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Aims: To investigate the efficacy of pre‐emptive remifentanil in alleviating pain during tracheal suctioning in patients under mechanical ventilation. Background: Goal‐directed sedation is recommended for patients under mechanical ventilation by the current guidelines. Whether goal‐directed sedation can prevent pain during tracheal suctioning in these patients is unknown. Design: This was a two‐centre, randomized, crossover, single‐blind trial conducted between August and October 2019. Methods: Patients under mechanical ventilation received low‐dose remifentanil, high‐dose remifentanil or placebo prior to each tracheal suctioning in a random order. The primary outcomes were evaluated using the critical‐care pain observation tool and Richmond agitation–sedation scale after tracheal suctioning. Adverse events were also documented. Results: A total of 39 patients who underwent 117 tracheal suctions were enrolled. After the tracheal suction, changes in the critical‐care pain observation tool and Richmond agitation–sedation scale scores were significantly lower in the low‐dose and high‐dose groups than in the placebo group (P < 0.001). A non‐significant increase in the absence of spontaneous breathing was observed in the high‐dose group compared to that in the placebo group. Conclusion: A pre‐emptive remifentanil bolus of 0.5 μg/kg can mitigate the pain associated with tracheal suctioning. SUMMARY STATEMENT: What is already known about this topic? Pre‐emptive analgesia is recommended by several guidelines to alleviate the pain associated with invasive and potentially painful procedures in ICU patients.Goal‐directed sedation can shorten the length of hospital stay and is recommended for patients in the ICU by several clinical practice guidelines.Literature regarding whether goal‐directed sedation management or pre‐emptive remifentanil can prevent the pain associated with tracheal suctioning in patients under mechanical ventilation is scarce. What this paper adds? A pre‐emptive remifentanil bolus of 0.5 μg/kg can mitigate the pain associated with tracheal suctioning. The implications of this paper: Normal opioid doses administered for goal‐directed sedation management might be insufficient to prevent the pain associated with tracheal suctioningPre‐emptive analgesia can alleviate the pain without increasing the risk of opioid‐related adverse events in ICU patients under mechanical ventilation. [ABSTRACT FROM AUTHOR]

Background: Limited data regarding the effects of school-based obesity prevention programs focusing on the changes in obesity-related knowledge and behaviors in China are available. The objective of this paper was to evaluate the effects of a school-based comprehensive lifestyle intervention among Chinese kids against obesity (CLICK-Obesity) in primary schools in Nanjing. Methods: We designed a cluster randomized controlled trial in eight randomly selected urban primary schools among 4th graders between May 2011 to April 2012 in Jianye, an urban district of Nanjing. Each school was randomly assigned to either the intervention or control group (four schools in each group). Mixed regression models and generalized estimating equations (GEE) were used to adjust for individual-level covariates under cluster randomization. Results: In this study, 1178 students (96.2%; 665 boys and 513 girls, 544 in control and 634 in intervention) participated in the baseline survey with mean age 10.2 ± 0.5 years. At the end of one-year intervention, 1125 students (91.8%; 628 boys and 497 girls, 513 in control and 612 in intervention) were reassessed. Notably, we found that the intervention group improved the knowledge and awareness of obesity-related risk factors, presented a lower increase of consumption of red/white meat (with a mean difference of −180.9 g/week, 95% CI: −350.6 to −11.2, p = 0.040), a larger increase in the time spent playing ball (with a mean difference of 24.2 min/week, 95% CI: −5.3 to 53.7, p = 0.090), and a significant reduction in screen time (with a mean difference of −71.0 min/week, 95% CI: −125.3 to −16.6, p = 0.020) compared to the control group after cluster (school) adjustment. Conclusion: The school-based integrated intervention was successful to modify unhealthy lifestyle behaviors and had a potential effect on childhood obesity prevention in urban China. However, the long-term effects and cost-effectiveness need to be evaluated in through further study. [ABSTRACT FROM AUTHOR]

Background Social-emotional ability is key to the well-being and future success of children; however, disparities in social-emotional development during an individual's early age can last a lifetime, which is particularly evident among children living in poverty-stricken areas. We aimed to determine the effectiveness, cost-effectiveness, and feasibility of a group-based intervention called the Care Group on social-emotional development for families living in poverty-stricken counties. Methods We conducted a cluster (township) randomized controlled trial (C-RCT) every two weeks from July 2019 to June 2020 in a poverty-stricken area located in Shanxi, China. The outbreak of the COVID-19 pandemic suspended the implementation of the intervention in January 2020. The caregiver-child pairs in the intervention group participated in 12 group-based sessions with a structured curriculum and learning materials emphasizing nurturing ability and early childhood development. We applied a difference-in-differences (DID) model to estimate the intervention's impact. The analysis follows the intention-to-treat (ITT) principle. We used standard economic costing methods to estimate the cost of implementing the Care Group over the intervention period and adopted a societal perspective in the analysis. Results We included 322 eligible caregiver-child pairs in the baseline (intervention n=136, control n=186) and surveyed 258 pairs in the endline (intervention n=117, control n=141). Compared with the control group, children in the intervention group had significantly fewer social-emotional problems (adjusted mean difference of Z score=-0.374, 95% CI=-0.718, -0.030, P=0.033) six months after intervention. In the first year, the annual cost of implementing Care Group was US$146.10 per child, reduced to US$47.20 per child in the second year due to the exclusion of non-recurrent costs. The incremental cost-effectiveness ratio (ICER) was US$390.60. Conclusions Care Group is an effective approach for promoting children's social-emotional development in poverty-stricken areas at an affordable cost and with high feasibility for scale-up. Considering the planned per capita health expenditure of the Chinese government for 2022, we believe that the presented evidence makes a solid scientific and financial case for integrating the Care Group intervention into the basic public health services (BPHS) package. [ABSTRACT FROM AUTHOR]

