Randomized Trials
RCT: In patients with complex regional pain syndrome, lumbar sympathetic ganglion block with botulinum toxin type A may reduce pain intensity.
3 Feb, 2022 | 08:25h | UTC
Cluster Randomized Trial: In older patients undergoing elective surgical procedures, a multimodal nonpharmacological prevention program reduced postoperative delirium occurrence and days with delirium.
2 Feb, 2022 | 08:38h | UTCAuthor Interview: Effective Delirium Prevention in Older Persons After Elective Surgery
Commentary on Twitter
Study suggests implementing a multifaceted multidisciplinary prevention intervention will improve care and outcomes in older patients undergoing elective general and orthopedic procedures https://t.co/lHU59ca5m5 pic.twitter.com/oj76KiV4It
— JAMA Surgery (@JAMASurgery) December 15, 2021
RCT: Safety and efficacy of agomelatine in children and adolescents with major depressive disorder receiving psychosocial counselling.
2 Feb, 2022 | 08:34h | UTCSafety and efficacy of agomelatine in children and adolescents with major depressive disorder receiving psychosocial counselling: a double-blind, randomised, controlled, phase 3 trial in nine countries – The Lancet Psychiatry (link to abstract – $ for full-text)
Commentary on Twitter
RCT: 10 to 25 mg/day agomelatine resulted in an improvement versus placebo in CDRS-R raw score of 4·22 (0·63–7·82) at 12 weeks in C&A with MDD, with a similar effect for fluoxetine. The overall effect was confirmed in adolescents, but not in children https://t.co/keecz57fQw
— P𝘧OL (@psychopharmacol) December 23, 2021
RCT: Efficacy and safety of Risankizumab for active psoriatic arthritis.
2 Feb, 2022 | 08:23h | UTC
RCT: In patients with rheumatoid arthritis, treatment with oral drug Tofacitinib increases cardiovascular and cancer risk compared to treatment with subcutaneous TNF inhibitors.
1 Feb, 2022 | 08:35h | UTCCardiovascular and Cancer Risk with Tofacitinib in Rheumatoid Arthritis – New England Journal of Medicine (link to abstract – $ for full-text)
Video: CV and Cancer Risk with Tofacitinib in RA – New England Journal of Medicine
Commentary: CV, Cancer Risk Up With Tofacitinib for Rheumatoid Arthritis – HealthDay
RCT: Early drain removal is safe in patients with low or intermediate risk of pancreatic fistula after pancreaticoduodenectomy.
1 Feb, 2022 | 08:33h | UTCEarly Drain Removal is Safe in Patients With Low or Intermediate Risk of Pancreatic Fistula After Pancreaticoduodenectomy: A Multicenter, Randomized Controlled Trial – Annals of Surgery (link to abstract – $ for full-text)
RCT: Sugemalimab improves progression-free survival vs. placebo in patients with metastatic non-small-cell lung cancer.
1 Feb, 2022 | 08:25h | UTCSugemalimab versus placebo, in combination with platinum-based chemotherapy, as first-line treatment of metastatic non-small-cell lung cancer (GEMSTONE-302): interim and final analyses of a double-blind, randomised, phase 3 clinical trial – The Lancet Oncology (link to abstract – $ for full-text)
Related study: Sugemalimab versus placebo after concurrent or sequential chemoradiotherapy in patients with locally advanced, unresectable, stage III non-small-cell lung cancer in China (GEMSTONE-301): interim results of a randomised, double-blind, multicentre, phase 3 trial – The Lancet Oncology (link to abstract – $ for full-text)
Commentaries:
Sugemalimab shows promise for locally advanced, metastatic NSCLC – Medicine Matters
Sugemalimab Boosts Outcomes in NSCLC – MedPage Today (free registration required)
Commentary on Twitter
https://twitter.com/NatRevClinOncol/status/1483839169839255554
RCT: Vitamin D supplementation for older adults (mean age 67 years) for 5 years reduced the risk of autoimmune diseases by 22%. Absolute risk in the treatment group was 0.95% vs. 1.19% in the placebo group.
