Application of Wireless Dynamic Sleep Monitor in Acupuncture Treatment of Insomnia after Ischemic Stroke: A Retrospective Study

Purpose. Retrospective analysis of the clinical effect of acupuncture on insomnia after ischemic stroke by using a wireless sleep monitor as an innovative evaluation method. Methods. From March 1, 2018, to September 30, 2019, 105 cases of insomnia after ischemic stroke were extracted from the inpatient medical record system of Shenzhen Longhua District Central Hospital. According to differences in the treatment plan, the cases were divided into an acupuncture group (57 cases) and a drug group (48 cases). The acupuncture group was given acupuncture treatment on the basis of usual care, while the drug group was given estazolam oral treatment on the basis of usual care. Under the ICF framework, the related items of sleep function and emotion function were selected for evaluation. As outcome parameters, the alterations of the Pittsburgh sleep quality index (PSQI), the self-rating anxiety scale (SAS), and the self-rating depression scale (SDS) were used before the treatment, after treatment, and in a follow-up; meanwhile, the ActiSleep-BT wireless sleep monitor was used to measure total sleep time (TST), sleep efficiency (SE), and sleep arousal (SA) of the two groups before and after treatment and at follow-up. Results. Within-group comparison showed significant differences in the acupuncture group before treatment and after treatment on the ActiSleep-BT wireless dynamic sleep monitor data as well as in PSQI and ICF. Comparing the acupuncture group with the control group also showed significant differences in the ActiSleep-BT wireless dynamic sleep monitor data, PSQI, and ICF. Conclusion. By evaluation using ActiSleep-BT wireless sleep monitor, acupuncture treated insomnia after ischemic stroke; the effect is better than usual care.

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Efficacy of Guizhi Fuling Wan for Primary dysmenorrhea: protocol for a randomised controlled trial

10.21203/rs.3.rs-462906/v1 ◽

2021 ◽

Author(s):

Du Yun ◽

Yatong Li ◽

Xianyun Fu ◽

Yanan Luo ◽

Chenjie Li

Keyword(s):

Clinical Trial ◽

Short Form ◽

Controlled Trial ◽

Blood Stasis ◽

The Self ◽

Blood Stasis Syndrome ◽

Control Group ◽

Self Rating ◽

Double Blinded

Abstract BackgroundPrimary dysmenorrhea (PD) is one of main gynecological complaints in women of child-bearing age, but there are limited effective treatments available. Guizhi Fuling Wan (GFW), one of the most widely known traditional Chinese medicine (TCM) herbal formulas, has been the treatment of choice for gynecological disease in China. A growing number of studies have shown that GFW is beneficial for patients with PD. However, the quality of evidence is limited, and there are few studies on the treatment of PD by GFW with specific TCM syndromes. Therefor we will conduct a randomized controlled trial to explore the efficacy and safety of GFW for PD patients with heat-burning blood-stasis syndrome.Methods and analysisThis study is designed as a randomized, double-blinded, placebo-controlled clinical trial. Eligible patients will be randomly assigned to the GFW group (patients receive GFW) and the control group (patients receive a matching placebo) in a 1:1 ratio. The participants will receive either GFW or placebo, twice daily for 3 menstrual cycles with a 3-month follow-up. The primary outcome is the pain intensity reduction measured by a Visual Analog Scale. The secondary outcomes is the Cox Menstrual Symptom Scale, the Self-rating Depression Scale, the Self-rating Anxiety Scale, the 12-item Short-Form Health Survey and the dysmenorrhea diarymenstrual pain.. All outcomes are assessed at baseline, and the 4th, 8th, and 12th week during the interventions, as well as at the 16th, 20th and 24th week follow-up. Any adverse events will be recorded throughout the study.DiscussionThis is the first double-blinded RCT to assess the effectiveness and safety of GFW in treating PD with the heat-burning blood-stasis syndrome. The scientific and rigorous methodology design of this trial will provide significant evidence regarding the use of GFW to treat PD in future.Trial registrationChinese Clinical Trial Registry, ID: ChiCTR2000034118. Regisrered on 25 June 2020.

