Introducing a standardized assessment of patients' interest in and usage of CAM in routine cancer care: chances and risks from patients' and physicians' point of view.

BACKGROUND: Cancer patients often use complementary and alternative medicine (CAM), however, standardized assessment in clinical routine is missing. The aim of this study was to evaluate a screening questionnaire on CAM usage that was published in the S3 Guideline Complementary Medicine in the Treatment of Oncological Patients. METHODS: We developed a survey questionnaire to assess the practicability of the guideline questionnaire and communication on CAM between health care providers (HCPs) and patients. We collected 258 guideline questionnaires and 116 survey questionnaires from ten clinics and held twelve semi-structured interviews with HCPs. RESULTS: 85% used at least one of the listed CAM methods, 54 participants (N = 77) never disclosed usage to a physician. The most frequently used CAM methods were physical activity (76.4%) and vitamin D (46.4%). 25.2% used at least one method, that was labeled risky by the guideline. 53.4% did not know of CAM's risk of interactions and side effects. Introducing the guideline questionnaire in routine cancer care increased the rate of patients talking to an HCP regarding CAM significantly from 35.5 to 87.3%. The HCPs stated positive effects as an initiation of conversation, increased safety within CAM usage and patients feeling thankful and taken seriously. However, due to the limited amount of time available for discussions on CAM, generalized distribution to all patients was not feasible. CONCLUSION: Institutions should focus on implementing standard procedures and resources that help HCPs discuss CAM on a regular basis. HCPs should meet the patient's demands for CAM counseling and make sure they are equipped professionally.

Sense of coherence and its context with demographics, psychological aspects, lifestyle, complementary and alternative medicine and lay aetiology.

PURPOSE: For patients with a cancer diagnosis, coping abilities are of high importance. Cancer patients with a high sense of coherence may cope better. The purpose of this study is to learn more about the correlation of sense of coherence and different aspects, such as demographics, psychological factors, lifestyle, complementary and alternative medicine (CAM) and lay aetiology. METHODS: A prospective cross-sectional study was performed in ten cancer centres in Germany. The questionnaire consisted of ten sub-items, collecting information about sense of coherence, demographics, general life satisfaction, resilience, spirituality, self-efficacy, physical activity and sports, nutrition, CAM methods and cancer causes. RESULTS: As many as 349 participants were evaluable. The mean sense of coherence score was M = 47.30. Significant associations were shown for sense of coherence and financial situation (r = 0.230, p < 0.001), level of education (r = 0.187, p < 0.001), marital status (η = 0.177, p = 0.026) and time interval since diagnosis (r = - 0.109, p = 0.045). Sense of coherence and resilience correlated on a high level, as well as spirituality, self-efficacy and general life satisfaction (r = 0.563, r = 0.432, r = 0.461, r = 0.306, p's < 0.001). CONCLUSION: Several aspects, such as demographics and psychological factors, have a great influence on the sense of coherence. To help patients to cope better, physicians should try to strengthen sense of coherence, resilience and self-efficacy and, at the same time, consider patients' individual background such as level of education, financial capacity and emotional support by family members.

Resilience in cancer patients and how it correlates with demographics, psychological factors, and lifestyle.

BACKGROUND: Being diagnosed with cancer is challenging. Many patients wish to be actively involved in treatment and contribute to therapy, but the patients' coping abilities and desire for involvement differ. The individual level of resilience seems to play a major role. Our study aims to learn more about the associations of resilience and factors as demographics and psychological factors. METHODS: This multicentric cross-sectional study was conducted in ten oncological centers in Germany in summer 2021. The questionnaire collected information on demographics, resilience, self-efficacy, general satisfaction with life, and sense of coherence. Considered lifestyle-aspects were diet and physical activity. 416 patients were included in the analyses. RESULTS: A moderate mean resilience score was achieved (M = 69). Significant correlations in demographics were found for resilience and education (r = 0.146, p = 0.003), income (r = 0.205, p = 0.001), and time since receiving diagnosis (r = - 0.115, p = 0.021). Resilience and self-efficacy correlated on a high level (r = 0.595, p < 0.001), resilience and sense of coherence, and resilience and general satisfaction with life in a moderate way (r = 0.339, p < 0.001; r = 0.461, p = 0.001). CONCLUSIONS: Resilience portrays an important aspect in cancer treatment. Detecting patients at risk, stabilizing, or improving resilience are important to focus on and strengthen them accordingly. Possible negatively influencing factors (e.g., low self-efficacy) need to be considered. Factors affecting resilience but difficult to influence, as educational background, should be screened for. Also, the combination of low resilience and low income seems to describe a vulnerable patient group.