30 Jan, 2022 | 14:30h | UTCCommentary: Vitamin D and fish oil supplements may help prevent autoimmune disease, study says – CNN
Related:
USPSTF Statement: Insufficient evidence to recommend Vitamin D deficiency screening
Vitamin D, calcium, other vitamins, and supplements do not prevent cardiovascular diseases
RCT: Olanzapine may improve the control of vomiting in the delayed phase in children receiving highly emetogenic chemotherapy.
30 Jan, 2022 | 14:13h | UTCEfficacy and Safety of Olanzapine in Children Receiving Highly Emetogenic Chemotherapy: A Randomized, Double-blind Placebo-controlled Phase 3 Trial – Journal of Pediatric Hematology/Oncology (link to abstract – $ for full-text)
RCT: Axicabtagene Ciloleucel as second-line therapy for Large B-Cell Lymphoma.
30 Jan, 2022 | 13:41h | UTC
Commentary on Twitter
In a trial involving patients with relapsed or refractory large B-cell lymphoma, the CAR T-cell therapy axicabtagene ciloleucel led to significantly longer event-free survival than standard salvage chemotherapy. #ASH21 https://t.co/V1WfVJ2k9V pic.twitter.com/ZHUhx8es27
— NEJM (@NEJM) December 11, 2021
RCT: Electronic directly observed therapy is noninferior to in-person observed therapy for ensuring adherence to tuberculosis treatment.
26 Jan, 2022 | 01:58h | UTC
Commentary on Twitter
In this 2-year study, data showed that electronic directly observed therapy (eDOT) was as effective as traditional in-person DOT for ensuring high adherence to treatment of tuberculosis disease. @CDC_TB @nycHealthy @ColumbiaMed https://t.co/yTrU1JRuwn pic.twitter.com/QXthE4d266
— JAMA Network Open (@JAMANetworkOpen) January 20, 2022
A review of high impact journals found that misinterpretation of non-statistically significant results from randomized trials was common.
26 Jan, 2022 | 01:50h | UTC
RCT: Single-dose 1000 mg ertapenem is non-inferior to single-dose 500 mg ceftriaxone for the treatment of gonorrhea.
25 Jan, 2022 | 09:20h | UTCEfficacy of ertapenem, gentamicin, fosfomycin, and ceftriaxone for the treatment of anogenital gonorrhoea (NABOGO): a randomised, non-inferiority trial – The Lancet Infectious Diseases (link to abstract – $ for full-text)
Commentary on Twitter (thread – click for more)
New from @TheLancetInfDis Efficacy of ertapenem, gentamicin, fosfomycin, and ceftriaxone for the treatment of anogenital gonorrhoea (NABOGO): a randomised, non-inferiority trial by @henryjdevries and colleagues https://t.co/K2fw5ORNlm pic.twitter.com/d8wz1Vc41Q
— The Lancet HIV (@TheLancetHIV) January 24, 2022
RCT: Safety and efficacy of Daridorexant in patients with insomnia disorder.
25 Jan, 2022 | 09:15h | UTCSafety and efficacy of daridorexant in patients with insomnia disorder: results from two multicentre, randomised, double-blind, placebo-controlled, phase 3 trials – The Lancet Neurology (link to abstract – $ for full-text)
Long-term results of RCT: GH replacement with once-weekly somapacitan is comparable to daily GH in children with growth hormone deficiency.
25 Jan, 2022 | 09:07h | UTC
RCT: In children with peanut allergy, initiation of peanut oral immunotherapy before age 4 years induced desensitization in 71% of patients and remission in 21%.
24 Jan, 2022 | 08:18h | UTCEfficacy and safety of oral immunotherapy in children aged 1–3 years with peanut allergy (the Immune Tolerance Network IMPACT trial): a randomised placebo-controlled study – The Lancet (link to abstract – $ for full-text)
News Release: Oral immunotherapy induces remission of peanut allergy in some young children – NIH News Releases
Commentary: Peanut Oral Immunotherapy at Younger Age Ups Desensitization in Children – HealthDay
RCT: The addition of trastuzumab to neoadjuvant chemoradiotherapy for HER2-overexpressing esophageal cancer did not improve outcomes.
