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Randomized Trials

RCT | Baricitinib + topical corticosteroids effective in kids with moderate-severe atopic dermatitis

4 Apr, 2023 | 13:39h | UTC

Efficacy and safety of baricitinib in combination with topical corticosteroids in pediatric patients with moderate-to-severe atopic dermatitis with inadequate response to topical corticosteroids: results from a phase 3, randomized, double-blind, placebo-controlled study (BREEZE-AD PEDS) – British Journal of Dermatology

 

RCT | Comparable efficacy of cefotaxime, ceftriaxone, and ciprofloxacin in treating spontaneous bacterial peritonitis

3 Apr, 2023 | 14:01h | UTC

Summary: This multicenter, prospective, open-label, randomized controlled trial compared the efficacy of cefotaxime, ceftriaxone, and ciprofloxacin as initial treatments for spontaneous bacterial peritonitis (SBP) in patients with cirrhosis and ascites. The study included 261 patients aged 16 to 75, with liver cirrhosis, ascites, and a polymorphonuclear cell count of >250/mm3. Researchers performed follow-up paracentesis at 48 hours to evaluate the assigned antibiotics, and assessed resolution rates at 120 and 168 hours of treatment.

The primary endpoint, resolution rates at 120 hours, showed no statistically significant difference between the groups: 67.8% for cefotaxime, 77.0% for ceftriaxone, and 73.6% for ciprofloxacin. One-month mortality rates were also similar. The study concluded that these antibiotics are equally effective as initial treatments for SBP, particularly for community-acquired infections, when administered based on response-guided therapy.

Article: Response-Guided Therapy With Cefotaxime, Ceftriaxone, or Ciprofloxacin for Spontaneous Bacterial Peritonitis: A Randomized Trial: A Validation Study of 2021 AASLD Practice Guidance for SBP – American Journal of Gastroenterology (free for a limited period)

 

RCT | Vedolizumab for the treatment of chronic pouchitis

3 Apr, 2023 | 13:49h | UTC

Vedolizumab for the Treatment of Chronic Pouchitis – New England Journal of Medicine (link to abstract – $ for full-text)

News Release: New hope for patients after vedolizumab found effective to treat Chronic Pouchitis – University of Oxford

 

Commentary on Twitter

 

RCT | Pembrolizumab plus chemotherapy in advanced endometrial cancer

3 Apr, 2023 | 13:48h | UTC

Pembrolizumab plus Chemotherapy in Advanced Endometrial Cancer – New England Journal of Medicine (link to abstract – $ for full-text)

News Release: Adding Pembrolizumab to Standard Chemotherapy, Followed by Pembrolizumab Maintenance, Results in Longer PFS in Patients with Advanced or Recurrent Endometrial Cancer – ESMO

 

Commentary on Twitter

 

RCT | Dostarlimab for primary advanced or recurrent endometrial cancer

3 Apr, 2023 | 13:46h | UTC

Dostarlimab for Primary Advanced or Recurrent Endometrial Cancer – New England Journal of Medicine (link to abstract – $ for full-text)

Commentary:

RUBY Trial: Dostarlimab Plus Carboplatin and Paclitaxel in Advanced Endometrial Cancer – The ASCO Post

Dostarlimab Plus Chemotherapy Elicits PFS Benefit in Recurrent Endometrial Cancer – OncLive

 

RCTs | Fitusiran prophylaxis reduces bleeding in people with hemophilia A or hemophilia B

3 Apr, 2023 | 13:44h | UTC

Efficacy and safety of fitusiran prophylaxis in people with haemophilia A or haemophilia B with inhibitors (ATLAS-INH): a multicentre, open-label, randomised phase 3 trial – The Lancet (link to abstract – $ for full-text)

Fitusiran prophylaxis in people with severe haemophilia A or haemophilia B without inhibitors (ATLAS-A/B): a multicentre, open-label, randomised, phase 3 trial – The Lancet Haematology (link to abstract – $ for full-text)

News Release: Monthly injections of fitusiran reduces bleeds in patients with haemophilia A and B – The Lancet

 

RCT | Sparsentan reduces proteinuria in patients with IgA nephropathy

3 Apr, 2023 | 13:35h | UTC

Sparsentan in patients with IgA nephropathy: a prespecified interim analysis from a randomised, double-blind, active-controlled clinical trial – The Lancet (link to abstract – $ for full-text)

