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Effect of grape seed proanthocyanidin extract on hard exudates in patients with non-proliferative diabetic
Sang Woong Moon1, Yong Un Shin2, Heeyoon Cho2
1Department of Ophthalmology, Kyung Hee University College of Medicine.
Purpose:
To evaluate the efficacy and safety of orally administered grape seed proanthocyanidin extract (GSPE) in patients with non-proliferative diabetic retinopathy (NPDR).
Methods:
In this randomized (1:2:2), multicentre, double-blind trial, patients (n = 124; age: 40-78 years) were administered placebo, calcium dobesilate (CD; 750 mg/d), or GSPE (150 mg/d) orally for up to 12 months. All patients had retinal thickening with hard exudates (HEs) that met predefined criteria; the median best-corrected visual acuity was 0.8, as assessed using the Snellen visual acuity card. The main outcome measure was an improvement in HEs by at least 1 grade on a 10-grade severity scale. This was evaluated using fundus photography over 1 year.
Results:
The rate of improvement in the HE severity was higher in the GSPE group than in the CD group. No statistically significant difference existed among the study groups in optical coherence tomography parameters, such as central subfield macular thickness and total macular volume (TMV). However, in the GSPE group, TMV after 9 months of treatment was significantly decreased compared with that at baseline. The GSPE group showed a significantly greater improvement in HE severity than did the placebo or CD group. Four cases in the GSPE group and 2 in the CD group were determined to have developed potential treatment-related adverse reactions, which were all gastrointestinal in nature.
Conclusions:
Oral GSPE therapy for 1 year improved HEs in patients with NPDR. The efficacy of GSPE for HEs was higher than that of oral CD in the study patients.
Insights
Grape seed proanthocyanidin extract (GSPE) effectively improved hard exudates in non-proliferative diabetic retinopathy (NPDR). GSPE showed greater efficacy than calcium dobesilate for this condition.
Area of Science:
- Ophthalmology
- Diabetic Retinopathy Research
- Natural Product Therapeutics
Background:
- Diabetic retinopathy (DR) is a leading cause of vision loss.
- Non-proliferative diabetic retinopathy (NPDR) is an early stage characterized by retinal thickening and hard exudates (HEs).
- Effective treatments for NPDR, particularly for managing HEs, are crucial for preventing vision impairment.
Purpose of the Study:
- To assess the efficacy and safety of oral grape seed proanthocyanidin extract (GSPE) in patients diagnosed with non-proliferative diabetic retinopathy (NPDR).
- To compare the effects of GSPE with placebo and calcium dobesilate (CD) in managing NPDR symptoms.
Main Methods:
- A randomized, multicentre, double-blind trial involving 124 patients with NPDR.
- Patients received oral placebo, calcium dobesilate (750 mg/d), or GSPE (150 mg/d) for up to 12 months.
- The primary outcome was improvement in hard exudates (HEs) by at least one grade on a 10-grade scale, assessed via fundus photography.
Main Results:
- GSPE treatment led to a significantly greater improvement in HE severity compared to both placebo and calcium dobesilate.
- While optical coherence tomography parameters showed no significant differences, GSPE significantly decreased total macular volume (TMV) after 9 months.
- Adverse events were primarily gastrointestinal and mild, occurring in 4 GSPE cases and 2 CD cases.
Conclusions:
- Oral GSPE therapy for one year demonstrated efficacy in improving hard exudates in patients with NPDR.
- GSPE exhibited superior efficacy in reducing HEs compared to oral calcium dobesilate in the studied population.
- GSPE represents a promising therapeutic option for managing NPDR, with a favorable safety profile.
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