Evaluation of the effect of Nigella sativa oil on the outcome of missed abortion in women: A randomized double-blind clinical trial.

Background and Aim: Due to the concern about the side effects of chemical drugs and their ineffectiveness, the use of natural compounds as alternatives or complementary therapies has received increasing attention. The purpose of this study was to investigate the effect of Nigella sativa oil on the outcome of missed abortion. Methods: In this double-blind clinical trial, 70 nulliparous pregnant women referred to Hajar Hospital and Imam Ali clinics of Shahrekord and had missed abortion before the 12-week gestational age were selected and randomly divided into two interventions and control groups. The intervention group received 5 g of Nigella sativa oil alone daily for up to 3 days and the control group received a placebo. In case of nonresponse, 3 days after the last dose of medication or placebo, 800 µg of misoprostol (vaginal) were used. Data were analyzed by SPSS software. The chi-square test, Fisher's exact test, independent t-test and paired t-test were used for analytical statistics. Results: According to the results, 18 cases (51.4%) in the intervention group and seven cases (20%) in the control group showed complete evacuation of uterine contents which had a significant difference (p < 0.05). The frequency of vagina physical examination and type of hemorrhage did not show any significant difference between the two groups before and after the intervention. After the intervention, human chorionic gonadotropin (HCG) was significantly decreased in the intervention group but did not change in the control group (p < 0.05). The frequency of adverse events in the intervention group was three (8.6%) and in the control group was one (2.9%) which had no significant difference. Conclusion: Nigella sativa improves the outcome of missed abortion by reducing HCG and facilitating cervix dilatation and delivery of uterine contents.

The Effect of Iron Supplements on the Gut Microbiome of Females of Reproductive Age: A Randomized Controlled Trial.

BACKGROUND: Iron deficiency is the most common nutritional deficiency worldwide, particularly for young children and females of reproductive age. Although oral iron supplements are routinely recommended and generally considered safe, iron supplementation has been shown to alter the fecal microbiota in low-income countries. Little is known about the effect of iron supplementation on the fecal microbiota in high-income settings. OBJECTIVES: To assess the effect of oral iron supplementation compared with placebo on the gut microbiome in nonpregnant females of reproductive age in a high-income country. METHODS: A 21-d prospective parallel design double-blind, randomized control trial conducted in South Australia, Australia. Females (18-45 y) were randomly assigned to either iron (65.7 mg ferrous fumarate) or placebo. Fecal samples were collected prior to commencing supplements and after 21 d of supplementation. The primary outcome was microbiota ß-diversity (paired-sample weighted unique fraction metric dissimilarity) between treatment and placebo groups after 21 d of supplementation. Exploratory outcomes included changes in the relative abundance of bacterial taxa. RESULTS: Of 82 females randomly assigned, 80 completed the trial. There was no significant difference between the groups for weighted unique fraction metric dissimilarity (mean difference: 0.003; 95% confidence interval: -0.007, 0.014; P = 0.52) or relative abundance of common bacterial taxa or Escherichia-Shigella (q > 0.05). CONCLUSIONS: Iron supplementation did not affect the microbiome of nonpregnant females of reproductive age in Australia. This trial was registered at clinicaltrials.gov as NCT05033483.

Effects of timing of oral calcium administration on milk production in high-producing early-lactation Holstein cows.

