Biodegradable microneedle acupuncture has equivalent efficacy to traditional intradermal acupuncture for dry eye disease: A pilot single-blinded, randomized controlled trial

Abstract

Background: Dry eye disease (DED) is a common ocular disorder in which the tear film cannot maintain homeostasis. Acupuncture has been used to treat DED in Korean medicine. Particularly, intradermal acupuncture (IDA) is less painful and enables free movement after treatment. However, it can also provoke allergic reactions to metal. To overcome this, biodegradable microneedle acupuncture (BMA) has been developed. This study compared BMA with traditional IDA in terms of efficacy and safety in patients with DED. Methods: This study was designed as an investigator-initiated, assessor-blinded, single-center, parallel randomized controlled trial. Thirty patients with DED were enrolled and randomized to one of the treatments. One group was treated with BMA on the acupoints, including bilateral BL2, GB14, TE23, EX-HN5, and ST1. The other group was treated with traditional IDA at the same acupoints. Treatments were conducted 3 times a week for 4 weeks. The major endpoint was ocular surface disease index (OSDI). The minor endpoints were subjective symptoms visual analog scale (VAS), quality of life (QoL), and tear production measured by the Schirmer I test. Results: All enrolled participants successfully completed the trial, and all of their data was analyzed. Both treatments remarkably improved the OSDI score, VAS score, QoL score, and tear secretion after 4 weeks (P < .05). Except for tear production in the left eye (P < .05), there were no statistical differences between the 2 treatments on the final visit (P > .05). No adverse events were observed. Conclusion: BMA and IDA had the same therapeutic effect for improving DED and both were safe. BMA can be used in patients with DED as an alternative to traditional IDA.