To summarize the evidence from systematic reviews (SRs) of randomized controlled trials (RCTs) evaluating the efficacy and safety of sodium‐glucose cotransporter‐2 (SGLT2) inhibitors versus placebo or active comparators for type 2 diabetes mellitus.
Method: This secondary analysis of a randomized controlled trial of an injection of GC and local anaesthetic (LA) versus placebo included 44 patients with GTPS.
70 individuals were enrolled in a parallel-group, randomized, double-blind, placebo-controlled, forced-titration trial of CBZ (n=35) versus placebo (n=35).
METHODS
This was a randomized, double-blind, placebo-controlled trial of sucralfate versus placebo conducted between 2017 and 2018 in an urban pediatric emergency department.
We tested this hypothesis in a follow-up study of children born to obese mothers who had participated in a randomised controlled trial of metformin versus placebo in pregnancy (EMPOWaR).
5 In a multicenter exploratory, randomised controlled trial of various pharmacologic agents used for PDA closure versus placebo in 202 very preterm infants (<28 weeks' gestation) of whom 49% were intubated on IMV and 48% required nasal ventilation of CPAP, treated at 6– 14 days after birth, no differences in rates of ligation, the presence of PDA at hospital discharge, nor any differences in NEC, BPD, BPD and/or death, or death were found among those receiving pharmacologic closure versus placebotreated infants, while the rate of lateonset neonatal sepsis was increased among treated infants.
In Part B of the 2-part, phase 2 LILAC study (NCT02847598), the primary endpoint was met: BIIB059 significantly reduced CLE activity, as evidenced by a statistically significant dose response and statistically significant differences in least-squares mean percent changes in Cutaneous Lupus Erythematosus Disease Area and Severity Index – Activity (CLASI-A) score1 versus placebo.
METHODS
92 biomarkers associated with immunity, chemotaxis, and metabolism were measured in plasma samples from 61 PWH with NAFLD who participated in a double-blind, randomized trial of tesamorelin versus placebo for 12 months.
RESEARCH QUESTION
Does a single high-dose (540,000 IU) enteral treatment of vitamin D3 given shortly after hospital admission in vitamin D deficient, critically-ill patients improve long-term global cognition or executive function?
STUDY DESIGN AND METHODS
This study evaluated long-term cognitive outcomes among patients enrolled in a multicenter, blinded, randomized clinical trial comparing vitamin D3 treatment versus placebo in critically-ill adults with vitamin D deficiency.
Methods We performed a randomised double-blind placebo-controlled single-centre trial of simvastatin at a daily dose of 40 mg versus placebo in patients with Global Initiative for Chronic Obstructive Lung Disease criteria grades 2–4 at a tertiary care pulmonology department in Austria.
We report results of pooled analyses from 2 randomised, double-blind, placebo-controlled phase 3 studies (SINUS 24 [NCT02912468]; SINUS-52 [NCT02898454]) to evaluate dupilumab effect versus placebo in adults with CRSwNP with/without SCS use and sinonasal surgery.
In the era of VEGFtargeted therapy, a randomised controlled phase 3 trial of pazopanib versus placebo in treatmentnaive mRCC which allowed crossover into the active treatment arm upon progression demonstrated no statistically significant difference in final overall survival (OS) between pazopanibtreated and placebotreated patients (22.
The phase 3 trial PALISADE, comparing peanut (Arachis hypogaea) allergen powder-dnfp (PTAH) oral immunotherapy versus placebo in peanut-allergic children, reported that a significantly higher percentage of PTAH-treated participants tolerated higher doses of peanut protein after 1 year of treatment.
Background Sunitinib prolonged progression-free survival (PFS) versus placebo in patients with metastatic pancreatic neuroendocrine tumors (panNETs) in a phase III trial.
BACKGROUND
Olaparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, has previously been shown to extend progression-free survival versus placebo when given to patients with relapsed high-grade serous or endometrioid ovarian cancer who were platinum sensitive and who had a BRCA1 or BRCA2 (BRCA1/2) mutation, as part of the SOLO2/ENGOT-Ov21 trial.
Results: Empagliflozin reduced the combined risk of cardiovascular death, hospitalization for heart failure, or an emergency or urgent heart failure visit requiring intravenous treatment (432 versus 546 patients [empagliflozin versus placebo, respectively]; hazard ratio, 0.
Methods: An 8-week parallel arm, double-blind, randomised, placebo-controlled trial of OROS-methylphenidate versus placebo in 200 male prisoners from two young offender prisons in Southeast England and Scotland.
SELECTION CRITERIA
We considered double-blind, randomised controlled trials (RCTs) of cilostazol versus placebo, or versus other drugs used to improve claudication distance in patients with stable intermittent claudication.
Introduction Roxadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor that has demonstrated safety and efficacy versus placebo in phase III trials in patients with anemia of chronic kidney disease (CKD) who were not on dialysis (NDD).
Results: Both the q4w and q2w dupilumab + TCS regimens resulted in clinically meaningful and statistically significant improvement in signs, symptoms, and quality of life (QOL) versus placebo + TCS in all prespecified endpoints.
