Mindfulnes-Based Stress Reduction for Older Couples with Metabolic Syndrome: a Pilot Randomized Controlled Trial.

OBJECTIVE: We examined the feasibility and explored the physical, psychological, relational, and biological effects of Mindfulness-Based Stress Reduction (MBSR), an 8-week standardized mindfulness program, involving older married couples (60 years or older) with metabolic syndrome (one or both partners had metabolic syndrome). We also explored gender differences. METHODS: A pilot randomized controlled trial (RCT) compared MBSR to a Wait List Control (WLC) arm at baseline, post-intervention, and 3-month follow-up clinic visits. Twenty-two spouses (11 couples) self-reported stress, physical and mental functioning, mindfulness, and relationship satisfaction at each time point. Fasting glucose, cholesterol, triglycerides, blood pressure, weight, and waist circumference were measured. MBSR couples answered questions about partner influences on participation, adherence, and practice at the post-intervention visit. RESULTS: In terms of adherence to MBSR sessions, four of the six couples attended all 10 sessions; one couple attended 7; and one wife attended 6 and her husband attended 5 sessions. In terms of efficacy, there were no significant intervention effects; however, there were significant gender by intervention effects. Pre- to post-intervention, MBSR wives displayed greater increases in physical functioning (ß = 1.18, t(36) = 3.17, p = .003) and relationship satisfaction (ß = .72, t(36) = 2.81, p = .007) than WLC wives. Effects for husbands were not significant. Qualitatively, participants reported encouragement and increased relationship closeness. CONCLUSIONS: Engaging in MBSR as a couple to address symptoms of metabolic syndrome was well-received and feasible. Preliminary effects suggest more benefits for wives than husbands in terms of physical functioning and relational well-being.

Fermented Soy Beverage Q-CAN Plus Consumption Improves Serum Cholesterol and Cytokines.

Soy-based beverages are well recognized for their rich nutritional contents and positive health benefits. However, there is little information regarding the composition of various commercially available soy-based beverages and uncertainty among patients regarding the utility of fermented soy products. Current study evaluates the health benefits of QCAN® Plus-an easily available fermented soy drink. This study was performed in lean (n = 10) and obese (n = 10) subjects. The subjects were observed during pre-soy (weeks -2, -1, and 0), on-soy (weeks 1, 2, 3, and 4), and post-soy (weeks 6, 8, 10, and 12) periods. The serum samples during these visits were subjected to lipid profile analysis and multiplex assay for cytokines. The results revealed that total cholesterol and low-density lipoprotein (LDL) cholesterol levels were significantly reduced in both lean and obese individuals during on-soy (P ≤ .05). Furthermore, cytokines such as platelet-derived growth factor (PDGF) AA and AB/BB were significantly lowered on-soy compared with pre-soy (P ≤ .05) in lean subjects and PDGF AA, IL-1RA, and GMCSF were significantly reduced on-soy (P ≤ .05) in obese subjects. In addition, a qualitative and quantitative analysis of the Q-CAN Plus by a third-party laboratory confirmed its chemical and microbial safety. Our preliminary study on Q-CAN Plus ensures its safety for consumption and highlights its hypolipidemic and suppressive effect on certain cytokines. These observations and relevant studies in future might guide clinicians in future to consider Q-CAN Plus as a therapeutic nutritional supplement.

Efficacy and Safety of Massage for Osteoarthritis of the Knee: a Randomized Clinical Trial.

