3,3-Diindolylmethane (DIM): a nutritional intervention and its impact on breast density in healthy BRCA carriers. A prospective clinical trial.

Women who carry the BRCA mutation are at high lifetime risk of breast cancer, but there is no consensus regarding an effective and safe chemoprevention strategy. A large body of evidence suggests that 3,3-diindolylmethane (DIM), a dimer of indole-3-carbinol found in cruciferous vegetables, can potentially prevent carcinogenesis and tumor development. The primary aim of this prospective single-arm study was to investigate the effect of DIM supplementation on breast density, a recognized predictive factor of breast cancer risk. Participants were 23 healthy female BRCA carriers (median age 47 years; 78% postmenopausal) who were treated with oral DIM 100 mg × 1/day for 1 year. The amount of fibroglandular tissue (FGT) and background parenchymal enhancement (BPE) on magnetic resonance imaging (MRI) performed before and after the intervention was scored by two independent expert radiologists using the Breast Imaging and Reporting Data System. The results showed a decrease in the average score for FGT amount from 2.8 ± 0.8 at the onset to 2.65 ± 0.84 after 1 year (P = 0.031), with no significant change in BPE (P = 0.429). A group of DIM-untreated age- and menopausal-status-matched women from the BRCA clinic did not show a significant change in FGT amount (P = 0.33) or BPE (P = 0.814) in a parallel year. Mean estradiol level decreased from 159 to 102 pmol/l (P = 0.01), and mean testosterone level decreased from 0.42 to 0.31 pmol/l (P = 0.007). Side effects were grade 1. In conclusion, 1 year's supplementation with DIM 100 mg × 1/day in BRCA carriers was associated with a significant decline in FGT amount on MRI. Larger randomized studies are warranted to corroborate these findings.

The role of emotional processing in art therapy (REPAT) for breast cancer patients.

Emotional awareness and acceptance of emotion are associated with improved health in breast cancer (BC) patients. Art therapy (AT) uses visual art-making for expression and communication and has been shown to reduce psychological and physical symptoms in individuals with cancer. A major objective of AT is to encourage increases in emotion processing; however, few studies examine these changes. Purpose: To examine the effect of an eight-week AT group on emotion processing as a mechanism of symptom reduction in women with BC. Design: Randomized clinical trial. Sample: Twenty women diagnosed with breast cancer whom had completed primary treatment. Methods: Participants were randomized to participate in eight-weeks of AT or sham AT, which was a mandala coloring group. Participants answered questionnaires before and after the intervention. We used a Cohen's D calculator for effect sizes and a t-test to examine group differences. Findings: Statistically significant between-group differences in emotional awareness and acceptance of emotion were found after the intervention. We found large effect sizes between groups and over time in acceptance of emotion, emotional awareness and depressive symptoms. Conclusions: We conclude that emotion processing in AT may be a potential mechanism reducing depression and somatic symptoms in cancer patients. Implications for Psychosocial Providers: Art Therapy is a feasible intervention to increase emotional processing. A larger study is required to further examine its effect on psychological and physical symptoms in breast cancer patients.

[Do's and don'ts in the establishment of an integrative medicine service in the public health care system--challenges and insights].

Although gratifying, it is somewhat misleading to describe the progress made in recent years in the field of integrative medicine just by counting the number of new programs established. This count, albeit ever-increasing, represents only one facet of the complex challenge that should concern us all--the development of a better healthcare system. In the real field, other rules apply. It is not sufficient for new integrative medicine services to survive or even to thrive if this is done in parallel to, or worse off in disconnect from, conventional medicine. The two systems, complementary and alternative medicine (CAM) and allopathic medicine, must collaborate in harmony for the sake of synergy. In order for that to happen, careful prior planning that addresses the multiple interests of the various stakeholders is warranted. This paper describes five key challenges and insights [institutional acceptance, Leadership support, the day after, the human factor, and program evaluation) gained from establishing an integrative oncology section within a tertiary academic medical center in Israel. It includes practical advice and useful tips in the form of do's and don'ts with the hope that these pearls would help others to estabLish and develop their own integrative medicine programs within the unique context of their hospitals and healthcare systems.

[Traditional immunosuppression--Lei Gong Teng in modern medicine].

