Improving Parental Health Literacy in Primary Caregivers of 0- to 3-Year-Old Children Through a WeChat Official Account: Cluster Randomized Controlled Trial.

Background: Parental health literacy is important to children's health and development, especially in the first 3 years. However, few studies have explored effective intervention strategies to improve parental literacy. Objective: This study aimed to determine the effects of a WeChat official account (WOA)-based intervention on parental health literacy of primary caregivers of children aged 0-3 years. Methods: This cluster randomized controlled trial enrolled 1332 caregiver-child dyads from all 13 community health centers (CHCs) in Minhang District, Shanghai, China, between April 2020 and April 2021. Participants in intervention CHCs received purposefully designed videos via a WOA, which automatically recorded the times of watching for each participant, supplemented with reading materials from other trusted web-based sources. The contents of the videos were constructed in accordance with the comprehensive parental health literacy model of WHO (World Health Organization)/Europe (WHO/Europe). Participants in control CHCs received printed materials similar to the intervention group. All the participants were followed up for 9 months. Both groups could access routine child health services as usual during follow-up. The primary outcome was parental health literacy measured by a validated instrument, the Chinese Parental Health Literacy Questionnaire (CPHLQ) of children aged 0-3 years. Secondary outcomes included parenting behaviors and children's health outcomes. We used the generalized linear mixed model (GLMM) for data analyses and performed different subgroup analyses. The ß coefficient, risk ratio (RR), and their 95% CI were used to assess the intervention's effect. Results: After the 9-month intervention, 69.4% (518/746) of caregivers had watched at least 1 video. Participants in the intervention group had higher CPHLQ total scores (ß=2.51, 95% CI 0.12-4.91) and higher psychological scores (ß=1.63, 95% CI 0.16-3.10) than those in the control group. The intervention group also reported a higher rate of exclusive breastfeeding (EBF) at 6 months (38.9% vs 23.44%; RR 1.90, 95% CI 1.07-3.38) and a higher awareness rate of vitamin D supplementation for infants younger than 6 months (76.7% vs 70.5%; RR 1.39, 95% CI 1.06-1.82). No significant effects were detected for the physical score on the CPHLQ, breastfeeding rate, routine checkup rate, and children's health outcomes. Furthermore, despite slight subgroup differences in the intervention's effects on the total CPHLQ score and EBF rate, no interaction effect was observed between these subgroup factors and intervention factors. Conclusions: Using a WHO literacy model-based health intervention through a WOA has the potential of improving parental health literacy and EBF rates at 6 months. However, innovative strategies and evidence-based content are required to engage more participants and achieve better intervention outcomes.

Effectiveness of a program to lower unwanted media screens among 2-5-year-old children: a randomized controlled trial.

Background: Limited interventions exist on reducing unwanted screen time (ST) among children from low- and middle-income countries (LMICs), so we developed and assessed the effectiveness of the program to lower unwanted media screen time (PLUMS) among children aged 2-5 years in Chandigarh, Union Territory, North India. Methods: An open-label randomized control parallel group trial per CONSORT guidelines was conducted among randomly selected 340 families with children aged 2-5 (±3 months) years in Chandigarh, India. PLUMS was implemented at the family level with a focus on modifying the home media environment and targeted individual-level interventions using parent and child modules for 2 months. A post-intervention (immediately) and a follow-up assessment after 6 months was done. During the follow-up period, the interaction was done passively via WhatsApp groups. The control group received routine healthcare services. Validated and standardized tools, including a digital screen exposure questionnaire with a physical activity component, preschool child behavior checklist, and sleep disturbance scale for children, were used to collect data at baseline, post-intervention, and follow-up periods. The primary outcome was the mean difference in ST (minutes/day) among children in the intervention group versus the control group. Generalized estimating equation (GEE) analysis was performed to adjust for clustering. Results: An equal number of families (n = 170) were randomly assigned to the intervention and control arms. In the post-intervention assessment, 161 and 166 families continued while, at the follow-up assessment, 154 and 147 were in the intervention and control arm, respectively. The mean difference in ST on a typical day [27.7 min, 95% Confidence Interval (CI) 5.1, 50.3] at the post-intervention assessment significantly (p < 0.05) decreased in the intervention (102.6 ± 98.5 min) arm as compared with the control (130.3 ± 112.8 min) arm. A significant reduction in ST (ß = -35.81 min, CI -70.6, -1.04) from baseline (ß = 123.1 min) to follow-up phase (ß = 116 min) was observed in GEE analysis. The duration of physical activity increased both at post-intervention (ß = 48.4 min, CI = +6.6, +90.3) and follow-up (ß = 73.4 min, CI = 36.2, 110.5) assessments in the intervention arm. Conclusion: The PLUMS intervention significantly reduced the children's mean ST on a typical day and increased the physical activity immediately post-intervention and during the 6-month follow-up period. These results might guide the policymakers to include strategies in the national child health programs in the Southeast Asia Region to reduce unwanted ST.Clinical trial registration: https://clinicaltrials.gov/, identifier CTRI/2017/09/009761.

Effect of a Smartphone App (S-Check) on Actual and Intended Help-Seeking and Motivation to Change Methamphetamine Use Among Adult Consumers of Methamphetamine in Australia: Randomized Waitlist-Controlled Trial.

