Randomised controlled trial of tetanus treatment with antitetanus immunoglobulin by the intrathecal or intramuscular route

AbstractObjective To evaluate the effect of intrathecal therapy with human antitetanus immunoglobulin on clinical progression of and mortality from tetanus.Design Randomised controlled trial.Setting Intensive care unit of a university hospital, Pernambuco, Brazil.Participants 120 patients with tetanus allocated to antitetanus immunoglobulin by either the intrathecal and intramuscular route (n = 58) or the intramuscular route (n = 62; control group).Main outcome measures Clinical progression of disease, duration of hospital stay, duration of occurrence of spasms, complications, respiratory infection, respiratory failure or mechanical ventilation, duration of respiratory assistance, and mortality.Results Patients in the treatment group showed a better clinical progression than those in the control group (χ2 for trend 7.752, P = 0.005; difference in proportion of patients with improvement 20%, 95% confidence interval 4% to 35%). The duration of occurrence of spasms, hospital stay, and respiratory assistance were all shorter in patients the treatment group: respectively, 14.96, 0.0001 (difference in proportion of patients with spasms lasting ≤ 10 days 36%, 18% to 55%); 4.56, 0.03; and 6.56, 0.01 (proportion of patients who needed assistance for ≤ 10 days 69.2% in the treatment group and 30.8% in the control group (difference 38%, 12% to 65%)).Conclusion Patients treated with antitetanus immunoglobulin by the intrathecal route show better clinical progression than those treated by the intramuscular route.

Download Full-text

Clinical effects of high-intensity laser therapy on patients with chronic refractory wounds: a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-045866 ◽

2021 ◽

Vol 11 (7) ◽

pp. e045866

Author(s):

Qian Lu ◽

Zhifei Yin ◽

Xuefeng Shen ◽

Jinhua Li ◽

Panpan Su ◽

...

Keyword(s):

Treatment Group ◽

Randomised Controlled Trial ◽

High Intensity ◽

Wound Dressing ◽

Wound Care ◽

Controlled Trial ◽

Control Group ◽

High Intensity Laser ◽

Randomised Controlled ◽

Intensity Laser

ObjectiveTo investigate the effectiveness of high-intensity laser therapy (HILT) on chronic refractory wounds.DesignRandomised controlled trial.SettingThe outpatient wound care department of the Affiliated Jiangsu Shengze Hospital of Nanjing Medical University from August 2019 to June 2020.ParticipantsSixty patients were enrolled in this study and were randomised into control (n=30) and treatment (n=30) groups.Interventions and outcome measuresThe control group was treated only with conventional wound dressing, whereas the treatment group received irradiation with HILT in addition to standard wound care, such as debridement, wound irrigation with normal saline solution and application of dressing and sterile gauze. Patient scores on the Bates-Jensen Wound Assessment Tool (BWAT) and Pressure Ulcer Scale for Healing (PUSH) were evaluated before and after 1, 2 and 3 weeks of treatment.ResultsOne patient was excluded from the control group, and a total of 59 subjects completed the trial. The BWAT scores significantly decreased in the treatment group compared with the control group at the end of 3-week treatment (difference=−3.6; 95% CI −6.3 to–0.8; p<0.01). Similarly, patients in treatment group showed a significant reduction of PUSH scores compared with the control group (difference=−5.3; 95% CI −8.1 to –2.6; p<0.01).ConclusionsThe therapeutic effects of HILT on chronic refractory wounds are significant and far more superior to those of conventional wound dressing.Trial registration numberChinese Clinical Trial Registry; ChiCTR1900023157. URL: http://www.chictr.org.cn/showproj.aspx?proj=38866

Download Full-text

Hyperbaric oxygen as an adjuvant treatment for patients with COVID-19 severe hypoxaemia: a randomised controlled trial

Emergency Medicine Journal ◽

10.1136/emermed-2021-211253 ◽

2021 ◽

pp. emermed-2021-211253

Author(s):

Mariana Cannellotto ◽

Mariano Duarte ◽

Guillermo Keller ◽

Ramiro Larrea ◽

Eleonora Cunto ◽

...

