Qualitative analysis of the Meals, Mindfulness, & Moving Forward (M3 ) lifestyle programme: Cultivating a 'safe space' to start on a 'new path' for youth with early episode psychosis.

AIM: The Meals, Mindfulness, & Moving Forward (M3 ) programme included nutrition education, hands-on cooking classes, mindfulness meditation practice, physical activities and facilitated group sharing. M3 was designed as a supplement to standard care for youths (age 15-25 years) with first-episode psychosis (FEP) who were clients of coordinated specialty care teams. M3 's primary aim was feasibility by demonstrating high programme attendance; secondary aims included cardiometabolic measures. Data collection included quantitative and qualitative outcomes. The aim of the qualitative study was to understand participants' and study partners' experiences during the programme and to understand programme elements that were helpful for young people to sustain healthy lifestyle choices 6 weeks post-programme. METHODS: During the last programme session, we conducted two focus groups, one with participants (n = 13) and one with their study partners (n = 11); 6 weeks post-intervention, individual semi-structured interviews were conducted with 11 participants. All interviews were audio recorded and transcribed; grounded theory methods guided thematic analysis. RESULTS: Main themes from the focus groups included appreciation for a 'non-stigmatizing' environment providing participants and study partners with a sense of 'dignity' that enabled a 'new path'. Six weeks post-intervention, participants reported continued use of mindfulness practice to stay grounded and assist with making healthful lifestyle changes. However, many were unsure of how to sustain these changes long-term. CONCLUSION: The results suggest that young people with FEP value a non-stigmatizing space that allows for social engagement and facilitates healthy behaviours. Short-term, M3 participants reported behaviour change but wanted on-going support to sustain healthy behaviours.

Can supplementation of phytoestrogens/insoluble fibers help the management of duodenal polyps in familial adenomatous polyposis?

Familial adenomatous polyposis (FAP) is an autosomal dominant inherited disorder, and prophylactic colectomy has been shown to decrease the incidence of colorectal cancer (CRC). Duodenal cancer and desmoids are now the leading causes of death in FAP. We evaluate whether 3 months of oral supplementation with a patented blend of phytoestrogens and indigestible insoluble fibers (ADI) help the management of FAP patients with ileal pouch-anal anastomosis (IPAA). In a prospective open label study, we enrolled 15 FAP patients with IPAA and duodenal polyps who underwent upper gastrointestinal endoscopy at baseline and after 3 months of treatment. The primary endpoint was the change in gene expression in polyp mucosa, whereas the secondary endpoint was the reduction in polyp number and size. After 3 months of ADI treatment, all patients showed a reduction in the number and size of duodenal polyps (P = 0.021). Analysis of the expression of CRC promoting/inhibiting genes in duodenal polyps biopsies demonstrated that different CRC-promoting genes (PCNA, MUC1 and COX-2) were significantly downregulated, whereas CRC-inhibiting genes (ER-ß and MUC2) were significantly upregulated after ADI treatment. In conclusion, ADI proved to be safe and effective, and its long-term effects on FAP patients need further investigation. Judging from the results we observed on COX-2 and miR-101 expression, the short-term effects of ADI treatment could be comparable with those obtained using COX-2 inhibitors, with the advantage of being much more tolerable in chronic therapies and void of adverse events.

Consensus Recommendations to NCCIH from Research Faculty in a Transdisciplinary Academic Consortium for Complementary and Integrative Health and Medicine.

