Effectiveness of therapeutic massage for generalized anxiety disorder: a randomized controlled trial.

BACKGROUND: Although massage is one of the most popular complementary and alternative medical (CAM) treatments for anxiety, its effectiveness has never been rigorously evaluated for a diagnosed anxiety disorder. This study evaluates the effectiveness of therapeutic massage for persons with generalized anxiety disorder (GAD). METHODS: Sixty-eight persons with GAD were randomized to therapeutic massage (n=23), thermotherapy (n=22), or relaxing room therapy (n=23) for a total of 10 sessions over 12 weeks. Mean reduction in anxiety was measured by the Hamilton Anxiety Rating Scale (HARS). Secondary outcomes included 50% reduction in HARS and symptom resolution of GAD, changes in depressive symptoms (Patient Health Questionnaire (PHQ-8)), worry and GAD-related disability. We compared changes in these outcomes in the massage and control groups posttreatment and at 6 months using generalized estimating equation (GEE) regression. RESULTS: All groups had improved by the end of treatment (adjusted mean change scores for the HARS ranged from -10.0 to -13.0; P<.001) and maintained their gains at the 26-week followup. No differences were seen between groups (P=.39). Symptom reduction and resolution of GAD, depressive symptoms, worry and disability showed similar patterns. CONCLUSIONS: Massage was not superior to the control treatments, and all showed some clinically important improvements, likely due to some beneficial but generalized relaxation response. Because the relaxing room treatment is substantially less expensive than the other treatments, a similar treatment packaged in a clinically credible manner might be the most cost effective option for persons with GAD who want to try relaxation-oriented CAM therapies.

A single-blind placebo run-in study of venlafaxine XR for activity-limiting osteoarthritis pain.

OBJECTIVE: Osteoarthritis pain is a significant problem for our aging population. Non-steroidal anti-inflammatory drugs and opioids are effective treatments, but have significant adverse effects, so there is a need for alternative treatments. Selective norepinephrine-serotonin reuptake inhibitor antidepressants may provide a new treatment option for osteoarthritis pain. METHODS: We performed a single-blind placebo run-in trial of 150-225 mg of venlafaxine in 18 subjects with activity-limiting osteoarthritis pain. Each subject received 2 weeks of placebo followed by 10 weeks of venlafaxine. The primary outcome was reduction in average pain intensity between 2 and 12 weeks. For subjects not completing the trial, their last observation was carried forward as an imputed outcome. RESULTS: Average pain on the Brief Pain Inventory (BPI) was 4.7 at baseline, 4.4 after the 2-week placebo run-in, and 3.3 at 12 weeks (25% decrease, P = 0.03). Nine subjects (50%) reported at least 30% pain reduction between weeks 2 and 12. The Western Ontario and McMasters University Osteoarthritis Index (WOMAC) pain score at baseline was 2.0, 1.8 after 2 weeks, and 1.7 after 12 weeks. This represented a 6% decrease in pain between weeks 2 and 12 (P = 0.42), with two subjects (11%) reported at least 30% pain relief between weeks 2 and 12 on the WOMAC. Effects on self-reported physical and role function and depression were marginal or non-significant, and observed physical function did not improve. CONCLUSION: Venlafaxine significantly reduced pain intensity on the BPI and marginally improved self-reported function. Venlafaxine should be investigated further in a larger randomized trial for the treatment of osteoarthritis pain.

Implementing a clinical and research registry in obstetrics: overcoming the barriers.

OBJECTIVE: This study aimed to describe the obstacles and solutions in developing and implementing a prospective obstetric database registry that collects biopsychosocial data on women during pregnancy and postpartum. The clinical goals of the registry were to improve both diagnosis of mental health and substance use problems and access to mental health care during pregnancy. The research goals were to examine the impact of psychiatric illness and substance use on birth outcomes. STUDY SETTING AND REGISTRY DESIGN: A questionnaire that contained validated instruments for mental health, substance use and psychosocial stressors was developed and administered to all pregnant women in an academic medical center obstetric clinic. Results were incorporated with reminder and decision support systems to ensure active follow-up of patients with mental health needs. Automated medical record information was collected for future analysis of outcomes. PROGRAM IMPLEMENTATION: Barriers to program implementation were overcome by a multifaceted intervention that included educational outreach to patients, providers and staff; integration of the registry into preexisting clinical protocols; reminder systems at workstations; provision of mental health decision support through perinatal social work and psychiatric consultation; and utilization of a "stepped-care" model to delivering mental health services. CONCLUSION: A mental health registry that merges clinical and research needs can be successfully integrated into the obstetric clinic setting.

Not the same everywhere. Patient-centered learning environments at nine medical schools.

BACKGROUND: Learning environments overtly or implicitly address patient-centered values and have been the focus of research for more than 40 years, often in studies about the "hidden curriculum." However, many of these studies occurred at single medical schools and used time-intensive ethnographic methods. This field of inquiry lacks survey methods and information about how learning environments differ across medical schools. OBJECTIVE: To examine patient-centered characteristics of learning environments at 9 U.S. medical schools. DESIGN: Cross-sectional internet-based survey. PARTICIPANTS: Eight-hundred and twenty-three third- and fourth-year medical students in the classes of 2002 and 2003. MEASUREMENTS: We measured the patient-centeredness of learning environments with the Communication, Curriculum, and Culture (C3) Instrument, a 29-item validated measure that characterizes the degree to which a medical school's environment fosters patient-centered care. The C3 Instrument contains 3 content areas (role modeling, students' experiences, and support for students' patient-centered behaviors), and is designed to measure these areas independent of respondents' attitudes about patient-centered care. We also collected demographic and attitudinal information from respondents. RESULTS: The variability of C3 scores across schools in each of the 3 content areas of the instrument was striking and statistically significant (P values ranged from .001 to .004). In addition, the patterns of scores on the 3 content areas differed from school to school. CONCLUSIONS: The 9 schools demonstrated unique and different learning environments both in terms of magnitude and patterns of characteristics. Further multiinstitutional study of hidden curricula is needed to further establish the degree of variability that exists, and to assist educators in making informed choices about how to intervene at their own schools.