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Evaluating the Effectiveness of Diabetes Shared Medical Appointments (SMAs) as Implemented in Five Veterans Affairs Health Systems: a Multi-site Cluster Randomized Pragmatic Trial

Journal of General Internal Medicine ◽

10.1007/s11606-020-06570-y ◽

2021 ◽

Author(s):

Michele Heisler ◽

Jennifer Burgess ◽

Jeffrey Cass ◽

John F. Chardos ◽

Alexander B. Guirguis ◽

...

Keyword(s):

Clinical Practice ◽

Usual Care ◽

Health Systems ◽

Pragmatic Trial ◽

Veterans Affairs ◽

Control Group ◽

Shared Medical Appointments ◽

Site Cluster ◽

Cluster Randomized

Abstract Objective To examine whether diabetes shared medical appointments (SMAs) implemented as part of usual clinical practice in diverse health systems are more effective than usual care in improving and sustaining A1c improvements. Research Design and Methods A multi-site cluster randomized pragmatic trial examining implementation in clinical practice of diabetes SMAs in five Veterans Affairs (VA) health systems was conducted from 2016 to 2020 among 1537 adults with type 2 diabetes and elevated A1cs. Eligible patients were randomly assigned to either: (1) invitation to participate in a series of SMAs totaling 8–9 h; or (2) continuation of usual care. Relative change in A1c (primary outcome) and in systolic blood pressure, insulin starts, statin starts, and anti-hypertensive medication classes (secondary outcomes) were measured as part of usual clinical care at baseline, at 6 months and at 12 months (~7 months after conclusion of the final SMA in four of five sites). We examined outcomes in three samples of SMA participants: all those scheduled for a SMA, those attending at least one SMA, and those attending at least half of SMAs. Results Baseline mean A1c was 9.0%. Participants scheduled for an SMA achieved A1c reductions 0.35% points greater than the control group between baseline and 6-months follow up (p = .001). Those who attended at least one SMA achieved reductions 0.42 % points greater (p < .001), and those who attended at least half of scheduled SMAs achieved reductions 0.53 % points greater (p < .001) than the control group. At 12-month follow-up, the three SMA analysis samples achieved reductions from baseline ranging from 0.16 % points (p = 0.12) to 0.29 % points (p = .06) greater than the control group. Conclusions Diabetes SMAs as implemented in real-life diverse clinical practices improve glycemic control more than usual care immediately after the SMAs, but relative gains are not maintained. Our findings suggest the need for further study of whether a longer term SMA model or other follow-up strategies would sustain relative clinical improvements associated with this intervention. Trial Registration ClinicalTrials.gov ID NCT02132676

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The cerebral mechanism of acupuncture for chronic insomnia with gastrointestinal disorder: protocol for a randomized controlled trial

Trials ◽

10.1186/s13063-021-05332-3 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Wei Peng ◽

Xiaojuan Hong ◽

Yaru Huangfu ◽

Zhao Sun ◽

Wei Shen ◽

...

Keyword(s):

Rating Scale ◽

Acupuncture Treatment ◽

Sham Acupuncture ◽

Acupuncture Group ◽

Chronic Insomnia ◽

Self Rating ◽

Real Acupuncture ◽

Gi Symptoms ◽

Mri Scans ◽

Multimodal Mri

Abstract Background Many patients with chronic insomnia disorder (CID) have gastrointestinal (GI) symptoms. First-line insomnia medications do not treat GI problems. Acupuncture has a comprehensive regulative action on both CID and GI disorder and is receiving increasing attention. Recent studies indicate that both CID and GI diseases may cause abnormal brain activity. However, the neurological mechanism underlying the effect of acupuncture on such diseases is still unclear. The aim of this study is to explore the pathological mechanisms of CID with GI discomfort, as well as the main response characteristics of acupuncture treatment from multiple perspectives using multimodal magnetic resonance imaging (MRI). Methods A total of 60 participants with CID and GI disorders will be randomly divided into two groups (real acupuncture group and sham acupuncture group; ratio of 1:1). Patients will receive 20 sessions (five sessions per week) of real acupuncture treatment or sham acupuncture treatment. The primary outcome is the aggregate score on the Pittsburgh Sleep Quality Index. Secondary outcomes are scores on the Gastrointestinal Symptom Rating Scale, Self-Rating Anxiety Scale, and Self-Rating Depression Scale. Multimodal MRI scans and clinical assessments will be performed both at baseline and post-treatment. Another 30 age-, sex-, and education-matched healthy subjects will be recruited as controls and will receive MRI scans and clinical evaluations. Discussion This study aims to provide scientific evidence for the mechanism of acupuncture in treating CID with GI disorder using multimodal MRI imaging data on brain structure, function, and metabolism. Trial registration Chinese Clinical Trial Registry, ChiCTR1800017092 (URL: http://www.chictr.org.cn/showproj.aspx?proj=27173). Registered on July 11, 2018.

