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Randomized Trials

#ACC23 – RCT | Intravascular imaging–guided vs. angiography-guided complex PCI

7 Mar, 2023 | 13:20h | UTC

Intravascular Imaging–Guided or Angiography-Guided Complex PCI – New England Journal of Medicine (link to abstract – $ for full-text)

Commentary: Randomized Controlled Trial of Intravascular Imaging Guidance Versus Angiography-Guidance on Clinical Outcomes After Complex Percutaneous Coronary Intervention – RENOVATE-COMPLEX-PCI – American College of Cardiology

 

Commentary on Twitter

 

#ACC23 – RCT | Transcatheter repair for patients with tricuspid regurgitation

6 Mar, 2023 | 14:29h | UTC

Transcatheter Repair for Patients with Tricuspid Regurgitation – New England Journal of Medicine (link to abstract – $ for full-text)

Commentaries:

The TRILUMINATE Transcatheter Tricuspid Repair Trial: Positive but No Benefit? – Medscape (recommended reading – free registration required)

TRILUMINATE Pivotal: TEER With the TriClip Benefits Patients With Severe TR – TCTMD

Transcatheter Repair Benefits Quality of Life in Patients with Severe Tricuspid Regurgitation – HCP Live

 

Commentary on Twitter

 

RCT | Hydrochlorothiazide is not effective for the prevention of kidney-stone recurrence

6 Mar, 2023 | 14:26h | UTC

Summary:

This study aimed to assess the effectiveness of hydrochlorothiazide, a thiazide diuretic, in preventing the recurrence of calcium-containing kidney stones. The trial randomly assigned 416 patients with recurrent kidney stones to receive hydrochlorothiazide at a dose of 12.5 mg, 25 mg, or 50 mg once daily, or a placebo once daily, and followed them for a median of 2.9 years.

The results showed that the incidence of kidney stone recurrence did not differ significantly between the hydrochlorothiazide and placebo groups, regardless of the dose. Furthermore, patients who received hydrochlorothiazide were more likely to experience side effects such as hypokalemia, gout, new-onset diabetes mellitus, skin allergy, and a plasma creatinine level exceeding 150% of the baseline level.

Therefore, the effectiveness of hydrochlorothiazide in preventing kidney stone recurrence may be limited, and the common practice of prescribing it for these patients should be reevaluated.

 

Article: Hydrochlorothiazide and Prevention of Kidney-Stone Recurrence – New England Journal of Medicine (link to abstract – $ for full-text)

Video Summary: Hydrochlorothiazide and Kidney-Stone Recurrence | NEJM

Commentary: Hydrochlorothiazide and Prevention of Kidney Stones – NEJM Resident 360

 

#ACC23 – RCT | Five-year follow-up after transcatheter repair of secondary mitral regurgitation

6 Mar, 2023 | 14:28h | UTC

Five-Year Follow-up after Transcatheter Repair of Secondary Mitral Regurgitation – New England Journal of Medicine (link to abstract – $ for full-text)

Commentaries:

COAPT at 5 Years: MitraClip Still Ahead, but Deaths and Crossovers Cast Shadows – TCTMD

Minimally Invasive Mitral Valve Repair Reduces Hospitalizations and Deaths – American College of Cardiology

 

Commentary on Twitter

 

RCT | Antipsychotic association seems better than antidepressant switch in treatment-resistant geriatric depression

6 Mar, 2023 | 14:23h | UTC

Summary:

This open-label randomized trial compared the benefits and risks of augmenting therapy vs. switching antidepressants in older adults with treatment-resistant depression. In the first step, 619 patients were randomly assigned to augmentation of existing antidepressant medication with aripiprazole (an antipsychotic), augmentation with bupropion, or a switch from existing antidepressant medication to bupropion. In step 2, 248 patients who did not benefit from or were ineligible for step 1 were randomly assigned to augmentation with lithium or a switch to nortriptyline.

