Intradermal Acupuncture for Moderate to Severe Dry Eye Disease: a pilot randomized controlled trial.

Objectives: The aim of this study was to evaluate the efficacy of intradermal acupuncture for the treatment of moderate to severe dry eye disease (DED). Methods: Thirty patients with moderate to severe DED were randomly assigned (11) to either the Intradermal Acupuncture Group (IAG) or the Body Acupuncture Group (BAG). Both groups received 12 treatment sessions over four weeks (three times per week). The primary outcome was the Ocular Surface Disease Index (OSDI). Secondary outcomes included the Visual Analog Scale (VAS) for subjective symptoms, quality of life (QoL), the Schirmer I test (SIT), and general assessment. All outcomes were measured at baseline (Week 0), post-treatment (Week 4), and follow-up (Week 6). Results: No statistically significant between-group differences were found in OSDI scores at Weeks 4 and 6 compared to baseline (p = 0.262, p = 0.105). Similarly, changes in VAS, QoL, and SIT scores showed no significant differences between groups (all p > 0.05). No serious adverse events occurred in either group. Conclusion: Intradermal acupuncture showed comparable effectiveness to body acupuncture in relieving symptoms of moderate to severe DED, suggesting its potential as an alternative therapeutic option. While between-group differences were not definitive in this pilot study, the findings provide preliminary estimates to inform a future, properly powered non-inferiority trial aimed at determining whether IA can achieve clinically comparable outcomes with potential advantages in convenience and adherence.