Although the origin of many common modern medicines that are routinely being used nowadays in healthcare is in medicinal plants and fungi, herbal medicine as a standalone profession is no longer included in the curricula of most Western medical schools. The medicinal plant Lei Gong Teng [also known as Thunder God Vine, Tripterygium Wilfordii Hook f., that is core to traditional Chinese herbal medicine, was praised for its possible anti-inflammatory properties in ancient traditional scripts that date back thousands of years. Yet, modern interest in its proven immune-modulatory properties serves as a vivid example to the bridge that is being built, gradually but constantly, between the tradition of healing arts and the world of modern therapeutics. In this review we summarize the main findings from an increasing number of clinical and laboratory studies published in top peer-reviewed medical journals that verify the traditional indications for which Lei Gong Teng was used medicinally. Based on these findings, and the risk-benefit profile of the plant's debarked root, we conclude that Lei Gong Teng and its active metabolites should be included in the Israeli herbal pharmacopeia.

Evaluating intense rehabilitative therapies with and without acupuncture for children with cerebral palsy: a randomized controlled trial.

OBJECTIVE: To compare the outcomes of conventional therapies (physical, occupational, and hydrotherapies) plus acupuncture with those without acupuncture when administered intensely in the management of children with spastic cerebral palsy (CP). DESIGN: Evaluation-blind, prospective randomized controlled trial. SETTING: Therapies and video-recorded assessments at a children's hospital in Beijing, China, and blind scoring and data analyses at a university in the United States. PARTICIPANTS: Children (N=75), 12 to 72 months of age, with spastic CP. INTERVENTIONS: Intensely administered (5 times per week for 12wk) physical therapy, occupational therapy, and hydrotherapy either with acupuncture (group 1) or without acupuncture (group 2). To satisfy standard of care, group 2 subsequently received acupuncture (weeks 16-28). MAIN OUTCOME MEASURES: The Gross Motor Function Measure (GMFM)-66 and the Pediatric Evaluation of Disability Inventory (PEDI) assessments at 0, 4, 8, 12, 16, and 28 weeks. RESULTS: At the end of 12 weeks, there was no statistically significant difference between the 2 groups, but when group 2 received acupuncture (16-28wk) there was a shift toward improvement in the GMFM-66 and the PEDI-Functional Skills Self-Care and Mobility domain. When groups were combined, statistically significant improvements after intense therapies occurred from baseline to 12 weeks for each outcome measure at each Gross Motor Function Classification System (GMFCS) level. After adjusting for expected normative maturational gains based on age, the GMFM gains for children with GMFCS II level was statistically significant (P<.05) with a mean gain of 6.5 versus a predicted gain of 3.4. CONCLUSIONS: Intense early administered rehabilitation improves function in children with spastic CP. The contribution from acupuncture was unclear. Children's response varied widely, suggesting the importance of defining clinical profiles that identify which children might benefit most. Further research should explore how this approach might apply in the U.S.

Informed consent in complementary and alternative medicine.

The objective of this study was to examine complementary and alternative medicine (CAM) practitioners' (i) attitudes toward informed consent and (ii) to assess whether standards of practice exist with respect to informed consent, and what these standards look like. The design and setting of the study constituted face-to-face qualitative interviews with 28 non-MD, community-based providers representing 11 different CAM therapeutic modalities. It was found that there is great deal of variability with respect to the informed consent process in CAM across providers and modalities. No unique profession-based patterns were identified. The content analysis yielded five major categories related to (i) general attitude towards the informed consent process, (ii) type and amount of information exchange during that process, (iii) disclosure of risks, (iv) discussions of alternatives, and (v) potential benefits. There is a widespread lack of standards with respect to the practice of informed consent across a broad range of CAM modalities. Addressing this problem requires concerted and systematic educational, ethical and judicial remedial actions. Informed consent, which is often viewed as a pervasive obligation is medicine, must be reshaped to have therapeutic value. Acknowledging current conceptions and misconception surrounding the practice of informed consent may help to bring about this change. More translational research is needed to guide this process.

Risk factors for arterial ischemic and hemorrhagic stroke in childhood.