BACKGROUND: Interventions are required that address delays in treatment-seeking and low treatment coverage among people consuming methamphetamine. OBJECTIVE: We aim to determine whether a self-administered smartphone-based intervention, the "S-Check app" can increase help-seeking and motivation to change methamphetamine use, and determine factors associated with app engagement. METHODS: This study is a randomized, 28-day waitlist-controlled trial. Consenting adults residing in Australia who reported using methamphetamine at least once in the last month were eligible to download the app for free from Android or iOS app stores. Those randomized to the intervention group had immediate access to the S-Check app, the control group was wait-listed for 28 days before gaining access, and then all had access until day 56. Actual help-seeking and intention to seek help were assessed by the modified Actual Help Seeking Questionnaire (mAHSQ), modified General Help Seeking Questionnaire, and motivation to change methamphetamine use by the modified readiness ruler. χ2 comparisons of the proportion of positive responses to the mAHSQ, modified General Help Seeking Questionnaire, and modified readiness ruler were conducted between the 2 groups. Logistic regression models compared the odds of actual help-seeking, intention to seek help, and motivation to change at day 28 between the 2 groups. Secondary outcomes were the most commonly accessed features of the app, methamphetamine use, feasibility and acceptability of the app, and associations between S-Check app engagement and participant demographic and methamphetamine use characteristics. RESULTS: In total, 560 participants downloaded the app; 259 (46.3%) completed eConsent and baseline; and 84 (32.4%) provided data on day 28. Participants in the immediate access group were more likely to seek professional help (mAHSQ) at day 28 than those in the control group (n=15, 45.5% vs n=12, 23.5%; χ21=4.42, P=.04). There was no significant difference in the odds of actual help-seeking, intention to seek help, or motivation to change methamphetamine use between the 2 groups on the primary logistic regression analyses, while in the ancillary analyses, the imputed data set showed a significant difference in the odds of seeking professional help between participants in the immediate access group compared to the waitlist control group (adjusted odds ratio 2.64, 95% CI 1.19-5.83, P=.02). For participants not seeking help at baseline, each minute in the app increased the likelihood of seeking professional help by day 28 by 8% (ratio 1.08, 95% CI 1.02-1.22, P=.04). Among the intervention group, a 10-minute increase in app engagement time was associated with a decrease in days of methamphetamine use by 0.4 days (regression coefficient [ß] -0.04, P=.02). CONCLUSIONS: The S-Check app is a feasible low-resource self-administered intervention for adults in Australia who consume methamphetamine. Study attrition was high and, while common in mobile health interventions, warrants larger studies of the S-Check app. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12619000534189; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377288&isReview=true.

[Experience with an international study on standard-risk relapsed childhood acute lymphoblastic leukemia (IntReALL SR 2010 study) in Japan].

Many effective new agents for relapsed childhood acute lymphoblastic leukemia (ALL) are now becoming available, and international standard chemotherapy should be developed to optimize use of these agents. Randomized controlled trials (RCTs) are needed to establish a standard treatment, but few have been conducted for relapsed childhood ALL in Japan due to the small patient population. Participation in international RCTs is necessary to access sufficient patients for informative study results, but differences in approved drugs and healthcare systems between countries make this challenging. In 2014, the Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) participated in an international study on standard-risk relapsed childhood ALL (IntReALL SR 2010) involving two RCTs and multiple drugs not approved in Japan, which was addressed by replacing the unapproved drugs with alternative approved drugs with the same or similar efficacy. This article discusses the historical background of treatment development for relapsed childhood ALL, our experience in participating in the IntReALL SR 2010 trial, and prospects for treating relapsed childhood ALL.

Individual Placement and Support and Participatory Workplace Intervention on the Work Participation of People with Disabilities: A Randomised Controlled Trial.

PURPOSE: This study assessed the effectiveness of Individual Placement and Support (IPS), Participatory Workplace Intervention (PWI), and IPS + PWI on work participation and health of people with work disabilities. METHODS: A randomised controlled 2 × 2 factorial trial with 120 clients and an 18-month follow-up was performed. Differences between IPS and no-IPS and between PWI and no-PWI were assessed using log-rank tests and Cox proportional hazards models. RESULTS: In the IPS group, restricted mean survival time (RMST) for sustainable paid employment was 352 days, compared to 394 in the no-IPS group (HR = 1.47, 95% CI = 0.81-2.63). In the PWI group the RMST was 378 days, compared to 367 in the no-PWI group (HR = 0.89, 95% CI = 0.48-1.64). For the secondary outcome 'starting any paid employment, a trial placement, or education' RMST was significantly lower for the IPS group (222 days) than for the no-IPS group (335 days; HR = 1.85, 95% CI = 1.01-3.42). Mental health was significantly lower (worse) in the PWI group (difference -4.07, 95% CI = -7.93 to -0.22) than in the no-PWI group. For all other secondary outcomes, no statistically significant differences were found. CONCLUSION: No statistically significant differences were observed in the duration until starting sustainable employment between IPS and no-IPS, and between PWI and no-PWI. The duration until starting any paid employment, a trial placement, or education was shorter in the IPS group than in the no-IPS group, but further research should explore whether this also increases sustainable employment in the longer term.

Effect of reduced follow-up care on patient satisfaction with care among patients with endometrial cancer: The ENSURE randomized controlled trial.

