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Randomized Trials

RCT | Effects of focal vs. extended irreversible electroporation ablation of localized prostate cancer

12 Apr, 2023 | 13:05h | UTC

Effect of Focal vs Extended Irreversible Electroporation for the Ablation of Localized Low- or Intermediate-Risk Prostate Cancer on Early Oncological Control: A Randomized Clinical Trial – JAMA Surgery (link to abstract – $ for full-text)

Commentary: Focal vs Extended Irreversible Electroporation in Ablation of Localized Low- or Intermediate-Risk Prostate Cancer – The ASCO Post

 

Commentary on Twitter

 

Cluster RCT | Long-lasting insecticidal nets compared for malaria control

12 Apr, 2023 | 13:04h | UTC

Efficacy of pyriproxyfen-pyrethroid long-lasting insecticidal nets (LLINs) and chlorfenapyr-pyrethroid LLINs compared with pyrethroid-only LLINs for malaria control in Benin: a cluster-randomised, superiority trial – The Lancet

Invited Commentary: Getting ahead of insecticide-resistant malaria vector mosquitoes – The Lancet (free registration required)

 

RCTs | Eczema Care Online behavioral interventions may support self-care for children and young people

12 Apr, 2023 | 13:02h | UTC

Eczema Care Online behavioural interventions to support self-care for children and young people: two independent, pragmatic, randomised controlled trials – The BMJ

Editorial: How to make Eczema Care Online freely available – The BMJ

News Release: New website helps improve eczema in children and young people – University of Southampton

 

RCT | Low-dose olanzapine enhances appetite & weight gain in chemotherapy patients

11 Apr, 2023 | 14:41h | UTC

Randomized Double-Blind Placebo-Controlled Study of Olanzapine for Chemotherapy-Related Anorexia in Patients With Locally Advanced or Metastatic Gastric, Hepatopancreaticobiliary, and Lung Cancer – Journal of Clinical Oncology (link to abstract – $ for full-text)

Commentaries:

Olanzapine to Prevent Chemotherapy-Related Anorexia in Newly Diagnosed Patients With Advanced Cancers – The ASCO Post

Low-dose olanzapine improves appetite in chemotherapy patients – MDedge

 

Commentary on Twitter

 

Blinded, randomized trial of sonographer versus AI cardiac function assessment

11 Apr, 2023 | 14:34h | UTC

Blinded, randomized trial of sonographer versus AI cardiac function assessment – Nature

News Release: Is artificial intelligence better at assessing heart health? – Cedars-Sinai Medical Center

 

RCT | Efficacy and safety of a water-free topical cyclosporine, 0.1%, solution for the treatment of dry eye disease

11 Apr, 2023 | 14:10h | UTC

Efficacy and Safety of a Water-Free Topical Cyclosporine, 0.1%, Solution for the Treatment of Moderate to Severe Dry Eye Disease: The ESSENCE-2 Randomized Clinical Trial – JAMA Ophthalmology

Commentary: ESSENCE-2 Trial Confirms Efficacy of Cyclosporine Solution 0.1% for DED – HCP Live

 

Commentary on Twitter

 

RCT | Targeted hypoglossal nerve stimulation may benefit patients with obstructive sleep apnea

11 Apr, 2023 | 14:07h | UTC

Targeted Hypoglossal Nerve Stimulation for Patients With Obstructive Sleep Apnea: A Randomized Clinical Trial – JAMA Otolaryngology – Head & Neck Surgery

 

Commentary on Twitter

 

Preliminary study suggests a PEG-coated hemostatic patch reduces pancreatic fistula post-pancreatoduodenectomy

11 Apr, 2023 | 14:02h | UTC

Polyethylene glycol-coated haemostatic patch for prevention of clinically relevant postoperative pancreatic fistula after pancreatoduodenectomy: randomized clinical trial – BJS Open

 

Commentary on Twitter

 

RCT | Augmented ablation fails to outperform standard ablation in paroxysmal AF patients

11 Apr, 2023 | 13:57h | UTC

Standard vs Augmented Ablation of Paroxysmal Atrial Fibrillation for Reduction of Atrial Fibrillation Recurrence: The AWARE Randomized Clinical Trial – JAMA Cardiology (link to abstract – $ for full-text)

Commentary: Augmented Ablation Adds No Benefit in Prevention of Recurrent Atrial Arrhythmia – HCP Live

 

Commentary on Twitter

 

