Mingjing granule, a traditional Chinese medicine in the treatment of neovascular age-related macular degeneration: study protocol for a randomized controlled trial

Abstract

Background Neovascular age-related macular degeneration (nAMD) is the most common cause of irreversible vision loss and blindness among the older people aged 50 and over. Although anti-vascular endothelial growth factor (anti-VEGF) therapies have resulted in improving patient outcomes, there are limitations associated with these treatments. In China, traditional Chinese medicine (TCM) has been used to treat eye diseases for more than 2000 years. Previous studies have shown that TCM may be beneficial for nAMD patients. However, explicit evidence has not been obtained. The purpose of the present trial is to examine the efficacy and safety of the Mingjing granule, a compound Chinese herbal medicine, for nAMD patients. Methods/design This is a double-blind, placebo-controlled, randomized trial of Mingjing granule as an add-on to intravitreous ranibizumab for nAMD. One hundred eighty nAMD patients from six hospitals in China will be enrolled according to the inclusion and exclusion criteria and randomly allocated into two groups, 90 in each. All participants will receive a 24-week treatment and then be followed up for another 24 weeks. The primary outcome is the mean change of best-corrected visual acuity at week 24 and 48 as compared to the baseline. The secondary outcomes include mean change in central retinal thickness, area of retinal hemorrhage and exudation, and TCM syndrome score, mean number of intravitreal ranibizumab injection, and total cost of the treatment. Indexes of safety include blood regular test, urine regular test, liver function test, renal function test, and electrocardiogram from baseline to weeks 24 and 48. Qualitative control and some standard operating processes will be formed throughout the trial. Any ocular or systemic adverse events will be treated suitably, and related data will be recorded accurately and completely in the case report form. Discussion Based on previous empirical and animal laboratory studies, this study will address the question of whether Mingjing granule could contribute to improving efficacy, safety, and efficiency with need for fewer intravitreal injections of anti-VEGF, improving compliance and visual outcomes in the management of persons with nAMD. Trial registration Chinese Clinical Trial Registry (http://www.chictr.org.cn), ChiCTR2000035990. Registered on 21 August 2020.

Clinical Effect of Tongmai Fuming Decoction on Neovascular Ophthalmopathy

“…e treatment is based on tonifying the liver and kidney, accompanied by removing the blood stasis and clearing collaterals, thus reducing the production of pathological VEGF [25][26][27][28][29]. Contemporary pharmacological studies show that part of traditional Chinese medicine for supplementing the liver and kidneys has antioxidation, stabilizes the blood-eye barrier, and has sex hormone-like effects [30][31][32][33][34]. In the clinical treatment of eye disease with the liver and kidney Yin syndrome, the use of Western medicine can be reduced to a certain extent by considering the combination of traditional Chinese and Western medicine.…”

The role of traditional Chinese medicine on fracture surgery, hospitalization, and total mortality risks in diabetic patients with osteoporosis

“…It has also been noted that compared with type 1 diabetes that T2D is not currently included in the fracture risk assessment tool (FRAX) used to calculate the 10-year fracture risk probability, which may be related to the fact that more than half of T2D patients are overweight or obese [ 17 ], and the impact of T2D on bone fragility is complex [ 18 ], with T2D patients generally having higher bone mineral density (BMD) than non-diabetic patients [ 19 ]. Patients with T2D often suffer from retinal macular degeneration, and one study reported that TCM Mingjing Granules can help to improve the safety and efficacy of intravitreal injections of anti–vascular endothelial growth factor in treating neovascular age-related macular degeneration [ 20 ]. This can further reduce the incidence of retinal macular degeneration in diabetic patients, a symptom which can lead to accidents such as falls and fractures due to poor vision.…”

Gastrodin represses hydrogen peroxide-induced oxidative stress in retinal pigment epithelial cells through p38MAPK/iNOS pathway

“…Administration of antioxidant nutrients reduced the risk for AMD (Raniga and Elder, 2009). Therefore, traditional Chinese herbs with antioxidant capacity are widely used in the clinical prevention of AMD (Jin et al, 2018;Li et al, 2021). Gastrodin, isolated from Gastrodia elata Blume, exerted antioxidant effect against retinal neurodegenerative diseases (Wang et al, 2017), high glucose-induced retinal endothelial cell apoptosis (Zhang et al, 2018), and glaucoma-related retinal degeneration (Molinari et al, 2021).…”