BACKGROUND: Evidence on the optimal follow-up schedule after endometrial cancer is lacking. The study aim was to compare satisfaction with care between women who received reduced follow-up care and women who received usual guideline-directed follow-up care for three years after surgery. METHODS: The ENSURE (ENdometrial cancer SURvivors' follow-up carE) trial was a non-inferiority randomized controlled multicenter trial in 42 hospitals in the Netherlands. The intervention arm received reduced follow-up care (4 visits/3 years), while the control group received usual follow-up care (8-11 visits/3 years). Primary outcome was overall satisfaction with care, PSQIII score, over three years follow-up, with a non-inferiority margin of 6. Mixed linear regression, intention-to-treat and per-protocol analyses (presented below) were used. RESULTS: Among 316 women included, overall satisfaction with care was not lower in the reduced follow-up (mean 82; SD = 15) compared with the usual follow-up group (mean 80; SD = 15) group (B = 1.80(-2.09;5.68)). At 6, 12 and 36 months, more women (93/94/90%) in the reduced follow-up group were satisfied with their follow-up schedule than in the usual follow-up group (79/79/82%; p < 0.001; p < 0.001; p = 0.050). CONCLUSIONS AND RELEVANCE: Women with low-risk, early-stage endometrial cancer who received reduced follow-up care were no less satisfied with their care than women receiving usual follow-up care. Compared with usual follow-up, women in the reduced follow-up group had fewer clinical visits and, at the same time, more often reported being satisfied with their follow-up schedule. Findings suggest that reduced follow-up care may be the new standard, but should be tailored to meet additional needs where indicated.

The effect of a single session of psychological first aid in the emergency department on PTSD and depressive symptoms three months post-intervention: results of a randomised controlled trial.

Background: Despite its popularity, evidence of the effectiveness of Psychological First Aid (PFA) is scarce.Objective: To assess whether PFA, compared to psychoeducation (PsyEd), an attention placebo control, reduces PTSD and depressive symptoms three months post-intervention.Methods: In two emergency departments, 166 recent-trauma adult survivors were randomised to a single session of PFA (n = 78) (active listening, breathing retraining, categorisation of needs, assisted referral to social networks, and PsyEd) or stand-alone PsyEd (n = 88). PTSD and depressive symptoms were assessed at baseline (T0), one (T1), and three months post-intervention (T2) with the PTSD Checklist (PCL-C at T0 and PCL-S at T1/T2) and the Beck Depression Inventory-II (BDI-II). Self-reported side effects, post-trauma increased alcohol/substance consumption and interpersonal conflicts, and use of psychotropics, psychotherapy, sick leave, and complementary/alternative medicine were also explored.Results: 86 participants (51.81% of those randomised) dropped out at T2. A significant proportion of participants in the PsyEd group also received PFA components (i.e. contamination). From T0 to T2, we did not find a significant advantage of PFA in reducing PTSD (p = .148) or depressive symptoms (p = .201). However, we found a significant dose-response effect between the number of delivered components, session duration, and PTSD symptom reduction. No significant difference in self-reported adverse effects was found. At T2, a smaller proportion of participants assigned to PFA reported increased consumption of alcohol/substances (OR = 0.09, p = .003), interpersonal conflicts (OR = 0.27, p = .014), and having used psychotropics (OR = 0.23, p = .013) or sick leave (OR = 0.11, p = .047).Conclusions: Three months post-intervention, we did not find evidence that PFA outperforms PsyEd in reducing PTSD or depressive symptoms. Contamination may have affected our results. PFA, nonetheless, appears to be promising in modifying some post-trauma behaviours. Further research is needed.

Psychological First Aid (PFA) is widely recommended early after trauma.We assessed PFA's effectiveness for decreasing PTSD symptoms and other problems 3 months post-trauma.We didn't find definitive evidence of PFA's effectiveness. Still, it seems to be a safe intervention.

Electroacupuncture for slow flow/no-reflow phenomenon in patients with acute myocardial infarction undergoing percutaneous coronary intervention: protocol for a pilot randomized controlled trial.

Background: Slow flow/no-reflow (SF-NR) during percutaneous coronary intervention (PCI) is associated with poor prognosis of patients with acute myocardial infarction (AMI). Currently, effective treatment is not available for SF-NR. Electroacupuncture (EA) has shown significant efficacy as an adjuvant therapy for many cardiovascular diseases by improving microcirculation and reducing ischemia-reperfusion injury. However, its effects on SF-NR in the AMI patients during PCI are not clear. This pilot trial aims to determine the efficacy of intraoperative EA in alleviating SF-NR in AMI patients undergoing PCI. Methods: This prospective, single-center, randomized controlled, pilot trial will recruit 60 AMI patients scheduled for PCI at the Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, China. The patients will be randomized in a 1:1 ratio into the EA or the control groups. Patients in the control group will undergo standard PCI. Patients in the EA group will undergo intraoperative electroacupuncture while undergoing standard PCI. Incidence of SF-NR is the primary outcome for this study. This study will also assess secondary outcomes including cardiac biomarkers, inflammatory biomarkers, pain and anxiety scores, electrocardiography parameters, traditional Chinese medicine (TCM) symptom score, and major adverse cardiovascular and cerebrovascular events (MACCE). All the included patients will undergo laboratory tests including routine blood tests, levels of electrolytes, as well as liver and renal function tests. Patients will be followed up for 1 month after the procedure. Discussion: This pilot trial will provide evidence for the potential benefits of intraoperative EA in improving microvascular perfusion and preventing or alleviating SF-NR during PCI in patients with AMI. If proven effective, intraoperative EA will provide a new and effective strategy against SF-NR and provide evidence for subsequent multicenter trials. Clinical Trial Registration: ClinicalTrials.gov, identifier (ChiCTR2300072265). Registered on 8 June 2023.