BACKGROUND: Current treatment options for knee osteoarthritis have limited effectiveness and potentially adverse side effects. Massage may offer a safe and effective complement to the management of knee osteoarthritis. OBJECTIVE: Examine effects of whole-body massage on knee osteoarthritis, compared to active control (light-touch) and usual care. DESIGN: Multisite RCT assessing the efficacy of massage compared to light-touch and usual care in adults with knee osteoarthritis, with assessments at baseline and weeks 8, 16, 24, 36, and 52. Subjects in massage or light-touch groups received eight weekly treatments, then were randomized to biweekly intervention or usual care to week 52. The original usual care group continued to week 24. Analysis was performed on an intention-to-treat basis. PARTICIPANTS: Five hundred fifty-one screened for eligibility, 222 adults with knee osteoarthritis enrolled, 200 completed 8-week assessments, and 175 completed 52-week assessments. INTERVENTION: Sixty minutes of protocolized full-body massage or light-touch. MAIN MEASURES: Primary: Western Ontario and McMaster Universities Arthritis Index. Secondary: visual analog pain scale, PROMIS Pain Interference, knee range of motion, and timed 50-ft walk. KEY RESULTS: At 8 weeks, massage significantly improved WOMAC Global scores compared to light-touch (- 8.16, 95% CI = - 13.50 to - 2.81) and usual care (- 9.55, 95% CI = - 14.66 to - 4.45). Additionally, massage improved pain, stiffness, and physical function WOMAC subscale scores compared to light-touch (p < 0.001; p = 0.04; p = 0.02, respectively) and usual care (p < 0.001; p = 0.002; p = 0.002; respectively). At 52 weeks, the omnibus test of any group difference in the change in WOMAC Global from baseline to 52 weeks was not significant (p = 0.707, df = 3), indicating no significant difference in change across groups. Adverse events were minimal. CONCLUSIONS: Efficacy of symptom relief and safety of weekly massage make it an attractive short-term treatment option for knee osteoarthritis. Longer-term biweekly dose maintained improvement, but did not provide additional benefit beyond usual care post 8-week treatment. TRIAL REGISTRATION: clinicaltrials.gov NCT01537484.

Mindfulness-Based Stress Reduction for Adolescents with Functional Somatic Syndromes: A Pilot Cohort Study.

OBJECTIVE: To assess the feasibility of a mindfulness-based stress reduction (MBSR) program for adolescents with widespread chronic pain and other functional somatic symptoms and to make preliminary assessments of its clinical utility. STUDY DESIGN: Three cohorts of subjects completed an 8-week MBSR program. Child- and parent-completed measures were collected at baseline and 8 and 12 weeks later. Measures included the Functional Disability Inventory (FDI), the Fibromyalgia/Symptom Impact Questionnaire-Revised (FIQR/SIQR), the Pediatric Quality of Life Inventory, the Multidimensional Anxiety Scale (MASC2), and the Perceived Stress Scale. Subjects and parents were interviewed following the program to assess feasibility. RESULTS: Fifteen of 18 subjects (83%) completed the 8-week program. No adverse events occurred. Compared with baseline scores, significant changes were found in mean scores on the FDI (33% improvement, P = .026), FIQR/SIQR (26% improvement, P = .03), and MASC2 (child: 12% improvement, P = .02; parent report: 17% improvement, P = .03) at 8 weeks. MASC2 scores (child and parent) and Perceived Stress Scale scores were significantly improved at 12 weeks. More time spent doing home practice was associated with better outcomes in the FDI and FIQR/SIQR (44% and 26% improvement, respectively). Qualitative interviews indicated that subjects and parents reported social support as a benefit of the MBSR class, as well as a positive impact of MBSR on activities of daily living, and on pain and anxiety. CONCLUSIONS: MBSR is a feasible and acceptable intervention in adolescents with functional somatic syndromes and has preliminary evidence for improving functional disability, symptom impact, and anxiety, with consistency between parent and child measures. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02190474.

Massage Therapy and Quality of Life in Osteoarthritis of the Knee: A Qualitative Study.