Supportive therapy and complementary medicine in renal cell carcinoma.

PURPOSE: As part of the German interdisciplinary S3-guideline "Diagnosis, Treatment and Followup of Renal Cell Carcinoma", this article aimes to provide guidance regarding the use of supportive therapy and complementary medicine in patients with advanced or metastatic renal cell carcinoma. METHODS: The German interdisciplinary S3-guidelines are national clinical practice guidelines that implement the highest methodological quality of evidence-based medicine. Recommendations and evidence-based statements are provided according to available evidence. RESULTS: Supportive and palliative care are important areas of tumor treatment and require knowledge on the management of a variety of issues. This article outlines the management of tumor-related symptoms such as pain, undesired treatment-related effects, palliative care and end-of-life care in patients with renal cell carcinoma. CONCLUSION: Patients with advanced or metastatic renal cell carcinoma should have access to supportive and palliative care according to their individual needs. There is very limited evidence regarding the impact of complementary medicine for the treatment of patients with renal cell carcinoma.

Early major complications after bariatric surgery in the USA, 2003-2014: a systematic review and meta-analysis.

The effectiveness of bariatric surgery has been well-studied. However, complications after bariatric surgery have been understudied. This review assesses <30-d major complications associated with bariatric procedures, including anastomotic leak, myocardial infarction and pulmonary embolism. This review included 71 studies conducted in the USA between 2003 and 2014 and 107,874 patients undergoing either gastric bypass, adjustable gastric banding or sleeve gastrectomy, with mean age of 44 years and pre-surgery body mass index of 46.5 kg m-2 . Less than 30-d anastomotic leak rate was 1.15%; myocardial infarction rate was 0.37%; pulmonary embolism rate was 1.17%. Among all patients, mortality rate following anastomotic leak, myocardial infarction and pulmonary embolism was 0.12%, 0.37% and 0.18%, respectively. Among surgical procedures, <30-d after surgery, sleeve gastrectomy (1.21% [95% confidence interval, 0.23-2.19%]) had higher anastomotic leak rate than gastric bypass (1.14% [95% confidence interval, 0.84-1.43%]); gastric bypass had higher rates of myocardial infarction and pulmonary embolism than adjustable gastric banding or sleeve gastrectomy. During the review, we found that the quality of complication reporting is lower than the reporting of other outcomes. In summary, <30-d rates of the three major complications after either one of the procedures range from 0% to 1.55%. Mortality following these complications ranges from 0% to 0.64%. Future studies reporting complications after bariatric surgery should improve their reporting quality.

PPARß/δ directs the therapeutic potential of mesenchymal stem cells in arthritis.

