Interpreting Breast International Group (BIG) 1-98: a randomized, double-blind, phase III trial comparing letrozole and tamoxifen as adjuvant endocrine therapy for postmenopausal women with hormone receptor-positive, early breast cancer

The Breast International Group (BIG) 1-98 study is a four-arm trial comparing 5 years of monotherapy with tamoxifen or with letrozole or with sequences of 2 years of one followed by 3 years of the other for postmenopausal women with endocrine-responsive early invasive breast cancer. From 1998 to 2003, BIG -98 enrolled 8,010 women. The enhanced design f the trial enabled two complementary analyses of efficacy and safety. Collection of tumor specimens further enabled treatment comparisons based on tumor biology. Reports of BIG 1-98 should be interpreted in relation to each individual patient as she weighs the costs and benefits of available treatments.

Changes in hemodynamics and tissue oxygenation saturation in the brain and skeletal muscle induced by speech therapy - a near-infrared spectroscopy study

Arts speech therapy (AST) is a therapeutic method within complementary medicine and has been practiced for decades for various medical conditions. It comprises listening and the recitation of different forms of speech exercises under the guidance of a licensed speech therapist. The aim of our study was to noninvasively investigate whether different types of recitation influence hemodynamics and oxygenation in the brain and skeletal leg muscle using near-infrared spectroscopy (NIRS). Seventeen healthy volunteers (eight men and nine women, mean age ± standard deviation 35.6 ± 12.7 years) were enrolled in the study. Each subject was measured three times on different days with the different types of recitation: hexameter, alliteration, and prose verse. Before, during, and after recitation, relative concentration changes of oxyhemoglobin (Δ[O2Hb]), deoxyhemoglobin (Δ[HHb]), total hemoglobin (Δ[tHb]), and tissue oxygenation saturation (StO2) were measured in the brain and skeletal leg muscle using a NIRS device. The study was performed with a randomized crossover design. Significant concentration changes were found during recitation of all verses, with mainly a decrease in Δ[O2Hb] and ΔStO2 in the brain, and an increase in Δ[O2Hb] and Δ[tHb] in the leg muscle during recitation. After the recitations, significant changes were mainly increases of Δ[HHb] and Δ[tHb] in the calf muscle. The Mayer wave spectral power (MWP) was also significantly affected, i.e., mainly the MWP of the Δ[O2Hb] and Δ[tHb] increased in the brain during recitation of hexameter and prose verse. The changes in MWP were also significantly different between hexameter and alliteration, and hexameter and prose. Possible physiological explanations for these changes are discussed. A probable reason is a different effect of recitations on the sympathetic nervous system. In conclusion, these changes show that AST has relevant effects on the hemodynamics and oxygenation of the brain and muscle.

Complementary and conventional medicine in Switzerland: comparing characteristics of general practitioners

OBJECTIVES: Do structural characteristics of general practitioners (GPs) who practice complementary medicine (CAM) differ from those GPs who do not? Assessed characteristics included experience and professional integration of general practitioners (GPs), workload, medical activities, and personal and technical resources of practices. The investigated CAM disciplines were anthroposophic medicine, homoeopathy, traditional Chinese medicine, neural therapy and herbal medicine. MATERIAL AND METHODS: We designed a cross-sectional study with convenience and stratified samples of GPs providing conventional (COM) and/or complementary primary care in Switzerland. The samples were taken from the database of the Swiss medical association (FMH) and from CAM societies. Data were collected using a postal questionnaire. RESULTS: Of the 650 practitioners who were included in the study, 191 were COM, 167 noncertified CAM and 292 certified CAM physicians. The proportion of females was higher in the population of CAM physicians. Gender-adjusted age did not differ between CAM and COM physicians. Nearly twice as many CAM physicians work part-time. Differences were also seen for the majority of structural characteristics such as qualification of physicians, type of practice, type of staff, and presence of technical equipment. CONCLUSION: The study results show that structural characteristics of primary health care do differ between CAM and COM practitioners. We assumed that the activities of GPs are defined essentially by analyzed structures. The results are to be considered for evaluations in primary health care, particularly when quality of health care is assessed.