 

Commentary on Twitter

 

RCT | Early postpartum IUD placement noninferior vs. placement at 6-8 weeks for complete expulsion, but not for partial expulsion

31 Mar, 2023 | 13:48h | UTC

Early vs Interval Postpartum Intrauterine Device Placement: A Randomized Clinical Trial – JAMA (link to abstract – $ for full-text)

News Release: Study: Risk of IUD Expulsion in Early Postpartum Placement – UC San Diego Health

Commentary: IUD Placement at Two to Four Weeks Postpartum Noninferior – HealthDay

Related:

SR | Immediate versus delayed postpartum insertion of contraceptive implant and IUD for contraception.

Placement of an intrauterine device within 48 hours after early medical abortion – a randomized controlled trial – American Journal of Obstetrics & Gynecology

 

Commentary on Twitter

 

RCT | Pulsed oral azithromycin vs. 6-week oral doxycycline for moderate to severe meibomian gland dysfunction

31 Mar, 2023 | 13:33h | UTC

Pulsed Oral Azithromycin vs 6-Week Oral Doxycycline for Moderate to Severe Meibomian Gland Dysfunction: A Randomized Clinical Trial – JAMA Ophthalmology (link to abstract – $ for full-text)

Commentary: 3-Week MGD treatment equivalent to 6-week course in efficacy and adverse events – Ophthalmology Times

 

Commentary on Twitter

 

RCT | Efficacy and safety of garadacimab, a factor XIIa inhibitor for hereditary angioedema prevention

31 Mar, 2023 | 13:26h | UTC

Efficacy and safety of garadacimab, a factor XIIa inhibitor for hereditary angioedema prevention (VANGUARD): a global, multicentre, randomised, double-blind, placebo-controlled, phase 3 trial – The Lancet (link to abstract – $ for full-text)

 

Commentary on Twitter (thread – click for more)

 

RCT | Zavegepant 10 mg nasal spray vs. placebo for the acute treatment of migraine

31 Mar, 2023 | 13:24h | UTC

Safety, tolerability, and efficacy of zavegepant 10 mg nasal spray for the acute treatment of migraine in the USA: a phase 3, double-blind, randomised, placebo-controlled multicentre trial – The Lancet Neurology (link to abstract – $ for full-text)

 

2ry analysis of a RCT | Vitamin D supplementation does not affect cognitive function in older adults

30 Mar, 2023 | 14:14h | UTC

Vitamin D supplementation and cognition—Results from analyses of the D-Health trial – Journal of the American Geriatrics Society (link to abstract – $ for full-text)

Original Study: RCT: Oral Vitamin D supplementation (60.000 IU per month) did not reduce mortality in patients 60 years or older (unscreened individuals in Australia, many without insufficiency, average 30ng/mL). Exploratory analyses pointed towards an increased risk of death from cancer.

Related:

Randomized Trial: Vitamin D Supplements and Prevention of Cancer and Cardiovascular Disease

Meta-Analysis: Vitamin D Not Effective for Cardiovascular Disease Prevention

Association between vitamin D supplementation and mortality: systematic review and meta-analysis – The BMJ

USPSTF Draft Statement: Insufficient evidence to recommend multivitamin supplements for the prevention of CVD or cancer. The statement also recommends against the use of beta-carotene (increases risk of CVD mortality and lung cancer) or vitamin E (clear evidence of no benefit)

Vitamin D, calcium, other vitamins, and supplements do not prevent cardiovascular diseases

Research: Circulating vitamin D concentration and risk of seven cancers

Research: Vitamin D and risk of total and site specific cancers

 

RCT | Ganitumab added to chemotherapy did not improve outcomes in patients with metastatic Ewing sarcoma

30 Mar, 2023 | 14:16h | UTC

Randomized Phase III Trial of Ganitumab With Interval-Compressed Chemotherapy for Patients With Newly Diagnosed Metastatic Ewing Sarcoma: A Report From the Children’s Oncology Group – Journal of Clinical Oncology (link to abstract – $ for full-text)

Commentary: Ganitumab Provides No Benefit in Metastatic Ewing Sarcoma – Cancer Therapy Advisor

 

RCT | Hydroxychloroquine in children with proliferative lupus nephritis

30 Mar, 2023 | 14:11h | UTC

Hydroxychloroquine in children with proliferative lupus nephritis: a randomized clinical trial – European Journal of Pediatrics