METHODS
We conducted a randomized control trial of amoxicillin 500 mg twice daily versus placebo for 7 days in women ages 18-45 without vaginitis who screened positive for vaginal colonization with GV by qPCR.
1,2 In STYLE (NCT03123471), oral apremilast 30 mg twice daily (BID) demonstrated significantly greater improvements in moderate to severe plaque psoriasis of the scalp, scalp itch, whole body itch, and QOL versus placebo3 during the 16-week, placebo-controlled phase; safety and tolerability were consistent with the known safety profile of apremilast.
SELECTION CRITERIA
Randomised clinical trials assessing the effects of antibiotics versus placebo or no intervention for secondary prevention of coronary heart disease in adult participants (≥18 years).
We conducted a systematic review and meta-analysis to explore the influence of colchicine administration versus placebo on treatment efficacy for coronary heart disease.
BACKGROUND
In the phase 3 KEYNOTE-189 study (NCT02578680), pembrolizumab plus pemetrexed and platinum-based chemotherapy (pemetrexed-platinum) significantly improved overall survival (OS) and progression-free survival (PFS) in patients with previously untreated metastatic nonsquamous NSCLC versus placebo plus pemetrexed-platinum.
Objective: Delayed-release and extended-release methylphenidate (DR/ER-MPH), the first stimulant predicted to be absorbed primarily in the colon, demonstrated significant improvements in attention-deficit/hyperactivity disorder (ADHD) symptoms and functional impairment from awakening until evening versus placebo in clinical trials.
Objective: To examine the efficacy of lisdexamfetamine (LDX) versus placebo on behavioral attributes of sluggish cognitive tempo (SCT) in adults with attention-deficit/hyperactivity disorder (ADHD) and SCT.
PURPOSE
In MONARCH 2, abemaciclib plus fulvestrant significantly prolonged progression-free survival (PFS) and overall survival (OS) versus placebo plus fulvestrant in patients with hormone receptor positive (HR+), HER2- advanced breast cancer.
Conclusions: The study met its primary endpoint, demonstrating that dalpiciclib plus fulvestrant significantly improved PFS versus placebo plus fulvestrant, with a manageable safety profile.
We included randomized controlled trials (RCTs) in addition to cohort studies that compared tofacitinib oral treatment versus placebo in patients with active UC, with a moderate to severe degree.
We included randomized controlled trials comparing the effects of psychotropic drugs versus placebo or versus another drug of the same class, for at least 5 weeks.
Pairwise comparisons showed greater mean improvement from baseline in MCCB overall composite T-score at week 12 with BI 425809 10 mg and 25 mg versus placebo (adjusted mean difference 1·98 [95% CI 0·43-3·53] for 10 mg and 1·73 [0·18-3·28] for 25 mg; standardised effect size 0·34 for 10 mg and 0·30 for 25 mg).
The study met its primary endpoint: the adjusted mean difference in 2-h C-peptide AUC at 12 months for imatinib versus placebo treatment was 0·095 (90% CI -0·003 to 0·191; p=0·048, one-tailed test).
Patients & methods: PACIFIC was a Phase III study of durvalumab versus placebo after CRT in patients with unresectable, stage III non-small-cell lung cancer.
Ramucirumab plus docetaxel versus placebo plus docetaxel for second-line treatment of stage IV non-small-cell lung cancer after disease progression on platinum-based therapy (REVEL): a multicentre, double-blind, randomised phase 3 trial.
1 Phase 2 results showed deucravacitinib was efficacious and well tolerated versus placebo in patients with moderate to severe plaque psoriasis or active psoriatic arthritis.
Significant improvements in markers of haemolysis, as assessed by the difference in adjusted mean percentage change from baseline at week 72 versus placebo, were observed in the voxelotor 1500 mg group in indirect bilirubin concentrations (-26·6% [95% CI -40·2 to -12·9]) and percentage of reticulocytes (-18·6% [-33·9 to -3·3]).
Among patients with chronic pain, moderate certainty evidence found that medical cannabis probably results in a small improvement in sleep quality versus placebo (modeled risk difference [RD] for achieving the minimally important difference [MID], 8% [95% CI, 3 to 12]).
IR methylphenidate versus placebo We found very low-certainty evidence that, compared with placebo, IR methylphenidate may reduce symptoms of ADHD when measured with investigator-rated scales (MD -20.
Ketorolac versus placebo Very low-certainty evidence from eight studies (658 participants) suggests that ketorolac results in a large increase in the number of participants achieving at least 50% pain relief over four hours compared to placebo, but the evidence is very uncertain (risk ratio (RR) 2.
Patients with compensated cirrhosis with clinically significant portal hypertension will be stratified based upon the concomitant use of nonselective beta-blockers and randomized to simvastatin 40 mg/day versus placebo for up to 24 months.
Patients with compensated cirrhosis with clinically significant portal hypertension will be stratified based upon the concomitant use of nonselective beta-blockers and randomized to simvastatin 40 mg/day versus placebo for up to 24 months.
METHODS AND RESULTS
We performed a systematic review and meta-analysis of RCTs to compare SGLT2i versus placebo (treatment duration >3 months) on cardiac remodelling parameters as measured by cardiac magnetic resonance imaging (cMRI) in patients with HF and/or diabetes.
