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To the Editor: Published clinical trial reports often fail to adequately document safety findings.¹ In this respect, Dr Rowbotham and colleagues² should be commended for providing detailed safety data in their study on the use of gabapentin for the treatment of postherpetic neuralgia.

However, some of the adverse event (AE) reporting appears to have been filtered. Unlike the analysis comparing the incidence rates between groups for the most frequently reported AEs, the reporting of AEs that were minor or severe and those that led to withdrawal from the trial were restricted to events deemed related to the study medication by the investigator. One of the primary reasons for using a randomized, double-blind study design is to eliminate, or at least reduce, bias in the reporting of AEs. Restricting analyses to only those events deemed related to the study medication by the investigators has the potential to defeat one of the . . . [Full Text of this Article]

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RELATED ARTICLE

Gabapentin for the Treatment of Postherpetic Neuralgia: A Randomized Controlled Trial
Michael Rowbotham, Norman Harden, Brett Stacey, Paula Bernstein, Leslie Magnus-Miller, and for the Gabapentin Postherpetic Neuralgia Study Group
JAMA. 1998;280(21):1837-1842.
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