Therapy for recurrent genital herpes is difficult to evaluate because of the short duration of lesions and viral shedding. Very early treatment, however, can be begun by patients who experience prodromes before onset of lesions. We have found prodromes to occur in 73 percent of male and 84 percent of female patients; 57 percent of the men and 68 percent of the women experienced prodromes in at least three out of every four recurrent episodes. Variables that might affect results of such a patient-initiated study evaluating topical acyclovir included: application of the ointment (drug or placebo) without prodrome (10 percent); the possibility of a false prodrome (<- 10 percent); long intervals between experiencing a prodrome and ointment application (15 percent > 24 hours); the inability to sense a prodrome during sleep; lack of ointment application to the involved areas with initial or later lesions (approximately 15 percent); noncompliance of enrollees in returning for study evaluations (≥ 10 percent). Such variables will need to be considered when the code is broken in this multicenter study, as well as for patient-initiated studies with other formulations of acyclovir or with other drugs. Earlier negative studies with other agents given within two to three days of appearance of lesions might also require reevaluation with similar patient-initiated studies.
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