Introduction: A previous 6-month report showed that adjunctive auricular acupoint stimulation (AAS) slowed myopia progression compared with 0.01% atropine (0.01% A) alone. This 12-month report was to determine whether the antimyopic effect of AAS, when added to 0.01% A, continued beyond treatment cessation, and explore the mode of action of AAS from the accommodative response. Design and Interventions: One hundred four children were randomly assigned to either a 0.01% A group or a 0.01% A + AAS group. Participants in the 0.01% A + AAS group received AAS in addition to 0.01% A for 6 months, and then kept using 0.01% A for the following 6 months. Participants in the 0.01% A group only used 0.01% A. The primary outcome was the difference in the mean cycloplegic spherical equivalent refraction (SER) from the baseline to the 12-month visit. Secondary outcomes included axial length (AL) and accommodative lag assessments. Results: The adjusted mean change from baseline to month 12 in the SER was -0.62 D for 0.01% A and -0.46 D for 0.01% A + AAS (difference, 0.16 D; p = 0.01), with a respective mean increase of 0.37 and 0.31 mm in AL (difference, -0.05 mm; p = 0.05). For the 5D near target, there was a reduction in the accommodative lag in children receiving add-on AAS relative to 0.01% A alone at 1 and 6 months (both p = 0.002). Conclusions: AAS treatment produced additional benefits >0.01% A in slowing myopia progression over the 12-month period, where the efficacy was sustained after the cessation of AAS. An effect of add-on AAS on reducing accommodative lag in response to 5D stimulus was found, but its role in mediating therapeutic response remained unclear. Chinese Clinical Trial Registry number: ChiCTR1900021316.
Keywords: atropine; auricular acupoint; clinical trials; complementary medicine; myopia.