Keyword(s):

Acute Respiratory Distress Syndrome ◽

Treatment Group ◽

Randomised Controlled Trial ◽

Interim Analysis ◽

Distress Syndrome ◽

Controlled Trial ◽

Control Group ◽

Safety And Efficacy ◽

Severe Hypoxaemia ◽

Randomised Controlled

BackgroundHyperbaric oxygen (HBO2) therapy has been proposed to treat hypoxaemia and reduce inflammation in COVID-19. Our objective was to analyse safety and efficacy of HBO2 in treatment of hypoxaemia in patients with COVID-19 and evaluate time to hypoxaemia correction.MethodsThis was a multicentre, open-label randomised controlled trial conducted in Buenos Aires, Argentina, between July and November 2020. Patients with COVID-19 and severe hypoxaemia (SpO2 ≤90% despite oxygen supplementation) were assigned to receive either HBO2 treatment or the standard treatment for respiratory symptoms for 7 days. HBO2 treatment was planned for ≥5 sessions (1 /day) for 90 min at 1.45 atmosphere absolute (ATA). Outcomes were time to normalise oxygen requirement to SpO2 ≥93%, need for mechanical respiratory assistance, development of acute respiratory distress syndrome and mortality within 30 days. A sample size of 80 patients was estimated, with a planned interim analysis after determining outcomes on 50% of patients.ResultsThe trial was stopped after the interim analysis. 40 patients were randomised, 20 in each group, age was 55.2±9.2 years. At admission, frequent symptoms were dyspnoea, fever and odynophagia; SpO2 was 85.1%±4.3% for the whole group. Patients in the treatment group received an average of 6.2±1.2 HBO2 sessions. Time to correct hypoxaemia was shorter in treatment group versus control group; median 3 days (IQR 1.0–4.5) versus median 9 days (IQR 5.5–12.5), respectively (p<0.010). OR for recovery from hypoxaemia in the HBO2 group at day 3 compared with the control group was 23.2 (95% CI 1.6 to 329.6; p=0.001) Treatment had no statistically significant effect on acute respiratory distress syndrome, mechanical ventilation or death within 30 days after admission.ConclusionOur findings support the safety and efficacy of HBO2 in the treatment of COVID-19 and severe hypoxaemia.Trial registration numberNCT04477954.

Download Full-text

Diet and anthropometry at 2 years of age following an oral health promotion programme for Australian Aboriginal children and their carers: a randomised controlled trial

British Journal Of Nutrition ◽

10.1017/s000711451700318x ◽

2017 ◽

Vol 118 (12) ◽

pp. 1061-1069 ◽

Cited By ~ 5

Author(s):

Lisa G. Smithers ◽

John Lynch ◽

Joanne Hedges ◽

Lisa M. Jamieson

Keyword(s):

Health Promotion ◽

Oral Health ◽

Treatment Group ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Control Group ◽

Culturally Appropriate ◽

Oral Health Promotion ◽

Randomised Controlled ◽

Aboriginal Children

AbstractThere are marked disparities between indigenous and non-indigenous children’s diets and oral health. Both diet and oral health are linked to longer-term health problems. We aimed to investigate whether a culturally appropriate multi-faceted oral health promotion intervention reduced Aboriginal children’s intake of sugars from discretionary foods at 2 years of age. We conducted a single-blind, parallel-arm randomised controlled trial involving women who were pregnant or had given birth to an Aboriginal child in the previous 6 weeks. The treatment group received anticipatory guidance, Motivational Interviewing, health and dental care for mothers during pregnancy and children at 6, 12 and 18 months. The control group received usual care. The key dietary outcome was the percent energy intake from sugars in discretionary foods (%EI), collected from up to three 24-h dietary recalls by trained research officers who were blind to intervention group. Secondary outcomes included intake of macronutrients, food groups, anthropometric z scores (weight, height, BMI and mid-upper arm circumference) and blood pressure. We enrolled 224 children to the treatment group and 230 to the control group. Intention-to-treat analyses showed that the %EI of sugars in discretionary foods was 1·6 % lower in the treatment group compared with control (95 % CI −3·4, 0·2). This culturally appropriate intervention at four time-points from pregnancy to 18 months resulted in small changes to 2-year-old Aboriginal children’s diets, which was insufficient to warrant broader implementation of the intervention. Further consultation with Aboriginal communities is necessary for understanding how to improve the diet and diet-related health outcomes of young Aboriginal children.

