Acupuncture and dry eye: current perspectives. A double-blinded randomized controlled trial and review of the literature

Purpose: Dry eye disease (DED) is a common disorder that negatively impacts quality of life and vision. Prior studies have shown some benefit of acupuncture for dry eye, but very few have included control group to mitigate placebo effect. This study was designed with a sham acupuncture control group to evaluate true acupuncture treatment effect. Methods: This is a prospective, randomized, double-blinded, sham-acupuncture-controlled trial. Acupuncture treatment for dry eye was performed as per the Niemtzow Protocol. Twenty-four patients received true acupuncture and twenty-five received sham acupuncture. Treatment efficacy was assessed by the Ocular Surface Disease Index (OSDI) Questionnaire, ocular surface staining, tear flow, tear film break-up time (TBUT), and a general questionnaire. Atmospheric data were collected to control for the effect of atmospheric conditions on symptoms of dry eye. Results: OSDI scores in the treatment group improved compared to baseline (1 week, p<0.01, 1 month p<0.05, 3 months p<0.05, and 6 months p<0.01). OSDI scores in the control group improved, but did not reach significance (p=0.09). Secondary outcome measures showed no significant improvement in TBUT, Schiermer's Test, ocular surface grading, or artificial tear application. However, at 3 months, a significant reduction in the frequency of eye closing was observed among participants receiving true acupuncture treatment when compared to baseline (p=0.002). Furthermore, intragroup analysis showed significant reduction in symptoms of discomfort (p=0.01), dryness (p=0.001), scratchiness (p=0.001), and redness (p=0.01) in the true acupuncture group at 3 months. Conclusion: Both true and sham acupuncture improved OSDI at 1 week after treatment, however, the improvement in OSDI was significantly greater in the true treatment groups than the sham group at 6 months after acupuncture. True acupuncture treatment improved many subjective assessments of dry eye symptoms, however, other common indicators used to objectively assess dry eye (tear flow, corneal staining, TBUT) remained unchanged. While there were trends towards improvement in the sham acupuncture group, this did not reach statistical significant during the study period. This suggests a true treatment effect of acupuncture rather than a placebo effect. Acupuncture can, therefore, be an effective adjunct to routine clinical treatment of dry eye.