randomized controlled trials as topic


Summary: Works about clinical trials that involve at least one test treatment and one control treatment, concurrent enrollment and follow-up of the test- and control-treated groups, and in which the treatments to be administered are selected by a random process, such as the use of a random-numbers table.

Top Publications

  1. Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, et al. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA. 1996;276:637-9 pubmed
  2. Rennie D. CONSORT revised--improving the reporting of randomized trials. JAMA. 2001;285:2006-7 pubmed
  3. Wijeysundera D, Bender J, Beattie W. Alpha-2 adrenergic agonists for the prevention of cardiac complications among patients undergoing surgery. Cochrane Database Syst Rev. 2009;:CD004126 pubmed publisher
    ..Additionally, future research must determine which specific alpha-2 adrenergic agonist should be used, and whether it is safe to combine them with other perioperative interventions (for example beta-adrenergic blockade). ..
  4. Altman D, Bland J. Absence of evidence is not evidence of absence. BMJ. 1995;311:485 pubmed
  5. . A proposal for structured reporting of randomized controlled trials. The Standards of Reporting Trials Group. JAMA. 1994;272:1926-31 pubmed
  6. Lachin J. Statistical considerations in the intent-to-treat principle. Control Clin Trials. 2000;21:167-89 pubmed
    ..In such cases, a landmark analysis using the observations from the last patient evaluation is likely to prove more powerful than life-table or longitudinal analyses. Examples are described. ..
  7. Luce B, Kramer J, Goodman S, Connor J, Tunis S, Whicher D, et al. Rethinking randomized clinical trials for comparative effectiveness research: the need for transformational change. Ann Intern Med. 2009;151:206-9 pubmed
  8. Moher D, Hopewell S, Schulz K, Montori V, Gøtzsche P, Devereaux P, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c869 pubmed publisher
  9. Mukerji S, MacIntyre C, Seale H, Wang Q, Yang P, Wang X, et al. Cost-effectiveness analysis of N95 respirators and medical masks to protect healthcare workers in China from respiratory infections. BMC Infect Dis. 2017;17:464 pubmed publisher
    ..In the case of a highly pathogenic pandemic, respirator use in HCWs would likely be a cost-effective intervention. ..

More Information


  1. Romantsik O, Calevo M, Bruschettini M. Head midline position for preventing the occurrence or extension of germinal matrix-intraventricular hemorrhage in preterm infants. Cochrane Database Syst Rev. 2017;7:CD012362 pubmed publisher
  2. Choi S, Oh D, Jerng U. A systematic review of the pharmacokinetic and pharmacodynamic interactions of herbal medicine with warfarin. PLoS ONE. 2017;12:e0182794 pubmed publisher
    ..Additional studies that remedy these vulnerabilities are necessary to verify these results. ..
  3. Li M, Yang Y, Jiang D, Ying M, Wang Y, Zhao R. Efficacy and safety of liraglutide versus sitagliptin both in combination with metformin in patients with type 2 diabetes: A systematic review and meta-analysis. Medicine (Baltimore). 2017;96:e8161 pubmed publisher
    ..Meanwhile, the adverse reactions such as gastrointestinal problems were common in the liraglutide treatment group. Thus, this will provide an important reference for the treatment of patients with type 2 diabetes. ..
  4. Shea B, Reeves B, Wells G, Thuku M, Hamel C, Moran J, et al. AMSTAR 2: a critical appraisal tool for systematic reviews that include randomised or non-randomised studies of healthcare interventions, or both. BMJ. 2017;358:j4008 pubmed publisher
  5. Moore K, Tritchler D, Kaufman K, Lankes H, Quinn M, Van Le L, et al. Genome-wide association study evaluating single-nucleotide polymorphisms and outcomes in patients with advanced stage serous ovarian or primary peritoneal cancer: An NRG Oncology/Gynecologic Oncology Group study. Gynecol Oncol. 2017;147:396-401 pubmed publisher
    ..The SNP's identified in this GWAS study will require validation and these preliminary findings may lead to identification of novel pathways and biomarkers. ..
  6. Capetti A, Astuti N, Cattaneo D, Rizzardini G. Pharmacokinetic drug evaluation of dolutegravir plus rilpivirine for the treatment of HIV. Expert Opin Drug Metab Toxicol. 2017;13:1183-1192 pubmed publisher
    ..Further data from these studies may help elucidate the possible advantage in terms of safety and metabolic effect in the next few months. ..
