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      Compound Danshen Dripping Pill for Treating Nonproliferative Diabetic Retinopathy: A Meta-Analysis of 13 Randomized Controlled Trials

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          Abstract

          Objective

          We assess the clinical effect of compound Danshen dripping pill (CDDP) for treating diabetic retinopathy (DR).

          Methods

          Electronic databases were searched from January 2001 to October 2016 to locate randomized controlled trials (RCTs). Efficacy was measured as main outcome and microaneurysms, hemorrhage, exudate, vision, and fundus fluorescein angiography (FFA) were measured as second outcomes. Methodological quality for each study was evaluated, RevMan 5 software was used to assess treatment effects, and GRADE was used to rate quality of evidence.

          Results

          We located 13 RCTs and methodological quality was evaluated as high risk. Statistics indicated CDDP for treating DR was better than controls and DR risk was reduced 64% with CDDP (RR: 0.36, P = 0.68); retinal microaneurysms (MD = −4.32NO, P < 0.00001); retinal hemorrhages (MD = −0.70PD, P = 0.03); exudate improvements (MD = −0.09PD, P = 0.79); visual changes (MD = −0.12 letter, P = 0.006); FFA (RR: 0.40, P = 0.003). About GRADE, quality of evidence was “low.” Conclusion. CDDP may be safe and efficacious for treating or delaying DR and may improve vision or delay vision loss.

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          Generation of allocation sequences in randomised trials: chance, not choice.

          Kenneth F Schulz, David A Grimes (2002)
          The randomised controlled trial sets the gold standard of clinical research. However, randomisation persists as perhaps the least-understood aspect of a trial. Moreover, anything short of proper randomisation courts selection and confounding biases. Researchers should spurn all systematic, non-random methods of allocation. Trial participants should be assigned to comparison groups based on a random process. Simple (unrestricted) randomisation, analogous to repeated fair coin-tossing, is the most basic of sequence generation approaches. Furthermore, no other approach, irrespective of its complexity and sophistication, surpasses simple randomisation for prevention of bias. Investigators should, therefore, use this method more often than they do, and readers should expect and accept disparities in group sizes. Several other complicated restricted randomisation procedures limit the likelihood of undesirable sample size imbalances in the intervention groups. The most frequently used restricted sequence generation procedure is blocked randomisation. If this method is used, investigators should randomly vary the block sizes and use larger block sizes, particularly in an unblinded trial. Other restricted procedures, such as urn randomisation, combine beneficial attributes of simple and restricted randomisation by preserving most of the unpredictability while achieving some balance. The effectiveness of stratified randomisation depends on use of a restricted randomisation approach to balance the allocation sequences for each stratum. Generation of a proper randomisation sequence takes little time and effort but affords big rewards in scientific accuracy and credibility. Investigators should devote appropriate resources to the generation of properly randomised trials and reporting their methods clearly.
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            Prevalence of diabetic retinopathy in rural China: the Handan Eye Study.

            David Friedman, Evelyn Wang, J. Wang … (2009)
            To describe the age- and gender-specific prevalence, characteristics, and severity of diabetic retinopathy (DR) in a rural population in northern China. A population-based cross-sectional study. A total of 6830 Han Chinese aged 30 years and older from 13 villages of Yongnian County, Handan City, Hebei Province, China. All participants underwent a standardized interview, a comprehensive eye examination, and fasting blood glucose testing according to the American Diabetes Association diagnostic criteria (fasting plasma glucose >or=7.0 mmol/l). Retinal photographs obtained after pupil dilation were graded for the presence and severity of DR according to the modified Early Treatment Diabetic Retinopathy Study classification system. Any DR, retinopathy grades, macular edema, or vision-threatening retinopathy. Of the 6830 eligible individuals participating in the study, 5597 (81.9%) had fasting blood glucose results available. Of these, 387 participants (6.9%) were diagnosed with diabetes mellitus, including 247 subjects with new diabetes mellitus (NDM) and 140 subjects with known diabetes mellitus (KDM). For these, gradable photographs were available for 368 subjects (95.1%). The overall prevalence of DR was 43.1% (95% confidence interval, 38.1-48.4) and was higher in persons with KDM (65.2%) than NDM (33.5%). The prevalence of proliferative DR, macular edema, and vision-threatening retinopathy was 1.6%, 5.2%, and 6.3%, respectively, with 12.1% with KDM having untreated vision-threatening DR. No age- or gender-related differences were present. The prevalence of DR was strongly related to duration of disease. Our study reports a high prevalence of DR among adults 30 years and older with diabetes in rural China. On the basis of estimates obtained from our study, we projected that in rural China, 21.1 million persons aged 30+ years have diabetes and 9.2 million have DR, including 1.3 million with vision-threatening DR. There is a pressing need for appropriate screening and management of diabetes and its complications in rural China.
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              Diabetic Retinopathy and Other Ocular Findings in the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Study