BACKGROUND: This commentary presents the most impactful, shared priorities for research investment across the licensed complementary and integrative health (CIH) disciplines according to the Academic Consortium for Complementary and Alternative Health Care (ACCAHC). These are (1) research on whole disciplines; (2) costs; and (3) building capacity within the disciplines' universities, colleges, and programs. The issue of research capacity is emphasized. DISCUSSION: ACCAHC urges expansion of investment in the development of researchers who are graduates of CIH programs, particularly those with a continued association with accredited CIH schools. To increase capacity of CIH discipline researchers, we recommend National Center for Complementary and Integrative Health (NCCIH) to (1) continue and expand R25 grants for education in evidence-based healthcare and evidence-informed practice at CIH schools; (2) work to limit researcher attrition from CIH institutions by supporting career development grants for clinicians from licensed CIH fields who are affiliated with and dedicated to continuing to work in accredited CIH schools; (3) fund additional stand-alone grants to CIH institutions that already have a strong research foundation, and collaborate with appropriate National Institutes of Health (NIH) institutes and centers to create infrastructure in these institutions; (4) stimulate higher percentages of grants to conventional centers to require or strongly encourage partnership with CIH institutions or CIH researchers based at CIH institutions, or give priority to those that do; (5) fund research conferences, workshops, and symposia developed through accredited CIH schools, including those that explore best methods for studying the impact of whole disciplines; and (6) following the present NIH policy of giving priority to new researchers, we urge NCCIH to give a marginal benefit to grant applications from CIH clinician-researchers at CIH academic/research institutions, to acknowledge that CIH concepts require specialized expertise to translate to conventional perspectives. SUMMARY: We commend NCCIH for its previous efforts to support high-quality research in the CIH disciplines. As NCCIH develops its 2016-2020 strategic plan, these recommendations to prioritize research based on whole disciplines, encourage collection of outcome data related to costs, and further support capacity-building within CIH institutions remain relevant and are a strategic use of funds that can benefit the nation's health.

Naturopathic practice at north american academic institutions: description of 300,483 visits and comparison to conventional primary care.

This study collected patient visit data to explore similarities and differences between conventional and naturopathic primary care (PC). Administrative data from practice management software systems from the main teaching clinics of four of the eight accredited North American naturopathic academic institutions were abstracted into an integrated database containing five years (2006-2010) of visit, patient, laboratory, and prescribing data. Descriptive analyses of healthcare services were compared to the National Ambulatory Medical Care Survey (NAMCS). Over the five-year period, 300,483 patient visits to naturopathic doctors occurred at clinics, excluding visits at clinics operated by the schools in community settings. Patients were 69% female; mean age was 39 (SE 0.09). Older adults (>65) comprised 9% of the population and children (<16) comprised 8%. Comparing academic naturopathic clinics to national conventional PC (NAMCS), we found more patients paid out of pocket at naturopathic clinics (50 vs. 4%) and naturopathic clinics more frequently offered discounted care (26 vs. 0.3%). There was a 44% overlap in the most frequent 25 diagnoses for PC at conventional community clinics. Overall, these data suggest substantial similarities in care offered by academic naturopathic clinics, at which most Naturopathic Doctor (ND) students are trained, and by conventional PC practices.

Expectancy, Self-Efficacy, and Placebo Effect of a Sham Supplement for Weight Loss in Obese Adults.

This study examined the role of expectancy in the placebo effect of a sham dietary supplement for weight loss in 114 obese adults with metabolic syndrome. All participants received lifestyle education and were randomized to 1 of 3 conditions: (1) a daily placebo capsule and told that they were taking an active weight loss supplement, (2) daily placebo and told they had a 50% random chance of receiving either the active or placebo, or (3) no capsules. At 12 weeks, weight loss and metabolic outcomes were similar among the 3 groups. Participants in both groups that took capsules showed decreased weight loss self-efficacy and increased expectations of benefit from dietary supplements. Participants not taking capsules showed the opposite. Adverse events were more frequently reported in groups taking capsules than those who were not. These findings suggest that supplements without weight loss effects may have nocebo effects through diminished self-efficacy.

Eviendep® reduces number and size of duodenal polyps in familial adenomatous polyposis patients with ileal pouch-anal anastomosis.