OBJECTIVES: To define how peroxisome proliferator-activated receptor (PPAR) ß/δ expression level in mesenchymal stem cells (MSCs) could predict and direct both their immunosuppressive and therapeutic properties. PPARß/δ interacts with factors such as nuclear factor-kappa B (NF-κB) and regulates the expression of molecules including vascular cell adhesion molecule (VCAM)-1 and intercellular adhesion molecule (ICAM)-1. Since these molecules are critical for MSC function, we investigated the role of PPARß/δ on MSC immunosuppressive properties. METHODS: We either treated human MSCs (hMSCs) with the irreversible PPARß/δ antagonist (GSK3787) or derived MSCs from mice deficient for PPARß/δ (PPARß/δ-/- MSCs). We used the collagen-induced arthritis (CIA) as model of immune-mediated disorder and the MSC-immune cell coculture assays. RESULTS: Modulation of PPARß/δ expression in hMSCs either using GSK3787 or hMSCs from different origin reveals that MSC immunosuppressive potential is inversely correlated with Ppard expression. This was consistent with the higher capacity of PPARß/δ-/- MSCs to inhibit both the proliferation of T lymphocytes, in vitro, and arthritic development and progression in CIA compared with PPARß/δ+/+ MSCs. When primed with proinflammatory cytokines to exhibit an immunoregulatory phenotype, PPARß/δ-/- MSCs expressed a higher level of mediators of MSC immunosuppression including VCAM-1, ICAM-1 and nitric oxide (NO) than PPARß/δ+/+ MSCs. The enhanced NO2 production by PPARß/δ-/- MSCs was due to the increased retention of NF-κB p65 subunit on the κB elements of the inducible nitric oxide synthase promoter resulting from PPARß/δ silencing. CONCLUSIONS: Our study is the first to show that the inhibition or knockdown of PPARß/δ in MSCs primes their immunoregulatory functions. Thus, the regulation of PPARß/δ expression provides a new strategy to generate therapeutic MSCs with a stable regulatory phenotype.

Prostate cancer patients' report on communication about endocrine therapy and its association with adherence.

BACKGROUND: Endocrine therapy is a mainstay of prostate cancer therapy. Given that few data exist on patient physician communication with regard to this field of therapy and adherence, we conducted a survey of patient members of a German support organization. PATIENTS AND METHODS: We developed a structured questionnaire that was tested in a pilot version and then programmed as an online questionnaire. RESULTS: The questionnaire was completed by 694 patients. While 58 % of participants rated the information they received as comprehensive, 42 % did not. Fifty-one percentage stated that they were informed of side effects in detail, and 35 % received information on supportive treatments available in the event of side effects. Patients with higher education more often reported receiving information on side effects (p = 0.036) as well as alternatives for treatment (p = 0.001). Only 13 % stated that their questions were answered in detail, with 43 % receiving no answers or only non-detailed answers. Additional information was sought by 82 %, mostly from the Internet (67 %) and patient support groups (66 %). Seventy-six percentage experienced side effects that imposed limitations on their daily activities. Of those patients with side effects, 60 % reported that their physicians did not react to their complaints. There is a significant association between side effects in general and depression in particular and non-adherence (p < 0.01 and p = 0.002, respectively). In contrast, better information on side effects is associated with better adherence (p < 0001). CONCLUSION: In order to improve adherence, detailed information on side effects and comprehensive supportive care is most important. Physicians should not rely on written information but should rather mainly engage in direct communication.

Discontinuation and non-adherence to endocrine therapy in breast cancer patients: is lack of communication the decisive factor?

INTRODUCTION: Non-adherence to anti-hormonal therapy is a major problem in gynecologic oncology. Reasons reported are side effects and lack of support. The aim of our study was an analysis of influence of experiences of patients with endocrine therapy and communication and information on this topic and their influence on adherence. METHODS: We developed a structured questionnaire which was tested in a pilot version and then programmed as online questionnaire and presented to patient members of self-help and breast cancer organizations. RESULTS: Patients only had received scarce information on endocrine therapy. Only 12.8% stated that their questions were answered in detail, 43.2% got no answers or only non-detailed answers. 76% had side effects limiting functions of daily life. 60% of physicians did not react on these side effects. There is a significant correlation between number and intensity of side effects and non-adherence or disruption of therapy (p = 0.029 and p < 0.01, respectively). Women who reported having received detailed answers to their questions also reported better adherence (p = 0.014). CONCLUSION: In order to improve adherence, detailed information on side effects and answers in case of symptoms are most important. Physicians should not rely on presenting written information but should mainly engage in direct communication.

Counseling cancer patients on complementary and alternative medicine. Background, theory, and implementation of nationwide counseling facilities.

