Acyclovir with and without prednisone for the treatment of herpes zoster. A randomized, placebo-controlled trial. The National Institute of Allergy and Infectious Diseases Collaborative Antiviral Study Group.
OBJECTIVE
To determine the effect of acyclovir and prednisone treatment of herpes zoster on chronic pain and quality-of-life outcomes.


METHODS
Randomized, double-blind, placebo-controlled study with a 2 x 2 factorial design.


METHODS
15 university hospitals or affilliated clinics.


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


METHODS
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.


METHODS
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 clinical 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% Cl, 1.46 to 3.55) for total crusting and 2.07 (Cl, 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 [Cl, 1.42 to 6.41]), time to return to uninterrupted sleep (risk ratio, 2.12 [Cl, 1.25 to 3.58]); time to return to usual daily activity (risk ratio, 3.22 [Cl, 1.92 to 5.40]); and time to cessation of analgesic therapy (risk ratio, 3.15 [Cl, 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.
Whitley
R J
RJ
Department of Pediatrics, University of Alabama at Birmingham, Children's Hospital 35233, USA.
Weiss
H
H
Gnann
J W
JW
Tyring
S
S
Mertz
G J
GJ
Pappas
P G
PG
Schleupner
C J
CJ
Hayden
F
F
Wolf
J
J
Soong
S J
SJ
D000212:Acyclovir / Q000009:adverse effects / Q000627:therapeutic use*; D000368:Aged; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002908:Chronic Disease; D004359:Drug Therapy, Combination; D005260:Female; D005938:Glucocorticoids / Q000009:adverse effects / Q000627:therapeutic use*; D006562:Herpes Zoster / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000209:etiology / Q000517:prevention & control; D010919:Placebos; D011241:Prednisone / Q000009:adverse effects / Q000627:therapeutic use*; D011788:Quality of Life; D012044:Regression Analysis
D000998:Antiviral Agents; D005938:Glucocorticoids; D010919:Placebos; D011241:Prednisone; D000212:Acyclovir