Medicine · 2 authors, 1 centre
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This pilot randomized controlled trial found that biodegradable microneedle acupuncture (BMA) and traditional intradermal acupuncture (IDA) both significantly improved dry eye symptoms, quality of life, and tear production after 4 weeks of treatment, with no significant differences between groups except for left eye tear secretion favoring BMA. Both treatments were safe with no adverse events. BMA may serve as an alternative for patients with metal sensitivity.
**Background:** Dry eye disease (DED) is a common ocular disorder characterized by tear film instability, with prevalence ranging from 5% to 50% worldwide. Conventional treatments like artificial tears, corticosteroids, and immunosuppressants have limitations and side effects. Acupuncture, particularly intradermal acupuncture (IDA), is used in Korean medicine for DED due to its less painful nature and ability to allow free movement. However, IDA can cause allergic reactions to metal. Biodegradable microneedle acupuncture (BMA), made from hyaluronic acid, was developed to overcome this. This pilot study compared the efficacy and safety of BMA versus traditional IDA in patients with DED.
**Methods:** This was an investigator-initiated, assessor-blinded, single-center, parallel randomized controlled trial conducted from July 6 to September 19, 2022. Thirty participants with DED (OSDI ≥ 13, Schirmer I test ≤ 10 mm/5 min) were randomized 1:1 to BMA or IDA groups (n=15 each). Both groups received treatment on bilateral acupoints BL2, GB14, TE23, EX-HN5, and ST1, with needles/microneedles attached for 4 hours, 3 times per week for 4 weeks (12 sessions total). The primary endpoint was OSDI score; secondary endpoints included subjective symptoms VAS, QoL (0-6 scale), and Schirmer I test. Assessments were performed at baseline (visit 1), midterm (visit 7, week 2), and final (visit 13, week 4). Statistical analyses used paired t-tests or Wilcoxon signed-rank tests for within-group comparisons and two-sample t-tests or Mann-Whitney U tests for between-group comparisons.
**Key Results:** All 30 participants completed the trial with no dropouts. Baseline characteristics were similar between groups (mean age 34.3 ± 12.36 years, 56.7% female). Both groups showed significant improvements from baseline to final visit in all endpoints (P < .05). OSDI scores decreased from 57.1 ± 20.42 to 22.4 ± 16.22 in the BMA group and from 60.8 ± 14.47 to 25.6 ± 13.35 in the IDA group, with no significant between-group difference (P = .983). VAS scores improved from 62.7 ± 14.86 mm to 30.7 ± 13.35 mm (BMA) and from 68.7 ± 15.98 mm to 38.0 ± 15.21 mm (IDA) (P = .758). QoL scores improved from 3.7 ± 0.88 to 1.5 ± 0.64 (BMA) and from 3.9 ± 0.83 to 1.8 ± 0.68 (IDA) (P = .699). Schirmer I test in the left eye showed a significantly greater increase in the BMA group (11.81 ± 9.41 mm) compared to IDA (4.1 ± 6.99 mm) (P = .025), but right eye differences were not significant (P = .868). No adverse events were reported in either group.
**Clinical Implications:** This pilot study demonstrates that BMA and IDA have equivalent therapeutic effects for improving dry eye symptoms, quality of life, and tear production, with both being safe. BMA, made from biodegradable hyaluronic acid, offers an alternative for patients with metal allergies or sensitivities to traditional IDA needles. The findings support the potential of BMA as a novel, safer option in acupuncture-based DED management. However, limitations include the small sample size (pilot trial), lack of long-term follow-up, and absence of a conventional treatment control group (e.g., artificial tears). Larger confirmatory trials with extended follow-up and active comparators are needed to establish superiority and durability of effects.