Major depression.

Major depression is a common, disabling condition seen frequently in primary care practices. Non-psychiatrist ambulatory providers are increasingly responsible for diagnosing, and primarily managing patients suffering from major depressive disorder (MDD). The goal of this review is to help primary care providers to understand the natural history of MDD, identify practical tools for screening, and a thoughtful approach to management. Clinically challenging topics like co-morbid conditions, treatment resistant depression and pharmacotherapy selection with consideration to side effects and medication interactions, are also covered.

Comparative effectiveness of a prenatal medical food to prenatal vitamins on hemoglobin levels and adverse outcomes: a retrospective analysis.

BACKGROUND: The role of folate in pregnancy is well established, with most prenatal vitamins (PNVs) on the market containing at least 800 µg of folic acid. Folic acid must be converted in the body to L-methylfolate, the natural and biologically active form of folate. The role of vitamin B(12) in pregnancy is less characterized, and most PNV formulations contain only 0 to 12 µg. The present study was undertaken to evaluate whether taking a prenatal medical food containing L-methylfolate and much higher doses of vitamin B(12) results in higher hemoglobin levels and thus, a lower incidence of anemia during pregnancy. OBJECTIVE: The objective of this exploratory study was to evaluate the effects of the prenatal medical food versus standard PNVs on hemoglobin levels and adverse outcomes throughout pregnancy. METHODS: For this retrospective analysis, we reviewed the charts of female patients taking either a prenatal medical food or standard PNV during pregnancy. Hemoglobin levels measured at initiation of prenatal care, end of second trimester, and delivery were recorded. Patients who had received additional iron supplementation, beyond that contained in the prenatal medical food or PNV they were taking and before anemia screening at the end of the second trimester, were excluded from the study. Fisher exact test, χ(2) test, student t test, and ANOVA were used to evaluate differences between the treatment groups. RESULTS: Data were analyzed from 112 charts: 58 patients (51.8%) were taking the prenatal medical food; 54 patients (48.2%) were taking standard PNVs. Mean (SD) age at first prenatal visit was 27 (4.6) years in the medical food group and 28.8 (3.5) years in the PNV group (P = 0.024). Mean (SD) body mass indices were 29.1 (6.5) and 31.7 (8.9) in the medical food and PNV groups, respectively (P = NS). In the medical food group, 35 women (60.3%) were white/Caucasian, 17 (29.3%) were African American, and 6 (10.4%) were of other races. In the PNV group, 24 women (44.4%) were white/Caucasian, 25 (46.3%) were African American, and 5 (9.3%) were of other races. However, race was not significantly different between the two groups. At end of second trimester and at delivery, mean (SD) hemoglobin levels were higher in the prenatal medical food group (11.8 [1.1] g/dL and 11.8 [1.3] g/dL, respectively) than in the PNV group (11.3 [1.2] g/dL and 10.7 [1.2] g/dL, respectively) (P = 0.011 and P = 0.001, respectively). Significantly fewer cases of anemia were reported at end of second trimester in the prenatal medical food group than in the PNV group (39.7% vs 74.1%; P = 0.001). CONCLUSIONS: In the present study, supplementation with a prenatal medical food containing L-methylfolate and high-dose vitamin B(12) may maintain hemoglobin levels and decrease rates of anemia in pregnancy more effectively than standard prenatal vitamins; however, prospective, controlled studies are warranted. ClinicalTrials.gov identifier: NCT01193192.

A single-blind, placebo run-in study of duloxetine for activity-limiting osteoarthritis pain.

UNLABELLED: Osteoarthritis pain is a significant problem for our aging population. Antidepressants that are serotonin-norepinephrine reuptake inhibitors are effective for other forms of chronic pain and may provide a new treatment option for osteoarthritis pain. We performed a single-blind, placebo run-in trial of 60 to 90 mg of duloxetine in 25 subjects with activity-limiting osteoarthritis pain. Each subject received 2 weeks of placebo followed by 10 weeks of duloxetine. The primary outcome was reduction in average pain intensity between 2 and 12 weeks for subjects completing the trial. Average pain on the Brief Pain Inventory (BPI) was 5.7 at baseline, 4.8 after the 2-week placebo run-in, and 3.5 at 12 weeks for the 17 patients completing the trial (28% decrease between 2 and 12 weeks, P = .122). Eight of 15 study completers who had nonmissing BPI results (53%) reported at least 30% pain reduction between weeks 2 and 12. The Western Ontario McMaster Osteoarthritis Index (WOMAC) pain score at baseline was 2.3, 1.8 after 2 weeks, and 1.3 after 12 weeks (30% decrease between 2 and 12 weeks, P = .018). Ten of 17 patients (59%) reported at least 30% pain relief between weeks 2 and 12 on the WOMAC. Significant improvements in self-reported physical and role function were reported but observed physical function did not improve. PERSPECTIVE: Duloxetine did not significantly reduce pain intensity on the BPI but did improve pain intensity and self-reported function on the WOMAC. Duloxetine warrants further investigation as a novel treatment for osteoarthritis pain.