Zhaolin Liu1,2,3, Ming Jin4, Ying Li5, Jun Liu6, Xianghua Xiao7, Hongsheng Bi8, Zhiqiang Pan9, Huijun Shi10, Xiaofeng Xie8, Minglian Zhang10, Xuemin Gao11, Lei Li11, Weijie Ouyang1,2,3, Liying Tang1,2,3, Jieli Wu1,2,3, Yiran Yang1,2,3, Jiaoyue Hu1,2,3, Zuguo Liu1,2,3. 1. Department of Ophthalmology, Xiang'an Hospital of Xiamen University, Fujian Provincial Key Laboratory of Ophthalmology and Visual Science, Xiamen 361102, China. 2. Eye Institute of Xiamen University, School of Medicine, Xiamen University, Xiamen 361102, China. 3. Department of Ocular Surface, Xiamen University Affiliated Xiamen Eye Center, Xiamen 361102, China. 4. Department of Ophthalmology, China-Japan Friendship Hospital, Beijing100029, China. 5. Department of Ophthalmology, Peking Union Medical College Hospital, Beijing 100006, China. 6. Department of Ophthalmology, Shenzhen Eye Hospital, Shenzhen 518040, China. 7. Department of Ophthalmology, Xi'an First Hospital, Shaanxi Eye Research Institute, Shaanxi 710001, China. 8. Department of Ophthalmology, Shandong University of Traditional Chinese Medicine Affiliated Eye Hospital, Jinan 250004, China. 9. Department of Ophthalmology, Capital Medical University Affiliated Beijing Tongren Hospital, Beijing 100730, China. 10. Department of Ophthalmology, Hebei Eye Hospital, Xingtai 054001, China. 11. Technical Center for Drug Research and Evaluation of China Association of Traditional Chinese Medicine, Beijing 100061, China.
Abstract
PURPOSE: To evaluate the efficacy and safety of Houttuynia eye drops (a Chinese traditional medicine) atomization treatment in meibomian gland dysfunction (MGD)-related dry eye disease (DED) patients. METHODS: A total of 240 eligible patients diagnosed with MGD-related DED were assigned either Houttuynia eye drops or placebo for atomization once daily for four weeks in a multi-center, randomized, double-blind, placebo-controlled clinical study. Primary outcome evaluations used included eye symptom score (using the Chinese Dry Eye Questionnaire), meibum quality, and tear break-up time (TBUT), while safety evaluations included adverse events (AEs), visual acuity, and intraocular pressure monitoring. Indicators were measured at baseline as well as one week, two weeks, and four weeks after treatment. RESULTS: Primary outcome measures of the Houttuynia group were improved compared with their placebo counterparts following four-week treatment. Eye symptom scores were significantly reduced relative to the baseline in the Houttuynia group (mean ± standard error of the mean, 9.00 ± 0.61) compared with the placebo group (6.29 ± 0.55; p = 0.0018). Reduction in meibum quality score in the Houttuynia group (0.91 ± 0.10) was also significantly higher compared with the placebo group (0.57 ± 0.10; p = 0.0091), while TBUT in the treatment group (6.30 ± 0.22) was also longer than in the latter (5.60 ± 0.24; p = 0.0192). No medication-related adverse events were observed. CONCLUSIONS: Atomization treatment with Houttuynia eye drops is both clinically and statistically effective for the treatment of mild to moderate MGD-related DED patients. This approach is generally safe and was tolerated well by patients.
RCT Entities:
PURPOSE: To evaluate the efficacy and safety of Houttuynia eye drops (a Chinese traditional medicine) atomization treatment in meibomian gland dysfunction (MGD)-related dry eye disease (DED) patients. METHODS: A total of 240 eligible patients diagnosed with MGD-related DED were assigned either Houttuynia eye drops or placebo for atomization once daily for four weeks in a multi-center, randomized, double-blind, placebo-controlled clinical study. Primary outcome evaluations used included eye symptom score (using the Chinese Dry Eye Questionnaire), meibum quality, and tear break-up time (TBUT), while safety evaluations included adverse events (AEs), visual acuity, and intraocular pressure monitoring. Indicators were measured at baseline as well as one week, two weeks, and four weeks after treatment. RESULTS: Primary outcome measures of the Houttuynia group were improved compared with their placebo counterparts following four-week treatment. Eye symptom scores were significantly reduced relative to the baseline in the Houttuynia group (mean ± standard error of the mean, 9.00 ± 0.61) compared with the placebo group (6.29 ± 0.55; p = 0.0018). Reduction in meibum quality score in the Houttuynia group (0.91 ± 0.10) was also significantly higher compared with the placebo group (0.57 ± 0.10; p = 0.0091), while TBUT in the treatment group (6.30 ± 0.22) was also longer than in the latter (5.60 ± 0.24; p = 0.0192). No medication-related adverse events were observed. CONCLUSIONS: Atomization treatment with Houttuynia eye drops is both clinically and statistically effective for the treatment of mild to moderate MGD-related DED patients. This approach is generally safe and was tolerated well by patients.
Authors: Jiawei Ling; Ben Chung-Lap Chan; Miranda Sin-Man Tsang; Xun Gao; Ping Chung Leung; Christopher Wai-Kei Lam; Jiang-Miao Hu; Chun Kwok Wong Journal: Front Med (Lausanne) Date: 2022-01-17