Effects of Nudge Strategy-Based Dietary Education Intervention in Patients with Type 2 Diabetes Mellitus: A Cluster Randomized Controlled Trial.

OBJECTIVES: We aimed to assess the clinical effects of dietary education intervention utilizing the nudge strategy in individuals with type 2 diabetes mellitus (T2DM). BACKGROUND: The global prevalence of T2DM and its associated complications presents a significant health challenge. While the benefits of dietary education intervention for blood glucose management are widely acknowledged, patients often struggle to adhere to dietary recommendations. The implementation of the nudge strategy may offer a promising solution to change unhealthy dietary behavior and enhance diabetes control among individuals with T2DM. METHODS: This is a sub-study within a broader cluster-randomized trial that evaluated the effects of nudge-based dietary education and traditional dietary education intervention. Measurements of HbA1c, fasting blood glucose (FBG), body mass index (BMI), blood lipid levels, blood pressure, dietary behavior, and diabetes distress were assessed at baseline and 3 months after the intervention in 147 individuals with T2DM from six primary care practices in Beijing, China. RESULTS: All outcome measurements were complete at two time points for 134 participants. Results showed that compared to the control group, the intervention group achieved a significantly greater reduction in HbA1c, FBG, BMI, total cholesterol, low-density lipoprotein cholesterol, blood pressure, total energy intake, carbohydrate intake, fat intake, and protein intake and had lower diabetes distress. The intervention group also maintained HDL-C levels and had a significantly greater increase in vegetable intake, while changes in triglycerides were similar in the two groups . CONCLUSION: The present study provides evidence that nudge strategy-based dietary education intervention is effective in improving blood glucose, BMI, blood lipid levels, and blood pressure and facilitating changes in patients' dietary behavior and diabetes distress. These findings suggest that implementing nudge strategies can contribute to the optimization of T2DM dietary management and overall patient well-being.

Schizophrenia interactome derived repurposable drugs and randomized control trials of two candidates.

There is a substantial unmet need for effective and patient-acceptable drugs to treat severe mental illnesses like schizophrenia. Computational analysis of genomic, transcriptomic, and pharmacologic data generated in the past two decades enables repurposing of drugs or compounds with acceptable safety profiles, namely those that are FDA-approved or reached late stages in clinical trials. We developed a rational approach to achieve this computationally for schizophrenia by studying drugs that target the proteins in its protein interaction network ('interactome'). This involved contrasting the transcriptomic modulations observed in the disorder and the drug; our analyses resulted in 12 candidate drugs, 9 of which had additional supportive evidence: their target networks were enriched for pathways relevant to schizophrenia etiology or for genes that had an association with diseases pathogenically similar to schizophrenia. To translate these computational results to the clinic, these shortlisted drugs must be tested empirically through randomized controlled trials (RCT), where their prior safety approvals obviate the need for time-consuming phase I and II studies. We selected two among the shortlisted candidates based on likely adherence and side effect profiles. We are testing them through adjunctive RCTs for patients with schizophrenia or schizoaffective disorder who experienced incomplete resolution of psychotic features with conventional treatment. The integrated computational analysis for identifying and ranking drugs for clinical trials can be iterated as additional data are obtained. Our approach could be expanded to enable disease subtype-specific drug discovery in future and should also be exploited for other psychiatric disorders.

[Row-like needling along the spleen meridian combined with autonomous functional exercise in treatment of postpartum diastasis recti abdominis: a randomized controlled trial].

OBJECTIVE: To observe the clinical effect of the row-like needling along the spleen meridian combined with autonomous functional exercise in treatment of postpartum diastasis recti abdominis. METHODS: A total of 72 patients with postpartum diastasis recti abdominis were randomly divided into an observation group (36 cases, 3 cases excluded) and a control group (36 cases, 3 cases dropped out). In the control group, the autonomous functional exercise was performed on the rectus abdominis. In the observation group, on the basis of the treatment as the control group, the row-like needling along the spleen meridian was delivered. Along the distribution of the spleen meridian on the abdomen, besides Daheng (SP 15), acupuncture was operated at the sites 3 cm and 6 cm directly above and below Daheng (SP 15) bilaterally. Five points on each side were stimulated along the meridian. Acupuncture was delivered once every two days, 3 interventions a week. One course of treatment, composed of 10 treatments, was required. Before treatment and after 5 and 10 treatments, the inter-rectus distance (IRD) and the score of the medical outcomes study 36-item short form health survey (SF-36) were observed in the two groups, respectively. RESULTS: After 5 and 10 treatments, the IRD at the sites 3 cm above the umbilicus, in the center of the umbilicus and below the umbilicus was reduced when compared with that before treatment in the observation group, respectively (P<0.01); and the IRD at the site 3 cm above the umbilicus was decreased in comparison with that before treatment in the control group (P<0.05). After treated for 5 times, compared with the control group, the IRD at the site 3 cm below the umbilicus was reduced in the observation group (P<0.05); and after treated for 10 times, compared with the control group, the IRD at the sites 3 cm above the umbilicus, in the center of the umbilicus and below the umbilicus was reduced in the observation group (P<0.01). After the completion of 5 and 10 treatments, the scores of physical functioning (PF), role-physical (RP), role-emotional (RE) and health change (HC), as well as the total score of SF-36 were all higher than those before treatment in the observation group (P<0.01); while in the control group, the scores of PF, RP and RE, as well as the total score of SF-36 were increased in comparison with those before treatment (P<0.01). After 5 treatments, the scores of general health (GH) and HC in the observation group were higher than those of the control group (P<0.05, P<0.01); and after 10 treatments, the score of PF, GH and HC, as well as the total score of SF-36 in the observation group were higher than those of the control group (P<0.01). CONCLUSION: On the basis of autonomous functional exercise, the row-like needling along the spleen meridian can promote the recovery of postpartum diastasis recti abdominis and improve the quality of life of the patients.