In a phase 2b dose-ranging study of baricitinib in combination with traditional disease-modifying antirheumatic drugs (DMARDs) in RA patients, magnetic resonance imaging showed that baricitinib 2 mg or 4 mg once daily provided dose-dependent suppression of synovitis, osteitis, erosion and cartilage loss at weeks 12 and 24 versus placebo.
This investigator-initiated phase 2, double-blind, placebo-controlled study of SLE that was refractory to conventional treatment randomly assigned 52 patients to belimumab versus placebo 4 to 8 weeks after treatment with rituximab.
PURPOSE
The double-blind, placebo-controlled, phase III TOURMALINE-MM1 study demonstrated a statistically significant improvement in progression-free survival with ixazomib-lenalidomide-dexamethasone (ixazomib-Rd) versus placebo-Rd in patients with relapsed or refractory multiple myeloma.
The CaCo trial [2], which is an ongoing double-blinded, placebo-controlled, randomized trial comparing the effect of different doses of caffeine versus placebo on bowel recovery after elective colectomy, is also randomizing patients to study groups only after the surgical procedure.
We performed a post hoc analysis of data from a randomized, double-blinded, placebo-controlled trial to investigate the effect that monthly, high-dose vitamin D supplementation (versus placebo) had on older adults with asthma and/or COPD.
METHODS
We searched in databases and gray literature to include randomized controlled clinical trials in adults that compare the use of AED versus placebo or any other medication.
METHODS AND RESULTS
Ovid MEDLINE was searched from 2015 to 15th of September 2020 to include randomized controlled trials that assessed aspirin versus placebo in adults with non-end stage CKD without a previous diagnosis of CVD.
In the phase 2b PATHWAY study, tezepelumab significantly reduced annualized asthma exacerbation rates (AAERs) versus placebo, irrespective of baseline disease characteristics, and improved lung function and symptom control, in adults with severe, uncontrolled asthma.
In phase 2b and 3 studies, tezepelumab significantly reduced exacerbations versus placebo in patients with severe uncontrolled asthma, irrespective of baseline levels of type 2 inflammatory biomarkers.
Results SRI-4 response rates were similar across the paediatric and adult studies; more belimumab-treated patients achieved SRI-4 responses versus placebo (PLUTO: 52.
In case studies, the models were used to compare incremental cost utility of orlistat, rimonabant or sibutramine versus placebo; standard behavioural therapy (SBT) plus meal plans and shopping lists versus SBT alone or nothing; rimonibant versus diet and exercise; and Slimming World versus best supportive care.
Methods This is a randomized phase 2, placebo-controlled, double-blind clinical trial in 198 patients to compare efficacy of degarelix plus best supportive care versus placebo plus best supportive care on improving the clinical outcomes of male Veterans who have been hospitalized due to COVID-19.
Patients were randomized to 1:1 losartan (25 mg orally twice daily unless estimated glomerular filtration rate, eGFR, was reduced, when dosing was reduced to once daily) versus placebo for 10 days, and all patients and outcome assesors were blinded.
ABSTRACT
We previously reported a higher incidence of non-albumin proteinuria and a small but significant decline in estimated glomerular filtration rate among HIV-negative adults randomized to emtricitabine/ tenofovir disoproxil fumarate pre-exposure prophylaxis (FTC/TDF PrEP) versus placebo.
Findings/Results Esketamine plus standard of care demonstrated significantly greater improvement in Montgomery-Åsberg Depression Rating Scale total score versus placebo plus standard of care at 24 hours (least square mean difference [95% confidence interval], −3.
Methods: We reviewed randomized, placebo-controlled trials and used random-effects meta-analysis to compare odds ratio (OR) versus placebo, as well as numbers-needed-to-treat (NNT) and to-harm (NNH), for adding SGAs, esketamine, or lithium to antidepressants for major depressive episodes.
A recent post hoc safety analysis of placebo-controlled trials of JAK inhibitors in rheumatoid arthritis (RA) reported an imbalance in the incidence of VTE for a 4-mg daily dose of baricitinib versus placebo.
Methods and findings The study was based on the resource provided by the Blood Pressure Lowering Treatment Trialists’ Collaboration (BPLTTC), in which individual participant data (IPD) were extracted from trials with over 1,000 patient-years of follow-up in each arm, and that had randomly assigned patients to different classes of BP-lowering drugs, BP-lowering drugs versus placebo, or more versus less intensive BP-lowering regimens.
Methods We did a meta-analysis of individual participant-level data from 48 randomised trials of pharmacological blood pressure lowering medications versus placebo or other classes of blood pressure-lowering medications, or between more versus less intensive treatment regimens, which had at least 1000 persons-years of follow-up in each group.
Introduction In ARIEL3 (NCT01968213), the poly(adenosine diphosphate-ribose) polymerase inhibitor rucaparib significantly improved progression-free survival versus placebo regardless of biomarker status when used as maintenance treatment for recurrent ovarian cancer.
BUP/SAM has shown efficacy versus placebo as an adjunctive treatment for major depressive disorder (MDD) and a consistent safety profile in previously reported, placebo-controlled clinical studies.
