Randomized double-blind trial of tromantadine versus aciclovir in recurrent herpes orofacialis

The present study represents the first randomized, double-blind trial comparing the clinical efficacy of tromantadine (Viru-Merz) vs aciclovir. Both medication groups contained 60 patients. The inclusion criteria required that patients show a history of recurrent manifestations of herpes orofacialis and that they not be recruited later than 24 h following the initial prodromal symptoms. Medication was dispensed randomly in identical tubes to cover a treatment period of up to 5 days. The patients were instructed to keep the tubes close at hand, to initiate therapy as soon as possible after experiencing the first symptoms of the recurrence and to visit the company physician within 24 h after the onset of symptoms. The herpes lesions were assessed daily by the same doctor for 14 days, except on weekends. The data of 119 patients (59 treated with tromantadine, 60 treated with aciclovir) were evaluated. The average time between the first signs of a new recurrence and the beginning of treatment was 7 hours in both treatment groups. The course of the healing process was rated by 4 subjective symptoms (itching, burning, skin tautness and pain) and by the following objective criteria: number of days in the vesicular stage and duration of complete healing, abortive lesions and new lesions. The results of these assessments showed no differences between the medication groups. Global clinical efficacy and tolerance were rated as being "very good" and "good" in more than 83% by patients and doctor in both groups. The results show that it is the early application of the virustatic that is important for successful treatment--regardless of the choice of agent tested.