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The Acupuncture Randomized Trials Study (Back Pain) Was Unblinded Too Early—Reply
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In reply
In his comment, Wettig writes that our publication1 of a short version of the study protocol in a medical journal in late August 20032 may have "potentially broadly unblinded" the investigation.
In response we would first like to point out that it is good practice to make study protocols available to an expert audience. Indeed, many leading medical journals now require that information on study protocols be published in advance in trial registers before they will even accept a manuscript.3
Although it is theoretically possible, it is nevertheless extremely unlikely that participants in our study would have had access to the publication in question. Moreover, by the time the short version of the study protocol was published, data for the primary end point at 8 weeks, as well as for the follow-up at 6 months, and almost all data on the follow-up at 12 months had already been . . . [Full Text of this Article]
AUTHOR INFORMATION
Benno Brinkhaus, MD;
Claudia Witt, MD;
Stefan Willich, MD, MPH;
Klaus Linde, MD;
Dieter Melchart, MD
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