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Oral Acyclovir To Suppress Frequently Recurrent Herpes Labialis: A Double-Blind, Placebo-Controlled Trial

James F. Rooney, MD; Stephen E. Straus, MD; Margaret L. Mannix, RN; Charles R. Wohlenberg, BS; David W. Alling, MD; Juan A. Dumois, MD; and Abner Louis Notkins, MD
[+] Article and Author Information

From the National Institute of Dental Research and the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland. Request for Reprints: James F. Rooney, MD, Laboratory of Oral Medicine, National Institute of Dental Research, National Institutes of Health, Building 30, Room 121, Bethesda, MD 20892. Acknowledgments: The authors thank George Grimes, Jr., PD, Sanjay Jagannath, BS, L. Gray Davis, PhD, Gloria Boone, BS, MBA, and Stephen Banks, PhD, for assistance in study design and execution and Eloise Mange for editorial assistance. Grant Support: In part by Burroughs Wellcome Company, Research Triangle Park, North Carolina.


Copyright ©2004 by the American College of Physicians


Ann Intern Med. 1993;118(4):268-272. doi:10.7326/0003-4819-118-4-199302150-00004
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Objective: To determine whether oral acyclovir reduces the incidence of recurrent herpes labialis in otherwise healthy patients with proven frequently recurrent disease.

Design: Randomized, double-blind, placebo-controlled, crossover trial.

Setting: Outpatient facility of the Clinical Center, National Institutes of Health, Bethesda, Maryland.

Patients: Fifty-six otherwise healthy adults who reported frequently recurrent herpes labialis (≥ 6 episodes/y) were enrolled into the study. During a 4-month observation period, 22 patients had herpes labialis two or more times and were eligible for study treatment.

Interventions: Twenty-two patients were randomized to receive either acyclovir, 400 mg twice daily, or matched placebo for 4 months. After the first treatment period, patients were given the alternate treatment for another 4 months and were then taken off study medication to observe the first post-treatment recurrence. Recurrent outbreaks were determined by examination and by viral culture.

Results: Twenty patients completed blind treatment with both acyclovir and placebo. The median time to first clinically documented recurrence was 46 days for placebo courses and 118 days for acyclovir courses (P = 0.05). The mean number of recurrences per 4-month treatment period was 1.80 episodes per patient during placebo treatment and 0.85 episodes per patient during acyclovir treatment (P = 0.009). The mean number of virologically confirmed recurrences per patient was 1.40 with placebo therapy compared with 0.40 with acyclovir (P = 0.003).

Conclusions: Oral acyclovir, 400 mg twice daily, is effective in suppressing herpes labialis in immunocompetent adults confirmed to have frequently recurrent infection. Treatment with acyclovir in this study resulted in a 53% reduction in the number of clinical recurrences and a 71% reduction in virus culture-positive recurrences compared with placebo therapy.

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