This study assessed potential etiologies of arterial ischemic stroke and hemorrhagic stroke among children of Mainland China. From January 1996-June 2006, 251 patients with consecutive childhood stroke (aged 1 month through 16 years) were admitted to Beijing Children's Hospital. Arterial ischemic stroke accounted for the majority of cases (62.5%). Idiopathic stroke (32.5%) was more common than cardiac stroke (8.9%), vascular or arteriopathic stroke (21.0%), hematologic disorder-associated stroke (10.8%), and other etiologies (26.8%). Vitamin K deficiency was a major etiology in 72 of 94 hemorrhagic strokes (76.6%), most of which occurred in breastfeeding infants (80.6%) and those who received no vitamin K after birth (73.6%). Arteriovenous malformation (6.4%) was a frequent etiology in the remaining hemorrhagic stroke cases. We found that ischemic stroke in children is more common than hemorrhagic stroke, and many cases of ischemic stroke are idiopathic. Vitamin K deficiency was a major etiology in these young infants who experienced hemorrhagic stroke.

[Touching cancer: shiatsu as complementary treatment to support cancer patients].

In recent years there has been an increase in the interest of cancer patients in receiving complementary medicine therapies as supportive measures to cure the disease. In response, medical units that combine conventional and complementary medicine (integrative medicine) have been established in leading cancer centers worldwide. In Israel, a special integrative medicine unit that combines mind-body, Chinese medicine, nutrition, herbs, supplements, and manual therapies (such as shiatsu) before, during and after conventional anti-cancer therapies has been established as an integral part of the Davidoff Comprehensive Cancer Center in 2006. Shiatsu represents a group of manual therapeutic techniques, including acupressure. Shiatsu offers cancer patients a non-pharmacologic method to relieve symptoms and improve quality of life throughout the course of illness. Research indicates that acupressure is relatively effective and safe for common cancer-related symptoms such as nausea, vomiting and insomnia. In our experience, shiatsu is also relatively effective and safe for other common symptoms such as fatigue, muscular pain and body image dissatisfaction. Yet, insufficient evidence exists to delineate the best means by which shiatsu and other manual therapies could or should be integrated into routine cancer care. The purpose of the present paper is to describe what is currently known about this topic in order to support decision-making that is based on facts, rather than on myths and misconceptions. We call for more research that examines the effectiveness and safety of shiatsu and other manual therapies in the care of cancer patients.

Integrative Oncology in Supportive Cancer Care in Israel.

PURPOSE: Integrative oncology (IO) services provide complementary/integrative medicine (CIM) therapies to patients as part of their supportive cancer care. In this study, we examine and compare the structural, operational, financial and academic/research-related aspects of IO services in Israeli oncology centers. METHODS: The medical directors of seven Israeli IO programs completed questionnaires which explored the objectives and organizational features of their service within the context of supportive cancer care. RESULTS: All participating IO services addressed patient-reported concerns related to quality of life and function, within the context of conventional supportive cancer care. The centers shared similar characteristics regarding the procedure of referral to their service and emphasized research and teaching initiatives within an academic framework, as part of their clinical practice. A number of obstacles to integration were identified, primarily those related to financial considerations, such as the need for patients to carry the cost of the CIM treatments. CONCLUSIONS: IO services situated within conventional oncology departments in Israel share a number of characteristics, as well as obstacles to their incorporation into standard care. All participating centers described both clinical and academic activities, including research initiatives and the promotion of CIM in an academic setting. Further research is needed in order to better understand the place of CIM in the oncology setting and prioritize the allocation of resources in order to advance the inclusion of CIM in standard supportive cancer care.

Effect of Adherence-enhancing Interventions on Adherence to Tyrosine Kinase Inhibitor Treatment in Chronic Myeloid Leukemia (TAKE-IT): A Quasi-experimental Pre-Post Intervention Multicenter Pilot Study.