AIM: To evaluate if 3 mo oral supplementation with Eviendep® was able to reduce the number of duodenal polyps in familial adenomatous polyposis (FAP) patients with ileal pouch-anal anastomosis (IPAA). METHODS: Eleven FAP patients with IPAA and duodenal polyps were enrolled. They underwent upper gastrointestinal (GI) endoscopy at the baseline and after 3 mo of treatment. Each patient received 5 mg Eviendep twice a day, at breakfast and dinner time, for 3 mo. Two endoscopists evaluated in a blinded manner the number and size of duodenal polyps. Upper GI endoscopies with biopsies were performed at the baseline (T0) with the assessment of the Spigelman score. Polyps > 10 mm were removed during endoscopy and at the end of the procedure a new Spigelman score was determined (T1). The procedure was repeated 3 mo after the baseline (T2). Four photograms were examined for each patient, at T1 and T2. The examined area was divided into 3 segments: duodenal bulb, second and third portion duodenum. Biopsy specimens were taken from all polyps > 10 mm and from all suspicious ones, defined by the presence of a central depression, irregular surface, or irregular vascular pattern. Histology was classified according to the updated Vienna criteria. RESULTS: At baseline the mean number of duodenal detected polyps was 27.7 and mean sizes were 15.8 mm; the mean Spigelman score was 7.1. After polypectomy the mean number of duodenal detected polyps was 25.7 and mean sizes were 7.6 mm; the mean Spigelman score was 6.4. After 3 mo of Eviendep bid, all patients showed a reduction of number and size of duodenal polyps. The mean number of duodenal polyps was 8 (P = 0.021) and mean size was 4.4 mm; the mean Spigelman score was 6.6. Interrater agreement was measured. Lesions > 1 cm found a very good degree of concordance (kappa 0.851) and a good concordance was as well encountered for smaller lesions (kappa 0.641). CONCLUSION: Our study demonstrated that short-term (90 d) supplementation with Eviendep® in FAP patients with IPAA and with recurrent adenomas in the duodenal mucosa, resulted effective in reducing polyps number of 32% and size of 51%.

Patient-reported experiences with first-time naturopathic care for type 2 diabetes.

Differences in the effectiveness of diverse healthcare providers to promote health behavior change and successful diabetes self-care have received little attention. Because training in naturopathic medicine (NM) emphasizes a patient-centered approach, health promotion, and routine use of clinical counseling on wellness and prevention, naturopathic physicians (NDs) may be particularly well-prepared for promoting behavior change. However, patients' experiences with NM have not been well studied. This study provides the first report of the perceptions of persons with type 2 diabetes of their first experiences with naturopathic care for their diabetes. Following their participation in a one-year prospective cohort study of adjunctive naturopathic care for diabetes, twenty-two patients were interviewed about their experiences working with a naturopathic physician. Using a content analysis approach, nine dominant themes were identified. Three themes characterized the nature of the ND-patient interaction: 1) patient-centered, 2) holistic health rather than diabetes focused, and 3) collaborative. Five themes characterized the content of the clinical encounter: 1) individualized and detailed health promotion, 2) counseling that promoted self-efficacy, 3) pragmatic and practical self-care recommendations, 4) novel treatment options that fostered hopefulness, and 5) patient education that addressed both diabetes self-care and general health. A ninth theme was cross-cutting: the contrast between ND care and conventional medical care. Results indicate that the routine clinical approach used by NDs is consistent with behavior change theory and clinical strategies found most effective in promoting self-efficacy and improving clinical outcomes.

Adjunctive naturopathic care for type 2 diabetes: patient-reported and clinical outcomes after one year.

