Effect of Chinese Patent Medicines on Ocular Fundus Signs and Vision in Calcium Dobesilate-Treated Persons With Non-Proliferative Diabetic Retinopathy: A Systematic Review and Meta-Analysis

Abstract

BackgroundDiabetic retinopathy (DR), one of the commonest microvascular complications in diabetic patients, is featured by a series of fundus lesions. Conventional Western medicine therapies for DR are always with modest treatment outcome. This paper is to assess the ocular fundus signs, vision and safety of Chinese patent medicines (CPMs) as an add-on treatment for DR.Method7 electronic databases were searched to determine eligible trials. Randomized controlled trials (RCTs) of non-proliferative diabetic retinopathy (NPDR) in which the intervention group received CPMs combined with calcium dobesilate (CD), and the control group received only CD were included for analysis. Two reviewers extracted the data independently. Results expressing as mean differences (MD) and relative risks (RR) were analyzed with a fixed-effects or random-effects models.Results19 RCTs involved 1568 participants with 1622 eyes met our inclusion criteria. The results suggested that compared with CD alone, CPMs plus CD for NPDR was superior at reducing the microaneurysm volume (MD -3.37; 95% confidence interval [CI], -3.59 to -3.14), microaneurysm counts (MD -2.29; 95%CI -2.97 to -1.61), hemorrhage area (MD -0.79; 95%CI -0.83 to -0.75), and macular thickness (MD -59.72; 95%CI -63.24 to -56.20). Participants in CPMs plus CD group also achieved a better vision. No obvious adverse events occurred.ConclusionCPMs as an add-on therapy for NPDR have additional benefits and be generally safe. This meta‐analysis demonstrated that CPMs combined with CD could improve retinal microaneurysm, hemorrhage, macular thickness, visual acuity, fasting blood glucose (FBG), and glycosylated hemoglobin (HbAlc) compared with CD alone. Further studies are needed to provide more conclusive evidence.Systematic Review RegistrationPROSPERO https://www.crd.york.ac.uk/prospero/, identifier CRD42021257999.

The comparative effects of oral Chinese patent medicines in non-proliferative diabetic retinopathy: A Bayesian network meta-analysis of randomized controlled trials

“…This NMA systematically evaluated the efficacy and safety of 7 commonly used OCPMs (CXC, CDDP, QG, SDMUC, MMDHP, HXMMT, and DHHYK) alone or combined with CD in patients with NPDR based on information from 42 studies involving 7 categories of outcomes. Our results showed that OCPMs alone or combined with CD were superior to CD alone in terms of an improved clinical efficacy rate, improved visual acuity and visual field gray value, reduced fundus hemorrhage and exudation, and better drug safety, which is consistent with the results of a published pairwise meta-analysis ( 11 ). More so, by comparing different types of proprietary Chinese medicines, the NMA also suggests that more attention should be given to CDDP, CXC, HXMMT, and SDMMC in the clinical treatment of NPDR.…”

“…Therefore, early treatment and prevention at the stage of NPDR have become an urgent clinical problem to be solved. In China, clinicians often apply OCPMs for the treatment of NPDR with good clinical efficacy ( 11 ). DR belongs to the category of “thirsty eye disease” according to traditional Chinese medicine, and its pathogenesis is mainly attributed to the deficiency of both qi and yin and the stasis of ocular collateral ( 61 ).…”

“…Several recent basic studies have shown that the active ingredients of OCPMs can reduce retinal ischemia and hypoxia, and improve retinal structure and function through various pathways, such as reducing pericyte loss, attenuating oxidative stress and inflammatory responses ( 9 , 10 ). Moreover, a growing body of clinical evidence suggested that OCPMs alone or combined with CD for treating NPDR patients could effectively improve patients’ visual function and fundus signs ( 11 ). However, there is still debate about which OCPM is most effective in treating NPDR.…”

Traditional Chinese medicine could play an important role in diabetes management: Commentary on “National Chinese medicine guideline for the prevention and treatment of diabetes in primary care (2022)”

“…Previous meta‐analyses have demonstrated that the Chinese patent medicines (including Compound Danshen Dripping Pills, Compound Xueshuantong Capsule, Qiming granule) as an add‐on therapy for diabetic retinopathy have additional benefits and are generally safe. Chinese patent medicines combined with calcium dobesilate could improve retinal microaneurysm, hemorrhage, macular thickness, visual acuity, fasting blood glucose, and HbA1c compared with calcium dobesilate alone 25 . Another network meta‐analysis that included 41 RCTs found that the treatment plan of Dihuang pill prescriptions combined with conventional treatment could reduce serum creatinine, 24‐h urinary protein, and fasting blood glucose urine protein excretion rate and improve the total clinical effective rate; the combination of medicine was obviously better than conventional medicine alone 26 .…”

“…Chinese patent medicines combined with calcium dobesilate could improve retinal microaneurysm, hemorrhage, macular thickness, visual acuity, fasting blood glucose, and HbA1c compared with calcium dobesilate alone. 25 Another network meta‐analysis that included 41 RCTs found that the treatment plan of Dihuang pill prescriptions combined with conventional treatment could reduce serum creatinine, 24‐h urinary protein, and fasting blood glucose urine protein excretion rate and improve the total clinical effective rate; the combination of medicine was obviously better than conventional medicine alone. 26 As for TCM foot baths and acupoint massages, they may promote microcirculation, enhance skin permeability, and increase drug absorption.…”