Background: For patients with sepsis receiving non-invasive ventilation (NIV), early rehabilitation is crucial. The Sitting Baduanjin (SBE) is an efficient early rehabilitation exercise suitable for bed patients. There is no consensus about the effect of SBE on the early rehabilitation of septic patients with NIV. This study focused on how the SBE affected the early rehabilitation of sepsis patients with NIV. Methods: 96 sepsis patients with NIV were randomly assigned to either an Baduanjin group that received the SBE based on the routine rehabilitation exercise (n = 48) or a control group (n = 48) that received routine rehabilitation exercise. The primary outcome was the Medical Research Council(MRC)score, and the Barthel Index score, the duration of NIV, length of ICU stay, length of total stay, hospitalization expense as secondary outcomes. Results: A total of 245 sepsis patients were screened, with 96 randomly assigned. The study was completed by 90 patients out of the 96 participants.Results revealed that the MRC score increased in both groups, but the improvement of muscle strength in Baduanjin group was more obvious, with statistical significance (p < 0.001).There was statistically significantly difference between the two groups in Barthel Index at the day of transfer out of ICU(P = 0.028).The patients in the Baduanjin group had an average reduction of 24.09 h in the duration of NIV and 3.35 days in total length of hospital stay compared with the control group (p < 0.05).Of note, the Baduanjin group had significantly reduction the total hospitalization expense. No serious adverse events occurred during the intervention period. Conclusions: In patients with sepsis, the SBE appears to improve muscle strength and activities of daily living (ADL), and lowed the duration of NIV, the length of the total stay, and the hospitalization expense. Trial registration: The study registered on the Chinese Clinical Trial Registry (www.chictr.org.cn), Clinical Trials identifier ChiCTR1800015011 (28/02/2018). [ABSTRACT FROM AUTHOR]

Objective: The fragility index (FI), which is the minimum number of changes in status from "event" to "non-event" resulting in a loss of statistical significance, serves as a significant supplementary indicator for clinical physicians in interpreting clinical trial results and aids in understanding the outcomes of randomized controlled trials (RCTs). In this systematic literature survey, we evaluated the FI for RCTs evaluating Chinese herbal medicine (CHM) for irritable bowel syndrome (IBS), and explored potential associations between study characteristics and the robustness of RCTs. Methods: A comprehensive search was conducted in four databases in Chinese and four databases in English from their inception to January 1, 2023. RCTs encompassed 1:1 ratio into two parallel arms and reported at least one binary outcome that demonstrated statistical significance were included. FI was calculated by the iterative reduction of a target outcome event in the treatment group and concomitant subtraction of a non-target event from that group, until positive significance (defined as P < 0.05 by Fisher's exact test) is lost. The lower the FI (minimum 1) of a trial outcome, the more fragile the positive result of the outcome was. Linear regression models were adopted to explore influence factors of the value of FI. Results: A total of 30 trials from 2 4118 potentially relevant citations were finally included. The median FI of total trials included was 1.5 (interquartile range [IQR], 1–5), and half of the trials (n = 15) had a FI equal to 1. In 12 trials (40%), the total number of participants lost to follow-up surpassed the respective FI. The study also identified that increased FI was significantly associated with no TCM syndrome differentiation for inclusion criteria of the patients, larger total sample size, low risk of bias, and larger numbers of events. Conclusions: The majority of CHM IBS RCTs with positive results were found to be fragile. Ensuring adequate sample size, scientifically rigorous study design, proper control of confounding factors, and a quality control calibration for consistency of TCM diagnostic results among clinicians should be addressed to increase the robustness of the RCTs. We recommend reporting the FI as one of the components of sensitivity analysis in future RCTs to facilitate the assessment of the fragility of trials. [ABSTRACT FROM AUTHOR]

Background: Child and adolescent mental health is a major public health concern worldwide. The development of children's social and emotional skills helps to improve mental health and wellbeing, and prevent anxiety and depression. The school-based social emotional learning (SEL) programmes have proved effective in a number of countries. But in Mainland China, there has been no empirical research of the effectiveness on children's mental health. The study conducted a SEL programme in China during the COVID-19 pandemic and aimed to determine whether: (1) a SEL programme can reduce anxiety and depression, (2) the intervention effect is influenced by sociodemographic characteristics, (3) the programme effects change children's emotion management and communication. Methods: Participants were 230 children aged 8–12 years in the intervention school and 325 in the control school in two poor villages in central China. The study was a quasi-experimental trial, comprising 16 weekly 90-minute sessions. It used a mixed-methods design, with a quantitative survey administered at baseline, post-intervention, and 5-month follow-up, and qualitative interviews. Linear mixed effects regression modeling was used to analyse the intervention effectiveness, linear models were conducted to examine the moderation effect of sociodemographic variables, and the inductive thematic analysis approach was used for interview data. Results: The intervention had no significant effect on anxiety or depression, except that intervention school children who lived with neither parent (left behind children) reported lower depression scores than control school at post-intervention and 5-month follow-up. Qualitative interviews showed after intervention children were more able to control tempers and better communicated their thoughts and feelings, improving their relationships with family and friends. Conclusions: The programme was cheap, easy to implement, and warmly welcomed by children, schools and caregivers, suggesting it was feasible and potentially sustainable. More research is needed on the adaptation of the SEL programme in the Chinese context. [ABSTRACT FROM AUTHOR]