BACKGROUND: Several small, uncontrolled studies have found improvements in self-care behaviors and reductions in clinical risk in persons with type 2 diabetes who received care from licensed naturopathic physicians. To extend these findings and determine the feasibility and promise of a randomized clinical trial, we conducted a prospective study to measure the effects of adjunctive naturopathic care (ANC) in primary care patients with inadequately controlled type 2 diabetes. METHODS: Forty patients with type 2 diabetes were invited from a large integrated health care system to receive up to eight ANC visits for up to one year. Participants were required to have hemoglobin A1c (HbA1c) values between 7.5-9.5 % and at least one additional cardiovascular risk factor (i.e., hypertension, hyperlipidemia or overweight). Standardized instruments were administered by telephone to collect outcome data on self-care, self-efficacy, diabetes problem areas, perceived stress, motivation, and mood. Changes from baseline scores were calculated at 6- and 12-months after entry into the study. Six and 12-month changes in clinical risk factors (i.e., HbA1c, lipid and blood pressure) were calculated for the ANC cohort, and compared to changes in a cohort of 329 eligible, non-participating patients constructed using electronic medical records data. Between-cohort comparisons were adjusted for age, gender, baseline HbA1c, and diabetes medications. Six months was pre-specified as the primary endpoint for outcome assessment. RESULTS: Participants made 3.9 ANC visits on average during the year, 78 % of which occurred within six months of entry into the study. At 6-months, significant improvements were found in most patient-reported measures, including glucose testing (P = 0.001), diet (P = 0.001), physical activity (P = 0.02), mood (P = 0.001), self-efficacy (P = 0.0001) and motivation to change lifestyle (P = 0.003). Improvements in glucose testing, mood, self-efficacy and motivation to change lifestyle persisted at 12-months (all P < 0.005). For clinical outcomes, mean HbA1c decreased by -0.90 % (P = 0.02) in the ANC cohort at 6-months, a -0.51 % mean difference compared to usual care (P = 0.07). Reductions at 12-months were not statistically significant (-0.34 % in the ANC cohort, P = 0.14; -0.37 % difference compared to the usual care cohort, P = 0.12). CONCLUSIONS: Improvements were noted in self-monitoring of glucose, diet, self-efficacy, motivation and mood following initiation of ANC for patients with inadequately controlled type 2 diabetes. Study participants also experienced reductions in blood glucose that exceeded those for similar patients who did not receive ANC. Randomized clinical trials will be necessary to determine if ANC was responsible for these benefits.

Survey of CAM interest, self-care, and satisfaction with health care for type 2 diabetes at group health cooperative.

BACKGROUND: Very little research has explored the factors that influence interest in complementary and alternative medicine (CAM) treatments. We surveyed persons with sub-optimally controlled type 2 diabetes to evaluate potential relationships between interest in complementary and alternative medicine (CAM) treatments, current self-care practices, motivation to improve self-care practices and satisfaction with current health care for diabetes. METHODS: 321 patients from a large integrated healthcare system with type 2 diabetes, who were not using insulin and had hemoglobin A1c values between 7.5-9.5%, were telephoned between 2009-2010 and asked about their self-care behaviors, motivation to change, satisfaction with current health care and interest in trying naturopathic (ND) care for their diabetes. Responses from patients most interested in trying ND care were compared with those from patients with less interest. RESULTS: 219 (68.5%) patients completed the survey. Nearly half (48%) stated they would be very likely to try ND care for their diabetes if covered by their insurance. Interest in trying ND care was not related to patient demographics, health history, clinical status, or self-care behaviors. Patients with greater interest in trying ND care rated their current healthcare as less effective for controlling their blood sugar (mean response 5.9 +/- 1.9 vs. 6.6 +/- 1.5, p = 0.003), and were more determined to succeed in self-care (p = 0.007). Current CAM use for diabetes was also greater in ND interested patients. CONCLUSIONS: Patients with sub-optimally controlled type 2 diabetes expressed a high level of interest in trying ND care. Those patients with the greatest interest were less satisfied with their diabetes care, more motivated to engage in self-care, and more likely to use other CAM therapies for their diabetes.

Brain functional changes in patients with ulcerative colitis: a functional magnetic resonance imaging study on emotional processing.

