Olanzapine compared to lithium in mania: a double-blind randomized controlled trial.

Neuroleptics are of established efficacy in mania. Controlled data on the use of olanzapine in mania is however, absent. In this study, 30 patients meeting DSM-IV criteria for mania were randomly allocated to receive either olanzapine or lithium in a 4 week double-blind randomized controlled design. There were no significant outcome differences between the two groups on any of the primary outcome measures, the Brief Psychiatric Rating Scale (lithium 28.2; olanzapine 28.0; P = 0.44); Clinical Global Impression (CGI) improvement scale (lithium 2.75, olanzapine 2.36; P = 0.163) or the Mania Scale (lithium 13.2, olanzapine 10.2; P = 0.315). Olanzapine was however, significantly superior to lithium on the CGI-severity scale at week 4 (lithium 2.83, olanzapine 2.29; P = 0.025). Olanzapine did not differ from lithium in terms of treatment emergent extrapyramidal side-effects as measured by the Simpson-Angus Scale. Olanzapine appears to be at least as effective as lithium in the treatment of mania.

Risperidone compared with both lithium and haloperidol in mania: a double-blind randomized controlled trial.

Case reports and studies of other neuroleptics suggest the efficacy of risperidone in the treatment of mania. Forty-five inpatients with DSM-IV mania were studied in a 28-day randomized, controlled, double-blind trial of either 6 mg daily of risperidone, 10 mg daily of haloperidol, or 800 to 1200 mg daily of lithium. The patients in all three groups showed a similar improvement on the total score for all rating scales at day 28 (Brief Psychiatric rating scale; lithium 9.1, haloperidol 4.9, risperidone 6.5, F = 1.01, df = 2, p = 0.37; Mania rating scale; lithium 15.7, haloperidol 10.2, risperidone 12.4, F = 1.07, df = 2, p = 0.35 [analysis of variance]). The Global Assessment of Functioning and Clinical Global Impression data showed a similar pattern of improvement. This study suggests that risperidone is of equivalent efficacy to lithium and haloperidol in the management of acute mania. The extrapyramidal side effects of risperidone and haloperidol were not significantly different.

Superiority of lithium over verapamil in mania: a randomized, controlled, single-blind trial.

Both case reports and small controlled studies suggest the efficacy of verapamil in the treatment of mania.

The impact of whole-of-diet interventions on depression and anxiety: a systematic review of randomised controlled trials

Non-pharmacological approaches to the treatment of depression and anxiety are of increasing importance, with emerging evidence supporting a role for lifestyle factors in the development of these disorders. Observational evidence supports a relationship between habitual diet quality and depression. Less is known about the causative effects of diet on mental health outcomes. Therefore a systematic review was undertaken of randomised controlled trials of dietary interventions that used depression and/or anxiety outcomes and sought to identify characteristics of programme success.

A randomized controlled trial to reduce falls in people with Parkinson's Disease

Background. Falls are common and disabling in people with Parkinson's disease (PD). There is a need to quantify the effects of movement rehabilitation on falls in PD. Objective. To evaluate 2 physical therapy interventions in reducing falls in PD. Methods. We randomized 210 people with PD to 3 groups: progressive resistance strength training coupled with falls prevention education, movement strategy training combined with falls prevention education, and life-skills information (control). All received 8 weeks of out-patient therapy once per week and a structured home program. The primary end point was the falls rate, recorded prospectively over a 12 month period, starting from the completion of the intervention. Secondary outcomes were walking speed, disability, and quality of life. Results. A total of 1547 falls were reported for the trial. The falls rate was higher in the control group compared with the groups that received strength training or strategy training. There were 193 falls for the progressive resistance strength training group, 441 for the movement strategy group and 913 for the control group. The strength training group had 84.9% fewer falls than controls (incidence rate ratio [IRR] = 0.151, 95% CI 0.071-0.322, P < .001). The movement strategy training group had 61.5% fewer falls than controls (IRR = 0.385, 95% CI 0.184-0.808, P = .012). Disability scores improved in the intervention groups following therapy while deteriorating in the control group. Conclusions. Rehabilitation combining falls prevention education with strength training or movement strategy training reduces the rate of falls in people with mild to moderately severe PD and is feasible.