 

RCT | Efficacy and safety of colesevelam for the treatment of bile acid diarrhea

30 Mar, 2023 | 14:06h | UTC

Efficacy and safety of colesevelam for the treatment of bile acid diarrhoea: a double-blind, randomised, placebo-controlled, phase 4 clinical trial – The Lancet Gastroenterology & Hepatology (link to abstract – $ for full-text)

 

Commentary on Twitter

 

Phase 2b RCT | Efficacy and safety of PL-5 (Peceleganan) spray for wound infections

27 Mar, 2023 | 13:08h | UTC

Efficacy and Safety of PL-5 (Peceleganan) Spray for Wound Infections: A Phase IIb Randomized Clinical Trial – Annals of Surgery

 

RCT | No reduction in parastomal hernia rate 3 years after stoma construction with prophylactic Mesh

27 Mar, 2023 | 13:07h | UTC

No Reduction in Parastomal Hernia Rate 3 Years After Stoma Construction With Prophylactic Mesh: Three-year Follow-up Results From STOMAMESH—A Multicenter Double-blind Randomized Controlled Trial – Annals of Surgery

 

RCT | Topical lidocaine or lidocaine/diltiazem ointment following rubber band ligation of hemorrhoids

27 Mar, 2023 | 13:05h | UTC

Topical Lidocaine or Lidocaine/Diltiazem Ointment Following Rubber Band Ligation of Hemorrhoids: A Prospective Three-Armed Randomized Controlled Trial – Diseases of the Colon & Rectum (link to abstract – $ for full-text)

 

Trends of randomized clinical trials citing prior systematic reviews, 2007-2021

27 Mar, 2023 | 12:56h | UTC

Trends of Randomized Clinical Trials Citing Prior Systematic Reviews, 2007-2021 – JAMA Network Open

Invited Commentary: Should a Systematic Review Be Required in a Clinical Trial Report? Perhaps, But Not Yet – JAMA Network Open

 

Commentary on Twitter

 

RCT | Safety and efficacy of pitolisant in children aged 6 years or older with narcolepsy with or without cataplexy

23 Mar, 2023 | 12:44h | UTC

Safety and efficacy of pitolisant in children aged 6 years or older with narcolepsy with or without cataplexy: a double-blind, randomised, placebo-controlled trial – The Lancet Neurology (link to abstract – $ for full-text)

 

RCT | Hydrocortisone reduces mortality in severe community-acquired pneumonia

22 Mar, 2023 | 13:44h | UTC

Summary: Practice-changing! In a phase 3, multicenter, double-blind, randomized controlled trial involving 800 patients with severe community-acquired pneumonia admitted to the ICU, hydrocortisone treatment was found to reduce the risk of death by day 28 compared to a placebo group. The hydrocortisone group had a 6.2% death rate, while the placebo group had an 11.9% death rate.

Hydrocortisone also led to fewer endotracheal intubations among patients not on mechanical ventilation at baseline and reduced the need for vasopressor therapy in patients not receiving it at baseline. There was no significant difference in hospital-acquired infections or gastrointestinal bleeding between the two groups, but patients in the hydrocortisone group required higher daily doses of insulin during the first week of treatment.

Article: Hydrocortisone in Severe Community-Acquired Pneumonia – New England Journal of Medicine (link to abstract – $ for full-text)

Commentary: Steroid drug reduces death rate in severe pneumonia, study shows – STAT

 

Commentary on Twitter

 

RCT | Low-calorie, low-protein feeding improves recovery time in ventilated adults with shock

22 Mar, 2023 | 13:42h | UTC

Summary: The NUTRIREA-3 study aimed to determine the optimal calorie and protein intakes during the acute phase of severe critical illness. The study was a randomized, controlled, multicenter, open-label, parallel-group trial conducted in 61 French intensive care units (ICUs) involving 3044 adults receiving invasive mechanical ventilation and vasopressor support for shock. During the first seven ICU days, participants were randomly assigned to early nutrition with either low or standard calorie and protein targets. The primary endpoints were time to readiness for ICU discharge and day 90 all-cause mortality, while key secondary outcomes included secondary infections, gastrointestinal events, and liver dysfunction.

