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Objective: To assess efficacy of Chinese medicine (CM) on insomnia considering characteristics of treatment based on syndrome differentiation. Methods: A total of 116 participants aged 18 to 65 years with moderate and severe primary insomnia were randomized to the placebo (n=20) or the CM group (n=96) for a 4-week treatment and a 4-week follow-up. Three CM clinicians independently prescribed treatments for each patient based on syndromes differentiation. The primary outcome was change in total sleep time (TST) from baseline. Secondary endpoints included sleep onset latency (SOL), wake time after sleep onset (WASO), sleep efficiency, Pittsburgh Sleep Quality Index (PSQI) and CM symptoms. Results: The CM group had an average 0.6 h more (95% confidence interval (CI): 0.3–0.9, P<0.001) TST and 34.1% (10.3%–58.0%, P=0.005) more patients beyond 0.5 h TST increment than that of the placebo group. PSQI was changed −3.3 (−3.8 to −2.7) in the CM group, a −2.0 (−3.2 to −0.8, P<0.001) difference from the placebo group. The CM symptom score in the CM group decreased −2.0 (−3.3 to −0.7, P=0.003) more than the placebo group. SOL and WASO changes were not significantly different between groups. The analysis of prescriptions by these clinicians revealed blood deficiency and Liver stagnation as the most common syndromes. Prescriptions for these clinicians displayed relative stability, while the herbs varied. All adverse events were mild and were not related to study treatment. Conclusion: CM treatment based on syndrome differentiation can increase TST and improve sleep quality of primary insomnia. It is effective and safe for primary insomnia. In future studies, the long-term efficacy validation and the exploratory of eutherapeutic clinicians' fixed herb formulas should be addressed (Registration No. NCT01613183). [ABSTRACT FROM AUTHOR]

Disruptive behavior disorders [including conduct disorder (CD) and oppositional defiant disorder (ODD)] are common childhood and adolescent psychiatric conditions often linked to altered arousal. The recommended first-line treatment is multi-modal therapy and includes psychosocial and behavioral interventions. Their modest effect sizes along with clinically and biologically heterogeneous phenotypes emphasize the need for innovative personalized treatment targeting impaired functions such as arousal dysregulation. A total of 37 children aged 8–14 years diagnosed with ODD/CD were randomized to 20 sessions of individualized arousal biofeedback using skin conductance levels (SCL-BF) or active treatment as usual (TAU) including psychoeducation and cognitive–behavioral elements. The primary outcome was the change in parents´ ratings of aggressive behavior measured by the Modified Overt Aggression Scale. Secondary outcome measures were subscales from the Child Behavior Checklist, the Inventory of Callous-Unemotional traits, and the Reactive-Proactive Aggression Questionnaire. The SCL-BF treatment was neither superior nor inferior to the active TAU. Both groups showed reduced aggression after treatment with small effects for the primary outcome and large effects for some secondary outcomes. Importantly, successful learning of SCL self-regulation was related to reduced aggression at post-assessment. Individualized SCL-BF was not inferior to active TAU for any treatment outcome with improvements in aggression. Further, participants were on average able to self-regulate their SCL, and those who best learned self-regulation showed the highest clinical improvement, pointing to specificity of SCL-BF regulation for improving aggression. Further studies with larger samples and improved methods, for example by developing BF for mobile use in ecologically more valid settings are warranted. [ABSTRACT FROM AUTHOR]

Objective: To assess the efficacy and safety of Sanjie Analgesic Capsule (SAC) in Chinese patients with endometriosis-associated pain. Methods: This was a multicenter, randomized, double-blind, placebo-controlled trial conducted at 15 centers between November 2013 and July 2017 in China. Eligible 323 patients with endometriosis were randomized at a 3:1 ratio to the SAC group (241 cases) and placebo group (82 cases) by stratified block randomization. Patients in the SAC or placebo groups were given SAC or placebo 1.6 g 3 times per day, orally, respectively since the first day of menstruation for 3 consecutive menstrual cycles. The primary endpoint was clinical response to dysmenorrhea evaluated using a 10-point Visual Analogue Scale at 3 and 6 months. The secondary endpoint was the pain score evaluated by VAS (chronic pelvic pain, defecation pain, and dyspareunia) at 3 and 6 months, and the pain recurrence rate at 6 months. Adverse events (AEs) were recorded during the study. Results: A total of 241 women were included in the SAC group, and 82 were in the placebo group. Among these women, 217 (90.0%) and 71 (86.6%) completed the intervention, respectively. At 3 months, overall response rate (ORR) was significantly higher in women administered SAC (80.1%) compared with those who received a placebo (30.5%, P<0.01). Six months after treatment, the ORR for dysmenorrhea was 62.7% in the SAC group and 31.7% in the placebo group (P<0.01). Chronic pelvic pain and defecation pain were significantly improved by SAC compared with placebo (both P<0.05). The incidence rates of total AEs events in the SAC and placebo groups were 6.6% and 9.8%, respectively, and no significant difference was shown between the two groups (P=0.339). Conclusion: SAC is well-tolerated and may improve dysmenorrhea in women with endometriosis-associated pain. (Trial registration: ClinicalTrials.gov, No. NCT02031523) [ABSTRACT FROM AUTHOR]

Objective: To confirm the efficacy and safety of Ganyushu Granule (GYSG) in treating premenstrual syndrome (PMS) in patients with Gan (Liver) depression and qi stagnation syndrome (GDQSS) and determine its effective dosage. Methods: From June 2018 to March 2021, a total of 240 PMS women with GDQSS were included and randomly divided into 3 groups in a 1:1:1 ratio using central block randomization: high-dose GYSG group (n=78, GYSG 2 packs/time), low-dose GYSG group (n=82, GYSG and its simulant 1 pack/time), and placebo group (n=80, GYSG simulant 2 packs/time). Treatment with GYSG or placebo was given thrice daily and for up to 3 menstrual cycles. Primary outcomes were PMS diary (PMSD) score and premenstrual tension syndrome self-rating scale (PMTS). Secondary outcomes were Chinese medicine (CM) syndrome efficacy. PMSD, PMTS, and efficacy of CM were evaluated with menstrual cycles during the treatment period. Outcome indicators were analyzed after each menstrual cycle. All analyses were performed using an intention-to-treat method, and clinical safety was assessed. Results: Of the 216 patients included in the effectiveness analysis, 70, 75, and 71 patients were in the high-, low-dose GYSG, and placebo groups, respectively. From the 2nd treatment cycle, the change in PMSD scores in the high- and low-dose groups was lower than that in the placebo group (P<0.05). PMTS scores in the high-dose GYSG group after the 1st treatment cycle was lower than that in the placebo group (P<0.05), while after the 3rd treatment cycle, that in the low-dose group was lower than that in the placebo group (P<0.05). After the 2nd treatment cycle, the high-dose GYSG group had the best CM syndrome efficacy (P<0.05). No serious adverse reactions were reported. Conclusions: GYSG was safe and well-tolerated at both doses for treating PMS patients with GDQSS. High-dose GYSG might be the optimal dose for a phase III trial. (Registration No. ChiCTR1800016595) [ABSTRACT FROM AUTHOR]

Objective: To investigate whether Naoxueshu Oral Liquid (NXS) could promote hematoma absorption in post-craniotomy hematoma (PCH) patients. Methods: This is an open-label, multicenter, and randomized controlled trial conducted at 9 hospitals in China. Patients aged 18–80 years with post-craniotomy supratentorial hematoma volume ranging from 10 to 30 mL or post-craniotomy infratentorial hematoma volume less than 10 mL, or intraventricular hemorrhage following cranial surgery were enrolled. They were randomly assigned at a 1:1 ratio to the NXS (10 mL thrice daily for 15 days) or control groups using a randomization code table. Standard medical care was administered in both groups. The primary outcome was the percentage reduction in hematoma volume from day 1 to day 15. The secondary outcomes included the percentage reduction in hematoma volume from day 1 to day 7, the absolute reduction in hematoma volume from day 1 to day 7 and 15, and the change in neurological function from day 1 to day 7 and 15. The safety was closely monitored throughout the study. Moreover, subgroup analysis was performed based on age, gender, history of diabetes, and etiology of intracerebral hemorrhage (ICH). Results: A total of 120 patients were enrolled and randomly assigned between March 30, 2018 and April 15, 2020. One patient was lost to follow-up in the control group. Finally, there were 119 patients (60 in the NXS group and 59 in the control group) included in the analysis. In the full analysis set (FAS) analysis, the NXS group had a greater percentage reduction in hematoma volume from day 1 to day 15 than the control group [median (Q1, Q3): 85% (71%, 97%) vs. 76% (53%, 93%), P<0.05]. The secondary outcomes showed no statistical significance between two groups, either in FAS or per-protocol set (P>0.05). Furthermore, no adverse events were reported during the study. In the FAS analysis, the NXS group exhibited a higher percentage reduction in hematoma volume on day 15 in the following subgroups: male patients, patients younger than 65 years, patients without diabetes, or those with initial cranial surgery due to ICH (all P<0.05). Conclusions: The administration of NXS demonstrated the potential to promote the percentage reduction in hematoma volume from day 1 to day 15. This intervention was found to be safe and feasible. The response to NXS may be influenced by patient characteristics. (Registration No. ChiCTR1800017981) [ABSTRACT FROM AUTHOR]