Download Full-text

Effectiveness of a novel, automated telephone intervention on time to hospitalisation in patients with COPD: A randomised controlled trial

Journal of Telemedicine and Telecare ◽

10.1177/1357633x18800211 ◽

2018 ◽

Vol 26 (3) ◽

pp. 132-139

Author(s):

Eric Sink ◽

Kunjan Patel ◽

Jacob Groenendyk ◽

Robert Peters ◽

Avik Som ◽

...

Keyword(s):

Treatment Group ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Primary Care Clinic ◽

Automated System ◽

Control Group ◽

Number Needed To Treat ◽

Care Clinic ◽

Patient Reported ◽

Randomised Controlled

Introduction Owing to its capacity to perform remote assessments, telemedicine is rising as a new force in chronic obstructive pulmonary disease (COPD) management. We conducted an eight month randomised-controlled-trial to study the effect of an automated telemedicine intervention on patients’ time-to-hospitalisation. Methods A total of 168 patients with a diagnosis of COPD in the past 24 months were enrolled to receive the intervention at a primary care clinic. The treatment group received daily phone messages from an automated system asking them to report if they were breathing better than, worse than, or the same as the day prior. Patients reported their breathing status by responding to the text message or call. If a patient reported breathing worse, an alert was sent directly to that patient’s provider within the clinic. The control group received the same daily phone messages as the treatment group. However, no proactive breathing alerts were ever generated to the provider for these subjects. The primary outcome was the subjects’ time-to-first-COPD-related hospitalisation following the start of messages. Results The treatment group’s time-to-hospitalisation was significantly different than the control group’s with a hazard ratio of 2.36 (95% confidence interval 1.02–5.45, p = 0.0443). The number needed-to-treat ratio was 8.62. Subject engagement consistently ranged between 60% and 75%. The treatment group received both proactive monitoring and follow-up care from the providers. Discussion Active monitoring with provider feedback enables the detection of exacerbation events early enough for subjects to avoid admissions. The use of non-smartphone interventions reduces barriers to care presented by more complicated and expensive technologies. This intervention represents a simple, innovative, and inexpensive tool for improved COPD management.

Download Full-text

A double-blind randomised controlled trial on the effect of Tocovid, a tocotrienol-rich capsule on postoperative atrial fibrillation at the National Heart Institute, Kuala Lumpur: an interim blinded analysis

Journal of Cardiothoracic Surgery ◽

10.1186/s13019-021-01721-6 ◽

2021 ◽

Vol 16 (1) ◽

Author(s):

Ahmad Farouk Musa ◽

Jeswant Dillon ◽

Mohamed Ezani Md Taib ◽

Alwi Mohamed Yunus ◽

Abdul Rais Sanusi ◽

...

Keyword(s):