Objective: We hypothesized that participants receiving Swedish massage would experience benefits such as stress reduction and enhanced quality of life, in addition to the osteoarthritis-specific effects assessed in a randomized controlled clinical trial. Design: Qualitative methods were used to explore a deeper contextual understanding of participants' experiences with massage and osteoarthritis, in addition to the quantitative data collected from primary and secondary outcome measures of the dose-finding study. Setting: Two community hospitals affiliated with academic health centers in Connecticut and New Jersey. Subjects: Eighteen adults who previously participated in a dose-finding clinical trial of massage therapy for osteoarthritis of the knee. Methods: Face-to-face and telephone interviews using a standardized interview guide. Triangulation of qualitative and quantitative data allowed for a more thorough understanding of the effects of massage therapy. Results: Three salient themes emerged from our analysis. Participants discussed 1) relaxation effects, 2) improved quality of life associated with receiving massage therapy, and 3) the accessibility of massage therapy in treating osteoarthritis. Conclusions: Participant responses noted empowerment with an improved ability to perform activities of daily living after experiencing massage therapy. The majority of statements were consistent with their quantitative changes on standard osteoarthritis measures. Future research in pain conditions should include health-related quality of life assessments as well as outcomes related to perceived well-being, along with greater exploration of the concept of salutogenic side effects of an intervention in the context of complementary and integrative therapies.

Integrative Medicine in Preventive Medicine Education: Competency and Curriculum Development for Preventive Medicine and Other Specialty Residency Programs.

During 2012, the USDHHS's Health Resources and Services Administration funded 12 accredited preventive medicine residencies to incorporate an evidence-based integrative medicine curriculum into their training programs. It also funded a national coordinating center at the American College of Preventive Medicine, known as the Integrative Medicine in Preventive Medicine Education (IMPriME) Center, to provide technical assistance to the 12 grantees. To help with this task, the IMPriME Center established a multidisciplinary steering committee, versed in integrative medicine, whose primary aim was to develop integrative medicine core competencies for incorporation into preventive medicine graduate medical education training. The competency development process was informed by central integrative medicine definitions and principles, preventive medicine's dual role in clinical and population-based prevention, and the burgeoning evidence base of integrative medicine. The steering committee considered an interdisciplinary integrative medicine contextual framework guided by several themes related to workforce development and population health. A list of nine competencies, mapped to the six general domains of competence approved by the Accreditation Council of Graduate Medical Education, was operationalized through an iterative exercise with the 12 grantees in a process that included mapping each site's competency and curriculum products to the core competencies. The competencies, along with central curricular components informed by grantees' work presented elsewhere in this supplement, are outlined as a roadmap for residency programs aiming to incorporate integrative medicine content into their curricula. This set of competencies adds to the larger efforts of the IMPriME initiative to facilitate and enhance further curriculum development and implementation by not only the current grantees but other stakeholders in graduate medical education around integrative medicine training.

Disease Prevention and Health Promotion: How Integrative Medicine Fits.

As a discipline, preventive medicine has traditionally been described to encompass primary, secondary, and tertiary prevention. The fields of preventive medicine and public health share the objectives of promoting general health, preventing disease, and applying epidemiologic techniques to these goals. This paper discusses a conceptual approach between the overlap and potential synergies of integrative medicine principles and practices with preventive medicine in the context of these levels of prevention, acknowledging the relative deficiency of research on the effectiveness of practice-based integrative care. One goal of integrative medicine is to make the widest array of appropriate options available to patients, ultimately blurring the boundaries between conventional and complementary medicine. Both disciplines should be subject to rigorous scientific inquiry so that interventions that are efficacious and effective are systematically distinguished from those that are not. Furthermore, principles of preventive medicine can be infused into prevalent practices in complementary and integrative medicine, promoting public health in the context of more responsible practices. The case is made that an integrative preventive approach involves the responsible use of science with responsiveness to the needs of patients that persist when conclusive data are exhausted, providing a framework to make clinical decisions among integrative therapies.

Project ASPIRE: Incorporating Integrative Medicine Into Residency Training.