Background: Intra-operative anaesthesia management should be optimised to reduce the occurrence of postoperative nausea and vomiting in high-risk patients; however, a single intervention may not effectively reduce postoperative nausea and vomiting in such patients. This study assessed the effect of an optimised anaesthetic protocol versus a conventional one on postoperative nausea and vomiting in patients who underwent laparoscopic sleeve gastrectomy. Methods: A single-centre randomised trial was conducted at Peking University Shenzhen Hospital from June 2021 to December 2022. Among 168 patients who underwent laparoscopic sleeve gastrectomy, 116 qualified, and 103 completed the study with available data. Patients were categorized into the conventional group (received sevoflurane and standard fluids) and the optimised group (underwent propofol-based anaesthesia and was administered goal-directed fluids). The primary endpoints were postoperative nausea and vomiting incidence and severity within 24 h. Results: Postoperative nausea and vomiting assessment at 0–3 h post-surgery revealed no significant differences between groups. However, at 3–24 h, the optimised anaesthetic protocol group showed lower postoperative nausea and vomiting incidence and severity than those of the conventional group (P = 0.005). In the conventional group, 20 (37.04%) patients experienced moderate-to-severe postoperative nausea and vomiting, compared to six (12.25%) patients in the optimised group (odds ratio = 0.237; 95% CI = 0.086, 0.656; P = 0.006). No significant differences were noted in antiemetic treatment, moderate-to-severe pain incidence, anaesthesia recovery, post-anaesthetic care unit stay, or postoperative duration between the groups. While the total intra-operative infusion volumes were comparable, the optimised group had a significantly higher colloidal infusion volume (500 mL vs. 0 mL, P = 0.014) than that of the conventional group. Conclusions: The incidence and severity of postoperative nausea and vomiting 3–24 h postoperatively in patients who underwent laparoscopic sleeve gastrectomy were significantly lower with propofol-based total intravenous anaesthesia and goal-directed fluid therapy than with sevoflurane anaesthesia and traditional fluid management. Total intravenous anaesthesia is an effective multimodal antiemetic strategy for bariatric surgery. Trial registration: This trial was registered with the Chinese Clinical Trial Registry (ChiCTR-TRC- 2,100,046,534, registration date: 21 May 2021). [ABSTRACT FROM AUTHOR]

The aim of this study was to assess the effect of the use of a clinical nursing pathway for patients undergoing endoscopic thyroidectomy by conducting a meta-analysis. Electronic databases were searched for relevant controlled trials published prior to August 2013. Only papers that compared the use of a clinical nursing pathway to usual care for patients undergoing endoscopic thyroidectomy were selected. The outcome measures were mean difference and 95% confidence interval for length of hospital stay and hospital charges and risk ratio for patient satisfaction. Six controlled trials were identified. The use of a clinical nursing pathway reduced the length of hospital stay and hospital charges. Furthermore, it improved patient satisfaction. This meta-analysis indicates that application of a clinical nursing pathway appears to reduce length of hospital stay and hospital charges and improve patient satisfaction for patients undergoing endoscopic thyroidectomy. [ABSTRACT FROM AUTHOR]

Children with intellectual disabilities often face challenges in balance ability and lower limb muscle strength, which negatively impact their daily lives and motor function. Therefore, it is crucial to enhance the balance ability and lower limb muscle strength of children with intellectual disabilities. This study aimed to investigate the effects of a 12-week aquatic exercise and floor curling intervention on the balance ability and lower limb muscle strength of children with intellectual disabilities. Forty-two participants were randomly assigned to the aquatic exercise group, floor curling group, and control group. The aquatic exercise and floor curling groups received a 12-week intervention, while the control group engaged in supervised free activities. The participants' balance ability and lower limb muscle strength were assessed using the Berg Balance Scale and a muscle strength testing device before and after the intervention. The results showed significant improvements in balance ability and lower limb muscle strength for both the aquatic exercise group and the floor curling group after the intervention. The aquatic exercise group demonstrated an average improvement of 10.84% in balance ability and an overall average improvement of 16.28% in lower limb muscle strength. The floor curling group showed an average improvement of 9.04% in balance ability and an overall average improvement of 15.67% in lower limb muscle strength. These improvement results were statistically significant (p < 0.05) and ranged from medium to large effect sizes (d = 0.5~0.8). The findings of this study validate the positive effects of aquatic exercise and floor curling on the balance ability and lower limb muscle strength of children with intellectual disabilities. These interventions can be considered effective approaches for functional rehabilitation in children with intellectual disabilities. [ABSTRACT FROM AUTHOR]