Supplementation of oral Ca via blanket administration of an oral Ca bolus at 0 and 24 h after calving has shown limited success in increasing production and minimizing adverse health events. Recent evidence that reductions in blood Ca at 4 d in milk (DIM) are more closely associated with negative outcomes than hypocalcemia at 0 to 24 h postpartum might explain this lack of Ca bolus efficacy. Therefore, our primary objective was to explore the effect of delayed oral Ca bolus supplementation on milk production, with secondary objectives of exploring the effects on disease incidence and postpartum blood Ca dynamics. We conducted a randomized controlled trial on multiparous Holstein cows (n = 998) from 4 herds in New York. At calving, cows were randomly assigned to 1 of 3 treatment groups: (1) control, no supplemental Ca at or around parturition (CON; n = 343); (2) conventional bolus, an oral Ca bolus containing 43 g of Ca at calving and 24 h later (BOL-C; n = 330); or (3) delayed bolus, an oral Ca bolus containing 43 g of Ca at 48 and 72 h after calving (BOL-D; n = 325). We created generalized linear mixed models to analyze differences in milk yield for the first 10 wk of lactation and serum total Ca (tCa) at 1 and 4 DIM between treatment groups; multivariable Poisson regression models were used to analyze adverse event outcomes (metritis, displaced abomasum, herd removal, or a combination of one or more of the 3) in the first 30 DIM. Milk yield increased by week and was not affected by treatment. However, a treatment by parity group interaction for milk yield showed that BOL-D cows in the third parity produced more milk than third-parity BOL-C or CON cows (BOL-D = 52.0 kg/d, 95% confidence interval [50.6, 53.4] kg/d, BOL-C = 47.9 [46.3, 49.5] kg/d, CON = 49.8 [48.2, 51.2] kg/d). The incidence of adverse health events was similar between treatments (BOL-D = 3.7%, BOL-C = 3.7%, CON = 3.6%). Serum tCa was lower at 1 than 4 DIM, and we detected no difference in tCa between treatment groups. Our findings suggest that delaying oral Ca bolus supplementation has limited influence on blood Ca concentrations but may be beneficial to cohorts of cows as a targeted prophylactic supplement to support milk production.

A randomized controlled trial of mindfulness-based cognitive therapy for major depressive disorder in undergraduate students: Dose- response effect, inflammatory markers and BDNF.

To examine the dose-response effect of mindfulness-based cognitive therapy (MBCT) for college students with major depressive disorder (MDD), a randomized control trial with MBCT and a wait-list (WL) group was performed. All participants were invited to self-administer a set of questionnaires at baseline, mid-intervention (4th week), and post-intervention (8th week) by the 9-item Patient Health Questionnaire (PHQ-9), the 7-item Generalized Anxiety Disorder scale (GAD-7), the Pittsburgh Sleep Quality Index (PSQI), the Five Facet Mindfulness Questionnaire (FFMQ), the Self-Compassion Scale (SCS). The serum levels of IL-1ß, IL-6, IL-8, TNF-α, BDNF were detected at baseline and post-intervention. After intervention, the scores of PHQ-9, GAD-7, PSQI, and the levels of IL-1ß, IL-6, IL-8 and TNF-α in the MBCT were significantly lower than those in WL group, and total scores of FFMQ, SCS, and the level of BDNF were significantly higher than those in WL group. In MBCT group, daily practice time and session numbers positively related to reduction rates of PHQ-9, GAD-7 and PSQI at post-intervention. The reduction rate of PHQ-9, GAD-7 and PSQI at post-intervention in the completers were higher significantly than those in the partial attendees. These findings suggested MBCT is effective for MDD, and the intervention has a dose-response effect. TRIAL REGISTRATION: Registration number is [ChiCTR2100044309].

Effect of herbal medicine compound promotes beta cell function among type 2 diabetes (T2D) adults: A randomized controlled clinical trial.

Background: Herbal medicine as complementary ways are needed for patients who refuse to take medicine for life. Early intervention and lifestyle could delay the time of taking drugs. Objective: To assess the efficacy of XiaokeGranules vs Sitagliptin in patients who diagnosed T2D. Methods: This is a randomized, double-blind trial. T2D patients were randomly assigned in a 1:1 ratio to Xiaoke Granules and Sitagliptin(50 mg), an anti-diabetic medicine group, for 12 weeks. Before randomization, the consenting participants were subjected to 2 weeks of screening, followed by twelve weeks of intervention. The primary outcome was change from baseline in glycosylated haemoglobin (HbA1C) and homeostasis model assessment-estimated insulin resistance (HOMA-IR) calculation at 12 week. Results: We recruited 103 patients, 84 patients participated in the clinical trial and finally 79 patients finished., the least square mean change in HbA1c and HOMA-IR from baseline was similar in both groups, in which HbA1c (6.93 ± 0.76, P = 0.007) and 2hPG (10.87 ± 2.20, P = 0.016) for the Control group, and HbA1c (6.76 ± 0.67, P < 0.001) and 2hPG (10.52 ± 2.46, P = 0.019). Conclusions: This study revealed that the herbal medicine Xiaoke Granules provides effective glycaemic control with similar safety and immunogenicity profile to Sitagliptin among T2D patients treated for 12 weeks. This study strongly suggests further studies and utilization of Xiaoke Granules usage for controlling hyperglycemia among T2D patients. Trial registration: ClinicalTrials: ChiCTR1900026782.

