The reporting quality of randomized controlled trials in Chinese herbal medicine (CHM) formulas for diabetes based on the consort statement and its extension for CHM formulas.

Background: This study aimed to assess the overall reporting quality of randomized controlled trials (RCTs) in Chinese herbal medicine (CHM) formulas for patients with diabetes, and to identify factors associated with better reporting quality. Methods: Four databases including PubMed, Embase, Cochrane Library and Web of Science were systematically searched from their inception to December 2022. The reporting quality was assessed based on the Consolidated Standards of Reporting Trials (CONSORT) statement and its CHM formula extension. The overall CONSORT and its CHM formula extension scores were calculated and expressed as proportions separately. We also analyzed the pre-specified study characteristics and performed exploratory regressions to determine their associations with the reporting quality. Results: Seventy-two RCTs were included. Overall reporting quality (mean adherence) were 53.56% and 45.71% on the CONSORT statement and its CHM formula extension, respectively. The strongest associations with reporting quality based on the CONSORT statement were multiple centers and larger author numbers. Compliance with the CHM formula extension, particularly regarding the disclosure of the targeted traditional Chinese medicine (TCM) pattern (s), was generally insufficient. Conclusion: The reporting quality of RCTs in CHM formulas for diabetes remains unsatisfactory, and the adherence to the CHM formula extension is even poorer. In order to ensure transparent and standardized reporting of RCTs, it is essential to advocate for or even mandate adherence of the CONSORT statement and its CHM formula extension when reporting trials in CHM formulas for diabetes by both authors and editors.

Risk prediction models for mortality and readmission in patients with acute heart failure: A protocol for systematic review, critical appraisal, and meta-analysis.

INTRODUCTION: A considerable number of risk models, which predict outcomes in mortality and readmission rates, have been developed for patients with acute heart failure (AHF) to help stratify patients by risk level, improve decision making, and save medical resources. However, some models exist in a clinically useful manner such as risk scores or online calculators, while others are not, providing only limited information that prevents clinicians and patients from using them. The reported performance of some models varied greatly when predicting at multiple time points and being validated in different cohorts, which causes model users uncertainty about the predictive accuracy of these models. The foregoing leads to users facing difficulties in the selection of prediction models, and even sometimes being reluctant to utilize models. Therefore, a systematic review to assess the performance at multiple time points, applicability, and clinical impact of extant prediction models for mortality and readmission in AHF patients is essential. It may facilitate the selection of models for clinical implementation. METHOD AND ANALYSIS: Four databases will be searched from their inception onwards. Multivariable prognostic models for mortality and/or readmission in AHF patients will be eligible for review. Characteristics and the clinical impact of included models will be summarized qualitatively and quantitatively, and models with clinical utility will be compared with those without. Predictive performance measures of included models with an analogous clinical outcome appraised repeatedly, will be compared and synthesized by a meta-analysis. Meta-analysis of validation studies for a common prediction model at the same time point will also be performed. We will also provide an overview of critical appraisal of the risk of bias, applicability, and reporting transparency of included studies using the PROBAST tool and TRIPOD statement. SYSTEMATIC REVIEW REGISTRATION: PROSPERO registration number CRD42021256416.

Effects of Electroacupuncture for Opioid-Induced Constipation in Patients With Cancer in China: A Randomized Clinical Trial.