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Endobronchial Therapy With Gentamicin and Dexamethasone After Airway Clearance by Bronchoscopy in Exacerbation of Non-Cystic Fibrosis Bronchiectasis: A Real-World Observational Study

Frontiers in Pharmacology ◽

10.3389/fphar.2021.773241 ◽

2021 ◽

Vol 12 ◽

Author(s):

Qiuhong Li ◽

Beijie Huang ◽

Hongyan Gu ◽

Ying Zhou ◽

Xizheng Shan ◽

...

Keyword(s):

Cystic Fibrosis ◽

Cox Regression ◽

Univariate Analysis ◽

Intratracheal Instillation ◽

Drug Group ◽

Control Group ◽

Cox Regression Analysis ◽

Airway Clearance ◽

Significant Prolongation

Background: The exacerbation of non-cystic fibrosis bronchiectasis (NCFB) may lead to poor prognosis. The objective of this study was to retrospectively analyze the clinical efficacy and safety of endobronchial therapy with gentamicin and dexamethasone after airway clearance by bronchoscopy in the exacerbation of NCFB.Methods: We retrospectively reviewed 2,156 patients with NCFB between January 2015 and June 2016 and 367 consecutive patients with exacerbation of bronchiectasis who had complete data and underwent airway clearance (AC) by bronchoscopy. The final cohort included 181 cases of intratracheal instillation with gentamicin and dexamethasone after AC (a group with airway drugs named the drug group) and 186 cases of AC only (a group without airway drugs named the control group). The last follow-up was on June 30, 2017.Results: The total cough score and the total symptom score in the drug group were improved compared to those in the control group during 3 months after discharge (p < 0.001). Re-examination of chest HRCT within 4–6 months after discharge revealed that the improvements of peribronchial thickening, the extent of mucous plugging, and the Bhalla score were all significantly improved in the drug group. Moreover, the re-exacerbations in the drug group were significantly decreased within 1 year after discharge. Univariate analysis showed a highly significant prolongation of the time to first re-exacerbation in bronchiectasis due to treatment with airway drugs compared with that of the control group. Multivariate Cox regression analysis showed that the risk of first re-exacerbation in the drug group decreased by 29.7% compared with that of the control group.Conclusion: Endobronchial therapy with gentamicin and dexamethasone after AC by bronchoscopy is a safe and effective method for treating NCFB.

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Abstract TP150: Effects of Pre-existing Psychotropic Medication Use on a Cohort of Patients With Ischemic Stroke Outcome

Stroke ◽

10.1161/str.51.suppl_1.tp150 ◽

2020 ◽

Vol 51 (Suppl_1) ◽

Author(s):

Dilip Jayaraman ◽

Nils Henninger ◽

Brian Silver ◽

Majaz Moonis ◽

Anthony Rothschild ◽

...

Keyword(s):