BACKGROUND AND PURPOSE: Complementary and alternative medicine (CAM) is of high relevance in oncology. Only a minority of professionals feel competent in CAM. Our aim was to provide a strategy for establishing evidence-based counseling on CAM in oncology in the German health system. METHODS: We performed a systematic search of the literature on patient counseling concerning CAM. Of 811 articles identified in this search 51 met our inclusion criteria. Data from these articles were analyzed and adapted to the needs of German patients by a group of experts of the DEGRO ("Deutschen Gesellschaft für Radioonkologie") and the German Cancer Society. In the next step a strategy about how to integrate evidence-based counseling on CAM at cancer centers and oncological institutions was developed. RESULTS: First, evidence-based recommendations on CAM counseling were derived. The core of our strategy combines two levels of information provision: level 1 will be oncologists, radiotherapists and other specialists and level 2 oncological CAM experts. The latter group will serve as trainers and backup for complicated or advanced questions and for individual counseling of patients with complex needs. Professionals in level 1 will be offered special training. CONCLUSION: Evidence-based counseling on CAM is not only possible but also mandatory in order to meet patient information needs. Our proposal would allow for integrated counseling available at all oncological institutions and guarantee a high quality. Furthermore, provision of information on two different levels allows the effective use of resources (manpower and financing).

Patients with advanced cancer and their usage of complementary and alternative medicine.

PURPOSE: A total of 40 % of cancer patients use complementary and alternative medicine (CAM), and patients with advanced cancer use CAM more often than others. The aim of our study was to gather data on CAM use and reasons to use CAM of patients with advanced cancer being admitted for residential palliative care and their relatives. METHODS: Structured interviews were carried out with 25 patients and 25 relatives of those patients, respectively, of a German comprehensive cancer center based on a standardized questionnaire of the working group Prevention and Integrative Oncology of the German Cancer Society. RESULTS: Median age of patients was 64.5 years (relatives: 53.5); 15 patients were male and 10 were female (relatives: 7 and 18). In total, 40 % of all patients used some CAM method at the time of the study, supplements and prayer being the most frequent method. Main reasons for using CAM were to sustain one's own strength (52 % for patients and 72 % for relatives) and to be able to do something by oneself (36 and 40 %). Sources of information were television/radio (48 and 28 %) and family/friends (40 and 48 %). Relatives also use the Internet (40 %). CONCLUSIONS: Also for patients in palliative care and their relatives, CAM is important. Reasons for using CAM are similar for patients with less advanced cancer. As most patients do not discuss using CAM with their physician, side effects and interactions of biologically based treatments may be dangerous. The desire of patients to act autonomously should be encouraged. Yet, physicians should ensure safe administration of complementary methods by including CAM in their communication with the patient and the family.

Potential interactions of complementary and alternative medicine with cancer therapy in outpatients with gynecological cancer in a comprehensive cancer center.

PURPOSE: About 40-50 % of cancer patients use complementary and alternative medicine (CAM). Women, and especially those with gynecological cancers, are more active in this field than men. The goal of our study was to estimate the likelihood of CAM use and the likelihood of interactions of CAM with cancer therapy in the setting of a gynecological outpatient clinic at a German Comprehensive Cancer Center (CCC). METHODS: One hundred consecutive gynecological outdoor patients of the CCC in Frankfurt am Main in Germany were interviewed with a standardized questionnaire on CAM use. An investigation on potential interactions was done by matching a scientific database systematically. RESULTS: Sixty-nine of the interviewed 100 women received chemotherapy, 23 endocrine therapy and 41 monoclonal antibodies. In total, 64 % used CAM, 48 % used at least one substance-bound CAM. In 17 out of those 48 cases (35 %), interactions were unlikely, whereas they were probable in 14 patients (29 %). Thus, a third of all patients in this study were in danger of interactions. More than half of all CAM users and three quarters of users of substance-bound CAM are at risk of interactions. This number is independent of whether the patient is taking chemotherapy, endocrine therapy or antibodies. CONCLUSIONS: The frequency of CAM use we found is in line with international data from CCCs in the USA. To our knowledge, this is the first study publishing data on the frequency of potential interactions. Thus, an initiative to protect women from the dangers of uncontrolled CAM use is urgently needed. In the discussion, we propose a concept of how to achieve this aim.

