ArticleDiabetes, metabolic syndrome and obesity : targets and therapy2026
Efficacy and Safety of Chinese Medicine Eye Nebulization in the Treatment of Diabetic Retinopathy: Protocol for a Double-Blind, Randomized, Placebo-Controlled Trial.
Article in Diabetes, metabolic syndrome and obesity : targets and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Background and Purpose: Diabetic retinopathy (DR) is one of the common and serious microvascular complications of diabetes mellitus (DM), DR carries a high risk of blindness and significantly impairs patients' quality of life. This study aims to systematically evaluate the efficacy and safety of Chinese Medicine Eye Nebulization (CMEN) therapy for DR and further explore its mechanisms of action. Patients and Methods: As a single-center, randomized, double-blind, placebo-controlled, parallel-group clinical trial, this study will enroll 80 patients with non-proliferative diabetic retinopathy (NPDR) at stage II, characterized by the TCM syndrome of Qi-Yin deficiency with blood stasis. Participants will be randomized in a 1:1 ratio to receive either CMEN therapy (n=40) or placebo aerosol therapy (n=40). The intervention will be administered continuously for 2 weeks. The primary outcome measures include the improvement of clinical symptoms (blurred vision, dry eyes) and quality of life, assessed using the "Xiaoke Eye Disease Primary Symptom Score Scale", the Ocular Surface Disease Index (OSDI) Dry Eye Score Scale, and the Diabetes Mellitus Quality of Life Scale (DMQLS) Chinese Version for type 2 diabetes. Secondary outcomes encompass changes in visual acuity, fall risk assessment, levels of inflammatory and oxidative stress biomarkers (VEGFA, TNF-α, IL-6, IL-8, CCL2, MDA, SOD, GSH), and the progression of fundus lesions evaluated by optical coherence tomography (OCT). Assessments will be conducted at baseline, the end of the 2-week treatment period, and the end of the 4-week follow-up period. Multivariate analysis of variance (MANOVA) will be employed to examine the associations between different groups, time points, and group-time interactions. Discussion: This study represents the pioneering application of CMEN therapy in the treatment of DR, with a specific focus on its effects on core clinical symptoms (blurred vision and dry eyes), quality of life, as well as inflammatory and oxidative stress biomarkers in DR patients.
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