Primary outcome was the proportion of responders (20% increase in Timed 25-Foot Walk (T25FW) speed) for 274 mg ADS-5102 versus placebo at end of double-blind (Study Week 16).
Methods/Procedures We conducted a 12-week placebo-controlled, randomized clinical trial of vortioxetine (flexibly dosed from 10 to 20 mg/d) versus placebo in adults with PTSD.
METHODS
We retrospectively studied patients with acute ischemic stroke enrolled in the AXIS-2 trial (AX200 in Ischemic Stroke Trial), a randomized controlled clinical trial of granulocyte colony-stimulating factor versus placebo.
Analysing hand and foot cases together yielded results consistent with the primary clinical efficacy endpoint (ACR20 response rate), as the abatacept 10- and 30/10-mg/kg groups showed significant differences versus placebo at Day 169;2 reduced sample size in separate hand and foot assessments may have prevented finding significant results corresponding to the combined analysis.
among patients with resected renal cell cancer (RCC) in a randomised clinical trial (Eastern Cooperative Oncology trial, E2805), who received adjuvant anti-vascular endothelial growth factor receptor tyrosine kinase inhibitors (TKI), sunitinib or sorafenib versus placebo.
The MONALEESA-3 trial demonstrated the efficacy and safety of ribociclib plus fulvestrant versus placebo plus fulvestrant for patients with hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2−) advanced breast cancer (ABC).
Methods We performed a randomised double-blind placebo-controlled single-centre trial of simvastatin at a daily dose of 40 mg versus placebo in patients with Global Initiative for Chronic Obstructive Lung Disease criteria grades 2–4 at a tertiary care pulmonology department in Austria.
This study evaluated NNT, NNH, and benefit–risk profiles (measured as likelihood to be helped or harmed, LHH) of galcanezumab 120 mg versus placebo in patients with EM or CM.
Caregivers of children on DR/ER-MPH reported significant reductions in CGSQ scores after 3 weeks of DR/ER-MPH treatment versus placebo (least-squares mean: 41.
We included randomized controlled trials (RCTs) in addition to cohort studies that compared tofacitinib oral treatment versus placebo in patients with active UC, with a moderate to severe degree.
Versus Placebo -
95]) versus placebo (0.[1]023) versus placebo; there were no significant differences between active treatments.[2]OBJECTIVE
To evaluate efficacy and safety of aboBoNT-A treatment of moderate-to-severe glabellar lines (GL) versus placebo, using a new reconstitution and injection volume.[3]In a large, rando mized trial of tenofovir disoproxil fumarate (TDF) versus placebo, two of three infants who acquired HBV infection, all in the placebo arm, had a very high HBV DNA load on the day of birth.[4]The clinical effectiveness of these seven drugs was: infliximab (versus placebo): risk ratio (RR) 50.[5]Results: In the pooled core studies, teriflunomide reduced annualized relapse rate (ARR) versus placebo across all ages.[6]5 mg and 3 mg) versus placebo, and 2 administration schedules [downward titration versus 3 times daily (TID)].[7]Results: Time-weighted average reduction in viral load (log10 copies/ml) through day 7 was significantly greater with REGEN-COV (combined 2400mg+8000mg dose groups) versus placebo in patients with baseline viral load >107 copies/ml (prespecified primary endpoint): -0.[8]Across age at asthma onset, lung function and airway reversibility subgroups, mepolizumab reduced the rate of clinically significant exacerbations by 49–63% versus placebo.[9]043]; versus placebo [P = 0.[10]Eine Post-hoc-Analyse von Daten der PhaseIII-SELECTION-Induktionsstudie zeigte bei Patienten mit mäßig bis schwer aktiver CU unter Filgotinib (1 × 200 mg/Tag) versus Placebo signifikante Verbesserungen der patientenberichteten Ergebnisse (PROs) der Stuhlfrequenz (SF) und der rektalen Blutung (RB) bereits in der ersten Behandlungswoche.[11]9–not estimable] versus placebo (n = 48; median 3.[12]5 mg/kg/day masitinib (n = 45) versus placebo (n = 62) in an enriched cohort with ⩾2 on each baseline ALSFRS-R individual component score (i.[13]7%) versus placebo (5/16, 31.[14]The CANTOS study demonstrated reduced incidence of NSCLC and decreased lung cancer-related mortality with canakinumab (interleukin 1β inhibitor) versus placebo, in a dose-dependent manner for patients with atherosclerosis.[15]The LIRA‐ADD2SGLT2i trial demonstrated that liraglutide + sodium‐glucose cotransporter‐2 inhibitors (SGLT2is) ± metformin significantly improved glycaemic control (not body weight) versus placebo in adults with type 2 diabetes (T2D).[16]In Part A of the 2-part, phase 2 LILAC study (NCT02847598), BIIB059 significantly reduced SLE activity, as evidenced by reduced total active joint count (primary endpoint) and higher SLE Responder Index (SRI-4)1 response (a secondary endpoint) versus placebo.[17]0%) versus placebo (4.[18]Ethics and dissemination In this overview, we will undertake an extensive literature search in an attempt to evaluate the potential benefits and risks of treatment with one PDE5i versus another or versus placebo and provide recommendations for clinicians and policy-makers.[19]All randomised clinical trials (RCTs) comparing TXA (intravenous or intra-articular) versus placebo in the arthroscopic ACLR surgery were included.