Randomized Trials
RCT | Mindfulness therapy proves more effective and affordable than cognitive behavioral therapy for depression
4 Apr, 2023 | 14:04h | UTCSummary: 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.
Commentary:
Mindfulness better than CBT for treating depression, study finds – The Guardian
Practitioner-Supported Mindfulness-Based Cognitive Therapy Aids Depression – HealthDay
Commentary on Twitter
Practitioner-supported mindfulness-based cognitive therapy self-help for mild-moderate depression is clinically- and cost-effective compared to currently recommended practitioner-support CBT self-help. https://t.co/H23AfwiO7X pic.twitter.com/xTHzYG4oqg
— JAMA Psychiatry (@JAMAPsych) March 22, 2023
RCT | No significant fracture reduction from monthly 60,000 IU vitamin D3 supplementation
4 Apr, 2023 | 13:58h | UTCThe 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:
RCT | Supplemental Vitamin D does not reduce incident fractures in midlife and older adults.
RCT | Vitamin D supplementation shows no significant impact on psoriasis severity
4 Apr, 2023 | 13:51h | UTCSummary: 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 on Twitter
This RCT, performed in North-Norway, found no measurable effect of vitamin D supplementation on psoriasis severity during winter. Low baseline severity, & lower-than-expected rise in 25(OH)D levels in intervention group, may have affected the results. https://t.co/ip17uFQsgM
— JAMA Dermatology (@JAMADerm) March 29, 2023
RCT | Comparable results in endovascular therapy using general anesthesia vs. procedural sedation for stroke treatment
4 Apr, 2023 | 13:45h | UTCOutcomes 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
RCT | Memantine outperforms placebo for hair-pulling and skin-picking behaviors
4 Apr, 2023 | 13:40h | UTCDouble-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
RCT | Comparable efficacy of cefotaxime, ceftriaxone, and ciprofloxacin in treating spontaneous bacterial peritonitis
3 Apr, 2023 | 14:01h | UTCSummary: 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)
RCT | Vedolizumab for the treatment of chronic pouchitis
3 Apr, 2023 | 13:49h | UTCVedolizumab for the Treatment of Chronic Pouchitis – New England Journal of Medicine (link to abstract – $ for full-text)
News Release: New hope for patients after vedolizumab found effective to treat Chronic Pouchitis – University of Oxford
Commentary on Twitter
In a phase 4, double-blind, randomized trial, vedolizumab therapy was more effective than placebo in inducing remission in patients with chronic pouchitis after ileal pouch–anal anastomosis for ulcerative colitis. Full results of EARNEST trial: https://t.co/5OnC72j2Ik pic.twitter.com/RcH1uAB1AI
— NEJM (@NEJM) March 29, 2023
RCT | Pembrolizumab plus chemotherapy in advanced endometrial cancer
3 Apr, 2023 | 13:48h | UTCPembrolizumab plus Chemotherapy in Advanced Endometrial Cancer – New England Journal of Medicine (link to abstract – $ for full-text)
Commentary on Twitter
Original Article: Pembrolizumab plus Chemotherapy in Advanced Endometrial Cancer https://t.co/dTyV1zTO0I
#SGOMtg @SGO_org pic.twitter.com/R3FDom8pVY— NEJM (@NEJM) March 29, 2023
RCT | Dostarlimab for primary advanced or recurrent endometrial cancer
3 Apr, 2023 | 13:46h | UTCDostarlimab for Primary Advanced or Recurrent Endometrial Cancer – New England Journal of Medicine (link to abstract – $ for full-text)