RCT | Maternal RSVpreF vaccination protects infants from severe RSV illness

10 Apr, 2023 | 13:56h | UTC

Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in Infants – New England Journal of Medicine (link to abstract – $ for full-text)

Commentary: Vaccination during pregnancy could prevent RSV illness in infants – Charité – Universitätsmedizin Berlin

 

Commentary on Twitter

 

RCT | RSVpreF vaccine successfully prevents RSV-associated respiratory illness in seniors

10 Apr, 2023 | 13:54h | UTC

Efficacy and Safety of a Bivalent RSV Prefusion F Vaccine in Older Adults – New England Journal of Medicine (link to abstract – $ for full-text)

 

Phase 2 RCT | Addition of metastasis-directed therapy to intermittent hormone therapy for oligometastatic prostate cancer

10 Apr, 2023 | 13:41h | UTC

Addition of Metastasis-Directed Therapy to Intermittent Hormone Therapy for Oligometastatic Prostate Cancer: The EXTEND Phase 2 Randomized Clinical Trial – JAMA Oncology (free for a limited period)

 

Commentary on Twitter

 

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

6 Apr, 2023 | 13:08h | 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)

Commentary: Pitolisant Improves Pediatric Narcolepsy Symptoms Regardless of Cataplexy in Phase 3 Study – Neurology Live

 

RCT | Etrasimod outperforms placebo in ulcerative colitis induction & maintenance

6 Apr, 2023 | 12:56h | UTC

Etrasimod as induction and maintenance therapy for ulcerative colitis (ELEVATE): two randomised, double-blind, placebo-controlled, phase 3 studies – The Lancet

 

Commentary on Twitter

 

RCT | Assessing low-dose ketamine’s antidepressant & antisuicidal effects in patients with treatment-resistant depression

5 Apr, 2023 | 13:44h | UTC

A Randomized Double-Blind Midazolam-Controlled Trial of Low-Dose Ketamine Infusion in Patients With Treatment-Resistant Depression and Prominent Suicidal Ideation – International Journal of Neuropsychopharmacology

 

Commentary on Twitter

 

RCT | Enzalutamide versus standard antiandrogen therapy in hormone-sensitive prostate cancer with metastasis

5 Apr, 2023 | 13:30h | UTC

Testosterone suppression plus enzalutamide versus testosterone suppression plus standard antiandrogen therapy for metastatic hormone-sensitive prostate cancer (ENZAMET): an international, open-label, randomised, phase 3 trial – The Lancet Oncology (link to abstract – $ for full-text)

News Release: ENZAMET shows promise as prostate cancer treatment – University of Adelaide

 

Updated ADAURA trial results | Adjuvant Osimertinib improves disease-free survival in resected EGFR-mutated NSCLC

5 Apr, 2023 | 13:21h | UTC

Adjuvant Osimertinib for Resected EGFR-Mutated Stage IB-IIIA Non–Small-Cell Lung Cancer: Updated Results From the Phase III Randomized ADAURA Trial – Journal of Clinical Oncology

News Release: Trial Shows Significant Disease-free Survival for Patients Diagnosed With Non-small Cell Lung Cancer – Yale School of Medicine

 

RCT | Mindfulness therapy proves more effective and affordable than cognitive behavioral therapy for depression

4 Apr, 2023 | 14:04h | UTC

Summary: The LIGHTMind Randomized Clinical Trial studied 410 adults with mild to moderate depression, comparing the clinical effectiveness and cost-effectiveness of practitioner-supported mindfulness-based cognitive therapy self-help (MBCT-SH) to practitioner-supported cognitive behavioral therapy self-help (CBT-SH). The trial provided participants with either an MBCT-SH or CBT-SH workbook and six support sessions with a trained practitioner. Depressive symptom severity was measured using the Patient Health Questionnaire (PHQ-9) score at 16 weeks after randomization.

Results showed that MBCT-SH led to significantly greater reductions in depressive symptoms and was more cost-effective than CBT-SH. The between-group difference was 1.5 PHQ-9 points, and MBCT-SH cost health services £526 ($631) less per participant over a 42-week follow-up period. A substantial portion of this cost difference was due to additional face-to-face individual psychological therapy accessed by CBT-SH participants outside of the study intervention.

The trial concluded that offering practitioner-supported MBCT-SH for mild to moderate depression could improve outcomes and save money compared to CBT-SH. To translate these findings into practice, proper training and supervision for practitioners delivering MBCT-SH are necessary. Future research should focus on corroborating and extending these findings, exploring factors contributing to MBCT-SH’s relative effectiveness, and examining potential barriers and facilitators for successful implementation in routine clinical practice.