Background: Subthreshold depression (sD) negatively impacts well-being and psychosocial function and is more prevalent compared with major depressive disorder (MDD). However, as adults with sD are less likely to seek face-to-face intervention, internet-based cognitive-behavioral therapy (ICBT) may overcome barriers of accessibility to psychotherapy. Although several trials explored the efficacy of ICBT for sD, the results remain inconsistent. This study evaluated whether ICBT is effective in reducing depressive symptoms among Chinese adults with sD. Methods: A randomized controlled trial was performed. The participants were randomly assigned to 5 weeks of ICBT, group-based face-to-face cognitive-behavioral therapy (CBT), or a waiting list (WL). Assessments were conducted at baseline, post-intervention and at a 6-month follow-up. The primary outcome measured depressive symptoms using the Center for Epidemiological Studies Depression Scale (CES-D). Outcomes were analyzed using a mixed-effects model to assess the effects of ICBT. Results: ICBT participants reported greater reductions on all the outcomes compared to the WL group at post-intervention. The ICBT group showed larger improvement on the Patient Health Questionnaire-9 (PHQ-9) at post-intervention (d = 0.12) and at follow-up (d = 0.10), and with CES-D at post-intervention (d = 0.06), compared to the CBT group. Conclusions: ICBT is effective in reducing depressive symptoms among Chinese adults with sD, and improvements in outcomes were sustained at a 6-month follow-up. Considering the low rates of face-to-face psychotherapy, our findings highlight the considerable potential and implications for the Chinese government to promote the use of ICBT for sD in China. [ABSTRACT FROM AUTHOR]

Background: This study aimed to compare the consistency of anesthesia consciousness index (Ai) with that of bispectral index (BIS) in monitoring the depth of anesthesia (DOA) during sevoflurane anesthesia, to reveal the optimal cutoff values in different states of consciousness, and explore the stability of DOA monitoring during intraoperative injurious stimulation. Methods: We enrolled 145 patients (97 men and 48 women) from 10 medical centers. General anesthesia was induced using intravenous anesthetics and maintained with sevoflurane. Ai and BIS values were recorded. Results: The mean difference between the Ai and BIS was-0.1747 (95% confidence interval, -0.6660 to 0.3166; p = 0.4857). The regression equation of Ai and BIS from the Deming regression analysis was y = 5.6387 + 0.9067x (y is BIS, x is Ai), and the slope and intercept were statistically significant. Meanwhile, the receiver operating characteristic curve analysis of anesthesia-induced unconsciousness, loss of consciousness, and recovery of consciousness revealed that the accuracy of Ai and BIS were similar. In addition, the optimal cutoff values of the different states of consciousness were not sensitive to age, and both Ai and BIS had no correlation with hemodynamics. Conclusion: We conclude that Ai and BIS show no systematic deviation in readings with high consistency, similar accuracy, and good stability; these insights provide more data for clinical application. [ABSTRACT FROM AUTHOR]

The purpose of this study was to compare the impact of velocity-based resistance training (VBRT) and percentage-based resistance training (PBRT) on anaerobic ability, sprint performance, and jumping ability. Eighteen female basketball players from a Sport College were randomly divided into two groups: VBRT (n = 10) and PBRT (n = 8). The six-week intervention consisted of two sessions per week of free-weight back squats with linear periodization from 65% to 95%1RM. In PBRT, the weights lifted were fixed based on 1RM percentage, while in VBRT, the weights were adjusted based on individualized velocity profiles. The T-30m sprint time, relative power of countermovement jump (RP-CMJ), and Wingate test were evaluated. The Wingate test assessed peak power (PP), mean power (MP), fatigue index (FI), maximal velocity (Vmax), and total work (TW). Results showed that VBRT produced a very likely improvement in RP-CMJ, Vmax, PP, and FI (Hedges' g = 0.55, 0.93, 0.68, 0.53, respectively, p < 0.01). On the other hand, PBRT produced a very likely improvement in MP (Hedges' g = 0.38) and TW (Hedges' g = 0.45). Although VBRT showed likely favorable effects in RP-CMJ, PP, and Vmax compared to PBRT (p < 0.05 for interaction effect), PBRT produced greater improvements in MP and TW (p < 0.05 for interaction effect). In conclusion, PBRT may be more effective in maintaining high-power velocity endurance, while VBRT has a greater impact on explosive power adaptations. [ABSTRACT FROM AUTHOR]

Background In China, heat-sensitive moxibustion (HSM) is used for knee osteoarthritis (KOA) to reduce pain and improve physical activity. However, there is little high-quality evidence of its effectiveness. Objective To evaluate the effectiveness of HSM in the treatment of KOA compared with usual care. Methods We performed a multicentre, randomised controlled trial. In total, 432 patients with KOA were randomly assigned to one of three groups (HSM, conventional moxibustion, or conventional injection with sodium hyaluronate). The primary end point was the guiding principle of clinical research on new drugs in the treatment of KOA (GPCRND-KOA). Measurements were obtained at baseline and after 1 and 6 months (month 7) of study. Result For GPCRND-KOA, there were significant differences among the three groups after treatment at months 1 and 7. Pairwise comparisons showed that HSM was more effective than the conventional drug. There was no difference in any measures between conventional moxibustion and the conventional drug. Compared with conventional moxibustion, HSM resulted in greater improvement in all outcomes. Conclusions This trial provided some evidence of the superiority of HSM in patients with KOA, suggesting that the observed differences might be due to superiority effects of a heat-sensitive point, although the effect of expectation cannot be ruled out. [ABSTRACT FROM AUTHOR]