Griffin Hospital, a community hospital affiliated with Yale School of Public Health and Yale School of Medicine, received Health Resources and Services Administration funding to strengthen and improve its combined internal medicine and general preventive medicine residency program by incorporating an integrative medicine curriculum. The purpose of project ASPIRE (Advancing Skills of Preventive medicine residents through Integrative medicine Education, Research and Evaluation) was to create, implement, and evaluate a needs-based, innovative training curriculum in integrative medicine. Through this robust new training, the authors aimed to produce preventive medicine-trained physicians with competencies in integrative medicine to collaboratively work with other integrative medicine practitioners in interdisciplinary teams to provide holistic, patient-centered care. The multifaceted collaborative curriculum was composed of didactics, grand rounds, journal club, objective structured clinical examinations, and two new practicum rotations in integrative medicine. The new practicum rotations included block rotations at the Integrative Medicine Center at Griffin Hospital and the Yale Stress Center. Between 2012 and 2014, three cohorts participated in the curriculum; two of these cohorts included three advanced preventive medicine residents each and the fourth included four residents. Project faculty conducted 14 lectures and journal clubs, and two grand rounds. Six of the ten participating residents (60%) completed integrative medicine clinical rotations. Residents' attitudes toward integrative medicine were evaluated through self-assessment using the Complementary, Alternative, and Integrative Medicine Attitudes Questionnaire; data were analyzed in 2015. This article describes the results of this prospective observational study based on single-institution experience over the course of the 2-year project period.

Perceptions of Massage Therapists Participating in a Randomized Controlled Trial.

BACKGROUND: Clinical practice and randomized trials often have disparate aims, despite involving similar interventions. Attitudes and expectancies of practitioners influence patient outcomes, and there is growing emphasis on optimizing provider-patient relationships. In this study, we evaluated the experiences of licensed massage therapists involved in a randomized controlled clinical trial using qualitative methodology. METHODS: Seven massage therapists who were interventionists in a randomized controlled trial participated in structured interviews approximately 30 minutes in length. Interviews focused on their experiences and perceptions regarding aspects of the clinical trial, as well as recommendations for future trials. Transcribed interviews were analyzed for emergent topics and themes using standard qualitative methods. RESULTS: Six themes emerged. Therapists discussed 1) promoting the profession of massage therapy through research, 2) mixed views on using standardized protocols, 3) challenges of sham interventions, 4) participant response to the sham intervention, 5) views on scheduling and compensation, and 6) unanticipated benefits of participating in research. CONCLUSIONS: Therapists largely appreciated the opportunity to promote massage through research. They demonstrated insight and understanding of the rationale for a clinical trial adhering to a standardized protocol. Evaluating the experiences and ideas of complementary and alternative medicine practitioners provides valuable insight that is relevant for the implementation and design of randomized trials.

Fibromyalgia Impact and Mindfulness Characteristics in 4986 People with Fibromyalgia.

CONTEXT AND OBJECTIVE: A growing body of literature suggests that mindfulness techniques may be beneficial in fibromyalgia. A recent systematic review and meta-analysis of six trials indicated improvement in depressive symptoms and quality of life, calling for increased rigor and use of standardized measures in future trials. The purpose of the study was to examine the relationship between mindfulness [as measured by the Five Facet Mindfulness Questionnaire (FFMQ)] and fibromyalgia impact [as measured by the Revised Fibromyalgia Impact Questionnaire (FIQR)]. DESIGN, SETTING, AND PARTICIPANTS: A cross-sectional survey was conducted with adults diagnosed with fibromyalgia from a national fibromyalgia advocacy foundation e-mail list. RESULTS: A total of 4986 respondents represented all 50 states in the United States and 30 countries. FIQR scores demonstrated moderate to severe fibromyalgia with the majority of subjects (59%) scoring ≤60. Scores on the FFMQ subscales ranged from 20.8 to 27.3, with highest scores for the observe subscale. All subscale correlations were small to moderate and indicated that more severe fibromyalgia impact was associated with less mindfulness except in the observe scale (r = .15, P > .000). No clinical or demographics explained as much variance in the FIQR total as any of the mindfulness subscales. CONCLUSIONS: Fibromyalgia patients experience symptoms that may be alleviated by mindfulness interventions. Baseline values for the observe subscale of the FFMQ were unexpectedly high. Further research is needed to know if this may be due to non-mindful observations and should be noted when the FFMQ is used in fibromyalgia clinical trials.

A point-of-sale communications campaign to provide consumers safety information on drug-dietary supplement interactions: a pilot study.

