scholarly journals Principles of Decision Making on the Prescription of Medicines. What else Do You Need to Know when Interpreting the Results of Clinical Trials?

2018 ◽  
Vol 15 (4) ◽  
pp. 343-348
Author(s):  
Yuliya A. Petrovskaya ◽  
Ludmila M. Ogorodova ◽  
Fedor I. Petrovskiy

What can become the basis for the decision making when prescribing a medicine, choosing one instead of another? Words and their combinations ‘randomised controlled study’, ‘double blind’, ‘meta-analysis’, ‘relevant difference’ have a kind of hypnotic effect on the doctor and often it is enough to make a positive impression and convince of the need to prescribe a medicine. Indeed, randomisation and a double-blind method of enrolling patients are the main ways to avoid systematic errors in research. However, this is not enough to decide what medicine to choose. When analysing the results of clinical trials, it is necessary to know a number of details that are important, sometimes critical, without regard to which it is possible to make false or incorrect conclusions about the efficacy of medicines. The article is devoted to the peculiarities of clinical trials which need to be paid no less attention than randomisation, double-blind method, and statistical significance of the obtained results.

Perfusion ◽  
2017 ◽  
Vol 32 (7) ◽  
pp. 591-597 ◽  
Author(s):  
Geoff G. Lockwood ◽  
Leilani Cabreros ◽  
Dorota Banach ◽  
Prakash P. Punjabi

Background: Continuous bilateral thoracic paravertebral blockade has been used for analgesia after cardiac surgery, but its efficacy has never been formally tested. Method: Fifty adult patients were enrolled in a double-blind, randomised, controlled study of continuous bilateral thoracic paravertebral infusion of 0.5% lidocaine (1 mg.kg-1.hr-1) for analgesia after coronary surgery. Control patients received a subcutaneous infusion of lidocaine at the same rate through catheters inserted at the same locations as the study group. The primary outcome was morphine consumption at 48 hours using patient-controlled analgesia (PCA). Secondary outcomes included pain, respiratory function, nausea and vomiting. Serum lidocaine concentrations were measured on the first two post-operative days. Results: There was no difference in morphine consumption or in any other outcome measure between the groups. Serum lidocaine concentrations increased during the study, with a maximum of 5.9 mg.l-1. There were no adverse events as a consequence of the study. Conclusion: Bilateral paravertebral infusion of lidocaine confers no advantage over systemic lidocaine infusion after cardiac surgery. Clinical trial registration: ISRCTN13424423 ( https://www.isrctn.com )


BMJ ◽  
1990 ◽  
Vol 301 (6764) ◽  
pp. 1308-1311 ◽  
Author(s):  
J Hojer ◽  
S Baehrendtz ◽  
G Matell ◽  
L L Gustafsson

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