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

Medicine · 2 authors, 1 centre

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TL;DR

Both treatments significantly improved key outcomes, and BMA was found to have equivalent efficacy and safety to IDA.

Full summary

454 CHARS

The primary outcome was the OSDI score, with secondary outcomes being VAS, QoL, and Schirmer I test scores. Both treatments produced statistically significant improvements in all four outcome measures from baseline. A significant difference was noted for tear production in the left eye. No adverse events were reported, supporting safety. The study suggests BMA is a safe and effective alternative to IDA, particularly for patients with metal allergies.

STUDY TYPE

RCT

SPECIALTY

ophthalmology

SUMMARISED BY

AI pipeline

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100% · A

ORIGINAL PAPER

PMC10783304

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

Medicine

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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.

CITATION EXPORT

Ji-Hoon Song, Soo-Yeon Park. Biodegradable microneedle acupuncture has equivalent efficacy to traditional intradermal acupuncture for dry eye disease: A pilot single-blinded, randomized controlled trial. Medicine. (2024). https://doi.org/10.1097/MD.0000000000036864

AUTHORS

2 · 1 CENTRES

Ji-Hoon Song, Soo-Yeon Park

aDepartment of Ophthalmology, Otolaryngology, and Dermatology, College of Korean Medicine, Dongshin University, Naju-si, Republic of Korea.