Efficacy and safety of acupuncture on oligomenorrhea due to polycystic ovary syndrome: An international multicenter,pilot randomized controlled trial

Background:Polycystic ovary syndrome (PCOS) is one of the most common disorders of reproductive endocrinology affecting women of reproductive age. Our study aims to explore the feasibility of a full-scale trial to evaluate the efficacy and safety of acupuncture for PCOS.Methods:This study is a two-armed, parallel, multi-country, multi-center, pilot randomized controlled trial (RCT) for PCOS with oligomenorrhea. We will recruit 60 women aged 20 to 40 years with oligomenorrhea due to PCOS. The participants will be randomly assigned to acupuncture and control groups. The acupuncture group will undergo a total of 40 sessions for 16 weeks with usual care. The control group will be managed with usual care (regular meals, sufficient sleep, and appropriate exercise) only. The primary clinical outcome is mean change in menstrual frequency from baseline to 16 weeks and 32 weeks (follow-up) after the start of the trial. The secondary outcomes are menstrual period, levels of estradiol, luteinizing hormone (LH), follicle-stimulating hormone (FSH), and total testosterone, LH/FSH ratio, antral follicle count and ovarian volume, body mass index, waist hip ratio, acne severity, and health-related quality of life questionnaire scores at 16 and 32 weeks after the start of the trial.Discussion:This is the first protocol for multi-country, multi-center RCTs for PCOS in Korea and China. The control group in this study will be subjected to usual care (regular meals, enough sleep, and appropriate exercise). The results of this study will provide evidence for future clinical decisions and guidelines.This trial has been registered at ClinicalTrials.gov (Identifier: {"type":"clinical-trial","attrs":{"text":"NCT04509817","term_id":"NCT04509817"}}NCT04509817).     

Kidney outcomes using a sustained ≥40% decline in eGFR: A meta‐analysis of SGLT2 inhibitor trials

BackgroundA recent meta‐analysis of sodium–glucose cotransporter 2 (SGLT2) inhibitor outcome trials reported that SGLT2 inhibitors were associated with reduction in the risk of adverse composite kidney outcomes, with moderate heterogeneity across the trials; however, the endpoints were defined differently across the trials.HypothesisThe apparent heterogeneity of the meta‐analysis of kidney composite outcomes of SGLT2 inhibitor trials will be substantially reduced by using a consistent assessment of sustained ≥40% decline in eGFR/chronic kidney dialysis/transplantation/renal death across trials.MethodsWe performed a meta‐analysis of kidney composite outcomes from the four SGLT2 cardiovascular outcome trial programs conducted in general type 2 diabetes mellitus populations, which included, as a surrogate of progression to kidney failure, a sustained ≥40% decline in eGFR along with kidney replacement therapy and kidney death. The trials assessed were VERTIS CV ({"type":"clinical-trial","attrs":{"text":"NCT01986881","term_id":"NCT01986881"}}NCT01986881), CANVAS Program ({"type":"clinical-trial","attrs":{"text":"NCT01032629","term_id":"NCT01032629"}}NCT01032629 and {"type":"clinical-trial","attrs":{"text":"NCT01989754","term_id":"NCT01989754"}}NCT01989754), DECLARE‐TIMI 58 ({"type":"clinical-trial","attrs":{"text":"NCT01730534","term_id":"NCT01730534"}}NCT01730534), and EMPA‐REG OUTCOME ({"type":"clinical-trial","attrs":{"text":"NCT01131676","term_id":"NCT01131676"}}NCT01131676).ResultsData from the trials comprised 42 516 individual participants; overall, 998 composite kidney events occurred. SGLT2 inhibition was associated with a significant reduction in the kidney composite endpoint (HR 0.58 [95% CI 0.51–0.65]) and with a highly consistent effect across the trials (Q statistic p = .64; I ² = 0.0%).ConclusionsOur meta‐analysis highlights the value of using similarly defined endpoints across trials and supports the finding of consistent protection against kidney disease progression with SGLT2 inhibitors as a class in patients with type 2 diabetes mellitus who either have established atherosclerotic cardiovascular disease or are at high cardiovascular risk with multiple cardiovascular risk factors.     