  7. Cai S, Bressler N. Aflibercept, bevacizumab or ranibizumab for diabetic macular oedema: recent clinically relevant findings from DRCR.net Protocol T. Curr Opin Ophthalmol. 2017;28:636-643 pubmed publisher
    ..When visual acuity loss is moderate or worse, aflibercept is more likely to improve visual acuity. ..
  8. Tieu J, Middleton P, Crowther C, Shepherd E. Preconception care for diabetic women for improving maternal and infant health. Cochrane Database Syst Rev. 2017;8:CD007776 pubmed publisher
    ..We have identified three ongoing studies that we will consider in the next review update. ..
  9. Li W, Wang B. Efficacy and safety of transepithelial corneal collagen crosslinking surgery versus standard corneal collagen crosslinking surgery for keratoconus: a meta-analysis of randomized controlled trials. BMC Ophthalmol. 2017;17:262 pubmed publisher
    ..35, 95% CI -0.43 to 9.13, P?=?0.07)). The standard CXL is more effective in decreasing the maximum keratometry than the transepithelial CXL; the transepithelial CXL provided favorable visual outcomes; they both exhibit similar safety. ..
  10. Villanti A, Collins L, Niaura R, Gagosian S, Abrams D. Menthol cigarettes and the public health standard: a systematic review. BMC Public Health. 2017;17:983 pubmed publisher
  11. Rimassa L, Pressiani T, Personeni N, Santoro A. Regorafenib for the treatment of unresectable hepatocellular carcinoma. Expert Rev Anticancer Ther. 2017;17:567-576 pubmed publisher
    ..The RESORCE trial demonstrates the beneficial effect of a sequential approach involving two multikinase inhibitors, namely sorafenib and regorafenib, whose antitumor activity extends beyond their antiangiogenic functions...
  12. Rossi A, Latiano T, Parente P, Chiarazzo C, Limosani F, Di Maggio G, et al. The potential role of nintedanib in treating colorectal cancer. Expert Opin Pharmacother. 2017;18:1153-1162 pubmed publisher
  13. Wander S, Mayer E, Burstein H. Blocking the Cycle: Cyclin-Dependent Kinase 4/6 Inhibitors in Metastatic, Hormone Receptor-Positive Breast Cancer. J Clin Oncol. 2017;35:2866-2870 pubmed publisher
    ..The patient reported mild pain that was adequately controlled with over-the-counter anti-inflammatory medications. She has remained active with an excellent performance status. ..
  14. Roy N, Fortin P, Bull K, Doree C, Trivella M, Hopewell S, et al. Interventions for chronic kidney disease in people with sickle cell disease. Cochrane Database Syst Rev. 2017;7:CD012380 pubmed publisher
    ..Trials of hydroxyurea, ACEI or red blood cell transfusion in older children and adults are urgently needed to determine any effect on prevention or reduction kidney complications in people with SCD. ..
  15. Miller A, Sellnow T, Neuberger L, Todd A, Freihaut R, Noyes J, et al. A Systematic Review of Literature on Effectiveness of Training in Emergency Risk Communication. J Health Commun. 2017;22:612-629 pubmed publisher
    ..However, certainty of findings was at best moderate due to lack of methodological rigor in most studies. ..
  16. Nicol A, Hurley R, Benzon H. Alternatives to Opioids in the Pharmacologic Management of Chronic Pain Syndromes: A Narrative Review of Randomized, Controlled, and Blinded Clinical Trials. Anesth Analg. 2017;125:1682-1703 pubmed publisher
    ..Utilization of rigorous and homogeneous research methodology would likely allow for better consistency and reproducibility, which is of utmost importance in guiding evidence-based care...
  17. Viani G, Fendi L. Adjuvant treatment or primary topical monotherapy for ocular surface squamous neoplasia: a systematic review. Arq Bras Oftalmol. 2017;80:131-136 pubmed publisher
    ..v) Primary topical 5-FU versus MMC versus interferon (IFN) showed similar rates of tumor recurrence, mild side effects for all drugs, and more severe side effects in the 5-FU arm, followed successively by MMC and IFN (level III, GR C). ..
  18. Wiffen P, Derry S, Bell R, Rice A, Tölle T, Phillips T, et al. Gabapentin for chronic neuropathic pain in adults. Cochrane Database Syst Rev. 2017;6:CD007938 pubmed publisher
    ..Over half of those treated with gabapentin will not have worthwhile pain relief but may experience adverse events. Conclusions have not changed since the previous update of this review. ..