Importance: Opioid-induced constipation (OIC) is prevalent among patients treated with opioids for cancer pain. Safe and effective therapies for OIC in patients with cancer remain an unmet need. Objective: To determine the efficacy of electroacupuncture (EA) for OIC in patients with cancer. Design, Setting, and Participants: This randomized clinical trial was conducted at 6 tertiary hospitals in China among 100 adult patients with cancer who were screened for OIC and enrolled between May 1, 2019, and December 11, 2021. Interventions: Patients were randomized to receive 24 sessions of EA or sham electroacupuncture (SA) over 8 weeks and then were followed up for 8 weeks after treatment. Main Outcomes and Measures: The primary outcome was the proportion of overall responders, defined as patients who had at least 3 spontaneous bowel movements (SBMs) per week and an increase of at least 1 SBM from baseline in the same week for at least 6 of the 8 weeks of the treatment period. All statistical analyses were based on the intention-to-treat principle. Results: A total of 100 patients (mean [SD] age, 64.4 [10.5] years; 56 men [56.0%]) underwent randomization; 50 were randomly assigned to each group. Among them, 44 of 50 patients (88.0%) in the EA group and 42 of 50 patients (84.0%) in the SA group received at least 20 (≥83.3%) sessions of treatment. The proportion of overall responders at week 8 was 40.1% (95% CI, 26.1%-54.1%) in the EA group and 9.0% (95% CI, 0.5%-17.4%) in the SA group (difference between groups, 31.1 percentage points [95% CI, 14.8-47.6 percentage points]; P < .001). Compared with SA, EA provided greater relief for most OIC symptoms and improved quality of life among patients with OIC. Electroacupuncture had no effects on cancer pain and its opioid treatment dosage. Electroacupuncture-related adverse events were rare, and, if any, all were mild and transient. Conclusions and Relevance: This randomized clinical trial found that 8-week EA treatment could increase weekly SBMs with a good safety profile and improve quality of life for the treatment of OIC. Electroacupuncture thus provided an alternative option for OIC in adult patients with cancer. Trial Registration: ClinicalTrials.gov Identifier: NCT03797586.

Efficacy and safety of lumbrokinase plus aspirin versus aspirin alone for acute ischemic stroke (LUCENT): study protocol for a multicenter randomized controlled trial.

BACKGROUND: Lumbrokinase has been widely used for patients with acute ischemic stroke (AIS) in China; however, because rigorously designed studies are lacking, safety and efficacy of lumbrokinase in the treatment of acute ischemic stroke remains largely unknown. In this multicenter, randomized, and controlled trial, we aim to compare lumbrokinase plus aspirin versus aspirin alone in patients with acute ischemic stroke. METHODS: A total of 220 eligible participants will be randomized to either the intervention or control group with a 1:1 ratio. These participants must be diagnosed with acute ischemic stroke for the first time, whose symptoms appear within 72 h. Their NIHSS score must be greater than 5 and less than 15, and their age must be between 35 and 85 years old. They must have not received intravenous thrombolysis, arterial thrombolysis, or intravascular intervention. Participants in the intervention group will be treated with lumbrokinase plus aspirin for the first 90 days. Participants in the control group will use placebo plus aspirin for the first 90 days. Then, all participants will be treated with aspirin only and followed up for another 90 days (180-day follow-up). The primary outcome is the modified Rankin Scale (mRS) score. The secondary outcomes are National Institutes of Health Stroke Scale (NIHSS) score, Activity of Daily Living (ADL) Scale score, coagulation function, and serum hypersensitive C-reactive protein. The exploratory outcomes are fasting lipid panel, recurrence rate, the occurrence of cardiovascular and cerebrovascular events, and the mortality rate. Safety evaluations include liver function and kidney function, serum fibrinogen, adverse events, serious adverse events, and bleeding events. Adherence of participants will also be assessed. DISCUSSION: This trial will investigate the efficacy and safety of lumbrokinase plus aspirin as compared to aspirin alone in the treatment of acute ischemic stroke. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR2000032952 . Registered on May 16, 2020.

Acetic Acid Use in Chronic Wound Healing: A Multiple Case Series.

BACKGROUND: Acetic acid is bacteriostatic or bactericidal to many gram-negative and gram-positive microorganisms, especially Pseudomonas. Nevertheless, it has also been found to possess cytotoxic effects in concentrations as low as 0.25% inhibiting the epithelialization process during wound healing. CASES: In this multiple case series, we present 2 cases of chronic traumatic leg wounds treated with gauze moistened with acetic acid (0.25%), which were covered with a securing dressing and compression stockinet. Both patients were told to apply gauze moistened with acetic acid (0.25%) twice daily. In both cases, the wound progressed to blue-green drainage and wet yellow slough tissue to near-complete beefy granulation tissue. At this point, acetic acid was replaced with collagen or petrolatum dressing until complete wound closure was achieved. The treatment of these wounds illustrated successful use of acetic acid for chronic wound care. CONCLUSION: Our experience with these cases suggests that appearance of blue-green wound drainage and wet yellow slough tissue is a reasonable indication for the use of gauze moistened with acetic acid (0.25%). Further research is needed to test the efficacy of these principles in guiding acetic acid use in wound care.