Phase 1b dose-escalation,safety, and pharmacokinetic study of IC14, a monoclonal antibody against CD14, for the treatment of amyotrophic lateral sclerosis

Background:The primary objective was to demonstrate the safety and tolerability of monoclonal antibody against CD14 (IC14) (atibuclimab) in amyotrophic lateral sclerosis patients. The secondary objectives were pharmacokinetics, pharmacodynamics, and preliminary effects on disease status and biomarkers.Methods:In this open-label, dose-escalation trial, IC14 was administered at 2 mg/kg intravenous (IV) followed by 1 mg/kg/d IV × 3 (n = 3) and in subsequent patients at 4 mg/kg IV followed by 2 mg/kg/d IV × 3 (n = 7) ({"type":"clinical-trial","attrs":{"text":"NCT03487263","term_id":"NCT03487263"}}NCT03487263). Disease status was measured using the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale, forced vital capacity, sniff nasal pressure, Edinburgh Cognitive and Behavioural ALS Screen, and Revised ALS-Specific Quality-of-Life Score. Disease biomarkers included cerebrospinal fluid and serum levels of neurofilament light chain (NfL) and urinary p75 neurotrophin receptor.Results:IC14 was safe and well tolerated. No antidrug antibodies were detected. The drug target saturation of monocyte CD14 receptors was rapid and sustained through day 8. There was no significant change in Revised Amyotrophic Lateral Sclerosis Functional Rating Scale, forced vital capacity, sniff nasal pressure, or Revised ALS-Specific Quality-of-Life Score following a single cycle of treatment. Cerebrospinal fluid NfL levels decreased in 6 of 9 patients sampled with declines of 15% to 40% between baseline (not significant [ns]) and day 8 in 3 patients. Serum NfL modestly decreased in 5 of 10 patients (ns) at day 8 and was sustained in 4 (4%-37%, ns) over 33 days of follow up.Conclusion:IC14 quickly and durably saturated its target in all patients. This study demonstrated safety and tolerability in patients with amyotrophic lateral sclerosis. Even though only a single cycle of treatment was given, there were promising beneficial trends in the neurofilament light chain, a disease biomarker. The emerging understanding of the role of systemic inflammation in neurodegenerative diseases, and the potential for IC14 to serve as a safe, potent, and broad-spectrum inhibitor of immune dysregulation merits further clinical study.Clinical Trial Registration:{"type":"clinical-trial","attrs":{"text":"NCT03487263","term_id":"NCT03487263"}}NCT03487263     

Effectiveness of electro-press needle for menopause-associated hot flashes: Protocol of a randomized controlled trial

Background:Hot flashes (HF) are a prevalent symptom associated with menopause affecting up to 85% of women aged 40 to 65 years. Previous studies indicated that acupuncture might relieve the symptom of HF significantly; however, its effectiveness has not been clarified quantitatively. Electro-press needles (EPN) is a novel acupuncture that combines a shallow tiny needle with an electrical transdermal stimulator. Either the needle or the electrical stimulator could function in the treatment. This study aims to evaluate the effectiveness of EPN in comparison with no intervention in relieving HF of perimenopausal and postmenopausal women.Methods/Design:This study will be a 2-arm randomized waitlist controlled trial. According to the ratio of 1:1 and block randomization, a total of 122 patients with moderate or severe HF will be randomly allocated to either EPN group or waitlist control group. The EPN group will receive 3 sessions of EPN treatment each week in consecutive 6 weeks, 18 sessions in total. The waitlist control group will get no intervention over the first 6 weeks. All the patients will be followed up in the next 24 weeks. The primary outcome will be the percentage of the participants whose 24-hour mean HF is 50% less than the baseline at Week 6. Secondary outcomes will include HF score, HF frequency, HF severity, the Menopause Rating Scale and Menopause-Specific Quality of Life Questionnaire Score.Discussion:This study will evaluate the effectiveness and safety of EPN treatment to alleviate HF symptoms in perimenopausal and postmenopausal women, excluding self-healing factors. The limitations of the trial design are its single-center scope, lack of placebo control and impossible to blind the acupuncturists and patients.Trial registration: This clinical trial has been registered in Clinical Trial Registry (registration number: {"type":"clinical-trial","attrs":{"text":"NCT04995107","term_id":"NCT04995107"}}NCT04995107; date of registration: Aug 6, 2021).     

Optimal extent of lymphadenectomy for radical surgery of pancreatic head adenocarcinoma: 2-year survival rate results of single-center,prospective, randomized controlled study

Background:Radical pancreaticoduodenectomy is the only possible cure for pancreatic head adenocarcinoma, and although several RCT studies have suggested the extent of lymph node dissection, this issue remains controversial. This article wanted to evaluate the survival benefit of different lymph node dissection extent for radical surgical treatment of pancreatic head adenocarcinoma.Methods:A total of 240 patients were assessed for eligibility in the study, 212 of whom were randomly divided into standard lymphadenectomy group (SG) or extended lymphadenectomy group (EG), there were 97 patients in SG and 95 patients in EG receiving the radical pancreaticoduodenectomy.Result:The demography, histopathology and clinical characteristics were similar between the 2 groups. The 2-year overall survival rate in the SG was higher than the EG (39.5% vs 25.3%; P = .034). The 2-year overall survival rate in the SG who received postoperative adjuvant chemotherapy was higher than the EG (60.7% vs 37.1%; P = .021). There was no significant difference in the overall incidence of complications between the 2 groups (P = .502). The overall recurrence rate in the SG and EG (70.7% vs 77.5%; P = .349), and the patterns of recurrence between 2 groups were no significant differences.Conclusion:In multimodality therapy system, the efficacy of chemotherapy should be based on the appropriate lymphadenectomy extent, and the standard extent of lymphadenectomy is optimal for resectable pancreatic head adenocarcinoma. The postoperative slowing of peripheral blood lymphocyte recovery might be 1 of the reasons why extended lymphadenectomy did not result in survival benefits.Clinical trial registration:This trial was registered at ClinicalTrials.gov ({"type":"clinical-trial","attrs":{"text":"NCT02928081","term_id":"NCT02928081"}}NCT02928081) in October 7, 2016. https://clinicaltrials.gov/     