FOLFIRI plus cetuximab versus FOLFIRI plus bevacizumab as first-line treatment for patients with metastatic colorectal cancer-subgroup analysis of patients with KRAS: mutated tumours in the randomised German AIO study KRK-0306.

BACKGROUND: The AIO KRK-0306 trial compares the efficacy of infusional 5-fluorouracil, folinic acid, irinotecan (FOLFIRI) plus cetuximab with FOLFIRI plus bevacizumab in first-line treatment of metastatic colorectal cancer (mCRC). In October 2008, an amendment terminated the inclusion of patients with KRAS-mutated tumours. This subgroup of patients is evaluated in the present analysis, while the study is ongoing for patients with KRAS wild-type tumours. METHODS: Patients were randomly assigned to FOLFIRI (Tournigand regimen) every 2 weeks plus cetuximab (400 mg/m2 day 1, followed by 250 mg/m2 weekly=arm A) or bevacizumab (5 mg/kg every 2 weeks=arm B). Among 336 randomised patients, KRAS mutation was demonstrated in 100 assessable patients. The primary study end point was objective response rate (ORR). RESULTS: ORR was 44% [95% confidence interval (CI) 29% to 59%] in arm A versus 48% (95% CI, 33% to 62%) in arm B. Progression-free survival was 7.5 versus 8.9 months (hazard ratio: 1.0) and overall survival was 22.7 versus 18.7 months (hazard ratio: 0.86) in arms A versus B, respectively. CONCLUSIONS: This is the first head to head comparison of cetuximab versus bevacizumab in first-line treatment of mCRC. In the present evaluation of patients with KRAS-mutated tumours, neither strategy demonstrated a clearly superior outcome.

[Complementary therapy in palliative medicine]. / Komplementärtherapie in der Palliativmedizin.

Even in the palliative context complementary therapy has a high value for patients and their relatives. In contrast to the methods of conventional medicine naturopathy as a holistic system has positive meanings for patients and their family. Complementary medicine in the palliative setting can be used as a supportive therapy in carefully selected cases. Doctors and patients should be careful regarding effect and side effects and should make sure that supportive therapy is given adequately and in effective doses. Complementary therapy should not be used in order to avoid the question of life and death. An adequate approach to the topic is mandatory, which acknowledges the needs of patients but also looks for their safety. Patients following alternative therapies sometimes neglect helpful therapeutic options. Carefully providing information on these therapies is mandatory. Physicians should avoid losing patients' confidence in their competence and attention in their final course of disease. Also in palliative medicine a sensitive approach to the topic of complementary medicine is mandatory, which accounts for the eligible wishes of patients and their relatives but puts the patients safety first.

Associated malformations in cases with neural tube defects.

Infants with neural tube defects (NTDs) may have other associated congenital defects. The reported incidence and the types of associated malformations vary between different studies. The purpose of this investigation was to assess the prevalence of associated malformations in a geographically defined population. The prevalences at birth of associated malformations in infants with NTDs were collected between 1979 and 2003 on all infants born in the area covered by the registry of congenital anomalies of Northeastern France in 334,262 consecutive births. Of the 360 infants with NTDs born during this period, 20.5 % had associated malformations. Associated malformations were more frequent in infants who had encephalocele (37.5 %) than in infants with anencephaly (11.8 %) or infants with spina bifida (23.7 %). Malformations in the face (oral clefts), in the musculoskeletal system, in the renal system, and in the cardiovascular system were the most common other anomalies. In conclusion the overall prevalence of malformations, which was one in five infants, emphasizes the need for a thorough investigation of infants with NTDs. A routine screening for other malformations especially facial clefts, musculoskeletal, renal and cardiac anomalies may need to be considered in infants with NTDs, and genetic counseling seems warranted in most of these complicated cases.

Immunotherapy of patients with hormone-refractory prostate carcinoma pre-treated with interferon-gamma and vaccinated with autologous PSA-peptide loaded dendritic cells--a pilot study.