Dyspnea Measurement in Acute Heart Failure: A Systematic Review and Evidence Map of Randomized Controlled Trials.

Background: Dyspnea is the most common presenting symptom among patients hospitalized for acute heart failure (AHF). Dyspnea relief constitutes a clinically relevant therapeutic target and endpoint for clinical trials and regulatory approval. However, there have been no widely accepted dyspnea measurement standards in AHF. By systematic review and mapping the current evidence of the applied scales, timing, and results of measurement, we hope to provide some new insights and recommendations for dyspnea measurement. Methods: PubMed, Embase, Cochrane Library, and Web of Science were searched from inception until August 27, 2020. Randomized controlled trials (RCTs) with dyspnea severity measured as the endpoint in patients with AHF were included. Results: Out of a total of 63 studies, 28 had dyspnea as the primary endpoint. The Likert scale (34, 54%) and visual analog scale (VAS) (22, 35%) were most widely used for dyspnea assessment. Among the 43 studies with detailed results, dyspnea was assessed most frequently on days 1, 2, 3, and 6 h after randomization or drug administration. Compared with control groups, better dyspnea relief was observed in the experimental groups in 21 studies. Only four studies that assessed tolvaptan compared with control on the proportion of dyspnea improvement met the criteria for meta-analyses, which did not indicate beneficial effect of dyspnea improvement on day 1 (RR: 1.16; 95% CI: 0.99-1.37; p = 0.07; I 2 = 61%). Conclusion: The applied scales, analytical approaches, and timing of measurement are in diversity, which has impeded the comprehensive evaluation of clinical efficacy of potential therapies managing dyspnea in patients with AHF. Developing a more general measurement tool established on the unified unidimensional scales, standardized operation protocol to record the continuation, and clinically significant difference of dyspnea variation may be a promising approach. In addition, to evaluate the effect of experimental therapies on dyspnea more precisely, the screening time and blinded assessment are factors that need to be considered.

Efficacy of Acupuncture for Chronic Prostatitis/Chronic Pelvic Pain Syndrome : A Randomized Trial.

BACKGROUND: Acupuncture has promising effects on chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), but high-quality evidence is scarce. OBJECTIVE: To assess the long-term efficacy of acupuncture for CP/CPPS. DESIGN: Multicenter, randomized, sham-controlled trial. (ClinicalTrials.gov: NCT03213938). SETTING: Ten tertiary hospitals in China. PARTICIPANTS: Men with moderate to severe CP/CPPS, regardless of prior exposure to acupuncture. INTERVENTION: Twenty sessions of acupuncture or sham acupuncture over 8 weeks, with 24-week follow-up after treatment. MEASUREMENTS: The primary outcome was the proportion of responders, defined as participants who achieved a clinically important reduction of at least 6 points from baseline on the National Institutes of Health Chronic Prostatitis Symptom Index at weeks 8 and 32. Ascertainment of sustained efficacy required the between-group difference to be statistically significant at both time points. RESULTS: A total of 440 men (220 in each group) were recruited. At week 8, the proportions of responders were 60.6% (95% CI, 53.7% to 67.1%) in the acupuncture group and 36.8% (CI, 30.4% to 43.7%) in the sham acupuncture group (adjusted difference, 21.6 percentage points [CI, 12.8 to 30.4 percentage points]; adjusted odds ratio, 2.6 [CI, 1.8 to 4.0]; P < 0.001). At week 32, the proportions were 61.5% (CI, 54.5% to 68.1%) in the acupuncture group and 38.3% (CI, 31.7% to 45.4%) in the sham acupuncture group (adjusted difference, 21.1 percentage points [CI, 12.2 to 30.1 percentage points]; adjusted odds ratio, 2.6 [CI, 1.7 to 3.9]; P < 0.001). Twenty (9.1%) and 14 (6.4%) adverse events were reported in the acupuncture and sham acupuncture groups, respectively. No serious adverse events were reported. LIMITATION: Sham acupuncture might have had certain physiologic effects. CONCLUSION: Compared with sham therapy, 20 sessions of acupuncture over 8 weeks resulted in greater improvement in symptoms of moderate to severe CP/CPPS, with durable effects 24 weeks after treatment. PRIMARY FUNDING SOURCE: China Academy of Chinese Medical Sciences and the National Administration of Traditional Chinese Medicine.