BACKGROUND: Ulcerative colitis (UC) is associated with psychological stress and poor emotional functioning. The neural emotional processing involves the complex integration of several cortical and subcortical brain structures. The amygdala plays a fundamental role in the neural processing of emotional stimuli and is a core structure of the brain-gut axis (BGA) that represents the anatomo-functional substrate for the bidirectional influences between emotions and gastrointestinal functions. The aim of this study was to investigate the brain emotional processing in UC patients compared to healthy people. METHODS: Ten UC patients in remission and 10 matched healthy controls underwent a functional magnetic resonance imaging (fMRI) scan while performing a task involving emotional visual stimuli. A set of negative, positive, and neutral pictures were used to study brain-related emotional responses. RESULTS: A significantly reduced blood oxygen level-dependent (BOLD) signal in UC patients relative to controls was found in the amygdala, thalamic regions, and cerebellar areas (P < 0.05 corrected for multiple comparisons). The group-related differences were detected in the brain activity in response to positive emotional stimuli. CONCLUSIONS: UC is associated with an emotional dysfunction characterized by decreased sensitivity to emotions with a positive content. The previous intestinal inflammatory activity in UC patients might have contributed to determine the functional changes of the amygdala that we found. On the other hand, the dysfunction of the amygdala may influence the course of the disease.

Applying principles from complex systems to studying the efficacy of CAM therapies.

In October 2007, a National Center for Complementary and Alternative Medicine (NCCAM)-sponsored workshop, entitled "Applying Principles from Complex Systems to Studying the Efficacy of CAM Therapies," was held at Georgetown University in Washington, DC. Over a 2-day period, the workshop engaged a small group of experts from the fields of complementary and alternative medicine (CAM) research and complexity science to discuss and examine ways in which complexity science can be applied to CAM research. After didactic presentations and small-group discussions, a number of salient themes and ideas emerged. This paper article describes the workshop program and summarizes these emergent ideas, which are divided into five broad categories: (1) introduction to complexity; (2) challenges to CAM research; (3) applications of complexity science to CAM; (4) CAM as a model of complexity applied to medicine; and (5) future directions. This discusses possible benefits and challenges associated with applying complexity science to CAM research. By providing an introductory framework for this collaboration and exchange, it is hoped that this article may stimulate further inquiry into this largely unexplored area of research.

Methodological considerations for future controlled influenza treatment trials in complementary and alternative medicine.

BACKGROUND: The continuous threat of influenza pandemic, as well as the ongoing costs to human life and health care systems from yearly epidemics, create a continual need for progress in this area of public health. The diversity of available complementary and alternative medicine (CAM) treatment options are well known to the CAM profession, but poorly understood and accepted in mainstream medicine. This situation comes as no surprise given conventional medicine's reliance on repeated, large-scale randomized controlled trials of standardized design to support evidence-based clinical use of influenza antiviral drugs. The relatively low volume of well-conducted clinical trials on the treatment of influenza with CAM therapies compared to the high availability of conventional antiviral drug trials magnifies this problem. OBJECTIVES: The aim of this article is to provide structured guidelines for future CAM influenza studies based on a thorough review of consistent and standard design elements present in the controlled-trial design of conventional antiviral influenza therapies. RESULTS: A selection of high-quality, influenza antiviral controlled trials from the published literature is reviewed, and important design elements are extracted and summarized to show both the consistency and the flexibility within study design elements. CONCLUSIONS: The standardized elements from influenza antiviral trials can be considered and mirrored in future CAM studies. In this way, CAM therapies might be looked at on similar grounds as conventional medicines in terms of potential usefulness and benefit in the treatment of influenza.

Effects of a standardized Bacopa monnieri extract on cognitive performance, anxiety, and depression in the elderly: a randomized, double-blind, placebo-controlled trial.