Concurrent use of dietary supplements with over-the-counter and prescription pharmaceuticals has become increasingly common, and with this trend, so has the incidence of adverse drug-supplement interactions. In the current market, consumers have no way to distinguish between safe and potentially harmful supplements. Thus, the primary objective of this study was to test the hypothesis that messages designed to increase consumers' awareness of potential health risks of concurrent use of dietary supplements with over-the-counter and prescription pharmaceuticals would promote further consideration and action, as evidenced by (a) seeking additional information from an authoritative source or qualified health care professional and (b) changing dietary supplement usage patterns. To test this hypothesis, an innovative consumer information delivery system, referred to as the Buyer Information Network (BuyIN), was utilized. BuyIN uses currently available, Web-enabled point-of-sale (POS) technology to provide up-to-date, evidence-based, health- and safety-related messages to consumers at the retail checkout counter. Results showed that more than one-fourth (27.1%) of consumers (n = 199) who purchased targeted items reported they were aware of the messages. Of this subgroup of aware consumers, 11.2% reported that they sought additional information from a physician or pharmacist, 11.5% reported that they visited the website listed on the coupon, and 10.5% indicated that they changed their dietary supplement usage patterns as a result of the messages. Future research should include a large-scale study of a fully implemented and capable system at multiple test sites around the country, including investigating the utility of BuyIN in different retail settings.

Development of a manualized protocol of massage therapy for clinical trials in osteoarthritis.

BACKGROUND: Clinical trial design of manual therapies may be especially challenging as techniques are often individualized and practitioner-dependent. This paper describes our methods in creating a standardized Swedish massage protocol tailored to subjects with osteoarthritis of the knee while respectful of the individualized nature of massage therapy, as well as implementation of this protocol in two randomized clinical trials. METHODS: The manualization process involved a collaborative process between methodologic and clinical experts, with the explicit goals of creating a reproducible semi-structured protocol for massage therapy, while allowing some latitude for therapists' clinical judgment and maintaining consistency with a prior pilot study. RESULTS: The manualized protocol addressed identical specified body regions with distinct 30- and 60-min protocols, using standard Swedish strokes. Each protocol specifies the time allocated to each body region. The manualized 30- and 60-min protocols were implemented in a dual-site 24-week randomized dose-finding trial in patients with osteoarthritis of the knee, and is currently being implemented in a three-site 52-week efficacy trial of manualized Swedish massage therapy. In the dose-finding study, therapists adhered to the protocols and significant treatment effects were demonstrated. CONCLUSIONS: The massage protocol was manualized, using standard techniques, and made flexible for individual practitioner and subject needs. The protocol has been applied in two randomized clinical trials. This manualized Swedish massage protocol has real-world utility and can be readily utilized both in the research and clinical settings. TRIAL REGISTRATION: Clinicaltrials.gov NCT00970008 (18 August 2009).

Massage therapy for osteoarthritis of the knee: a randomized dose-finding trial.

BACKGROUND: In a previous trial of massage for osteoarthritis (OA) of the knee, we demonstrated feasibility, safety and possible efficacy, with benefits that persisted at least 8 weeks beyond treatment termination. METHODS: We performed a RCT to identify the optimal dose of massage within an 8-week treatment regimen and to further examine durability of response. Participants were 125 adults with OA of the knee, randomized to one of four 8-week regimens of a standardized Swedish massage regimen (30 or 60 min weekly or biweekly) or to a Usual Care control. Outcomes included the Western Ontario and McMaster Universities Arthritis Index (WOMAC), visual analog pain scale, range of motion, and time to walk 50 feet, assessed at baseline, 8-, 16-, and 24-weeks. RESULTS: WOMAC Global scores improved significantly (24.0 points, 95% CI ranged from 15.3-32.7) in the 60-minute massage groups compared to Usual Care (6.3 points, 95% CI 0.1-12.8) at the primary endpoint of 8-weeks. WOMAC subscales of pain and functionality, as well as the visual analog pain scale also demonstrated significant improvements in the 60-minute doses compared to usual care. No significant differences were seen in range of motion at 8-weeks, and no significant effects were seen in any outcome measure at 24-weeks compared to usual care. A dose-response curve based on WOMAC Global scores shows increasing effect with greater total time of massage, but with a plateau at the 60-minute/week dose. CONCLUSION: Given the superior convenience of a once-weekly protocol, cost savings, and consistency with a typical real-world massage protocol, the 60-minute once weekly dose was determined to be optimal, establishing a standard for future trials. TRIAL REGISTRATION: ClinicalTrials.gov NCT00970008.

