, adhere to a patient-tailored approach, and investigate the systemic complexity of touch-based applications from WMSs.

Use of the Bovine Udder Skin model to evaluate the tolerability of Mesem cosmetic cream.

Observational studies of Mesem cream (based on Mesembryanthemum crystallinum L. plant extract) found that it had positive effects on skin hydration and smoothing of the skin. However, some patients reported skin irritation effects. The current study evaluated the skin tolerability of Mesem cream, as compared to the carrier cream (without the active ingredient), by using the isolated perfused bovine udder skin model. The primary outcomes investigated were cytotoxicity (i.e. cell viability), assessed with the MTT assay, and irritancy and inflammation, assessed by measuring PGE2 tissue levels. A total reaction score was calculated by combining the results for each parameter. In the case of a single topical application, significant differences were found between the carrier cream and the Mesem cream. While the application of carrier cream resulted in low cytotoxicity (-8.4% change in viability, as compared to the untreated control), the Mesem cream was more cytotoxic (-18.7% change). In addition, one hour after application, PGE2 levels were higher in Mesem cream-treated skin, as compared to carrier cream-treated skin (16.6% versus 11.3%). Further experiments (tape-stripped skin and repeated application) also found significant differences between the two creams in the results obtained. Evaluation of the effectiveness, safety and tolerability of phyto-cosmetic products is important. Our results confirmed the findings of two previous human observational studies (the human patch test and open application study). Future experiments to understand the underlying principles of its effectiveness, safety and tolerability should include extracts of M. crystallinum L. juice, as well as the Mesem cream itself.

[Mesembryanthemum crystallinum L. as dermatologically effective medicinal plant - first results from 3 pilot studies]. / Mesembryanthemum crystallinum L. als dermatologisch wirksame Heilpflanze - erste Ergebnisse aus 3 Pilotstudien.

BACKGROUND: Apart from well-known medical plants of rational phytotherapy there is a variety of plants, such as Mesembryanthemum crystallinum L., whose potential effects are not examined sufficiently to date. Therefore, in 3 pilot studies we investigated the dermatological effect of an extract of M. crystallinum (Mesem Cream). MATERIALS AND METHODS: In a retrospective user survey and a pre-post study with 6 persons in a wheelchair the efficacy profile of Mesem Cream was investigated. In a third placebo-controlled pilot study changes in skin hydration was measured using corneometer measurement in 6 healthy volunteers with dry skin. RESULTS: Compared to untreated skin, corneometer measurement revealed a significant increase of skin hydration with Mesem Cream (25.8 ± 5.8 pre to 46.6 ± 9.2 post treatment vs. 26.3 ± 6.0 pre to 33.8 ± 6.0 post treatment) as well as a statistical trend (p=0.11; t-Test) compared to basic cream (25.1 ± 4.7 pre to 41.9 ± 7.3 post treatment). Improvement in skin hydration was also found in 17 of 29 survey participants. Further, the volunteers in the wheelchair showed significant improvements in their subjectively rated skin softness and hydration level. CONCLUSION: These pilot studies investigated skin hydrating effects of the traditional medical plant M. crystallinum. Although the results were promising, they have to be interpreted with caution in particular due to low sample size. Further, study design should be more clear-cut and focus skin hydration as a main outcome parameter in more detail.

A pilot study on the effects of a team building process on the perception of work environment in an integrative hospital for neurological rehabilitation.

BACKGROUND: Neurological rehabilitation is one of the most care-intensive challenges in the health care system requiring specialist therapeutic and nursing knowledge. In this descriptive pilot study, we investigated the effects of a team building process on perceived work environment, self-ascribed professional competence, life satisfaction, and client satisfaction in an anthroposophic specialized hospital for neurological rehabilitation. The team-building process consisted of didactic instruction and training in problem-solving, teambuilding and constructive conflict resolution. METHODS: Seventy seven staff members and 44 patients' relatives were asked to complete a survey that included the Work Environment Scale (WES-10), a Life Satisfaction Scale (BMLSS), the Conviction of Therapeutic Competency (CTC) scale and the Client Satisfaction Questionnaire (CSQ-8). To evaluate the outcome of the team building process, we analyzed changes over time in the WES-10 subscales. Additionally the interrelationship between the WES-10 subscales with other subscales and with sociodemographic parameters like age, gender was calculated by means of a bivariate correlation analysis. RESULTS: The team building process had a significant positive effect on perceived work environment in only one area. There was a significant improvement in the ward staffs' perception of their ability to constructively resolve conflicts 3 years after inception of the team building process than there was before inception. However, even in a unit that utilized holistic treatment and nursing in the care of severely disable patients, such care necessitating a very heavy workload, the measurements on the Self Realization, Life Satisfaction and Conviction of Therapeutic Competency scales remained high and unchanged over the three year time period of the study. CONCLUSIONS: Strategic interventions might be an option to improve interpersonal relationships and finally quality of patient care.