BACKGROUND: Nonadherence to tyrosine kinase inhibitors (TKIs) in chronic myeloid leukemia (CML) has been associated with inferior outcomes. Scarce evidence exists on the effectiveness of adherence-enhancing interventions. The present pilot study evaluated the feasibility and effectiveness of an intervention to improve TKI adherence in adult CML patients. PATIENTS AND METHODS: Using a quasi-experimental pre-post intervention design, we included a convenience sample of 58 CML patients (median age, 60.5 years; interquartile range, 19) receiving TKI treatment in 4 hematology institutes in Israel (median previous treatment duration, 34 months; interquartile range, 60). Of the 58 patients, 36 (62%) were receiving first-line treatment. TKI adherence was assessed using electronic monitoring for 7 months (4 months for the baseline assessment and for 3 months after the intervention) and defined as the percentage of days with dosing taken as prescribed. The multilevel intervention combined training of health care workers and multiple behavioral change techniques (eg, motivational interviewing, feedback on electronic monitoring printouts, behavioral change techniques tailored to reasons for nonadherence). The baseline and postintervention adherence were compared using generalized estimating equation models. RESULTS: The median baseline electronically monitored adherence (n = 55) was 97.5% (range, 48%-100%). The odds of taking the drug daily as prescribed were 58% greater after intervention (odds ratio, 1.58; 95% confidence interval [CI], 1.16-2.15). Adherence improved by only 1.5% overall (95% CI, 0.1%-2.8%) but by 8.5% (i.e. from 71.2% average adherence before intervention, to 79.6% after; P = .04) in a subgroup of 10 nonadherent patients (baseline adherence < 90%). CONCLUSION: TKI adherence improved with our pilot intervention, mainly in patients with suboptimal baseline adherence.

Identifying Tyrosine Kinase Inhibitor Nonadherence in Chronic Myeloid Leukemia: Subanalysis of TAKE-IT Pilot Study.

BACKGROUND: There are inconsistencies in reports on correlates for nonadherence (NA) to tyrosine kinase inhibitors (TKIs) in chronic myeloid leukemia (CML). The diagnostic accuracy of subjective adherence measures using electronic monitoring (EM) as the reference standard is yet to be determined. This study aimed to evaluate correlates of TKI NA using EM and test the diagnostic accuracy of subjective adherence measures. PATIENTS AND METHODS: CML patients receiving a TKI for any duration were enrolled at 4 hematology institutes, and adherence was measured for 4 months. EM adherence was the reference adherence measure, expressed as the percentage of days with the drug taken as prescribed. Subjective adherence was measured using the Basel Assessment of Adherence to Immunosuppressive Medications Scale (BAASIS) self-report and clinician-reported visual analog scale (VAS) at 2 time points. Baseline theory-derived correlates of NA were identified using single and multiple regression analysis. The diagnostic accuracy of BAASIS and clinician-reported VAS was tested against an exploratory EM NA cutoff of < 95%. RESULTS: The median EM adherence (n = 55) was 97.5% (range, 48-100%), while the 25th percentile was 92.1%. Lack of membership in a CML patient support group, living alone, and third-line treatment were associated with EM NA on multiple regression analysis. The BAASIS self-report (n = 94) had a sensitivity of 67% and a specificity of 71% for diagnosing NA, while clinician-reported VAS (n = 89) had a sensitivity of 78% and specificity of 42%. CONCLUSION: A quarter of patients had potentially clinically meaningful NA. These NA correlates and the BAASIS provide a basis for identifying nonadherent patients who can be targeted by interventions.

Patients' experiences and perceptions of a consultative model integrative medicine clinic: a qualitative study.

OBJECTIVE: A common theme in integrative medicine (IM) is patient-centered partnering in care between patients and providers. Despite the stated ideals, few studies have assessed patients' perspectives on their actual experience in the context of a specific care model. The purpose of the present study was to retrospectively explore and compare experiences of cancer and noncancer patients under care in a consultative IM outpatient teaching clinic in the south-western United States. DESIGN: Qualitative study using inductive content analysis of focus group interview transcripts (2 groups of adult patients with cancers of various types and 1 group of chronically ill noncancer patients with mixed diagnoses). METHOD: Participants were recruited by random selection from a pool of eligible patients. Groups were conducted with patients who had completed their initial conventional cancer treatment and were at least 6 months postconsultation with an IM clinic physician. Transcripts of the audiotaped focus groups were analyzed. RESULTS: Cancer patients (n = 15) and noncancer patients (n = 6) (mean age, 60 years; 77% women) expressed overall satisfaction with IM, emphasizing (1) expansion of treatment options with lower perceived toxicity than conventional therapies, (2) positive experiences of the IM physician as caring and taking time to listen, and (3) improved self-care skills and sense of empowerment. Cancer patients noted positive relationships with their conventional MDs more than did noncancer patients, although both groups appreciated the IM physicians' communication styles. CONCLUSION: Patients experience a consultative integrative clinic model overall as favorable. The impact on outcomes, costs, and long-term quality of life requires additional study.