People with diabetes frequently have elevated diabetes distress. Although mindfulness‐based stress reduction (MBSR) therapy has been shown effective in reducing diabetes distress, it has only been delivered by psychologists or a multidisciplinary team with an attrition rate of up to 39%, which limits its dissemination to a broader audience. This study was aimed to pilot evaluate the feasibility of a nurse‐led MBSR therapy and explore its potential efficacy amongst people with type 2 diabetes mellitus. A total of 100 participants were randomly allocated either to the intervention group (nurse‐led MBSR therapy + regular diabetes education) or the control group (regular diabetes education). Data on diabetes distress, diabetes self‐efficacy, and diabetes self‐management were collected at baseline, 8 and 12 weeks. Hemoglobin A1c (HbA1c) was collected at baseline and 12 weeks. A generalized estimating equation analysis for repeated measures was used to determine intervention and time effects. As predicted, the nurse‐led MBSR therapy had a significant time‐by‐group interaction effect on diabetes distress total score (95% confidence interval [CI]: 0.58–0.77, p < 0.001), diabetes self‐efficacy (95% CI: −0.93 to −0.74, p < 0.001), diabetes self‐management (95% CI: −10.80 to −7.83, p < 0.001), and HbA1c levels (95% CI: 0.04–1.14, p = 0.03) in the intervention group compared with the control group over 12 weeks. This is the first nurse‐led MBSR therapy in a hospital setting that is feasible and has the potential to improve health outcomes. This approach may offer an innovative model to deliver MBSR therapy. A randomized controlled trial comparing the nurse‐led MBSR plus usual diabetes education with usual diabetes education along with a mechanism to equalize intervention attention between the groups is indicated. [ABSTRACT FROM AUTHOR]

Objective The purpose of this study is to investigate the optimal time window for initiating mobilizing after acute ischemic stroke. Methods The TIME Trial is a pragmatic, investigator-initiated, multi-center, randomized, 3-arm parallel group, clinical trial. This trial will be conducted in 57 general hospitals in mainland China affiliated with the China Stroke Databank Center and will enroll 6033 eligible patients with acute ischemic stroke. Participants will be randomly allocated to either (1) the very early mobilization group in which mobilization is initiated within 24 hours from stroke onset, (2) the early mobilization group in which mobilization begins between 24 and 72 hours poststroke, or (3) the late mobilization group in which mobilization is started after 72 hours poststroke. The mobilization protocol is otherwise standardized and identical for each comparison group. Mobilization is titrated by baseline mobility level and progress of patients throughout the intervention period. The primary outcome is death or disability assessed with the modified Rankin scale at 3 months poststroke. Secondary outcomes include impairment score of the National Institutes of Health Stroke Scale, dependence in activities of daily living as measured using the modified Barthel Index, cognitive ability assessed with the Mini-Mental State Examination, incidence of adverse events, hospital length of stay, and total medical costs. Impact The TIME Trial is designed to answer the question "when is the best time to start mobilization after stroke?" The effect of timing is isolated from the effect of type and dose of mobilization by otherwise applying a standard mobilization protocol across groups. The TIME Trial may, therefore, contribute to increasing the knowledge base regarding the optimal time window for initiating mobilization after acute ischemic stroke. [ABSTRACT FROM AUTHOR]

Objectives: Acute coronary syndrome (ACS) is an acute disease with high mortality. Although early percutaneous coronary intervention (PCI) is proved to be the practical approach in treating ACS, the incidence of cardiovascular events is still far from satisfactory. The combination of Suxiao Jiuxin Pill (SJP) and Western medicine is one conventional approach in the treatment of ACS. Many elementary and clinical trials have proved the efficacy and safety in the improvement of cardiocerebral vascular conditions. The aim of this project is to evaluate the safety and efficacy of SJP on ACS with early PCI patients. Trial Design: This is a multicenter randomized, double-blind placebo-controlled trial. Trial registration: ChiCTR-TRC-13003053. Settings: Hospitals. Subjects: A total of 200 ACS with early PCI patients were randomly divided into SJP group (n = 100) and placebo group (n = 100). Interventions: The SJP group was treated with routine treatment and SJP (taking eight SJP pills orally each time, three times per day). The placebo group was treated with routine treatment along with equal amounts of SJP placebo. The course of treatment was 6 months and a follow-up visit at 12 months. Outcome Measures: Assessments of major adverse cardiovascular events (MACE), safety assessments, adverse events, left ventricular systolic function (LVEF), Seattle angina questionnaire (SAQ), troponin C (cTNI), C-reactive protein (CRP), fibrinogen (Fib), and cystatin C (cysC). Results: The SJP group had a relatively low incidence of MACE than the placebo (p < 0.05, odds ratio: 1.916, 95% confidence interval [0.999–3.674]). LVEF was significantly higher in the SJP group than the placebo group on the 360-day follow-up (p < 0.01). SJP had a significant increase score in the SAQ subscale of physical limitation, angina frequency, and treatment satisfaction (p < 0.05). There is no significant difference in the cTNI and CRP level between the two groups. The serum concentration of Fib and cysC in the SJP was significantly decreased compared with the placebo (p < 0.05). The numbers of adverse events between the two groups were not statistically different (p > 0.05). Conclusions: SJP is associated with a reduction in MACE, and an improvement of heart function and quality of life in ACS patients with early PCI, and is probably safe to use. [ABSTRACT FROM AUTHOR]