Background: One anastomosis gastric bypass (OAGB) has been proposed as an effective alternative to the current standard procedure in Switzerland, Roux-en-Y gastric bypass (RYGB). Prospective data comparing both procedures are scarce. Therefore, we performed a non-inferiority randomized controlled trial assessing the effectiveness and safety of these 2 operative techniques. Method: Eighty patients were randomized 1:1. OAGB consisted of a very long gastric pouch with a 200 cm biliopancreatic limb, RYGB of a 150 cm ante-colic alimentary and a 60 cm biliopancreatic limb, respectively. Primary endpoint was the percent excess weight loss (%EWL) at 12 months after surgery. Results: Mean %EWL at 12 months was 87.9% (SD24.4) in the RYGB group and 104.1% (SD24.6) in the OAGB group (p = 0.006). There was no mortality. The rate of marginal ulcers was higher in patients with OAGB compared to those with RYGB (p = 0.011), while the total number of late complications did not statistically differ between the two groups. Except for the remission of GERD, which was higher in the RYGB group compared to OAGB, there was no difference between the groups regarding the remission of comorbidities. OAGB showed improved glucose control compared to the RYGB after 1 year (p = 0.001). Furthermore, glucagon-like peptide-1 increase was significantly higher in OAGB at 6 weeks (p = 0.041) and 1 year after surgery (p = 0.029). Quality of life improved after both surgeries, without differences between the groups. Conclusions: %EWL 1 year after surgery was higher in OAGB than in RYGB. A better glycemic control with a higher increase in GLP-1 was observed after OAGB compared to RYGB. Trial registration: This trial is registered on ClinicalTrials.gov under the identifier NCT02601092. [ABSTRACT FROM AUTHOR]

Objective: To assess the efficacy and safety of Bufei Jiedu (BFJD) ranules as adjuvant therapy for patients with multidrug-resistant pulmonary tuberculosis (MDR-PTB). Methods: A large-scale, multi-center, double-blinded, and randomized controlled trial was conducted in 18 sentinel hospitals in China from December 2012 to December 2016. A total of 312 MDR-PTB patients were randomly assigned to BFJD Granules or placebo groups (1:1) using a stratified randomization method, which both received the long-course chemotherapy regimen for 18 months (6 Am-Lfx-P-Z-Pto, 12 Lfx-P-Z-Pto). Meanwhile, patients in both groups also received BFJD Granules or placebo twice a day for a total of 18 months, respectively. The primary outcome was cure rate. The secondary outcomes included time to sputum-culture conversion, changes in lung cavities and quality of life (QoL) of patients. Adverse reactions were monitored during and after the trial. Results: A total of 216 cases completed the trial, 111 in the BFJD Granules group and 105 in the placebo group. BFJD Granules, as an adjuvant treatment, increased the cure rate by 13.6% at the end of treatment, compared with the placebo (58.4% vs. 44.8%, P=0.02), and accelerated the median time to sputum-culture conversion (5 months vs. 11 months). The cavity closure rate of the BFJD Granules group (50.6%, 43/85) was higher than that of the placebo group (32.1%, 26/81; P=0.02) in patients who completed the treatment. At the end of the intensive treatment, according to the 36-item Short Form, the BFJD Granules significantly improved physical functioning, general health, and vitality of patients relative to the placebo group (all P<0.01). Overall, the death rates in the two groups were not significantly different; 5.1% (8/156) in the BFJD Granules group and 2.6% (4/156) in the placebo group. Conclusions: Supplementing BFJD Granules with the long-course chemotherapy regimen significantly increased the cure rate and cavity closure rates, and rapidly improved QoL of patients with MDR-PTB (Registration No. ChiCTR-TRC-12002850) [ABSTRACT FROM AUTHOR]

Purpose: The aim of the present study was to examine the acute and chronic effects of wild blueberry supplementation on mood, executive function, and serum biomarkers of neuroplasticity, inflammation, and oxidative stress in emerging adults with moderate-to-severe depressive symptoms. Methods: In this double-blind trial, 60 emerging adults (Mage = 20.0 years, 32% male) with self-reported depressive symptoms were randomly assigned to receive a single blueberry drink (acute phase), followed by 6 weeks of daily blueberry supplementation (chronic phase), or a matched placebo drink. The primary outcome was Beck Depression Inventory-II (BDI-II) scores at 6-week follow-up. Further measures included momentary affect (PANAS-X) and accuracy on an executive function task. The data were analyzed using ANCOVAs adjusted for baseline values, sex, and habitual fruit and vegetable intake. Estimated marginal means were calculated to compare the treatment arms. Results: The blueberry drink significantly improved positive affect (p = 0.026) and executive function (p = 0.025) at 2 h post-ingestion, with change scores being positively correlated in the blueberry group (r = 0.424, p = 0.017). However, after six weeks of supplementation the reduction in BDI-II scores was greater in the placebo group by 5.8 points (95% CI: 0.8–10.7, p = 0.023). Generalized anxiety and anhedonia also decreased significantly more in the placebo group. No significant differences were found for any of the biomarkers. Conclusions: Six weeks of wild blueberry supplementation were inferior to placebo in reducing depressive symptoms. Nevertheless, the correlated improvements in positive affect and executive function after a single dose of blueberries point to a beneficial, albeit transient, psychological effect. These contrasting results suggest a biphasic, hormetic-like response that warrants further investigation. Trial registration: NCT04647019, dated 30 November, 2020. [ABSTRACT FROM AUTHOR]

Mastectomy serves as the main surgical treatment for both invasive and in situ breast carcinoma and large phyllodes tumors. It is associated with skin necrosis, seroma, and surgical site infection in up to 30% of patients. In the present trial, we compared the complications in patients undergoing skin flap elevation by one of the 4 techniques: thick skin flap raised by scalpel(group1), thin skin flap raised with scalpel (group 2), thick skin flap raised with diathermy (group 3), and thin skin flap raised with diathermy (group 4). A randomized trial with superiority hypothesis and 2 × 2 factorial design was conducted at All India Institute of Medical Sciences New Delhi. Mastectomy skin flap necrosis (MSN) was recorded as the main outcome of interest. MSN was noted in 2.5% in group1, 10% in group 2, 7.5% in group 3, and 30% in group 4. MSN was observed in 5% cases with thick flap compared to 20% cases with a thin skin flap (p = 0.007). Raising the flap with scalpel was associated with MSN in 6.25% compared to 18.75% in the diathermy group (p = 0.029). We conclude that raising a thick flap with scalpel is associated with lowest risk of skin flap necrosis. Trial Registration: Clinical Trial Registry- India CTRI/2014/09/004978 [ABSTRACT FROM AUTHOR]

We report midline impacts of a community-randomized cash transfer intervention to 1857 vulnerable mothers in 140 rural cocoa-farming communities of Côte d'Ivoire. Compared to mothers in the comparison group who participated in village savings and loan associations (VSLAs), treatment mothers participated in VSLAs and received 8 € each week for up to one year with no conditions attached (the midway point of a two-year program). We find small- to moderate-sized treatment effects on four of six indicators of economic well-being (d = 0.23–0.75), as well as small reductions in maternal stress (d = −0.27). We find no statistically detectable impacts on educational engagement, educational aspirations, or educational expectations for children. Results suggest that cash transfer programs in rural West African communities can improve economic well-being and reduce maternal stress. Implications for children and families and for future cash transfer evaluations are discussed. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effect and safety of foot baths with Tangbi Waixi Decoction (TW) in treating patients with diabetic peripheral neuropathy (DPN). Methods: It is a multicenter double-blinded randomized controlled trial. Participants with DPN were recruited between November 18, 2016 and May 30, 2018 from 8 hospitals in China. All patients received basic treatments for glycemic management. Patients received foot baths with TW herbal granules either 66.9 g (intervention group) or 6.69 g (control group) for 30 min once a day for 2 weeks and followed by a 2-week rest, as a therapeutic course. If the Toronto Clinical Scoring System total score (TCSS-TS) ⩾6 points, the patients received a total of 3 therapeutic courses (for 12 weeks) and were followed up for 12 weeks. The primary outcome was change in TCSS-TS score at 12 and 24 weeks. Secondary outcomes included changes in bilateral motor nerve conduction velocity (MNCV) and sensory nerve conduction velocity (SNCV) of the median and common peroneal nerve. Safety was also assessed. Results: Totally 632 patients were enrolled, and 317 and 315 were randomized to the intervention and control groups, respectively. After the 12-week intervention, patients in both groups showed significant declines in TCSSTS scores, and significant increases in MNCV and SNCV of the median and common peroneal nerves compared with pre-treatment (P<0.05). The reduction of TCSS-TS score at 12 weeks and the increase of SNCV of median nerve at 24 weeks in the control group were greater than those in the intervention group (P<0.05). The number of adverse events did not differ significantly between groups (P>0.05), and no serious adverse event was related with treatment. Conclusion: Treatment of TW foot baths was safe and significantly benefitted patients with DPN. A low dose of TW appeared to be more effective than a high dose. (Registry No. ChiCTR-IOR-16009331). [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effect of manual acupuncture on endometrial blood flow parameters by three-dimensional (3D) power Doppler ultrasound in women undergoing in vitro fertilization embryo transfer (IVF-ET). Methods: Seventy patients undergoing IVF-ET were equally randomized into traditional or sham acupuncture treatment group for totally 4 days (from the day of oocyte aspiration to the day of embryo transfer) of treatment by random envelope method at the Reproductive Medicine Center and Outpatient Department of Integrated Traditional Chinese and Western Medicine, Tongji Hospital, Tongji Medicine College, Huazhong University of Science and Technology from January 2013 to December 2015. Patients in the traditional acupuncture group accepted traditional acupuncture methods with manual acupuncture, and Zhongji (CV3), Qihai (CV 6), Sanyinjiao (SP6), Taichong (LR 3), Tianshu (ST 25), Guilai (ST 29) and Zusanli (ST 36) were chosen. Patients at the sham acupuncture group accepted shallow acupuncture methods at 4 non-meridian points at each shoulder and upper arm. Outcome measures included endometrial ultrasonic indices such as vascularization index (VI), flow index (FI) and vascularization flow index (VFI), endometrial thickness and volume, subendometrial VI (sVI), subendometrial FI (sFI), subendometrial VFI (sVFI), implantation rate, clinical pregnancy rate, abortion rate, live birth rate and number of live births. Results: Finally, 34 patients in the traditional acupuncture group and 35 in the sham acupuncture group completed this trial. VI, FI and VFI of the traditional acupuncture group were significantly higher than those in the sham acupuncture group (P<0.05). No significant differences were found in endometrial thickness, endometrial volume, sVI, sFI, sVFI, implantation rate, clinical pregnancy rate, abortion rate, live birth rate and number of live births (P>0.05). Conclusions: Manual acupuncture performed after oocyte aspiration and before transplantation improved the endometrial blood flow parameters VI, RI and VFI in women who underwent IVF-ET, instead of sVI, sFI and sVFI. Therefore, acupuncture might be beneficial in women undergoing IVF-ET by increasing endometrial blood flow and endometrial receptivity. (Registration No. ChiCTR2100053354) [ABSTRACT FROM AUTHOR]