Evidence-based medicine: discrepancy between perceived competence and actual performance among graduating medical students.

Since at the time of graduation from medical school physicians are expected to demonstrate adequate professional competence including mastery of critical appraisal skills, we conducted a preliminary, cross-sectional, web-based study to examine the extent to which fourth year medical students in the US are competent in core areas of evidence-based medicine (EBM). Using self-assessment instruments, subjects (n = 150) were asked to demonstrate their ability to understand the practical meaning of key methodological and data analysis constructs as they relate to patient care, to rate their perceived competence in core areas of EBM and to disclose their attitudes toward critical appraisal of the literature and EBM. The mean score in our cohort was 55% suggesting that students may have knowledge gaps that interfere with their ability to critically appraise the medical literature. There was an apparent chasm between subjects' perceived competence and their actual performance on the assessment instrument. These findings, if corroborated in larger studies, (1) suggest that better education in EBM is needed so as to avoid the possibility that patient care may inadvertently be jeopardized; and (2) cast doubt on the use of self-assessed knowledge as a proxy for actual skills with respect to EBM and medical decision-making.

Integrative medicine and systemic outcomes research: issues in the emergence of a new model for primary health care.

Clinicians and researchers are increasingly using the term integrative medicine to refer to the merging of complementary and alternative medicine (CAM) with conventional biomedicine. However, combination medicine (CAM added to conventional) is not integrative. Integrative medicine represents a higher-order system of systems of care that emphasizes wellness and healing of the entire person (bio-psycho-socio-spiritual dimensions) as primary goals, drawing on both conventional and CAM approaches in the context of a supportive and effective physician-patient relationship. Using the context of integrative medicine, this article outlines the relevance of complex systems theory as an approach to health outcomes research. In this view, health is an emergent property of the person as a complex living system. Within this conceptualization, the whole may exhibit properties that its separate parts do not possess. Thus, unlike biomedical research that typically examines parts of health care and parts of the individual, one at a time, but not the complete system, integrative outcomes research advocates the study of the whole. The whole system includes the patient-provider relationship, multiple conventional and CAM treatments, and the philosophical context of care as the intervention. The systemic outcomes encompass the simultaneous, interactive changes within the whole person.

Lack of standards in informed consent in complementary and alternative medicine.

OBJECTIVES: To examine whether U.S.-based professional complementary and alternative medicine (CAM) organizations have explicit informed consent policies. DESIGN AND SETTING: Phone survey conducted in July-August 2003. RESULTS: Data were obtained from 37 out of a total of 39 eligible and accessible organizations representing 19 commonly used provider-administered CAM techniques (95% response rate.) Only 21 organizations (57%) had any informed consent policy and standards, whilst only six (16%) mandate their clinician members to routinely obtain an informed consent. CONCLUSIONS: We found no consistent standards with respect to the practice of informed consent across a broad range of CAM practices. CAM information that is not communicated appropriately or is otherwise unavailable to patients during the decision-making process may increase the potential for healthcare oversights and adversity.

Is complementary and alternative medicine (CAM) cost-effective? A systematic review.