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Objective: We aimed to explore the feasibility of evaluating the comparative effectiveness and safety of electroacupuncture (EA) relative to manual acupuncture (MA) for the treatment of knee osteoarthritis (KOA). Methods: A multicenter randomized controlled clinical trial was conducted in Beijing from September 2017 to January 2018. A total of 60 participants with KOA were randomly allocated to either EA (n = 30) or MA (n = 30) groups. Participants in the EA group were treated with EA at six to seven local traditional acupuncture points or ah shi points, and two to three distal points. Participants in the MA group had the same schedule as the EA group except that the electrical apparatus featured a working power indicator without actual current output, constituting a sham EA procedure, in order to blind participants. Both groups received 24 sessions over 8 weeks. The primary outcome was response rate, defined as a change of ⩾50% from baseline in the total scores of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) after 8 weeks. Secondary outcomes included pain, stiffness, function, quality of life, and acupuncture-related adverse events (AEs) at 4 and 8 weeks. Results: Of 60 participants randomized, 53 (88%) completed the study. Response rates were 43% for the EA group and 30% for the MA group by the intention-to-treat analysis. Although significant differences were observed in WOMAC pain, stiffness, and function scores within both groups, between-group differences at 8 weeks did not reach statistical significance (odds ratio = 1.75 (95% confidence interval = 0.593–5.162)). Rates of AEs were low and similarly distributed between groups. Conclusion: Both EA and MA interventions in KOA were feasible and appeared safe. Whether or not EA may have a stronger impact on pain and function requires further evaluation through larger, adequately powered, randomized controlled trials. Trial registration number: NCT03274713. [ABSTRACT FROM AUTHOR]

Aims and objectives: To evaluate the effectiveness of a self‐efficacy‐focused structured education programme on outcomes in adults with type 2 diabetes (T2DM) without insulin therapy. Background: Structured education regarding metabolic control in T2DM adults without insulin therapy has not always been effective, and this lack of effectiveness might be due to overlooking self‐efficacy. Whether a self‐efficacy‐focused structured education programme could improve metabolic and psychosocial outcomes for T2DM adults more effectively remains unknown. Design: A multicentre parallel randomised controlled concealed label trial. Methods: The study conducted in outpatients of four hospitals in China. A total of 265 T2DM adults without insulin therapy were randomly assigned to an intervention group of a self‐efficacy‐focused structured education programme (n = 133), or to a control group of routine education (n = 132). The differences in metabolic and psychosocial outcomes were investigated at baseline, three‐ and 6‐month follow‐ups. Results: The primary outcome of A1C and the secondary outcomes of weight, body mass index, waist circumference, diastolic pressure, self‐efficacy, self‐management behaviours and knowledge improved significantly in the intervention group compared with the control group at 6‐month follow‐up. The differences in A1C between groups for patients with a low educational background at 6‐month follow‐up were significant. No significant differences were found in other secondary outcomes of systolic pressure, the blood lipid profile and diabetes distress between groups at 6‐month follow‐up. Conclusions: This programme can improve glycaemic control, weight control, diastolic pressure, self‐efficacy, self‐management behaviours and diabetes knowledge for T2DM adults. Relevance to clinical practice: This self‐efficacy‐focused structured education programme is effective and can be incorporated into regular clinical care and led by trained staff (e.g. nurses), and it can be implemented in patients with low educational backgrounds. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effectiveness of acupuncture in patients with vascular cognitive impairment no dementia (VCIND) in comparison with citicoline, an agent for cognitive disturbances associated with chronic cerebral disorders. Design: A randomized controlled multicenter trial. Setting: In three hospitals in Beijing, China. Subjects: A total of 216 patients with VCIND were recruited. Interventions: Patients with VCIND (mean age of 65.4 years) were randomized to receive acupuncture (two sessions per week) or oral citicoline (100 mg three times daily) over three months. Main measures: The primary outcome was the change from baseline to three months in cognitive symptom, measured by Alzheimer's disease Assessment Scale, cognitive subscale (ADAS-cog). Secondary outcomes included changes from baseline to six months in ADAS-cog, executive function measured by the Clock Drawing Test (CDT), and functional disability measured by the Ability of Daily Living (ADL) scale at three and six months. Results: At three months, the acupuncture group had a greater decrease in mean ADAS-cog score (−2.33 ± 0.31) than the citicoline group (−1.38 ± 0.34) with a mean difference of −0.95 (95% CI, −1.84 to −0.07, P = 0.035). The mean change from baseline to six months in ADAS-cog also significantly favored acupuncture treatments (acupuncture change −2.61 vs citicoline −1.25, difference: −1.36 points; 95% CI, −2.20 to −0.51; P = 0.002). There was no difference between the two groups on CDT and ADL scores at either time point. Conclusion: Compared with citicoline, acupuncture has comparable and even superior efficacy with improved cognitive and daily living performance as a complementary and alternative medicine treatment for VCIND. [ABSTRACT FROM AUTHOR]