The aripiprazole-augmentation group showed significant improvement in well-being compared to the switch-to-bupropion group. Remission occurred in 28.9% of patients in the aripiprazole-augmentation group, 28.2% in the bupropion-augmentation group, and 19.3% in the switch-to-bupropion group. In step 2, similar remission rates occurred in the lithium-augmentation group (18.9%) and the switch-to-nortriptyline group (21.5%).

 

Article: Antidepressant Augmentation versus Switch in Treatment-Resistant Geriatric Depression – New England Journal of Medicine (link to abstract – $ for full-text)

News Release: Adding antipsychotic med to antidepressant may help older adults with treatment-resistant depression – Washington University School of Medicine in St. Louis

 

Commentary on Twitter

 

RCT | Perioperative vs. postoperative calcium and vitamin D supplementation to prevent symptomatic hypocalcemia after total thyroidectomy

6 Mar, 2023 | 14:09h | UTC

Summary:

This study aimed to compare the efficacy of perioperative vs. postoperative calcium and vitamin D supplementation in reducing symptomatic hypocalcemia in patients who underwent thyroidectomy.

In a randomized placebo-controlled trial involving 134 patients, one group received calcium carbonate and alfacalcidol both 3 days before surgery and for 14 days after surgery, while the other group received the same treatment only after surgery.

Results showed that the perioperative group had significantly lower rates of symptomatic and biochemical hypocalcemia compared to the postoperative group. Patients who underwent central neck dissection were at increased risk of symptomatic hypocalcemia in this study, so perioperative supplementation could be more beneficial for these patients.

 

Article: Perioperative versus postoperative calcium and vitamin D supplementation to prevent symptomatic hypocalcemia after total thyroidectomy: a randomized placebo controlled trial – International Journal of Surgery

 

Phase 2 RCT | Neoadjuvant–adjuvant pembrolizumab improves event-free survival vs. adjuvant-only therapy in advanced melanoma

6 Mar, 2023 | 14:11h | UTC

Summary:

This phase 2 clinical trial evaluated whether giving pembrolizumab before and after surgery (neoadjuvant-adjuvant therapy) would increase event-free survival in patients with resectable stage III or IV melanoma, compared to adjuvant therapy alone. The trial involved 313 patients, with 154 in the neoadjuvant-adjuvant group and 159 in the adjuvant-only group.

At a median follow-up of 14.7 months, the neoadjuvant-adjuvant group had significantly longer event-free survival than the adjuvant-only group, with similar rates of adverse events between groups, suggesting that pembrolizumab given both before and after surgery may be an effective treatment option for these patients.

 

Article: Neoadjuvant–Adjuvant or Adjuvant-Only Pembrolizumab in Advanced Melanoma – New England Journal of Medicine (link to abstract – $ for full-text)

News Release: Neoadjuvant immunotherapy improves outlook in high-risk melanoma – MD Anderson Cancer Center

 

Commentary on Twitter

 

RCT | Immediate vs. delayed urinary catheter removal following non-hysterectomy benign gynecological laparoscopy

3 Mar, 2023 | 13:55h | UTC

Summary: This randomized clinical trial compared the rates of urinary retention and postoperative urinary tract infection between women with immediate vs. delayed removal of the indwelling catheter following benign gynecological laparoscopic surgery, excluding hysterectomy, pelvic floor, or surgeries with concomitant bowel procedures. A total of 693 women aged 18 years or older were randomized to immediate or delayed urinary catheter removal. The results showed an increased risk of urinary retention with immediate vs. delayed removal of the urinary catheter (8.2% vs. 4.2%), highlighting the need to ensure patients report normal voiding and emptying before discharge to reduce the need for readmission for management of urinary retention.

