Zhangyanming Tablets for Dry Eye Disease: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Study.
Hu-Ping Wu, Jian-Jun Gu, Jie Fang et al.
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In 30 seconds
This multicenter, stratified, randomized, double-blind, placebo-controlled trial evaluated Zhangyanming Tablets (ZYMT) added to 0.1% sodium hyaluronate eye drops in patients with dry eye disease. Of 144 enrolled participants, 119 completed 8 weeks. At week 8, OSDI improvement was greater with ZYMT than placebo, with an absolute between-group difference of -5.66 (95% CI, -9.56 to -1.76). The efficacy rate was 62.1% (36/58) versus 42.6% (26/61). Tear film breakup time and Chinese medicine symptom scores also improved more with ZYMT; no significant safety difference was observed.
Key findings
- At week 8, the between-group difference in OSDI change was -5.66 (95% CI, -9.56 to -1.76), favoring ZYMT.
- Efficacy rates were 62.1% (36/58) with ZYMT and 42.6% (26/61) with placebo (relative risk: 1.46, 95% CI, 1.02 to 2.08).
- TFBUT and Chinese medicine symptom score changes favored ZYMT at week 8; Schirmer's test and corneal fluorescein staining did not differ significantly.
- No significant between-group differences were observed in safety data.
Why it matters
The trial suggests that adding oral ZYMT to sodium hyaluronate drops may improve patient-reported dry-eye symptoms and some tear-film measures over eight weeks. The findings distinguish symptom and tear-film outcomes from measures that did not show a significant difference, and provide short-term comparative safety data for this combination in the studied population.
What to keep in mind
Only 119 of 144 randomized participants completed the study, and outcomes were assessed after 8 weeks; longer-term effects are not established by the abstract.