scholarly journals Effect of bromhexine in hospitalized patients with COVID-19

2021 ◽  
pp. jim-2020-001747
Author(s):  
Ramin Tolouian ◽  
Zuber D Mulla ◽  
Hamidreza Jamaati ◽  
Abdolreza Babamahmoodi ◽  
Majid Marjani ◽  
...  
Keyword(s):  
Hospital Discharge ◽  
Clinical Improvement ◽  
Primary Outcome ◽  
Adverse Drug Events ◽  
Antiviral Effect ◽  
Hospitalized Patients ◽  
Secondary Outcome ◽  
Risk Of Death ◽  
Significant Difference ◽  
Transmembrane Serine Protease

BackgroundBromhexine is a potent inhibitor of transmembrane serine protease 2 and appears to have an antiviral effect in controlling influenza and parainfluenza infection; however, its efficacy in COVID-19 is controversial.MethodsA group of hospitalized patients with confirmed COVID-19 pneumonia were randomized using 1:1 allocation to either standard treatment lopinavir/ritonavir and interferon beta-1a or bromhexine 8 mg four times a day in addition to standard therapy. The primary outcome was clinical improvement within 28 days, and the secondary outcome measures were time to hospital discharge, all-cause mortality, duration of mechanical ventilation, the temporal trend in 2019-nCoV reverse transcription-polymerase chain reaction positivity and the frequency of adverse drug events within 28 days from the start of medication.ResultsA total of 111 patients were enrolled in this randomized clinical trial and data from 100 patients (48 patients in the treatment arm and 52 patients in the control arm) were analyzed. There was no significant difference in the primary outcome of this study, which was clinical improvement. There was no significant difference in the average time to hospital discharge between the two arms. There were also no differences observed in the mean intensive care unit stay, frequency of intermittent mandatory ventilation, duration of supplemental oxygenation or risk of death by day 28 noted between the two arms.ConclusionBromhexine is not an effective treatment for hospitalized patients with COVID-19. The potential prevention benefits of bromhexine in asymptomatic postexposure or with mild infection managed in the community remain to be determined.

scholarly journals No significant benefit of moderate-dose vitamin C on severe COVID-19 cases

Open Medicine ◽  
2021 ◽  
Vol 16 (1) ◽  
pp. 1403-1414
Author(s):  
Shaoping Zheng ◽  
Qiaosen Chen ◽  
Hongbo Jiang ◽  
Chunxia Guo ◽  
Jinzhuo Luo ◽  
...  
Keyword(s):  
Vitamin C ◽  
Clinical Improvement ◽  
Significant Benefit ◽  
Ordinal Scale ◽  
Secondary Outcome ◽  
Moderate Dose ◽  
Risk Of Death ◽  
Significant Difference ◽  
Union Hospital ◽  
Intravenous Vitamin

Abstract There is no specific drug for coronavirus disease 2019 (COVID-19). We aimed to investigate the possible clinical efficacy of moderate-dose vitamin C infusion among inpatients with severe COVID-19. Data of 397 adult patients with severe COVID-19 admitted to a designated clinical center of Wuhan Union Hospital (China) between February 13 and February 29, 2020, were collected. Besides standard therapies, patients were treated with vitamin C (2–4 g/day) or not. The primary outcome was all-cause death. Secondary outcome was clinical improvement of 2 points on a 6-point ordinal scale. About 70 participants were treated with intravenous vitamin C, and 327 did not receive it. No significant association was found between vitamin C use and death on inverse probability treatment weighting (IPTW) analysis (weighted hazard ratio [HR], 2.69; 95% confidence interval [CI], 0.91–7.89). Clinical improvement occurred in 74.3% (52/70) of patients in the vitamin C group and 95.1% (311/327) in the no vitamin C group. No significant difference was observed between the two groups on IPTW analysis (weighted HR, 0.76; 95% CI, 0.55–1.07). Our findings revealed that in patients with severe COVID-19, treatment with moderate dose of intravenous vitamin C had no significant benefit on reducing the risk of death and obtaining clinical improvement.