[20]The Medline, Embase, Cochrane Library and Central databases were searched until 28 June 2020 for RCTs in which omega 3 supplementation was used versus placebo to reduce PTB risk.[21]Objectif Etude sur 1 an, evaluant efficacite sur Somnolence Diurne Excessive (SDE) et tolerance de Pitolisant (P), agent eveillant agoniste inverse des recepteurs H3 (histamine) versus placebo (pl) chez des patientsavec syndrome d’apnees obstructives du sommeil (SAOS) modere a severe ayant refuse la PPC.[22]Only prospective clinical trials randomly assigning COVID‐19 patients to HCQ plus standard of care therapy (test arm) versus placebo/standard of care (control arm) were included.[23]32]) versus placebo‐fulvestrant.[24]Objective: To evaluate the clinical efficacy and safety of oral mifepristone (10 mg/day) versus placebo in the preoperative treatment of uterine fibroids.[25]In Protocol 2 (proof‐of‐concept overnight study; n=12), we compared the effects of local heat (38°C applied with a water‐perfused heating pad placed under the torso from 10 pm to 6 am) versus placebo pill.[26]In Study E2006-G000-303 (Study 303; SUNRISE-2; NCT02952820), significantly greater percentages of subjects reported a positive impact of the dual orexin receptor antagonist lemborexant (LEM) versus placebo (PBO) at 1, 3, and 6mo for each of the PGI-I items related to medication effects.[27]The most relevant results were the significant reduction in the perception of physical fatigue in the Mel-Zinc group at the final treatment follow-up versus placebo (p < 0.[28]77) versus placebo reduced HHF, whereas none reduced MI and stroke.[29]001) versus placebo (-1.[30]Twenty-three trials conducted in adults with AIT comparing the efficacy of selenium with or without levothyroxine (LT4) versus placebo and/or LT4 were eligible.[31]In a later phase, patients with IVD were randomized to receive zinc (15 mg daily) versus placebo.[32]Differences in TNSS AUC(0-1 hr) versus placebo (day 8: -1.[33]The objective of this study was to compare a single intra-articular injection of an innovative high and low molecular weight hyaluronic acid formulation (HA-HL) versus placebo in treating moderate-to-severe symptomatic knee osteoarthritis.[34]DESIGN
Using leg arteriovenous balance technique and analyses of thigh muscle biopsies, we investigated the effect of beta2-agonist (24 mg oral salbutamol) versus placebo on leg glucose, lactate, and oxygen exchange before, during, and 0.[35]8%, 33/79) versus placebo (25.[36]5 mg/d versus placebo in mean change from baseline in FAST total score (p<.[37]We aimed to evaluate the efficacy/safety of lemborexant 5 mg (LEM5) and 10 mg (LEM10) versus placebo once daily in a subset of Japanese patients with insomnia and to compare the results with those of non-Japanese patients.[38]We also assessed data for the primary and secondary outcomes by patient subgroups (tobacco use; age <65 years or older; sex; time to diagnosis; CAS score 4 or 5, or 6 or 7; and thyrotropin binding inhibiting immunoglobulin [TBII] concentration <10 IU/L or ≥10 IU/L) versus placebo.[39]We compared the sequential regimen of topical calcitriol and methyl aminolevulinate (MAL) daylight-PDT (CAL-DL-PDT) versus placebo and MAL-DL-PDT (P-DL-PDT) on acral AKs in an intra-individual, randomized trial.[40]In the phase III BLISS-SC trial, subcutaneous (SC) belimumab 200 mgplus standard therapy was associated with significant reductions in time to severe flare, and risk of flares, versus placeboplus standard therapy, in adults with active SLE.[41]Healthy adults were randomly assigned to cohort 1 (n = 5; 3:2), cohort 2 (n = 8; 6:2), cohort 3, or cohort 4 (both n = 10; 8:2) to receive SCTA01 (5, 15, 30, and 50 mg/kg, respectively) versus placebo.[42]Finerenone also significantly reduced the primary kidney (time to kidney failure, sustained decrease in eGFR ≥40% from baseline, or renal death) and key secondary CV outcomes (time to CV death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for heart failure) versus placebo, with no clear difference due to GLP-1RA use at baseline (P value for interaction 0.[43]This analysis of phase 2 data quantified the benefit and risk of zuranolone (30mg) versus placebo and antidepressants in terms of number needed to treat (NNT) and number needed to harm (NNH).[44]4%, 75 of 133) versus placebo (29.[45]Findings 709 patients across eight centres were randomized to melatonin (n = 356) versus placebo (n = 353).[46]The PREDESCI study examined the role of NSBB in preventing decompensation, with patients allocated to propranolol, or carvedilol in HVPG nonresponders, versus placebo.[47]Dazu gehören Studien mit Nivolumab (versus Beobachtung) beim Merkel-Zell-Karzinom sowie Cemiplimab und Pembrolizumab (versus Placebo) beim kutanen Plattenepithelkarzinom.[48]High-sensitive (hs) troponin-I pre-PCI was similar between treatment groups (colchicine: 79 ng/L [4–1336] versus placebo: 35 [5–448], P=0.[49]Anti-IL-4Rα mAb (dupilumab) versus placebo/no treatment (all receiving intranasal steroids) Three studies (784 participants) evaluated dupilumab.[50]
Methods: This randomized controlled trial will assess the effect of 6 months of PAP therapy versus placebo on global cognitive function in PD patients with OSA and reduced baseline cognition.