Electroacupuncture vs Prucalopride for Severe Chronic Constipation: A Multicenter, Randomized, Controlled, Noninferiority Trial.

INTRODUCTION: This multicenter, randomized, noninferiority trial compared electroacupuncture with prucalopride for the treatment of severe chronic constipation (SCC). METHODS: Participants with SCC (≤ 2 mean weekly complete spontaneous bowel movements [CSBMs]) were randomly assigned to receive either 28-session electroacupuncture over 8 weeks with follow-up without treatment over 24 weeks or prucalopride (2 mg/d before breakfast) over 32 weeks. The primary outcome was the proportion of participants with ≥3 mean weekly CSBMs over weeks 3-8, based on the modified intention-to-treat population, with -10% as the noninferior margin. RESULTS: Five hundred sixty participants were randomized, 280 in each group. Electroacupuncture was noninferior to prucalopride for the primary outcome (36.2% vs 37.8%, with a difference of -1.6% [95% confidence interval, -8% to 4.7%], P < 0.001 for noninferiority); almost the same results were found in the per-protocol population. The proportions of overall CSBM responders through weeks 1-8 were similar in the electroacupuncture and prucalopride groups (24.91% vs 25.54%, with a difference of -0.63% [95% confidence interval, -7.86% to 6.60%, P = 0.864]). Except during the first 2-week treatment, no between-group differences were found in outcomes of excessive straining, stool consistency, and quality of life. Adverse events occurred in 49 (17.69%) participants in the electroacupuncture group and 123 (44.24%) in the prucalopride group. One non-treatment-related serious adverse event was recorded in the electroacupuncture group. DISCUSSION: Electroacupuncture was noninferior to prucalopride in relieving SCC with a good safety profile. The effects of 8-week electroacupuncture could sustain for 24 weeks after treatment. Electroacupuncture is a promising noninferior alternative for SCC (see Visual Abstract, http://links.lww.com/AJG/B776).

SARS-CoV-2 and Anti-Cardiolipin Antibodies.

The current COVID-19 pandemic caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has led to distinct diagnostic and management challenges for front-line healthcare workers. The risk of excessive coagulation activation leading to a cascade of thrombotic events in critically ill patients with SARS-CoV-2 is now well reported. We discuss a recent case of COVID-19 with concurrent acute pulmonary embolism and a positive cardiolipin antibody (IgM). The presence of antiphospholipid antibodies is key to diagnosing antiphospholipid syndrome (APS). However, their presence can be transient or persistent after viral infections. Serial inflammatory markers in conjunction with anti-phospholipid antibody testing is critical for the diagnosis of APS in this emerging patient population. Our case report reviews details suggestive of APS in the setting of SARS-CoV-2 and aims to provide clinical diagnostic clues that could help warrant further workup and assist with management strategies.

Cardiovascular Manifestations and Mechanisms in Patients with COVID-19.

Coronavirus disease 2019 (COVID-19) patients with pre-existing cardiovascular disease (CVD) or with cardiovascular complications have a higher risk of mortality. The main cardiovascular complications of COVID-19 include acute cardiac injury, acute myocardial infarction (AMI), myocarditis, arrhythmia, heart failure, shock, and venous thromboembolism (VTE)/pulmonary embolism (PE). COVID-19 can cause cardiovascular complications or deterioration of coexisting CVD through direct or indirect mechanisms, including viral toxicity, dysregulation of the renin-angiotensin-aldosterone system (RAAS), endothelial cell damage and thromboinflammation, cytokine storm, and oxygen supply-demand mismatch. We systematically review cardiovascular manifestations, histopathology, and mechanisms of COVID-19, to help to formulate future research goals and facilitate the development of therapeutic management strategies.

Sequencing Systemic Therapy Pathways for Advanced Hepatocellular Carcinoma: A Cost Effectiveness Analysis.

