controlled clinical trials as topic


Summary: Works about clinical trials involving one or more test treatments, at least one control treatment, specified outcome measures for evaluating the studied intervention, and a bias-free method for assigning patients to the test treatment. The treatment may be drugs, devices, or procedures studied for diagnostic, therapeutic, or prophylactic effectiveness. Control measures include placebos, active medicines, no-treatment, dosage forms and regimens, historical comparisons, etc. When randomization using mathematical techniques, such as the use of a random numbers table, is employed to assign patients to test or control treatments, the trials are characterized as RANDOMIZED CONTROLLED TRIALS AS TOPIC.

Top Publications

  1. Altman D, Bland J. Absence of evidence is not evidence of absence. BMJ. 1995;311:485 pubmed
  2. Nose M, Ballette F, Bighelli I, Turrini G, Purgato M, Tol W, et al. Psychosocial interventions for post-traumatic stress disorder in refugees and asylum seekers resettled in high-income countries: Systematic review and meta-analysis. PLoS ONE. 2017;12:e0171030 pubmed publisher
    ..Yet, the number of studies is small and their methodological quality limited, so that more rigorous trials should be conducted in the future. ..
  3. Espallargues M, Valderas J, Alonso J. Provision of feedback on perceived health status to health care professionals: a systematic review of its impact. Med Care. 2000;38:175-86 pubmed
    ..This is especially true with regard to mental health status information. Nevertheless, there is still need for a more through evaluation of this type of intervention. ..
  4. McCormack S, Hayes R, Lacey C, Johnson A. Microbicides in HIV prevention. BMJ. 2001;322:410-3 pubmed
  5. Michalsen A, Kessler C. Science-based yoga - stretching mind, body, and soul. Forsch Komplementmed. 2013;20:176-8 pubmed publisher
  6. Lenzer J. Why we can't trust clinical guidelines. BMJ. 2013;346:f3830 pubmed publisher
  7. Elger C, Hoppe C. Informed consent in off-label use and incapacitated persons. Epilepsia. 2009;50 Suppl 12:79-80 pubmed publisher
  8. Zarate C, Tohen M, Baldessarini R. Clozapine in severe mood disorders. J Clin Psychiatry. 1995;56:411-7 pubmed
  9. Vukadinovic D, Lavall D, Vukadinović A, Pitt B, Wagenpfeil S, Bohm M. True rate of mineralocorticoid receptor antagonists-related hyperkalemia in placebo-controlled trials: A meta-analysis. Am Heart J. 2017;188:99-108 pubmed publisher
    ..Therefore, non-MRA-related rises in potassium levels might be underestimated and should be rigorously explored before cessation of the evidence-based therapy with MRAs. ..

