Randomized Trials
RCTs | Secukinumab in moderate-to-severe hidradenitis suppurativa
3 Mar, 2023 | 13:30h | UTCSecukinumab 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 | UTCCommentary: 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 | UTCCommentary: 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
RCT | Endovascular ultrasound renal denervation is modestly effective in the treatment of hypertension
1 Mar, 2023 | 14:11h | UTCSummary: 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 The trial enrolled 224 patients who were withdrawn from such medications and randomly assigned to receive either ultrasound renal denervation or a sham procedure.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
RCT | Momelotinib vs. danazol in symptomatic patients with anemia and myelofibrosis
1 Mar, 2023 | 13:39h | UTCMomelotinib 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)
RCT | Efficacy of oral vs. long-acting antipsychotic treatment in patients with early-phase schizophrenia
1 Mar, 2023 | 13:38h | UTCEfficacy 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 | UTCSummary: 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.
Original Study: Randomized Trial: Platelet-Transfusion Thresholds in Neonates
Commentary from the author on Twitter (thread – click for more)
We already knew from the @PlaNeT2_trial that a higher prophylactic platelet transfusion threshold (<50) in preterm babies is associated with significantly increased mortality or major bleeding compared with a lower one (<25)… https://t.co/pJrE44BIIx
— Carmel Moore (@carmelmoore) February 22, 2023
RCT | Ligation of intersphincteric fistulous tract vs. endorectal advancement flap for high-type fistula in ano
28 Feb, 2023 | 13:40h | UTCLigation 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
The FRAIL trial randomized patients into 2 arms: LIFT (Ligation of Intersphincteric Fistula tract) and ERAF (Endorectal Advancement Flap). At 2 years, LIFT had no incontinence and a healing rate that was higher than ERAF.https://t.co/EnlYQXsjg6@kumar_surg pic.twitter.com/AVIXnvPmwY
— JACS (@acsJACS) December 21, 2022
Cluster RCT | Effectiveness of an intensive care telehealth program to improve process quality
28 Feb, 2023 | 13:31h | UTC
Commentary on Twitter
? A structured, bundled telemedical quality improvement implemented in a local network of?? hospitals improved quality of acute #ICU care vs to standard of care, increasing adherence to evidence-based performance indicators.
Open #FOAMc on @yourICM
? https://t.co/WV56tXoiHM pic.twitter.com/YQQvm2HUO5— Intensive Care Medicine (@yourICM) January 16, 2023
RCT | Single-dose psilocybin-assisted therapy in major depressive disorder
28 Feb, 2023 | 13:26h | UTCRelated:
Phase 2 RCT | Single-dose Psilocybin for a treatment-resistant episode of major depression.
Research: “Magic mushrooms” for treatment-resistant depression
Commentary on Twitter
?New placebo-controlled, double-blind, RCT: Single-dose #psilocybin-assisted therapy in #majordepressivedisorder
Results suggest that a single dose of psilocybin significantly reduces depressive symptoms compared to placebo for at least 2 weekshttps://t.co/Ps43rxHv6r pic.twitter.com/Qc8xSgnalw
— eClinicalMedicine – The Lancet Discovery Science (@eClinicalMed) January 18, 2023
RCT | Tight glycemic control did not preserve pancreatic beta cell function in newly diagnosed pediatric type 1 diabetes
27 Feb, 2023 | 13:16h | UTCSummary: 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
Intensive diabetes management with automated insulin delivery did not affect the decline in pancreatic C-peptide secretion at 52 weeks in youths with newly diagnosed type 1 diabetes. https://t.co/e1n5xagrtv #ATTD2023 pic.twitter.com/C6743BmqyH
— JAMA (@JAMA_current) February 24, 2023
RCT | Verapamil partially preserved pancreatic beta cell function in newly diagnosed pediatric type 1 diabetes
27 Feb, 2023 | 13:14h | UTCSummary: 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
In youth with newly diagnosed type 1 diabetes, verapamil partially preserved stimulated C-peptide secretion at 52 weeks from diagnosis compared with placebo. https://t.co/m4xbczf93C #ATTD2023 pic.twitter.com/teM0jjh1tT
— JAMA (@JAMA_current) February 24, 2023
RCT | Effects of globus pallidus focused ultrasound ablation in Parkinson’s disease
27 Feb, 2023 | 13:02h | UTCSummary: 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)
Commentary: Focused ultrasound reduces physical symptoms of Parkinson’s disease – Health Imaging
Video Summary: Focused Ultrasound Ablation for Parkinson’s Disease | NEJM
RCT | Epirubicin + Paclitaxel vs Epirubicin and Cyclophosphamide followed by Paclitaxel in operable ERBB2-negative and lymph node–positive BC
27 Feb, 2023 | 12:55h | UTC
Commentary on Twitter
RCT: Epirubicin + paclitaxel was non-inferior to the standard epirubicin + cyclophosphamide followed by paclitaxel in patients with operable HRBB2 negative and lymph nodes-positive breast cancer. https://t.co/Z672x44dQL pic.twitter.com/WdNJDtktLX
— JAMA Network Open (@JAMANetworkOpen) February 24, 2023
RCT | Isolated ambulatory phlebectomy vs. saphenous thermal ablation with concomitant phlebectomy in saphenous trunk and tributary incompetence
27 Feb, 2023 | 12:39h | UTC
RCT | Aspirin discontinuation at 24 to 28 weeks’ gestation in pregnancies at high risk of preterm preeclampsia
24 Feb, 2023 | 13:56h | UTCArticle: Aspirin Discontinuation at 24 to 28 Weeks’ Gestation in Pregnancies at High Risk of Preterm Preeclampsia: A Randomized Clinical Trial – JAMA (free for a limited period)
Editorial: Biomarkers and the Risk of Preeclampsia – JAMA (free for a limited period)
Commentary on Twitter
Aspirin discontinuation at 24 to 28 weeks of gestation was noninferior to aspirin continuation for preventing preterm preeclampsia in pregnant individuals at high risk of preeclampsia and a normal sFlt-1:PlGF ratio. https://t.co/6yIBsfxwU5 pic.twitter.com/RGqQLvb20l
— JAMA (@JAMA_current) February 21, 2023
RCT | Laparoscopic proximal gastrectomy with double-tract reconstruction vs. total gastrectomy in upper-third early gastric cancer
23 Feb, 2023 | 13:29h | UTCSummary: This randomized trial examined whether laparoscopic proximal gastrectomy with double-tract reconstruction (LPG-DTR) is a superior surgical treatment compared to laparoscopic total gastrectomy (LTG) for patients with early gastric cancer (GC) in the upper third of the stomach. The study found that LPG-DTR resulted in significantly decreased amounts of vitamin B12 supplementation, but no significant difference in hemoglobin change compared to LTG. The study also found no difference in complication rates or overall and disease-free survival rates between the two groups. The study suggests that LPG-DTR may be a function-preserving procedure for the treatment of patients with upper-third early GC.
