Hu Wen-Long, Wu Pei-Chang, Pan Li-Yen, Yu Hun-Ju, Pan Chih-Chin, Hung Yu-Chiang
Department of Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine Fooyin University College of Nursing Kaohsiung Medical University College of Medicine Department of Ophthalmology, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung Department of Ophthalmology, Linkou Chang Gung Memorial Hospital, Taoyuan Sunming Eye Clinic, Kaohsiung School of Chinese Medicine for Post Baccalaureate I-Shou University, Kaohsiung, Taiwan.
Medicine (Baltimore). 2018 Jun;97(22):e10875. doi: 10.1097/MD.0000000000010875.
Dry eye is a common ophthalmologic disorder that causes ocular discomfort and has become a worldwide health concern. Patients with dry eye often turn to complementary and alternative medicine (CAM) because of unsatisfactory conventional treatments. Acupuncture is one of the most popular interventions of CAM used, and laser acupuncture (LA) is a noninvasive technique.
This protocol is a 2-center randomized controlled trial investigating the effect of laser acupuncture on dry eye. Two hundred participants aged 20 to 65 years will be randomly assigned to the experimental group (LA plus conventional treatment) or the sham control group (LA without laser output plus conventional treatment) at 2 clinical research centers in South Taiwan. The subjects will undergo LA treatment thrice a week for 12 weeks. The subjects in the experimental group will sequentially receive 0.375 J of energy at each of the following acupoints: BL2, TE23, ST2, LI4, ST36, and GB37. The subjects in the control group will also receive a sham LA treatment, without any laser output. Outcome assessments will include evaluation of the ocular surface disease index (OSDI), tear film break-up time (TFBUT), Schirmer-I test finding, and the visual analog scale (VAS) score at 4 and 12 weeks before treatment. The OSDI, TFBUT, Schirmer-I test result, and VAS score of the participants will be analyzed and compared between the experimental and control groups using the paired t test and one-way analysis of variance.
The aim of this protocol is to investigate the efficacy of LA therapy in patients with dry eye.
ClinicalTrials.gov NCT03204903.
干眼症是一种常见的眼科疾病，会导致眼部不适，已成为全球关注的健康问题。由于传统治疗效果不理想，干眼症患者常求助于补充和替代医学（CAM）。针灸是最常用的CAM干预措施之一，而激光针灸（LA）是一种非侵入性技术。
本方案是一项2中心随机对照试验，旨在研究激光针灸对干眼症的疗效。200名年龄在20至65岁之间的参与者将在台湾南部的2个临床研究中心被随机分配到实验组（LA加传统治疗）或假对照组（无激光输出的LA加传统治疗）。受试者将每周接受3次LA治疗，持续12周。实验组的受试者将依次在以下穴位各接受0.375焦耳的能量：膀胱经2穴、三焦经23穴、胃经2穴、大肠经4穴、胃经36穴和胆经37穴。对照组的受试者也将接受假LA治疗，无任何激光输出。结果评估将包括在治疗前4周和12周时对眼表疾病指数（OSDI）、泪膜破裂时间（TFBUT）、Schirmer - I试验结果和视觉模拟量表（VAS）评分的评估。将使用配对t检验和单因素方差分析对实验组和对照组参与者的OSDI、TFBUT、Schirmer - I试验结果和VAS评分进行分析和比较。
本方案的目的是研究LA疗法对干眼症患者的疗效。
ClinicalTrials.gov NCT03204903。
