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The Acupuncture Randomized Trials Study (Back Pain) Was Unblinded Too Early
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The study by Brinkhaus et al1 was published online in August 20032 and was also made available through German libraries free of charge also to patients. This potentially unblinding publication made public all the secret details of the study under discussion: all verum and sham acupuncture points were described in great detail. This enabled some interested patients to identify to which group (verum or placebo) they belonged, while they were probably still being followed up.
In the study under discussion,1 2 evaluators had to analyze patients' back pain diaries. Whenever patients made remarks in their diaries relating to the locations of their acupuncture needles, evaluators could guess to which group the patients belonged. The probability of that guess to be true was higher than mere chance when evaluators had been unblinded.
Whenever a patient mentioned that the acupuncturist inserted the needles only a little bit and that this was not . . . [Full Text of this Article]
AUTHOR INFORMATION
Dieter Wettig, PhD, MD
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