Commentary on Twitter
RCT: Proximal gastrectomy with double tract reconstruction had an advantage of less vitamin B12 supplementation than total gastrectomy similar complication rates and survival in patients with upper third early gastric cancer. https://t.co/tdAktJxkpL pic.twitter.com/5miUbb9Ia6
— JAMA Network Open (@JAMANetworkOpen) February 15, 2023
RCT | An initial 8-week bedaquiline-linezolid regimen shows promise for the treatment of rifampin-susceptible tuberculosis
22 Feb, 2023 | 12:50h | UTCSummary: This randomized trial compared a standard 6-month rifampin-based tuberculosis treatment to a strategy that involved shorter initial treatment with extended therapy for persistent disease, monitoring, and retreatment for relapse. The results showed that the strategy involving an 8-week bedaquiline-linezolid regimen was noninferior to standard treatment for clinical outcomes. The experimental strategy was associated with a shorter total duration of treatment with no evident safety concerns.
Article: Treatment Strategy for Rifampin-Susceptible Tuberculosis – New England Journal of Medicine (link to abstract – $ for full-text)
Commentary: Shorter drug regimen shows promise in TB trial – CIDRAP
RCT | Temporary cessation vs. continuation of first-line tyrosine kinase inhibitor in advanced clear cell renal cell carcinoma
22 Feb, 2023 | 12:40h | UTCSummary: The STAR trial investigated whether a tyrosine kinase inhibitor drug-free interval strategy was non-inferior to a conventional continuation strategy for first-line treatment of advanced clear cell renal cell carcinoma. All patients received standard dosing schedules of oral sunitinib (50 mg per day) or oral pazopanib (800 mg per day) for 24 weeks before moving into their randomly allocated group. Although non-inferiority could not be concluded for the primary endpoint of overall survival, temporary treatment cessation was found to preserve quality of life and was cost-effective. Therefore, planned breaks in tyrosine kinase inhibitor treatment represent a reasonable option for selected patients with renal cell carcinoma, providing potential lifestyle and health economic benefits. The study provides a rationale for further exploration of treatment breaks in patients with other cancers.
Commentary on Twitter
NOW OF: The STAR open-label ph 2/3 RCT could not conclude that a TKI drug-free interval strategy was non-inferior to a conventional continuation strategy for first-line treatment of advanced clear cell renal cell carcinoma. #rccsmhttps://t.co/xzCU1jdLE7 pic.twitter.com/Ks1Eh0vMId
— The Lancet Oncology (@TheLancetOncol) February 14, 2023
RCT | Cold snare polypectomy reduces bleeding compared to hot snare polypectomy
22 Feb, 2023 | 12:34h | UTCCold Versus Hot Snare Polypectomy for Small Colorectal Polyps: A Pragmatic Randomized Controlled Trial – Annals of Internal Medicine (link to abstract – $ for full-text)
News Release: Cold snare polypectomy significantly reduces bleeding risk compared to hot snare polypectomy – Science News Net
Phase 2b RCT | Effects of OPT-302, a VEGF-C/D inhibitor for neovascular age-related macular degeneration
22 Feb, 2023 | 12:21h | UTC
RCT | Breast-conserving surgery without irradiation may be an option for older patients with early breast cancer
17 Feb, 2023 | 13:25h | UTCSummary: The article reports a phase 3 randomized trial that investigated the efficacy of omitting irradiation after breast-conserving surgery in women aged 65 years or older with hormone receptor-positive, node-negative, T1 or T2 primary breast cancer, and tumors ≤3 cm in the largest dimension, who received adjuvant endocrine therapy. A total of 1326 women were enrolled, with 658 receiving whole-breast irradiation and 668 receiving no irradiation. The results showed that the omission of radiotherapy led to an increased incidence of local breast cancer recurrence but had no negative effect on distant recurrence as the first event or overall survival. The study suggests that omission of radiotherapy could be a viable treatment option for older women with low-risk, hormone receptor–positive early breast cancer who receive adjuvant endocrine therapy.*
Article: Breast-Conserving Surgery with or without Irradiation in Early Breast Cancer – New England Journal of Medicine (link to abstract – $ for full-text)
Commentaries:
For many older breast cancer patients, study finds radiation doesn’t affect survival – STAT
Do Older Patients Need Radiation Rx After Breast Cancer Surgery? – HealthDay
*Note: This summary was created through the collaboration of a medical editor and ChatGPT.
RCT | Home high-flow nasal cannula oxygen therapy for stable hypercapnic COPD
17 Feb, 2023 | 12:53h | UTC