Ischemic Stroke ◽

Psychotropic Medication ◽

Medication Use ◽

Female Gender ◽

Control Group ◽

Stroke Outcome ◽

Stroke Registry ◽

Post Stroke ◽

Significant Difference

Background: Although SSRI use for ischemic stroke related motor recovery has been studied with mixed results, the effects of the pre-existing psychotropic medication use (PPMU), such as antidepressants, on a long-term ischemic stroke outcome is unknown. Objective: We sought to determine the prevalence of PPMU, and the clinical outcome in a cohort of patients presenting with acute ischemic strokes. Methods: We retrospectively analyzed 323 consecutive patients who presented with an acute ischemic stroke that were included in an institutional stroke registry between January 2015 and December 2017. Baseline characteristics, functional outcome measured by mRS, cardiovascular complications and death within 90 days and 365 days were recorded. The control was defined as a group of ischemic stroke patients that were not on psychotropic medications pre- and/or post-ischemic stroke. Results: The prevalence of PPMU in the studied cohort was 21.4% (69/323). The prevalence of female gender in PPMU was higher compared to the control and post stroke-psychotropic medication use groups (P<0.001), and the patients with PPMU had similar vascular risk factors compared to the control (NS), except for an increased presence of hyperlipidemia (68.1% vs. 57.5%, p<0.05). Among the patients with an available 90-day follow-up (n=175) and 365-day follow-up (n=246), there was no statistically significant difference in outcome events of MI, stroke, death, and dementia. The mRS was higher on PPMU and poststroke-psychotropic medication use groups compared to the control group within the 365-day follow-up (P=0.013). Conclusion: The prevalence of PPMU is common in ischemic stroke, and it is not associated with worsened post-stroke complications within 1 year.

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Abstract 225: A Depression Quality Program and Cardiovascular Disease: Assessing the Impact on Care

Circulation Cardiovascular Quality and Outcomes ◽

10.1161/circoutcomes.10.suppl_3.225 ◽

2017 ◽

Vol 10 (suppl_3) ◽

Author(s):

Linda Gordon ◽

Amanda Malecky ◽

Andrew Althouse ◽

Nicole Ansani

Keyword(s):

Usual Care ◽

Goal Attainment ◽

Intervention Group ◽

Phone Call ◽

Categorical Variables ◽

Care Group ◽

Control Group ◽

Surrogate Outcome ◽

The Impact

Background: Data demonstrate an adverse association between depression and coronary artery disease prognosis. Therefore, a depression screening program was initiated in the catheterization (cath) lab. The goals were to improve HEDIS depression compliance rates and determine the impact on clinical outcomes. Methods: Adult patients in an inpatient cath lab from 3 cardiology practices were screened for enrollment in a randomized controlled trial. All cath lab patients received a PHQ-9 depression screener. Those who screened positive for depression (score ≥ 10) were randomized to intervention or usual care. The usual care group received a follow-up phone call to re-administer the PHQ-9 at 6-8 weeks and within 210 days of discharge. The intervention group was administered the PHQ-9 and received intensive education at baseline, 6-8 weeks, and within 210 days of discharge. Education included targeted depression information with a mental health care provider and comprehensive disease management education with a cardiovascular nurse practitioner. Outcomes included: differences in HEDIS depression goal attainment; depression response/remission rates; and cardiovascular goals. Differences between groups were tested using chi-squared tests (categorical variables) and t-tests (continuous variables). Results: Baseline characteristics were similar between control (N=43) and intervention (N=40) groups, with the exception of significantly fewer African American patients in the control group (N=2, 4.7%) vs intervention (N=9, 22.5%). Changes in HEDIS goal attainment show that patients in the intervention group were slightly more likely to be referred to a provider to address depression (95.0% vs 86.0%, p=0.314), or receive meds for depression (65.0% vs 51.2%, p=0.219), but these differences are not statistically significant. More patients in the intervention group refused meds for depression compared to control (15.0% vs. 2.3%, p=0.041); have received blood work (65.0% vs 41.9%, p=0.030); and have received follow-up within 210 days (82.5% vs 46.5%, p<0.001). Treatment adjustment rate was higher in the intervention group compared to control (85.0% vs. 65.1%, p=0.037). Hospital readmission rate was similar between groups (p=0.896) and there was no difference in depression remission or response rates (p=0.426). Further, no differences were seen in cardiovascular surrogate outcome parameters, including cholesterol, A1c, CRP, or BNP between groups; except SGOT was significantly different between groups (-5.0 intervention vs 2.0 control p=0.045). Conclusions: These data demonstrate improvements in attaining a surrogate outcome measure of quality (HEDIS goals); however, this does not appear to translate to a significant clinical impact. Quality measures may need to be continuously reassessed to ensure efficiency and effectiveness of care.

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Abstract 65: Effects of Immediate Blood Pressure Reduction on Two-Year Mortality and Major Disability in Patients With Acute Ischemic Stroke

Stroke ◽

10.1161/str.48.suppl_1.65 ◽

2017 ◽

Vol 48 (suppl_1) ◽

Author(s):

Jiang He ◽

Yonghong Zhang ◽

Tan Xu ◽

Dali Wang ◽

Chung-Shiuan Chen ◽

...