  19. Liu B, Liu R, Wang L. A meta-analysis of the preoperative use of gabapentinoids for the treatment of acute postoperative pain following spinal surgery. Medicine (Baltimore). 2017;96:e8031 pubmed publisher
    ..Further studies should determine the optimal dose and whether pregabalin is superior to gabapentin in controlling acute pain after spine surgery. ..
  20. Paauw N, Terstappen F, Ganzevoort W, Joles J, Gremmels H, Lely A. Sildenafil During Pregnancy: A Preclinical Meta-Analysis on Fetal Growth and Maternal Blood Pressure. Hypertension. 2017;70:998-1006 pubmed publisher
    ..The greatest beneficial effects on fetal growth are with dosages greater than those currently used in human studies. ..
  21. Dooley D, Lam P, Ahmed A, Aronow W. The Role of Positive Inotropic Drugs in the Treatment of Older Adults with Heart Failure and Reduced Ejection Fraction. Heart Fail Clin. 2017;13:527-534 pubmed publisher
    ..However, recommendations from national heart failure guidelines may be generalized to older HFrEF patients on an individual basis, taking into consideration the basic geriatric principles of pharmacotherapy: start low and go slow. ..
  22. Momany M, Martinez Gutierrez J, Soto M, Capurro D, Ciampi F, Thompson B, et al. Development of mobile technologies for the prevention of cervical cancer in Santiago, Chile study protocol: a randomized controlled trial. BMC Cancer. 2017;17:847 pubmed publisher
    ..If successful, this strategy may reduce the incidence of cervical cancer. Clinicaltrials.gov NCT02376023 Registered 2/17/2015. First participant enrolled Feb 22nd 2016. ..
  23. Poitras V, Gray C, Janssen X, Aubert S, Carson V, Faulkner G, et al. Systematic review of the relationships between sedentary behaviour and health indicators in the early years (0-4 years). BMC Public Health. 2017;17:868 pubmed publisher
  24. Zeng W, Liu Z, Dai H, Yan M, Luo H, Ke M, et al. Anti-fibrotic, anti-VEGF or radiotherapy treatments as adjuvants for pterygium excision: a systematic review and network meta-analysis. BMC Ophthalmol. 2017;17:211 pubmed publisher
    ..Adjuvants such as MMC, bevacizumab, and ?-RT could effectively prevent recurrence following pterygium excision. However, their efficacy and acceptability require further clarification in future randomized controlled trials. ..
  25. Sheng L, Li Z. Adjuvant treatment with monosialoganglioside may improve neurological outcomes in neonatal hypoxic-ischemic encephalopathy: A meta-analysis of randomized controlled trials. PLoS ONE. 2017;12:e0183490 pubmed publisher
    ..However, these findings should be interpreted with caution because of methodological flaws in the included trials. Furthermore, safety of monosialoganglioside use should also be further evaluated. ..
  26. Rogers S, Garcia C, Wu S. Discontinuation of Everolimus Due to Related and Unrelated Adverse Events in Cancer Patients: A Meta-Analysis. Cancer Invest. 2017;35:552-561 pubmed publisher
    ..3% and 4.7% respectively. Relative risk of everolimus discontinuation due to related AE was 2.60. Risk of discontinuation varied by tumor type, however everolimus dose or concomitant chemotherapy was not significant. ..
  27. Alfirevic Z, Stampalija T, Dowswell T. Fetal and umbilical Doppler ultrasound in high-risk pregnancies. Cochrane Database Syst Rev. 2017;6:CD007529 pubmed publisher
    ..Serial monitoring of Doppler changes in ductus venosus may be beneficial, but more studies of high quality with follow-up including neurological development are needed for evidence to be conclusive. ..
  28. Charalampopoulos D, Hesketh K, Amin R, Paes V, Viner R, Stephenson T. Psycho-educational interventions for children and young people with Type 1 Diabetes in the UK: How effective are they? A systematic review and meta-analysis. PLoS ONE. 2017;12:e0179685 pubmed publisher
    ..prospero crd42015010701. ..