Article: Clinical Effectiveness and Cost-Effectiveness of Supported Mindfulness-Based Cognitive Therapy Self-help Compared With Supported Cognitive Behavioral Therapy Self-help for Adults Experiencing Depression: The Low-Intensity Guided Help Through Mindfulness (LIGHTMind) Randomized Clinical Trial – JAMA Psychiatry

Commentary:

Mindfulness better than CBT for treating depression, study finds – The Guardian

Practitioner-Supported Mindfulness-Based Cognitive Therapy Aids Depression – HealthDay

 

Commentary on Twitter

 

RCT | No significant fracture reduction from monthly 60,000 IU vitamin D3 supplementation

4 Apr, 2023 | 13:58h | UTC

The effect of monthly vitamin D supplementation on fractures: a tertiary outcome from the population-based, double-blind, randomised, placebo-controlled D-Health trial – The Lancet Diabetes & Endocrinology (link to abstract – $ for full-text)

Related:

SR | Calcium and vitamin D supplements do not increase bone mineral density or prevent fractures in premenopausal women

RCT | Supplemental Vitamin D does not reduce incident fractures in midlife and older adults.

Comparison of fracture risk using different supplemental doses of vitamin D, calcium or their combination: a network meta-analysis of randomised controlled trials – BMJ Open

Association Between Calcium or Vitamin D Supplementation and Fracture Incidence in Community-Dwelling Older Adults: A Systematic Review and Meta-analysis – JAMA

 

RCT | Vitamin D supplementation shows no significant impact on psoriasis severity

4 Apr, 2023 | 13:51h | UTC

Summary: In a randomized, double-blind, placebo-controlled clinical trial involving 122 participants with plaque psoriasis, researchers investigated the effects of vitamin D supplementation on psoriasis severity during winter. Participants received either vitamin D (cholecalciferol, 100,000 IU loading dose followed by 20,000 IU/week) or a placebo for four months. The primary outcome was Psoriasis Area Severity Index (PASI) scores, with secondary outcomes including Physician Global Assessment, self-administered PASI, and Dermatology Life Quality Index scores.

The study found no significant difference in PASI scores or secondary outcomes between the two groups. The results suggest that vitamin D supplementation does not affect psoriasis severity. However, low baseline severity scores and a lower than expected increase in 25-hydroxyvitamin D levels in the intervention group may have influenced the findings, indicating that further research may be needed to account for these factors.

Article: Effect of Vitamin D Supplementation on Psoriasis Severity in Patients With Lower-Range Serum 25-Hydroxyvitamin D Levels: A Randomized Clinical Trial – JAMA Dermatology (free for a limited period)

Commentary: Vitamin D Ineffective for Psoriasis Patients with Lower Serum 25-Hydroxyvitamin D Levels in Winter – HCP Live

 

Commentary on Twitter

 

RCT | Comparable results in endovascular therapy using general anesthesia vs. procedural sedation for stroke treatment

4 Apr, 2023 | 13:45h | UTC

Outcomes After Endovascular Therapy With Procedural Sedation vs General Anesthesia in Patients With Acute Ischemic Stroke: The AMETIS Randomized Clinical Trial – JAMA Neurology (free for a limited period)

See also: Visual Abstract

Related: M-A | General Anesthesia vs. to Non-GA in endovascular thrombectomy for ischemic stroke

 

RCT | Pelvic intraoperative neuromonitoring prevents dysfunction in patients with rectal cancer

4 Apr, 2023 | 13:43h | UTC

Pelvic Intraoperative Neuromonitoring Prevents Dysfunction in Patients With Rectal Cancer: Results From a Multicenter, Randomized, Controlled Clinical Trial of a NEUROmonitoring System (NEUROS) – Annals of Surgery

 

RCT | Memantine outperforms placebo for hair-pulling and skin-picking behaviors

4 Apr, 2023 | 13:40h | UTC

Double-Blind Placebo-Controlled Study of Memantine in Trichotillomania and Skin-Picking Disorder – American Journal of Psychiatry (link to abstract – $ for full-text)

News release: New research points to drug option for hair-pulling, skin-picking disorders – University of Chicago

Commentary: Memantine May Reduce Symptoms of Hair-Pulling, Skin-Picking Disorder – Psychiatric News Alert

 

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)

 

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