Effects of a Mindfulness-Based Weight Loss Intervention on Long-Term Psychological Well-Being Among Adults with Obesity: Secondary Analyses from the Supporting Health by Integrating Nutrition and Exercise (SHINE) Trial.

Objective: This study tested whether a mindfulness-based intervention for obesity that included components aimed at emotion regulation and mindful eating improved psychological outcomes including stress, anxiety, positive emotion, and depression, during the intervention period and at longer-term follow-up. Methods: Adults with obesity (N=194) were randomized to a 5.5-month diet-exercise weight loss intervention with or without mindfulness training focused on emotion regulation and mindful eating. Participants completed self-report measures of mindfulness and psychological well-being, which were planned secondary outcomes, at baseline, mid-intervention (3 months), and at 6-, 12-, and 18-months post-baseline (maintenance period). Mixed effects models and linear regression were used to test between- and within-group changes in psychological well-being. Finally, this study explored whether changes in mindfulness (from baseline to each 6- and 18-months post-baseline) mediated the effects of intervention arm on changes in psychological outcomes during those respective time periods. This study explored whether changes in mindfulness from baseline to 6 months mediated the effects of intervention arm on changes in psychological outcomes from baseline to 18 months. Results: Participants randomized to the mindfulness arm had significant increases in positive emotions at all follow-up times compared to controls. There were statistically significant increases in mindfulness, psychological flexibility, and reflection, as well as decreases in anxiety and depressive symptoms at 12 months compared to control participants. These changes remained significant for psychological flexibility and reflection at 18 months. There were no significant differences in perceived stress. Among mindfulness participants, greater increases in mindfulness from 6-18 months was associated with greater positive emotions and psychological flexibility as well as lower perceived stress, anxiety, depressive symptoms, and rumination at 18 months, adjusting for 6-month values. Mediation analyses indicated that randomization to the mindfulness intervention arm was associated with 6-month increases in mindfulness, and these increases were in turn associated with improved psychological outcomes at 6 months and 18 months. Changes from baseline to 18 months did not mediate 18-month changes in psychological outcomes. Conclusions: Mindfulness training in emotion regulation and mindful eating may provide greater longer-term psychological well-being benefits in non-clinical populations with obesity compared to conventional diet-exercise interventions.

Exploratory Analysis of Racial/Ethnic and Educational Differences in a Randomized Controlled Trial of a Mindfulness-Based Weight Loss Intervention.

OBJECTIVE: People of color and lower socioeconomic groups have higher obesity prevalence, lose less weight compared with Whites and higher socioeconomic groups, and are underrepresented in randomized controlled trials of mindfulness-based interventions. We examined whether mindfulness approaches reduce disparities in weight loss interventions. METHODS: We analyzed data from a randomized controlled trial of 194 participants with obesity (41% participants of color, 36% without college degree) comparing a 5.5-month mindfulness-based weight loss intervention to an active-control with identical diet-exercise guidelines. We assessed attendance, 18-month attrition, and weight change at 6, 12, and 18 months by race/ethnicity and education level using linear mixed models, adjusting for baseline body mass index, age, and education or race/ethnicity, respectively. RESULTS: Participants without versus with a college degree attended fewer sessions and had higher attrition across interventions. Participants of color attended fewer intervention sessions in the mindfulness compared with the control intervention. Overall, participants of color lost significantly less weight at 12 and 18 months compared with Whites. However, during the 6- to 18-month maintenance period, we found an interaction of intervention arm, race/ethnicity, and time (p = .035), indicating that participants of color compared with Whites regained more weight in the control (0.33 kg/mo; p = .005) but not mindfulness intervention (0.06 kg/mo; p = .62). Participants without a college degree had greater initial weight loss in the mindfulness compared to control intervention from 0 to 6 months (-0.46 kg/mo; p = .039). CONCLUSIONS: Although disparities persist, mindfulness approaches may mitigate some racial/ethnic and socioeconomic differences in weight loss compared with conventional diet-exercise programs.Trial Registration: Clinicaltrials.gov registration: NCT00960414.

A Community Choir Intervention to Promote Well-Being Among Diverse Older Adults: Results From the Community of Voices Trial.

