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eCAM Advance Access published online on September 13, 2007

eCAM, doi:10.1093/ecam/nem085
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© 2007 The Author(s).
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/2.0/uk/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.


Review

Blinding Techniques in Randomized Controlled Trials of Laser Therapy: An Overview and Possible Solution

Ian Relf1, Roberta Chow2 and Marie Pirotta1

1Department of General Practice, University of Melbourne, 200 Berkeley Street Carlton 3053, Victoria, and 2Private Medical Practice, NSW, Australia

Low-level laser therapy has evidence accumulating about its effectiveness in a variety of medical conditions. We reviewed 51 double blind randomized controlled trials (RCTs) of laser treatment. Analysis revealed 58% of trials showed benefit of laser over placebo. However, less than 5% of the trials had addressed beam disguise or allocation concealment in the laser machines used. Many of the trials used blinding methods that rely on staff cooperation and are therefore open to interference or bias. This indicates significant deficiencies in laser trial methodology. We report the development and preliminary testing of a novel laser machine that can blind both patient and operator to treatment allocation without staff participation. The new laser machine combines sealed preset and non-bypassable randomization codes, decoy lights and sound, and a conical perspex tip to overcome laser diode glow detection.

Keywords: low-level laser therapy – allocation concealment – treatment blinding


For reprints and all correspondence: Dr Ian Relf, Department of General Practice, University of Melbourne, 200 Berkeley Street Carlton 3053, Victoria, Australia. Tel: 61 3 8344 7276; E-mail: i.relf{at}unimelb.edu.au

Received April 1, 2006; accepted March 9, 2007


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