Physicians' philosophy of care: a comparison of complementary and conventional medicine

BACKGROUND: This project is part of an evaluation of complementary and alternative medicine (CAM) aimed at providing a scientific basis for the Swiss Government to include 5 CAM methods in basic health coverage: anthroposophic medicine, homeopathy, neural therapy, phytotherapy and Traditional Chinese Medicine (TCM). OBJECTIVES: The objective was to explore the philosophy of care (convictions and values, priorities in medical activity, motivation for CAM, criteria for the practice of CAM, limits of the used methods) of conventional and CAM general practitioners (GPs) and to determine differences between both groups. MATERIALS AND METHODS: This study was a cross-sectional survey of a representative sample of 623 GPs who provide complementary or conventional primary care. A mailed questionnaire with open-ended questions focusing on the philosophy of care was used for data collection. An appropriate methodology using a combination of quantitative and qualitative approaches was developed. RESULTS: Significant differences between both groups include philosophy of care (holistic versus positivistic approaches), motivation for CAM (intrinsic versus extrinsic) and priorities in medical activity. Both groups seem to be aware of limitations of the therapeutic methods used. The study reveals that conventional physicians are also using complementary medicine. DISCUSSION: Our study provides a wealth of data documenting several aspects of physicians' philosophy of care as well as differences and similarities between conventional and complementary care. Implications of the study with regard to quality of care as well as ethical and health policy issues should be investigated further.

Health status and health care utilisation of patients in complementary and conventional primary care in Switzerland--an observational study

BACKGROUND: The study is part of a nationwide evaluation of complementary and alternative medicine (CAM) in primary care in Switzerland. OBJECTIVES: Patient health status with respect to demographic attributes such as gender, age, and health care utilisation pattern was studied and compared with conventional primary care. METHODS: The study was performed as a cross-sectional survey including 11932 adult patients seeking complementary or conventional primary care. Patients were asked to document their self-perceived health status by completing a questionnaire in the waiting room. Physicians were performing conventional medicine and/or various forms of complementary primary care such as homeopathy, anthroposophic medicine, neural therapy, herbal medicine, or traditional Chinese medicine. Additional information on patient demographics and yearly consultation rates for participating physicians was obtained from the data pool of all Swiss health insurers. These data were used to confirm the survey results. RESULTS: We observed considerable and significant differences in demographic attributes of patients seeking complementary and conventional care. Patients seeking complementary care documented longer lasting and more severe main health problems than patients in conventional care. The number of previous physician visits differed between patient groups, which indicates higher consumption of medical resources by CAM patients. CONCLUSIONS: The study supports the hypothesis of differences in socio-demographic and behavioural attributes of patients seeking conventional medicine or CAM in primary care. The study provides empirical evidence that CAM users are requiring more physician-based medical services in primary care than users of conventional medicine.

Patients motives for choosing a physician: Comparison between conventional and complementary medicine in Swiss primary care

Background The study is part of a nationwide evaluation of complementary and alternative medicine (CAM) in primary care in Switzerland. The Objective was to identify patients' expectations and reasons governing the choice of complementary medicine compared with conventional primary care (CONV). Methods The data were derived from the PEK study (Programm Evaluation Komplementärmedizin), which was conducted in 2002–2003 with 7879 adult patients and parents of 1291 underage patients, seeking either complementary (CAM) or conventional (CONV) primary care. The study was performed as a cross-sectional survey. The respondents were asked to document their (or their children's) self-perceived health status, reasons governing their choice, and treatment expectations. Physicians were practicing conventional medicine and/or complementary methods (homeopathy, anthroposophic medicine, neural therapy, and traditional Chinese medicine). Reasons governing the choice of physician were evaluated on the basis of a three-part classification (physician-related, procedure-related, and pragmatic/other reasons) Results and Discussion Patients seeing CAM physicians tend to be younger and more often female. CAM patients referred to procedure-related reasons more frequently, whereas pragmatic reasons dominated among CONV patients. CAM respondents expected fewer adverse side effects compared to conventional care patients. Conclusion The majority of alternative medicine users appear to have chosen CAM mainly because they wish to undergo a certain procedure; additional reasons include desire for more comprehensive treatment, and expectation of fewer side-effects.

Patient satisfaction of primary care for musculoskeletal diseases: A comparison between Neural Therapy and conventional medicine

Background The main objective of this study was to assess and compare patient satisfaction with Neural Therapy (NT) and conventional medicine (COM) in primary care for musculoskeletal diseases. Methods A cross-sectional study in primary care for musculoskeletal disorders covering 77 conventional primary care providers and 18 physicians certified in NT with 241 and 164 patients respectively. Patients and physicians documented consultations and patients completed questionnaires at a one-month follow-up. Physicians documented duration and severity of symptoms, diagnosis, and procedures. The main outcomes in the evaluation of patients were: fulfillment of expectations, perceived treatment effects, and patient satisfaction. Results The most frequent diagnoses belonged to the group of dorsopathies (39% in COM, 46% in NT). We found significant differences between NT and COM with regard to patient evaluations. NT patients documented better fulfilment of treatment expectations and higher overall treatment satisfaction. More patients in NT reported positive side effects and less frequent negative effects than patients in COM. Also, significant differences between NT and COM patients were seen in the quality of the patient-physician interaction (relation and communication, medical care, information and support, continuity and cooperation, facilities availability, and accessibility), where NT patients showed higher satisfaction. Differences were also found with regard to the physicians' management of disease, with fewer work incapacity attestations issued and longer consultation times in NT. Conclusion Our findings show a significantly higher treatment and care-related patient satisfaction with primary care for musculoskeletal diseases provided by physicians practising Neural Therapy.