OBJECTIVES: Study aims were to evaluate effects of Bacopa monnieri whole plant standardized dry extract on cognitive function and affect and its safety and tolerability in healthy elderly study participants. DESIGN: The study was a randomized, double-blind, placebo-controlled clinical trial with a placebo run-in of 6 weeks and a treatment period of 12 weeks. SETTING/LOCATION: Volunteers were recruited from the community to a clinic in Portland, Oregon by public notification. SUBJECTS: Fifty-four (54) participants, 65 or older (mean 73.5 years), without clinical signs of dementia, were recruited and randomized to Bacopa or placebo. Forty-eight (48) completed the study with 24 in each group. INTERVENTIONS: Standardized B. monnieri extract 300 mg/day or a similar placebo tablet orally for 12 weeks. OUTCOME MEASURES: The primary outcome variable was the delayed recall score from the Rey Auditory Verbal Learning Test (AVLT). Other cognitive measures were the Stroop Task assessing the ability to ignore irrelevant information, the Divided Attention Task (DAT), and the Wechsler Adult Intelligence Scale (WAIS) letter-digit test of immediate working memory. Affective measures were the State-Trait Anxiety Inventory, Center for Epidemiologic Studies Depression scale (CESD)-10 depression scale, and the Profile of Mood States. Vital signs were also monitored. RESULTS: Controlling for baseline cognitive deficit using the Blessed Orientation-Memory-Concentration test, Bacopa participants had enhanced AVLT delayed word recall memory scores relative to placebo. Stroop results were similarly significant, with the Bacopa group improving and the placebo group unchanged. CESD-10 depression scores, combined state plus trait anxiety scores, and heart rate decreased over time for the Bacopa group but increased for the placebo group. No effects were found on the DAT, WAIS digit task, mood, or blood pressure. The dose was well tolerated with few adverse events (Bacopa n = 9, placebo n = 10), primarily stomach upset. CONCLUSIONS: This study provides further evidence that B. monnieri has potential for safely enhancing cognitive performance in the aging.

A pilot whole systems clinical trial of traditional Chinese medicine and naturopathic medicine for the treatment of temporomandibular disorders.

OBJECTIVES: To assess the feasibility and acceptability of studying whole systems of Traditional Chinese Medicine (TCM) and Naturopathic medicine (NM) in the treatment of temporomandibular disorders (TMD), and to determine whether there is indication to support further research. DESIGN: A pilot study using a randomized controlled clinical trial design of whole system TCM and NM versus state-of-the-art specialty care (SC). SETTING/LOCATION: Kaiser Permanente Northwest (KPNW), and practitioner offices in Portland, Oregon. SUBJECTS: One hundred and sixty (160) women 25-55 years of age attending a KPNW TMD specialty clinic. INTERVENTIONS: Whole system TCM and NM, and KPNW TMD clinic SC; the intervention protocols were designed to model the individually tailored type of community care offered in alternative medicine practices in Portland and in the KPNW TMD clinic, using protocols that enhanced similarities among practitioners within each system and permitted full descriptions of the treatments provided. OUTCOME MEASURES: TMD was ascertained using the Research Diagnostic Criteria/TMD; outcomes were self-reported worst and average facial pain and interference with activities (scaled 0-10 where 10 is worst). RESULTS: Of 948 consecutive eligible patients, 160 were randomized to one of three arms; 128 provided endpoint data. TCM and NM demonstrated significantly greater in-treatment reductions for worst facial pain compared to SC (adjusted regression analysis; higher negative values indicate greater improvement, = -1.11 +/- 0.43, p = 0.010 and -1.02 +/- 0.45, p = 0.025 for TCM and NM, respectively, compared to SC) and at 3 months post-treatment (-1.07 +/- 0.51, p = 0.037 and -1.27 +/- 0.54, p = 0.019 for TCM and NM versus SC, respectively). Additionally, TCM provided significantly greater decreases in average pain than SC; NM provided significantly greater decreases than SC or TCM in TMD-related psychosocial interference. CONCLUSIONS: These alternative medicine approaches each resulted in significantly greater reduction of pain and psychosocial interference than SC. Further research on the potential benefits of traditional whole systems of medicine for TMD appears warranted.

