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Randomized Trials

RCT | Preliminary evidence for right median nerve stimulation in awakening from acute traumatic coma

30 May, 2023 | 11:36h | UTC

Acute traumatic coma awakening by right median nerve electrical stimulation: a randomised controlled trial – Intensive Care Medicine

 

Commentary on Twitter

 

RCT | Group support and skill-based learning reduce opioid use in chronic pain, but leads to no effect on pain perception

29 May, 2023 | 11:14h | UTC

Reducing Opioid Use for Chronic Pain With a Group-Based Intervention: A Randomized Clinical Trial – JAMA (free for a limited period)

See also: Visual Abstract

News Release: New treatment helps people stop addictive opioid painkillers used for chronic pain – University of Warwick

 

RCT | Communication-priming intervention boosts goals-of-care discussions for seriously ill patients

29 May, 2023 | 11:12h | UTC

Intervention to Promote Communication About Goals of Care for Hospitalized Patients With Serious Illness: A Randomized Clinical Trial – JAMA (free for a limited period)

Editorial: Conversations on Goals of Care With Hospitalized, Seriously Ill Patients – JAMA (free for a limited period)

See also: Visual Abstract

Commentary: Some Surrogate Endpoints Are Fine – By Dr John Mandrola

 

Phase 2 RCT | Peresolimab outperforms placebo in patients with moderate-to-severe rheumatoid arthritis

24 May, 2023 | 13:07h | UTC

A Phase 2 Trial of Peresolimab for Adults with Rheumatoid Arthritis – New England Journal of Medicine (link to abstract – $ for full-text)

Commentary: Peresolimab Demonstrates Efficacy in Treating Patients With Rheumatoid Arthritis – HCP Live

 

Commentary on Twitter

 

Cluster RCT | Single-dose rifapentine reduces 4-year leprosy incidence in household contacts

23 May, 2023 | 13:09h | UTC

Single-Dose Rifapentine in Household Contacts of Patients with Leprosy – New England Journal of Medicine (link to abstract – $ for full-text)

Commentary:

Tuberculosis drug shows protective effect against leprosy – CIDRAP

Study: Giving an antibiotic to household contacts of people with leprosy slashes chances of spread – STAT

 

RCT | Effectiveness of genotype-specific tricyclic antidepressant dosing in patients with major depressive disorder

23 May, 2023 | 12:52h | UTC

Effectiveness of Genotype-Specific Tricyclic Antidepressant Dosing in Patients With Major Depressive Disorder: A Randomized Clinical Trial – JAMA Network Open

 

Commentary on Twitter

 

RCT | No significant differences among three exercise strategies for knee osteoarthritis

23 May, 2023 | 12:38h | UTC

Improving the Effectiveness of Exercise Therapy for Adults with Knee Osteoarthritis: A Pragmatic Randomised Controlled Trial (BEEP trial) – Archives of Rehabilitation Research and Clinical Translation

 

RCT | Remote pulmonary artery monitoring may improve QoL, reduce hospitalizations in symptomatic (NYHA III) heart failure

22 May, 2023 | 13:47h | UTC

Remote haemodynamic monitoring of pulmonary artery pressures in patients with chronic heart failure (MONITOR-HF): a randomised clinical trial – The Lancet (link to abstract – $ for full-text)

News Release: Remote monitoring reduces heart failure hospitalisations and improves quality of life – European Society of Cardiology

Commentary: CardioMEMS Beats Standard Care in First European RCT: MONITOR-HF – TCTMD

 

Commentary on Twitter

 

RCT | Apixaban fails to match warfarin in preventing valve thrombosis in On-X mechanical heart valve patients

22 May, 2023 | 13:44h | UTC

Apixaban or Warfarin in Patients with an On-X Mechanical Aortic Valve – NEJM Evidence

Commentary: Apixaban or Warfarin in Patients With On-X Mechanical Aortic Valve – American College of Cardiology

 

Commentary on Twitter

 

RCT | Ruxolitinib achieves greater molecular response and EFS in hydroxycarbamide-resistant Polycythemia Vera

22 May, 2023 | 13:35h | UTC

Ruxolitinib Versus Best Available Therapy for Polycythemia Vera Intolerant or Resistant to Hydroxycarbamide in a Randomized Trial – Journal of Clinical Oncology

Commentary: Ruxolitinib Appears to Yields Superior Responses in Polycythemia Vera Subtype – Cancer Network

 

RCT | Superior progression-free survival with Venetoclax-based regimens in first-line CLL treatment

22 May, 2023 | 13:32h | UTC

First-Line Venetoclax Combinations in Chronic Lymphocytic Leukemia – New England Journal of Medicine (link to abstract – $ for full-text)