Atrial Fibrillation ◽

Randomised Controlled Trial ◽

Hospital Stay ◽

Controlled Trial ◽

Control Group ◽

Inflammatory Agent ◽

Significant Difference ◽

The Mean ◽

Anti Inflammatory ◽

Randomised Controlled

Abstract Introduction Post-operative atrial fibrillation (POAF) is associated with poorer outcomes, increased resource utilisation, morbidity and mortality. Its pathogenesis is initiated by systemic inflammation and oxidative stress. It is hypothesised that a potent antioxidant and anti-inflammatory agent such as tocotrienol, an isomer of Vitamin E, could reduce or prevent POAF. Aims The aim of this study is to determine whether a potent antioxidative and anti-inflammatory agent, Tocovid, a tocotrienol-rich capsule, could reduce the incidence of POAF and affect the mortality and morbidity as well as the duration of ICU, HDU and hospital stay. Methods This study was planned as a prospective, randomised, controlled trial with parallel groups. The control group received placebo containing palm superolein while the treatment group received Tocovid capsules. We investigated the incidence of POAF, the length of hospital stay after surgery and the health-related quality of life. Results Recruitment commenced in January 2019 but the preliminary results were unblinded as the study is still ongoing. Two-hundred and two patients have been recruited out of a target sample size of 250 as of January 2021. About 75% have completed the study and 6.4% were either lost during follow-up or withdrew; 4% of participants died. The mean age group was 61.44 ± 7.30 years with no statistical difference between the groups, with males having a preponderance for AF. The incidence of POAF was 24.36% and the mean time for developing POAF was 55.38 ± 29.9 h post-CABG. Obesity was not a predictive factor. No statistically significant difference was observed when comparing left atrial size, NYHA class, ejection fraction and the premorbid history. The mean cross-clamp time was 71 ± 34 min and the mean bypass time was 95 ± 46 min, with no difference between groups. There was a threefold increase in death among patients with POAF (p = 0.008) and an increase in the duration of ICU stay (p = 0.01), the total duration of hospital stay (p = 0.04) and reintubation (p = 0.045). Conclusion A relatively low incidence rate of POAF was noted although the study is still ongoing. It remains to be seen if our prophylactic intervention using Tocovid would effectively reduce the incidence of POAF. Clinical Registration Number: US National Library of Medicine. Clinical Trials - NCT03807037. Registered on 16th January 2019. Link: https://clinicaltrials.gov/ct2/show/NCT03807037

Download Full-text

Tenofovir alafenamide fumarate therapy in subjects with positive HBV-DNA and normal levels of alanine transaminase: a study protocol for a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-048410 ◽

2021 ◽

Vol 11 (8) ◽

pp. e048410

Author(s):

Lu Wang ◽

Lina Wu ◽

Xuejun Li ◽

Ying Zhang ◽

Jing Lai ◽

...

Keyword(s):

Treatment Group ◽

Randomised Controlled Trial ◽

Hepatitis B ◽

Study Protocol ◽

Controlled Trial ◽

Hbv Dna ◽

Alanine Transaminase ◽

Control Group ◽

Tenofovir Alafenamide ◽

Randomised Controlled

IntroductionThe current clinical guidelines do not recommend antiviral therapy for subjects with positive hepatitis B virus (HBV)-DNA and normal alanine transaminase (ALT). In this study, we will assess the safety and efficacy of tenofovir alafenamide fumarate (TAF) in the treatment of adults with positive HBV-DNA and normal ALT, including long-term prognosis.Methods and analysisThis study is a non-double-blind randomised controlled trial. Study participants will be randomised into the treatment group and the control group. In the treatment group, subjects will receive TAF monotherapy, while those in the control group will receive no antiviral treatment. Subjects will be followed up at the beginning of the study and every 12 or 24 weeks thereafter for review of laboratory findings and to record adverse events. The primary endpoint is the proportion of patients with serum hepatitis B surface antigen loss.Ethics and disseminationThis study protocol was approved by the Ethics Committee of the Third Affiliated Hospital of Sun Yat-Sen University for Human Study (reference number [2019]02-599-01). The results of this study will be submitted for publication in a peer-reviewed journal.Trial registration numberNCT04231565.

Download Full-text

Comparison of the effects of intravenous propofol and inhalational desflurane on the quality of early recovery after hand-assisted laparoscopic donor nephrectomy: a prospective, randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-039881 ◽

2020 ◽

Vol 10 (12) ◽

pp. e039881

Author(s):

Jaesik Park ◽

Minhee Kim ◽

Yong Hyun Park ◽

Jung-Woo Shim ◽

Hyung Mook Lee ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Hospital Stay ◽