INTRODUCTION: Hepatocellular carcinoma (HCC) is the most common form of liver cancer worldwide and carries a poor prognosis. Historically, sorafenib was the only available systemic treatment for advanced HCC. However, in recent years, 6 new treatments have been approved by the US Food and Drug Administration (FDA): regorafenib, lenvatinib, cabozantinib, pembrolizumab, ramucirumab, and nivolumab. Data are lacking regarding the most appropriate sequencing pathway for these agents. Our objective was to conduct a comprehensive cost effectiveness analysis (CEA) of different 1st- and 2nd-line treatment pathways for HCC reflecting all new drug approvals, and then use our data to provide guidance for clinicians on which pathway is the most cost-effective. MATERIALS AND METHODS: Markov models were used to evaluate the cost effectiveness of 8 different 1st- and 2nd-line treatment sequences. The model allowed for 9 possible states. Cost effectiveness ratios (CER) and incremental CER (ICER) were calculated to compare costs between different pathways and against a willingness-to-pay (WTP) threshold. Efficacy and toxicity data were extracted from the landmark trials for each agent. All agents except ramucirumab were included. The cost of each agent was based on the wholesale acquisition cost (WAC) in USD as of June 2019. Monte-Carlo methods were used to simulate the experience of 1,000,000 patients per treatment sequence for a 12-month period. RESULTS: The pathway with the lowest CER was sorafenib, followed by pembrolizumab (USD 227,741.03/quality-adjusted life year [QALY]). ICER analysis supported implementing 2nd-line pembrolizumab-based pathways at a higher WTP threshold of 300,000/quality-adjusted life year. Sensitivity analysis did not substantially change these results. CONCLUSIONS: The most cost-effective strategy was 1st-line tyrosine kinase inhibitor therapy followed by 2nd-line immunotherapy. All pathways exceeded a commonly accepted WTP of USD 100-150,000/QALY. Our preliminary results warrant further studies to best inform real-world practices.

Outcomes and Characteristics of Wound Healing in an Outpatient Physical Therapy Clinic.

INTRODUCTION: Detailed understandings regarding the outcomes and characteristics of healing in wounds of different etiologies are lacking. OBJECTIVE: In the present study, data on 265 patients treated at an outpatient physical therapy wound care clinic were extracted. METHODS: Using Kaplan-Meier analyses, wound healing outcomes for different wound etiologies were evaluated and compared. RESULTS: The results revealed venous leg ulcers (VLUs) healed faster than non-VLUs, pressure ulcers (PUs), diabetic foot ulcers (DFUs), and arterial wounds but not faster than surgical and traumatic wounds (STWs). The estimated medians (mean for arterial wounds) of total treatment durations for complete wound closure were 87, 152, 100, 170, 525.44, 773 days in VLUs, non-VLUs, STWs, DFUs, arterial wounds, and PUs, respectively. Compared with patients with VLUs, patients with non-VLUs were younger (69.72 vs. 61.35, respectively), had a higher proportion of men (odds ratio [OR] = 2.26), were less likely to have more than 1 wound (OR = 0.25), reached complete wound closure upon discharge (OR = 0.41), or had a body mass index value greater than or equal to 25 (OR = 0.39). CONCLUSIONS: Venous leg ulcers and other wound etiologies (ie, STWs, PUs, DFUs, and arterial wounds) appear to differ in wound healing outcomes and certain characteristics. These results may be of interest to clinicians, patients, health care policy makers, and insurers. Future research is warranted to compare wound healing outcomes and patient characteristics among different settings.

Rationale and design of the AUGUST-AHF Study.

AIMS: We aim to assess the effect of a lyophilized herbal injection on 90 day mortality and readmission rates in patients with acute heart failure (AHF). METHODS AND RESULTS: The AUGUST-AHF study is a multicentre, randomized, double-blind, placebo-controlled trial enrolling 1270 hospitalized patients for AHF. Patients are randomized to receive YiqiFumai lyophilized injection (5.2 g/day) or placebo for 10 days, in addition to standard therapy, using a 1:1 ratio via an interactive web response system. The primary endpoint is the 90 day all-cause mortality or AHF readmission rates. Secondary endpoints include 180 day all-cause mortality or heart failure readmission rates, length of hospital stay for the indexed AHF, 90 day cardiac-specific mortality rate, occurrence of worsening heart failure through Day 10, changes in the Minnesota Living with Heart Failure Quality of Life scale score through Day 180, and 90 day major adverse cardiac events. Additional secondary endpoints include change in dyspnoea via visual analogue scale (VAS) and Likert 7-point comparator scale, N terminal pro-B-type natriuretic peptide value and New York Heart Association functional class, and the total amount of diuretics for the indexed AHF hospitalization. Study recruitment is expected to be completed by March 2021, and follow-up will end in September 2021. In an optional sub-study, patients will be followed up for 3 years. CONCLUSIONS: To our best knowledge, AUGUST-AHF is the first study assessing the efficacy of a Chinese herbal injection in patients with AHF. The results will be valuable to guide clinicians in using YiqiFumai lyophilized injection, which was included in the latest Chinese Health Insurance Catalog.