A randomised controlled trial of perivenous tumescent anaesthesia in addition to general anaesthesia for surgical ligation and stripping of the great saphenous vein

2019 ◽  
Vol 35 (5) ◽  
pp. 305-315 ◽  
Author(s):  
Sandip Nandhra ◽  
Tom Wallace ◽  
Joseph El-Sheikha ◽  
Daniel Carradice ◽  
Ian Chetter
Keyword(s):  
Quality Of Life ◽  
General Anaesthesia ◽  
Saphenous Vein ◽  
Primary Outcome ◽  
Great Saphenous Vein ◽  
Bodily Pain ◽  
Secondary Outcome ◽  
Surgical Ligation ◽  
Significant Difference

Introduction Open surgical ligation and stripping of the great saphenous vein is a highly cost-effective treatment when compared with conservative management and foam sclerotherapy but has limitations including post-operative morbidity and pain. This study aims to identify if the addition of tumescent anaesthesia could improve patient outcomes following treatment. Methods Patients with primary superficial venous incompetence undergoing open surgical ligation and stripping of the great saphenous vein were randomised to either General Anaesthesia (GA) alone (GA) procedure or the addition of tumescent (G + T). The primary outcome was bodily pain (within SF-36) at one week. Additional outcomes included post-procedural pain score (100 mm visual analogue scale), complications and quality of life. Results A total of 90 patients were randomised for inclusion. There was no significant difference in primary outcome; bodily pain at one week. Secondary outcome of 4-h post-procedural scores were significantly lower in the G + T group (32 (20–54) mm vs. (GA alone) 56 (24–70) mm (P = 0.016)). Complications were minor and equivalent. Both groups saw a significant increase (worsening) in Aberdeen Varicose Vein Questionnaire scores at week 1 with the G + T group faring worse at six weeks (10.0 (Interquartile Range [IQR] 5.6–17.9) vs. 4.3 (IQR 2.7–7.9) P = 0.004). Conclusion The G + T group did not demonstrate a significant difference in the one-week bodily pain domain. The addition of tumescent anaesthesia does improve immediate post-operative pain but appears to negatively impact on six-week quality of life. EudraCT Number: 2011-005574-39

scholarly journals Utility of opening rhythms in predicting time to return of spontaneous circulation in cardiac arrest victims in a resource constrained setting: a single centre prospective observational study

2019 ◽  
Vol 7 (12) ◽  
pp. 4709
Author(s):  
Appu Suseel ◽  
Siju V. Abraham ◽  
Radha K. R.
Keyword(s):  
Cardiac Arrest ◽  
Hospital Discharge ◽  
Cardiopulmonary Arrest ◽  
Spontaneous Circulation ◽  
Secondary Outcome ◽  
Resource Constrained ◽  
Return Of Spontaneous Circulation ◽  
Shockable Rhythm ◽  
Significant Difference ◽  
Mean Time

Background: Time to ROSC has been shown to be an important and independent predictor of mortality and adverse neurological outcome. In resource limited situations judicious deployment of resources is crucial. Prognostication of arrest victims may aid in better resource allocation. This study aimed to assess the time to Return of Spontaneous Circulation (ROSC) in cardiac arrest victims and its relationship with opening rhythms.Methods: Consecutive victims of cardiopulmonary arrest who presented to a single center were included in this study if they met the inclusion and exclusion criteria. Time at which opening rhythm was analyzed and time at which ROSC was achieved was noted. This was done for all cases and mean time to ROSC was calculated for each opening rhythm. All those patients who achieved ROSC were followed up till hospital discharge or death.  Primary outcome measured was achievement of ROSC and the secondary outcome was the survival to hospital discharge.Results: A sample size of 100 was calculated to yield a significance criterion of 0.05 and a power of 0.80 based on prior studies. Out of 100 patients studied. 58% had shockable rhythms and 42% had non-shockable rhythms.  Mean time to ROSC for shockable rhythm was 5.55±3.51 minutes, and for non-shockable rhythm is 17.29±4.18 minutes.  There was a statistically significant difference between opening rhythms in terms of survival to hospital discharge (p=0.0329).Conclusions: Cardiac arrests with shockable rhythms attained ROSC faster when compared to nonshockable rhythms. Shockable rhythms have a better survival to hospital discharge when compared to shockable rhythms. Opening rhythms may aid the clinician in better utility of resources in a resource constrained setting.