Article: Immediate versus delayed urinary catheter removal following non-hysterectomy benign gynecological laparoscopy: a randomised trial – BJOG (link to abstract – $ for full-text)

Related: Feasibility of immediate removal of urinary catheter after laparoscopic gynecological surgery for benign diseases: A meta-analysis of randomized controlled trials – Obstetrics & Gynecology (link to abstract – $ for full-text)

 

RCT | Effects of a vibrating capsule for chronic constipation

3 Mar, 2023 | 13:41h | UTC

Randomized Placebo-Controlled Phase 3 Trial of Vibrating Capsule for Chronic Constipation – Gastroenterology (link to abstract – $ for full-text)

Commentary: Researchers reveal the impact of vibrating capsules in chronic constipation patients – News Medical

 

RCT | Baricitinib vs. placebo for systemic lupus erythematosus

3 Mar, 2023 | 13:39h | UTC

Baricitinib for systemic lupus erythematosus: a double-blind, randomised, placebo-controlled, phase 3 trial (SLE-BRAVE-I) – The Lancet (link to abstract – $ for full-text)

See also: Baricitinib for systemic lupus erythematosus: a double-blind, randomised, placebo-controlled, phase 3 trial (SLE-BRAVE-II) – The Lancet (link to abstract – $ for full-text)

Commentary: Benefit of baricitinib for treatment of patients with moderately to severely active SLE is unclear – Monash University

 

Commentary on Twitter

 

RCTs | Secukinumab in moderate-to-severe hidradenitis suppurativa

3 Mar, 2023 | 13:30h | UTC

Secukinumab in moderate-to-severe hidradenitis suppurativa (SUNSHINE and SUNRISE): week 16 and week 52 results of two identical, multicentre, randomised, placebo-controlled, double-blind phase 3 trials – The Lancet (link to abstract – $ for full-text)

 

RCT | Impact of supplementation with milk–cereal mix during 6–12 months of age on growth at 12 months in Delhi, India

2 Mar, 2023 | 12:50h | UTC

Impact of supplementation with milk–cereal mix during 6–12 months of age on growth at 12 months: a 3-arm randomized controlled trial in Delhi, India – The American Journal of Clinical Nutrition

Commentary: High-protein supplementation improves linear growth in infants – 2 Minute Medicine

 

RCT | Electrostimulation with the Alpha-Stim AID device is not better than sham treatment in major depression

2 Mar, 2023 | 12:49h | UTC

Clinical effectiveness of active Alpha-Stim AID versus sham Alpha-Stim AID in major depression in primary care in England (Alpha-Stim-D): a multicentre, parallel group, double-blind, randomised controlled trial – The Lancet Psychiatry

Commentary: Active AID Device Not More Effective Than Sham at Improving Depressive Symptoms – Neurology Advisor

 

RCT | Addition of preoperative transversus abdominis plane block to multimodal analgesia in open gynecological surgery

2 Mar, 2023 | 12:43h | UTC

Addition of preoperative transversus abdominis plane block to multimodal analgesia in open gynecological surgery: a randomized controlled trial – BMC Anesthesiology

 

RCT | Endovascular ultrasound renal denervation is modestly effective in the treatment of hypertension

1 Mar, 2023 | 14:11h | UTC

Summary: The RADIANCE II randomized clinical trial investigated the efficacy and safety of endovascular ultrasound renal denervation in patients with hypertension without the influence of antihypertensive medications. The trial enrolled 224 patients who were withdrawn from such medications and randomly assigned to receive either ultrasound renal denervation or a sham procedure. Results showed that ultrasound renal denervation reduced ambulatory systolic blood pressure by 6.3 mmHg on average at 2 months, compared to the sham procedure, without any reported adverse events. While these findings suggest that ultrasound renal denervation may be modestly effective in the treatment of hypertension, the short-term follow-up period limits the generalizability of these results to daily practice. Additionally, the clinical relevance of a procedure that reduces blood pressure only after withdrawing blood pressure medications should be considered.