              Lloyd Paul Aiello, (2013)
              OBJECTIVE To evaluate whether intensive treatment (INT) with the goal of achieving blood glucose levels as close to the nondiabetic range as safely possible reduced the risk of onset and progression of diabetic retinopathy (DR) in subjects with type 1 diabetes (T1D) compared with conventional therapy (CON). RESEARCH DESIGN AND METHODS The Diabetes Control and Complications Trial (DCCT) (1982–1993) was a multicenter, controlled clinical trial comparing INT with CON for onset and progression of DR. The Epidemiology of Diabetes Interventions and Complications (EDIC) study (1994–present) is an observational follow-up of the DCCT cohort. RESULTS Of the 1,441 DCCT subjects, 726 had no DR (primary prevention cohort) and 715 had mild DR (secondary intervention cohort) at baseline. Subjects were followed for a mean of 6.5 years. INT median HbA1c was 7% compared with CON median of 9%. INT reduced the adjusted mean risk for the development of DR by 76% and slowed progression of DR by 54% compared with CON. Following DCCT, the HbA1c levels in the original INT and CON groups converged (year 8, INT 7.98%; CON 8.07%); nevertheless, the groups continued to have a durable effect of initial assigned therapy with significantly lower incidence of further DR progression in the INT group (hazard reduction 53–56%). Severe retinal outcomes and procedures to treat them were reduced by 50% in the original INT group. CONCLUSIONS INT delays the onset and slows the progression of DR. Furthermore, the early effects of metabolic control continue to accrue over many years despite subsequent comparable glycemic control (metabolic memory). These results emphasize the need for optimizing glycemic control as early as possible in patients with diabetes.
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                Author and article information

                Contributors
                Fengmei Lian:
                ORCID: http://orcid.org/0000-0003-2222-7487
                Journal
                Journal ID (nlm-ta): Evid Based Complement Alternat Med
                Journal ID (iso-abbrev): Evid Based Complement Alternat Med
                Journal ID (publisher-id): ECAM
                Title: Evidence-based Complementary and Alternative Medicine : eCAM
                Publisher: Hindawi
                ISSN (Print): 1741-427X
                ISSN (Electronic): 1741-4288
                Publication date (Print): 2017
                Publication date (Electronic): 24 August 2017
                Volume: 2017
                Electronic Location Identifier: 4848076
                Affiliations
                1Department of Endocrinology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beixiange 5, Xicheng District, Beijing 100053, China
                2China Academy of Chinese Medical Sciences, Beixiange 5, Xicheng District, Beijing 100700, China
                Author notes

                Academic Editor: Mona Abdel-Tawab

                Author information
                http://orcid.org/0000-0001-7713-6406
                http://orcid.org/0000-0003-2222-7487
                Article
                DOI: 10.1155/2017/4848076
                PMC ID: 5610889
                SO-VID: 4d1a2f3d-ecbb-44b9-96b0-8f91cc9ea21f
                Copyright © Copyright © 2017 Wenjing Huang et al.
                License:

                This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                Date received : 4 December 2016
                Date revision received : 12 February 2017
                Date accepted : 23 April 2017
                Funding
                Funded by: 2015 Traditional Chinese Medicine Scientific Research
                Award ID: 201507001-11
                Categories
                Subject: Review Article

                ScienceOpen disciplines: Complementary & Alternative medicine
                Data availability:
                ScienceOpen disciplines: Complementary & Alternative medicine

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