Orphans and vulnerable children (OVC) in sub-Saharan Africa are at high risk for HIV infection and transmission. HIV prevention and treatment efforts with OVC are hindered by mental health and substance use problems. This randomized controlled trial compared a mental health intervention, Trauma Focused Cognitive Behavioral Therapy (TF-CBT), to an enhanced version of an existing HIV Psychosocial Counseling (PC+) program among 610 adolescents who met PEPFAR criteria for OVC and had HIV risk behaviors in Lusaka, Zambia. Outcomes included HIV risk behaviors (e.g., risky sexual behaviors), mental health (internalizing symptoms, externalizing behaviors, PTSD) and substance use. At 12-month follow-up, there were significant within group reductions in both groups for all outcomes, with the only significant between group difference being for substance use, in which OVC who received TF-CBT had significantly greater reductions than OVC who received PC+. In a subgroup analysis of OVC with high levels of PTSD symptoms, TF-CBT was superior to PC + in reducing internalizing symptoms, functional impairment, and substance use. Findings support TF-CBT for reducing substance use among OVC. Subgroup analysis results suggest that a robust intervention such as TF-CBT is warranted for OVC with significant mental and behavioral health comorbidities. The similar performance of TF-CBT and PC + in the overall sample for risky sexual behavior and mild mental health problems indicates that enhancing existing psychosocial programs, such as PC, with standard implementation factors like having a defined training and supervision schedule (as was done to create PC+) may improve the efficacy of HIV risk reduction efforts. Clinical Trials Number: NCT02054780 [ABSTRACT FROM AUTHOR]

Objective: Mirtazapine and SSRIs are widely prescribed as first-line agents for late-life depression. However, evidence for these drugs is mostly based on non-elderly patients. Therefore, we reanalyzed a randomized controlled trial of mirtazapine versus SSRIs for depression in a sub-population of late-life patients. Methods: A randomized controlled trial was conducted with 141 patients, of whom 41 were elderly, and 100 were non-elderly. This study compared SSRIs and mirtazapine in late-life depression, examined late-onset and early adult-onset separately and compared elderly and non-elderly patients for each drug. Treatment effects and adverse events were assessed using the Hamilton Depression Rating Scale and the Udvalg for Kliniske Undersøgelser Side Effect Rating Scale, respectively. Results: In late-life depression, mirtazapine showed faster HAM-D total score improvement (3.3 points difference, p = 0.021) and higher improvement in insomnia (1.7 points difference, p = 0.001) and appetite (1.2 points difference, p = 0.020). Similar findings were observed for late-onset depression with the HAM-D total score (4.3 points difference, p = 0.007) and appetite (0.9 points difference, p = 0.004), favoring mirtazapine. Depressive symptoms were generally less improved in late-life depression than in non-late-life depression. Regarding the effect of mirtazapine on appetite, late-life depression showed greater improvement (0.7 points difference, p = 0.008). Nausea and micturition disturbances were more common with SSRIs in late-life depression than in non-late-life depression. In contrast, somnolence was less common in late-life depression with mirtazapine. Conclusion: The potential usefulness of mirtazapine in elderly patients was demonstrated. The results also showed differences in the treatment response to SSRIs and mirtazapine between elderly and non-elderly patients. [ABSTRACT FROM AUTHOR]

Purpose: To explore the theoretical constructs that functioned as mediators of interventions for moderate-to-vigorous physical activity (MVPA) maintenance among breast cancer survivors. Method: 161 survivors were randomized into 3 groups: Reach Plus, Reach Plus Message or Reach Plus Phone. All participants received a 3-month theory-based intervention delivered by volunteer coaches. During months 4–9, all participants monitored their MVPA and received feedback reports. Additionally, Reach Plus Message received weekly text/email messages and Reach Plus Phone received monthly calls from their coaches. Assessments of weekly MVPA minutes and theoretical constructs (self-efficacy, social support, physical activity [PA] enjoyment and PA barriers) were obtained at baseline, 3, 6, 9 and 12-months. Analyses: Using a multiple mediator analysis with a product of coefficients approach, we examined mechanisms associated with between-group differences over time in weekly MVPA minutes. Results: Self-efficacy mediated effects of Reach Plus Message vs. Reach Plus at 6 (ab = 16.99) and 9 M (ab = 27.45); social support mediated effects at 6 (ab = 4.86), 9 (ab = 14.30) and 12 M (ab = 6.18). Self-efficacy mediated effects of Reach Plus Phone vs. Reach Plus at 6 (ab = 18.76), 9 (ab = 28.93) and 12 M (ab = 18.18). Social support mediated effects of Reach Plus Phone vs. Reach Plus Message at 6 (ab=-5.50) and 9 M (ab=-13.20); PA enjoyment mediated effects at 12 M (ab=-3.63). Conclusions: PA maintenance efforts should focus on strengthening breast cancer survivors' self-efficacy and obtaining social support. The trial was registered at ClinicalTrials.Gov: NCT02694640 (Feb. 26, 2016). [ABSTRACT FROM AUTHOR]

Objective: To determine the feasibility of conducting a full-scale randomized controlled trial (RCT) and investigate the basic information and safety of acupuncture for patients with chronic spontaneous urticaria (CSU). Methods: A total of 80 participants with CSU from July 2018 to July 2019 were randomly assigned to receive active acupuncture (n=41) on a fixed prescription of acupoints or sham acupuncture (n=39) with superficial acupuncture on non-acupuncture points through the completely randomized design. Patients in both groups received 5 sessions per week for 2 weeks, and participants were followed for a further 2 weeks. Feasibility was assessed by recruitment and randomization rates, retention of participants, treatment protocol adherence, and the incidence of adverse events (AEs). The clinical primary outcome was the changes from baseline weekly urticaria activity scores (UAS7) after treatment at 2 weeks. Secondary outcomes included the Visual Analogue Scale (VAS) score of itching intensity, Dermatology Life Quality Index (DLQI), Hamilton Depression Scale (HAMD), and Hamilton Anxiety Scale (HAMA). Results: A total of 80 participants were enrolled. The recruitment rate of 24.02%, randomization rate of 100%, a loss rate of 6.25%, and no obvious AEs were observed in either group. The decrease from baseline in the mean UAS7 total score at week 2 in the active acupuncture group was −8.63 (95%CI, −11.78 to −5.49) and −6.21 (95%CI, −9.43 to −2.98) in the sham acupuncture group for a between-group difference of −2.42 (95% CI, −6.93 to 2.07). The change in the DLQI, VAS of itching intensity, HAMA, and HAMD were a slightly better improvement trend in the active acupuncture group than the sham acupuncture group, but the between-group difference was not significant. Conclusions: Active acupuncture had a better improvement trend in alleviating symptoms, improving quality of life and regulating the mood of anxiety and depression in patients with CSU than sham acupuncture. (Registration Nos. AMCTR-ICR-18000190 and ChiCTR2100054776) [ABSTRACT FROM AUTHOR]

Objective: To assess the effect and safety of Reyanning Mixture (RYN) in treating asymptomatic or mild severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in children and adolescents. Methods: This is a prospective, open-label, randomized controlled trial. Patients aged 1–17 years and diagnosed with asymptomatic or mild coronavirus disease-2019 (COVID-19) were assigned to an intervention group (RYN plus standard care) and a control group (standard care) according to a randomization list. The primary outcomes were SARS-CoV-2 negative conversion time. Secondary outcomes included negative conversion rate on days 3 and 7, hospital length of stay, symptom relief rate, new-onset symptoms of asymptomatic infected patients, and progressive disease rate. The cycle threshold (Ct) values of ORF1ab or N genes were also tested. Results: A total of 214 patients in the intervention group and 217 in the control group were analyzed. The SARS-CoV-2 negative conversion time was significantly shortened in the intervention group [5 days (interquartile range (IQR): 5–6) vs. 7 days (IQR: 6–7), P<0.01]. By days 3 and 7, the negative conversion rates were significantly higher in the intervention group (day 3: 32.7% vs. 21.2%, P=0.007; day 7: 75.2% vs. 60.8%, P=0.001). Ct values significantly increase on day 2 [ORF1ab gene: 35.62 (IQR: 29.17–45.00) vs. 34.22 (IQR: 28.41–39.41), P=0.03; N gene: 34.97 (IQR: 28.50–45.00) vs. 33.51 (IQR: 27.70–38.25), P=0.024] and day 3 [ORF1ab gene: 38.00 (IQR: 32.72–45.00) vs. 35.81 (IQR: 29.96–45.00), P=0.003; N gene: 37.16 (IQR: 32.01–45.00) vs. 35.26 (IQR: 29.09–45.00), P=0.01]. No significant difference was found in hospital length of stay between the two groups (P>0.05). Symptoms of cough were significantly improved (82.2% vs. 70.0%, P=0.02) and wheezing was significantly reduced (0.7% vs. 12.9%, P<0.01) in the intervention group compared with the control group. During the trial, no disease progression or serious adverse events were reported. Conclusion: Adding RYN to standard care may be a safe and effective treatment for children with asymptomatic and mild SARS-CoV-2 infection. (Registration No. ChiCTR2200060292) [ABSTRACT FROM AUTHOR]