Imatinib mesylate in combination with pembrolizumab in patients with advanced KIT-mutant melanoma following progression on standard therapy: A phase I/II trial and study protocol

Introduction:Genetic alterations of KIT gene are known to be one of the major causes of melanoma. Those are more common in the mucous and acral subtypes and KIT is regarded as major oncogene in Asian melanomas, where the prevalence of these subtypes is high. Up to date, several clinical trials have been conducted to target KIT gene alterations in melanoma with unsatisfied efficacies. Imatinib mesylate, a small-molecule inhibitor of the KIT tyrosine kinase, provides a rapid but not durable clinical response in KIT-mutant melanoma. Meanwhile, recent basic and clinical evidence have revealed another aspect of KIT-targeted therapy, namely the enhancement of antitumor activity of immune checkpoint inhibitors. Herein, we designed clinical trial of co-administrating imatinib mesylate and pembrolizumab (anti-PD-1 antibody) to evaluate its safety and efficacy.Methods and analysis:This is an open-label, single-arm, phase I/II clinical trial involving Japanese patients with metastatic KIT-mutant melanoma that are refractory to standard therapy including anti-PD-1 therapy. Phase I study is a dose-escalation study comprising two dose levels of imatinib mesylate (200 and 400 mg/day, respectively) with fixed dose of pembrolizumab (200 mg every 3 weeks) to evaluate safety and tolerability and determine recommended phase II dose. The primary endpoint of the phase II study is the objective response rate after 4 cycles (3 weeks/cycle) of pembrolizumab and imatinib mesylate at the dose determined in phase I, based on RECIST version 1.1. A Simon''s minimax two-stage design is employed to test the null hypothesis of a 5% response rate vs 30% alternative, which will be rejected when a lower confidence limit of two-sided 90% confidence interval of true response rate is over than threshold response rate. The secondary endpoints include progression free survival, overall survival, best overall response and incidence of adverse events. Totally, a target size of 22 patients will be expected.Discussion:If this study shows efficacy and acceptable safety profile, it will contribute to the development of novel treatment option for patients with KIT-mutant melanoma that are refractory to standard therapy.Trial registration:{"type":"clinical-trial","attrs":{"text":"NCT04546074","term_id":"NCT04546074"}}NCT04546074. Date of Registration: September 11, 2020 (https://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT04546074","term_id":"NCT04546074"}}NCT04546074). Date of First Participant Enrollment: December 23, 2020.     

Soluble fms-like tyrosine kinase 1, placental growth factor and procalcitonin as biomarkers of gram-negative sepsis: Analysis through a derivation and a validation cohort

Further improvement of the diagnostic and prognostic performance of biomarkers for the critically ill is needed. Procalcitonin (PCT), placental growth factor (PlGF) and soluble fms-like tyrosine kinase-1 raise interest for sepsis diagnosis and prognosis.Serum samples from 2 cohorts of 172 patients (derivation cohort) and of 164 patients (validation cohort) comprising only patients with microbiologically confirmed gram-negative infections were analyzed. PlGF, s-Flt-1 and procalcitonin (PCT) were measured in serum within 24 hours from sepsis onset and repeated on days 3 and 7.PCT and s-Flt-1 baseline levels were higher in sepsis and septic shock compared to non-sepsis; this was not the case for PlGF. s-Flt-1 at concentrations greater than 60 pg/ml diagnosed sepsis with sensitivity 72.3% and specificity 54.9% whereas at concentrations greater than 70 pg/ml predicted unfavorable outcome with specificity 73.0% and sensitivity 63.7%. At least 80% decrease of PCT and/or PCT less than 0.5 ng/ml on day 7 was protective from sepsis-associated death.Both s-Flt-1 and PCT should be measured in the critically ill since they provide additive information for sepsis diagnosis and prognosis.ClinicalTrials.gov numbers {"type":"clinical-trial","attrs":{"text":"NCT01223690","term_id":"NCT01223690"}}NCT01223690 and {"type":"clinical-trial","attrs":{"text":"NCT00297674","term_id":"NCT00297674"}}NCT00297674.     