PURPOSE: We conducted a pilot trial to assess the feasibility and tolerability of a prime/boost vaccine strategy using interferon-gamma (IFN-gamma) and autologous dendritic cells (DCs) pulsed with HLA-A2-specific prostate-specific antigen (PSA) peptides (PSA-1 [141-150]; PSA-2 [146-156]; PSA-3 [154-163]) for the treatment of 12 patients with hormone refractory prostate carcinoma. PATIENTS AND METHODS: All patients were vaccinated four times with intracutaneously injected PSA-peptide loaded DCs after subcutaneous administration of IFN-gamma 2 hr before DC administration (50 microg/m(2) body surface). Objectives were safety, clinical benefit, clinical and biochemical response, quality of life, and immunological parameters. RESULTS: The vaccination was well tolerated without any vaccination-associated adverse events. One partial and one mixed responder were identified, four patients showed stable diseases. Two patients had a decrease and four a slow-down velocity slope in the PSA serum level. All responders showed a positive DTH-response, but only two a slight increase in PSA-peptide specific T-lymphocytes. CONCLUSION: The immunotherapy with IFN-gamma and PSA-peptide loaded DCs was feasible and well tolerated. The observed responses imply a potential antitumor activity.

Are the recommendations on the prevention of neural tube defects working?

Many studies showed that reduction by an estimated 80% or more of neural tube defects (NTD) by consumption of folic acid from before conception is achievable. The objectives of this study were to evaluate the effectiveness of recommendations on folic acid aimed at reducing the occurrence of NTD in our region. Cases of NTD were ascertained among liveborn infants, stillbirths, and terminations of pregnancy. Incidences and trends in rates of NTD before and after 1992 (the year of the first recommendations) and before and after 1995 (the year of local recommendations) were obtained. The results showed that the issuing of recommendations on folic acid was followed by no detectable improvement in the trends of incidence of NTD. The rates of NTD per 10,000 were before 1992 9.07, from 1993 to 1995 8.14, and after 1995 10.62, respectively. The incidence rate ratios (IRRs) were not different from 1.00. In conclusion new cases preventable by folic acid continue to accumulate. Recommendations alone did not influence trends in NTD in our country up to 11 years after the confirmation of the effectiveness of folic acid in clinical trials. New strategies are needed.

Prenatal detection of congenital renal malformations by fetal ultrasonographic examination: an analysis of 709,030 births in 12 European countries.

The study was performed to evaluate the prevalence of prenatal ultrasound diagnoses for renal anomalies in 20 registries of 12 European countries, and to compare the different prenatal scanning policies. Standardized data were acquired from 709,030 livebirths, stillbirths, and induced abortions during the study period of 2.5 years and transmitted for central analysis. At least one renal malformation was diagnosed in 1130 infants and fetuses. Prenatal diagnosis (PD) was given in 81.8% of all cases, 29% of these pregnancies were terminated. The highest detection rate was reported for unilateral multicystic dysplastic kidneys with 97% (102/105). An early diagnosis was documented for exstrophy of bladder at a mean gestational age of 18.5 weeks. Dilatations of the upper urinary tract were seen late in pregnancy at 28.3 weeks. Terminations of pregnancies (TOP) were performed in 67% (58/86) of the detected bilateral renal agenesis/dysgenesis, but only 4% of the unilateral multicystic dysplastic renal malformations (4/102). In about 1/3 of the cases, renal malformations are within the category of associated malformations, which include multiple non-syndromal malformations, chromosomal aberrations, and non-chromosomal syndromes. Renal malformations were detected in 2/3 of the associated category by the first prenatal ultrasound scan. Detection rates vary in the different countries of the European community due to diverse policies, ethical, and religious background. Countries with no routine ultrasound show the lowest rates in detection, and termination of pregnancy. Prenatally detected renal malformations should result in a careful examination for further anomalies. Prenatal ultrasound fulfills the needs of screening examinations and is a good tool in detecting lethal and severe renal malformations.