  29. Bosch J, Eikelboom J, Connolly S, Bruns N, Lanius V, Yuan F, et al. Rationale, Design and Baseline Characteristics of Participants in the Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) Trial. Can J Cardiol. 2017;33:1027-1035 pubmed publisher
  30. Westby M, Dumville J, Soares M, Stubbs N, Norman G. Dressings and topical agents for treating pressure ulcers. Cochrane Database Syst Rev. 2017;6:CD011947 pubmed publisher
  31. Lakdawalla D, Shafrin J, Hou N, Peneva D, Vine S, Park J, et al. Predicting Real-World Effectiveness of Cancer Therapies Using Overall Survival and Progression-Free Survival from Clinical Trials: Empirical Evidence for the ASCO Value Framework. Value Health. 2017;20:866-875 pubmed publisher
    ..Real-world OS treatment benefits were similar to those observed in RCTs based on OS endpoints, but were 16% less than RCT efficacy estimates based on surrogate endpoints. These results, however, varied by tumor and line of therapy. ..
  32. Assem N, Alves M, Lopes A, Gualberto E, Garcia V, Theodoro L. Antibiotic therapy as an adjunct to scaling and root planing in smokers: a systematic review and meta-analysis. Braz Oral Res. 2017;31:e67 pubmed publisher
    ..These clinical improvements, although statistically significant, appeared to be of little clinical relevance. ..
  33. Chaput J, Gray C, Poitras V, Carson V, Gruber R, Birken C, et al. Systematic review of the relationships between sleep duration and health indicators in the early years (0-4 years). BMC Public Health. 2017;17:855 pubmed publisher
    ..Better-quality studies with stronger research designs that can provide information on dose-response relationships are needed to inform contemporary sleep duration recommendations. ..
  34. Morris C. Biopolitics and Boundary Work in South Africa's Sutherlandia Clinical Trial. Med Anthropol. 2017;36:685-698 pubmed publisher
  35. Wang X, Sun Y, Wang L, Hao X. Femoral nerve block versus fascia iliaca block for pain control in total knee and hip arthroplasty: A meta-analysis from randomized controlled trials. Medicine (Baltimore). 2017;96:e7382 pubmed publisher
    ..5) Publication bias in present meta-analysis may influence the results. ..
  36. Bundhun P, Janoo G, Yanamala C, Huang F. Adverse cardiovascular events associated with biodegradable polymer drug-eluting stents and durable polymer everolimus-eluting stents: A systematic review and meta-analysis of 10 randomized controlled trials. Medicine (Baltimore). 2017;96:e7510 pubmed publisher
    ..38-1.17, P?=?.16, these results were not statistically significant. Between 6 months and 3 years, BP-DES were similar in terms of cardiovascular outcomes compared to DP-EES. However, further long-term follow-up research is recommended. ..
  37. Martí Carvajal A, Ramon Pardo P, Javelle E, Simon F, Aldighieri S, Horvath H, et al. Interventions for treating patients with chikungunya virus infection-related rheumatic and musculoskeletal disorders: A systematic review. PLoS ONE. 2017;12:e0179028 pubmed publisher
    ..Rigorous trials with sufficient statistical power are urgently needed, with results stratified by disease stage and symptomology. ..
  38. Schmidt Hansen M, Bennett M, Arnold S, Bromham N, Hilgart J. Oxycodone for cancer-related pain. Cochrane Database Syst Rev. 2017;8:CD003870 pubmed publisher
    ..For clinical purposes, oxycodone or morphine can be used as first-line oral opioids for relief of cancer pain in adults. ..
  39. Nammas W, Pietilä M, Romppanen H, Sia J, Debelder A, Karjalainen P. Outcome of poor initial TIMI flow in patients presenting with acute coronary syndrome. Scand Cardiovasc J. 2017;51:248-254 pubmed publisher
    ..Definite ST occurred more in patients with poor, versus good, initial TIMI flow, mainly driven by difference in early events. ..
  40. Hosseini H, Kaklamanos E, Athanasiou A. Treatment outcomes of pre-surgical infant orthopedics in patients with non-syndromic cleft lip and/or palate: A systematic review and meta-analysis of randomized controlled trials. PLoS ONE. 2017;12:e0181768 pubmed publisher
    ..However, given the multitude of parameters, which may have affected the results, good practice would suggest further research, in order to reach more robust relevant recommendations for management decisions in individual cases. ..
  41. Lipman D, Pieters B, de Reijke T. Improving postoperative radiotherapy following radical prostatectomy. Expert Rev Anticancer Ther. 2017;17:925-937 pubmed publisher
    ..In this way, patients with only high risk pathological features can avoid unnecessary treatment and toxicity, and early intervention in progressing patients would not compromise the outcome. ..
  42. Arentz S, Smith C, Abbott J, Bensoussan A. Nutritional supplements and herbal medicines for women with polycystic ovary syndrome; a systematic review and meta-analysis. BMC Complement Altern Med. 2017;17:500 pubmed publisher
    ..High quality trials of nutritional supplements and herbal medicines examining menstrual regulation and adverse effects in women with PCOS are needed. ..