Efficacy of moxibustion in diabetes peripheral neuropathy

Background:Diabetic peripheral neuropathy (DPN) is one of the most common complications of diabetes mellitus. The main clinical manifestations of DPN include pain, numbness, paraesthesia, and weakness of the lower limbs which often leads to diabetic foot ulceration, eventually resulting in amputation. Based on Traditional Chinese Medicine theory, moxibustion has a great effect on treating and preventing DPN. However, randomized clinical trials done to evaluate the efficacy of this treatment are still lacking. Hence, this study is carried out to evaluate the effectiveness and safety of moxibustion therapy on diabetic peripheral neuropathy.Methods:This study will be a pilot, interventional, randomized, 2-armed, parallel, singled-masked, controlled trial. A total of 40 diabetes mellitus patients with peripheral neuropathy will be recruited and assigned randomly into 2 groups (moxibustion group and waiting group) at a 1:1 ratio. This trial consists of an 8-week intervention period and a 4-week follow-up period. During the intervention period, the moxibustion group will take 3 moxibustion sessions per week, whereas no intervention will be done on the waiting group to act as the control group. The outcome will be assessed by an outcome assessor who is unaware of the group assignment. The primary outcome will be pain assessment measured with algometry, Leeds Assessment of Neuropathic Symptoms and Signs pain scale, visual analogue scale, and neuropathy pain scale. The secondary outcome will be an evaluation of functional performance capacity with 6 minutes walking test, evaluation of the Foot and Ankle Ability Measure, and serum HbA1c and albumin levels.Discussion:We hope that this trial will provide valuable insights on the efficacy of moxibustion in the management of diabetic peripheral neuropathy.Trial registration:ClinicalTrials.gov Registry No.: {"type":"clinical-trial","attrs":{"text":"NCT04894461","term_id":"NCT04894461"}}NCT04894461 (URL: https://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT04894461","term_id":"NCT04894461"}}NCT04894461?term={"type":"clinical-trial","attrs":{"text":"NCT04894461","term_id":"NCT04894461"}}NCT04894461&draw=2&rank=1) Registered on May 20, 2021.     

Glucose tolerance in fibromyalgia

Objectives:Fibromyalgia (FM) patients have an increased risk for glucose metabolism disturbances, and impaired glucose tolerance may be associated with symptom severity. Elevated levels of plasma lactate have been detected in FM patients. Both pyruvate and lactate are produced in glucose metabolism and reflect oxidative metabolism. The objective of our study was to analyse disturbances in glucose, pyruvate, or lactate metabolism in FM patients.Methods:We measured plasma levels of glucose, pyruvate, and lactate during an oral glucose tolerance test in 40 non-diabetic, female FM patients and 30 age- and gender-matched healthy controls.Results:FM patients showed a higher glycaemic response to the glucose load at 1 hour (F [1,68] = 10.4, P = .006) and 2 hours (F [1,68] = 7.80, P = .02), and higher glucose area under the curve (13.8 [SD 2.92] vs 11.6 [SD 2.31], P < .01), than healthy controls. Group differences were explained by higher body mass index and percentage of smokers among the FM patients. Pyruvate and lactate levels were similar in both groups.Discussion:Impaired glucose regulation in FM patients is likely not due to FM itself, but to associated lifestyle factors. Our results highlight the importance of assessing the glucose regulation status and the lifestyle factors affecting glucose regulation in FM patients for prevention or early treatment of diabetes and associated complications.Trial Registration:ClinicalTrials.gov ({"type":"clinical-trial","attrs":{"text":"NCT03300635","term_id":"NCT03300635"}}NCT03300635)     

The efficacy and safety of non-resistance manual therapy in inpatients with acute neck pain caused by traffic accidents: A randomized controlled trial

Background:Neck pain and functional impairment are common complications of traffic accidents (TAs); however, the effects of manual therapy on these symptoms have rarely been studied in the literature. Thus, this randomized controlled trial aims to assess the effectiveness and safety of non-resistance manual therapy (NRT)—a treatment combining mobilization and pressure release techniques—on acute neck pain caused by TA.Method:This study will use a two-armed, parallel, assessor-blinded randomized controlled trial design and will be conducted in the Daejeon Jaseng Hospital of Korean Medicine in South Korea. One hundred twenty patients will be recruited and randomized into an integrative Korean medicine treatment (IMKT) + NRT group and IMKT group in a 1:1 ratio. The primary outcome is a change in the numeric rating scale for neck pain immediately after treatment on hospital day 5 compared to those at baseline. The secondary outcomes are numeric rating scale for radiating arm pain, visual analogue scale for neck pain and radiating arm pain, cervical active range of motion, neck disability index, Patient Global Impression of Change, Short Form-12 Health Survey, and Posttraumatic Stress Disorder Checklist for DSM-5.Discussion:The findings of this study on the effectiveness and safety of NRT will be helpful for patients with TA-induced neck pain in clinical practice and will provide evidence for developing relevant healthcare-related policies.Trial registration:This protocol has been registered at Clinicaltrials.gov ({"type":"clinical-trial","attrs":{"text":"NCT04660175","term_id":"NCT04660175"}}NCT04660175).     