Controlled Trial ◽

Early Recovery ◽

Total Hospital ◽

Kidney Donors ◽

Living Kidney Donors ◽

Total Hospital Stay ◽

Randomised Controlled

ObjectivesWe compared early recovery outcomes between living kidney donors who received total intravenous (IV) propofol versus inhalational desflurane during hand-assisted laparoscopic nephrectomy.DesignA single-centre, prospective randomised controlled trial.SettingUniversity hospital.ParticipantsStudy participants were enrolled between October 2019 and February 2020. A total of 80 living donors were randomly assigned to an intravenous propofol group (n=40) or a desflurane group (n=40).InterventionPropofol group received intravenous propofol and desflurane group received desflurane, as a maintenance anaesthetic.Primary and secondary outcome measuresThe quality of postoperative functional recovery was primarily assessed using the Korean version of the Quality of Recovery-40 (QoR-40K) questionnaire on postoperative day 1. Secondarily, ambulation, pain score, rescue analgesics, complications and total hospital stay were assessed postoperatively.ResultsOur study population included 35 males and 45 females. The mean age was 46±13 years. The global QoR-40K score (161 (154–173) vs 152 (136–161) points, respectively, p=0.001) and all five subdimension scores (physical comfort, 49 (45–53) vs 45 (42–48) points, respectively, p=0.003; emotional state, 39 (37–41) vs 37 (33–41) points, respectively, p=0.005; psychological support, 30 (26–34) vs 28 (26–32) points, respectively, p=0.04; physical independence, 16 (11–18) vs 12 (8-14) points, respectively, p=0.004; and pain, 31 (28–33) vs 29 (25-31) points, respectively, p=0.021) were significantly higher in the intravenous propofol group than the desflurane group. The early ambulation success rate and numbers of early and total steps were higher, but the incidence of nausea/vomiting was lower, in the intravenous propofol group than the desflurane group. The total hospital stay after surgery was shorter in the intravenous propofol group than the desflurane group.ConclusionsIntravenous propofol may enhance the quality of postoperative recovery in comparison to desflurane in living kidney donors.Trial registration numberKCT0004365.

Download Full-text

Supported progressive resistance exercise training to counter the adverse side effects of robot-assisted radical prostatectomy: a randomised controlled trial

Supportive Care in Cancer ◽

10.1007/s00520-021-06002-5 ◽

2021 ◽

Author(s):

Ruth E. Ashton ◽

Jonathan J. Aning ◽

Garry A. Tew ◽

Wendy A Robson ◽

John M Saxton

Keyword(s):

Randomised Controlled Trial ◽

Radical Prostatectomy ◽

Muscular Strength ◽

Controlled Trial ◽

Control Group ◽

Robot Assisted ◽

Resistance Exercise Training ◽

Home Based ◽

Aerobic Exercise Capacity ◽

Randomised Controlled

Abstract Purpose To investigate the effects of a supported home-based progressive resistance exercise training (RET) programme on indices of cardiovascular health, muscular strength and health-related quality of life (HR-QoL) in prostate cancer (PCa) patients after treatment with robot-assisted radical prostatectomy (RARP). Methods This study was a single-site, two-arm randomised controlled trial, with 40 participants randomised to either the intervention or control group over a 10-month period. In addition to receiving usual care, the intervention group completed three weekly RET sessions using resistance bands for 6 months. Participants performed 3 sets of 12–15 repetitions for each exercise, targeting each major muscle group. The control group received usual care only. Brachial artery flow-mediated dilatation (FMD) was the primary outcome and assessed at baseline, 3 and 6 months. Secondary outcomes included body weight, body fat, aerobic fitness, strength and blood-borne biomarkers associated with cardiometabolic risk. Results There was no significant difference between the groups in FMD at 3 or 6 months. However, there were improvements in aerobic exercise capacity (P < 0.01) and upper- (P < 0.01) and lower-limb (P = 0.01) strength in favour of the RET group at 6 months, accompanied by greater weight loss (P = 0.04) and a reduction in body fat (P = 0.02). Improvements in HRQoL were evident in the RET group at 3 and 6 months via the PCa-specific component of the FACT-P questionnaire (both P < 0.01). Five adverse events and one serious adverse event were reported throughout the trial duration. Conclusion This study demonstrates that home-based RET is an effective and safe mode of exercise that elicits beneficial effects on aerobic exercise capacity, muscular strength and HR-QoL in men who have undergone RARP. Trial registration ISRCTN10490647.