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Background: Frailty is associated with poor outcomes among older adults with hypertension and complicates its pharmacological management. Here, we assessed whether 12-weeks of instructor-guided, group Tai Chi (TC) practice improved frailty relative to Healthy Aging Practice-centered Education (HAP-E) classes in older adults with hypertension. Methods: Secondary analysis of a randomized controlled trial in San Diego County, USA, of 167 community-dwelling individuals aged ≥ 60 yrs (70% female; 72.1 ± 7.5 yrs), defined as non-frail (66%) or frail (34%) based on 53-item deficit accumulation frailty index (FI). Linear mixed-effects models were used to assess pre-to-post intervention differences in FI and logistic regression to explore differential odds of clinically meaningful FI change. Results: One hundred thirty-one participants completed post-intervention assessments. Frailty decreased pre-to-post intervention in the TC (ΔFI = − 0.016, d = − 0.39, − 0.75 to − 0.03), but not the HAP-E arm (ΔFI = − 0.009, d = − 0.13, − 0.52–0.27), despite no significant group differences between the TC and HAP-E arms (d = − 0.11, − 0.46–0.23). Furthermore, greater odds of improved FI were observed for frail participants in the TC (OR = 3.84, 1.14–14.9), but not the HAP-E (OR = 1.34, 0.39–4.56) arm. Subgroup analysis indicated treatment effects in TC were attributed to frail participants (frail: ΔFI = − 0.035, d = − 0.68, -1.26 to − 0.08; non-frail: ΔFI = − 0.005, d = − 0.19, − 0.59–0.22), which was not the case in the HAP-E arm (frail: ΔFI = − 0.017, d = − 0.23, − 0.81–0.35; non-frail: ΔFI = − 0.003, d = − 0.07, − 0.47–0.33). Frail participants were no more likely to drop-out of the study than non-frail (71% vs. 69% retained). Conclusions: Twelve weeks of twice-weekly guided TC practice was well-tolerated, associated with decreases in frailty, and increased odds of clinically meaningful FI improvement at post-intervention. [ABSTRACT FROM AUTHOR]

Background: Subthreshold depression is a highly prevalent mood disorder in young adults. Mind–body exercises, such as Tai Chi, have been adopted as interventions for clinical depressive symptoms. However, the possible effect and underlying mechanism of Tai Chi on subthreshold depression of young individuals remain unclear. This randomized controlled study aimed to evaluate the effects of Tai Chi training and tested the combined stress and reward circuitry model for subthreshold depression. Results: A total of 103 participants completed this trial, with 49 in the 12-week 24-style Tai Chi group and 54 participants in control group. Our results showed significantly lower scores on depressive symptoms (P = 0.002) and anxiety symptoms (P = 0.009) and higher scores on quality of life (P = 0.002) after Tai Chi training. There were significant reductions in salivary cortisol levels (P = 0.007) and putamen gray matter volume (P < 0.001) in the Tai Chi group. The changes in cortisol levels and putamen gray matter volume had direct (bootstrapping confidence interval [− 0.91, − 0.11]) and indirect effects (bootstrapping confidence interval [− 0.65, − 0.19]) on the changes induced by Tai Chi training on depressive symptoms, respectively. Conclusion: The stress–reward complex results indicated an interaction between lowering stress levels and increasing reward circuitry activity associated with the alleviation of depressive symptoms among participants. The 12-week Tai Chi training was effective in improving the symptoms and quality of life of young adults with subthreshold depression. Trial Registration Chinese Registry of Clinical Trials (Registration Number: ChiCTR1900028289, Registered December 12, 2019). Key points: Tai Chi training improves depressive and anxiety symptoms and quality of life in young people with subthreshold depression. Improvements in depressive symptoms are associated with reduction in putamen volume and salivary cortisol levels. Involvement of the stress and reward circuit suggests Tai Chi would improve stress regulation and reward preference. [ABSTRACT FROM AUTHOR]

Objective: To analyze the efficacy of Biejiajian Pill (BJJP) on intestinal microbiota in patients with hepatitis B cirrhosis/liver fibrosis, and explore its relationship with liver fibrosis. Methods: This was a prospective, randomized double-blind controlled trial. Using the stratified block randomization method, 35 patients with hepatitis B liver cirrhosis/liver fibrosis were randomly assigned (1:1) to receive entecavir (0.5 mg/d) combined with BJJP (3 g/time, 3 times a day) or placebo (simulator as control, SC group, simulator 3 g/time, 3 times a day) for 48 weeks. Blood and stool samples were collected from patients at baseline and week 48 of treatment, respectively. Liver and renal functions as well as hematological indices were detected. Fecal samples were analyzed by 16S rDNA V3–V4 high-throughput sequencing, and intestinal microbiota changes in both groups before and after treatment were compared, and their correlations with liver fibrosis were analyzed. Results: Compared with the SC group, there was no significant difference in liver function, renal function and hematology indices in the BJJP group, however, the improvement rate of liver fibrosis was higher in the BJJP group (94.4% vs. 64.7%, P=0.041). Principal coordinate analysis (PCoA) based on weighted Unifrac distance showed significant differences in intestinal microbiota community diversity before and after BJJP treatment (P<0.01 and P=0.003), respectively. After 48 weeks' treatment, the abundance levels of beneficial bacteria (Bifidobacteria, Lactobacillus, Faecalibacterium and Blautia) increased, whereas the abundance levels of potential pathogenic bacteria, including Escherichia coli, Bacteroides, Ruminococcus, Parabacteroides and Prevotella decreased, among which Ruminococcus and Parabacteroides were significantly positively correlated with degree of liver fibrosis (r=0.34, P=0.04; r=0.38, P=0.02), respectively. The microbiota in the SC group did not change significantly throughout the whole process of treatment. Conclusion: BJJP had a certain regulatory effect on intestinal microbiota of patients with hepatitis B cirrhosis/liver fibrosis (ChiCTR1800016801). [ABSTRACT FROM AUTHOR]

Background: Studies assessing the effects of parenting programs have focused on interventions delivered through face-to-face modalities. There is a need for research to evaluate the effects of online parenting programs on child development, such as the BEM Program ('Play Teaches Change' in English), an online play-based parenting program that teaches caregivers on how to introduce playful interactions into their daily household chores. Objective: To assess the effects of the BEM Program on child development and the quality of caregiver-child interaction. Method: A two-arm randomized controlled trial was conducted in a socioeconomically disadvantaged district of São Paulo city in Brazil. 129 children aged 12–23 months and their caregiver were randomly assigned to receive either the BEM Program for 8 weeks (intervention, n = 66) or standard child care (control, n = 63). Data were collected at baseline and endline of the intervention through home visits and online interviews. An intention-to-treat analysis was conducted. Results: The intervention showed positive effects on child development, by improving language development (Cohen's d = 0.20, 95%CI 0.08–0.47) and reduced intrusiveness (Cohen's d = 0.35, 95%CI 0.06–0.65) of caregiver-child interaction. No significant differences were observed in caregiver's repertoire and engagement in age-appropriate play activities with the child while doing the household chores, parenting sense of competence and perceived stress. Conclusions: Despite the small size and low adherence to the program, such promising results advance evidences for fully remote parenting programs and their effects on child development. [ABSTRACT FROM AUTHOR]

An individual based randomized controlled trial (RCT) was designed to evaluate the impact of a customized short message service (SMS) intervention on HIV-related high-risk behaviors among Men who have sex with men (MSM). In total, 631 HIV-negative MSM were enrolled at baseline and divided into intervention and control groups randomly. Nine months later, the intervention group who received additional customized SMS intervention reported significantly lower rates of multiple partners, unclear partner infection status and condomless anal intercourse compared to the control group who received the routine intervention only. Six months post stopping the SMS intervention, the rates of unclear partner infection status and condomless anal intercourse still remained lower report in the intervention group. Our study shown that the customized SMS interventions can significantly reduce the HIV-related high-risk behaviors among MSM and with sustained effects over a period of time. [ABSTRACT FROM AUTHOR]

Objective: This study examined whether a 4-week group-based mindfulness intervention would be superior in reducing psychological distress in colorectal cancer (CRC) patients compared to a psychoeducation and cognitive behavioural skills learning support active control group. Methods: Patients with CRC were randomized via Computerised Permuted Block Randomisation to mindfulness or active control groups (2-h weekly sessions over 4 weeks). Outcomes were measured pre-intervention, and 8 weeks and 6 months post-baseline. The primary outcome was psychological distress measured by the Hospital Anxiety and Depression Scale. Secondary outcomes were generic quality of life (QoL), disease specific QoL, mindfulness, and intervention credibility and acceptability. Results: Sixty-eight participants were randomized to mindfulness (n=35) or active control group (n=33). Uptake of potentially eligible patients consenting was low (28.0%) and the dropout rate was 33.8%. Depression scores were reduced in both groups at week 8 (P=0.020). Control participants had greater improvement in generic mental QoL scores at week 8 than mindfulness (P=0.023). In disease specific QoL, there was reduction in impotence symptom in the mindfulness group (P=0.022) and reduction in faecal incontinence in the control group (P=0.019). The embarrassment symptom had a significantly lower increase in the mindfulness group at week 8 compared to the control group (P=0.009). Both groups rated the treatments as credible and acceptable. Conclusions: Mindfulness was not superior to the active control group in terms of alleviating psychological distress but both treatments were associated with some improvements in depression. There was low uptake of both interventions. (Trial registration number: ACTRN12616001033437) [ABSTRACT FROM AUTHOR]

