ZEDS (postherpetic neuralgia)
Trial question
What is the effect of suppressive valacyclovir treatment in patients with pain secondary to herpes zoster ophthalmicus?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
59.0% female
41.0% male
N = 73
73 patients (43 female, 30 male).
Inclusion criteria: adult immunocompetent, nonpregnant patients with a history of herpes zoster ophthalmicus rash, documented keratitis or iritis within 1 year.
Key exclusion criteria: immunocompromised status; renal insufficiency; allergy or adverse reaction to valacyclovir or acyclovir; history of vaccination against zoster within 1 month prior to enrolment; keratorefractive surgery; pregnancy or lactation; incarceration.
Interventions
N=34 valacyclovir (oral dose of 1,000 mg daily for 12 months).
N=39 placebo (matching placebo for 12 months).
Primary outcome
Prevalence of postherpetic neuralgia at 12 months
38%
40%
40.0 %
30.0 %
20.0 %
10.0 %
0.0 %
Valacyclovir
Placebo
No significant
difference ↔
No significant difference in prevalence of postherpetic neuralgia at 12 months (38% vs. 40%; ARD -2.5, 95% CI -25.8 to 20.8).
Secondary outcomes
Significant decrease in mean pain duration at 18 months (13.6 months vs. 18.7 months; MD -3.39, 95% CI -6.73 to -0.04).
Significant decrease in mean pain score at 18 months, participants < 60 years of age (0.2 points vs. 1 points; MD -0.8, 95% CI -1.47 to -0.13).
Significant decrease in total daily dose of neuropathic pain medication at 12 months (271.4 mg/day vs. 363.4 mg/day; MD -92, 95% CI -157.59 to -26.41).
Conclusion
In adult immunocompetent, nonpregnant patients with a history of herpes zoster ophthalmicus rash, documented keratitis or iritis within 1 year, valacyclovir was not superior to placebo with respect to prevalence of postherpetic neuralgia at 12 months.
Reference
David B Warner, Bennie H Jeng, Jiyu Kim et al. Low-Dose Valacyclovir for Postherpetic Neuralgia in the Zoster Eye Disease Study: A Randomized Clinical Trial. JAMA Ophthalmol. 2025 Apr 1;143(4):277-285.
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