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Randomized Trials

RCT | Temporary transvenous phrenic nerve stimulation does not benefit difficult-to-wean patients in the ICU.

8 Aug, 2022 | 11:41h | UTC

Randomized Clinical Study of Temporary Transvenous Phrenic Nerve Stimulation in Difficult-to-Wean Patients – American Journal of Respiratory and Critical Care Medicine

Editorial: Transvenous Phrenic Nerve Stimulation: A Novel Therapy Gathering Pace – American Journal of Respiratory and Critical Care Medicine

 

RCT | Partial breast irradiation vs. whole breast irradiation for early breast cancer.

8 Aug, 2022 | 11:36h | UTC

Partial Breast Irradiation Versus Whole Breast Irradiation for Early Breast Cancer Patients in a Randomized Phase III Trial: The Danish Breast Cancer Group Partial Breast Irradiation Trial – Journal of Clinical Oncology (link to abstract – $ for full-text)

 

RCT | Balloon pulmonary angioplasty versus riociguat for the treatment of inoperable chronic thromboembolic pulmonary hypertension.

8 Aug, 2022 | 11:30h | UTC

Balloon pulmonary angioplasty versus riociguat for the treatment of inoperable chronic thromboembolic pulmonary hypertension (RACE): a multicentre, phase 3, open-label, randomised controlled trial and ancillary follow-up study – The Lancet Respiratory Medicine (link to abstract – $ for full-text)

 

Commentary on Twitter

 

RCT | Therapeutic value of sentinel lymph node biopsy in patients with melanoma.

4 Aug, 2022 | 14:05h | UTC

Therapeutic Value of Sentinel Lymph Node Biopsy in Patients With Melanoma: A Randomized Clinical Trial – JAMA Surgery (free for a limited period)

Invited Commentary: Prognostic or Therapeutic—The Role of Sentinel Lymph Node Biopsy in Contemporary Practice – JAMA Surgery (free for a limited period)

 

RCT | Transcranial direct current stimulation vs. sham for the treatment of inattention in adults with attention-deficit/hyperactivity disorder.

4 Aug, 2022 | 13:50h | UTC

Transcranial Direct Current Stimulation vs Sham for the Treatment of Inattention in Adults With Attention-Deficit/Hyperactivity Disorder: The TUNED Randomized Clinical Trial – JAMA Psychiatry (free for a limited period)

See also: Visual Abstract

 

RCT | Comparison of switching to 6-week dosing of natalizumab versus continuing with 4-week dosing in patients with relapsing-remitting multiple sclerosis.

4 Aug, 2022 | 13:28h | UTC

Comparison of switching to 6-week dosing of natalizumab versus continuing with 4-week dosing in patients with relapsing-remitting multiple sclerosis (NOVA): a randomised, controlled, open-label, phase 3b trial – The Lancet Neurology (link to abstract – $ for full-text)

Commentary: Less Frequent Dosing With MS Drug Safe With No Loss of Efficacy – Medscape (free registration required)

 

RCT | Total vs. partial posterior fundoplication in the surgical repair of para-esophageal hernias: randomized clinical trial.

4 Aug, 2022 | 13:22h | UTC

Total versus partial posterior fundoplication in the surgical repair of para-oesophageal hernias: randomized clinical trial – BJS Open

 

Commentary on Twitter

 

RCT | Patiromer for the management of hyperkalemia in heart failure with reduced ejection fraction.

3 Aug, 2022 | 14:06h | UTC

Patiromer for the management of hyperkalemia in heart failure with reduced ejection fraction: the DIAMOND trial – European Society of Cardiology

 

Commentary on Twitter

 

RCT | Safety and efficacy of Tirzepatide as an add-on to single oral antihyperglycaemic medication in patients with type 2 diabetes in Japan.

2 Aug, 2022 | 12:05h | UTC

Safety and efficacy of tirzepatide as an add-on to single oral antihyperglycaemic medication in patients with type 2 diabetes in Japan (SURPASS J-combo): a multicentre, randomised, open-label, parallel-group, phase 3 trial – The Lancet Diabetes & Endocrinology (link to abstract – $ for full-text)

See also (note: the dulaglutide dosage used in this trial was probably suboptimal): Efficacy and safety of tirzepatide monotherapy compared with dulaglutide in Japanese patients with type 2 diabetes (SURPASS J-mono): a double-blind, multicentre, randomised, phase 3 trial – The Lancet Diabetes & Endocrinology (link to abstract – $ for full-text)

Related:

Tirzepatide Once Weekly for the Treatment of Obesity – New England Journal of Medicine

Management of type 2 diabetes with the dual GIP/GLP-1 receptor agonist tirzepatide: a systematic review and meta-analysis – Diabetologia