Keyword(s):

Blood Pressure ◽

Ischemic Stroke ◽

Treatment Group ◽

Acute Ischemic Stroke ◽

Antihypertensive Treatment ◽

Blood Pressure Reduction ◽

Control Group ◽

Antihypertensive Medications ◽

Vascular Events

Although elevated blood pressure (BP) is very common in patients with acute ischemic stroke, the management of hypertension among them remains controversial. We tested the effect of immediate BP reduction on two-year mortality and major disability in acute ischemic stroke patients. The China Antihypertensive Trial in Acute Ischemic Stroke, a randomized, single-blind, blinded end-points trial, was conducted in 4,071 patients with ischemic stroke within 48 hours of onset and elevated systolic BP (SBP). Patients were randomly assigned to receive antihypertensive treatment (n=2,038) or to discontinue all antihypertensive medications (n=2,033) during hospitalization. Post-treatment follow-ups were conducted at 3, 12, and 24 months after hospital discharge. The primary outcome was a composite of death and major disability at the two-year follow-up visit. Mean SBP was reduced by 21.8 in the treatment group and 12.7 mm Hg in the control group within 24 hours after randomization (P<0.001). Mean SBP was 137.3 mm Hg in the treatment group and 146.5 in the control group at day 7 after randomization (P<0.001). At two-year follow-up, study outcomes were obtained in 1945 (95.4%) participants in the treatment group and 1925 (94.7%) in the control group. 78.8% of the patients in the treatment group and 72.6% in the control group reported the use of antihypertensive medications (p<0.001). SBP was 138.8 mmHg in the antihypertensive treatment group and 139.7 in the control group (p=0.02). Among patients in the antihypertensive treatment group, 24.5% (476/1945) died or had a major disability, compared with 22.1% (425/1925) in the control group (odds ratio 1.14 [95% CI 0.99 to 1.33], p=0.078). Hazard ratios for all-cause mortality (1.01 [0.81, 1.25], p=0.95), recurrent stroke (0.91 [0.73, 1.13], p=0.40), and vascular events (0.97 [0.79, 1.19], p=0.76) were not statistically significant comparing the antihypertensive treatment group to the control group. The effect of antihypertensive treatment did not differ by pre-defined subgroups. In conclusion, among patients with acute ischemic stroke, BP reduction with antihypertensive medications during hospitalization did not reduce or increase the composite outcome of death and major disability over two years.

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Effects of a Tailored Exercise Intervention in Acutely Hospitalized Oldest Old Diabetic Adults: An Ancillary Analysis

The Journal of Clinical Endocrinology & Metabolism ◽

10.1210/clinem/dgaa809 ◽

2020 ◽

Author(s):

Nicolás Martínez-Velilla ◽

Pedro L Valenzuela ◽

Mikel L Sáez de Asteasu ◽

Fabricio Zambom-Ferraresi ◽

Robinson Ramírez-Vélez ◽

...

Keyword(s):

Usual Care ◽

Barthel Index ◽

Exercise Intervention ◽

Handgrip Strength ◽

Cognitive Status ◽

Control Group ◽

Diabetic Patients ◽

Hospitalized Elderly ◽

Secondary Endpoints

Abstract Objective To analyze the effects of a tailored exercise intervention in acutely hospitalized elderly diabetic patients. Research Design and Methods This is an ancillary analysis of a randomized controlled trial (RCT). A total of 103 acutely hospitalized elderly adults (mean age ~87 years) with type II diabetes were randomized to an intervention (exercise, n = 54) or control group (usual care, n = 49). The primary endpoint was change in functional status from baseline to hospital discharge as assessed with the Barthel Index and the Short Physical Performance Battery (SPPB). Secondary endpoints comprised cognitive function and mood status, quality of life (QoL), incidence of delirium, and handgrip strength. Exercise-related side effects, length of hospital stay, and incidence of falls during hospitalization were also assessed, as well as transfer to nursing homes, hospital readmission, and mortality during a 3-month follow-up. Results The median length of stay was 8 days (interquartile range, 4) for both groups. The intervention was safe and provided significant benefits over usual care on SPPB (2.7 [95% confidence interval (CI) 1.8, 3.5]) and Barthel Index (8.5 [95% CI: 3.9, 13.1]), as well as on other secondary endpoints such as cognitive status, depression, QoL, and handgrip strength (all P < 0.05). No significant between-group differences were found for the remainder of secondary endpoints. Conclusions An in-hospital individualized multicomponent exercise intervention was safe and effective for the prevention of functional and cognitive decline in acutely hospitalized elderly diabetic patients, although it had no influence on other endpoints assessed during hospitalization or at the 3-month follow-up after discharge.