OBJECTIVES: To test effects of the Community of Voices choir intervention on the health, well-being, and health care costs of racial/ethnically diverse older adults. METHOD: Twelve Administration-on-Aging-supported senior centers were cluster randomized into two groups: the intervention group started the choir immediately and a wait-list control group began the choir 6 months later. The choir program was designed for community-dwelling adults aged 60 years and older. The multimodal intervention comprises activities that engage participants cognitively, physically, and socially. Outcome measures assessed these three domains as well as health care utilization and costs. The intention-to-treat comparison was at 6 months. RESULTS: The sample (N = 390) had a mean age of 71.3 years (SD = 7.2); 65% were nonwhite. Six-month retention was 92%. Compared to controls, intervention group members experienced significantly greater improvements in loneliness (p = .02; standardized effect size [ES = 0.34] and interest in life (p = .008, ES = 0.39). No significant group differences were observed for cognitive or physical outcomes or for health care costs. DISCUSSION: Findings support adoption of community choirs for reducing loneliness and increasing interest in life among diverse older adults. Further efforts need to examine the mechanisms by which engagement in choirs improves aspects of well-being and reduces health disparities among older adults, including potential longer-term effects. CLINICALTRIALS.GOV REGISTRATION: NCT01869179 registered January 9, 2013.

A Randomized Controlled Trial of a Mindfulness-Based Weight Loss Intervention on Cardiovascular Reactivity to Social-Evaluative Threat Among Adults with Obesity.

OBJECTIVE: Mindfulness-based interventions have been found to reduce psychological and physiological stress reactivity. In obesity, however, stress reactivity is complex, with studies showing both exaggerated and blunted physiological responses to stressors. A nuanced view of stress reactivity is the "challenge and threat" framework, which defines adaptive and maladaptive patterns of psychophysiological stress reactivity. We hypothesized that mindfulness training would facilitate increased challenge-related appraisals, emotions, and cardiovascular reactivity, including sympathetic nervous system activation paired with increased cardiac output (CO) and reduced total peripheral resistance (TPR) compared to a control group, which would exhibit an increased threat pattern of psychophysiological reactivity to repeated stressors. METHODS: Adults (N=194) with obesity were randomized to a 5.5-month mindfulness-based weight loss intervention or an active control condition with identical diet-exercise guidelines. Participants were assessed at baseline and 4.5 months later using the Trier Social Stress Task. Electrocardiogram, impedance cardiography, and blood pressure were acquired at rest and during the speech and verbal arithmetic tasks to assess pre-ejection period (PEP), CO, and TPR reactivity. RESULTS: Mindfulness participants showed significantly greater maintenance of challenge-related emotions and cardiovascular reactivity patterns (higher CO and lower TPR) from pre to post-intervention compared to control participants, but groups did not differ in PEP. Findings were independent of changes in body mass index. CONCLUSIONS: Mindfulness training may increase the ability to maintain a positive outlook and mount adaptive cardiovascular responses to repeated stressors among persons with obesity though findings need to be replicated in other populations and using other forms of mindfulness interventions.

Weight Loss Maintenance and Cellular Aging in the Supporting Health Through Nutrition and Exercise Study.

OBJECTIVE: The aim of the study was to determine, within a weight loss clinical trial for obesity, the impact of intervention arm, weight change, and weight loss maintenance on telomere length (TL). METHODS: Adults (N = 194) with a body mass index between 30 and 45 were randomized to a 5.5-month weight loss program with (n = 100) or without (n = 94) mindfulness training and identical diet-exercise guidelines. We assessed TL at baseline and 3-, 6-, and 12-month postbaseline in immune cell populations (primarily in peripheral blood mononuclear cells [PBMCs], but also in granulocytes and T and B lymphocytes). We defined weight loss maintenance as having lost at least 5% or 10% of body weight (tested in separate models) from preintervention to postintervention, and having maintained this loss at 12 months. We predicted that greater weight loss and weight loss maintenance would be associated with TL lengthening. RESULTS: Neither weight loss intervention significantly predicted TL change nor did amount of weight change, at any time point. Across all participants, weight loss maintenance of at least 10% was associated with longer PBMC TL (b = 239.08, 95% CI = 0.92 to 477.25, p = .049), CD8+ TL (b = 417.26, 95% CI = 58.95 to 775.57, p = .023), and longer granulocyte TL (b = 191.56, 95% CI = -4.23 to 387.35, p = .055) at 12 months after accounting for baseline TL. Weight loss maintenance of 5% or more was associated with longer PBMC TL (b = 163.32, 95% CI = 4.00 to 320.62, p = .045) at 12 months after accounting for baseline TL. These tests should be interpreted in light of corrections for multiple tests. CONCLUSIONS: Among individuals with obesity, losing and maintaining a weight loss of 10% or more may lead to TL lengthening, which may portend improved immune and metabolic function. TL lengthening in this study is of unknown duration beyond 12 months and requires further study. TRIAL REGISTRATION: Clinicaltrials.govidentifierNCT00960414; Open Science Framework (OSF) preregistration: https://osf.io/t3r2g/.

