PROCESS (herpes zoster)
Trial question
What is the effect of duloxetine premedication in patients with herpes zoster reactivation?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
51.0% female
49.0% male
N = 750
750 patients (382 female, 368 male).
Inclusion criteria: adults, aged ≥ 50 years, with herpes zoster who presented with vesicles within 72 hours.
Key exclusion criteria: no informed consent; a raw score of > 50 points on the Zung Self-Rating Depression Scale; herpes zoster with head, neck, ocular, mucus membrane, cranial nerve, or CNS involvement or generalized herpes zoster; hepatic, renal, or immune dysfunction.
Interventions
N=375 duloxetine (initiated at a dose of 20 mg/day, adjusted to a maximum dose of 60 mg/day until Visual Analog Scale score of 0).
N=375 standard therapy (standard treatment).
Primary outcome
Incidence of postherpetic neuralgia at 12 weeks
22.9%
28.8%
28.8 %
21.6 %
14.4 %
7.2 %
0.0 %
Duloxetine
Standard
therapy
No significant
difference ↔
No significant difference in incidence of postherpetic neuralgia at 12 weeks (22.9% vs. 28.8%; RR 5.9, 95% CI -0.42 to 12.22).
Secondary outcomes
Significant decrease in the proportion of patients with Visual Analog Scale score > 0 at week 8 (25.1% vs. 40.5%; RR 0.6, 95% CI 0.5 to 0.8).
Significant decrease in the proportion of patients with Visual Analog Scale score ≥ 3 at week 12 (17.6% vs. 28.3%; RR 0.6, 95% CI 0.5 to 0.8).
Significant increase in Patient Global Impression of Change scale responders at week 12 (97.9% vs. 88%; RR 1.1, 95% CI 1.1 to 1.2).
Safety outcomes
No significant difference in nausea.
Significant differences in loss of appetite (2.4% vs. 0.5%), somnolence (4.0% vs. 0.8%), fatigue (5.3% vs. 1.1%), insomnia (4.8% vs. 0.8%), dry mouth (3.0% vs. 0%).
Conclusion
In adults, aged ≥ 50 years, with herpes zoster who presented with vesicles within 72 hours, duloxetine was not superior to standard therapy with respect to incidence of postherpetic neuralgia at 12 weeks.
Reference
Chunmei Zhao, Tingjie Zhang, Qian Zhu et al. PROCESS Trial: Effect of Duloxetine Premedication for Postherpetic Neuralgia Within 72 Hours of Herpes Zoster Reactivation-A Randomized Controlled Trial. Clin Infect Dis. 2024 Apr 10;78(4):880-888.
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