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Effects of a simple reminiscence intervention program on the reminiscence functions in older adults

International Psychogeriatrics ◽

10.1017/s1041610220000174 ◽

2020 ◽

pp. 1-10

Author(s):

Encarnación Satorres ◽

Iraida Delhom ◽

Juan C. Meléndez

Keyword(s):

Older Adults ◽

Problem Solving ◽

Intervention Program ◽

Intervention Group ◽

The Self ◽

Control Group ◽

Identity Problem ◽

Healthy Older Adults ◽

Positive Functions

ABSTRACT Objectives: Reminiscence promotes the acceptance of oneself and others, a sense of meaning, and the integration of the present and the past. The currently accepted classification contains eight reminiscence functions grouped in three broader functions: self-positive functions (identity, problem-solving, and death preparation); self-negative functions (bitterness revival, boredom reduction, and intimacy maintenance); and prosocial functions (conversation and teach-inform). The main objective of this study was to investigate how the eight dimensions change over time in a sample of healthy older adults after an intervention based on simple reminiscence and subsequent follow-up. Design: Participants were randomly assigned to the treatment or control group. Setting: Participants were evaluated individually before, immediately after, and 3 months after the intervention. Participants: Participants included 139 healthy older adults (71 intervention group and 68 control group). Intervention: Ten weekly sessions lasting 2 hours each were administered, based on a simple reminiscence program. Measurements: Participants were assessed with the Reminiscence Functions Scale. Results: After the intervention, in the treatment group, there was a significant increase in the self-positive functions of problem-solving and death preparation, and these effects were maintained even at the follow-up; there was a significant reduction in the self-negative functions of bitterness revival and intimacy maintenance; and there was a significant increase in the prosocial function of conversation. Conclusions: When applying an intervention based on reminiscence, it is important to evaluate how it influences these functions because this information can help us to modify the objectives of the intervention and increase its effectiveness.

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A Children’s Asthma Education Program: Roaring Adventures of Puff (RAP), Improves Quality of Life

Canadian Respiratory Journal ◽

10.1155/2010/327650 ◽

2010 ◽

Vol 17 (2) ◽

pp. 67-73 ◽

Cited By ~ 27

Author(s):

Shawna L McGhan ◽

Eric Wong ◽

Heather M Sharpe ◽

Patrick A Hessel ◽

Puish Mandhane ◽

...

Keyword(s):

Quality Of Life ◽

Usual Care ◽

Education Program ◽

Intervention Group ◽

Asthma Management ◽

Control Group ◽

Asthma Education ◽

Children With Asthma

BACKGROUND: It is postulated that children with asthma who receive an interactive, comprehensive education program would improve their quality of life, asthma management and asthma control compared with children receiving usual care.OBJECTIVE: To assess the feasibility and impact of ‘Roaring Adventures of Puff’ (RAP), a six-week childhood asthma education program administered by health professionals in schools.METHODS: Thirty-four schools from three health regions in Alberta were randomly assigned to receive either the RAP asthma program (intervention group) or usual care (control group). Baseline measurements from parent and child were taken before the intervention, and at six and 12 months.RESULTS: The intervention group had more smoke exposure at baseline. Participants lost to follow-up had more asthma symptoms. Improvements were significantly greater in the RAP intervention group from baseline to six months than in the control group in terms of parent’s perceived understanding and ability to cope with and control asthma, and overall quality of life (P<0.05). On follow-up, doctor visits were reduced in the control group.CONCLUSION: A multilevel, comprehensive, school-based asthma program is feasible, and modestly improved asthma management and quality of life outcomes. An interactive group education program offered to children with asthma at their school has merit as a practical, cost-effective, peer-supportive approach to improve health outcomes.

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