A randomized, controlled trial of mindfulness-based stress reduction in HIV infection.

OBJECTIVE: Evidence links depression and stress to more rapid progression of HIV-1 disease. We conducted a randomized controlled trial to test whether an intervention aimed at improving stress management and emotion regulation, mindfulness-based stress reduction (MBSR), would improve immunological (i.e. CD4+ T-cell counts) and psychological outcomes in persons with HIV-1 infection. METHODS: We randomly assigned participants with HIV-1 infection and CD4 T-cell counts >350 cells/µl who were not on antiretroviral therapy in a 1:1 ratio to either an MBSR group (n = 89) or an HIV disease self-management skills group (n = 88). The study was conducted at the University of California at San Francisco. We assessed immunologic (CD4, c-reactive protein, IL-6, and d-dimer) and psychological measures (Beck Depression Inventory for depression, modified Differential Emotions Scale for positive and negative affect, Perceived stress-scale, and mindfulness) at 3, 6 and 12 months after initiation of the intervention; we used multiple imputation to address missing values. RESULTS: We observed statistically significant improvements from baseline to 3-months within the MBSR group in depression, positive and negative affect, perceived stress, and mindfulness; between group differences in change were significantly greater in the MBSR group only for positive affect (per item difference on DES-positive 0.25, 95% CI 0.049, 0.44, p = .015). By 12 months the between group difference in positive affect was not statistically significant, although both groups had trends toward improvements compared to baseline in several psychological outcomes that were maintained at 12-months; these improvements were only statistically significant for depression and negative affect in the MBSR group and perceived stress for the control group. The groups did not differ significantly on rates of antiretroviral therapy initiation (MBSR = 39%, control = 29%, p = .22). After 12 months, the mean decrease in CD4+ T-cell count was 49.6 cells/µl in participants in the MBSR arm, compared to 54.2 cells/µl in the control group, a difference of 4.6 cells favoring the MBSR group (95% CI, -44.6, 53.7, p = .85). The between group differences in other immunologic-related outcomes (c-reactive protein, IL-6, HIV-1 viral load, and d-dimer) were not statistically significant at any time point. CONCLUSIONS: MBSR improved positive affect more than an active control arm in the 3 months following the start of the intervention. However, this difference was not maintained over the 12-month follow-up and there were no significant differences in immunologic outcomes between intervention groups. These results emphasize the need for further carefully designed research if we are to translate evidence linking psychological states to immunological outcomes into evidence-based clinical practices.

Impact of a Mindfulness-Based Weight-Loss Intervention on Sleep Quality Among Adults with Obesity: Data from the SHINE Randomized Controlled Trial.

BACKGROUND AND OBJECTIVE: Sleep disturbance is a common problem among adults with obesity. Mindfulness interventions have been shown to improve sleep quality in various populations but have not been investigated in adults with obesity. The aim of this study was to compare the effects of a mindfulness-based weight-loss intervention with an active control on self-reported sleep quality among adults with obesity. METHOD: This study was a secondary analysis of a randomized controlled trial and included 194 adults with a body mass index in the range 30-45 kg/m2. The treatment intervention included mindfulness-based eating and stress-management practices, and the active control intervention included training in progressive muscle relaxation (PMR). Both groups received identical diet and exercise guidelines in 17 group sessions conducted over 5.5 months that were matched for time, attention, and social support. The primary outcome of this analysis was between-group change in self-reported sleep quality, which was assessed using the Pittsburgh Sleep Quality Index (PSQI) global score at baseline and at 6, 12, and 18 months. RESULTS: Between-group differences in mean PSQI change scores in the mindfulness group (n = 100) compared to the control group (n = 94) were -0.27 (-0.68, 1.22; p = 0.58) at 6 months, -0.57 (-0.35, 1.50; p = 0.22) at 12 months, and -0.50 (-0.53, 1.53; p = 0.34) at 18 months, all in the direction of more sleep improvement in the mindfulness group but none reaching statistical significance. In the mindfulness group, average weekly minutes of meditation practice time was associated with improved sleep quality from baseline to 6 months. CONCLUSIONS: No statistically significant evidence was found that a weight-loss program that incorporates mindfulness improves self-reported sleep quality compared to a control diet/exercise intervention that included PMR. Within the mindfulness group, average weekly minutes of mindfulness practice was associated with improved sleep quality.