scholarly journals Role of Preoperative Calcium and Vitamin D Therapy to prevent Post-thyroidectomy Hypocalcemia

2020 ◽  
Author(s):  
Sunghwan suh ◽  
Ju Won Seok ◽  
Keunyoung Kim ◽  
Mi Kyoung Park ◽  
Kyoungjune Pak ◽  
...  
Keyword(s):  
Vitamin D ◽  
English Language ◽  
Primary Outcome ◽  
Potential Role ◽  
Meta Analysis ◽  
Vitamin D Supplementation ◽  
Secondary Outcome ◽  
Significant Difference ◽  
Symptomatic Hypocalcemia

Abstract Purpose: Postsurgical hypocalcemia is the most common and troublesome consequence of thyroidectomy. We investigated the potential role of routine calcium or vitamin D supplementation in preventing postsurgical hypocalcemia. Materials and Methods: We searched MEDLINE and EMBASE for English-language publications using the keywords “calcium”, “vitamin D”, and “thyroid cancer”. The primary outcome was any postoperative hypocalcemia, and the secondary outcome was symptomatic hypocalcemia. Results: Four studies that included 381 patients were eligible for this meta-analysis. The random-effects model showed no significant difference in the occurrence of hypocalcemia between calcium/vitamin D treatment and placebo/no treatment. The occurrence of symptomatic hypocalcemia was lower in patients with calcium/vitamin D treatment. In combined results, preoperative calcium and vitamin D supplementation was associated with a reduced incidence of symptomatic hypocalcemia.Conclusion: We support the use of preoperative calcium and vitamin D supplementation in conjunction with routine postsurgical supplementation for patients after total thyroidectomy.

scholarly journals Side Effects of Intravenous Patient-Controlled Analgesia with Remifentanil Compared with Intermittent Epidural Bolus for Labour Analgesia – A Randomized Controlled Trial

PRILOZI ◽  
2019 ◽  
Vol 40 (3) ◽  
pp. 99-108
Author(s):  
Dafina Karadjova ◽  
Mirjana Shosholcheva ◽  
Еmilija Ivanov ◽  
Аtanas Sivevski ◽  
Ivo Kjaev ◽  
...  
Keyword(s):  
Side Effects ◽  
Epidural Analgesia ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Patient Controlled Analgesia ◽  
Obstetric Anaesthesia ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Remifentanil Group

Abstract Introduction: Epidural analgesia is considered a gold standard in obstetric anaesthesia and analgesia. However, in situation when it is contraindicated, unwanted by the patient or simply unavailable, remifentanil can be an excellent alternative. The goal of our study is to analyse the side effects of intravenous patient-controlled analgesia (IV PCA) with remifentanil compared with epidural analgesia during delivery. Material and methods: This study included 155 pregnant women in term for birth, divided into 2 groups: a remifentanil group (RG), and an epidural group (EG). Patients in the RG received intravenous PCA with remifentanil, while patients in the ЕG received epidural analgesia with programmed intermittent bolus dosing. Our primary outcome was maternal safety; the secondary outcome was neonatal safety. Results: The results present a significantly lower SaO2 value of the parturients in the RG (96.95 ± 1.4 vs 98.22 ± 0.6), and a significantly higher respiratory rate per minute in the EG at all time points after the onset of analgesia (20.85 ± 1.4 vs 18.67 ± 0.9). There was more frequent sedation, nausea and vomiting in the RG, while in the EG there was a more elevated temperature, itching and irregularities in the CTG record. Regarding the newborn, there was no significant difference between the two groups in the Apgar scores, pH, pCO2, pO2, and bicarbonate, while there was a significantly lower value of the base excess in the RG group. Conclusion: PCA with remifentanil is safe for the mother, foetus and the newborn, with minimal side effects. Continuous respiratory monitoring, oxygen supply and following of all consensus recommendations are mandatory.

