Oral Chinese medicines for treating diabetic macular edema: Protocol for a systematic search of randomized studies and meta-analysis

Abstract

Introduction The diabetic macular edema (DME) is a relevant cause of visual impairment in diabetes. The current treatments are limited by high costs, risk of infections and damage to retinal cells. Randomized controlled studies (RCTs) have investigated oral traditional Chinese medicines (TCMs) for the treatment of DME. We aimed at determining the efficacy and safety of oral TCMs by systematically reviewing the full set of studies. Methods and analysis Published RCTs will be searched through 12 databases until October 1, 2022. Two investigators will conduct independent literature search, data extraction and assessment of quality. The risk of bias will be judged with the version 2 of the Cochrane risk-of-bias tool. The RevMan software will be utilized to analyze data. Dichotomous data will be assessed by using odds ratios and 95% confidence intervals (CIs). We will evaluate continuous data by using weighted mean differences and 95% CIs. We are going to assess heterogeneity by Cochran's Q test and the I2 statistics. We plan sensitivity analysis and subgroup analysis to identify sources of heterogeneity. Funnel plots, Egger's tests and Begg's tests will be also performed.

Competing Interest Statement

The authors have declared no competing interest.

Funding Statement

This work is funded by the National Natural Science Foundation of China (grant No. 81874491). The funders will not have a role in study design, collection of data, data analysis and preparation of the article.

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The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

This is a clinical research design protocol

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Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

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I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

All data produced in the present work are contained in the manuscript

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