Purpose: To test the hypothesis that daily supplementation with low-dose B vitamins plus betaine could significantly reduce plasma homocysteine concentrations in Chinese adults with hyperhomocysteinemia and free from background mandatory folic acid fortification. Methods: One hundred apparently healthy adults aged 18–65 years with hyperhomocysteinemia were recruited in South China from July 2019 to June 2021. They were randomly assigned to either the supplement group (daily supplementation: 400 μg folic acid, 8 mg vitamin B6, 6.4 μg vitamin B12 and 1 g betaine) or the placebo group for 12 weeks. Fasting venous blood was collected at baseline, week 4 and week 12 to determine the concentrations of homocysteine, folate, vitamin B12 and betaine. Generalized estimation equations were used for statistical analysis. Results: Statistically significant increments in blood concentrations of folate, vitamin B12 and betaine after the intervention in the supplement group indicated good participant compliance. At baseline, there were no significant differences in plasma homocysteine concentration between the two groups (P = 0.265). After 12-week supplementation, compared with the placebo group, there was a significant reduction in plasma homocysteine concentrations in the supplement group (mean group difference − 3.87; covariate-adjusted P = 0.012; reduction rate 10.1%; covariate-adjusted P < 0.001). In the supplement group, the decreased concentration of plasma homocysteine was associated with increments of blood concentrations of both folate (β = –1.680, P = 0.004) and betaine (β = –1.421, P = 0.020) after 12 weeks of supplementation. Conclusions: Daily supplementation with low-dose B vitamins plus betaine for 12 weeks effectively decreased plasma homocysteine concentrations in Chinese adults with hyperhomocysteinemia. Trial registration: This trial was registered at clinicaltrials.gov as NCT03720249 on October 25, 2018. Website:https://clinicaltrials.gov/ct2/show/NCT03720249. [ABSTRACT FROM AUTHOR]

This was a randomized controlled trial, conducted to determine the effectiveness of CBT for depression delivered by trained therapists with an adapted Bengali CBT (BaCBT) manual, as compared to a control group. A total of 148 patients with a diagnosis of depression and attending psychiatry departments of three hospitals in Dhaka, Bangladesh, were assessed for eligibility, and 107 were randomly allocated to either treatment (n = 54) or a waitlist (n = 53). Assessments of outcome were completed at 3 time points (pre-test, post-test, and 1-month follow-up). The results revealed significant reductions in depression severity, anxiety, perceived stress, and suicidal ideation in the group that received the intervention, but modest to no significant changes in the control group. This is the first report of the results of an adapted CBT program for depression from Bangladesh. Although several limitations of the study are noted, and further studies are needed to generalize these current results, they indicate that CBT is an efficacious treatment option for depression in varied cultures. [ABSTRACT FROM AUTHOR]

The objective of this study was to investigate changes in sedentary and active behaviors when previously inactive adults start exercising in the morning or evening. One-hundred adults with overweight or obesity (BMI ≥ 25 kg/m2) were recruited for a 12-week intervention and randomized to one of three groups: (i) morning exercise (AMEx; 0600–0900); (ii) evening exercise (PMEx; 1600–1900); or (iii) waitlist control. AMEx and PMEx were prescribed self-paced aerobic exercise to achieve a weekly total of 250 min via a combination of supervised and unsupervised training. Sedentary and active behavior times were measured at baseline, mid- and post-intervention using the multimedia activity recall for children and adults. Time spent engaging in physical activity was significantly increased from baseline at both mid- (+ 14–22 min·day−1) and post-intervention (+ 12–19 min·day−1), for AMEx and PMEx. At 12-weeks, participants in both morning and evening exercise groups reported increased time spent Sleeping (+ 36 and + 20 min·day−1, respecitively), and reduced time spent watching TV/playing videogames (− 32 and − 25 min·day−1, respectively). In response to an exercise stimulus, previously inactive adults make encouraging modifications in how they use their time, and the patterns of change are similar with morning and evening exercise. [ABSTRACT FROM AUTHOR]

Cyclical mastalgia of moderate to severe degree requires systemic drug therapy. Tamoxifen is the drug of choice worldwide. A novel molecule, centchroman/Ormeloxifene, developed in India, was found to be equally effective in previous studies. However, its optimal dose regimen is uncertain. We conducted three-arm randomized controlled trial to compare the effectiveness in relieving breast pain. Group 1 received tamoxifen 10 mg daily, and groups 2 and 3 received centchroman 30 mg twice and 30 mg thrice a week, respectively, for 3 months with a follow-up of 3 more months. Breast pain score, nodularity score, sonographic evaluation of the breasts and ovaries, quality of life scores, and adverse events were recorded. The number of patients enrolled was 32, 31, and 30 in group 1, group 2, and group 3, respectively. All three groups had significant improvement in breast pain scores [group 1 (5 → 2), group 2 (5 → 2), group 3 (6 → 2), p < 0.001)], nodularity scores [group1 (1 → 0), group 2 (1 → 0), group 3 (1 → 0), p < 0.001)] and in the quality of life scores over time. However, no significant differences were observed in-between the groups. Transient ovarian cyst formation and menstrual irregularities were more common with a higher dose of centchroman. Centchroman in the dosages of 30 mg twice or thrice a week is as effective as a daily dose of tamoxifen 10 mg in relieving pain, nodularity, and improving quality of life scores. The dose of centchroman 30 mg twice a week for 12 weeks has the least adverse effects and should be accepted as the optimal dosage regimen. There is a need of further study with a greater number of participants and longer follow-up. Trial registration number: CTRI/2018/02/012043 (Registered on: 21/02/2018). [ABSTRACT FROM AUTHOR]

Purpose Pain and stress-related ill-health are major causes of long-term disability and sick leave. This study evaluated the effects of a brief psychosocial program, which previously has been tested for an at-risk population of employees. Methods The Effective Communication within the Organization (ECO) program, where supervisors and employees were trained in communication and problem solving, was compared to an active control consisting of psychoeducative lectures (PE) about pain and stress in a cluster randomized controlled trial. First-line supervisors were randomized to ECO or PE, and a total of 191 mainly female employees with self-reported pain and/or stress-related ill-health were included. The hybrid format programs consisted of 2–3 group sessions. Sick leave data was collected from social insurance registers, before and 6-months after the program. Secondary outcomes (work ability, work limitations, pain-disability risk, exhaustion symptoms, perceived stress, perceived health, quality of life, perceived communication and support from supervisors) were assessed at baseline, post intervention, and at 6-months follow-up. Results No effects were observed on primary or secondary outcome variables. Pain symptoms were common (89%), however a lower proportion (30%) were identified as at risk for long-term pain disability, which might explain the lack of evident effects. The Covid-19 pandemic affected participation rates and delivery of intervention. Conclusion In this study, preventive effects of the ECO program were not supported. Altogether, the findings point at the importance of selecting participants for prevention based on screening of psychosocial risk. Further research on workplace communication and support, and impact on employee health is warranted. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate whether the 24-weeks postoperative fracture union rate for the investigational TFNA intramedullary nail was non-inferior compared to the control product PFNA-II. Methods: The study was a prospective, randomized, single-blind, noninferiority dual-arm study drawing from 9 trauma centers across China, between November 2018 and September 2020, with follow-up measurements at 24 weeks after internal fixation. The full analysis data set (FAS [Intent-to-Treat]) was analyzed and is summarized here. The primary outcome was fracture union rate, a composite score combining clinical and radiographic assessment. Secondary endpoints comprised (a) clinical outcomes including (1) SF-12, (2) Harris Hip, and (3) EQ-5D Scores, (b) radiographic incidence of complications such as loosening or cut-out requiring revision, (c) revision rates, (d) reoperation rates, and (e) adverse events, including 24-weeks revision and reoperation rates. Results: Both TFNA and PFNA-II group fracture healing rates were 100% at 24 weeks; TFNA was therefore shown to be non-inferior to PFNA-II. With baseline data matched in all parameters except age in both the TFNA and PFNA-II groups, comparisons of union rates, SF-12, Harris Hip, and EQ-5D Scores yielded p values > 0.05 indicating no significant difference between the two groups, further supporting the noninferiority of TFNA. In both groups, revision and re-operation rates were 0, and the incidences of serious adverse events were 19.4% and 17.4%, respectively. Conclusion: In terms of fracture union rate at 24 weeks, the DePuy Synthes Trochanteric Fixation Nail Advanced (TFNA) was not inferior to the marketed Proximal Femoral Nail Antirotation (PFNA-II) device produced by the same manufacturer. Secondary and safety outcomes showed no significant differences between the two groups. Registration: Registration was completed at ClinicalTrials.gov NCT03635320. [ABSTRACT FROM AUTHOR]

Suicide prevention videos featuring young people's personal narratives of hope and recovery are increasingly used in suicide prevention, but research on their effects is scarce. A double-blind randomized controlled trial was conducted to test the effects of a suicide prevention video featuring an adolescent mastering his suicidal ideation by getting help on 14 to 19-year-olds. N = 299 adolescents were randomly allocated to watch the intervention video (n = 148) or a control video unrelated to mental health (n = 151). Questionnaire data were collected before (T1) and immediately after exposure (T2), and 4 weeks later (T3). Data were analyzed with a repeated-measures ANCOVA. The primary outcome was suicidal ideation, assessed with the Reasons for Living Inventory for Adolescents. Secondary outcomes were help-seeking intentions, attitudes towards suicide, stigmatization of suicidality, and mood. There was an immediate beneficial effect of the intervention on suicidal ideation (T2 mean change from baseline within intervention group MChange = − 0.16 [95% CI − 0.20 to − 0.12], mean difference compared to control group MDiff = − 0.09 [95% CI − 0.15 to − 0.03], ηp2 = 0.03), which was not maintained at T3. Participants reported significantly higher help-seeking intentions, which was maintained at 4-week follow-up. They also reported a sustained reduction of favorable attitudes to suicide. Effects on suicidal ideation were mediated by identification with the featured protagonist. Adolescents appear to benefit from suicide prevention narratives featuring personal stories from peers on coping with suicidal ideation and help-seeking. Trial registration DRKS00017405; 24/09/19; retrospectively registered. [ABSTRACT FROM AUTHOR]