Long-term efficacy of a tele-health intervention for acute coronary syndrome patients with depression: 12-month results of the MoodCare randomized controlled trial

Depression is common after a cardiac event; however it often remains untreated. Previously, we reported the efficacy and feasibility of a 6-month tele-health programme (MoodCare), which integrates depression management into a cardiovascular disease (CVD) risk reduction programme for Acute Coronary Syndrome (ACS) patients with low mood. Here, we evaluate the long-term efficacy of the programme at 12-month follow-up.

Recovery of hypoglycemia awareness in long-standing type 1 diabetes: a multicenter 2 × 2 factorial randomized controlled trial comparing insulin pump with multiple daily injections and continuous with conventional glucose self-monitoring (HypoCOMPaSS)

To determine whether impaired awareness of hypoglycemia (IAH) can be improved and severe hypoglycemia (SH) prevented in type 1 diabetes, we compared an insulin pump (continuous subcutaneous insulin infusion [CSII]) with multiple daily injections (MDIs) and adjuvant real-time continuous glucose monitoring (RT) with conventional self-monitoring of blood glucose (SMBG).

Effectiveness of patient feedback as an educational intervention to improve medical student consultation (PTA Feedback Study): study protocol for a randomized controlled trial.

Oral feedback from clinical educators is the traditional teaching method for improving clinical consultation skills in medical students. New approaches are needed to enhance this teaching model. Multisource feedback is a commonly used assessment method for learning among practising clinicians, but this assessment has not been explored rigorously in medical student education. This study seeks to evaluate if additional feedback on patient satisfaction improves medical student performance.

Randomised controlled trials in child health in developing countries: trends and lessons over 11 years.

Using a uniform systematic approach annually, we reviewed 1553 publications from randomised controlled trials in child health in developing countries published between July 2002 and June 2013. There were annual increases in such publications, from 38 in the 12 months to July 2003 to over 200 in each of 2012 and 2013. These trials involved children in 76 developing countries. Studies of nutrition (366 publications, 23.6%) and malaria (336 publications, 21%) predominated. 79% of nutrition trials have been of micronutrients (288 publications), with comparatively few publications related to macronutrient interventions or complimentary feeding (48 publications) or measures to improve breast feeding (20 publications). Trials of malaria have involved a comprehensive range of treatment and preventive strategies and have heralded the implementation of new interventions as routine health strategies, and reductions in malaria in each affected country in the world in the last decade. There have been a relatively small number of trials of interventions for treatment or prevention of acute respiratory infection (98 publications, 6.3%), neonatal health (64 publications, 4.1%) and tuberculosis in children (26 publications, 1.7%). In the last 5 years there has been increasing focus on non-communicable diseases such as asthma and allergy, obesity, diabetes and cardiac disease, and behavioural-developmental disorders. Mental health conditions have received little attention (21 publications, 1.4% of publications). There is increasing research activity and capacity in child health in developing countries. Some areas have been the subject of a large amount of research, and have led to the design and implementation of effective public health interventions and reduced disease burdens, while in other areas comprehensive approaches and the systematic application of research findings have been lacking.

Memory improvements in elderly women following 16 weeks treatment with a combined multivitamin, mineral and herbal supplement: a randomized controlled trial.

RATIONALE: There is potential for multivitamin supplementation to improve cognition in the elderly. This randomized, double-blind, placebo-controlled trial was conducted to investigate the effects of 16 weeks multivitamin supplementation (Swisse Women's 50+ Ultivite ®) on cognition in elderly women. METHODS: Participants in this study were 56 community dwelling, elderly women, with subjective complaints of memory loss. Cognition was assessed using a computerized battery of memory and attention tasks designed to be sensitive to age-related declines to fluid intelligence, and a measure of verbal recall. Biochemical measures of selected nutrients, homocysteine, markers of inflammation, oxidative stress, and blood safety parameters were also collected. All cognitive and haematological parameters were assessed at baseline and 16 weeks post-treatment. RESULTS: The multivitamin improved speed of response on a measure of spatial working memory, however benefits to other cognitive processes were not observed. Multivitamin supplementation decreased levels of homocysteine and increased levels of vitamin B(6) and B(12), with a trend for vitamin E to increase. There were no hepatotoxic effects of the multivitamin formula indicating this supplement was safe for everyday usage in the elderly. CONCLUSION: Sixteen weeks ssupplementation with a combined multivitamin, mineral and herbal formula may benefit working memory in elderly women at risk of cognitive decline.