  43. Ziehm S, Rosendahl J, Barth J, Strauss B, Mehnert A, Koranyi S. Psychological interventions for acute pain after open heart surgery. Cochrane Database Syst Rev. 2017;7:CD009984 pubmed publisher
  44. Li M, Zhang X, Bao H, Li C, Zhang P. Acupuncture for asthma: Protocol for a systematic review. Medicine (Baltimore). 2017;96:e7296 pubmed publisher
    ..It is not necessary for ethical approval because individuals cannot be identified. The protocol will be disseminated in a peer-reviewed journal or presented at a relevant conference. PROSPERO CRD42017054562. ..
  45. Richardson P, Roy A, Acharyya S, Panneerselvam A, Mendelson E, Gunther A, et al. Treatment-free interval as a metric of patient experience and a health outcome of value for advanced multiple myeloma: the case for the histone deacetylase inhibitor panobinostat, a next-generation novel agent. Expert Rev Hematol. 2017;10:933-939 pubmed publisher
    ..TFI has not been traditionally measured in clinical trials, but should be assessed in prospective data collection given its value to payers, providers, and patients. ..
  46. Zhang T, Wang Y, Yang Q, Dong Y. Procalcitonin-guided antibiotic therapy in critically ill adults: a meta-analysis. BMC Infect Dis. 2017;17:514 pubmed publisher
    ..More studies on these endpoints were not recommended. ..
  47. Papageorgiou A, Loke Y, Fromage M. Communication skills training for mental health professionals working with people with severe mental illness. Cochrane Database Syst Rev. 2017;6:CD010006 pubmed publisher
    ..Adding a CST programme appears to have a modest positive effect on patients' experiences of the therapeutic relationship. More high-quality research is needed in this area. ..
  48. Hummel J, Rucker G, Stiller B. Prophylactic levosimendan for the prevention of low cardiac output syndrome and mortality in paediatric patients undergoing surgery for congenital heart disease. Cochrane Database Syst Rev. 2017;8:CD011312 pubmed publisher
  49. Nassif M, Tang Y, Cleland J, Abraham W, Linde C, Gold M, et al. Precision Medicine for Cardiac Resynchronization: Predicting Quality of Life Benefits for Individual Patients-An Analysis From 5 Clinical Trials. Circ Heart Fail. 2017;10: pubmed publisher
    ..69 for at least a moderate improvement, and 0.73 for predicting a large improvement were observed. There is marked heterogeneity of treatment benefit of CRT that can be predicted based on baseline QoL, age, and QRS duration. ..
  50. Canevelli M, Cesari M, Lucchini F, Valletta M, Sabino M, Lacorte E, et al. Need to Recalibrate Research Outcomes in Alzheimer's Disease: Focus on Neuropsychiatric Symptoms. J Am Geriatr Soc. 2017;65:2071-2073 pubmed publisher
    ..Although these symptoms are widely recognized as the most-stressful and -challenging manifestations of dementia, they are addressed much less often than other research targets. ..
  51. Holmskov M, Storebø O, Moreira Maia C, Ramstad E, Magnusson F, Krogh H, et al. Gastrointestinal adverse events during methylphenidate treatment of children and adolescents with attention deficit hyperactivity disorder: A systematic review with meta-analysis and Trial Sequential Analysis of randomised clinical trials. PLoS ONE. 2017;12:e0178187 pubmed publisher
    ..No differences in the risks of gastrointestinal adverse events according to type, dose, or duration of administration were found. ..
  52. Kakkos S, Kakisis I, Tsolakis I, Geroulakos G. Endarterectomy achieves lower stroke and death rates compared with stenting in patients with asymptomatic carotid stenosis. J Vasc Surg. 2017;66:607-617 pubmed publisher
    ..There is an urgent need for high-quality research before a firm recommendation is made that CAS is inferior or not to CEA. ..
  53. Demaerschalk B, Brown R, Roubin G, Howard V, Cesko E, Barrett K, et al. Factors Associated With Time to Site Activation, Randomization, and Enrollment Performance in a Stroke Prevention Trial. Stroke. 2017;48:2511-2518 pubmed publisher
    ..Overall, selection of sites with high enrollment rates will likely require customization to align the sites selected to the factor under study in the trial. URL: http://www.clinicaltrials.gov. Unique identifier: NCT02089217. ..