Effects of a mindfulness-based weight loss intervention in adults with obesity: A randomized clinical trial.

OBJECTIVE: To determine whether adding mindfulness-based eating and stress management practices to a diet-exercise program improves weight loss and metabolic syndrome components. METHODS: In this study 194 adults with obesity were randomized to a 5.5-month program with or without mindfulness training and identical diet-exercise guidelines. Intention-to-treat analyses with multiple imputation were used for missing data. The primary outcome was 18-month weight change. RESULTS: Estimated effects comparing the mindfulness to control arm favored the mindfulness arm in (a) weight loss at 12 months, -1.9 kg (95% CI: -4.5, 0.8; P = 0.17), and 18 months, -1.7 kg (95% CI: -4.7, 1.2; P = 0.24), though not statistically significant; (b) changes in fasting glucose at 12 months, -3.1 mg/dl (95% CI: -6.3, 0.1; P = 0.06), and 18 months, -4.1 mg/dl (95% CI: -7.3, -0.9; P = 0.01); and (c) changes in triglyceride/HDL ratio at 12 months, -0.57 (95% CI: -0.95, -0.18; P = 0.004), and 18 months, -0.36 (95% CI: -0.74, 0.03; P = 0.07). Estimates for other metabolic risk factors were not statistically significant, including waist circumference, blood pressure, and C-reactive protein. CONCLUSIONS: Mindfulness enhancements to a diet-exercise program did not show substantial weight loss benefit but may promote long-term improvement in some aspects of metabolic health in obesity that requires further study.

Reduced reward-driven eating accounts for the impact of a mindfulness-based diet and exercise intervention on weight loss: Data from the SHINE randomized controlled trial.

Many individuals with obesity report over eating despite intentions to maintain or lose weight. Two barriers to long-term weight loss are reward-driven eating, which is characterized by a lack of control over eating, a preoccupation with food, and a lack of satiety; and psychological stress. Mindfulness training may address these barriers by promoting awareness of hunger and satiety cues, self-regulatory control, and stress reduction. We examined these two barriers as potential mediators of weight loss in the Supporting Health by Integrating Nutrition and Exercise (SHINE) randomized controlled trial, which compared the effects of a 5.5-month diet and exercise intervention with or without mindfulness training on weight loss among adults with obesity. Intention-to-treat multiple mediation models tested whether post-intervention reward-driven eating and psychological stress mediated the impact of intervention arm on weight loss at 12- and 18-months post-baseline among 194 adults with obesity (BMI: 30-45). Mindfulness (relative to control) participants had significant reductions in reward-driven eating at 6 months (post-intervention), which, in turn, predicted weight loss at 12 months. Post-intervention reward-driven eating mediated 47.1% of the total intervention arm effect on weight loss at 12 months [ß = -0.06, SE(ß) = 0.03, p = .030, 95% CI (-0.12, -0.01)]. This mediated effect was reduced when predicting weight loss at 18 months (p = .396), accounting for 23.0% of the total intervention effect, despite similar weight loss at 12 months. Psychological stress did not mediate the effect of intervention arm on weight loss at 12 or 18 months. In conclusion, reducing reward-driven eating, which can be achieved using a diet and exercise intervention that includes mindfulness training, may promote weight loss (clinicaltrials.gov registration: NCT00960414).

Effects of a mindfulness-based intervention on mindful eating, sweets consumption, and fasting glucose levels in obese adults: data from the SHINE randomized controlled trial.