Tirzepatide cardiovascular event risk assessment: a pre-specified meta-analysis – Nature Medicine

Effect of Subcutaneous Tirzepatide vs Placebo Added to Titrated Insulin Glargine on Glycemic Control in Patients With Type 2 Diabetes: The SURPASS-5 Randomized Clinical Trial – JAMA (link to abstract – $ for full-text)

Tirzepatide versus insulin glargine in type 2 diabetes and increased cardiovascular risk (SURPASS-4): a randomised, open-label, parallel-group, multicentre, phase 3 trial – The Lancet (link to abstract – $ for full-text)

Once-weekly tirzepatide versus once-daily insulin degludec as add-on to metformin with or without SGLT2 inhibitors in patients with type 2 diabetes (SURPASS-3): a randomised, open-label, parallel-group, phase 3 trial – The Lancet (link to abstract – $ for full-text)

Efficacy and safety of a novel dual GIP and GLP-1 receptor agonist tirzepatide in patients with type 2 diabetes (SURPASS-1): a double-blind, randomised, phase 3 trial – The Lancet (link to abstract – $ for full-text)

Tirzepatide versus Semaglutide Once Weekly in Patients with Type 2 Diabetes – New England Journal of Medicine (link to abstract – $ for full-text)

 

Commentary on Twitter

 

RCT | In patients at risk for antithrombin deficiency after cardiac surgery, preoperative antithrombin supplementation did not result in better outcomes.

2 Aug, 2022 | 11:39h | UTC

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Preoperative Antithrombin Supplementation in Patients at Risk for Antithrombin Deficiency After Cardiac Surgery – Anesthesia & Analgesia (link to abstract – $ for full-text)

 

RCT | Intervention with methotrexate in patients with arthralgia at risk of rheumatoid arthritis to reduce the development of persistent arthritis and its disease burden.

1 Aug, 2022 | 12:32h | UTC

Intervention with methotrexate in patients with arthralgia at risk of rheumatoid arthritis to reduce the development of persistent arthritis and its disease burden (TREAT EARLIER): a randomised, double-blind, placebo-controlled, proof-of-concept trial – The Lancet (link to abstract – $ for full-text)

News Release: Treatment before patients develop rheumatism provides lasting relief – Leiden University Medical Centre

 

Commentaries on Twitter:

 

When underlying biology threatens the randomization principle — initial gout flares of urate-lowering therapy.

1 Aug, 2022 | 12:12h | UTC

When underlying biology threatens the randomization principle — initial gout flares of urate-lowering therapy – Nature Reviews Rheumatology (if the link is paywalled, try this one in PMC)

 

Commentary on Twitter

 

RCT | Efficacy and safety of viloxazine extended-release capsules in adults with attention-deficit/hyperactivity disorder.

1 Aug, 2022 | 11:57h | UTC

A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial Assessing the Efficacy and Safety of Viloxazine Extended-Release Capsules in Adults with Attention-Deficit/Hyperactivity Disorder – CNS Drugs

 

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

28 Jul, 2022 | 13:31h | UTC

Supplemental Vitamin D and Incident Fractures in Midlife and Older Adults – New England Journal of Medicine (link to abstract – $ for full-text)

Commentary: Daily Vitamin D supplements don’t lower risk of bone fractures, study finds – STAT

Related:

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

 

Commentary on Twitter

 

RCT | Effects of walking exercise at a pace with vs. without ischemic leg symptoms on functional performance measures in people with lower extremity peripheral artery disease.

28 Jul, 2022 | 13:27h | UTC

Effects of Walking Exercise at a Pace With Versus Without Ischemic Leg Symptoms on Functional Performance Measures in People With Lower Extremity Peripheral Artery Disease: The LITE Randomized Clinical Trial – Journal of the American Heart Association

News Release: ‘No pain, no gain’ approach improves walking ability with peripheral artery disease – American Heart Association

 

RCT | Trial of Anti-BDCA2 antibody Litifilimab for cutaneous Lupus Erythematosus.

28 Jul, 2022 | 13:06h | UTC

Trial of Anti-BDCA2 Antibody Litifilimab for Cutaneous Lupus Erythematosus – New England Journal of Medicine (link to abstract – $ for full-text)

Commentary: BDCA2-Targeting Antibody May Be Effective for Cutaneous Lupus — In small randomized trial, litifilimab shows superiority over placebo for skin disease activity – MedPage Today (free registration required)

 

Commentary on Twitter

 

RCT | Vitamin B6 supplements could reduce anxiety and depression.