[Nape seven needles combined with pressing moxibustion for cervical vertigo: a randomized controlled trial].

OBJECTIVE: To observe the clinical effect of nape seven needles combined with pressing moxibustion for cervical vertigo (CV). METHODS: A total of 70 patients with CV were randomized into an observation group and a control group, 35 cases in each group. In the observation group, nape seven needles combined with pressing moxibustion was delivered, once a day, 6 times a week, for consecutive 2 weeks. In the control group, betahistine hydrochloride tablet and aceclofenac dispersible tablet were given orally, for 2 weeks and 3 days respectively. Before and after treatment, the evaluation scale for cervical vertigo (ESCV) score was observed, the plasma levels of neuropeptide Y (NPY), endothelin-1 (ET-1) and calcitonin gene related peptide (CGRP) were detected, the hemorheologic and hemodynamic indexes were measured, and the clinical efficacy was evaluated after treatment in the two groups. RESULTS: After treatment, the scores of dizziness, daily life and work ability, psychological and social adaptability, and headache, as well as the total scores of ESCV were increased compared with those before treatment (P<0.01, P<0.05) in the two groups, and the score and total score of neck and shoulder pain of ESCV was increased compared with that before treatment (P<0.01) in the observation group; each sub-item score and total score of ESCV in the observation group were higher than those in the control group (P<0.01, P<0.05). After treatment, the plasma levels of NPY and ET-1 were decreased compared with those before treatment (P<0.01), while the plasma levels of CGRP were increased compared with those before treatment (P<0.01, P<0.05) in the two groups; the plasma levels of NPY and ET-1 in the observation group were lower than those in the control group (P<0.01), the plasma level of CGRP in the observation group was higher than that in the control group (P<0.01). After treatment, the whole blood high shear viscosity, plasma viscosity and whole blood low shear viscosity were decreased compared with those before treatment (P<0.01, P<0.05), the mean velocity of basilar artery (BA), left vertebral artery (LVA) and right vertebral artery (RVA) were increased compared with those before treatment (P<0.05) in the two groups; the whole blood high shear viscosity, plasma viscosity and whole blood low shear viscosity in the observation group were lower than those in the control group (P<0.01), and the mean velocity of BA, LVA and RVA in the observation group were higher than those in the control group (P<0.05). The total effective rate in the observation group was 91.4% (32/35), which was superior to 71.4% (25/35) in the control group (P<0.05). CONCLUSION: Nape seven needles combined with pressing moxibustion can effectively alleviate the clinical symptoms, and improve the hemorheology and hemodynamics in CV patients.

[Effect of interactive scalp acupuncture on upper limb function in patients with hemiplegia after stroke].

OBJECTIVE: To explore the clinical effect of interactive scalp acupuncture combined with task-oriented mirror therapy on hemiplegia after stroke. METHODS: A total of 86 patients with hemiplegia after stroke were randomly divided into an observation group (43 cases, 2 cases dropped out) and a control group (43 cases, 2 cases dropped out). Both groups received routine treatment and rehabilitation treatment for stroke. The control group was treated with task-oriented mirror therapy, 40 min each time, once a day, 6 days a week. The observation group was treated with interactive scalp acupuncture at ipsilateral upper 1/5 and 2/5 of the parietal and temporal anterior oblique line and upper 1/5 and 2/5 of the parietal and temporal posterior oblique line on the basis of the treatment as the control group, 45 min each time, once a day, 6 days a week. Both groups were treated for 4 weeks. Before and after treatment and in follow-up of 8 weeks after treatment completion, the Fugl-Meyer assessment (FMA) score, modified Ashworth scale (MAS) score, shoulder abduction angle, wrist dorsiflexion angle and N20 latency and amplitude of somatosensory evoked potential were compared between the two groups. RESULTS: After treatment and in follow-up, the FMA scores were increased (P<0.01), the MAS scores were decreased (P<0.01) compared with those before treatment in the two groups; the FMA scores in the observation group were higher than those in the control group (P<0.01), the MAS scores were lower than those in the control group (P<0.01). After treatment and in follow-up, the shoulder abduction angle and wrist dorsiflexion angle was increased (P<0.01), the N20 latency was shortened and amplitude was increased (P<0.01) compared with that before treatment in both groups; the shoulder abduction angle and wrist dorsiflexion angle in the observation group was greater than that in the control group (P<0.01), the N20 latency was shorter than that in the control group (P<0.01), and the N20 amplitude was higher than that in the control group (P<0.01). CONCLUSION: Interactive scalp acupuncture combined with task-oriented mirror therapy can improve upper limb function in patients with hemiplegia after stroke, and reduce the muscular tone of the affected limb.

[Acupuncture combined with repeated transcranial magnetic stimulation for mild to moderate post-stroke depression: a randomized controlled trial].