Although parents of siblings play a crucial role in the development of both the positive and negative aspects of their children's relationships, relatively few parenting programs specifically target sibling conflict alongside sibling warmth. To bridge this gap, the current study reports the outcomes of a randomized controlled trial evaluating a brief parenting intervention focusing on improving sibling relationships. A total of 74 parents reporting concerns about sibling conflict were randomized to either the Triple P brief discussion group intervention condition (n = 37) or the waitlist control condition (n = 37). Parents were predominately Caucasian, female, from a middle-income background. Parents completed a range of self-report measures examining the quality of the sibling relationship, parenting practices, family functioning, and child emotional and behavioral problems. Across treatment groups, participants showed improvements on almost all measures of sibling conflict, sibling warmth, child emotional and behavioral problems, parenting practices, and parenting confidence. Participants in the treatment group also experienced a greater reduction in the amount of help they wanted to manage sibling warmth, relative to participants in the control group. These results suggest that a low-intensity parenting intervention may only have a small effect on improving sibling relationships. Additional research is needed to determine how to broaden program efficacy for sibling conflict and parental adjustment, for families from diverse levels of income and family composition. Trial registration: ANZCTR 365567. Highlights: Sibling relationships that are more strongly positive than negative may support child, parent and family wellbeing. To date, no evidence-based parenting program has promoted positive sibling relationships while decreasing sibling conflict. A brief discussion group was developed within the Triple P system to target warmth and agonism in sibling relationships. A randomized control trial revealed an improvement in parent-reported warmth in the sibling relationship, but not agonism. Intervention effectiveness may be further explored with more diverse samples and multi-informant measures. [ABSTRACT FROM AUTHOR]

Objectives: Sarcopenia is recognized as a major public health concern because of its association with several adverse health events. Beta-hydroxy-beta-methylbutyrate (HMB) supplementation reportedly delays the loss of muscle mass and function; however, the effect of HMB on sarcopenia remains inconclusive. We aimed to evaluate the impact of HMB intervention on muscle strength, physical performance, body compositions, and inflammatory factors in older adults with sarcopenia. Design: Randomized, double-blind, placebo-controlled trial. Setting and Participants: This study included subjects aged ≥60 years with sarcopenia which were assigned to the HMB group (HMBG, n=18) and the placebo group (PG, n=16). Intervention: The HMBG and PG were supplied with HMB and placebo products twice daily for 12 weeks, and both received resistance exercise training twice a week in 12 weeks. Measurements: Hand grip strength was selected as the primary outcome; gait speed, five-time chair stand test, body composition and inflammatory indicators were selected as the secondary outcomes. The differences in changes from baseline between the two groups were analyzed using the analysis of covariance(ANCOVA). Results: After the 12-week intervention, the HMBG demonstrated significantly greater improvements in handgrip strength (4.61(95%CI:2.93,6.28) kg, P<0.001), gait speed (0.11(95%CI:0.02,0.20)m/s, P=0.014), five-time chair stand test (−3.65 (95%CI:−5.72, −1.58)s, P=0.001), muscle quality (2.47(95%CI:1.15,3.80),kg·kg−1 P=0.001) and tumor necrosis factorlike weak inducer of apoptosis (−15.23(95%CI:−29.80,−0.66)pmol/mL, P=0.041) compared with the PG; no significant differences in skeletal muscle mass, skeletal muscle index, and other body composition parameters were found between the two groups. Conclusion: In older adults with sarcopenia, HMB significantly enhance the effect of resistance exercise training on muscle strength, physical performance, muscle quality, and reduced inflammatory factors. Therefore, HMB supplementation could be an effective treatment for sarcorpenia. The trial protocol was registered at http://www.chictr.org.cn/showproj.aspx?proj=47571 as ChiCTR2000028778. [ABSTRACT FROM AUTHOR]

Previous studies have shown that self-affirmation increases acceptance of a message and motivates health behavior change. The present study investigated whether self-affirmation increases the acceptance of persuasive messages on COVID-19 vaccines and promotes vaccination intention. A total of 144 participants were randomly assigned to the self-affirmation (n = 72) or control (n = 72) groups before reading a persuasive message on COVID-19 vaccines. The results revealed that the self-affirmation group showed significantly higher acceptance of persuasive information on COVID-19 vaccines than the control group. Additionally, the self-affirmation group also showed significantly higher post-experiment vaccination intention than the control group. Mediation analysis indicated that increased acceptance of persuasive information significantly mediated the beneficial effects of self-affirmation on post-experiment vaccination intention. The present study demonstrated that self-affirmation could be an effective strategy for increasing the acceptance of persuasive messages on COVID-19 vaccines and promoting vaccination intention. [ABSTRACT FROM AUTHOR]

Objective: To examine whether the combination of Naoxintong Capsule with standard care could further reduce the recurrence of ischemic stroke without increasing the risk of severe bleeding. Methods: A total of 23 Chinese medical centers participated in this trial. Adult patients with a history of ischemic stroke were randomly assigned in a 1:1 ratio using a block design to receive either Naoxintong Capsule (1.2 g orally, twice a day) or placebo in addition to standard care. The primary endpoint was recurrence of ischemic stroke within 2 years. Secondary outcomes included myocardial infarction, death due to recurrent ischemic stroke, and all-cause mortality. The safety of drugs was monitored. Results were analyzed using the intention-to-treat principle. Results: A total of 2,200 patients were enrolled from March 2015 to March 2016, of whom 143 and 158 in the Naoxintong and placebo groups were lost to follow-up, respectively. Compared with the placebo group, the recurrence rate of ischemic stroke within 2 years was significantly lower in the Naoxintong group [6.5% vs. 9.5%, hazard ratio (HR): 0.665, 95% confidence interval (CI): 0.492-0.899, P=0.008]. The two groups showed no significant differences in the secondary outcomes and safety, including rates of severe hemorrhage, cerebral hemorrhage and subarachnoid hemorrhage (P>0.05). Conclusion: The combination of Naoxintong Capsule with standard care reduced the 2-year stroke recurrence rate in patients with ischemic stroke without increasing the risk of severe hemorrhage in high-risk patients. (Trial registration No. NCT02334969) [ABSTRACT FROM AUTHOR]

We assessed an intervention aimed at improving adherence to antiretroviral therapy (ART) among pregnant and postpartum women living with HIV (PPWLH). We randomized 133 pregnant women initiating ART in Uganda to receive text reminders generated by real time-enabled electronic monitors and data-informed counseling through 3 months postpartum (PPM3) or standard care. Intention-to-treat analyses found low adherence levels and no intervention impact. Proportions achieving ≥95% adherence in PPM3 were 16.4% vs. 9.1% (t = -1.14, p = 0.26) in intervention vs. comparison groups, respectively; 30.9% vs. 29.1% achieved ≥80% adherence. Additional analyses found significant adherence declines after delivery, and no effect on disease progression (CD4-cell count, viral load), though treatment interruptions were significantly fewer in intervention participants. Per-protocol analyses encompassing participants who used adherence monitors as designed experienced better outcomes, suggesting potential benefit for some PPWLH. The study was registered on ClinicalTrials.Gov (NCT02396394). [ABSTRACT FROM AUTHOR]

Children with chronic illness (CI) are at risk for internalizing problems, which reduce their quality of life, hamper treatment, and increase family stress. Accordingly, behavioral interventions are provided at the family level. However, the effects of parental involvement on child outcomes are not consistently beneficial. Therefore, it is relevant to study the working mechanisms. In the present study, we tested child coping and parenting stress as underlying mechanisms of the effect of an intervention for children and an additional group intervention for parents. Data were analyzed from a randomized controlled trial. Families of children with chronic illness (N = 120, child M age = 12.11 years, range 7.98–18.07) participated in a cognitive-behavioral-based group intervention and were randomized in the child-only intervention or parent–child intervention. Primary outcomes were parent- and child-reported internalizing problems, whereas the mediators were the use of child active coping skills and parenting stress. The causal model was tested with multilevel mediation analysis. Active coping skills and parenting stress stood out as significant mediators of the effect of the intervention on parent- and child-reported internalizing behavior (Cohen's d effect size range 0.29–1.57). When parents were involved in the intervention, children increased their use of active coping skills and parents decreased in parenting stress, which in turn improved child internalizing problems. Knowing that coping skills and parenting stress underlie the benefit of involving parents can be used for optimizing interventions for children with CI and addressing the risk of internalizing problems. Highlights: Parental involvement in interventions for children with chronic illness can be beneficial, however explanations are still unclear. In this randomized efficacy trial, child use of active coping skills and parenting stress appeared significant temporal mediators. Parental involvement supported child coping and diminished parenting stress, which in turn decreased child internalizing problems. Interventions for children with internalizing problems might be optimized by focusing on determined active components. [ABSTRACT FROM AUTHOR]