Commentary: First-Line Venetoclax Combinations vs Chemoimmunotherapy in Fit Patients With CLL – The ASCO Post

 

Commentary on Twitter

 

RCT | Once-weekly insulin icodec shows non-inferiority to daily insulin glargine in type 2 diabetes patients

18 May, 2023 | 13:48h | UTC

Switching to once-weekly insulin icodec versus once-daily insulin glargine U100 in individuals with basal-bolus insulin-treated type 2 diabetes (ONWARDS 4): a phase 3a, randomised, open-label, multicentre, treat-to-target, non-inferiority trial – The Lancet (link to abstract – $ for full-text)

 

RCT | The addition of Quizartinib to chemotherapy improves overall survival vs placebo in FLT3-ITD-positive AML patients

18 May, 2023 | 13:40h | UTC

Quizartinib plus chemotherapy in newly diagnosed patients with FLT3-internal-tandem-duplication-positive acute myeloid leukaemia (QuANTUM-First): a randomised, double-blind, placebo-controlled, phase 3 trial – The Lancet (link to abstract – $ for full-text)

 

Commentary on Twitter (thread – click for more)

 

RCT | Cabozantinib addition to nivolumab and ipilimumab extends progression-free survival in renal-cell carcinoma

18 May, 2023 | 13:38h | UTC

Cabozantinib plus Nivolumab and Ipilimumab in Renal-Cell Carcinoma – New England Journal of Medicine (link to abstract – $ for full-text)

Commentary: Cabozantinib in Renal-Cell Carcinoma – NEJM Resident 360

 

Commentary on Twitter

 

Phase 2 RCT | Ropeginterferon shows better results in hematocrit control vs phlebotomy alone in patients withr polycythemia vera

18 May, 2023 | 13:37h | UTC

Ropeginterferon versus Standard Therapy for Low-Risk Patients with Polycythemia Vera – NEJM Evidence

 

Cluster RCT | Early detection and treatment bundle reduces postpartum hemorrhage complications

16 May, 2023 | 15:02h | UTC

Summary: An international, cluster-randomized trial assessed the effectiveness of a multicomponent clinical intervention for postpartum hemorrhage in patients having vaginal delivery. The study involved 80 secondary-level hospitals across Kenya, Nigeria, South Africa, and Tanzania, with 210,132 patients. The intervention group utilized a calibrated blood-collection drape for early detection of postpartum hemorrhage and a first-response treatment bundle, while the control group received usual care.

The primary outcome measured was a composite of severe postpartum hemorrhage (blood loss ≥1000 ml), laparotomy for bleeding, or maternal death from bleeding. The results showed a significant reduction in primary-outcome events in the intervention group (1.6%) compared to the usual-care group (4.3%) with a risk ratio of 0.40 (95% CI, 0.32 to 0.50; P<0.001). Postpartum hemorrhage detection rates were 93.1% and 51.1% in the intervention and usual-care groups, respectively, and treatment bundle adherence was 91.2% and 19.4%, respectively.

These findings demonstrate that early detection of postpartum hemorrhage and the use of a bundled treatment approach can significantly reduce the risk of severe postpartum hemorrhage, laparotomy for bleeding, or death from bleeding among patients having vaginal delivery. The results have important implications for improving clinical practice and reducing postpartum hemorrhage complications globally.

Article: Randomized Trial of Early Detection and Treatment of Postpartum Hemorrhage – New England Journal of Medicine (link to abstract – $ for full-text)

Commentary: Lifesaving solution dramatically reduces severe bleeding after childbirth – World Health Organization

 

Commentary on Twitter

 

RCT | Motixafortide and G-CSF to mobilize hematopoietic stem cells for autologous transplantation in multiple myeloma

16 May, 2023 | 14:48h | UTC

Motixafortide and G-CSF to mobilize hematopoietic stem cells for autologous transplantation in multiple myeloma: a randomized phase 3 trial – Nature Medicine

News Release: Investigational drug may improve stem cell transplantation for multiple myeloma patients – Washington University in St. Louis

 

Commentary on Twitter

 

RCT | Colchicine ineffective for pain relief in hand osteoarthritis patients

16 May, 2023 | 14:42h | UTC

Colchicine twice a day for hand osteoarthritis (COLOR): a double-blind, randomised, placebo-controlled trial – The Lancet Rheumatology (link to abstract – $ for full-text)

Commentary: Colchicine Does Not Relieve OA-Related Hand Pain Compared With Placebo – DocWireNews

 

Commentary on Twitter

 

RCT | Per-oral endoscopic myotomy outperforms pneumatic dilation for post-laparoscopic heller myotomy achalasia