Article: Endovascular Ultrasound Renal Denervation to Treat Hypertension: The RADIANCE II Randomized Clinical Trial – JAMA (free for a limited period)

Editorial: Is There a Role for Renal Denervation in the Treatment of Hypertension? – JAMA Cardiology (free for a limited period)

 

RCT | US-assisted carbon nanoparticle suspension mapping vs. dual tracer-guided sentinel lymph node biopsy in patients with early breast cancer

1 Mar, 2023 | 13:42h | UTC

Ultrasound-assisted carbon nanoparticle suspension mapping versus dual tracer-guided sentinel lymph node biopsy in patients with early breast cancer (ultraCars): phase III randomized clinical trial – British Journal of Surgery

 

RCT | Momelotinib vs. danazol in symptomatic patients with anemia and myelofibrosis

1 Mar, 2023 | 13:39h | UTC

Momelotinib versus danazol in symptomatic patients with anaemia and myelofibrosis (MOMENTUM): results from an international, double-blind, randomised, controlled, phase 3 study – The Lancet (link to abstract – $ for full-text)

News Release: Targeted therapy momelotinib provides significant symptom and anemia improvements in patients with myelofibrosis – University of Texas M. D. Anderson Cancer Center

 

RCT | Efficacy of oral vs. long-acting antipsychotic treatment in patients with early-phase schizophrenia

1 Mar, 2023 | 13:38h | UTC

Efficacy of oral versus long-acting antipsychotic treatment in patients with early-phase schizophrenia in Europe and Israel: a large-scale, open-label, randomised trial (EULAST) – The Lancet Psychiatry (link to abstract – $ for full-text)

Commentary: No benefit of long-acting antipsychotics in schizophrenia? – MDedge

 

RCT | 2-y outcomes confirm the harms caused by high prophylactic platelet transfusion thresholds in preterm infants

28 Feb, 2023 | 13:53h | UTC

Summary: The study investigated the long-term outcomes of preterm infants who participated in a randomized trial of platelet transfusions at different threshold levels. Infants with platelet counts below 50×109/L were enrolled and randomized to either a higher threshold of 50×109/L or a lower threshold of 25×109/L. The study found that infants randomized to the higher threshold had a higher rate of death or significant neurodevelopmental impairment at a corrected age of 2 years compared to the lower threshold group. The study further supports evidence of harm caused by high prophylactic platelet transfusion thresholds in preterm infants. The mechanisms by which platelet transfusions could mediate harmful effects remain unknown, but the study identified increased rates of intraventricular hemorrhage and bronchopulmonary dysplasia in the higher threshold group, which may contribute to the adverse outcomes observed.

Article: Two-year outcomes following a randomised platelet transfusion trial in preterm infants – ADC Fetal & Neonatal

Original Study: Randomized Trial: Platelet-Transfusion Thresholds in Neonates

 

Commentary from the author on Twitter (thread – click for more)

 

RCT | Ligation of intersphincteric fistulous tract vs. endorectal advancement flap for high-type fistula in ano

28 Feb, 2023 | 13:40h | UTC

Ligation of Intersphincteric Fistulous Tract vs Endorectal Advancement Flap for High-Type Fistula in Ano: A Randomized Controlled Trial – Journal of the American College of Surgeons (link to abstract – $ for full-text)

 

Commentary on Twitter

 

Cluster RCT | Effectiveness of an intensive care telehealth program to improve process quality

28 Feb, 2023 | 13:31h | UTC

Effectiveness of an intensive care telehealth programme to improve process quality (ERIC): a multicentre stepped wedge cluster randomised controlled trial – Intensive Care Medicine

 

Commentary on Twitter

 

RCT | Single-dose psilocybin-assisted therapy in major depressive disorder

28 Feb, 2023 | 13:26h | UTC

Single-dose psilocybin-assisted therapy in major depressive disorder: A placebo-controlled, double-blind, randomised clinical trial – eClinicalMedicine

Commentary: A single, moderate dose of psilocybin reduces depressive symptoms for at least two weeks, controlled study finds – PsyPost

Related:

Phase 2 RCT | Single-dose Psilocybin for a treatment-resistant episode of major depression.

RCT | In patients with alcohol use disorder, the percentage of heavy drinking days was reduced with a psychedelic drug.