70 individuals were enrolled in a parallel-group, randomized, double-blind, placebo-controlled, forced-titration trial of CBZ (n=35) versus placebo (n=35).[1]METHODS
This was a randomized, double-blind, placebo-controlled trial of sucralfate versus placebo conducted between 2017 and 2018 in an urban pediatric emergency department.[2]Study participants were TC survivors with a mild Leydig cell insufficiency who participated in a randomized double-blind study of testosterone replacement therapy versus placebo for 52 weeks (N = 69).[3]The Colchicine in STEMI Patients Study (COVERT-MI) is an ongoing confirmative prospective, multicenter, randomized, double-blind trial testing whether a short course oral treatment with colchicine versus placebo decreases myocardial injury in patients presenting with STEMI referred for PPCI.[4]DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS
BETonMACE was an event-driven, randomized, double-blind, placebo-controlled trial comparing effects of apabetalone versus placebo on major adversecardiovascular events and heart failure hospitalizations in 2425 participants with type 2 diabetes and a recent acute coronary syndrome, including 288 participants with CKD with eGFR <60 ml/min per 1.[5]SEAL was a Phase 2-3 randomized, double-blind, study of selinexor versus placebo in pts with progressive DDLS and 2-5 prior systemic therapies.[6]This single-center, randomized, double-blind, two-way crossover study (NCT04155047) evaluated the efficacy of a single dose of nebulized LAMA [glycopyrrolate (GLY) 25 µg] versus placebo in patients with COPD and lung hyperinflation.[7]Introduction Pembrolizumab plus chemotherapysignificantly improved survival outcomes versus placeboplus chemotherapy in patients with previously untreated metastatic squamous NSCLC in the randomized, double-blind, phase 3 KEYNOTE-407 study.[8]Methods We performed an 18-week, randomized, double-blind, placebo-controlled crossover pilot study examining the effect of sodium bicarbonate therapy versus placebo on vascular function in 20 adult KTRs at least 1 year from transplant with an estimated glomerularfiltration rate (eGFR) ≥45 ml/min per 1.[9]We performed a randomized, double-blind, placebo-controlled trial of a 5-day course of 20 mg oral furosemide versus placebo in women with gestational hypertension and preeclampsia with/without severe features from June 2018 to October 2019.[10]Methods This was a phase II randomized, double-blind, placebo-controlled pilot study with 2:1 random parallel group assignment to daily extended-release oral lorcaserin 20 mgversus placebo (clinicaltrials.[11]A total of 1142 patients with TRD participated from four multicenter, randomized, double-blind, phase III studies: three short-term studies (two in patients aged 18–64 years, one in patients ≥65 years), and one long-term maintenance study of esketamine nasal spray + AD versus placebonasal spray + AD.[12]This was a single-center randomized, double-blind crossover phase IIclinical trial of SGS-742 versus placebo in patients with succinic semialdehyde dehydrogenase deficiency.[13]Methods
This was a randomized, double-blind pilot clinical trial comparing NTZ 600 mg BID versus Placebo for seven days among 50 individuals (25 each arm) with SARS-COV-2 RT-PCR+ (PCR) that were hospitalized with mild respiratory insufficiency from May 20th, 2020, to September 21st, 2020 (ClinicalTrials.[14]gov identifier: NCT02763579), a randomized, double-blind, phase I/III study, demonstrated that adding atezolizumab (anti-programmed death-ligand 1 [PD-L1]) to carboplatin plus etoposide (CP/ET) for first-line (1L) treatment of extensive-stage small-cell lung cancer (ES-SCLC) resulted in significant improvement in overall survival (OS) and progression-free survival (PFS) versus placebo plus CP/ET.[15]BAN2401-G000-201, a randomized double-blind clinical trial, utilized a Bayesian design with response-adaptive randomization to assess 3 doses across 2 regimens of lecanemab versus placebo in early Alzheimer’s disease, mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD dementia.[16]Patients and Methods This randomized, double-blind, Phase III local registration trial compared the efficacy and safety of pregabalin (flexibly dosed 300–450 mg/day) versus placebo for the management of pain in Chinese adults diagnosed with FM according to American College of Rheumatology 1990 criteria, across 22 centers within China.[17]Methods: This is a post-hoc analysis of LUMINA-1 (NCT03188666) a phase 2, randomized, double-blind, placebo-controlled study, which evaluated the safety and efficacy of GAR (10 mg/kg/week IV) versus placebo (PBO) in adult patients with FOP over 28 weeks.[18]Methods Data were pooled from 2 randomized double-blind trials of the effects of 1 week of pancrelipase (n = 59) versus placebo (n = 57) on CFA and stool frequency, stool consistency, abdominal pain, and flatulence; 1 trial included a 51-week open-label pancrelipase treatment period (n = 34).[19]IMPLICATIONS
We present the largest randomized, double-blind, placebo-controlled clinical trial of cyproheptadine versus placebo in healthy adults with poor appetite using the lowest effective dosage of cyproheptadine.[20]Methods: This was a randomized, double-blind, placebo-controlled, two-arm, parallel study on COVID-19 female outpatients, that compared the use of proxalutamide versus placebo.[21]Methods: The in vitro effect of NTZ in VERO E6 cells was evaluated, followed by a randomized double-blind phase two clinical trial comparing NTZ 600 mg BID versus placebo for 7 days among 50 individuals (25 each arm) with SARS-COV-2 RT-PCR+ (PCR) that were hospitalized with mild respiratory insufficiency.[22]METHODS