We evaluated changes in mindful eating as a potential mechanism underlying the effects of a mindfulness-based intervention for weight loss on eating of sweet foods and fasting glucose levels. We randomized 194 obese individuals (M age = 47.0 ± 12.7 years; BMI = 35.5 ± 3.6; 78% women) to a 5.5-month diet-exercise program with or without mindfulness training. The mindfulness group, relative to the active control group, evidenced increases in mindful eating and maintenance of fasting glucose from baseline to 12-month assessment. Increases in mindful eating were associated with decreased eating of sweets and fasting glucose levels among mindfulness group participants, but this association was not statistically significant among active control group participants. Twelve-month increases in mindful eating partially mediated the effect of intervention arm on changes in fasting glucose levels from baseline to 12-month assessment. Increases in mindful eating may contribute to the effects of mindfulness-based weight loss interventions on eating of sweets and fasting glucose levels.

Feasibility and Preliminary Efficacy of a Novel RDoC-Based Treatment Program for Adolescent Depression: "Training for Awareness Resilience and Action" (TARA)-A Pilot Study.

BACKGROUND: The novel group treatment program Training for Awareness, Resilience, and Action (TARA) was developed to target specific mechanisms based on neuroscience findings in adolescent depression and framed within the National Institute of Mental Health Research Domain Criteria. TARA contains training of autonomic and emotional self-regulation, interoceptive awareness, relational skills, and value-based committed action. METHODS: We performed a single-arm trial to test the feasibility and preliminary efficacy of TARA in reducing depression and anxiety levels and assessed whether the specific targeted domains of function reflected the hypothesized symptom change. Twenty-six adolescents (14-18 years old, 7 males and 19 females) participated in the 12-week group program. Assessment was performed before (T0), immediately after (T1), and 3 months after the end of TARA (T2). RESULTS: Significant improvement was seen in depression symptoms (Reynolds Adolescent Depression Scale Second Edition) between T0-T1 (t-value = -3.56, p = 0.002, CI = -6.64, -1.77) and T0-T2 (t-value = -4.17, p < 0.001, CI = -11.20, -3.75) and anxiety symptoms (Multidimensional Anxiety Scale for Children) between T0-T1 (t-value = -2.26, p = 0.033, CI = -4.61, -0.21) and T0-T2 (t-value = -3.06, p = 0.006, 95% confidence interval = -9.02, -1.73). Significant improvements in psychological flexibility, sleep, and mindfulness skills were also found between T0 and T2. LIMITATIONS: The sample size was small without a control condition. The pilot design did not allow for testing the hypothesized brain changes and effect of TARA on relevant systemic biomarkers. CONCLUSION: TARA is feasible in a sample of clinically depressed and/or anxious adolescents and preliminary efficacy was demonstrated by reduced depression and anxiety symptoms. The specific symptom and behavioral outcomes corresponded well with the hypothesized mechanisms of change.

Acute responses to opioidergic blockade as a biomarker of hedonic eating among obese women enrolled in a mindfulness-based weight loss intervention trial.

There are currently no commonly used or easily accessible 'biomarkers' of hedonic eating. Physiologic responses to acute opioidergic blockade, indexed by cortisol changes and nausea, may represent indirect functional measures of opioid-mediated hedonic eating drive and predict weight loss following a mindfulness-based intervention for stress eating. In the current study, we tested whether cortisol and nausea responses induced by oral ingestion of an opioidergic antagonist (naltrexone) correlated with weight and self-report measures of hedonic eating and predicted changes in these measures following a mindfulness-based weight loss intervention. Obese women (N = 88; age = 46.7 ± 13.2 years; BMI = 35.8 ± 3.8) elected to complete an optional sub-study prior to a 5.5-month weight loss intervention with or without mindfulness training. On two separate days, participants ingested naltrexone and placebo pills, collected saliva samples, and reported nausea levels. Supporting previous findings, naltrexone-induced cortisol increases were associated with greater hedonic eating (greater food addiction symptoms and reward-driven eating) and less mindful eating. Among participants with larger cortisol increases (+1 SD above mean), mindfulness participants (relative to control participants) reported greater reductions in food addiction symptoms, b = -0.95, SE(b) = 0.40, 95% CI [-1.74, -0.15], p = .021. Naltrexone-induced nausea was marginally associated with reward-based eating. Among participants who endorsed naltrexone-induced nausea (n = 38), mindfulness participants (relative to control participants) reported greater reductions in food addiction symptoms, b = -1.00, 95% CI [-1.85, -0.77], p = .024, and trended toward reduced reward-based eating, binge eating, and weight, post-intervention. Single assessments of naltrexone-induced cortisol increases and nausea responses may be useful time- and cost-effective biological markers to identify obese individuals with greater opioid-mediated hedonic eating drive who may benefit from weight loss interventions with adjuvant mindfulness training that targets hedonic eating.