24 Jan, 2022 | 08:04h | UTCTrastuzumab with trimodality treatment for oesophageal adenocarcinoma with HER2 overexpression (NRG Oncology/RTOG 1010): a multicentre, randomised, phase 3 trial – The Lancet Oncology (link to abstract – $ for full-text)
Commentary on Twitter
In a phase III trial in 203 pts with HER2+ oesophageal cancer, adding trastuzumab to neoadjuvant CRT did not significantly improve mDFS (19.6 vs 14.2 months; HR 0.99; P = 0.97). The incidence of grade 3 and 4 TRAEs was 43% & 21% vs 54% & 22%: https://t.co/wx0NmVMyCR #esocsm
— NatureRevClinOncol (@NatRevClinOncol) January 21, 2022
A faster way to find good medical treatments is gaining ground – “A type of clinical trial that tests many therapies at once is being used for COVID and Alzheimer’s”.
24 Jan, 2022 | 07:50h | UTCA Faster Way to Find Good Medical Treatments Is Gaining Ground – Scientific American
Reporting of physicians’ or investigators’ choice of treatment in oncology randomized clinical trials.
24 Jan, 2022 | 07:49h | UTC
Commentary from the author on Twitter (thread – click for more)
Our new paper is out now in @JAMANetworkOpen !
When a randomized trial designs a « Physicians’ choice » or « Investigators’ choice » control arm, you might think :
« Great, the control arm is standard of care ! »
➡️ you may be surprised 🧵👇🏻https://t.co/uho2pvXcG5— Timothée Olivier, MD (@Timothee_MD) January 21, 2022
RCT: Immunogenicity and reactogenicity of different vaccine boosters after a first J&J vaccine.
21 Jan, 2022 | 10:12h | UTC
Commentary on Twitter
Trial examined effects of boosting with one of the three approved #COVI19 vaccines — AD26.COV2.S, mRNA-1273, or BNT162b2 — 3 mos after the primary vaccination. All increased neutralizing-antibody levels & T-cell responses; mRNA vaccines were higher. https://t.co/qkpQFvNliJ pic.twitter.com/MUfa1OEsLP
— NEJM (@NEJM) January 19, 2022
RCT: Lenvatinib plus pembrolizumab improve outcomes compared to chemotherapy in patients with advanced endometrial cancer.
21 Jan, 2022 | 09:46h | UTCLenvatinib plus Pembrolizumab for Advanced Endometrial Cancer – New England Journal of Medicine
Commentary on Twitter
In women with advanced endometrial cancer, the median progression-free survival was 7.2 months with lenvatinib plus pembrolizumab and 3.8 months with chemotherapy; the median overall survival was 18.3 months and 11.4 months, respectively. https://t.co/lzqFDnhAQn pic.twitter.com/Tm2BJZuh1D
— NEJM (@NEJM) January 19, 2022
The validity of progression-free survival 2 as a surrogate trial end point for overall survival.
21 Jan, 2022 | 09:31h | UTCThe validity of progression-free survival 2 as a surrogate trial end point for overall survival – Cancer (link to abstract – $ for full-text)
RCT: In patients with previously untreated Diffuse Large B-Cell Lymphoma, a modified regimen of R-CHOP (pola-R-CHP), in which vincristine was replaced with polatuzumab, was associated with improved outcomes compared to standard R-CHOP treatment.
21 Jan, 2022 | 09:28h | UTCPolatuzumab Vedotin in Previously Untreated Diffuse Large B-Cell Lymphoma – New England Journal of Medicine (link to abstract – $ for full-text)
RCT: Among patients with recurrent Clostridioides difficile infection, the use of SER-109, an oral microbiome therapy, reduced recurrence rate compared to placebo (12% vs. 40%).
20 Jan, 2022 | 09:11h | UTCSER-109, an Oral Microbiome Therapy for Recurrent Clostridioides difficile Infection – New England Journal of Medicine (link to abstract – $ for full-text)
RCT: In very young children with Type 1 Diabetes, a hybrid closed-loop therapy (“artificial pancreas”) resulted in better glycemic control without increased risk of hypoglycemia vs. sensor-augmented pump therapy.
20 Jan, 2022 | 09:07h | UTCRandomized Trial of Closed-Loop Control in Very Young Children with Type 1 Diabetes – New England Journal of Medicine (link to abstract – $ for full-text)