Virtually-Delivered Emotion Focused Mindfulness Therapy (EFMT) Group vs. Wait-List Control for Late-Life Anxiety: A Randomized Controlled Trial.

BACKGROUND: The worldwide annual prevalence of anxiety in older adults is estimated to be between 6% and 10%. Emotion Focused Mindfulness Therapy (EFMT) is a mindfulness-based group intervention that has been demonstrated to reduce symptoms of anxiety in community dwelling adults. No study has yet assessed EFMT for older adults with late-life anxiety. The aim of this study was to determine the feasibility of video-delivered group EFMT for older adults living in community settings, a novel and potentially scalable intervention. METHODS: This was a feasibility randomized controlled trial (RCT) of 48 older adults (≥55 years old), recruited through primary care, community organizations and snowball methods. Participants were randomized to group EFMT delivered by Zoom vs. a wait-list control. Data were collected at baseline (T1), 9 weeks following baseline (T2, primary study endpoint) and 17 weeks following baseline (T3). Random allocation was conducted immediately after each group of 12 participants had been enrolled into the trial, with groups beginning on a rolling basis each time a block of 12 participants had been enrolled. The main efficacy outcome examined changes over time to anxiety. RESULTS: Recruitment was successfully completed in 32 weeks. Enrollment was calculated at 62.3% (48 of 77 people screened). Retention (80.0%) and adherence (100.0% for intervention group participants) were excellent. The EFMT group had significant improvements in anxiety at T2 compared to the wait-list control group (-3.47 [4.12] vs.-1.22 [3.25] points, p = 0.05). CONCLUSIONS: Virtually-delivered EFMT appears to be a feasible, acceptable, and efficacious group treatment to improve late-life anxiety.

The Therapeutic Impact of Plant-Based and Nutritional Supplements on Anxiety, Depressive Symptoms and Sleep Quality among Adults and Elderly: A Systematic Review of the Literature.

BACKGROUND: The emerging research in the literature continues to forecast a drastic and alarming increase in negative mental health and sleep health outcomes among populations, especially after the COVID-19 pandemic, which significantly influenced people's way of life. With mental health pharmaceutical interventions continuing to be stigmatized and inaccessible among populations, natural supplements provide an opportunity for intervention. OBJECTIVE: This study sought to conduct a systematic review of the literature on the most recent comprehensive evidence for which nutritional supplements have the greatest therapeutic impact on symptoms of anxiety, depression, and insomnia. METHODS: A systematic search of the literature, utilizing several databases, including PubMed and Web of Science, was conducted on 29 April 2022. We used developed keywords and MeSH terms for the search. The study eligibility criteria included (1) a randomized control trial; (2) investigating a plant-based therapeutic or natural supplement as the intervention; (3) measuring at least one health outcome of the following: anxiety symptoms, depressive symptoms, or sleep health outcomes; (4) utilizing validated measurement tools to measure the outcome of interest; (5) written in the English language; (6) peer reviewed; and (7) focused on adults and elderly populations. MAIN RESULTS: Following the PRISMA guidelines, 76 studies were included in this review. We used the revised Risk of Bias tool (RoB2) to assess the quality of all included randomized control trials. A qualitative data synthesis was conducted. Overall, we found several valuable insights from the evidence in the literature, including evidence that demonstrates the benefits of probiotics and vitamin B complexes on anxiety symptoms, depressive symptoms, and sleep quality. Implication of Key Findings: This review provides the most updated findings in the literature on the topic, including an abundance of research that was published in the past 5 years. Given the expected rise in negative mental and sleep health outcomes following the pandemic, the supplements and therapeutics identified in this study should be the target of intervention measures to increase their accessibility and affordability and allow them to be incorporated into clinical guidelines of treatment. PROSPERO registration number: CRD42022361130.

Tai Chi Exercise for Mental and Physical Well-Being in Patients with Depressive Symptoms: A Systematic Review and Meta-Analysis.

