Pain typically accompanies acute herpes tester and, in a proportion of
patients, it persists well beyond rash healing. Pain must therefore b
e analyzed in trials of antiviral agents in herpes tester, but differe
nt methods have been used to analyze pain in recent published trials.
These reports are reviewed and their methodological strengths and weak
nesses examined. Based on this review? recommendations for the design
and analysis of future trials of antiviral agents in herpes tester are
proposed. The principal recommendation is that antiviral efficacy sho
uld be evaluated both by distinguishing post-herpetic neuralgia from a
cute pain and by considering pain as a continuum. The primary endpoint
should address both the prevalence and duration of post-herpetic neur
algia and should be examined in those patients who have post-herpetic
neuralgia. Adopting the proposed recommendations in design and analysi
s of future trials should facilitate comparison across trials of the e
fficacy of antiviral agents in the treatment of herpes tester. Copyrig
ht (C) 1997 Elsevier Science B.V.