Yoga breathing for cancer chemotherapy-associated symptoms and quality of life: results of a pilot randomized controlled trial.

BACKGROUND: Many debilitating symptoms arise from cancer and its treatment that are often unrelieved by established methods. Pranayama, a series of yogic breathing techniques, may improve cancer-related symptoms and quality of life, but it has not been studied for this purpose. OBJECTIVES: A pilot study was performed to evaluate feasibility and to test the effects of pranayama on cancer-associated symptoms and quality of life. DESIGN: This was a randomized controlled clinical trial comparing pranayama to usual care. SETTING: The study was conducted at a university medical center. SUBJECTS: Patients receiving cancer chemotherapy were randomized to receive pranayama immediately or after a waiting period (control group). INTERVENTIONS: The pranayama intervention consisted of four breathing techniques taught in weekly classes and practiced at home. The treatment group received pranayama during two consecutive cycles of chemotherapy. The control group received usual care during their first cycle, and received pranayama during their second cycle of chemotherapy. OUTCOME MEASURES: Feasibility, cancer-associated symptoms (fatigue, sleep disturbance, anxiety, depression, stress), and quality of life were the outcomes. RESULTS: Class attendance was nearly 100% in both groups. Sixteen (16) participants were included in the final intent-to-treat analyses. The repeated-measures analyses demonstrated that any increase in pranayama dose, with dose measured in the number of hours practiced in class or at home, resulted in improved symptom and quality-of-life scores. Several of these associations--sleep disturbance (p=0.04), anxiety (p=0.04), and mental quality of life (p=0.05)--reached or approached statistical significance. CONCLUSIONS: Yoga breathing was a feasible intervention among patients with cancer receiving chemotherapy. Pranayama may improve sleep disturbance, anxiety, and mental quality of life. A dose-response relationship was found between pranayama use and improvements in chemotherapy-associated symptoms and quality of life. These findings need to be confirmed in a larger study.

Hematopoietic cell transplant and use of massage for improved symptom management: results from a pilot randomized control trial.

Background. Pediatric hematopoietic cell transplant (HCT) is a lifesaving treatment that often results in physical and psychological discomfort. An acupressure-massage intervention may improve symptom management in this setting. Methods. This randomized controlled pilot trial compared a combined massage-acupressure intervention to usual care. Children were offered three practitioner-provided sessions per week throughout hospitalization. Parents were trained to provide additional acupressure as needed. Symptoms were assessed using nurses' reports and two questionnaires, the behavioral affective and somatic experiences scale and the Peds quality of life cancer module. Results. We enrolled 23 children, ages 5 to 18. Children receiving the intervention reported fewer days of mucositis (Hedges' g effect size ES = 0.63), lower overall symptom burden (ES = 0.26), feeling less tired and run-down (ES = 0.86), having fewer moderate/severe symptoms of pain, nausea, and fatigue (ES = 0.62), and less pain (ES = 0.42). The intervention group showed trends toward increasing contentness/serenity (ES = +0.50) and decreasing depression (ES = -0.45), but not decreased anxiety (ES = +0.42). Differences were not statistically significant. Discussion. Feasibility of studying massage-acupressure was established in children undergoing HCT. Larger studies are needed to test the efficacy of such interventions in reducing HCT-associated symptoms in children.

Use of complementary medicine in pediatric patients with inflammatory bowel disease: results from a multicenter survey.