This is a secondary analysis of a randomized, double-blind, placebo-controlled clinical trial (n = 60) originally designed to examine the effect of atorvastatin (n = 27) versus placebo (n = 33) for lithium-induced diabetes insipidus in BD and MDD patients who were using lithium.[23]
We tested this hypothesis in a follow-up study of children born to obese mothers who had participated in a randomised controlled trial of metformin versus placebo in pregnancy (EMPOWaR).[1]5 In a multicenter exploratory, randomised controlled trial of various pharmacologic agents used for PDA closure versus placebo in 202 very preterm infants (<28 weeks' gestation) of whom 49% were intubated on IMV and 48% required nasal ventilation of CPAP, treated at 6– 14 days after birth, no differences in rates of ligation, the presence of PDA at hospital discharge, nor any differences in NEC, BPD, BPD and/or death, or death were found among those receiving pharmacologic closure versus placebotreated infants, while the rate of lateonset neonatal sepsis was increased among treated infants.[2]Methods We determined the rs12936231 genotype of mother–child pairs from two randomised controlled trials: the Vitamin D Antenatal Asthma Reduction Trial (VDAART, n=613) and the Copenhagen Prospective Studies on Asthma in Childhood 2010 (COPSAC2010, n=563), to examine the effect of maternal genotype variation on offspring asthma/recurrent wheeze at age 0–3 years between groups who received high-dose prenatal vitamin D3 supplementation versus placebo.[3]SELECTION CRITERIA
We included randomised controlled trials (RCTs) and quasi-RCTs comparing oral dextrose gel versus placebo, no intervention, or other therapies for the prevention of neonatal hypoglycaemia.[4]In a randomised controlled trial (RCT) of zoledronic acid versus placebo in men commencing extended-duration ADT, we aimed to examine the effects on fat mass and glucose metabolism.[5]SELECTION CRITERIA
Randomised controlled trials of active drugversus placebo in people with ESRD undergoing haemodialysis via an AVF or prosthetic interposition AVG.[6]Methods We did a meta-analysis using individual participant-level data from randomised controlled trials of pharmacological blood-pressure-lowering versus placebo or other classes of blood-pressure-lowering medications, or between more versus lessintensive treatment strategies, which had at least 1000 persons-years of follow-up in each treatment group.[7]Methods - Due to the post-hoc nature of the ACS-to-birth interval, a randomised controlled trial (RCT) of ACS versus placebo is not able to examine the importance of the interval.[8]Due to the post hoc nature of the ACS-to-birth interval, a randomised controlled trial (RCT) of ACS versus placebo is not able to examine the importance of the interval.[9]SELECTION CRITERIA
We selected randomised controlled trials of medication versus placebo or other medication for TTM in adults, children and adolescents.[10]SELECTION CRITERIA
We included randomised controlled trials (RCTs) comparing CHM versus placebo, no treatment or conventional (western) therapies for the treatment of subfertile women with PCOS.[11]SELECTION CRITERIA
We included all prospective randomisedcontrolled trials evaluating the effect of administration of antihelminthics versus placebo or no treatment during the second or third trimester of pregnancy; both individual-randomised and cluster-randomised trials were eligible.[12]MATERIALS AND METHODS
Seven international and Chinese databases were searched for randomised controlled trials (RCTs) on HM versus placebo.[13]SELECTION CRITERIA
Randomised controlled trials of PCV versus placebo or control vaccine.[14]
METHODS
92 biomarkers associated with immunity, chemotaxis, and metabolism were measured in plasma samples from 61 PWH with NAFLD who participated in a double-blind, randomized trial of tesamorelin versus placebo for 12 months.[1]STUDY DESIGN
A prospective double-blind randomized controlled trial of mupirocin versus placebo in S.[2]METHODS
We conducted a double-blind, randomized trial of lidocaine nasal sprayversus placebo (saline) before EM and PM.[3]Methods: This prospective, multicenter, double-blind, randomized, controlled phase 2 trial evaluated the efficacy and safety of a single 10 mg/kg dose of teprasiran versus placebo (1:1), in reducing the incidence, severity, and duration of AKI after cardiac surgery in high-risk patients.[4]A double-blind randomized clinical trial was designed to use Magnetic Tape® versus placebo Kinesio tape.[5]Methods The phase 3 BETonMACE trial was a double-blind, randomized comparison of apabetalone versus placebo on the incidence of major adversecardiovascular events (MACE) in 2425 patients with a recent ACS and diabetes.[6]performed a double-blind, randomized controlled trial exploring host-directed effects of the MMP inhibitor doxycycline versus placebo when added to standard ATT for pulmonary tuberculosis.[7]This was a pre-planned secondary analysis of a double-blind, randomized clinical trial comparing the use of a single dose of lorazepam plus haloperidol versus placebo plus haloperidol in patients with agitated delirium.[8]Conclusions: This double-blind, randomized controlled trial (RCT) of an herbal galactagogue versus placebo among healthy, exclusively/fully breastfeeding mothers and infants found no adverse events associated with the test tea across the 30-day study or the first year of their infant’s life.[9]
Methods
This randomized clinical trial compared HCTZ 50 mgversus placebo for 3 days in patients with ADHF and signs of congestion.[1]RESEARCH QUESTION
Does a single high-dose (540,000 IU) enteral treatment of vitamin D3 given shortly after hospital admission in vitamin D deficient, critically-ill patients improve long-term global cognition or executive function?