Effect of fruit and vegetable concentrates on endothelial function in metabolic syndrome: a randomized controlled trial.

BACKGROUND AND OBJECTIVE: Dehydrated fruit and vegetable concentrates provide an accessible form of phytonutrient supplementation that may offer cardioprotective effects. This study assessed the effects of two blends of encapsulated juice powder concentrates (with and without added berry powders) on endothelial function in persons with metabolic syndrome, a risk factor for type 2 diabetes and cardiovascular disease. METHODS: Randomized, double blind, placebo controlled crossover clinical trial with three treatment arms. 64 adults with metabolic syndrome were enrolled and received 8-week sequences of each blend of the concentrates and placebo. The primary outcome measure was change in endothelial function (assessed as flow-mediated dilatation of the brachial artery) 2 hr after consuming a 75 g glucose load, after 8-weeks of daily consumption (sustained) or 2 hr after consumption of a single dose (acute). Secondary outcome measures included plasma glucose, serum insulin, serum lipids, and body weight. RESULTS: No significant between-group differences in endothelial function with daily treatment for 8 weeks were seen. No other significant treatment effects were discerned in glucose, insulin, lipids, and weight. CONCLUSION: Encapsulated fruit and vegetable juice powder concentrates did not alter insulin or glucose measures in this sample of adults with metabolic syndrome. TRIAL REGISTRATION: clinicaltrials.gov NCT01224743.

Chromium effects on glucose tolerance and insulin sensitivity in persons at risk for diabetes mellitus.

OBJECTIVE: To investigate the effects of daily chromium picolinate supplementation on serum measures of glucose tolerance and insulin sensitivity in patients at high risk for type 2 diabetes mellitus. METHODS: We conducted a randomized, double-blind, placebo-controlled, modified cross-over clinical trial with 6-month sequences of intervention and placebo followed by a 6-month postintervention assessment. Adult patients with impaired fasting glucose, impaired glucose tolerance, or metabolic syndrome were enrolled. Participants received 6-month sequences of chromium picolinate or placebo at 1 of 2 dosages (500 or 1000 mcg daily). Primary outcome measures were change in fasting plasma glucose, 2-hour plasma glucose during oral glucose tolerance testing, fasting and 2-hour insulin, and homeostasis model assessment of insulin resistance (HOMA-IR). Secondary outcomes included anthropometric measures, blood pressure, endothelial function, hemoglobin A1c, lipids, and urinary microalbumin. RESULTS: Fifty-nine participants were enrolled. No changes were seen in glucose level, insulin level, or HOMA-IR (all P>.05) after 6 months of chromium at either dosage level (500 mcg or 1000 mcg daily) when compared with placebo. None of the secondary outcomes improved with either chromium dosage compared with placebo (P>.05). CONCLUSIONS: Chromium supplementation does not appear to ameliorate insulin resistance or impaired glucose metabolism in patients at risk for type 2 diabetes and thus is unlikely to attenuate diabetes risk.

A brief report: Yale Research Symposium on Complementary and Integrative Medicine.

The 2010 Yale Research Symposium on Complementary and Integrative Medicine highlighted original research in related areas by Yale faculty and provided a forum to discuss and debate issues of evidence and plausibility. In this brief report, we describe selected presentations on such diverse foci as nutritional influences on cancer, acupuncture for low back pain, protein intake's effects on bone consumption, Chinese herb-derived adjuvant chemotherapy, and the relationship between anger and cardiac arrhythmia. This symposium demonstrated that rigorous research methods are being used to study unconventional therapies and that an integrative medicine approach requires a solid scientific foundation.