Objective: To assess the efficacy and safety of Bushen Huoxue Formula (BSHXF) for the treatment of discogenic low-back pain (DLBP). Methods: This was a parallel, double-blind, randomized, clinical trial performed between May 2019 and June 2020. Seventy patients were assigned by computerized random number table to the treatment group (lumbar traction and BSHXF, 35 cases) or the control group (lumbar traction and placebo, 35 cases). The patients received intervention for 3 weeks. Assessment was conducted before treatment and at week 1, 2, 3 during treatment. Primary outcome was the self-reported score of Oswestry Disability Index (ODI). Secondary outcomes included Visual Analog Scale (VAS), clinical efficacy rate by minimal clinically important difference (MCID) as well as lumbar tenderness, muscle tone and lumbar spine mobility. Adverse reactions were recorded. Follow-up was performed at 1 and 3 months after the end of treatment. Results: In the treatment group, ODI score was significantly decreased compared with baseline (P<0.05) and the control group at 2- and 3- week treatment. Similarly, VAS score decreased compared with the baseline (P<0.05) and was lower than that in the control group at 2- and 3- week treatment (P<0.05). The clinical efficacy rate of the treatment group was higher than that of the control group after treatment [32.35% (11/34) vs. 3.13% (1/32), P<0.05). Moreover, the tenderness, and muscle tone, as well as the back extension and left flexion in lumbar spine mobility in the treatment group at 3-week treatment were significantly improved compared with the control group (P<0.05). Follow-up showed that at 1-month after treatment, the treatment group had better outcomes than the control group with regard to a total score of ODI and VAS scores, as well as clinical efficacy rate (all P<0.05). Moreover, VAS score was still significantly lower than the control group at 3-month follow-up (P<0.05). No adverse reactions were reported during the study. Conclusion: BSXHF combined with lumbar traction can significantly improve the clinical symptoms including pain intensity, functionality, muscle tone, and lumbar spine mobility in DLBP patients. (Registration No. ChiCTR1900027777). [ABSTRACT FROM AUTHOR]

Collaborations with traditional healers have been proposed to improve HIV testing uptake. We hypothesized that healer-delivered HIV testing would improve HIV testing uptake, compared with referral to clinic-based HIV testing. We conducted a cluster randomized trial to determine the effectiveness of traditional healers delivering counseling and HIV testing in Mwanza, Tanzania (ClinicalTrials.gov NCT#04071873). Intervention arm healers provided counseling and offered point-of-care HIV tests to adult clients of unknown HIV serostatus. Control arm healers provided referral for clinic-based testing. Primary outcome was receipt of an HIV test within 90 days of enrollment. Secondary outcomes were new HIV diagnosis and linkage to care. In the intervention, 100 clients (100%) received an HIV test, compared with 73 (73%) of control participants (p < 0.001). Two intervention arm participants (2%) had a new diagnosis compared with zero in the control arm (p = 0.50). Engaging traditional healers might provide a culturally concordant opportunity to improve HIV testing uptake. [ABSTRACT FROM AUTHOR]

Parents of children with ASD (N = 86; mean age 44.8 months; 67 boys) were randomized to either WHO Caregiver Skills Training (CST) delivered in public health settings in Italy or enhanced treatment-as-usual. Primary blinded outcomes were 3-months post-intervention change scores of autism severity and engagement during caregiver-child interaction. CST was highly acceptable to caregivers and feasibly delivered by trained local clinicians. Intention-to-treat analysis showed a large and significant effect on parent skills supporting joint engagement and a smaller significant effect on flow of interaction. Expected changes in child autism severity and joint engagement did not meet statistical significance. Analysis of secondary outcomes showed a significant effect on parenting stress, self-efficacy, and child gestures. Strategies to improve the effectiveness of CST are discussed. [ABSTRACT FROM AUTHOR]

Lactational breast abscess results from inadequate or partially treated mastitis. Recently, needle aspiration or catheter suction drainage is being adopted in place of incision and drainage. We planned to evaluate the effectiveness of needle aspiration versus vacuum suction drainage in resolution of puerperal breast abscess. One-hundred-twelve mothers with lactational breast abscess were randomized to either ultrasound-guided needle aspiration or vacuum suction drainage. These patients were followed up on alternate days and assessed for complete resolution of breast abscess, pain in the breast on Visual Analog Scale (VAS) of 0–10, day of return to normal breast feeding, number of aspirations needed, recurrence of abscess and total cost of care. In the suction drain group, 98% of mothers enjoyed complete resolution within 10 days as compared to 87% of mothers treated with needle aspiration. Mean VAS at first follow-up was 2.89 in aspiration group and 2.62 in suction group. The VAS reduced to 0.74 in aspiration group and 0.53 in suction drainage group, at the last follow-up. The mean day of recovery was 7 days for aspiration and 5.73 days for suction. Most patients required 3 aspirations. The mean drainage time was 4.5 days. Vacuum suction drainage is the more effective method for achieving resolution of lactational breast abscess and offers greater patient satisfaction compared to needle aspiration. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the efficacy and safety of Tibetan medicine Ruyi Zhenbao Pills (RZPs) in the treatment of patients with motor and sensory dysfunction after stroke. Methods: A total of 120 convalescent stroke patients hospitalized in the Rehabilitation Department of Guangdong Provincial Hospital of Chinese Medicine from June 2017 to December 2019 were enrolled in this trial. Patients were assigned to control (60 cases) and research (60 cases) groups by computer random assignment. All patients received internal treatment and modern rehabilitation training. On this basis, the research group was given oral RZPs for 4 weeks, while the control group was given oral placebo. The primary outcome was motor function of the affected side evaluated by simplified Fugl-Meyer Motion Assessment Scale (FMA-M). The secondary outcomes included sensory function, activity of daily living (ADL), quality of life, balance function, and pain, which were assessed by Fugl-Meyer Sensory Assessment Scale (FMA-S), Modified Barthel Index (MBI), Special Scale of the Quality of Life (SS-QOL), Berg Balance Scale (BBS), and Visual Analogue Scale (VAS), respectively. All of the assessments were performed before treatment, and 4 and 8 weeks after treatment. Vital signs, liver and kidney functions, routine blood test, blood coagulation profile, and routine urinalysis of patients were monitored. Results: After 4-week treatment, the FMA-M, BBS and FMA-S scores in the research group significantly increased compared with the control group (P<0.05). At 8-week follow-up, the BBS and MBI scores in the research group were higher than the control group (P<0.05). There was no statistical difference between the 2 groups in the SS-QOL and VAS scores at 4 and 8 weeks (P>0.05). Moreover, after treatment, there was no significant difference in vital signs, liver and kidney functions, blood coagulation function, blood routine and urinalysis between the 2 groups (P>0.05). Conclusion: RZPs improved limb motor, balance, and sensory functions of stroke patients during recovery period with good safety. (Trial registration No. NCT04029701) [ABSTRACT FROM AUTHOR]

Objective: To observe the efficacy and safety of Guihuang Formula (GHF) in treating patients with type III prostatitis and Chinese medicine syndrome of dampness-heat and blood stasis. Methods: Sixty-six patients diagnosed with type III prostatitis with dampness-heat and blood stasis syndrome were randomly divided into the treatment group (GHF) and the control group (tamsulosin) using a random number table, with 33 cases each group. The treatment group received GHF twice a day, and the control group received tamsulosin 0.2 mg once daily before bedtime. Patients in both groups received treatment for 6 weeks and was followed up for 2 weeks. The outcomes included the National Institute of Health Chronic Prostatitis Symptom Index (NIH-CPSI) score, Chinese Medicine Symptoms Score (CMSS), expressed prostatic secretions (EPS) and adverse events (AEs). Results: After treatment, the NIH-CPSI total score and domain scores of pain discomfort, urination and quality of life decreased significantly from the baseline in both groups (P<0.05). The CMSS score decreased in both groups (P<0.05). The WBC count decreased and lecithin body count increased in both groups (P<0.05). GHF showed a more obvious advantage in reducing the pain discomfort and quality of life domain scores of NIH-CPSI, reducing the CMSS score, increasing the improvement rate of the WBC and lecithin body counts, compared with the control group (P<0.05). There were no significant differences in decreasing urination domain score of NIH-CPSI between two groups (P>0.05). In addition, no serious AEs were observed. Conclusion: GHF is effective in treating type III prostatitis patients with dampness-heat and blood stasis syndrome without serious AEs. (Registration No. ChiCTR1900026966) [ABSTRACT FROM AUTHOR]

In a randomized controlled trial, we tested the efficacy of Baby Triple P in a community sample of first-time parent couples. The intervention was developed to promote better mental health, a positive couple relationship, positive parenting, and a better parent-infant relationship. One hundred and fifty six couples were randomly allocated to intervention (n = 78) or care as usual (n = 78) conditions. The intervention was delivered in four antenatal face-to-face group sessions followed by four early postnatal individual telephone sessions. Couples completed self-report assessments at baseline, immediately postintervention and at 12 and 24 months. The study had one primary (the Depression, Anxiety and Stress Scale) and 11 secondary outcomes. Over half of the intervention and care as usual participants remained in the study for the full 24 months. Intention to treat analysis of the full sample yielded positive results in some mental health domains for mothers and fathers, but this was not evident when follow up sensitivity analysis was conducted on a subsample of the data. There was limited support for the intervention in relation to secondary outcomes such as the couple relationship, social support and parenting. However, the parent couples were positive about the intervention and described it as providing the support that they wanted. This trial provides some evidence in support of Baby Triple P as an early intervention for new parent couples. High levels of satisfaction with the intervention are promising, especially in relation to the engagement of fathers. Trial Registration: ISRCTN31955576 Highlights: This randomized controlled trial provides some evidence that the mental health of new parents is amenable to intervention. This randomized controlled trial provides some evidence in support of Baby Triple P as an early intervention. Evidence from this study demonstrates that engagement and retention of fathers is possible and fathers value involvement. Initial engagement is a critical point in the delivery of early interventions; couples who are engaged are more likely to complete the intervention. [ABSTRACT FROM AUTHOR]

