Blinding Techniques in Randomized Controlled Trials of Laser Therapy An Overview and Possible Solution英文文献资料.docVIP

Advance Access Publication 13 September 2007 eCAM 2008;5(4)383–389 doi:10.1093/ecam/nem085 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-levellasertherapyhasevidenceaccumulatingaboutitseffectivenessinavarietyofmedical 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 machinesused.Manyofthetrialsusedblindingmethodsthatrelyonstaffcooperationandare 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.Thenewlasermachinecombinessealedpresetandnon-bypassablerandomization 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 Introduction pain (3) and the non-contact laser irradiation technique tofacilitateskinandwoundhealing(4).Althoughtheuse of laser on acupuncture points is not yet a proven substitute for needles, it does have demonstrated effec- tiveness in a limited range of acupuncture responsive conditions(5).Asmallnumberofrandomizedcontrolled trials (RCTs) have demonstrated significant benefits including treatment of; neck pain, (6–9) low back pain, (10) chronic tension headache, (11) fibromyalgia, (12) enuresis, (5) and post-operative vomiting (2). The advantages of low-level laser over needles include: easeofapplication,usageinanatomicallydanger