Supplementary Material for: The efficacy and safety of Chinese eye exercise of acupoints in dry eye patients: a randomized controlled trial.

Abstract
Introduction: Dry eye disorder (DED) is a growing global issue linked to excessive digital screen time. Chinese eye exercise of acupoint (CEA), a set of self-massages on shared CA acupoints, has been used to reduce visual-related ocular symptoms and possibly as an alternative treatment for DED. This study aimed to assess the efficacy and safety of CEA.
Methods:
A single-blind randomized controlled trial was conducted at Thammasat University Hospital in Thailand, recruiting 56 participants aged 20-60 years, equally divided into two groups: the treatment group with CEA and the control group with standard lid hygiene treatment (STD). The intervention program lasted 12 weeks. Main outcome measures: Ocular surface disease index (OSDI), tear break-up time (TBUT), Schirmer I test (SIT), corneal surface staining (CSS), and self-recorded forms for safety and adverse effects were measured at baseline, week 4 and week 12. An independent sample t-test, paired t-test, and repeated measures (ANOVA) were used to compare results between both groups, study visits, and primary and secondary outcome measurements, respectively. P-values < 0.05 were considered statically significant.
Results: The characteristics were not statistically different between both groups at the baseline. The mean OSDI scores were significantly reduced in both groups at week 4 and week 12 compared to baseline (p-value < 0.05). Additionally, both CEA and STD showed significant improvement in TBUT and SIT (p-value < 0.05). CSS was significantly improved only in the CEA groups (p-value < 0.05). No significant differences were observed between the study groups, except for SIT at week 12 (p-value < 0.05). For the safety, there were no adverse side effects in either group.
Conclusion: CEA seemed to be as effective as STD in improving the OSDI, TBUT and SIT of DED without causing any side effects.

摘要
引言：干眼症（Dry eye disorder, DED）是日益凸显的全球性健康问题，与过度使用电子屏幕密切相关。穴位眼保健操（Chinese eye exercise of acupoint, CEA）是一套针对共通穴位的自我按摩方案，长期被用于缓解视觉相关性眼部不适，或可作为干眼症的替代治疗手段。本研究旨在评估穴位眼保健操的疗效与安全性。

方法：本研究于泰国法政大学医院开展单盲随机对照试验，招募56名年龄介于20至60岁的受试者，按1:1比例分为两组：试验组接受穴位眼保健操干预，对照组接受标准眼睑卫生治疗（standard lid hygiene treatment, STD）。干预周期共计12周。主要结局指标：分别于基线、第4周及第12周检测眼表疾病指数（ocular surface disease index, OSDI）、泪膜破裂时间（tear break-up time, TBUT）、施墨I试验（Schirmer I test, SIT）、角膜表面染色（corneal surface staining, CSS），并通过受试者自行填写的问卷评估安全性与不良反应。分别采用独立样本t检验、配对t检验及重复测量方差分析（repeated measures ANOVA），比较两组受试者、各随访时点以及主要与次要结局指标间的差异，以P<0.05为差异具有统计学意义。

结果：两组受试者基线特征差异无统计学意义。与基线相比，两组在第4周及第12周的平均眼表疾病指数评分均显著降低（P<0.05）。此外，穴位眼保健操与标准眼睑卫生治疗均能显著改善泪膜破裂时间与施墨I试验结果（P<0.05）。角膜表面染色仅在穴位眼保健操组中得到显著改善（P<0.05）。除第12周的施墨I试验结果存在显著差异外，两组间其余指标差异均无统计学意义（P<0.05）。安全性方面，两组均未观察到明显不良反应。

结论：穴位眼保健操在改善干眼症患者的眼表疾病指数、泪膜破裂时间与施墨I试验结果方面，疗效与标准眼睑卫生治疗相当，且未引发任何不良反应。