Commentary:
Dostarlimab Plus Chemotherapy Elicits PFS Benefit in Recurrent Endometrial Cancer – OncLive
RCTs | Fitusiran prophylaxis reduces bleeding in people with hemophilia A or hemophilia B
3 Apr, 2023 | 13:44h | UTCEfficacy and safety of fitusiran prophylaxis in people with haemophilia A or haemophilia B with inhibitors (ATLAS-INH): a multicentre, open-label, randomised phase 3 trial – The Lancet (link to abstract – $ for full-text)
Fitusiran prophylaxis in people with severe haemophilia A or haemophilia B without inhibitors (ATLAS-A/B): a multicentre, open-label, randomised, phase 3 trial – The Lancet Haematology (link to abstract – $ for full-text)
News Release: Monthly injections of fitusiran reduces bleeds in patients with haemophilia A and B – The Lancet
RCT | Sparsentan reduces proteinuria in patients with IgA nephropathy
3 Apr, 2023 | 13:35h | UTCSparsentan in patients with IgA nephropathy: a prespecified interim analysis from a randomised, double-blind, active-controlled clinical trial – The Lancet (link to abstract – $ for full-text)
Commentary on Twitter
PROTECT (Interim results): Sparsentan reduces proteinuria in patients with IgA Nephropathy (IgAN)#ISNWCN ?? #Nephpearls#VisualAbstract by @dakidneydochttps://t.co/ViW9YncwI6 pic.twitter.com/zEGRSY8N3x
— Edgar V. Lerma ?? (@edgarvlermamd) April 1, 2023
RCT | Early postpartum IUD placement noninferior vs. placement at 6-8 weeks for complete expulsion, but not for partial expulsion
31 Mar, 2023 | 13:48h | UTCEarly vs Interval Postpartum Intrauterine Device Placement: A Randomized Clinical Trial – JAMA (link to abstract – $ for full-text)
News Release: Study: Risk of IUD Expulsion in Early Postpartum Placement – UC San Diego Health
Commentary: IUD Placement at Two to Four Weeks Postpartum Noninferior – HealthDay
Related:
Commentary on Twitter
Early IUD placement at 2 to 4 weeks postpartum compared with 6 to 8 weeks postpartum was noninferior for complete expulsion, but not partial expulsion. https://t.co/VMfWce3JJd pic.twitter.com/vdLrhCXa5Q
— JAMA (@JAMA_current) March 23, 2023
RCT | Pulsed oral azithromycin vs. 6-week oral doxycycline for moderate to severe meibomian gland dysfunction
31 Mar, 2023 | 13:33h | UTCPulsed Oral Azithromycin vs 6-Week Oral Doxycycline for Moderate to Severe Meibomian Gland Dysfunction: A Randomized Clinical Trial – JAMA Ophthalmology (link to abstract – $ for full-text)
Commentary: 3-Week MGD treatment equivalent to 6-week course in efficacy and adverse events – Ophthalmology Times
Commentary on Twitter
A 3-week course of weekly oral azithromycin was equivalent to a 6-week course of oral doxycycline in treating moderate to severe meibomian gland dysfunction. https://t.co/nE312KxGki pic.twitter.com/xWmqYWby7j
— JAMA Ophthalmology (@JAMAOphth) March 23, 2023
RCT | Efficacy and safety of garadacimab, a factor XIIa inhibitor for hereditary angioedema prevention
31 Mar, 2023 | 13:26h | UTCEfficacy and safety of garadacimab, a factor XIIa inhibitor for hereditary angioedema prevention (VANGUARD): a global, multicentre, randomised, double-blind, placebo-controlled, phase 3 trial – The Lancet (link to abstract – $ for full-text)
Commentary on Twitter (thread – click for more)
Hereditary angioedema is a rare disease associated with unpredictable, recurrent angioedema attacks that can be life-threatening.