OBJECTIVE: To explore the clinical effect of acupuncture combined with repeated transcranial magnetic stimulation (rTMS) for mild to moderate post-stroke depression. METHODS: Ninety patients with mild to moderate post-stroke depression were randomly divided into a combination group (30 cases, 4 cases dropped out), an acupuncture group (30 cases, 3 cases dropped out) and a rTMS group (30 cases, 5 cases dropped out). All the three groups received basic treatment, the combination group was treated with acupuncture combined with rTMS, the acupuncture group was treated with acupuncture, and the rTMS group was treated with rTMS. The acupuncture was applied at Baihui (GV 20), Yintang (GV 24+) , Danzhong (CV 17) and bilateral Shenmen (HT 7), Taichong (LR 3), Neiguan (PC 6). All the three groups were treated once a day, 5 times a week for 4 weeks. The Hamilton depression scale (HAMD-17) score, Pittsburgh sleep quality index (PSQI) score and event-related potential were compared among the three groups before and after treatment. RESULTS: After treatment, the HAMD-17 scores and PSQI scores in the three groups were reduced compared with those before treatment (P<0.01) , and the HAMD-17 score and PSQI score in the combination group were lower than those in the acupuncture group and the rTMS group (P<0.05). After treatment, the latency of event-related potential (P300, mismatch negativityï¼»MMNï¼½) in the three groups was shortened compared with that before treatment (P<0.05), and the latency of event-related potential in the combination group was shorter than that in the acupuncture group and the rTMS group (P<0.05). CONCLUSION: Acupuncture combined with rTMS can effectively alleviate the depressive state of patients with mild to moderate post-stroke depression, improve the sleep quality and the latency of event-related potential P300 and MMN.

[Clinical effect of acupuncture based on the specific response of jing-well point for intractable insomnia: a randomized controlled trial].

OBJECTIVE: To evaluate clinical effect and safety on the basis of detecting the specific response of jing-well point in treatment of intractable insomnia with acupuncture by meridian differentiation. METHODS: Sixty-four patients with intractable insomnia were randomized into an observation group (32 cases, 1 case dropped out and 1 case was eliminated) and a control group (32 cases, 1 case was eliminated). In the observation group, the meridian imbalance value detected at the jing-well point was taken as the evidence so that the corresponding yuan-source and back-shu points were stimulated with acupuncture. In the control group, the routine acupuncture was operated at Baihui (GV 20), Sishencong (EX-HN 1), and bilateral Shenmen (HT 7), Sanyinjiao (SP 6), Shenmai (BL 62) and Zhaohai (KI 6). Besides, the detection at jing-well point was performed for blindness in the control group. In the two groups, the interventions were delivered once daily, 5 times a weeks and for consecutive 4 weeks. In the two groups, the scores of Pittsburgh sleep quality index (PSQI), insomnia severity index (ISI) and the TCM symptom scale were observed before treatment and after 2 and 4 weeks of treatment; the clinical effect and safety were evaluated after treatment; the changes of meridian imbalance value were observed before and after treatment and the correlation analysis with the total score of PSQI was conducted. RESULTS: After 2 and 4 weeks of treatment, except the scores for hypnotic drug in the two groups and sleep disorder after 2 weeks of treatment in the control group, the scores of the other factors and the total scores of PSQI were all reduced when compared with those before treatment in the two groups (P<0.05). After 4 weeks of treatment, except the scores for hypnotic drug in the two groups and sleep disorder in the control group, the scores of the other factors and the total scores of PSQI were lower than those after 2 weeks of treatment in the two groups (P<0.05). After 2 weeks of treatment, the scores for time to fall asleep, sleep efficiency and daytime dysfunction in the observation group were lower than those of the control group (P<0.05); and after 4 weeks of treatment, except the scores for sleep disorder and hypnotic drug, the scores of the other factors and the total score of PSQI in the observation group were all lower than those of the control group (P<0.05). After 2 and 4 weeks of treatment, ISI scores and the scores of TCM symptom scale decreased when compared with those before treatment (P<0.05), and the scores of these two scales after 4 weeks of treatment were lower than those after 2 weeks of treatment (P<0.05) in the two groups; and the scores in the observation group were lower than thoese in the control group (P<0.05). The total effective rate was 93.3% (28/30) in the observation group, higher than that (90.3% [28/31]) in the control group (P<0.05). Of 64 cases, there was only 1 case of mild hematoma in the control group; and no any other adverse events occurred. Among 64 cases, the meridians, with the imbalance frequency ≥30 times, included the pericardium meridian of hand-jueyin and the heart meridian of hand-shaoyin; those with the imbalance frequency ≥20 times, were the kidney meridian of foot-shaoyin, the triple energizers meridian of hand-shaoyang, the gallbladder meridian of foot-shaoyang, the spleen meridian of foot-taiyin and the stomach meridian of foot-yangming. Except the lung meridian of hand-taiyin in the control group, the imbalance value of each meridian was reduced after treatment (P<0.05, P<0.001, P<0.01), and the meridian imbalance value presented a linear positive correlation with the total score of PSQI in the two groups . CONCLUSION: Meridian differentiation acupuncture based on detecting the specific response of jing-well point can significantly improve the sleep quality and reduce the related symptoms in the patients with intractable insomnia. This therapy promotes the conversion of the meridians from the imbalance to the balance and is satisfactory in its safe operation.

[Clinical effect of the warm acupuncture of Mongolian medicine on insomnia in the elderly and its brain-gut peptide mechanism: a randomized controlled trial].