More Information


  1. Pease A, Krumholz H, Downing N, Aminawung J, Shah N, Ross J. Postapproval studies of drugs initially approved by the FDA on the basis of limited evidence: systematic review. BMJ. 2017;357:j1680 pubmed publisher
  2. Zanchetti A, Mancia G. The dilemma of placebo controlled studies: scientific evidence, guidelines, ethics and regulatory recommendations. J Hypertens. 2009;27:1-2 pubmed publisher
  3. Hlavin G, Hampson L, Koenig F. Many-to-one comparisons after safety selection in multi-arm clinical trials. PLoS ONE. 2017;12:e0180131 pubmed publisher
    ..The operating characteristics of the proposed procedures are assessed via simulation. ..
  4. Zhang Z, Yang Q, Xin W, Zhang Y. Comparison of local infiltration analgesia and sciatic nerve block as an adjunct to femoral nerve block for pain control after total knee arthroplasty: A systematic review and meta-analysis. Medicine (Baltimore). 2017;96:e6829 pubmed publisher
  5. Camacho L. Current Status of Biosimilars in Oncology. Drugs. 2017;77:985-997 pubmed publisher
  6. Hayden E. Ethical dilemma for Ebola drug trials. Nature. 2014;515:177-8 pubmed publisher
  7. Perry C, Wagstaff A. Famciclovir. A review of its pharmacological properties and therapeutic efficacy in herpesvirus infections. Drugs. 1995;50:396-415 pubmed
  8. Shorvon S. Safety of topiramate: adverse events and relationships to dosing. Epilepsia. 1996;37 Suppl 2:S18-S22 pubmed
    ..No clinically significant treatment-related abnormalities were observed in clinical laboratory parameters or in neurologic, electrocardiographic, ophthalmologic, or audiologic tests. ..
  9. Dowell S, Schwartz B, Phillips W. Appropriate use of antibiotics for URIs in children: Part II. Cough, pharyngitis and the common cold. The Pediatric URI Consensus Team. Am Fam Physician. 1998;58:1335-42, 1345 pubmed
  10. Bocchi E, Marcondes Braga F, Bacal F, Ferraz A, Albuquerque D, Rodrigues D, et al. [Updating of the Brazilian guideline for chronic heart failure - 2012]. Arq Bras Cardiol. 2012;98:1-33 pubmed
  11. Karlawish J, Whitehouse P. Is the placebo control obsolete in a world after donepezil and vitamin E?. Arch Neurol. 1998;55:1420-4 pubmed
    ..Community dialogue should be the norm for the design and review of AD clinical trials. We conclude with suggestions to foster this dialogue and issues that should be addressed. ..
  12. Whitelaw A, Lee Kelland R. Repeated lumbar or ventricular punctures in newborns with intraventricular haemorrhage. Cochrane Database Syst Rev. 2017;4:CD000216 pubmed publisher
  13. Yurdaydin C, Idilman R. Therapy of Delta Hepatitis. Cold Spring Harb Perspect Med. 2015;5: pubmed publisher
    ..New treatment strategies targeting different steps of the HDV life cycle, such as hepatocyte entry inhibitors or prenylation inhibitors, are emerging and provide hope for the future. ..
  14. Greenstein R, Cameron D, Brown S. Yet Another Flawed "Placebo Controlled" Study in Crohn's Disease?. Foodborne Pathog Dis. 2015;12:812 pubmed publisher
  15. Ruan S, Lin H, Huang C, Kuo P, Wu H, Yu C. Exploring the heterogeneity of effects of corticosteroids on acute respiratory distress syndrome: a systematic review and meta-analysis. Crit Care. 2014;18:R63 pubmed publisher
    ..Current data do not support routine use of corticosteroids in ARDS. More clinical trials are needed to specify the favorable and unfavorable subgroups for corticosteroid therapy. ..
  16. Diehl D, Adler D, Conway J, Farraye F, Kantsevoy S, Kaul V, et al. Endoscopic retrieval devices. Gastrointest Endosc. 2009;69:997-1003 pubmed publisher
  17. Hosein F, Bobrovitz N, Berthelot S, Zygun D, Ghali W, Stelfox H. A systematic review of tools for predicting severe adverse events following patient discharge from intensive care units. Crit Care. 2013;17:R102 pubmed publisher
    ..Although risk stratification tools may help clinician decision-making, further evaluation of the existing tools' effects on care is required prior to clinical implementation. ..
  18. Fox W, Ellard G, Mitchison D. Studies on the treatment of tuberculosis undertaken by the British Medical Research Council tuberculosis units, 1946-1986, with relevant subsequent publications. Int J Tuberc Lung Dis. 1999;3:S231-79 pubmed
  19. Hemilä H. Vitamin C supplementation and common cold symptoms: factors affecting the magnitude of the benefit. Med Hypotheses. 1999;52:171-8 pubmed
    ..Since few trials have examined the effects of therapeutic supplementation and their results have been variable, further therapeutic trials are required to examine the role of vitamin C in the treatment of colds. ..
  20. Masiye F, Mayosi B, de Vries J. "I passed the test!" Evidence of diagnostic misconception in the recruitment of population controls for an H3Africa genomic study in Cape Town, South Africa. BMC Med Ethics. 2017;18:12 pubmed publisher
    ..In this study, the main challenges were diagnostic misconception among RHDGen controls and therapeutic misconception among RHDGen cases. ..
  21. Mucke L. Neuroscience: Alzheimer's disease. Nature. 2009;461:895-7 pubmed publisher
  22. Cuijpers P. Bibliotherapy in unipolar depression: a meta-analysis. J Behav Ther Exp Psychiatry. 1997;28:139-47 pubmed
    ..No traditional relationship between therapist and patient is developed. In this article the relevance of bibliotherapy for the clinical practice is presented and a meta-analysis of the research into bibliotherapy is described. ..
  23. Dinicolantonio J, O Keefe J. The History of the Salt Wars. Am J Med. 2017;130:1011-1014 pubmed publisher
    ..The overall evidence in the first half of the 1900s suggests that a low-salt diet was not a reasonable strategy for treating hypertension. ..
  24. Keefe R, Davis V, Harvey P, Atkins A, Haig G, Hagino O, et al. Placebo Response and Practice Effects in Schizophrenia Cognition Trials. JAMA Psychiatry. 2017;74:807-814 pubmed publisher
    ..Placebo-controlled trials for cognitive impairment associated with schizophrenia are at risk for these practice effects, which can be difficult to distinguish from placebo effects...
  25. Rush A. Star-D: lessons learned and future implications. Depress Anxiety. 2011;28:521-4 pubmed publisher