The study found that early calorie and protein restriction did not decrease mortality. However, it was associated with faster recovery and fewer complications compared to standard calorie and protein targets. The low-calorie, low-protein group had a shorter median time to readiness for ICU discharge and lower proportions of patients with vomiting, diarrhea, bowel ischemia, and liver dysfunction. The proportions of patients with secondary infections did not differ significantly between the two groups.

In conclusion, the NUTRIREA-3 study provides evidence that patients may benefit from restricted calorie and protein intakes during the acute phase of critical illness, as it expedites recovery and reduces the risk of complications.

Article: Low versus standard calorie and protein feeding in ventilated adults with shock: a randomised, controlled, multicentre, open-label, parallel-group trial (NUTRIREA-3) – The Lancet Respiratory Medicine (free registration required)

 

Commentary on Twitter

 

RCT | 4F-PCC fails to reduce blood product consumption and raises thromboembolic events in trauma patients

22 Mar, 2023 | 13:41h | UTC

Summary: The PROCOAG Randomized Clinical Trial aimed to investigate the efficacy and safety of 4-factor prothrombin complex concentrate (4F-PCC) in trauma patients at risk of massive transfusion. Conducted in 12 French trauma centers, this double-blind, randomized, placebo-controlled superiority trial involved 324 patients. All patients were treated according to European traumatic hemorrhage guidelines and received early ratio-based transfusion (packed red blood cells:fresh frozen plasma ratio of 1:1 to 2:1). The primary outcome measured was 24-hour blood product consumption (efficacy), while arterial or venous thromboembolic events were assessed as a secondary outcome (safety).

The trial revealed no significant difference in 24-hour blood product consumption between the 4F-PCC and placebo groups, with median consumption of 12 units and 11 units, respectively. However, the study identified a statistically significant higher risk of thromboembolic events in the 4F-PCC group, with 35% of patients experiencing at least one event compared to 24% in the placebo group.

In conclusion, the study found no beneficial effect of incorporating 4F-PCC into a ratio-based transfusion strategy for patients with severe trauma at risk of massive transfusion. Furthermore, the higher rate of thromboembolic events in the 4F-PCC group indicated potential harm. The findings do not support the routine use of 4F-PCC in patients experiencing trauma who are at risk for extensive transfusion.

Article: Efficacy and Safety of Early Administration of 4-Factor Prothrombin Complex Concentrate in Patients With Trauma at Risk of Massive Transfusion: The PROCOAG Randomized Clinical Trial – JAMA (free for a limited period)

See also: Visual Abstract

 

RCT | 3-6 month DAPT noninferior to 12 month DAPT in patients undergoing PCI with third-generation DES

22 Mar, 2023 | 13:29h | UTC

Summary: In a randomized trial involving 2,013 patients across 37 centers in South Korea, researchers compared the effectiveness of 3-6 month dual antiplatelet therapy (DAPT) versus 12 months of DAPT after percutaneous coronary intervention (PCI) using third-generation drug-eluting stents.

The primary outcome was net adverse clinical events (NACE), a composite of cardiac death, target vessel myocardial infarction, clinically driven target lesion revascularization, stent thrombosis, or major bleeding.

The study found that 3-6 month DAPT was non-inferior to 12-month DAPT for NACE (3.7% vs. 4.1%, respectively), with a consistent treatment effect across various subgroups. No significant differences were observed in target lesion failure or major bleeding between the two groups.

Despite these findings, further research is needed to generalize the results to other populations and to determine the ideal regimen for 3-6 month DAPT.

Article: Comparison Of 3-6 Month Versus 12 Month Dual Antiplatelet Therapy After Coronary Intervention Using the Contemporary Drug-eluting Stents With Ultrathin Struts: The HOST-IDEA Randomized Clinical Trial – Circulation (link to abstract – $ for full-text)

Commentary: Short DAPT Noninferior to 1 Year After Ultrathin DES PCI: HOST-IDEA – TCTMD

Related:

Short Duration of DAPT Versus De-Escalation After Percutaneous Coronary Intervention for Acute Coronary Syndromes – JACC: Cardiovascular Interventions

Long-term Effects of P2Y12 Inhibitor Monotherapy After Percutaneous Coronary Intervention: 3-Year Follow-up of the SMART-CHOICE Randomized Clinical Trial – JAMA Cardiology (link to abstract – $ for full-text)