27 Jul, 2022 | 12:19h | UTC

News Release: Vitamin B6 supplements could reduce anxiety and depression – University of Reading

Original Study: High-dose Vitamin B6 supplementation reduces anxiety and strengthens visual surround suppression – Human Psychopharmacology: Clinical and Experimental

Commentary: B6 a New Approach for Depression, Anxiety? – Medscape (free registration required)

 

RCT | Effectiveness of intensive home treatment as a substitute for hospital admission in acute psychiatric crisis resolution.

27 Jul, 2022 | 12:08h | UTC

The effectiveness of intensive home treatment as a substitute for hospital admission in acute psychiatric crisis resolution in the Netherlands: a two-centre Zelen double-consent randomised controlled trial – The Lancet Psychiatry (link to abstract – $ for full-text)

Commentary: Intensive home treatment effective in place of hospital admission for psychiatric crisis – Healio (free registration required)

 

Commentary on Twitter

https://twitter.com/TheLancetPsych/status/1544594945331412992

 

RCT | Effect of intravitreal Aflibercept vs. Laser Photocoagulation on treatment success of retinopathy of prematurity.

27 Jul, 2022 | 12:01h | UTC

Effect of Intravitreal Aflibercept vs Laser Photocoagulation on Treatment Success of Retinopathy of Prematurity: The FIREFLEYE Randomized Clinical Trial – JAMA (free for a limited period)

See also: Visual Abstract

 

RCT | Intra-articular botulinum toxin A injection for painful base-of-thumb osteoarthritis.

27 Jul, 2022 | 11:56h | UTC

Intra-articular botulinum toxin A injection for painful base-of-thumb osteoarthritis: a double-blind, randomised, controlled, phase 3 trial (RHIBOT) – The Lancet Rheumatology (link to abstract – $ for full-text)

Commentaries:

Botulinum toxin A injection may ease base-of-thumb osteoarthritis pain – medwire News

Intra-articular Botulinum Toxin A Targets Chronic Pain in Base-of-Thumb Osteoarthritis – Rheumatology Advisor

 

Commentary on Twitter

 

RCT | Safety and efficacy of Liraglutide vs. Colesevelam for treating bile acid diarrhea.

26 Jul, 2022 | 12:29h | UTC

Safety and efficacy of liraglutide versus colesevelam for the treatment of bile acid diarrhoea: a randomised, double-blind, active-comparator, non-inferiority clinical trial – The Lancet Gastroenterology & Hepatology (link to abstract – $ for full-text)

Commentary: Diabetes Drug for Bile Acid Diarrhea Bests Standard of Care in Small Trial — Liraglutide proves superior to colesevelam for cutting daily stool frequency in Danish trial – MedPage Today (free registration required)

 

Commentary on Twitter

 

RCT | The effect of inhaled hypertonic saline on lung structure in children aged 3–6 years with cystic fibrosis.

26 Jul, 2022 | 11:50h | UTC

The effect of inhaled hypertonic saline on lung structure in children aged 3–6 years with cystic fibrosis (SHIP-CT): a multicentre, randomised, double-blind, controlled trial – The Lancet Respiratory Medicine (link to abstract – $ for full-text)

Commentary: Inhaled hypertonic saline improves structural airway changes in children with cystic fibrosis – Healio (free registration required)

 

RCT | External support for saphenous vein grafts in coronary artery bypass surgery.

26 Jul, 2022 | 11:44h | UTC

External Support for Saphenous Vein Grafts in Coronary Artery Bypass Surgery: A Randomized Clinical Trial – JAMA Cardiology (link to abstract – $ for full-text)

Commentary: In CABG patients, external graft support devices fail to prolong patency of saphenous vein graft: JAMA – Medical Dialogues

 

Commentary on Twitter

 

[PREPRINT] RCT | Inhaled fluticasone not beneficial for outpatients with Covid-19.

25 Jul, 2022 | 13:01h | UTC

Inhaled Fluticasone for Outpatient Treatment of Covid-19: A Decentralized, Placebo-controlled, Randomized, Platform Clinical Trial – medRxiv

News Release: Study finds no benefit to taking fluticasone furoate for COVID-19 symptoms – Duke Clinical Research Institute

Commentary: Asthma Drug Fluticasone Fails as Potential COVID-19 Treatment – HealthDay

 

RCT | Efficacy and safety of Abrocitinib vs. Dupilumab in adults with moderate-to-severe atopic dermatitis.

25 Jul, 2022 | 12:44h | UTC

Efficacy and safety of abrocitinib versus dupilumab in adults with moderate-to-severe atopic dermatitis: a randomised, double-blind, multicentre phase 3 trial – The Lancet (link to abstract – $ for full-text)

Related: Abrocitinib versus Placebo or Dupilumab for Atopic Dermatitis – New England Journal of Medicine

 

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