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Acyclovir with and without Prednisone for the Treatment of Herpes Zoster: A Randomized, Placebo-Controlled Trial

Richard J. Whitley, MD; Heidi Weiss, PhD; John W. Gnann Jr., MD; Steven Tyring, MD, PhD; Gregory J. Mertz, MD; Peter G. Pappas, MD; Charles J. Schleupner, MD; Frederick Hayden, MD; John Wolf, MD; and Seng-jaw Soong, PhD
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the National Institute of Allergy and Infectious Diseases Collaborative Antiviral Study Group* Grant Support: By contracts NO1-AI-15113, NO1-AI-62554, and NO1-AI-12667 from the Antiviral Research Branch of the National Institute of Allergy and Infectious Diseases; grant RR-032 from the Division of Research Resources of the National Institutes of Health; a Bristol Myers Squibb Unrestricted Infectious Disease Award; and a grant from the State of Alabama. Requests for Reprints: Richard J. Whitley, MD, Departments of Pediatrics, Microbiology, and Medicine, University of Alabama at Birmingham, 616 Children's Hospital, 1600 7th Avenue South, Birmingham, AL 35233. Current Author Addresses: Dr. Whitley: Departments of Pediatrics, Microbiology, and Medicine, University of Alabama at Birmingham, 616 Children's Hospital, 1600 7th Avenue South, Birmingham, AL 35233.


Copyright ©2004 by the American College of Physicians


Ann Intern Med. 1996;125(5):376-383. doi:10.7326/0003-4819-125-5-199609010-00004
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Objective: To determine the effect of acyclovir and prednisone treatment of herpes zoster on chronic pain and quality-of-life outcomes.

Design: Randomized, double-blind, placebo-controlled study with a 2 × 2 factorial design.

Setting: 15 university hospitals or affiliated clinics.

Patients: 208 immunocompetent patients older than 50 years of age who had localized herpes zoster that developed less than 72 hours before study enrollment.

Intervention: Acyclovir or a matched placebo was administered orally, 800 mg five times daily, for 21 days. Prednisone or a matched placebo was administered orally at 60 mg/d for the first 7 days, 30 mg/d for days 8 to 14, and 15 mg/d for days 15 to 21. The four treatments regimens given were acyclovir plus prednisone; acyclovir plus prednisone placebo; prednisone plus acyclovir placebo; and placebos for both acyclovir and prednisone.

Measurements: Patients were monitored daily for the first 28 days for lesion healing, resolution of pain, return to usual activity, and return to uninterrupted sleep. Monitoring was then done monthly for 6 months. Patients documented analgesic requirements each day, and adverse events and laboratory abnormalities were recorded at each clinic visit. An intention-to-treat analysis was used.

Results: Patients were randomly allocated to receive one of the four regimens. Demographic characteristics were similar for each group. Time to total crusting and healing was accelerated for patients receiving acyclovir plus prednisone compared with patients receiving two placebos; the risk ratios were 2.27 (95% CI, 1.46 to 3.55) for total crusting and 2.07 (CI, 1.26 to 3.38) for healing. Similarly, compared with the placebo group, patients receiving acyclovir plus prednisone had accelerated time to cessation of acute neuritis (risk ratio, 3.02 [CI, 1.42 to 6.41]), time to return to uninterrupted sleep (risk ratio, 2.12 [CI, 1.25 to 3.58]); time to return to usual daily activity (risk ratio, 3.22 [CI, 1.92 to 5.40]); and time to cessation of analgesic therapy (risk ratio, 3.15 [CI, 1.69 to 5.89]). In the acyclovir plus prednisone group, resolution of pain during the 6 months after disease onset did not statistically differ from that in the other groups. No important clinical or laboratory adverse events occurred in any group.

Conclusions: In relatively healthy persons older than 50 years of age who have localized herpes zoster, combined acyclovir and prednisone therapy can improve quality of life.

*For members of the National Institute of Allergy and Infectious Diseases Collaborative Antiviral Study Group, see the Appendix.

Figures

Grahic Jump Location
. Time to total healing of localized herpes zoster in the normal host. = 0.008 for acyclovir plus prednisone compared with prednisone plus acyclovir placebo; = 0.06 for acyclovir plus prednisone compared with placebos; = 0.05 for acyclovir plus prednisone placebo compared with prednisone plus acyclovir placebo. * = number of patients at risk on study days 20 and 30; ACV = acyclovir.
Figure 1PPP
Grahic Jump Location

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