A pilot study of chromium picolinate for weight loss.

BACKGROUND: Chromium is an essential trace element and nutritional supplement that has garnered interest for use as a weight loss aid. OBJECTIVE: This trial assesses the effects of chromium picolinate supplementation, alone and combined with nutritional education, on weight loss in apparently healthy overweight adults. DESIGN: This was a randomized, double-blind, placebo-controlled trial of 80 otherwise healthy, overweight adults assessed at baseline for central adiposity measured by computerized tomography. Subjects were randomly assigned to daily ingestion of 1000 microg of chromium picolinate or placebo for 24 weeks. All subjects received passive nutritional education at the 12-week point in both the intervention and control groups. Outcomes include weight, height, blood pressure, percent body fat, serum, and urinary biomarkers. RESULTS: At baseline, both the chromium and placebo groups had similar mean body mass index (BMI) (chromium = 36 +/- 6.7 kg/m(2) versus placebo = 36.1 +/- 7.6 kg/m(2); p = 0.98). After 12 weeks, no change was seen in BMI in the intervention as compared to placebo (chromium = 0.3 +/- 0.8 kg/m(2) versus placebo = 0.0 +/- 0.4 kg/m(2); p = 0.07). No change was seen in BMI after 24 weeks in the intervention as compared to placebo (chromium = 0.1 +/- 0.2 kg/m(2) versus placebo = 0.0 +/- 0.5 kg/m(2); p = 0.81). Variation in central adiposity did not affect any outcome measures. CONCLUSIONS: Supplementation of 1000 microg of chromium picolinate alone, and in combination with nutritional education, did not affect weight loss in this population of overweight adults. Response to chromium did not vary with central adiposity.

Intravenous micronutrient therapy (Myers' Cocktail) for fibromyalgia: a placebo-controlled pilot study.

OBJECTIVES: Intravenous micronutrient therapy (IVMT), and specifically the Myers' Cocktail, is a popular approach for treating fibromyalgia syndrome (FMS) among complementary and alternative medicine practitioners, but its efficacy is uncertain. This trial assessed the feasibility, safety, and provided insights into the efficacy of this therapy. DESIGN: This was a randomized, double-blind, placebo-controlled pilot study. LOCATIONS: The study locations were an academic research center, teaching hospital, and affiliated Integrative Medicine Center in Derby, CT. SUBJECTS: The subjects were 34 adults with American College of Rheumatology (ACR)-defined FMS. INTERVENTION: Subjects were randomly assigned either to treatment (weekly infusions of IVMT) or to placebo (weekly infusions of lactated Ringer's solution) for 8 weeks. OUTCOME MEASURES: Primary outcome was change in the Tender Point Index, assessed 8 and 12 weeks after initiation. Secondary measures included a Visual Analog Scale to assess global pain, and validated measures of physical function (Fibromyalgia Impact Questionnaire), mood (Beck Depression Index), and quality of life (Health Status Questionnaire 2.0). RESULTS: Clinically significant improvements were noted (of a magnitude similar to other effective interventions). However, in part because of the high placebo response and the small sample size, no statistically significant differences were seen between groups, in any outcome measure, at 8 and 16 weeks. Statistically significant within-group differences were seen in both the intervention and placebo groups, demonstrating a treatment effect for both IVMT and placebo. At 8 weeks, the IVMT group experienced significantly improved tender points, pain, depression, and quality of life directly following treatment (all p < or = 0.02), while the placebo group experienced significantly improved tender points only (p < or = 0.05). The treatment effects of IVMT persisted at 4 weeks postintervention for tender points, pain, and quality of life, while placebo effects persisted only for tender points. A single minor adverse event was noted in one subject in the intervention group. CONCLUSIONS: This first controlled pilot study established the safety and feasibility of treating FMS with IVMT. Most subjects experienced relief as compared to baseline, but no statistically significant differences were seen between IVMT and placebo. The efficacy of IVMT for fibromyalgia, relative to placebo, is as yet uncertain.