Randomized Clinical Trial Comparing Efficacy of Simo Decoction and Acupuncture or Chewing Gum Alone on Postoperative Ileus in Patients With Hepatocellular Carcinoma After Hepatectomy

To compare the efficacy of simo decoction (SMD) combined with acupuncture at the tsusanli acupoint or chewing gum alone for treating postoperative ileus in patients with hepatocellular carcinoma (HCC) after hepatectomy.In postoperative ileus, a frequent complication following hepatectomy, bowel function recovery is delayed, which increases length of hospital stay. Studies suggest that chewing gum may reduce postoperative ileus; SMD and acupuncture at the tsusanli acupoint have long been used in China to promote bowel movement.Patients with primary HCC undergoing hepatectomy between January 2015 and August 2015 were randomized to receive SMD and acupuncture (n = 55) or chewing gum (n = 53) or no intervention (n = 54) starting on postoperative day 1 and continuing for 6 consecutive days or until flatus. Primary endpoints were occurrence of postoperative ileus and length of hospital stay; secondary endpoints were surgical complications.Groups treated with SMD and acupuncture or with chewing gum experienced significantly shorter time to first peristalsis, flatus, and defecation than the no-intervention group (all P < 0.05). Hospital stay was significantly shorter in the combined SMD and acupuncture group (mean 14.0 d, SD 4.9) than in the no-intervention group (mean 16.5 d, SD 6.8; P = 0.014), while length of stay was similar between the chewing gum group (mean 14.7, SD 6.2) and the no-intervention group (P = 0.147). Incidence of grades I and II complications was slightly lower in both intervention groups than in the no-intervention group.The combination of SMD and acupuncture may reduce incidence of postoperative ileus and shorten hospital stay in HCC patients after hepatectomy. Chewing gum may also reduce incidence of ileus but does not appear to affect hospital stay. (Clinicaltrials.gov registration number: {"type":"clinical-trial","attrs":{"text":"NCT02438436","term_id":"NCT02438436"}}NCT02438436.)     

The effects of electroacupuncture and laser acupuncture therapy for patients with major trauma: A study protocol

Background:Major trauma is the leading cause of death in the young population. The inflammatory and anti-inflammatory responses are associated with posttraumatic morbidity and mortality; however, it is not fully clear how to reestablish the homeostasis in patients with major trauma.Methods:This study will be a prospective, randomized, placebo-controlled, partially double-blinded, three-armed trial. One hundred eighty participants diagnosed with major trauma will be randomly assigned to an electroacupuncture (EA), a laser acupuncture (LA), or a sham laser acupuncture group in a 1:1:1 ratio. All participants will undergo EA, LA, or sham laser acupuncture intervention once a day on 5 acupoints (LI4, PC6, ST36, SP6, and EX-HN1) for 14 consecutive days after enrollment. The primary outcome measure will be the length of hospital stay. Secondary outcomes will be inflammatory mediators, including serum C-reactive protein, interleukin (IL)-6, tumor necrosis factor-α, IL-1β, and IL-10. Clinical outcomes will be numeric rating scale scores for pain, sequential organ failure assessment, ICU length of stay, 30-day mortality, and WHO Disability Assessment Schedule. Data will be analyzed by chi-square test or t test for pairwise comparisons, as well as one-way ANOVA followed by post hoc Tukey method between groups.Objectives:The aim of this protocol is to investigate the clinical effects of EA and LA on major trauma.Trial registration:ClinicalTrials.gov Identifier: {"type":"clinical-trial","attrs":{"text":"NCT04970433","term_id":"NCT04970433"}}NCT04970433. Registered on July 21, 2021.     

Acute Care Utilization After Recovery Coaching Linkage During Substance-Related Inpatient Admission: Results of Two Randomized Controlled Trials