Tai Chi is a mindfulness-body practice that has physiological and psychosocial benefits and can be integrated into the prevention and rehabilitation of various medical conditions; however, the effectiveness of Tai Chi in the treatment of depression remains unclear. This review aimed to determine the effects of Tai Chi exercise on mental and physical well-being in patients with depressive symptoms. We searched databases for English language publications that appeared during January 2000-2022. The included trials were RCTs that involved people with depression with no other medical conditions, and included both adolescent and adult samples. A meta-analysis was performed using a random effects model and the heterogeneity was estimated using I2 statistics. The quality of each trial was assessed according to the Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) methodology. The eight trials were divided into two comparisons: (1) a combination of Tai Chi and antidepressants versus standard antidepressants; (2) Tai Chi versus no intervention. The Tai Chi intervention showed improvements in mental and physical well-being as evidenced by the reductions in depression and anxiety and improved quality of life (QOL) of the patients with depressive symptoms. Further well-controlled RCTs are recommended with a precision trial design and larger sample sizes.

Comparison of the effectiveness of local anesthesia for the digital block between single-volar subcutaneous and double-dorsal finger injections: a systematic review and meta-analysis of randomized control trials.

Local anesthesia is an effective method to perform digital nerve blocks. In this study, we compare the effectiveness of single-volar subcutaneous and double-dorsal injection through a systematic review and meta-analysis of randomized controlled trials (RCTs). A systematic search of PubMed, Embase, and the Cochrane Library from inception to 7 April 2021 was performed. RCTs with the effects of single-volar subcutaneous and double-dorsal injection were eligible. Meta-analysis was performed using random effect models with pooled standardized mean differences (SMDs) and 95% confidence intervals (CI). RoB 2.0 and GRADE of Recommendation Assessment, Development, and Evaluation criteria were applied for evaluating the bias. A total of 2484 studies were initially identified, with 11 eligible RCTs finally included in the meta-analysis (1363 patients). The pooled data of nine studies showed single-volar injection had a statistically significantly lower pain score (pooled SMD: 0.20, 95% CI, 0.01 to 0.39, p = 0.041, I2 = 58%, N = 1187) and higher patient preference but invalid anesthesia at the dorsal proximal digit. No significant differences were observed in the onset of anesthesia, adjacent digit invalid numbness, distal phalanx invalid anesthesia, additional injection rate, and adverse effects. In conclusion, this meta-analysis of RCTs showed that the single-volar injection was associated with a lower pain sensation during injection and higher patient satisfaction with a reduced anesthetic effect over the proximal dorsal phalanx. Further high-quality RCTs with a higher number of cases are needed to validate our results.

The Effect of Lavender on Anxiety and Hemodynamic Status Before Septorhinoplasy and Rhinoplasty.

PURPOSE: Anxiety is one of the most common problems before surgery and surgery of the nose is one of the most concerning and challenging surgeries among the plastic surgeries. The aim of this research is to consider the impact of lavender fragrance on anxiety and hemodynamics status before the septorhinoplasty and rhinoplasty. DESIGN: Parallel randomized control trial. METHODS: This research was done by testing thirty-four candidates who were about to have the surgery in two groups of lavender (intervention) and control. The anxiety before and after surgery was examined by the Speilberger State Anxiety Inventory questionnaire and the hemodynamics status. For the analysis, the T- Test, Mann Whitney Test and the χ2 Test were used. FINDINGS: The demographic features of the two groups were similar. Anxiety after the experiment was meaningful. The obvious anxiety in the lavender category was 25.8% and the controlled group had that decreased to 1.8%. The latent anxiety was reduced by 24.3% in the lavender group and increased by 8% in the controlled group. The systolic, diastolic and the heart rate after the intervention was less in the lavender group. CONCLUSIONS: Due to the ease of the inhalation of lavender and the lack of any report for the existence of any kind of side-effects for the prevention of anxiety during nose surgeries, it can be suggested that this approach can be effective for the controlling of the consistency of the patients' hemodynamics.

Assessing the efficacy and safety of Yinqiao powder-maxing Ganshi decoction in the treatment of the major symptoms of mild and moderate COVID-19 by telemedicine-study protocol for a randomized, double-blind, placebo-controlled trial.