Background: It is becoming increasingly evident that platelet chemokines are involved in distinct aspects of atherosclerosis. The aim of this study was to examine the effects of long-term supplementation with purified anthocyanins on platelet chemokines in hypercholesterolemic individuals and to identify correlations of decreased platelet chemokine levels with serum lipid and inflammatory marker levels. Methods: A total of 146 hypercholesterolemic individuals were recruited and treated with 320 mg of purified anthocyanins (n = 73) or a placebo (n = 73) daily for 24 weeks in this randomized, double-blind, placebo-controlled trial. Results: Anthocyanin supplementation for 24 weeks significantly decreased the plasma CXCL7 (-12.32% vs. 4.22%, P =0 . 001), CXCL5 (-9.95% vs. 1.93%, P = 0.011), CXCL8 (-6.07% vs. 0.66%, P = 0.004), CXCL12 (-8.11% vs. 5.43%, P = 0.023) and CCL2 levels (-11.63% vs. 12.84%, P = 0.001) compared with the placebo. Interestingly, the decreases in the CXCL7 and CCL2 levels were both positively correlated with the decreases in the serum low-density lipoprotein-cholesterol (LDL-C), high-sensitivity C-reactive protein (hsCRP) and interleukin-1β (IL-1β) levels after anthocyanin supplementation for 24 weeks. The decrease in the CXCL8 level was negatively correlated with the increase in the how-density lipoprotein- cholesterol (HDL-C) level and was positively correlated with the decrease in the soluble P-selectin (sP-selectin) level in the anthocyanin group. In addition, a positive correlation was observed between the decreases in the CXCL12 and tumornecrosis factor-α (TNF-α) levels after anthocyanin supplementation. However, the plasma CXCL4L1, CXCL1, macrophage migration inhibitory factor (MIF) and human plasminogen activator inhibitor 1 (PAI-1) levels did not significantly change following anthocyanin supplementation. Conclusions: The present study supports the notion that platelet chemokines are promising targets of anthocyanins in the prevention of atherosclerosis. Trial registration: ChiCTR-TRC-08000240. Registered: 10 December 2008. [ABSTRACT FROM AUTHOR]

Background: Danlou tablets, a patented Chinese Medicine, have been long approved for the treatment of ischemic heart disease in China. While numerous empirical observations suggested Danlou tablets could decrease frequency and duration of angina pectoris attacks, evidence supporting its efficacy on cardiac remodeling remains inadequate. Therefore, this pilot trial was designed to determine whether Danlou tablets would reduce adverse left ventricular (LV) remodeling in patients with myocardial infarction (MI). Methods and Results: Eligible patients with acute MI were enrolled and randomly assigned to Danlou tablets or placebo groups, superimposed on standard treatment for MI. Then, in addition to assessment of the clinical outcome, the changes in LV volumes were evaluated by a serial echocardiography. In total, 83 patients (Danlou tablets 42 and placebo 41) completed 90 days of treatment and had complete baseline and outcome data. Standard echocardiographic evaluations revealed significant differences in the change of LV end-diastolic volume index (LVEDVi) between group of patients treated with Danlou tablets and the placebo group (-4.49 ± 7.29 vs. -0.34 ± 9.01 mL/m², P < 0.001). The reduction in LVEDVi was independent of beta-blocker, ACE inhibitors/ARBs use. Furthermore, treatment with Danlou tablets significantly reduced LV end-systolic volume index (-4.09 ± 5.85 vs. -0.54 ± 5.72 mL/m², P < 0.001) and improved the LV ejection fraction (4.83 ± 9.23 vs. 0.23 ± 8.15%, P < 0.001), as compared to placebo. Meaningfully, the incidence of the major adverse cardiovascular events was also lower in patients receiving Danlou tablets (P < 0.05). Conclusion: Superimposed on the standard pharmacologic treatment, Danlou tablets significantly reversed post-MI adverse LV remodeling, thereby contributed to the overall positive clinical outcome. Trial registration: clinicaltrials.gov identifier NCT02675322 (February 1, 2016). [ABSTRACT FROM AUTHOR]

HIV prevalence among Chinese men who have sex with men has rapidly increased in recent years. In this randomized, controlled study, we tested the feasibility and efficacy of motivational interviewing to reduce high-risk sexual behaviors among this population in Changsha, China. Eighty men who have sex with men were randomly assigned to either the intervention group, in which participants received a three-session motivational interviewing intervention over 4 weeks, or the control group, in which participants received usual counseling from peer educators. High-risk behavior indicators and HIV knowledge level were evaluated at baseline and 3 months after the intervention. Motivational interviewing significantly improved consistent anal condom use. However, there was no significant change in consistent condom use for oral sex or in the number of sexual partners over time. HIV knowledge scores improved equally in both groups. This study demonstrated that an intervention using motivational interviewing is feasible and results in increased condom use during anal sex for Chinese men who have sex with men. However, further work must be done to increase the use of condoms during oral sexual encounters. [ABSTRACT FROM AUTHOR]

The article discusses research which investigated effectiveness of a school-based education programme in reducing salt intake of children and their families. Topics explored include the measurement of salt intake through urinary sodium excretion measurement, the salt reduction message relayed to children and their families, and the salt intake changes recorded in both intervention and control groups studied.