BackgroundFor patients with substance use disorder (SUD), a peer recovery coach (PRC) intervention increases engagement in recovery services; effective support services interventions have occasionally demonstrated cost savings through decreased acute care utilization.ObjectiveExamine effect of PRCs on acute care utilization.DesignCombined results of 2 parallel 1:1 randomized controlled trials.ParticipantsInpatient adults with substance use disorderInterventionsInpatient PRC linkage and follow-up contact for 6 months vs usual care (providing contact information for SUD resources and PRCs)Main MeasuresAcute care encounters (emergency and inpatient) 6 months before and after enrollment; encounter type by primary diagnosis code category (mental/behavioral vs medical); 30-day readmissions with Lace+ readmission risk scores.Key ResultsA total of 193 patients were randomized: 95 PRC; 98 control. In the PRC intervention, 66 patients had a pre-enrollment acute care encounter and 56 had an encounter post-enrollment, compared to the control group with 59 pre- and 62 post-enrollment (odds ratio [OR] = −0.79, P = 0.11); there was no significant effect for sub-groups by encounter location (emergency vs inpatient). There was a significant decrease in mental/behavioral ED visits (PRC: pre-enrollment 17 vs post-enrollment 10; control: pre-enrollment 13 vs post-enrollment 16 (OR = −2.62, P = 0.02)) but not mental/behavioral inpatient encounters or medical emergency or inpatient encounters. There was no significant difference in 30-day readmissions corrected for Lace+ scores (15.8% PRC vs 17.3% control, OR = 0.19, P = 0.65).ConclusionsPRCs did not decrease overall acute care utilization but may decrease emergency encounters related to substance use.Trial RegistrationClinicalTrials.gov ({"type":"clinical-trial","attrs":{"text":"NCT04098601","term_id":"NCT04098601"}}NCT04098601, {"type":"clinical-trial","attrs":{"text":"NCT04098614","term_id":"NCT04098614"}}NCT04098614)Supplementary InformationThe online version contains supplementary material available at 10.1007/s11606-021-07360-w.KEY WORDS: substance use disorders, randomized controlled trial, peer recovery coaching, admissions     

Efficacy of medium-chain triglyceride oil massage on growth in preterm infants: a randomized controlled trial: A CONSORT-compliant article

Background:Medium-chain triglyceride (MCT) oil consists of 8–12 carbons with higher absorption and provides better calories than long-chain triglyceride oil. This study was to explore the effect of MCT oil massage on growth in preterm infants.Methods:A prospective, single-blind, randomized (two treatments and one control) study was conducted. Preterm infants weighing between 1500 and 2000 g were recruited and randomly assigned to three groups: the MCT oil massage, massage alone and no massage groups. The standardized massage intervention consisted of two 5-min phases, including tactile and kinesthetic stimulation, which were given three times a day for 7 consecutive days. Premature infants in the oil massage group received massage with 10 mL/kg/day of MCT oil divided equally into three applications. Weight, length and head circumference were measured in the three groups at birth and on study days 1 to 7.Results:Forty-eight neonates were evaluated with 16 in each of three groups. The linear mixed effect model was adjusted for other factors, and results showed that weight gain on the 4th day in the oil massage group was greater than that in the no massage group (P < .05). From the 5th to 7th day, weight gain in the oil massage group was greater than that in the other two groups (P < .05). Regarding head circumference and height, this study found that the MCT oil massage group did not have better results than the other two groups. No adverse events were noted in the massage groups.Conclusion:The results indicate that preterm infant daily massage with MCT oil is an effective intervention for weight gain that should be recognized as part of low-birth-weight infant developmental care.Trial registration:clinicaltrials.gov identifier {"type":"clinical-trial","attrs":{"text":"NCT04281563","term_id":"NCT04281563"}}NCT04281563, Registered on 24 February 2020.     

Intramuscular administration of autologous total immunoglobulin G induces immunomodulatory effects on T cells in healthy human subjects: An open-labeled prospective single-arm trial

Background:We hypothesized that intramuscular administration of autologous total immunoglobulin G (IgG) could induce an immunomodulatory effect in human subjects. In our previous studies, we showed that intramuscular administration of autologous total IgG could induce significant clinical improvements and increases of the serum levels of interleukin-10 (IL-10) and interferon-gamma (IFN-γ) in patients with atopic dermatitis.Objective:To investigate the mechanism of immunomodulation induced by intramuscular administration of autologous total IgG, we evaluated changes in T cells before and after intramuscular administrations of autologous total IgG in this study.Methods:Thirteen healthy adults received 8 intramuscular injections of 50 mg autologous total IgG for 4 weeks (from week 0 to week 4). The percentages of IL-10- or IFN-γ-producing peripheral blood T cells, as well as serum levels of IL-10, IFN-γ, and immunoglobulins, were measured at baseline (week 0) and at weeks 4, 8, and 12.Results:The percentage of IL-10-producing CD4⁺ T cells was significantly increased at weeks 8 and 12 compared to baseline (P < .05), while the percentage of IFN-γ-producing CD3⁺ T cells was significantly increased at week 12 compared to baseline (P < .05). There were no significant differences in the serum levels of IL-10, IFN-γ, and immunoglobulins before and after intramuscular administration of autologous total IgG (P > .05). No serious adverse events were observed.Conclusion:Intramuscular administration of autologous total IgG induced immunomodulatory effects on T cells in healthy human subjects. This simple intervention could be a safe, effective, and economical T cell immunomodulation method for human subjects ({"type":"clinical-trial","attrs":{"text":"NCT03695757","term_id":"NCT03695757"}}NCT03695757).     