OBJECTIVES: We examined the use of complementary and alternative medicine (CAM) at 3 US pediatric medical centers, comparing a group of children with inflammatory bowel disease (IBD) with children presenting with chronic constipation. MATERIALS AND METHODS: Surveys were administered by postal mail and at pediatric IBD centers in San Francisco, Houston, and Atlanta from 2001 to 2003. A comparison group consisting of pediatric patients with chronic constipation also was surveyed. Data were analyzed by t tests and by exact tests of contingency tables. RESULTS: In all, 236 surveys were collected from the IBD group; 126 surveys were collected from the chronic constipation comparison group. CAM therapies were used by 50% in the IBD group and 23% in the chronic constipation group. The overall regional breakdown of CAM use in IBD revealed no differences, although the types of CAM therapy used varied by site. The most commonly used CAM therapies in the IBD group were spiritual interventions (25%) and nutritional supplements (25%). Positive predictors for CAM use in IBD include the patient's self-reported overall health, an increase in the number of side effects associated with allopathic medications, white ethnicity, and parental education beyond high school. CONCLUSIONS: This is the first US study to characterize CAM use in pediatric patients with IBD with another chronic gastrointestinal disorder. CAM use was twice as common with the IBD group compared with the chronic constipation group. Regional variations exist with the types of CAM therapy used. Practitioners should know that half of their pediatric patients with IBD may be using CAM in conjunction with or as an alternative to other treatments and that certain predictors can help identify those using CAM therapies.

Symptom management with massage and acupuncture in postoperative cancer patients: a randomized controlled trial.

The level of evidence for the use of acupuncture and massage for the management of perioperative symptoms in cancer patients is encouraging but inconclusive. We conducted a randomized, controlled trial assessing the effect of massage and acupuncture added to usual care vs. usual care alone in postoperative cancer patients. Cancer patients undergoing surgery were randomly assigned to receive either massage and acupuncture on postoperative Days 1 and 2 in addition to usual care, or usual care alone, and were followed over three days. Patients' pain, nausea, vomiting, and mood were assessed at four time points. Data on health care utilization were collected. Analyses were done by mixed-effects regression analyses for repeated measures. One hundred fifty of 180 consecutively approached cancer patients were eligible and consented before surgery. Twelve patients rescheduled or declined after surgery, and 138 patients were randomly assigned in a 2:1 scheme to receive massage and acupuncture (n=93) or to receive usual care only (n=45). Participants in the intervention group experienced a decrease of 1.4 points on a 0-10 pain scale, compared to 0.6 in the control group (P=0.038), and a decrease in depressive mood of 0.4 (on a scale of 1-5) compared to +/-0 in the control group (P=0.003). Providing massage and acupuncture in addition to usual care resulted in decreased pain and depressive mood among postoperative cancer patients when compared with usual care alone. These findings merit independent confirmation using larger sample sizes and attention control.

Randomized, controlled trial of breath therapy for patients with chronic low-back pain.

CONTEXT: Patients suffering from chronic low back pain (cLBP) are often unsatisfied with conventional medical care and seek alternative therapies. Many mind-body techniques are said to help patients with low back pain by enhancing body awareness, which includes proprioception deficit in cLBP, but have not been rigorously studied in cLBP. Breath therapy is a western mind-body therapy integrating body awareness, breathing, meditation, and movement. Preliminary data suggest benefits from breath therapy for proprioception and low back pain. OBJECTIVE: To assess the effect of breath therapy on cLBP. DESIGN: Randomized, controlled trial. SETTING: Academic medical center. PARTICIPANTS: Thirty-six patients with cLBP. INTERVENTIONS: Six to eight weeks (12 sessions) of breath therapy versus physical therapy. MAIN OUTCOME MEASURES: Pain by visual analog scale (VAS), function by Roland Scale, overall health by Short Form 36 (SF-36) at baseline, six to eight weeks, and six months. Balance as a potential surrogate for proprioception and body-awareness measured at the beginning and end of treatment. RESULTS: Pre- to post-intervention, patients in both groups improved in pain (VAS: -2.7 with breath therapy, -2.4 with physical therapy; SF-36: +14.9 with breath therapy and +21.0 with physical therapy). Breath therapy recipients improved in function (Roland: -4.8) and in the physical and emotional role (SF-36: +15.5 and 14.3). Physical therapy recipients improved in vitality (SF-36: +15.0). Average improvements were not different between groups. At six to eight weeks, results showed a trend favoring breath therapy; at six-months, a trend favoring physical therapy. Balance measures showed no improvements and no correlations with other outcomes. CONCLUSIONS: Patients suffering from cLBP improved significantly with breath therapy. Changes in standard low back pain measures of pain and disability were comparable to those resulting from high-quality, extended physical therapy. Breath therapy was safe. Qualitative data suggested improved coping skills and new insight into the effect of stress on the body as a result of breath therapy. Balance measures did not seem to be valid measures of clinical change in patients' cLBP.