Objectives: To observe the effect of a Baduanjin exercise intervention on fatigue in people with fatigue-predominant subhealth (FPSH). Participants: A total of 131 participants were included in this cohort study. Those who met the inclusion criteria were grouped into the Baduanjin cohort ( n=64) or the control cohort ( n=67). Intervention: The Baduanjin cohort exercised for 30 minutes twice a day for 6 weeks; the control cohort received no treatments. The study period was 18 weeks. Outcome measures: The fatigue states of all participants were evaluated by using the Fatigue Self-Assessment Scale (FSAS) at baseline, the fourth and sixth weeks of treatment, and during post-treatment follow-ups at the end of the 12th and 18th weeks. Results: The scores for the six factors on the FSAS at baseline did not significantly differ between the two groups. In the Baduanjin cohort, the total score on the FSAS (TSF) and scores for physical fatigue (PF), mental fatigue (MF), consequence of fatigue (CF), and response of fatigue to sleep and rest (RFSAR) were significantly decreased at the end of the sixth week. These patients also had significantly decreased scores for TSF, PF, MF, and CF at baseline, at the end of the fourth and sixth weeks of the intervention, and during post-treatment follow-ups at the end of the 12th and 18th weeks. No adverse effects of treatment were reported. Conclusions: This study suggests that Baduanjin exercise has an effect on relieving fatigue in patients with FPSH. [ABSTRACT FROM AUTHOR]

The article offers information on a study which determines the effectiveness of infection control intervention programme in preventing the prevalence of meticillin resistant staphylococcus aureus (MRSA) transmission among Hong Kong's residential care homes for the elderly (RCHEs). It mentions that two-arm cluster randomized controlled trial was used to guide this study. It shows that the intervention programme which focuses on hand hygiene (HH) was not effective in preventing MRSA transmission.

Conclusion: Our data indicate that the mitochondrial 12S rRNA gene, and particularly the A827G mutation, may be associated with susceptibility to age-related hearing loss. Objective: Hearing loss associated with aging is common among elderly persons. In all genetic backgrounds, mitochondrial DNA (mtDNA) mutations may be one of the most important factors contributing to aging and age-related hearing loss. The mitochondrial 12S rRNA is a hot spot for deafness-associated mutations in Chinese populations. The purpose of the present study was to elucidate the relationship of 12S rRNA gene polymorphisms and age-related hearing loss. Methods: The 12S rRNA gene polymorphisms were detected by direct sequencing. Statistical analyses were performed to assess the associations between age-related hearing loss and 12S rRNA gene variants. Results: We report here a systematic mutational screening of the mitochondrial 12S rRNA gene in 662 elderly subjects from the general population with various hearing threshold levels (211 controls and 451 age-related hearing loss subjects). Mutational screening of the mitochondrial 12S rRNA gene identified 55 nucleotide changes, including 4 mutations localized at highly conserved sites and 51 known variants. Of the known deafness-associated mutations in the mitochondrial 12S rRNA gene, the incidence of the A1555G mutation was 0.15%, A827G was 4.38%, T1095C was 0.45%, and T1005C was 3.78%. The incidence of the other known variants was 0.15-99.85%. We found statistically significant differences in the proportions of subjects with the A827G mutation among the various age-related hearing loss groups and normal controls. [ABSTRACT FROM AUTHOR]

BACKGROUND: The EACH study assessed the efficacy of oxaliplatin, 5-fluorouracil, and leucovorin (the FOLFOX4 regimen) compared with doxorubicin alone in terms of overall survival (OS), progression-free survival (PFS), and safety in patients with advanced hepatocellular carcinoma (HCC). We present the results of this study in Chinese patients. METHODS: In a multicenter, open-label, randomized, phase III study (NCT00471965), 371 patients (279 patients from the People's Republic of China) were randomized 1:1 to receive either FOLFOX4 or doxorubicin until disease progression, intolerable toxicity, death, or surgical resection. RESULTS: Baseline characteristics of the Chinese patients enrolled in the study were similar for the 2 treatment groups and in comparison with the whole EACH cohort. Median OS at the prespecified time point of treatment was 5.7 months with FOLFOX4 and 4.3 months with doxorubicin (hazard ratio [HR]: 0.74; 95% confidence interval [CI]: 0.55-0.98; p = .03). At the end of the follow-up period, median OS was 5.9 months with FOLFOX4 and 4.3 months with doxorubicin (HR: 0.75; 95% CI: 0.58-0.98; p = .03). Median PFS was 2.4 months and 1.7 months in the FOLFOX4 and doxorubicin groups, respectively (HR: 0.55; 95% CI: 0.45-0.78; p = .0002). The response rate (RR) and disease control rate (DCR) were significantly higher in the FOLFOX4 group than in the doxorubicin group (RR: 8.6% vs. 1.4%, p = .006; DCR: 47.1% vs. 26.6%, p = .0004). Hematological toxicity was more frequently reported in the FOLFOX4 group. CONCLUSION: For Chinese HCC patients enrolled in the EACH study, FOLFOX4 significantly improved the RR and DCR and prolonged survival compared with doxorubicin. Systemic chemotherapy with oxaliplatin-based regimens may play an important role in the treatment of Chinese patients with advanced HCC. [ABSTRACT FROM AUTHOR]