Acceptance and Commitment group Therapy for patients with multiple functional somatic syndromes: a three-armed trial comparing ACT in a brief and extended version with enhanced care

2018 ◽  
Vol 49 (6) ◽  
pp. 1005-1014 ◽  
Author(s):  
Heidi Frølund Pedersen ◽  
Johanne L. Agger ◽  
Lisbeth Frostholm ◽  
Jens S. Jensen ◽  
Eva Ørnbøl ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Psychological Treatment ◽  
Secondary Outcome ◽  
Health Improvement ◽  
Extended Version ◽  
Functional Somatic Syndromes ◽  
Global Improvement ◽  
Acceptance And Commitment ◽  
Significant Difference ◽  
Secondary Outcomes

AbstractBackgroundPsychological treatment for functional somatic syndromes (FSS) has been found moderately effective. Information on how much treatment is needed to obtain improvement is sparse. We assessed the efficacy of a brief and extended version of group-based Acceptance and Commitment Therapy (ACT) v. enhanced care (EC) for patients with multiple FSS operationalised as Bodily Distress Syndrome multi-organ type.MethodsIn a randomised controlled three-armed trial, consecutively referred patients aged 20–50 with multiple FSS were randomly assigned to either (1) EC; (2) Brief ACT: EC plus 1-day workshop and one individual consultation; or (3) Extended ACT: EC plus nine 3-h group-based sessions. Primary outcome was patient-rated overall health improvement on the five-point clinical global improvement scale 14 months after randomisation. A proportional odds model was used for the analyses.ResultsA total of 180 patients were randomised; 60 to EC, 61 to Brief ACT, and 59 to Extended ACT. Improvement on the primary outcome after Extended ACT was significantly greater than after EC with an unadjusted OR of 2.9 [95% CI (1.4–6.2), p = 0.006]. No significant differences were found between Brief ACT and EC. Of the 18 secondary outcomes, the only significant difference found was for physical functioning in the comparison of Extended ACT with EC.ConclusionsPatients rated their overall health status as more improved after Extensive ACT than after EC; however, clinically relevant secondary outcome measures did not support this finding. Discrepancies between primary and secondary outcomes in this trial are discussed.

scholarly journals Convalescent plasma for COVID-19 in hospitalised patients: an open-label, randomised clinical trial

2021 ◽  
pp. 2101471
Author(s):  
Leo Sekine ◽  
Beatriz Arns ◽  
Bruna R. Fabro ◽  
Murillo M. Cipolatt ◽  
Rafael R. G. Machado ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Improvement ◽  
Critically Ill ◽  
Primary Outcome ◽  
Ventilatory Support ◽  
Standard Of Care ◽  
Randomised Clinical Trial ◽  
Open Label ◽  
Hospitalised Patients ◽  
Significant Difference