BRAF/MEK Pathway is Associated With Breast Cancer in ER-dependent Mode and Improves ER Status-based Cancer Recurrence Prediction.

BACKGROUND: Aberrant BRAF/MEK signaling was found in nearly 50% of human malignancies and proved to play a critical role in the tumorigenesis of multiple cancers. However, this pathway was relatively seldom studied in breast cancer, and the role of this pathway in the pathogenesis of breast cancer is still controversial. MATERIALS AND METHODS: Breast cancer gene expression data from The Cancer Genome Atlas (TCGA) and 43 Affymetrix microarray datasets were analyzed. The BRAF/MEK pathway activity was presented with phosphorylated ERK level (for the TCGA dataset) or computed by a gene signature-based algorithm (for Affymetrix datasets). Aberrant activation of BRAF/MEK pathway in breast cancer was assessed in matched normal/tumor tissues. The associations of the BRAF/MEK pathway with clinical outcome in patients with breast cancer were analyzed by logistic regression, Cox regression, and Kaplan-Meier methods. RESULTS: Down-regulation of the BRAF/MEK pathway was observed in atypical ductal hyperplasia, ductal carcinoma in situ, and invasive breast cancers, with the exception of human epidermal growth factor receptor 2-positive and triple-negative breast cancers. Higher BRAF/MEK pathway activities were associated with better survival in estrogen receptor (ER)-positive (overall hazard ratio [HR], 0.85; P = 5.47E-5; n = 3128) or progesterone receptor-positive (overall HR, 0.85; P = 4.19E-3; n = 1537) breast cancers, but with worse survival in ER-negative (overall HR, 1.13; P = .01; n = 1107) or progesterone receptor-negative (overall HR, 1.13; P = .01; n = 1219) breast cancers. Combination with BRAF/MEK pathway activities could improve ER status-based recurrence prediction for breast cancer. CONCLUSION: BRAF/MEK pathway was associated with the recurrence risk of breast cancer in an ER status-dependent mode. Combination with BRAF/MEK pathway activities could improve the ER status-based recurrence prediction in breast cancer.

Positive acute viral infection markers, autoimmune disease and type II mixed cryoglobulinemia: a rare concurrence.

Cryoglobulins are abnormal serum immunoglobulins that tend to precipitate in intravascular compartments at temperatures lower than 37°C causing blood flow restriction to vital organs. They are divided into type I, II and III based on the immunoglobulin subtypes of the cryoprecipitates. Type II cryoglobulinemia is most commonly associated with viral infections, autoimmune diseases and lymphoproliferative disorders. Here, we reported an 80-year-old man who presented with fatigue, acute kidney injury, palpable purpura, anaemia and altered mental status. He was diagnosed with type II cryoglobulinemia with concomitant positive autoimmune markers, varicella IgM antibody and IgM hepatitis B core antibody. The patient responded well to intravenous and oral steroid treatment.

The duration of acupuncture effects and its associated factors in chronic severe functional constipation: secondary analysis of a randomized controlled trial.