A randomized pilot study of naturopathic medicine in multiple sclerosis.

BACKGROUND: Complementary and alternative medicine (CAM) use is high in people with multiple sclerosis (MS), yet there are limited reports on safety and effectiveness of CAM in MS. Naturopathic medicine encompasses a broad range of CAM modalities and may improve quality of life in patients with MS. OBJECTIVE: To assess quality of life in MS subjects who received interventions designed to "model" the "whole practice" of naturopathy. DESIGN: A pilot, randomized, controlled study with a 6-month intervention period. PARTICIPANTS: Participants who met criteria for clinically definite MS. INTERVENTIONS: The 3 intervention arms were usual care, naturopathic medicine plus usual care, and MS education plus usual care. OUTCOME MEASURES: The primary outcome measure was quality of life (36-item short form health survey [SF-36]). Secondary outcome measures included fatigue (Modified Fatigue Impact Scale); depression (Beck Depression Inventory); cognition battery (Stroop test and Paced Auditory Serial Addition Test 3), and neurologic impairment (Expanded Disability Status Scale [EDSS] and Multiple Sclerosis Functional Composite). Adverse event reporting and laboratory measures were used to assess safety. RESULTS: Forty-five (45) participants (15 per group) were randomized and all completed the 6-month intervention. There were no significant differences between groups on any outcome measure. There was a trend in favoring the naturopathic group in the General Health subscale of the SF-36 (p = 0.11), Timed Walk (p = 0.11), and neurologic impairment (EDSS) (p = 0.07). There was a trend favoring the Education group in the Stroop attention test (p = 0.07). There was no difference between groups in adverse events or laboratory changes. CONCLUSIONS: Naturopathic medicine combined with usual care for MS showed a trend in improvement in the General Health subscale of the SF-36, Timed Walk, and neurologic impairment. Evaluation of naturopathic medicine, as a multimodality regimen, warrants further investigation.

Survival in HIV-1-positve adults practicing psychological or spiritual activities for one year.

OBJECTIVE: To investigate associations between survival and use of psychological and spiritual activities practiced over 1 year in HIV-positive (HIV+) patients. METHOD: Nine hundred one HIV+ adults living in the United States using at least 1 form of complementary and alternative medicine (CAM) completed a questionnaire 3 times between 1995 and 1998. Information on specific mind-body therapies included psychotherapy (group therapy, support groups, individual therapy) and spiritual therapies (self-defined "spiritual" activities, prayer, meditation, affirmations, psychic healing, visualizations). Subsequent death was ascertained from the National Death Index (NDI). Cox proportional-hazards regression assessed risk of death through 1999. RESULTS: Use of any psychological therapy reported in both the 6-month and 12-month follow-up questionnaires (1 year continuous use) was associated with a reduced risk of death (hazard ratio [HR]: 0.5, 95% CI: 0.3-0.9) adjusted for income, clinical acquired immune deficiency syndrome, CD4 count, smoking, alcohol use, and use of antiretroviral therapy or highly active antiretroviral therapy (HAART). The relationship between spiritual activities and survival was modified by use of HAART, which may reflect severity of illness. Individuals not currently using HAART and who participated in spiritual activities over the previous year were found to be at a reduced risk of death (HR: 0.4, 95% CI: 0.2-0.9) compared to those not practicing spirituality. CONCLUSIONS: Participation in spiritual and psychological therapies may be related to beneficial clinical outcomes in HIV+ individuals, including improved survival. Due to the self-selection of therapies in this observational cohort, it is not possible to distinguish use of the therapies from other characteristics or activities of the people participating in them.

Binaural beat technology in humans: a pilot study to assess neuropsychologic, physiologic, and electroencephalographic effects.