Background: The Coronavirus disease 2019 (COVID-19) is the largest global epidemic in recent time. Chinese medicine has been recognized by the World Health Organization as an effective treatment for COVID-19, but there is still a lack of high-quality randomized, double-blind trials using placebo as the control to support its application, which may hinder its further promotion locally and internationally. Objectives: This study will evaluate the efficacy and safety of Yinqiao Powder-Maxing Ganshi Decoction with variation in relieving major symptoms of mild and moderate COVID-19 by telemedicine. Methods and design: This clinical study is a randomized, double-blind, placebo-controlled trial that applies telemedicine to evaluate the efficacy and safety of Yinqiao Powder-Maxing Ganshi Decoction in the treatment of mild and moderate COVID-19. Eligible subjects will be randomly divided into either treatment or placebo groups for up to 14 days after stratification according to age (A:18-49, B:50-65) and the number of vaccinations (a: ≥3 doses, b: ≤2 doses). The treatment group will receive Yinqiao Powder-Maxing Ganshi Decoction granules along with certain variation based on their symptoms, and the placebo group will receive the same amount of placebo granules. Subjects will be prescribed different additions based on their symptoms and pathogenesis at the inclusion. The oral temperature, oximeter, result of rapid antigen test and symptom score will be recorded by subjects until they have stopped the medication. Subjects are required to have follow-up assessment by video-conference on days 7, 14 and 35. The time for the body temperature returning to normal will be used as the primary outcome. Discussion: This trial will provide scientific evidence on the use of Yinqiao Powder-Maxing Ganshi Decoction for the treatment of COVID-19, and the results would help raise the awareness in Hong Kong and the international community on the use of Chinese herbal medicine for treating COVID-19. Clinical Trial Registration: clinicaltrials.gov, identifier NCT05787327.

Protocol of a randomized controlled trial to investigate the efficacy and neural correlates of mindfulness-based habit reversal training in children with Tourette syndrome.

Background: Tourette syndrome (TS) is a developmental neuropsychiatric disorder. Behavior therapy, especially habit reversal training (HRT), has gradually become regarded as one of the core therapies for TS. Mindfulness approaches can improve psychological adjustment and reduce stress and anxiety, suggesting potential benefits when incorporated into behavior therapy. To improve the efficacy of HRT, we combined it with mindfulness, an approach named mindfulness-based habitual reversal training (MHRT). The aim of this protocol is to investigate the efficacy and neural mechanisms of MHRT for TS. Methods/design: We will perform a randomized control trial (RCT) to evaluate the efficacy and neural mechanisms of MHRT. The sample will include 160 participants (including 120 patients with TS and 40 healthy controls). The patient sample will be randomly divided into three groups exposed to three different types of training: MHRT, HRT, and psychoeducation and supportive therapy (PST). Participants will be assessed and undergo resting-state fMRI scans at baseline and at the end of the 12-week training. The Yale Global Tic Severity Scale (YGTSS) and Premonitory Urge for Tic Scale (PUTS) will be used to assess the severity of tic symptoms and premonitory urges. The primary outcomes are change scores on the YGTSS and other assessments from baseline and the end of the training. The secondary outcomes are the neural correlates of these trainings among these groups based on graph theory, which is used to characterize brain functional connectivity networks. The default mode network (DMN) and the salience network (SN) will be assessed (which have been associated with mindfulness as well as the generation of tic symptoms) by network parameters, including clustering coefficients and shortest path lengths. Changes in these network parameters will be regarded as the neural correlates of the behavioral training. Discussion: MHRT was newly developed for the treatment of TS. MHRT may lead to greater reductions in tic severity than traditional HRT. Changes in the network parameters of the DMN and SN may show associations with the efficacy of MHRT. Clinical trial registration: http://www.chictr.org.cn, ChiCTR2100053077, China.

Combining mussel with fucoidan as a supplement for joint pain and prediabetes: Study protocol for a randomized, double-blinded, placebo-controlled trial.