Increased FIO2 influences SvO2 interpretation and accuracy of Fick-based cardiac output assessment in cardiac surgery patients: A prospective randomized study

Introduction:The study aimed to reveal how the fraction of inspired oxygen (FIO₂) affected the value of mixed venous oxygen saturation (SvO₂) and the accuracy of Fick-equation-based cardiac output (Fick-CO).Methods:Forty two adult patients who underwent elective cardiac surgery were enrolled and randomly divided into 2 groups: FIO₂ < 0.7 or >0.85. Under stable general anesthesia, thermodilution-derived cardiac output (TD-CO), SvO₂, venous partial pressure of oxygen, hemoglobin, arterial oxygen saturation, arterial partial pressure of oxygen, and blood pH levels were recorded before surgical incision.Results:Significant differences in FIO₂ values were observed between the 2 groups (0.56 ± 0.08 in the <70% group and 0.92 ± 0.03 in the >0.85 group; P < .001). The increasing FIO₂ values lead to increases in SvO₂, venous partial pressure of oxygen, and arterial partial pressure of oxygen, with little effects on cardiac output and hemoglobin levels. When comparing to TD-CO, the calculated Fick-CO in both groups had moderate Pearson correlations and similar linear regression results. Although the FIO₂ <0.7 group presented a less mean bias and a smaller limits of agreement, neither group met the percentage error criteria of <30% in Bland-Altman analysis.Conclusion:Increased FIO₂ may influence the interpretation of SvO₂ and the exacerbation of Fick-CO estimation, which could affect clinical management.Trial Registration:ClinicalTrials.gov ID number: {"type":"clinical-trial","attrs":{"text":"NCT04265924","term_id":"NCT04265924"}}NCT04265924, retrospectively registered (Date of registration: February 9, 2020).     

Screening cardiovascular risk factors of diabetes patients in the primary diabetes clinics

To evaluate the atherosclerotic cardiovascular diseases (ASCVD) risk factors in type 2 diabetes patients from the primary diabetes clinics for further comprehensive intervention in China.A cross-sectional study was conducted in 5 primary diabetes chain hospitals in Beijing, Lanzhou, Harbin, Chengdu, and Taiyuan in continuous patients with type 2 diabetes from March 2016 to December 2019. The data collected at the first visit were analyzed, and proportions of patients reached the targets (glycosylated hemoglobin [HbA₁c] < 7%, blood pressure < 130/80 mm Hg, and low-density lipoprotein cholesterol [LDL-C] < 2.6mmol/l) were calculated. The clinical characteristics and the associated factors with achievement in HbA₁c, blood pressure, and LDL-C targets were analyzed.A total of 20,412 participants, including 11,353 men (55.6%), with an average age of (59.4 ± 10.4) years were enrolled. Nearly 95% diabetes had one or more ASCVD risk factors other than hyperglycemia. The control rates of HbA₁c, blood pressure, and LDL-C were 26.5%, 27.8%, and 42.6%, respectively. Only 4.1% patients achieved all 3 targets. Nearly 95% patients had one or more ASCVD risk factors other than hyperglyciemia. Diabetes duration, family history, and overweight/obesity were associated with the number of aggregated ASCVD risk factors. The patients with older age, no overweight/obesity, not smoking, less ASCVD risk factors, and having special diabetes care insurance (Chengdu) were associated with a higher control rates.To deal with poor control status, global management of ASCVD risk factors, weight loss, and smoking cessation must be emphasized in the primary diabetes care settings. Special diabetes care insurance should be advocated.Current ClinicalTrial.gov protocol ID {"type":"clinical-trial","attrs":{"text":"NCT03707379","term_id":"NCT03707379"}}NCT03707379. Date of Registration: October 16, 2018. https://clinicaltrials.gov.     

Adolescents’ Experiences of Using a Smartphone Application Hosting a Closed-loop Algorithm to Manage Type 1 Diabetes in Everyday Life: Qualitative Study

