Randomisation publications

Babyak, Michael A., James A. Blumenthal, Steve Herman, Parinda Khatri, P. Murali Doraiswamy, Kathleen A. Moore, W. Edward Craighead, Teri T. Baldewicz and K. Ranga Krishnan, Exercise Treatment for Major Depression Maintenance of Therapeutic Benefit at 10 Months , Psychosomatic Medicine 62 (2000) 633-38 Barbui, Corrado, Andrea Cipriani and Irving Kirsch, Is the Paroxetine-Placebo Efficacy Separation Mediated by Adverse Events A Systematic Re-Examination of Randomised Double-Blind Studies , submitted for publication (2009)... 

How the baseline measurement will be used in relation to the critical evaluable endpoints must be determined before analysis. Comparison of two or more treatments usually takes into account the differences between baseline values between treatment groups at the point of randomisation. The way in which the analysis will influence the report and publications needs to be decided, as some regulatory authorities have their own statistical criteria that need to be observed (e.g. for bioequivalence studies ). 

Yancovitz SR, Des Jarlais DC, Peyser NP, Drew E, Freidmann P, Trigg HL Robinson JW (1991). A randomised trial of an interim methadone maintenance clinic. American Journal of Public Health, 81, 1185-91... 

Alberts MJ for the Publications Committee of the WALLSTENT (2001). Results of a multicentre prospective randomised trial of carotid artery stenting vs. carotid endarterectomy. Stroke 32 325... 

Publication/ Study drua Disease Study design Patients randomised. N Regimen Measure of renal Impairment Renal safety results... 

Despite a massive number of publications reporting the use of AC in poisoning treatment, there is a lack of systematic comprehensive clinical studies which should have involved a randomised statistically significant number of patients in several clinical centres. The usefulness of AC in poisoning treatment has never been proven or questioned ever since, and the attitixle of clinicians to this subject seems to be ambivalent. The general perception is that administration of AC is beneficial to the patient as it adsorbs the toxic substance and reduces its concentration in the body. Some authors, however, argue that despite this reduction, it has never been proven that administration of AC actually improves the clinical outcome [24J. 

Beck K, Conlon C, Kruger R, Coad J, Stonehouse W. The effect of gold kiwifruit consumed with an iron fortified breakfast cereal meal on iron status in women with low iron stores a 16 week randomised controlled intervention study. BMC Public Health. 2010 Jan 26 10 36. 

A recent publication on bupivacaine extended release vs bupivacaine HQ summarised a phase 2 randomised double-blind dose-ranging study, four phase 1 studies and 10 wound infiltration studies [33 ]. Results on any echo-cardiographic changes and cardiac adverse effects were pooled and assessed by the authors who concluded that bupivacaine extended release has a safe cardiac risk profile. 

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