Introduction: Pharmaceutical drugs are beneficial to inflammatory conditions but with side effects, which led to the search for alternative therapies. Perna canaliculus, the New Zealand green-lipped mussel, have shown promise in placebo-controlled trials for inflammatory conditions. Fucoidan, an extract from seaweed Undaria pinnatifida, has been found to have beneficial effects on joint pain and insulin resistance. However, green-lipped mussel and fucoidan have never been combined. Methods and analysis: A parallel, two-arm, double-blind, randomized, placebo-controlled trial will be conducted in New Zealand to determine whether a food product supplemented with green-lipped mussel and fucoidan improves joint pain and/or insulin resistance. Those who are ethnically Chinese, are aged over 30 years, have prediabetes and hip or knee joint pain will be eligible to participate. They will be randomized at 1:1 ratio to consume either dark chocolate supplemented with 1000 mg mussel powder and 1000 mg fucoidan or dark chocolate with no active substances daily for 100 days. The primary endpoints are change in insulin resistance and patient-reported joint pain. Secondary endpoints include anthropometry, fasting glucose and insulin, HbA1c, inflammatory markers, satiety, quality of life, physical function, pain intensity, and analgesic medication use. A sample size of 150 (75 per arm) will provide 90% power at an overall significance level of 5% (two-sided) to detect a standardized effect size of 0.625 on either of the two co-primary outcomes allowing for 10% loss. Ethics and dissemination: The study was approved by the Health and Disability Ethics Committee (number: 20/STH/153). Results will be made available to participants, funders, and other researchers. Discussion: This trial will provide data on the potential utility of a mussel-fucoidan supplement in reducing joint pain and/or insulin resistance, to inform the development of a supplemented food product suitable for the Chinese market. Clinical trial registration: https://trialsearch.who.int/Trial2.aspx?TrialID=ACTRN12621000413820, ANZCTR Registration: ACTRN12621000413820, on 15 April 2021.

Effect of 3, 2-Drug Combinations of Antihypertensive Therapies on Blood Pressure Variability in Black African Patients: Secondary Analyses of the CREOLE Trial.

BACKGROUND: The effect of 3 commonly recommended combinations of anti-hypertensive agents-amlodipine plus hydrochlorothiazide (calcium channel blocker [CCB]+thiazide), amlodipine plus perindopril (CCB+ACE [angiotensin-converting enzyme]-inhibitor), and perindopril plus hydrochlorothiazide (ACE-inhibitor+thiazide) on blood pressure variability (V) are unknown. METHODS: We calculated the blood pressure variability (BPV) in 405 patients (130, 146, and 129 randomized to ACE-inhibitor+thiazide, CCB+thiazide, and CCB+ACE-inhibitor, respectively) who underwent ambulatory blood pressure monitoring after 6 months of treatment in the Comparisons of Three Combinations Therapies in Lowering Blood Pressure in Black Africans trial (CREOLE) of Black African patients. BPV was calculated using the SD of 30-minute interval values for 24-hour ambulatory BPs and for confirmation using the coefficient of variation. Linear mixed model regression was used to calculate mean differences in BPV between treatment arms. Within-clinic BPV was also calculated from the mean SD and coefficient of variation of 3 readings at clinic visits. RESULTS: Baseline distributions of age, sex, and blood pressure parameters were similar across treatment groups. Participants were predominately male (62.2%) with mean age 50.4 years. Those taking CCB+thiazide had significantly reduced ambulatory systolic and diastolic BPV compared with those taking ACE-inhibitor+thiazide. The CCB+thiazide and CCB+ACE-inhibitor groups showed similar BPV. Similar patterns of BPV were apparent among groups using within-clinic blood pressures and when assessed by coefficient of variation. CONCLUSIONS: Compared with CCB-containing combinations, ACE-inhibitor plus thiazide was associated with higher levels, generally significant, of ambulatory and within-clinic systolic and diastolic BPV. These results supplement the differential ambulatory blood pressure-lowering effects of these therapies in the CREOLE trial.

Effect of 24-Week, Late-Evening Ingestion of a Calcium-Fortified, Milk-Based Protein Matrix on Biomarkers of Bone Metabolism and Site-Specific Bone Mineral Density in Postmenopausal Women with Osteopenia.