[Evaluation of nursing processes in psychiatry--a field study project]. / Evaluation der pflegerischen Expertise in der Psychiatrie--ein Praxisforschungsprojekt an der Friedrich-Husemann-Klinik bei Freiburg im Breisgau.

Professional nursing care can be characterised as a support in handling of and coping with activities of daily living. While somatic care mainly focusses on the compensation of physical complaints, the needs in the field of psychiatry leading to nursing interventions are quite different. The descriptive and explorative study presented here aims at finding typical needs for psychiatric nursing care and characteristic intervention patterns of nurses. Within the setting of a qualitative field study in an anthroposophically oriented hospital for mental disorders heuristic methods (Grounded Theory) were applied to evaluate those nursing events which induced a unique and specific nursing benefit. The narrative data from 59 episodes generated this way yielded four typical patterns of interpretation of nursing needs: integration versus autonomy and routine nursing versus crisis intervention. Our results are limited by the fact that only data of one hospital were analysed. However, due to quality control of internal and external validity, and adjustment of the results towards current findings it can be concluded that the study results have a heuristic potential for describing and precising other settings within and outside psychiatric care.

Effects of rhythmic embrocation therapy with solum oil in chronic pain patients: a prospective observational study.

BACKGROUND: Chronic pain is one of the most frequent physical symptoms worldwide and requires intervention on many levels. Complementary therapies in particular are becoming increasingly relevant and popular in the treatment of chronic pain. The present study evaluates the therapeutic effects of rhythmic embrocation with a lavender/peat extract [Solum Oil (German: Solum Ol)]. MATERIALS AND METHODS: In a prospective observational study 100 patients with chronic pain were treated three times (T1-T3) within 24 days by rhythmic embrocation with Solum Oil. Main active constituents per 10 g of Solum Oil: aqueous peat extract (1:5) 1.96 g, and Lavandulae aetheroleum 0.5 g. The Mood Scale (Bf-S) and Pain Perception Scale (sensory PPS, affective PPS) were measured before the first and after each of the 3 treatments. To measure the therapeutic effects, effect sizes were calculated. RESULTS: Patients were mainly female (89%), mean duration of chronic pain (low back pain): 8.8 years; 1 drop-out due to urticaria. Bf-S was reduced from 25.8 [95% confidence interval (CI); 22.8-28.1] before T1 to 13.3 (95% CI; 11.7-15.0) after T3; sensory PPS from 18.8 (95% CI; 17.7-19.8) to 15.2 (95% CI; 14.1-16.4), affective PPS from 29.8 (95% CI; 27.9-31.7) to 21.3 (95% CI; 19.4-23.0) (all P<0.01). Effect sizes (d): Bf-S: d=0.81; affective PPs: d=0.85; sensory PPS: d=0.55. CONCLUSIONS: The high effect sizes indicate that repeated rhythmic embrocation with Solum Oil may improve mood, pain perception (sensory PPS), and the ability to cope with pain (affective PPS) in patients with chronic low back pain. To further assess the efficacy of this method, a randomized clinical trial is recommended.

[Investigation of the rhythmical embrocating according to Wegman/Hauschka]. / Erforschung der Rhythmischen Einreibungen nach Wegman/Hauschka--eine Struktur- phänomenologische Untersuchung.

INTRODUCTION: With the research on Rhythmical Embrocating according to Wegman/Hauschka (RE) since the 1990ies, nursing science has made an important contribution in obtaining acceptance for complementary methods. AIM, MATERIAL AND METHODS: Based on methods of phenomenology of the living body inspired by Goethean science, we aimed to investigate on the following question: What are the typical psychosomatic reactions of patients treated with RE? Theoretical sampling led to the inclusion of 13 nursing experts on RE. RESULTS: We found three typical pattern of patient-reaction on RE: being uncaged - re-identifing - empowering. These patterns do not only rely on changes of physical parameters, but also suggest changes of vegetative, mental and spiritual dimensions. CONCLUSION: A careful interpretation of our results leads to the conclusion, that the concepts derived here might be seen as archetypes of human reaction on specific kinds of therapeutic touch.