Efficacy of the combination of amlodipine and valsartan in patients with hypertension uncontrolled with previous monotherapy: the Exforge in Failure after Single Therapy (EX-FAST) study

In this randomized, double-blind, multicenter study, patients whose blood pressure (BP) was uncontrolled by monotherapy were switched directly to amlodipine/valsartan 5/160 mg (n=443) or 10/160 mg (n=451). After 16 weeks, BP control (levels <140/90 mm Hg or <130/80 mm Hg for diabetics) was achieved in 72.7% (95% confidence interval [CI], 68.6-76.9) of patients receiving amlodipine/valsartan 5/160 mg and in 74.8% (95% CI, 70.8-78.9) receiving amlodipine/valsartan 10/160 mg. Incremental reductions from baseline in mean sitting systolic and diastolic BP were significantly greater with the higher dose (20.0+/-0.7 vs 17.5+/-0.7 mm Hg; P=.0003 and 11.6+/-0.4 vs 10.4+/-0.4 mm Hg; P=.0046). Incremental BP reductions were also achieved with both regimens irrespective of previous monotherapy, hypertension severity, diabetic status, body mass index, and age. Peripheral edema was the most frequent adverse event. These results provide support for the BP-lowering benefits of complementary antihypertensive therapy with amlodipine and valsartan in patients with hypertension uncontrolled by previous monotherapy.

[Role of complementary medicine in type 1 diabetes mellitus in two Swiss centres]

Insulin replacement is the only effective treatment of type 1 Diabetes mellitus (T1DM). Nevertheless, many complementary treatments are in use for T1DM. In this study we assessed by questionnaire that out of 342 patients with T1DM, 48 (14%; 13.4% adult, 18.5% paediatric; 20 male, 28 female) used complementary medicine (CM) in addition to their insulin therapy. The purpose of the use of CM was to improve general well-being, ameliorate glucose homeostasis, reduce blood glucose levels as well as insulin doses, improve physical fitness, reduce the frequency of hypoglycaemia, and control appetite. The modalities most frequently used are cinnamon, homeopathy, magnesium and special beverages (mainly teas). Thus, good collaboration between health care professionals will allow optimal patient care.

The influence of inner and heard speech in arts speech therapy on brain oxygenation and hemodynamics

Purpose: Artistic speech therapy is applied in anthroposophically extended medicine to treat several diseases. The aim is to understand the physiology by investigating the effect of inner and heard speech on brain hemodynamics and oxygenation and analyzing whether these changes were affected by changes in arterial carbon dioxide pressure. Methods: In 29 healthy adult volunteers changes in cerebral absolute oxyhemoglobin ([O2Hb]), deoxyhemoglobin ([HHb]), total hemoglobin ([tHb]) concentrations and tissue oxygen saturation (StO2) were measured by functional near-infrared spectroscopy (fNIRS). End-tidal CO2 (PETCO2) was assessed by capnography. Each subject performed six tasks: inner speech, heard speech from a person and heard speech from a record with each two different recitation texts: hexameter and alliteration according to a randomized crossover design. Results: Significant changes during tasks: A decrease in StO2, [O2Hb], [tHb] and PETCO2 (only for inner speech); an increase in [HHb]. There was a significant difference between hexameter and alliteration. Particularly, changes in [tHb] at the left prefrontal cortex during tasks and after them were statistically different. Furthermore we found significant relations between changes in [O2Hb], [HHb], [tHb] or StO2 and the participants’ age, the baseline PETCO2, or certain speech tasks. Conclusion: During the inner speech, hyperventilation led to a lower PETCO2 (hypocapnia). During heard speech no significant changes in PETCO2 occurred. But decreases in StO2, [O2Hb], [tHb] suggest hypocapnia also here. Hexameter and alliteration led to different changes in [tHb]. Consequently, our parameters are affected by an interplay of both PETCO2 response and task dependent functional brain activity.