Dietary calcium intake is a modifiable, lifestyle factor that can affect bone health and the risk of fracture. The diurnal rhythm of bone remodelling suggests nocturnal dietary intervention to be most effective. This study investigated the effect of daily, bed-time ingestion of a calcium-fortified, milk-derived protein matrix (MBPM) or control (CON), for 24 weeks, on serum biomarkers of bone resorption (C-terminal telopeptide of type I collagen, CTX) and formation (serum pro-collagen type 1 N-terminal propeptide, P1NP), and site-specific aerial bone mineral density (BMD), trabecular bone score (TBS), in postmenopausal women with osteopenia. The MBPM supplement increased mean daily energy, protein, and calcium intake, by 11, 30, and 107%, respectively. 24-week supplementation with MBPM decreased CTX by 23%, from 0.547 (0.107) to 0.416 (0.087) ng/mL (p < 0.001) and P1NP by 17%, from 60.6 (9.1) to 49.7 (7.2) µg/L (p < 0.001). Compared to CON, MBPM induced a significantly greater reduction in serum CTX (mean (CI95%); −9 (8.6) vs. −23 (8.5)%, p = 0.025 but not P1NP −19 (8.8) vs. −17 (5.2)%, p = 0.802). No significant change in TBS, AP spine or dual femur aerial BMD was observed for CON or MBPM. This study demonstrates the potential benefit of bed-time ingestion of a calcium-fortified, milk-based protein matrix on homeostatic bone remodelling but no resultant treatment effect on site-specific BMD in postmenopausal women with osteopenia.

Impact of Steam Inhalation, Saline Gargling, and Povidone-Iodine Gargling on Clinical Outcome of COVID-19 Patients in Bengaluru, Karnataka: A Randomized Control Trial.

Context: In the absence of any specific treatment available for COVID-19, people started practicing traditional nonpharmacological preventive home remedies such as salt water gargling and steam inhalation. The available research evidence on some of these measures opines that steam inhalation, saline gargling, and povidone-iodine gargling does have virucidal properties and do provide symptomatic relief. Aims: The aim is to test this hypothesis, and the present trial was undertaken with an objective to assess the effect of steam inhalation, saline gargling, and povidone-iodine gargling among the COVID-19-positive patients with respect to early test negativity and clinical recovery. Methodology: Open-labeled, parallel, randomized controlled trial was conducted among asymptomatic or mild COVID-19-positive patients in Bangalore from September 2020 to February 2021. In each group of steam inhalation, saline gargling, povidone-iodine gargling, and control, twenty participants were allocated. Daily follow-up was done for 21 days to assess early test negativity and clinical recovery. Trial Registry Number: Clinical Trial Registry India/2020/09/027687. Results: Among 80 participants recruited, 65 (81.3%) were symptomatic. Early test negativity was seen in povidone-iodine gargling group of 6 days (KaplanMeier survival curve, BreslowGeneralized Wilcoxon test P = 0.7 as per the intention-to-treat and as per-protocol P = 0.8). Significant clinical recovery was seen in saline gargling group (4 days, P = 0.01). Conclusion: Povidone-iodine gargling was effective in providing early test negativity, whereas saline gargling was effective in early clinical recovery.

Health Care Workers' Need for Headspace: Findings From a Multisite Definitive Randomized Controlled Trial of an Unguided Digital Mindfulness-Based Self-help App to Reduce Healthcare Worker Stress.

BACKGROUND: Health care workers experience high stress. Accessible, affordable, and effective approaches to reducing stress are lacking. In-person mindfulness-based interventions can reduce health care worker stress but are not widely available or accessible to busy health care workers. Unguided, digital, mindfulness-based self-help (MBSH) interventions show promise and can be flexibly engaged with. However, their effectiveness in reducing health care worker stress has not yet been explored in a definitive trial. OBJECTIVE: This study aimed to investigate the effectiveness of an unguided digital MBSH app (Headspace) in reducing health care worker stress. METHODS: This was a definitive superiority randomized controlled trial with 2182 National Health Service staff in England recruited on the web and allocated in a 1:1 ratio to fully automated Headspace (n=1095, 50.18%) or active control (Moodzone; n=1087, 49.82%) for 4.5 months. Outcomes were subscales of the Depression, Anxiety, and Stress (primary outcome) Scale short form; Short Warwick Edinburgh Mental Well-being Scale; Maslach Burnout Inventory; 15-item Five-Facet Mindfulness Questionnaire minus Observe items; Self-Compassion Scale-Short Form; Compassionate Love Scale; Penn State Worry Questionnaire; Brooding subscale of the Ruminative Response Scale; and sickness absence. RESULTS: Intention-to-treat analyses found that Headspace led to greater reductions in stress over time than Moodzone (b=-0.31, 95% CI -0.47 to -0.14; P<.001), with small effects. Small effects of Headspace versus Moodzone were found for depression (b=-0.24, 95% CI -0.40 to -0.08; P=.003), anxiety (b=-0.19, 95% CI -0.32 to -0.06; P=.004), well-being (b=0.14, 95% CI 0.05-0.23; P=.002), mindfulness (b=0.22, 95% CI 0.09-0.34; P=.001), self-compassion (b=0.48, 95% CI 0.33-0.64; P<.001), compassion for others (b=0.02, 95% CI 0.00-0.04; P=.04), and worry (b=-0.30, 95% CI -0.51 to -0.09; P=.005) but not for burnout (b=-0.19, -0.04, and 0.13, all 95% CIs >0; P=.65, .67, and .35), ruminative brooding (b=-0.06, 95% CI -0.12 to 0.00; P=.06), or sickness absence (γ=0.09, 95% CI -0.18 to 0.34). Per-protocol effects of Headspace (454/1095, 41.46%) versus Moodzone (283/1087, 26.03%) over time were found for stress, self-compassion, and compassion for others but not for the other outcomes. Engagement (practice days per week) and improvements in self-compassion during the initial 1.5-month intervention period mediated pre- to postintervention improvements in stress. Improvements in mindfulness, rumination, and worry did not mediate pre- to postintervention improvements in stress. No serious adverse events were reported. CONCLUSIONS: An unguided digital MBSH intervention (Headspace) can reduce health care workers' stress. Effect sizes were small but could have population-level benefits. Unguided digital MBSH interventions can be part of the solution to reducing health care worker stress alongside potentially costlier but potentially more effective in-person mindfulness-based interventions, nonmindfulness courses, and organizational-level interventions. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number ISRCTN15424185; https://tinyurl.com/rv9en5kc.