Effect of 1-Month Dual Antiplatelet Therapy Followed by Clopidogrel vs 12-Month Dual Antiplatelet Therapy on Cardiovascular and Bleeding Events in Patients Receiving PCI: The STOPDAPT-2 Randomized Clinical Trial – JAMA

Effect of P2Y12 Inhibitor Monotherapy vs Dual Antiplatelet Therapy on Cardiovascular Events in Patients Undergoing Percutaneous Coronary Intervention: The SMART-CHOICE Randomized Clinical Trial – JAMA

Comparison of Clopidogrel Monotherapy After 1 to 2 Months of Dual Antiplatelet Therapy With 12 Months of Dual Antiplatelet Therapy in Patients With Acute Coronary Syndrome: The STOPDAPT-2 ACS Randomized Clinical Trial – JAMA Cardiology

Six months versus 12 months dual antiplatelet therapy after drug-eluting stent implantation in ST-elevation myocardial infarction (DAPT-STEMI): randomised, multicentre, non-inferiority trial – The BMJ

6-month versus 12-month or longer dual antiplatelet therapy after percutaneous coronary intervention in patients with acute coronary syndrome (SMART-DATE): a randomised, open-label, non-inferiority trial – The Lancet

Dual Antiplatelet Therapy Duration Based on Ischemic and Bleeding Risks After Coronary Stenting – Journal of the American College of Cardiology

 

Commentary on Twitter

 

RCT | Comparable 5-year relapse-free survival for laparoscopic vs. open distal gastrectomy in advanced gastric cancer

22 Mar, 2023 | 13:27h | UTC

Summary: The JLSSG0901 randomized clinical trial aimed to compare the 5-year survival outcomes of laparoscopy-assisted distal gastrectomy (LADG) and open distal gastrectomy (ODG) with D2 lymph node dissection for locally advanced gastric cancer.

The study involved 507 patients from 37 institutes in Japan. The primary endpoint was 5-year relapse-free survival. The results showed that the 5-year relapse-free survival rates were 73.9% and 75.7% for the ODG and LADG groups, respectively, confirming the noninferiority of LADG, and no significant differences were observed in severe postoperative complications between the two groups.

The study concluded that LADG with D2 lymph node dissection, when performed by qualified surgeons, was proven noninferior to ODG, and could become a standard treatment for locally advanced gastric cancer.

Article: Five-Year Survival Outcomes of Laparoscopy-Assisted vs Open Distal Gastrectomy for Advanced Gastric Cancer: The JLSSG0901 Randomized Clinical Trial – JAMA Surgery (link to abstract – $ for full-text)

Related:

Laparoscopic vs. open distal gastrectomy for locally advanced gastric cancer: A systematic review and meta-analysis of randomized controlled trials – Frontiers in Surgery

Laparoscopic vs Open Distal Gastrectomy for Locally Advanced Gastric Cancer: 5-Year Outcomes of the KLASS-02 Randomized Clinical Trial – JAMA Surgery

Short-and long-term outcomes of laparoscopic versus open gastrectomy in patients with gastric cancer: a systematic review and meta-analysis of randomized controlled trials – World Journal of Surgical Oncology

Laparoscopic versus open distal gastrectomy for gastric cancer: A systematic review and meta-analysis – Surgery

Laparoscopic vs Open Distal Gastrectomy for Locally Advanced Gastric Cancer: Five-Year Outcomes From the CLASS-01 Randomized Clinical Trial – JAMA Surgery

Laparoscopic Versus Open Gastrectomy for Gastric Cancer (LOGICA): A Multicenter Randomized Clinical Trial – Journal of Clinical Oncology

Morbidity and Mortality of Laparoscopic vs Open Total Gastrectomy for Clinical Stage I Gastric Cancer: The CLASS02 Multicenter Randomized Clinical Trial – JAMA Oncology

Survival outcomes after laparoscopy-assisted distal gastrectomy versus open distal gastrectomy with nodal dissection for clinical stage IA or IB gastric cancer (JCOG0912): a multicentre, non-inferiority, phase 3 randomised controlled trial – The Lancet Gastroenterology & Hepatology

Effect of Laparoscopic Distal Gastrectomy vs Open Distal Gastrectomy on Long-term Survival Among Patients With Stage I Gastric Cancer: The KLASS-01 Randomized Clinical Trial – JAMA Oncology

 

Commentary on Twitter

 

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