Integrative medicine research · 2026
Safety and efficacy of biodegradable microneedle acupuncture for dry eye: A multicenter, randomized, active-controlled pivotal trial.
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Park Soo-Yeon, Kim Min-Ji, Jung Min-Yeong, Son So-Eun, Chae Hyun-Gyung
Аннотация
BACKGROUND: Biodegradable microneedle acupuncture (BMA) is a novel technique designed to enhance therapeutic efficacy while minimizing adverse effects associated with conventional acupuncture. Dry eye (DE) is a common condition that significantly affects quality of life. This clinical trial aimed to assess the safety and efficacy of BMA compared to sterile acupuncture (SA) in treating DE.
METHODS: A total of 224 participants with DE were randomly assigned in a 1:1 ratio to either the BMA group (BMAG) or the SA group (SAG). Treatment was administered three times per week for four weeks at eight bilateral acupoints (GB14, TE23, EX-HN5, and ST1). The primary outcome was the proportion of participants experiencing at least one treatment-related adverse event (AE) during the 5-week treatment period. Secondary outcomes included changes in the Ocular Surface Disease Index (OSDI), visual analog scale for subjective symptoms (VAS-SS), quality-of-life (QoL) scores, treatment satisfaction, and additional safety assessments.
RESULTS: The proportion of participants experiencing treatment-related AEs was significantly lower in the BMAG than in the SAG (risk ratio, 0.17; 95% CI, 0.11-0.28; p < 0.0001). Greater improvements were observed in the BMAG for OSDI (mean difference -16.23; 95% confidence interval [CI], -19.32 to -13.15), VAS-SS (-19.33; 95% CI, -22.00 to -16.66), and QoL (0.96; 95% CI, 0.74-1.19). No skin allergy-related AEs occurred in the BMAG, whereas such events were observed in the SAG.
CONCLUSIONS: BMA was associated with a lower risk of treatment-related AEs and greater clinical improvement compared with sterile acupuncture in patients with DE. These findings suggest that BMA may represent a safer and more effective therapeutic option for DE management.
TRIAL REGISTRATION: Clinical Research Information Service, Republic of Korea (KCT0008802).
METHODS: A total of 224 participants with DE were randomly assigned in a 1:1 ratio to either the BMA group (BMAG) or the SA group (SAG). Treatment was administered three times per week for four weeks at eight bilateral acupoints (GB14, TE23, EX-HN5, and ST1). The primary outcome was the proportion of participants experiencing at least one treatment-related adverse event (AE) during the 5-week treatment period. Secondary outcomes included changes in the Ocular Surface Disease Index (OSDI), visual analog scale for subjective symptoms (VAS-SS), quality-of-life (QoL) scores, treatment satisfaction, and additional safety assessments.
RESULTS: The proportion of participants experiencing treatment-related AEs was significantly lower in the BMAG than in the SAG (risk ratio, 0.17; 95% CI, 0.11-0.28; p < 0.0001). Greater improvements were observed in the BMAG for OSDI (mean difference -16.23; 95% confidence interval [CI], -19.32 to -13.15), VAS-SS (-19.33; 95% CI, -22.00 to -16.66), and QoL (0.96; 95% CI, 0.74-1.19). No skin allergy-related AEs occurred in the BMAG, whereas such events were observed in the SAG.
CONCLUSIONS: BMA was associated with a lower risk of treatment-related AEs and greater clinical improvement compared with sterile acupuncture in patients with DE. These findings suggest that BMA may represent a safer and more effective therapeutic option for DE management.
TRIAL REGISTRATION: Clinical Research Information Service, Republic of Korea (KCT0008802).