OBJECTIVE: To observe the clinical effect and safety of the warm acupuncture of Mongolian medicine in treatment of insomnia in the elderly, and to explore its underlying brain-gut peptide mechanism. METHODS: Sixty elderly patients with insomnia were randomly divided into a warm acupuncture group and a western medication group, 30 cases in each group. In the warm acupuncture group, the warm acupuncture of Mongolian medicine was operated at Dinghuixue (at the center of the vertex, the crossing site of the anterior midline and the line connected the upper edges of two ear apexes), Heyixue (at the depression of the spinous process of the 7th cervical vertebra) or Xinxue (at the depression of the spinous process of the 6th thoracic vertebra) in each treatment. Only one of the above points was selected and stimulated for 20 min one treatment and the three points were used alternatively. The treatment was given once every day or every other day, 3 times a week, and for a total of 3 weeks. In the western medication group, estazolam tablets were administered orally, once a day, 1 mg before bedtime, consecutively for 3 weeks. Before and after treatment, as well as in 1-month follow-up visit after the treatment completion, the scores of the Pittsburgh sleep quality index (PSQI) and the insomnia severity index (ISI) were observed in the two groups. The serum brain-related peptide markers (substance P [SP], neuropeptide Y [NPY], 5-hydroxytryptamine 1A [5-HT1A] and 5-hydroxytryptamine 2A [5-HT2A]) were measured before and after treatment, and the clinical efficacy and safety was evaluated in the two groups. RESULTS: After treatment and in follow-up, the scores of sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance and daytime dysfunction, as well as the total scores of PSQI, and ISI scores were all reduced in the two groups (P<0.05, P<0.01); and the scores in the warm acupuncture group were lower than those of the western medication group (P<0.05, P<0.01). After treatment, the levels of serum SP and 5-HT2A were decreased (P<0.01) and the levels of serum NPY and 5-HT1A were increased (P<0.01) when compared with those before treatment in the two groups. The levels of serum SP and 5-HT2A in the warm acupuncture group were lower than those of the western medication group (P<0.05), and the levels of serum NPY and 5-HT1A were higher than those of the western medication group (P<0.05). After treatment, the total effective rate was 93.3% (28/30) in the warm acupuncture group, which was higher than 83.3% (25/30) of the western medication group (P<0.05). No serious adverse reactions were found in the two groups. CONCLUSION: Warm acupuncture of Mongolian medicine can effectively improve the sleep quality of the elderly patients with insomnia, and its mechanism may be related to the regulation of the levels of serum SP, NPY, 5-HT1A and 5-HT2A.

[Acupoint massage, acupoint sticking combined with moxibustion for postpartum urinary retention: a randomized controlled trial].

OBJECTIVE: To observe the clinical efficacy of acupoint massage, acupoint sticking combined with moxibustion at Shuidao (ST 28) for postpartum urinary retention. METHODS: A total of 120 patients with postpartum urinary retention were randomly divided a triple-combination group, a double-combination group, and a massage group, with 40 patients in each group. All groups received standard postpartum care to stimulate urination. The patients in the massage group received rapid acupoint massage at the bilateral Shuidao (ST 28); the patients in the double-combination group additionally received acupoint sticking of self-made Tongquan powder at bilateral Shuidao (ST 28); the patients in the triple-combination group further received moxibustion at bilateral Shuidao (ST 28). The treatment was given once in all three groups. After 5 hours of treatment completion, bladder residual volume was measured; the time and volume of first urination as well as total urination volume after 5 hours of treatment completion were recorded; the patients' sensation of urination smoothness, satisfaction rate, length of hospital stay, and hospital costs were evaluated. RESULTS: The triple-combination group showed significantly lower residual urine volumes (P<0.05), earlier first urination time (P<0.05, P<0.001), and higher first urination volumes and total urination volumes after 5 hours of treatment completion compared to the other two groups (P<0.05, P<0.001). The sensation of urination smoothness and patient satisfaction were also significantly better in the triple-combination group (P<0.001, P<0.05). The double-combination group had higher volume of first urination and total urination volume after 5 hours of treatment completion than the massage group (P<0.05), and better sensation of urination smoothness and patient satisfaction (P<0.05). There was no significant difference in the length of hospital stay and costs among the three groups (P>0.05). The total effective rates were 100.0% (40/40) for the triple-combination group, 90.0% (36/40) for the double-combination group, and 70.0% (28/40) for the massage group, with the triple-combination group significantly outperforming the other two groups (P<0.05, P<0.001), and double-combination group outperforming the massage group (P<0.05). CONCLUSION: Acupoint massage, acupoint sticking combined with moxibustion at Shuidao (ST 28) could effectively improve urination in patients with postpartum urinary retention, and enhance patient satisfaction.

[Effects of Zhoutian moxibustion on pain symptoms and inflammatory factors in patients with ankylosing spondylitis of cold-damp obstruction].