Complementary Medicine in Nursing Homes - Results of a Mixed Methods Pilot Study

Background ‘Kneipp Therapy’ (KT) is a form of Complementary and Alternative Medicine (CAM) that includes a combination of hydrotherapy, herbal medicine, mind-body medicine, physical activities, and healthy eating. Since 2007, some nursing homes for older adults in Germany began to integrate CAM in the form of KT in care. The study investigated how KT is used in daily routine care and explored the health status of residents and caregivers involved in KT. Methods We performed a cross-sectional pilot study with a mixed methods approach that collected both quantitative and qualitative data in four German nursing homes in 2011. Assessments in the quantitative component included the Quality of Life in Dementia (QUALIDEM), the Short Form 12 Health Survey (SF-12), the Barthel-Index for residents and the Work Ability Index (WAI) and SF-12 for caregivers. The qualitative component addressed the residents’ and caregivers’ subjectively experienced changes after integration of KT. It was conceptualized as an ethnographic rapid appraisal by conducting participant observation and semi-structured interviews in two of the four nursing homes. Results The quantitative component included 64 residents (53 female, 83.2 ± 8.1 years (mean and SD)) and 29 caregivers (all female, 42.0 ± 11.7 years). Residents were multimorbid (8 ± 3 diagnoses), and activities of daily living were restricted (Barthel-Index 60.6 ± 24.4). The caregivers’ results indicated good work ability (WAI 37.4 ± 5.1), health related quality of life was superior to the German sample (SF-12 physical CSS 49.2 ± 8.0; mental CSS 54.1 ± 6.6). Among both caregivers and residents, 89% considered KT to be positive for well-being. The qualitative analysis showed that caregivers perceived emotional and functional benefits from more content and calmer residents, a larger variety in basic care practices, and a more self-determined scope of action. Residents reported gains in attention and caring, and recognition of their lay knowledge. Conclusion Residents showed typical characteristics of nursing home inhabitants. Caregivers demonstrated good work ability. Both reported to have benefits from KT. The results provide a good basis for future projects, e.g. controlled studies to evaluate the effects of CAM in nursing homes.

Long-term results of therapeutic local anesthesia (neural therapy) in 280 referred refractory chronic pain patients

BACKGROUND: Can the application of local anesthetics (Neural Therapy, NT) alone durably improve pain symptoms in referred patients with chronic and refractory pain? If the application of local anesthetics does lead to an improvement that far exceeds the duration of action of local anesthetics, we will postulate that a vicious circle of pain in the reflex arcs has been disrupted (hypothesis). METHODS: Case series design. We exclusively used procaine or lidocaine. The inclusion criteria were severe pain and chronic duration of more than three months, pain unresponsive to conventional medical measures, written referral from physicians or doctors of chiropractic explicitly to NT. Patients with improvement of pain who started on additional therapy during the study period for a reason other than pain were excluded in order to avoid a potential bias. Treatment success was measured after one year follow-up using the outcome measures of pain and analgesics intake. RESULTS: 280 chronic pain patients were included; the most common reason for referral was back pain. The average number of consultations per patient was 9.2 in the first year (median 8.0). After one year, in 60 patients pain was unchanged, 52 patients reported a slight improvement, 126 were considerably better, and 41 pain-free. At the same time, 74.1 % of the patients who took analgesics before starting NT needed less or no more analgesics at all. No adverse effects or complications were observed. CONCLUSIONS: The good long-term results of the targeted therapeutic local anesthesia (NT) in the most problematic group of chronic pain patients (unresponsive to all evidence based conventional treatment options) indicate that a vicious circle has been broken. The specific contribution of the intervention to these results cannot be determined. The low costs of local anesthetics, the small number of consultations needed, the reduced intake of analgesics, and the lack of adverse effects also suggest the practicality and cost-effectiveness of this kind of treatment. Controlled trials to evaluate the true effect of NT are needed.

Usage of Complementary Medicine in Switzerland: Results of the Swiss Health Survey 2012 and Development Since 2007

Background Complementary medicine (CM) is popular in Switzerland. Several CM methods (traditional Chinese medicine/acupuncture, homeopathy, anthroposophic medicine, neural therapy, and herbal medicine) are currently covered by the mandatory basic health insurance when performed by a certified physician. Treatments by non-medical therapists are partially covered by a supplemental and optional health insurance. In this study, we investigated the frequency of CM use including the evolvement over time, the most popular methods, and the user profile. Methods Data of the Swiss Health Surveys 2007 and 2012 were used. In 2007 and 2012, a population of 14,432 and 18,357, respectively, aged 15 years or older answered the written questionnaire. A set of questions queried about the frequency of use of various CM methods within the last 12 months before the survey. Proportions of usage and 95% confidence intervals were calculated for these methods and CM in general. Users and non-users of CM were compared using logistic regression models. Results The most popular methods in 2012 were homeopathy, naturopathy, osteopathy, herbal medicine, and acupuncture. The average number of treatments within the 12 months preceding the survey ranged from 3 for homeopathy to 6 for acupuncture. 25.0% of the population at the age of 15 and older had used at least one CM method in the previous 12 months. People with a chronic illness or a poor self-perceived health status were more likely to use CM. Similar to other countries, women, people of middle age, and those with higher education were more likely to use CM. 59.9% of the adult population had a supplemental health insurance that partly covered CM treatments. Conclusions Usage of CM in Switzerland remained unchanged between 2007 and 2012. The user profile in Switzerland was similar to other countries, such as Germany, United Kingdom, United States or Australia.