BACKGROUND: Electroacupuncture (EA) has been shown to improve complete spontaneous bowel movements (CSBMs), but the duration of its effects remains unknown. The objective of this study was to explore the duration of acupuncture effects after treatment and its associated factors for chronic severe functional constipation (CSFC). METHODS: This was a secondary analysis of a multicenter, randomized, sham-acupuncture (SA) controlled trial that included 1075 participants with CSFC. The primary outcome, the duration of acupuncture effects after treatment, was the number of weeks during the 12-week follow-up period that participants were to meet the weekly CSBM responder criteria. A weekly CSBM responder was defined as a participant who had at least three CSBMs for a given week and an increase from baseline of at least one CSBM for that same week. We performed a retrospective multivariate analysis to explore potential factors associated with sustained acupuncture effects. RESULTS: The duration of acupuncture effects in the EA group (5.5 weeks) was significantly higher than the duration of SA effects in the SA group (2.2 weeks) with a between-group difference of 3.2 weeks (95% CI, 2.77-3.78; p < 0.001). A younger age and higher baseline CSBMs per week [regression coefficient (RC) -0.06, 95% confidence interval (CI) (-0.06 to -0.04); RC 2.43, 95% CI 1.78-3.60; respectively] were associated with longer durations of acupuncture effects. CONCLUSIONS: EA had sustained post-treatment effects for CFSC. A significant association among a younger age, higher baseline CSBMs and sustained acupuncture effects was observed. Further research is needed to confirm the association. TRIAL REGISTRATION: ClinicalTrials.gov (NCT01726504). Registered on 26 August 2012.

Tapering off long-term methadone: A case study.

Opioid tapering may be necessary for patients on long-term opioids. Here, the authors presented a patient who had uncontrolled chronic musculoskeletal pain while on chronic methadone. Upon methadone tapering, the patient had been taking methadone for longer than six years and had severe methadone-related adverse effects. Using multidisciplinary interventions of patient education and counseling, physical interventions, and nonopioid medications, patient's methadone was discontinued after longer than one year tapering with relatively good pain control. The tapering process highlights the importance of pain management during opioid tapering using multidisciplinary interventions to prevent and treat opioid withdrawal and pain relapses.

Screening for Cardiovascular Disease Risk Factors in a Physical Therapist Wound Care Practice: A Retrospective, Observational Study.

Understanding the prevalence of cardiovascular risk factors among individuals seeking physical therapist services in a wound care center is important, especially if aerobic exercise or other physical activity is recommended. PURPOSE: This study assessed the prevalence of cardiovascular risk factors in individuals seeking physical therapist services for an integumentary disorder in an outpatient wound care center. METHODS: Using a retrospective, observational study design, records from patients who were screened upon initial evaluation by a physical therapist for cardiovascular risk according to the American College of Sports Medicine (ACSM) guidelines were abstracted. The screening process entailed assessment of current signs and symptoms of cardiovascular, pulmonary, or metabolic disease; an individual or family history of cardiovascular disease; whether the patient was considered obese; and whether the patient was a current smoker, had a sedentary lifestyle, dyslipidemia, elevated glucose, or blood pressure ⟩140/90 mm Hg. Patient demographics and wound history also were summarized and described, including wound type and duration and pain associated with the wound. Wounds then were classified by the physical therapist as either venous leg ulcers or nonvenous leg ulcers based upon the referring physician's diagnosis. Descriptive statistics and frequency distributions were calculated to assess the prevalence of individual cardiovascular risk factors, total number of cardiovascular risk factors, cardiovascular risk stratification, and patient disposition. Frequencies of individual cardiovascular risk factors, total number of cardiovascular risk factors, and cardiovascular risk stratification also were assessed between patients with venous leg ulcers and nonvenous leg ulcers using chi-square tests for categorical data and t tests for continuous data. The alpha level was set at P <.05. RESULTS: Among the 70 study participants (41 male, 29 female; mean age 63.5 ± 15.1 years), 38 were treated for venous leg ulcers and 32 were treated for nonvenous leg ulcers. Overall, 38 patients (54%) had a history of cardiovascular disease and 29 (41%) had current signs and symptoms of cardiovascular disease. Patients with nonvenous leg ulcers had a significantly higher frequency of having a family history of cardiovascular disease than patients with venous leg ulcers (28% vs. 8%; P = .03). According to the ACSM guidelines, 5 patients (7%) were considered low risk, 22 (31%) were moderate risk, and 43 (62%) were at high risk for experiencing a future cardiovascular event. Cardiovascular risk did not vary significantly according to wound type. CONCLUSION: The patient risk-stratification profile in this study strongly suggested physical therapists should screen for cardiovascular risk factors before prescribing aerobic exercise or other physical activity for all patients being seen for an integumentary disorder in an outpatient wound care practice.