OBJECTIVE: To observe the effects of Zhoutian moxibustion on pain symptoms and serum inflammatory factors in patients with ankylosing spondylitis of cold-damp obstruction. METHODS: Eighty-four patients with ankylosing spondylitis of cold-damp obstruction were randomly divided into a Zhoutian moxibustion group (42 cases, 2 cases dropped out) and a governor vessel moxibustion group (42 cases, 2 cases dropped out, 1 case discontinued). Both groups were given oral administration of sulfasalazine enteric-coated tablets as basic treatment. The governor vessel moxibustion group was treated with moxibustion box from Dazhui (GV 14) to Yaoyangguan (GV 3), one hour per treatment; the Zhoutian moxibustion group was treated with moxibustion box from Tiantu (CV 22) to Zhongji (CV 3) in addition to the governor vessel moxibustion group, two hours per treatment. Both groups were treated once every 3 days, twice a week, for a total of 9 weeks. The pain symptom scores of the two groups were observed before treatment and at the 3rd, 6th, and 9th weeks into treatment. ELISA was used to detect the levels of serum interleukin (IL)-1ß, IL-18, and tumor necrosis factor-α (TNF-α) before and after treatment, and the clinical efficacy of the two groups was evaluated after treatment. RESULTS: Except for the joint pain scores at the 3rd week into treatment, the total scores and the each sub-item score of pain symptom in the two groups were lower than those before treatment at the 3rd, 6th, and 9th weeks into treatment (P<0.05); at the 3rd, 6th, and 9th weeks into treatment, the total scores of pain symptom and the scores of lumbar sacral pain, back pain, joint cold pain, and limited mobility in the Zhoutian moxibustion group were lower than those in the governor vessel moxibustion group (P<0.05). After treatment, the levels of serum IL-1ß, IL-18 and TNF-α in both groups were lower than those before treatment (P<0.05), and the levels of serum IL-1ß, IL-18, and TNF-α in the Zhoutian moxibustion group were lower than those in the governor vessel moxibustion group (P<0.05). The total effective rate was 90.0% (36/40) in the Zhoutian moxibustion group, which was higher than 76.9% (30/39) in the governor vessel moxibustion group (P<0.05). CONCLUSION: Zhoutian moxibustion could effectively improve various pain symptoms in patients with ankylosing spondylitis of cold-damp obstruction, and reduce the expression of inflammatory factors.

Sonothrombolysis before and after percutaneous coronary intervention provides the largest myocardial salvage in ST-segment Elevation Myocardial Infarction.

BACKGROUND: Sonothrombolysis is a therapeutic application of ultrasound with ultrasound contrast for patients with ST elevation Myocardial Infarction (STEMI). Recent trials demonstrated that sonothrombolysis, delivered before and after primary percutaneous coronary intervention (pPCI), increase infarct vessel patency, improve microvascular flow, reduce infarct size, and improve ejection fraction. However, it is unclear whether pre-pPCI sonothrombolysis is essential for therapeutic benefit. We designed a parallel three-arm sham-controlled randomised controlled trial to address this. METHODS: Patients presenting with first STEMI undergoing pPCI within six hours of symptom onset were randomised 1:1:1 into three arms: sonothrombolysis pre/post pPCI (Group 1), Sham pre & sonothrombolysis post pPCI (Group 2), and Sham pre/post pPCI (Group 3). Our primary endpoint was infarct size (% LV mass) assessed by Cardiac MRI at day 4±2. Secondary endpoints included myocardial salvage index (MSI) and echocardiographic parameters at Day 4±2 and six months. RESULTS: Our trial was ceased early due to the COVID pandemic. From 122 patients screened between September 2020 and June 2021, 51 patients (Age 60, male 82%) were included post randomisation. Median sonothrombolysis took 5 minutes pre pPCI and 15 minutes post, without significant door-to-balloon delay. There was a trend towards reduction in median infarct size between Group 1 (8%[IQR 4,11]), Group 2 (11%[7,19]) or Group 3 (15%[9,22]). Similarly there was a trend towards improved MSI in Group 1 (79%[64,85]) compared to Groups 2 (51%[45,70]) and 3 (48%[37,73]) No major adverse cardiac events occurred during hospitalization. CONCLUSION: Pre-pPCI sonothrombolysis may be key to improving MSI in STEMI. Multicentre trials and health economic analyses are required before clinical translation.

Social Skills Interventions for Adolescents with Level 1 Autism Spectrum Disorder: A Systematic Review with Meta-Analysis of Randomized Controlled Trials.

Objective: Evidence on the efficacy of social skills training for adolescents with Level 1 Autism Spectrum Disorder (ASD) is unclear. Method: We searched Pubmed, Scopus, and Web of Science until July 27th, 2023, for randomized controlled trials (RCTs) of social skills training for pre-adolescents and adolescents (aged 9-18) with Level 1 ASD. We then pooled data on efficacy from individual RCTs by conducting multivariate mixed-effects meta-analyses in R. We estimated possible bias in the retained RCTs using the RoB2 tool. Results: We retained 36 RCTs (encompassing 2796 participants), including 18 RCTs comparing an experimental treatment to a waiting list, and 18 RCTs comparing it to standard care/control treatment. Meta-analyses showed that experimental treatments were significantly more efficacious than waiting list or standard care/ control treatments in improving social skills (SMD = 0.3745; 95%CI = [0.2396; 0.5093]), as well as reducing behavioral symptoms (0.3154;0.1783, 0.4525) and anxious/depressive symptoms (0.2780; 0.0432, 0.5128). However, for some outcomes there was significant heterogeneity across studies and evidence of publication bias. Subgroup analyses and meta-regressions did not identify any specific clinical or demographic factors as significant predictors of outcome. The most common risk of bias across studies was related to deviations from intended interventions and measurement of the outcomes. Conclusions: At the group level, social skills training for adolescents with Level 1 ASD is efficacious, with small-to-moderate effect size. Future research should focus on personalized medicine approaches, aimed at tailoring interventions to specific characteristics of adolescents with Level 1 ASD.