Phase 2 RCT: Psilocybin, a psychedelic compound, shows promise for the treatment of depression in a study with 59 patients

Research: “Magic mushrooms” for treatment-resistant depression

 

Commentary on Twitter

 

RCT | Tight glycemic control did not preserve pancreatic beta cell function in newly diagnosed pediatric type 1 diabetes

27 Feb, 2023 | 13:16h | UTC

Summary: The study aimed to determine if intensive diabetes management with an automated insulin delivery system could help preserve pancreatic beta cell function in youth with newly diagnosed type 1 diabetes. The randomized clinical trial included 113 youths aged 7 to 17 years and found that although the mean time in the target range of 70 to 180 mg/dL was 78% in the intensive management group vs. 64% in the standard care group, intensive diabetes management did not affect the decline in pancreatic C-peptide secretion at 52 weeks. The study concluded that near normalization of glucose levels instituted immediately after diagnosis of type 1 diabetes did not preserve pancreatic beta cell function in youth.

Article: Effect of Tight Glycemic Control on Pancreatic Beta Cell Function in Newly Diagnosed Pediatric Type 1 Diabetes: A Randomized Clinical Trial – JAMA (free for a limited period)

Editorial: Preserving Pancreatic Beta Cell Function in Recent-Onset Type 1 Diabetes – JAMA (free for a limited period)

 

Commentary on Twitter

 

RCT | Verapamil partially preserved pancreatic beta cell function in newly diagnosed pediatric type 1 diabetes

27 Feb, 2023 | 13:14h | UTC

Summary: The study aimed to determine whether verapamil could preserve pancreatic beta cell function in children and adolescents with newly diagnosed type 1 diabetes. The randomized clinical trial involved 88 participants who were given either verapamil or placebo once daily for 52 weeks. The study found that C-peptide levels were 30% higher in the verapamil group compared to the placebo group at 52 weeks, and the percentage of participants with a 52-week peak C-peptide level of 0.2 pmol/mL or greater was 95% in the verapamil group compared to 71% in the placebo group. The study also found that verapamil was well tolerated with few adverse events. The results suggest that verapamil may partially preserve stimulated C-peptide secretion in children and adolescents with newly diagnosed type 1 diabetes. However, further studies with patient-relevant outcomes are needed to determine the long-term effectiveness and the optimal length of therapy.

Article: Effect of Verapamil on Pancreatic Beta Cell Function in Newly Diagnosed Pediatric Type 1 Diabetes: A Randomized Clinical Trial – JAMA (free for a limited period)

Editorial: Preserving Pancreatic Beta Cell Function in Recent-Onset Type 1 Diabetes – JAMA (free for a limited period)

News Release: Verapamil shows beneficial effect on the pancreas in children with newly-diagnosed type 1 diabetes – University of Minnesota

 

Commentary on Twitter

 

RCT | Effects of globus pallidus focused ultrasound ablation in Parkinson’s disease

27 Feb, 2023 | 13:02h | UTC

Summary: The study evaluated the efficacy and safety of unilateral focused ultrasound ablation of the internal segment of globus pallidus in patients with Parkinson’s disease and dyskinesias or motor fluctuations. The randomized controlled trial involved 94 patients who were either assigned to undergo ultrasound ablation or a sham procedure. The study found that unilateral pallidal ultrasound ablation resulted in a higher percentage of patients who improved motor function or reduced dyskinesia than a sham procedure over a period of 3 months but was associated with adverse events. The study suggests the need for longer and larger trials to determine the effect and safety of this technique in persons with Parkinson’s disease.

Article: Trial of Globus Pallidus Focused Ultrasound Ablation in Parkinson’s Disease – New England Journal of Medicine (link to abstract – $ for full-text)

News Release: Parkinson’s Disease Patients Experience Significant Reduction in Symptoms with Non-Surgical Focused Ultrasound Treatment – University of Maryland School of Medicine

Commentary: Focused ultrasound reduces physical symptoms of Parkinson’s disease – Health Imaging

Video Summary: Focused Ultrasound Ablation for Parkinson’s Disease | NEJM

 

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