BACKGROUND: Out-of-pocket expenditures of over 34 billion dollars per year in the US are an apparent testament to a widely held belief that complementary and alternative medicine (CAM) therapies have benefits that outweigh their costs. However, regardless of public opinion, there is often little more than anecdotal evidence on the health and economic implications of CAM therapies. The objectives of this study are to present an overview of economic evaluation and to expand upon a previous review to examine the current scope and quality of CAM economic evaluations. METHODS: The data sources used were Medline, AMED, Alt-HealthWatch, and the Complementary and Alternative Medicine Citation Index; January 1999 to October 2004. Papers that reported original data on specific CAM therapies from any form of standard economic analysis were included. Full economic evaluations were subjected to two types of quality review. The first was a 35-item checklist for reporting quality, and the second was a set of four criteria for study quality (randomization, prospective collection of economic data, comparison to usual care, and no blinding). RESULTS: A total of 56 economic evaluations (39 full evaluations) of CAM were found covering a range of therapies applied to a variety of conditions. The reporting quality of the full evaluations was poor for certain items, but was comparable to the quality found by systematic reviews of economic evaluations in conventional medicine. Regarding study quality, 14 (36%) studies were found to meet all four criteria. These exemplary studies indicate CAM therapies that may be considered cost-effective compared to usual care for various conditions: acupuncture for migraine, manual therapy for neck pain, spa therapy for Parkinson's, self-administered stress management for cancer patients undergoing chemotherapy, pre- and post-operative oral nutritional supplementation for lower gastrointestinal tract surgery, biofeedback for patients with "functional" disorders (eg, irritable bowel syndrome), and guided imagery, relaxation therapy, and potassium-rich diet for cardiac patients. CONCLUSION: Whereas the number and quality of economic evaluations of CAM have increased in recent years and more CAM therapies have been shown to be of good value, the majority of CAM therapies still remain to be evaluated.

Methodological challenges in meditation research.

Like other complex, multifaceted interventions in medicine, meditation represents a mixture of specific and not-so-specific elements of therapy. However, meditation is somewhat unique in that it is difficult to standardize, quantify, and authenticate for a given sample of research subjects. Thus, it is often challenging to discern its specific effects in order to satisfy the scientific method of causal inferences that underlies evidence-based medicine. Therefore, it is important to consider the key methodological challenges that affect both the design and analysis of meditation research. The goal of this paper is to review those challenges and to offer some practical solutions. Among the challenges discussed are the mismatches between questions and designs, the variability in meditation types, problems associated with meditation implementation, individual differences across meditators, and the impossibility of double-blind, placebo-controlled meditation studies. Among the design solutions offered are aptitude x treatment interaction (ATI) research, mixed quantitative-qualitative methods, and practical (pragmatic) clinical trials. Similar issues and solutions can be applied more generally to the entire domain of mind-body therapies.

Alternative medicine or "alternative" patients: a qualitative study of patient-oriented decision-making processes with respect to complementary and alternative medicine.

BACKGROUND: Theory and clinical practice suggest that complementary and alternative medicine (CAM) decision-making processes may differ from those used in conventional medicine. If so, understanding the differences could improve patient-provider communication around treatment options. OBJECTIVES: To examine patient-oriented decision-making processes relative to CAM use. POPULATION: Adults with chronic rheumatological disorders who utilize allopathic medicine only, CAM only, or both. METHOD: An exploratory, cross-sectional naturalistic design with thematic and content analyses. RESULTS: Three distinct decision paths were developed, differing substantially on the importance of provider trust, disease severity/prognosis, willingness to experiment, intuitive/spiritual factors, and outcomes evidence. CONCLUSIONS: These divergent decision paths indicate the possibility of "alternative patients," not just "alternative therapies." Since informed decisions, tailored to the patient, would likely lead to sustainable improvements in health care outcomes, the findings may facilitate providers' capacity to effectively advise patients about treatment alternatives and CAM use.

On the definition of complementary, alternative, and integrative medicine: societal mega-stereotypes vs. the patients' perspectives.

Much confusion exists regarding the definitions of complementary, alternative, and integrative medicine. Whereas 'complementary and alternative medicine' (CAM) is used to describe a variable set of diagnostic and therapeutic modalities considered as non-conventional, 'integrative medicine' is commonly used to describe the combination of allopathy and CAM. CAM, however, is nothing more than a categorical label that subsumes numerous therapeutic modalities generally sharing few commonalities. Creating a unique category out of such diversity has lead to misunderstanding and skepticism. From the physician's stand-point, this can generate numerous stereotypes, prejudices, and misconceptions that may compromise the therapeutic relationship, impede compliance, and lead to treatment failure. To help avoid this dangerous pitfall, we propose a distinctly new operational definition for CAM; one that shifts the focus from the traditional, population-based approach to a definition that focuses on the individual. This paper outlines various definitions of CAM and discusses their relative strengths and weaknesses for the 21st century practice of medicine. It is our conclusion that individual patients, rather than society, should be the frame of reference and defining source for what constitutes integrative medicine and CAM.