Objective: To evalvate efficacy of Qizi Yusi Pills (QYP), a Chinese medicine compound preparation, on in vitro fertilization-embryo transfer (IVF-ET) in women of advanced reproductive age. Methods: This multicenter, randomized, double-blind, placebo-controlled trial was conducted from June 2018 to October 2019. A total of 124 patients were randomly allocated to either the QYP group or the placebo group using a stratified block randomization design, with 62 patients in each group. All patients completed controlled ovarian stimulation using a standard gonadotropin-releasing hormone agonist (GnRH-a) long protocol. As the QYP group, QYP was administered while the control group received placebo. QYP and placebo were administered for a total of 24 to 30 days from the day of GnRH-a pituitary downregulation to transvaginal oocyte retrieval. Both medications were taken orally at doses of 10 g three times each day. The primary outcome was cumulative pregnancy rate, and the secondary outcomes were periodic medication, follicular status, serum hormone and endometrial receptivity. Follow-up continued until 4 weeks after delivery. Maternal and neonatal complications, such as gestational diabetes, were also observed. Results: Overall, 119 patients completed the study, 60 in the QYP group and 59 in the placebo group. Per protocol (PP) analysis revealed that 6-month cumulative pregnancy rate in the QYP group was significantly higher than that in the placebo group [43.33% (26/60) vs. 25.42% (15/59), P=0.040). Additionally, more oocytes were retrieved from the QYP group than those from the placebo group (8.95 ± 3.12 vs. 7.85 ± 1.91, P=0.022). Moreover, the endometrial thickness of HCG day in the QYP group was significantly higher than that in the placebo group (11.78 ± 2.27 mm vs. 10.68 ± 2.07 mm, P=0.012). Maternal and neonatal complications between the two groups were not significantly different (P>0.05). Intention-to-treat analysis was in line with PP results. Conclusions: QYP can enhance ovarian reserve capacity and ovarian response, and possibly promote endometrial receptivity. QYP effectively improves cumulative pregnancy rates in older patients (⩾35 years) undergoing IVF-ET. (Registration No. ChiCTR1800014427) [ABSTRACT FROM AUTHOR]

Background: Prehospital administration of tranexamic acid (TXA) to injured patients is increasing worldwide. However, optimal TXA dose and need of a second infusion on hospital arrival remain undetermined. We investigated the efficacy and safety of the second in-hospital dose of TXA in injured patients receiving 1 g of TXA in the prehospital setting. We hypothesized that a second in-hospital dose of TXA improves survival of trauma patients. Methods: A prospective, double-blind, placebo-controlled randomized, clinical trial included adult trauma patients receiving 1 g of TXA in the prehospital settings. Patients were then blindly randomized to Group I (second 1-g TXA) and Group II (placebo) on hospital arrival. The primary outcome was 24-h (early) and 28-day (late) mortality. Secondary outcomes were thromboembolic events, blood transfusions, hospital length of stay (HLOS) and organs failure (MOF). Results: A total of 220 patients were enrolled, 110 in each group. The TXA and placebo groups had a similar early [OR 1.000 (0.062–16.192); p = 0.47] and late mortality [OR 0.476 (95% CI 0.157–1.442), p = 0.18].The cause of death (n = 15) was traumatic brain injury (TBI) in 12 patients and MOF in 3 patients. The need for blood transfusions in the first 24 h, number of transfused blood units, HLOS, thromboembolic events and multiorgan failure were comparable in the TXA and placebo groups. In seriously injured patients (injury severity score > 24), the MTP activation was higher in the placebo group (31.3% vs 11.10%, p = 0.13), whereas pulmonary embolism (6.9% vs 2.9%, p = 0.44) and late mortality (27.6% vs 14.3%, p = 0.17) were higher in the TXA group but did not reach statistical significance. Conclusion: The second TXA dose did not change the mortality rate, need for blood transfusion, thromboembolic complications, organ failure and HLOS compared to a single prehospital dose and thus its routine administration should be revisited in larger and multicenter studies. Trial registration: ClinicalTrials.gov Identifier: NCT03846973. [ABSTRACT FROM AUTHOR]

Introduction: A small but growing body of evidence suggests individualized support services and improved access to contraception can promote healthy birth spacing among adolescent mothers. This study examines the effectiveness of Steps to Success, a 2-year home visiting program in San Angelo, Texas, enhanced with content designed to reduce rapid repeat pregnancy among young mothers, increase fathers' involvement, and support mothers' education and career aspirations. Methods: The study used a randomized controlled trial, with 594 young mothers ages 14–20 randomly assigned to either a program group that received Steps to Success or a control group that received an existing home visiting program focused only on parenting and child development. Women in both research groups completed a baseline survey upon enrolling in the study and 1- and 2-year follow-up surveys. Results: After 2 years, participants in the Steps to Success and existing home visiting groups had similar rates of repeat pregnancy. However, women in the Steps to Success group were more likely to use long-acting reversible contraceptives (effect size = 0.18, p = 0.066), particularly younger adolescent mothers ages 14–18 (effect size = 0.34, p = 0.010). Steps to Success also decreased the incidence of unprotected sex for younger adolescent mothers (effect size = -0.25, p = 0.035). Steps to Success did not improve outcomes in other domains. Discussion: Steps to Success improved some outcomes related to healthy birth spacing among younger adolescent mothers. Communities interested in similar programming may want to consider focusing their services on this age group. [ABSTRACT FROM AUTHOR]

Purpose: The present study aimed to investigate fish oil plus vitamin D3 (FO + D) supplementation on biomarkers of non-alcoholic fatty liver disease (NAFLD). Methods: In a 3-month randomized controlled trial, 111 subjects with NAFLD, aged 56.0 ± 15.9 y, were randomized into FO + D group (n = 37), fish oil group (FO, n = 37) or corn oil group (CO, n = 37). The subjects consumed the following capsules (3 g/day), which provided 2.34 g/day of eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) + 1680 IU vitamin D3 (FO + D group), or 2.34 g/day of EPA + DHA (FO group), or 1.70 g/d linoleic acid (CO group). Results: Using multivariable-adjusted general linear model, there were significant net reductions in serum alanine aminotransferase (ALT), and triacylglycerol (TAG) and TNF-α levels in the FO + D and FO groups, compared with the control group (P < 0.05). The supplemental FO + D also showed significant reductions in insulin (− 1.58 ± 2.00 mU/L vs. − 0.63 ± 1.55 mU/L, P = 0.050) and IL-1β (− 6.92 ± 7.29 ng/L vs. 1.06 ± 5.83 ng/L, P < 0.001) in comparison with control group. Although there were no significant differences between FO + D and FO groups regarding biochemical parameters, supplemental FO + D showed decreases in ALT (from 26.2 ± 13.5 U/L to 21.4 ± 9.6 U/L, P = 0.007), aspartate aminotransferase (AST, from 22.5 ± 7.0 U/L to 20.2 ± 4.0 U/L, P = 0.029), HOMA-IR (from 3.69 ± 1.22 to 3.38 ± 1.10, P = 0.047), and TNF-α (from 0.43 ± 0.38 ng/L to 0.25 ± 0.42 ng/L, P < 0.001) levels following the intervention. Conclusion: The present study demonstrated that groups supplemented with FO + D and FO had similar beneficial effects on biomarkers of hepatocellular damage and plasma TAG levels in subjects with NAFLD, while in the FO + D group, there were some suggestive additional benefits compared with FO group on insulin levels and inflammation. Trial registration: ChiCTR1900024866. [ABSTRACT FROM AUTHOR]

Cognitive-Behavioral Therapy for Insomnia (CBT-I) is the gold-standard treatment for insomnia, which is common among breast cancer survivors (BCS). This pilot randomized controlled trial tested the first CBT-I intervention for Spanish-speaking BCS delivered using eHealth. Participants (N = 30) were Spanish-speaking BCS with insomnia symptoms recruited in Puerto Rico and randomized to a 6-week eHealth CBT-I group intervention or a waitlist control. Primary outcomes were acceptability (recruitment, treatment satisfaction) and feasibility (retention, attendance). Secondary outcomes were group differences in sleep outcomes post-treatment (i.e., insomnia symptoms, sleep disturbance, sleep efficiency). Recruitment (95%) and retention (97%) were excellent. All CBT-I participants (100%) attended ≥ 3 of 6 sessions. Satisfaction with CBT-I was acceptable. Post-intervention, there were medium to large group differences for average insomnia symptoms (d = 1.02), sleep disturbance (d = 1.25), and sleep efficiency (d = 0.77) favoring CBT-I. There were small/medium to medium/large group differences for the proportion of participants with clinically significant insomnia symptoms (d = 0.52), sleep disturbance (d = 0.67), and low sleep efficiency (d = 0.33) favoring CBT-I. Spanish-language eHealth CBT-I for BCS was acceptable and feasible and showed preliminary efficacy. ClinicalTrials.gov TRN: NCT04101526 (Posted September 24, 2019). [ABSTRACT FROM AUTHOR]

Robust clinical evidence has not been available for melatonin, a drug commonly administered for treating sleep problems of children with autism spectrum disorder (ASD). In a phase 3 randomized, placebo-controlled clinical trial, we administered 1-mg melatonin (n = 65), 4-mg melatonin (n = 65), or placebo (n = 66) to196 children with ASD once daily before bedtime under adequate sleep hygiene interventions. The primary outcome was sleep onset latency (SOL) assessed with the electronic sleep diary. SOL shortened significantly in the 1- and 4-mg melatonin groups compared to the placebo group (− 22.0, − 28.0, and − 5.0 min, respectively; p < 0.0001 each). This therapeutic regimen of melatonin is a reasonable clinical approach to cope with ASD-emergent difficulties in children with ASD. [ABSTRACT FROM AUTHOR]