16 May, 2023 | 14:36h | UTC

The Efficacy of Peroral Endoscopic Myotomy vs Pneumatic Dilation as Treatment for Patients With Achalasia Suffering From Persistent or Recurrent Symptoms After Laparoscopic Heller Myotomy: A Randomized Clinical Trial – Gastroenterology

 

RCT | Gefitinib plus chemotherapy vs. Gefitinib alone in untreated EGFR-mutant NSCLC with brain metastases

16 May, 2023 | 14:30h | UTC

Gefitinib Plus Chemotherapy vs Gefitinib Alone in Untreated EGFR-Mutant Non–Small Cell Lung Cancer in Patients With Brain Metastases: The GAP BRAIN Open-Label, Randomized, Multicenter, Phase 3 Study – JAMA Network Open

 

Commentary on Twitter

 

Clinical Trial Update | Pembrolizumab plus chemotherapy in squamous non–small-cell lung cancer

16 May, 2023 | 14:25h | UTC

Pembrolizumab Plus Chemotherapy in Squamous Non–Small-Cell Lung Cancer: 5-Year Update of the Phase III KEYNOTE-407 Study – Journal of Clinical Oncology

Commentaries:

At 5-Year Follow-Up, Benefits of Pembrolizumab on Clinical Outcomes in Squamous NSCLC Maintained – ASCO Daily News

Addition of Pembrolizumab to Chemotherapy in First-Line Treatment of Metastatic Squamous NSCLC: 5-Year Update of KEYNOTE-407 – The ASCO Post

Original Study: Pembrolizumab plus Chemotherapy for Squamous Non–Small-Cell Lung Cancer – New England Journal of Medicine

 

RCT | Bortezomib-Dexamethasone, Rituximab, and Cyclophosphamide for Waldenström’s Macroglobulinemia

16 May, 2023 | 14:24h | UTC

Bortezomib-Dexamethasone, Rituximab, and Cyclophosphamide as First-Line Treatment for Waldenström’s Macroglobulinemia: A Prospectively Randomized Trial of the European Consortium for Waldenström’s Macroglobulinemia – Journal of Clinical Oncology (link to abstract – $ for full-text)

Commentary: Addition of Bortezomib to First-Line Dexamethasone, Rituximab, and Cyclophosphamide for Waldenström’s Macroglobulinemia – The ASCO Post

 

RCT | Interrupted vs. continuous suture technique for biliary-enteric anastomosis

16 May, 2023 | 14:22h | UTC

Interrupted versus continuous suture technique for biliary-enteric anastomosis: randomized clinical trial – BJS Open

 

Commentary on Twitter

 

RCT | Rivaroxaban doesn’t reduce thrombotic events, hospitalization, or death in outpatients with COVID-19

15 May, 2023 | 13:19h | UTC

Summary: The PREVENT-HD trial, a double-blind, placebo-controlled randomized study, was conducted to evaluate the effectiveness of prophylactic anticoagulation in reducing venous and arterial thrombosis, hospitalization, and death in nonhospitalized patients with symptomatic COVID-19 and at least one thrombosis risk factor. The trial took place between August 2020 and April 2022 across 14 US integrated healthcare delivery networks, with 1,284 patients enrolled and randomly assigned to receive either 10 mg of oral rivaroxaban or placebo daily for 35 days.

However, the study was terminated prematurely due to enrollment challenges and lower-than-expected event rates. The primary efficacy outcome, a composite of various hazardous events, occurred in 3.4% of the rivaroxaban group and 3.0% of the placebo group, with no significant difference between the two groups (hazard ratio, 1.16 [95% CI, 0.63–2.15]; P=0.63). No critical-site or fatal bleeding was observed, and only one patient in the rivaroxaban group experienced a major bleed.

In conclusion, rivaroxaban prescribed for 35 days in nonhospitalized patients with symptomatic COVID-19 at risk for thrombosis does not appear to reduce the composite end point of venous and arterial thrombotic events, hospitalization, and death. The study’s premature termination and lower-than-expected event rates may limit the generalizability of these findings.

Article: Rivaroxaban for Prevention of Thrombotic Events, Hospitalization, and Death in Outpatients With COVID-19: A Randomized Clinical Trial – Circulation

 

Commentary on Twitter

 

RCT | Cognitive behavioral therapy proves effective for severe post-COVID-19 fatigue

15 May, 2023 | 13:16h | UTC

Efficacy of cognitive behavioral therapy targeting severe fatigue following COVID-19: results of a randomized controlled trial – Clinical Infectious Diseases

News Release: Cognitive behavioral therapy lessens post-viral fatigue after COVID-19 – Amsterdam UMC

 

Commentary on Twitter

 

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