Background:Closed-loop technology may help address health disparities experienced by adolescents, who are more likely to have suboptimal glycemic control than other age groups and, because of their age, find diabetes self-management particularly challenging. The CamAPS FX closed-loop has sought to address accessibility and usability issues reported by users of previous prototype systems. It comprises small components and a smartphone app used to: announce meal-time boluses, adjust (“boost” or “ease-off”) closed-loop insulin delivery, customize alarms, and review/share data. We explored how using the CamAPS FX platform influences adolescents’ self-management practices and everyday lives.Methods:Eighteen adolescents were interviewed after having ≥6 months experience using the closed-loop platform. Data were analyzed thematically.Results:Participants reported feeling less burdened and shackled by diabetes because closed-loop components were easier to carry/wear, finger-pricks were not required, the smartphone app provided a discreet and less stigmatizing way of managing diabetes in public, and they were able to customize alarms. Participants also reported checking and reviewing data more regularly, because they did so when using the smartphone for other reasons. Some reported challenges in school settings where use of personal phones was restricted. Participants highlighted how self-management practices were improved because they could easily review glucose data and adjust closed-loop insulin delivery using the “boost” and “ease-off” functions. Some described how using the system resulted in them forgetting about diabetes and neglecting certain tasks.Conclusions:A closed-loop system with small components and control algorithm on a smartphone app can enhance usability and acceptability for adolescents and may help address the health-related disparities experienced by this age group. However, challenges can arise from using a medical app on a device which doubles as a smartphone.Trial registration:Closed Loop From Onset in Type 1 Diabetes (CLOuD); {"type":"clinical-trial","attrs":{"text":"NCT02871089","term_id":"NCT02871089"}}NCT02871089; https://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT02871089","term_id":"NCT02871089"}}NCT02871089     

Effects of depth of neuromuscular blockade on the BIS-guided propofol requirement: A randomized controlled trial

Background:Deep neuromuscular blockade is considered beneficial for improving the surgical space condition during laparoscopic surgery. Adequacy of the surgical space condition may affect the anesthetists’ decision regarding titration of depth of anesthesia. We investigated whether deep neuromuscular blockade reduces the propofol requirement under bispectral index monitoring compared to moderate neuromuscular blockade.Methods:Adult patients undergoing elective laparoscopic colorectal surgery were randomly allocated to a moderate or deep group. A train-of-four count of 1–2 in the moderate group, and a post-tetanic count of 1–2 in the deep group, were maintained by continuous infusion of rocuronium. The induction and maintenance of anesthesia were achieved by target-controlled infusion of propofol and remifentanil. The dose of propofol was adjusted to maintain the bispectral index in the range of 40–50. The remifentanil dose was titrated to maintain the systolic blood pressure to within 20% of the ward values.Results:A total of 82 patients were included in the analyses. The mean±SD dose of propofol was 7.54 ± 1.66 and 7.42 ± 1.01 mg·kg⁻¹·h⁻¹ in the moderate and deep groups, respectively (P = .104). The mean±SD dose of remifentanil was 4.84 ± 1.74 and 4.79 ± 1.77 μg kg⁻¹ h⁻¹ in the moderate and deep groups, respectively (P = .688). In comparison to the moderate group, the deep group showed significantly lower rates of intraoperative patient movement (42.9% vs 22.5%, respectively, P = .050) and additional neuromuscular blocking agent administration (76% vs 53%, respectively, P = .007). Postoperative complications, including pulmonary complications, wound problems and reoperation, were not different between the two groups.Conclusion:Deep neuromuscular blockade did not reduce the bispectral index-guided propofol requirement compared to moderate neuromuscular blockade during laparoscopic colon surgery, despite reducing movement of the patient and the requirement for a rescue neuromuscular blocking agent.Trial registration:Clinicaltrials.gov ({"type":"clinical-trial","attrs":{"text":"NCT03890406","term_id":"NCT03890406"}}NCT03890406)     

Can the ETView VivaSight SL Rival Conventional Intubation Using the Macintosh Laryngoscope During Adult Resuscitation by Novice Physicians?: A Randomized Crossover Manikin Study

The aim of this study was to assess the performance of the ETView VivaSight SL (ETView) single-lumen airway tube with an integrated high-resolution imaging camera in a manikin-simulated cardiopulmonary resuscitation scenario with and without chest compression.This was a randomized crossover manikin trial. Following a brief training session, 107 volunteer novice physicians who were inexperienced with airway management attempted to intubate a manikin using a Macintosh laryngoscope (MAC) and an ETView, with and without chest compressions. The participants were instructed to make 3 attempts in each scenario. In this trial, we compared intubation time, intubation success rates, and glottic visibility using a Cormack & Lehane Grade. Dental compression and ease of use of each device were also assessed.Median intubation times for the ETView and MAC without chest compressions were 17 (IQR, 15–19) s and 27 (IQR, 25–33) s, respectively (P < 0.001). The ETView proved more successful on the first intubation attempt than the MAC, regardless of compressions. Continuation of compressions caused an increase in intubation times for both the ETView (P = 0.27) and the MAC (P < 0.005).The ETView VivaSight SL is an effective tool for endotracheal intubation when used by novice physicians in a manikin-simulated cardiac arrest, both with and without chest compressions.Trial Registration: clinicaltrials.gov Identifier: {"type":"clinical-trial","attrs":{"text":"NCT02295618","term_id":"NCT02295618"}}NCT02295618.