A parent-based intervention to promote healthy eating and active behaviours in pre-school children: evaluation of the MEND 2-4 randomized controlled trial.

BACKGROUND: There is a paucity of studies evaluating targeted obesity prevention interventions in pre-school children. OBJECTIVES: We conducted a randomized controlled trial to evaluate the efficacy of a parent-based obesity prevention intervention for pre-schoolers - MEND (Mind, Exercise, Nutrition … Do It!) 2-4 on child diet, eating habits, physical activity/sedentary behaviours, and body mass index (BMI). METHODS: Parent-child dyads attended 10 weekly 90-min workshops relating to nutrition, physical activity and behaviours, including guided active play and healthy snack time. Assessments were conducted at baseline, immediately post-intervention, and 6 and 12 months post-intervention; child intake of vegetables, fruit, beverages, processed snack foods, fussiness, satiety responsiveness, physical activity, sedentary behaviour and neophobia were assessed via parent proxy report. Parent and child height and weight were measured. RESULTS: Two hundred one parent-child dyads were randomized to intervention (n = 104) and control (n = 97). Baseline mean child age was 2.7 (standard deviation [SD] 0.6) years, and child BMI-for-age z-score (World Health Organization) was 0.66 (SD 0.88). We found significant positive group effects for vegetable (P = 0.01) and snack food (P = 0.03) intake, and satiety responsiveness (P = 0.047) immediately post-intervention. At 12 months follow-up, intervention children exhibited less neophobia (P = 0.03) than controls. CONCLUSION: Future research should focus on additional strategies to support parents to continue positive behaviour change. ACTRN12610000200088.

Mental health first aid training by e-learning: a randomized controlled trial.

OBJECTIVE: Mental Health First Aid training is a course for the public that teaches how to give initial help to a person developing a mental health problem or in a mental health crisis. The present study evaluated the effects of Mental Health First Aid training delivered by e-learning on knowledge about mental disorders, stigmatizing attitudes and helping behaviour. METHOD: A randomized controlled trial was carried out with 262 members of the Australian public. Participants were randomly assigned to complete an e-learning CD, read a Mental Health First Aid manual or be in a waiting list control group. The effects of the interventions were evaluated using online questionnaires pre- and post-training and at 6-months follow up. The questionnaires covered mental health knowledge, stigmatizing attitudes, confidence in providing help to others, actions taken to implement mental health first aid and participant mental health. RESULTS: Both e-learning and the printed manual increased aspects of knowledge, reduced stigma and increased confidence compared to waiting list. E-learning also improved first aid actions taken more than waiting list, and was superior to the printed manual in reducing stigma and disability due to mental ill health. CONCLUSIONS: Mental Health First Aid information received by either e-learning or printed manual had positive effects, but e-learning was better at reducing stigma.

The acute and sub-chronic effects of cocoa flavanols on mood, cognitive and cardiovascular health in young healthy adults: a randomized, controlled trial.

Cocoa supplementation has been associated with benefits to cardiovascular health. However, cocoa's effects on cognition are less clear. A randomized, placebo-controlled, double-blind clinical trial (n = 40, age M = 24.13 years, SD = 4.47 years) was conducted to investigate the effects of both acute (same-day) and sub-chronic (daily for four-weeks) 250 mg cocoa supplementation on mood and mental fatigue, cognitive performance and cardiovascular functioning in young, healthy adults. Assessment involved repeated 10-min cycles of the Cognitive Demand Battery (CDB) encompassing two serial subtraction tasks (Serial Threes and Sevens), a Rapid Visual Information Processing task, and a mental fatigue scale over the course of half an hour. The Swinburne University Computerized Cognitive Assessment Battery (SUCCAB) was also completed to evaluate cognition. Cardiovascular function included measuring both peripheral and central blood pressure and cerebral blood flow. At the acute time point, consumption of cocoa significantly improved self-reported mental fatigue and performance on the Serial Sevens task in cycle one of the CDB. No other significant effects were found. This trial was registered with the Australian and New Zealand Clinical Trial Registry (Trial ID: ACTRN12613000626763). Accessible via http://www.anzctr.org.au/TrialSearch.aspx?searchTxt=ACTRN12613000626763&ddlSearch=Registered.