OBJECTIVES: When two auditory stimuli of different frequency are presented to each ear, binaural beats are perceived by the listener. The binaural beat frequency is equal to the difference between the frequencies applied to each ear. Our primary objective was to assess whether steady-state entrainment of electroencephalographic activity to the binaural beat occurs when exposed to a specific binaural beat frequency as has been hypothesized. Our secondary objective was to gather preliminary data on neuropsychologic and physiologic effects of binaural beat technology. DESIGN: A randomized, blinded, placebo-controlled crossover experiment in 4 healthy adult subjects. INTERVENTION: Subjects were randomized to experimental auditory stimulus of 30 minutes of binaural beat at 7 Hz (carrier frequencies: 133 Hz L; 140 Hz R) with an overlay of pink noise resembling the sound of rain on one session and control stimuli of the same overlay without the binaural beat carrier frequencies on the other session. OUTCOME MEASURES: Data were collected during two separate sessions 1 week apart. Neuropsychologic and blood pressure data were collected before and after the intervention; electroencephalographic data were collected before, during, and after listening to either binaural beats or control. Neuropsychologic measures included State Trait Anxiety Inventory, Profile of Mood States, Rey Auditory Verbal List Test, Stroop Test, and Controlled Oral Word Association Test. Spectral and coherence analysis was performed on the electroencephalogram (EEG), and all measures were analyzed for changes between sessions with and without binaural beat stimuli. RESULTS: There were no significant differences between the experimental and control conditions in any of the EEG measures. There was an increase of the Profile of Mood States depression subscale in the experimental condition relative to the control condition (p = 0.02). There was also a significant decrease in immediate verbal memory recall (p = 0.03) in the experimental condition compared to control condition. CONCLUSIONS: We did not find support for steady-state entrainment of the scalp-recorded EEG while listening to 7-Hz binaural beats. Although our data indicated increased depression and poorer immediate recall after listening to binaural beats, larger studies are needed to confirm these findings.

Binaural beat technology in humans: a pilot study to assess psychologic and physiologic effects.

INTRODUCTION: Binaural beat technology (BBT) products are sold internationally as personal development and health improvement tools. Producers suggest benefit from regular listening to binaural beats including reduced stress and anxiety, and increased focus, concentration, motivation, confidence, and depth in meditation. Binaural beats are auditory brainstem responses that originate in the superior olivary nucleus as a result of different frequency auditory stimuli provided to each ear. Listeners to binaural beat "hear" a beat at a frequency equal to the difference between the frequencies of the applied tones. OBJECTIVES: The objectives of this pilot study were to gather preliminary data on psychologic and physiologic effects of 60 days daily use of BBT for hypothesis generation and to assess compliance, feasibility, and safety for future studies. DESIGN: Uncontrolled pilot study. SUBJECTS: Eight healthy adults participated in the study. INTERVENTION: Participants listened to a CD with delta (0-4 Hz) binaural beat frequencies daily for 60 days. OUTCOME MEASURES: Psychologic and physiological data were collected before and after a 60-day intervention. PSYCHOLOGIC: Depression (Beck Depression Inventory-2), anxiety (State-Trait Anxiety Inventory), mood (Profile of Mood States), absorption (Tellegen Absorption Scale) and quality of Life (World Health Organization-Quality of Life Inventory). PHYSIOLOGICAL: Cortisol, dehydroepiandrosterone, melatonin, insulin-like growth factor-1, serotonin, dopamine, epinephrine, norepinephrine, weight, blood pressure, high sensitivity C-reactive protein. RESULTS: There was a decrease in trait anxiety (p = 0.004), an increase in quality of life (p = 0.03), and a decrease in insulin-like growth factor-1 (p = 0.01) and dopamine (p = 0.02) observed between pre- and postintervention measurements. CONCLUSIONS: Binaural beat technology may exhibit positive effect on self-reported psychologic measures, especially anxiety. Further research is warranted to explore the effects on anxiety using a larger, randomized and controlled trial.