BackgroundThe effects of convalescent plasma (CP) therapy hospitalised patients with coronavirus disease 2019 (COVID-19) remain uncertain. This study investigates the effect CP on clinical improvement in these patients.MethodsThis is an investigator-initiated, randomised, parallel arm, open-label, superiority clinical trial. Patients were randomly (1:1) assigned to two infusions of CP plus standard of care (SOC) or SOC alone. The primary outcome was the proportion of patients with clinical improvement 28 days after enrolment.ResultsA total of 160 (80 in each arm) patients (66.3% were critically ill and 33.7%, severe) completed the trial. The median age was 60.5 years (interquartile range [IQR], 48–68), 58.1% were men and the median time from symptom onset to randomisation was 10 days (IQR, 8–12). Neutralising antibodies titres >1:80 were present in 133 (83.1%) patients at baseline. The proportion of patients with clinical improvement on day 28 was 61.3% in the CP+SOC and 65.0% in the SOC group (difference, −3.7%; 95% Confidence Interval [CI], −18.8%-11.3%). The results were similar in the subgroups of severe and critically ill. There was no significant difference between CP+SOC and SOC groups in prespecified secondary outcomes, including 28-day mortality, days alive and free of respiratory support and duration of invasive ventilatory support. Inflammatory and other laboratorial markers values on days 3, 7 and 14 were similar between groups.ConclusionsCP+SOC did not result in a higher proportion of clinical improvement on at day 28 in hospitalised patients with COVID-19 compared to SOC alone.

The Effect of β-Blockers for Burn Patients on Clinical Outcomes: Systematic Review and Meta-Analysis

2020 ◽  
pp. 088506662094018
Author(s):  
Nasreen Hassoun-Kheir ◽  
Oryan Henig ◽  
Tomer Avni ◽  
Leonard Leibovici ◽  
Mical Paul
Keyword(s):  
Systematic Review ◽  
Primary Outcome ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Hospitalized Patients ◽  
Sufficient Evidence ◽  
Selective Reporting ◽  
Significant Difference ◽  
Β Blocker ◽  
Β Blockers

Objectives: To assess the effects and safety of β-blockers in hospitalized patients with burns. Methods: A systematic review and meta-analysis of the literature. A broad search was conducted to identify all randomized controlled trials (RCTs) comparing β-blockers to control in hospitalized patients with burns. The primary outcome was 3-month all-cause mortality. Secondary outcomes were clinical patient-relevant end points. We subgrouped results by children/adults and burn severity. Risk of bias was assessed using the individual domain approach. Results: Four RCTs reported in 11 publications were included. Primary outcome of mortality was assessed in children (2 trials, n = 424) and adults (2 trials, n = 148) with severe burns. No significant difference was found between propranolol and control for mortality (risk ratio [RR] = 0.82, 95% CI = 0.48-1.39, 4 trials with broad confidence intervals in adults and children), sepsis (RR = 0.81, 95% CI = 0.46-1.43, 2 trials), and survivors’ length of stay (absolute mean difference = 2.53, 95% CI = −2.58–7.63, 3 trials). There was no significant difference in bradycardia (RR = 1.33, 95% CI = 0.77-2.3, 2 trials), hypotension (RR = 1.26, 95% CI = 0.73-2.17, 3 trials), or cardiac arrhythmia (RR: 2.97, 95% CI: 0.12-71.87, 1 trial). The evidence was graded as very low certainty, due to trial’s internal risk of bias, imprecision, and possible selective reporting. Conclusions: No sufficient evidence was found to support or refute an advantage for β-blocker use in children or adults after burns. Additional studies are needed to create a consensus and formulate practice guidelines on the optimal β-blocker to use, indications for initiation, and duration of treatment.

Defining the role of the condylar–C2 sagittal vertical alignment in Chiari malformation type I

2020 ◽  
Vol 26 (4) ◽  
pp. 439-444
Author(s):  
Vijay M. Ravindra ◽  
Rajiv R. Iyer ◽  
Al-Wala Awad ◽  
Robert J. Bollo ◽  
Huirong Zhu ◽  
...  
Keyword(s):  
Chiari Malformation ◽  
Primary Outcome ◽  
Group Versus ◽  
Secondary Outcome ◽  
Rank Test ◽  
Upper Cervical Spine ◽  
Type I ◽  
Occipitocervical Fusion ◽  
Chiari Malformation Type I ◽  
Significant Difference