Download Full-text

Nurse-based secondary preventive follow-up by telephone reduced recurrence of cardiovascular events: a randomised controlled trial

Scientific Reports ◽

10.1038/s41598-021-94892-0 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Anna-Lotta Irewall ◽

Anders Ulvenstam ◽

Anna Graipe ◽

Joachim Ögren ◽

Thomas Mooe

Keyword(s):

Randomised Controlled Trial ◽

Primary Endpoint ◽

Cardiovascular Events ◽

Controlled Trial ◽

Control Group ◽

Coronary Syndrome ◽

Secondary Endpoints ◽

Randomised Controlled

AbstractEnhanced follow-up is needed to improve the results of secondary preventive care in patients with established cardiovascular disease. We examined the effect of long-term, nurse-based, secondary preventive follow-up by telephone on the recurrence of cardiovascular events. Open, randomised, controlled trial with two parallel groups. Between 1 January 2010 and 31 December 2014, consecutive patients (n = 1890) admitted to hospital due to stroke, transient ischaemic attack (TIA), or acute coronary syndrome (ACS) were included. Participants were randomised (1:1) to nurse-based telephone follow-up (intervention, n = 944) or usual care (control, n = 946) and followed until 31 December 2017. The primary endpoint was a composite of stroke, myocardial infarction, cardiac revascularisation, and cardiovascular death. The individual components of the primary endpoint, TIA, and all-cause mortality were analysed as secondary endpoints. The assessment of outcome events was blinded to study group assignment. After a mean follow-up of 4.5 years, 22.7% (n = 214) of patients in the intervention group and 27.1% (n = 256) in the control group reached the primary composite endpoint (HR 0.81, 95% CI 0.68–0.97; ARR 4.4%, 95% CI 0.5–8.3). Secondary endpoints did not differ significantly between groups. Nurse-based secondary preventive follow-up by telephone reduced the recurrence of cardiovascular events during long-term follow-up.

Download Full-text

A Short Mindfulness Retreat for Students to Reduce Stress and Promote Self-Compassion: Pilot Randomised Controlled Trial Exploring Both an Indoor and a Natural Outdoor Retreat Setting

Healthcare ◽

10.3390/healthcare9070910 ◽

2021 ◽

Vol 9 (7) ◽

pp. 910

Author(s):

Dorthe Djernis ◽

Mia S. O’Toole ◽

Lone O. Fjorback ◽

Helle Svenningsen ◽

Mimi Y. Mehlsen ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Controlled Trial ◽

Effect Sizes ◽

Medium Effect ◽

Control Group ◽

Post Intervention ◽

Pilot Randomised Controlled Trial ◽

Self Compassion ◽

Randomised Controlled

Here, we developed and examined a new way of disseminating mindfulness in nature to people without meditation experience, based on the finding that mindfulness conducted in natural settings may have added benefits. We evaluated a 5-day residential programme aiming to reduce stress and improve mental health outcomes. We compared an indoor and an outdoor version of the programme to a control group in a pilot randomised controlled trial (RCT). Sixty Danish university students experiencing moderate to high levels of stress were randomised into a residential mindfulness programme indoors (n = 20), in nature (n = 22), or a control group (n = 18). Participants completed the Perceived Stress Scale and the Self-Compassion Scale (primary outcomes) along with additional secondary outcome measures at the start and end of the program and 3 months after. Stress was decreased with small to medium effect sizes post-intervention, although not statistically significant. Self-compassion increased post-intervention, but effect sizes were small and not significant. At follow-up, changes in stress were not significant, however self-compassion increased for both interventions with medium-sized effects. For the intervention groups, medium- to large-sized positive effects on trait mindfulness after a behavioural task were found post-intervention, and small- to medium-sized effects in self-reported mindfulness were seen at follow-up. Connectedness to Nature was the only outcome measure with an incremental effect in nature, exceeding the control with a medium-sized effect at follow-up. All participants in the nature arm completed the intervention, and so did 97% of the participants in all three arms. Overall, the results encourage the conduct of a larger-scale RCT, but only after adjusting some elements of the programme to better fit and take advantage of the potential benefits of the natural environment.

Download Full-text