New study data support the use of garadacimab as a potential prophylactic therapy in adolescents and adults: https://t.co/xlxoA3J3sh ? pic.twitter.com/VqCOHnaQAp
— The Lancet (@TheLancet) March 6, 2023
RCT | Zavegepant 10 mg nasal spray vs. placebo for the acute treatment of migraine
31 Mar, 2023 | 13:24h | UTCSafety, tolerability, and efficacy of zavegepant 10 mg nasal spray for the acute treatment of migraine in the USA: a phase 3, double-blind, randomised, placebo-controlled multicentre trial – The Lancet Neurology (link to abstract – $ for full-text)
2ry analysis of a RCT | Vitamin D supplementation does not affect cognitive function in older adults
30 Mar, 2023 | 14:14h | UTCVitamin D supplementation and cognition—Results from analyses of the D-Health trial – Journal of the American Geriatrics Society (link to abstract – $ for full-text)
Related:
Randomized Trial: Vitamin D Supplements and Prevention of Cancer and Cardiovascular Disease
Meta-Analysis: Vitamin D Not Effective for Cardiovascular Disease Prevention
Vitamin D, calcium, other vitamins, and supplements do not prevent cardiovascular diseases
Research: Circulating vitamin D concentration and risk of seven cancers
Research: Vitamin D and risk of total and site specific cancers
RCT | Ganitumab added to chemotherapy did not improve outcomes in patients with metastatic Ewing sarcoma
30 Mar, 2023 | 14:16h | UTCRandomized Phase III Trial of Ganitumab With Interval-Compressed Chemotherapy for Patients With Newly Diagnosed Metastatic Ewing Sarcoma: A Report From the Children’s Oncology Group – Journal of Clinical Oncology (link to abstract – $ for full-text)
Commentary: Ganitumab Provides No Benefit in Metastatic Ewing Sarcoma – Cancer Therapy Advisor
RCT | Hydroxychloroquine in children with proliferative lupus nephritis
30 Mar, 2023 | 14:11h | UTC
RCT | Efficacy and safety of colesevelam for the treatment of bile acid diarrhea
30 Mar, 2023 | 14:06h | UTCEfficacy and safety of colesevelam for the treatment of bile acid diarrhoea: a double-blind, randomised, placebo-controlled, phase 4 clinical trial – The Lancet Gastroenterology & Hepatology (link to abstract – $ for full-text)
Commentary on Twitter
New research – Borup et al – Efficacy and safety of colesevelam for the treatment of bile acid diarrhoea: a double-blind, randomised, placebo controlled, phase 4 clinical trialhttps://t.co/m1r0heRgjX#gitwitter #BAD #diarrhoea pic.twitter.com/zk1TnZFS6b
— The Lancet Gastroenterology & Hepatology (@LancetGastroHep) February 7, 2023
Phase 2b RCT | Efficacy and safety of PL-5 (Peceleganan) spray for wound infections
27 Mar, 2023 | 13:08h | UTC
RCT | No reduction in parastomal hernia rate 3 years after stoma construction with prophylactic Mesh
27 Mar, 2023 | 13:07h | UTC
RCT | Topical lidocaine or lidocaine/diltiazem ointment following rubber band ligation of hemorrhoids
27 Mar, 2023 | 13:05h | UTCTopical Lidocaine or Lidocaine/Diltiazem Ointment Following Rubber Band Ligation of Hemorrhoids: A Prospective Three-Armed Randomized Controlled Trial – Diseases of the Colon & Rectum (link to abstract – $ for full-text)
Trends of randomized clinical trials citing prior systematic reviews, 2007-2021
27 Mar, 2023 | 12:56h | UTCTrends of Randomized Clinical Trials Citing Prior Systematic Reviews, 2007-2021 – JAMA Network Open
Invited Commentary: Should a Systematic Review Be Required in a Clinical Trial Report? Perhaps, But Not Yet – JAMA Network Open
Commentary on Twitter
The percentage of RCTs citing systematic reviews increased from 36% in 2007-8 to 72% since 2020. RCTs with ≥100 participants, nonindustry funders, and authors from high-income countries were more likely to cite systematic reviews. https://t.co/rMN7eEmkqD
— JAMA Network Open (@JAMANetworkOpen) March 23, 2023