OBJECTIVEThe authors’ objective was to better understand the anatomical load-bearing relationship between the atlantooccipital joint and the upper cervical spine and its influence on the clinical behavior of patients with Chiari malformation type I (CM-I) and craniocervical pathology.METHODSIn a single-center prospective study of patients younger than 18 years with CM-I from 2015 through 2017 (mean age 9.91 years), the authors measured the occipital condyle–C2 sagittal vertebral alignment (C–C2SVA; defined as the position of a plumb line from the midpoint of the occiput (C0)–C1 joint relative to the posterior aspect of the C2–3 disc space), the pB–C2 (a line perpendicular to a line from the basion to the posteroinferior aspect of the C2 body on sagittal MRI), and the CXA (clivoaxial angle). Control data from 30 patients without CM-I (mean age 8.97 years) were used for comparison. The primary outcome was the need for anterior odontoid resection and/or occipitocervical fusion with or without odontoid reduction. The secondary outcome was the need for two or more Chiari-related operations.RESULTSOf the 60 consecutive patients with CM-I identified, 7 underwent anterior odontoid resection or occipitocervical fusion and 10 underwent ≥ 2 decompressive procedures. The mean C–C2SVA was greater in the overall CM-I group versus controls (3.68 vs 0.13 mm, p < 0.0001), as was the pB–C2 (7.7 vs 6.4 mm, p = 0.0092); the CXA was smaller (136° vs 148°, p < 0.0001). A C–C2SVA ≥ 5 mm was found in 35% of CM-I children and 3.3% of controls (p = 0.0006). The sensitivities and specificities for requiring ventral decompression/occipitocervical fusion were 100% and 74%, respectively, for C–C2SVA ≥ 5 mm; 71% and 94%, respectively, for CXA < 125°; and 71% and 75%, respectively, for pB–C2 ≥ 9 mm. The sensitivities and specificities for the need for ≥ 2 decompressive procedures were 60% and 70%, respectively, for C–C2SVA ≥ 5 mm; 50% and 94%, respectively, for CXA < 125°; and 60% and 76%, respectively, for pB–C2 ≥ 9 mm. The log-rank test demonstrated significant differences between C–C2SVA groups (p = 0.0007) for the primary outcome. A kappa value of 0.73 for C–C2SVA between raters indicated substantial agreement.CONCLUSIONSA novel screening measurement for craniocervical bony relationships, the C–C2SVA, is described. A significant difference in C–C2SVA between CM-I patients and controls was found. A C–C2SVA ≥ 5 mm is highly predictive of the need for occipitocervical fusion/ventral decompression in patients with CM-I. Further validation of this screening measurement is needed.

scholarly journals Efficacy of nature-based therapy for individuals with stress-related illnesses: randomised controlled trial

2018 ◽  
Vol 213 (1) ◽  
pp. 404-411 ◽  
Author(s):  
Ulrika Karlsson Stigsdotter ◽  
Sus Sola Corazon ◽  
Ulrik Sidenius ◽  
Patrik Karlsson Nyed ◽  
Helmer Bøving Larsen ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Well Being ◽  
Behavioural Therapy ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Significant Difference ◽  
Increasing Demand ◽  
Randomised Controlled

BackgroundStress-related illnesses are a major threat to public health, and there is increasing demand for validated treatments.AimsTo test the efficacy of nature-based therapy (NBT) for patients with stress-related illnesses.MethodRandomised controlled trial (ClinicalTrials.gov ID NCT01849718) comparing Nacadia® NBT (NNBT) with the cognitive–behavioural therapy known as Specialised Treatment for Severe Bodily Distress Syndromes (STreSS). In total, 84 participants were randomly allocated to one of the two treatments. The primary outcome measure was the mean aggregate score on the Psychological General Well-Being Index (PGWBI).ResultsBoth treatments resulted in a significant increase in the PGWBI (primary outcome) and a decrease in burnout (the Shirom–Melamed Burnout Questionnaire, secondary outcome), which were both sustained 12 months later. No significant difference in efficacy was found between NNBT and STreSS for primary outcome and secondary outcomes.ConclusionsThe study showed no statistical evidence of a difference between NNBT and STreSS for treating patients with stress-related illnesses.Declaration of interestNone.

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