Abstract
Purpose :
Dry eye is a highly prevalent disease worldwide with significant morbidity and burden to healthcare. Traditional Chinese medicine (TCM), a type of complementary alternative medicine, is popular among patients particularly in Asia. However randomized-controlled studies using TCM have not investigated endpoints relevant to the scientific basis of dry eye. We aim to evaluate the efficacy and safety of additional acupuncture or oral herbal medicine with artificial tear in the treatment of dry eye.
Methods :
We conducted a randomized investigator –masked interventional trial (NCT02219204) with parallel groups of 50 participants each on two TCM treatment modalities: acupuncture (AC), daily oral herbs (HB), versus standard therapy with artificial tears (AT, n=50). Eligible participants (age>40 years) had dry eye not requiring anti-inflammatory treatment, and lung/kidney yin deficiency. TCM was administered by nationally-accredited physicians off evaluation site. The primary outcome was the proportion of responders (dry eye symptoms on a visual analog scale improving at one month after treatment). Other outcomes include corneal fluorescein staining grade, automated tear break up times and ocular redness (Oculus Keratograph5M), Schirmer test, tear osmolarity, and thermography-based tear evaporation rate. Tear cytokines were quantified using a multiplex bead-based immunofluorescent assay.
Results :
Analyses included 149 participants. Participants treated with AC were more likely to respond to dry eye than those on AT (88% vs 72%, p=0.039) with a difference of 16% (95%CI: 0.18-31.1). The number-needed-to-treat with AC to achieve response in one person was 7 (3-157). Participants in the AC group also had reduced conjunctival redness compared to AT (p=0.043) and reduced tear Th1-cytokine TNF-α (p=0.027) and Th2-cytokine IL-4 concentrations (p=0.038). AC was not significantly superior to AT in other outcomes. No significant adverse effects were encountered. HB was not significantly different in the primary outcome from AT (80% vs 72%, p=0.26).
Conclusions :
Acupuncture provides significant benefit in mild-moderate dry eye, associated with demonstrable molecular evidence of reduced inflammation compared to artificial tears.
This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.