Evaluation of a Physical Activity and Multi-Micronutrient Intervention on Cognitive and Academic Performance in South African Primary Schoolchildren.

Executive functions (EFs) are essential for optimal academic development. Appropriate nutrition and physical activity (PA) have been shown to facilitate optimal cognitive development. Therefore, this study examined whether a 12-week school-based PA and multi-micronutrient supplementation (MMNS) intervention would improve cognitive and academic performance. A cluster-randomized controlled trial (RCT) was conducted. Children from four schools located in a peri-urban area of South Africa were randomly assigned to (i) PA + MMNS, (ii) PA + placebo, (iii) MMNS or (iv) placebo. Information processing and inhibitory control were measured with a computerized Flanker task. End-of-year results provided insight into academic achievement. Anthropometric measures were used to determine nutritional status. Data were analyzed with linear mixed-models, adjusting for baseline scores, school classes and age; 932 children (458 girls (49.1%), Mage (mean age) = 8.42 ± 1.94 years) completed baseline and post-intervention assessments. Cognitive performance improved among all four groups, with no significant group × time effects. For academic achievement, there was no significant interaction effect between the combined intervention group and placebo. We encourage future studies in this neglected area in order to determine the most optimal design of school-based nutrition and PA programs to enhance overall cognitive performance.

The Effects of Acupressure in the Prevention of Nausea and Vomiting Related to Chemotherapy in Children: A Randomized Double-Blinded Placebo-Controlled Study.

Background: Acupressure is known to be a nursing intervention used to prevent chemotherapy-induced nausea and vomiting in children. Methods: This study was conducted to evaluate and compare the effectiveness of manual and wristband acupressure in the prevention of chemotherapy-induced nausea and vomiting in children. This double-blinded and placebo-controlled study was conducted with 44 children aged between 5 and 18 years receiving chemotherapy in a university hospital's pediatric oncology clinic. Children were randomized into groups using a 2 × 2 factorial design: (a) The child who was given manual acupressure before the first chemotherapy was given placebo manual acupressure before the next chemotherapy; (b) the same child who was administered wristband acupressure before the first chemotherapy was administered placebo wristband acupressure before the next chemotherapy. After all interventions, the severity and number of episodes of nausea and vomiting and additional antiemetic needs in the children were monitored for 24 h. Results: In both groups, the severity and number of nausea and vomiting were lower according to their own placebo groups. Manual and wristband acupressure were effective in reducing the severity and number of nausea and vomiting, but manual acupressure was more effective in reducing the severity and number of nausea and vomiting in comparison to wristband acupressure (p < .05). No statistically significant difference was found between the groups regarding additional antiemetic drug use. Discussion: In this study, manual and wristband acupressure were determined to be effective in reducing the severity and number of nausea and vomiting related to chemotherapy.