STUDY DESIGN AND METHODS
This study evaluated long-term cognitive outcomes among patients enrolled in a multicenter, blinded, randomized clinical trial comparing vitamin D3 treatment versus placebo in critically-ill adults with vitamin D deficiency.[2]This randomized clinical trial compared HCTZ 50 mgversus placebo for 3 days in patients with ADHF and signs of congestion.[3]In total, 62 randomized clinical trials were included that enrolled 3546 participants diagnosed with various diseases (approximately 20 types of diseases) treated with intravenous or local implantation versus placebo or no treatment.[4]A pooled analysis of five randomized clinical trials (RCTs), including 1187 patients, concluded that MIRA 50 mg was associated with a greater reduction in frequency versus placebo (-0.[5]Methods: This randomized clinical trial compared HCTZ 50 mgversus placebo for 3 days in patients with ADHF and signs of congestion.[6]Randomized clinical trials (RCTs) that evaluated golimumab and infliximab versus placebo or conventional therapy were sought.[7]Using data from a phase III, multicenter, randomized clinical trial (NCT02137772, registered May 14, 2014), this study assessed CMV-associated and all-cause re-hospitalizations at weeks 14, 24, and 48 post-transplant among recipients of letermovir versus placebo.[8]To obtain more thorough understanding of the clinical efficacy and safety, a randomized clinical trial was conducted comparing intra-articular (IA) administration of single 6 ml Hylan G-F 20 injection versus placebo in knee OA patients of Chinese ethnicity.[9]
Methods We performed a randomised double-blind placebo-controlled single-centre trial of simvastatin at a daily dose of 40 mg versus placebo in patients with Global Initiative for Chronic Obstructive Lung Disease criteria grades 2–4 at a tertiary care pulmonology department in Austria.[1]We report results of pooled analyses from 2 randomised, double-blind, placebo-controlled phase 3 studies (SINUS 24 [NCT02912468]; SINUS-52 [NCT02898454]) to evaluate dupilumab effect versus placebo in adults with CRSwNP with/without SCS use and sinonasal surgery.[2]Here we report on a prospective, randomised, double-blind, placebo-controlled trial of two doses of HTD1801 (berberine ursodeoxycholate, an ionic salt of berberine and ursodeoxycholic acid), versus placebo that was conducted in 100 subjects with fatty liver disease and diabetes (NCT03656744).[3]OBJECTIVE
We present results from BALANCE-CF™ 1, a Phase II, placebo-controlled, randomised, double-blind study of four dose levels of BI 1265162 versus placebo for 4 weeks on top of standard of care in adults and adolescents with CF.[4]A randomised, double-blind, placebo-controlled, three-period, crossover, phase II study was performed to investigate the bronchodilator effect of IND/GLY/MF (150/50/80 μg) dosed morning and evening versus placebo in patients with mild-moderate asthma.[5]Licogliflozin versus placebo in women with polycystic ovary syndrome (PCOS): a randomised, double-blind, phase 2 trial.[6]In a phase 2, randomised, double-blind, placebo-controlled trial in adults with moderately-to-severely active ulcerative colitis [OASIS], etrasimod 2 mg provided significant benefitversus placebo and was generally well tolerated.[7](2014) Panobinostat plus bortezomib and dexamethasone versus placeboplus bortezomib and dexamethasone in patients with relapsed or relapsed and refractory multiple myeloma: a multicentre, randomised, double-blind phase 3 trial.[8]
The outcome data were extracted via hazard ratio (HR) and 95% confidence interval (CI) of gliflozins versus placebo.[1]In T2DM patients with obesity, GLP-1 RAs significantly reduced the risk of MACE versus placebo (relative risk, RR [95% confidence interval, CI]: 0.[2]After 8 weeks of treatment, fasting serum glucose decreased from baseline with tirzepatide versus placebo; the least squares (LS) mean decrease compared with placebo (95% confidence interval [CI]) was 52.[3]Main outcomes included pooled and single study point estimaates (in the absence of pooled estimates) with c