Chinese herbal medicine Shenqi compound for early intervention in patients at high cardiovascular risk of type 2 diabetes mellitus: the protocol of a multicenter, randomized, double-blind, placebo-controlled trial

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Abstract

Introduction

Reducing multiple cardiovascular risk factors is a key link and a challenging clinical problem to reduce the risk of cardiovascular complications and death in patients with diabetes. Currently, there is a lack of clinical studies on patients with diabetes combined with multiple risk factors. Traditional Chinese medicine is believed to have therapeutic effects that contribute to the comprehensive control of multiple cardiovascular factors. This study aims to provide evidence for the efficacy and safety of Shenqi compound (SQC) for early intervention in diabetic patients at high cardiovascular risk.

Methods and analysis

This study is a multicenter, randomized, double-blind, placebo-controlled trial. A total of 120 diabetic patients with high cardiovascular risk were enrolled in five research centers. After a 2-week run-in period, the intervention group received basic treatment and SQC granules, and the control group received basic treatment and placebo granules for a total of 24 weeks, with a 24-week follow-up. The endpoint outcomes are major adverse cardiovascular events and renal-related and peripheral vascular disease events. The primary efficacy outcome is carotid intima-media thickness, and the secondary efficacy outcomes are carotid shear stress, indicators of glucose and lipid metabolism, pancreatic islets function, hemorheology, traditional Chinese medicine syndrome score, and quality of life scale. Safety indicators and adverse events were used to assess the safety of SQC.

Discussion

This study comprehensively evaluated the efficacy and safety of SQC for early intervention in diabetic patients at high cardiovascular risk from the aspects of overall metabolic level, structure, and function of blood vessels, quality of life, and long-term follow-up of endpoint events, providing evidence-based evidence for the short-term efficacy and long-term benefits of early treatment to reduce the risk of diabetic cardiovascular complications.

Trial Registration: This trial is registered in the Chinese Clinical Trial Registry on March 9, 2023, https://www.chictr.org.cn/showproj.html?proj=192803 (No. ChiCTR2300069219).

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Most cited references 48

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Executive Summary of the Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III)

Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (2001)

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Effects of intensive blood-pressure control in type 2 diabetes mellitus.

, Martin L Katz, H Grimm … (2010)

There is no evidence from randomized trials to support a strategy of lowering systolic blood pressure below 135 to 140 mm Hg in persons with type 2 diabetes mellitus. We investigated whether therapy targeting normal systolic pressure (i.e., <120 mm Hg) reduces major cardiovascular events in participants with type 2 diabetes at high risk for cardiovascular events. A total of 4733 participants with type 2 diabetes were randomly assigned to intensive therapy, targeting a systolic pressure of less than 120 mm Hg, or standard therapy, targeting a systolic pressure of less than 140 mm Hg. The primary composite outcome was nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular causes. The mean follow-up was 4.7 years. After 1 year, the mean systolic blood pressure was 119.3 mm Hg in the intensive-therapy group and 133.5 mm Hg in the standard-therapy group. The annual rate of the primary outcome was 1.87% in the intensive-therapy group and 2.09% in the standard-therapy group (hazard ratio with intensive therapy, 0.88; 95% confidence interval [CI], 0.73 to 1.06; P=0.20). The annual rates of death from any cause were 1.28% and 1.19% in the two groups, respectively (hazard ratio, 1.07; 95% CI, 0.85 to 1.35; P=0.55). The annual rates of stroke, a prespecified secondary outcome, were 0.32% and 0.53% in the two groups, respectively (hazard ratio, 0.59; 95% CI, 0.39 to 0.89; P=0.01). Serious adverse events attributed to antihypertensive treatment occurred in 77 of the 2362 participants in the intensive-therapy group (3.3%) and 30 of the 2371 participants in the standard-therapy group (1.3%) (P<0.001). In patients with type 2 diabetes at high risk for cardiovascular events, targeting a systolic blood pressure of less than 120 mm Hg, as compared with less than 140 mm Hg, did not reduce the rate of a composite outcome of fatal and nonfatal major cardiovascular events. (ClinicalTrials.gov number, NCT00000620.) 2010 Massachusetts Medical Society

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Effect of a multifactorial intervention on mortality in type 2 diabetes.

Peter Gaede, Henrik Lund-Andersen, Hans-Henrik Parving … (2008)

Intensified multifactorial intervention - with tight glucose regulation and the use of renin-angiotensin system blockers, aspirin, and lipid-lowering agents - has been shown to reduce the risk of nonfatal cardiovascular disease among patients with type 2 diabetes mellitus and microalbuminuria. We evaluated whether this approach would have an effect on the rates of death from any cause and from cardiovascular causes. In the Steno-2 Study, we randomly assigned 160 patients with type 2 diabetes and persistent microalbuminuria to receive either intensive therapy or conventional therapy; the mean treatment period was 7.8 years. Patients were subsequently followed observationally for a mean of 5.5 years, until December 31, 2006. The primary end point at 13.3 years of follow-up was the time to death from any cause. Twenty-four patients in the intensive-therapy group died, as compared with 40 in the conventional-therapy group (hazard ratio, 0.54; 95% confidence interval [CI], 0.32 to 0.89; P=0.02). Intensive therapy was associated with a lower risk of death from cardiovascular causes (hazard ratio, 0.43; 95% CI, 0.19 to 0.94; P=0.04) and of cardiovascular events (hazard ratio, 0.41; 95% CI, 0.25 to 0.67; P<0.001). One patient in the intensive-therapy group had progression to end-stage renal disease, as compared with six patients in the conventional-therapy group (P=0.04). Fewer patients in the intensive-therapy group required retinal photocoagulation (relative risk, 0.45; 95% CI, 0.23 to 0.86; P=0.02). Few major side effects were reported. In at-risk patients with type 2 diabetes, intensive intervention with multiple drug combinations and behavior modification had sustained beneficial effects with respect to vascular complications and on rates of death from any cause and from cardiovascular causes. (ClinicalTrials.gov number, NCT00320008.) Copyright 2008 Massachusetts Medical Society.

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Author and article information

Contributors

Yulin Leng: URI : https://loop.frontiersin.org/people/2425065/overviewRole: Role: Role: Role:

Zehua Zhang: URI : https://loop.frontiersin.org/people/1739462/overviewRole: Role: Role:

Nairong Yao: Role: Role: Role:

Xiaoxu Fu: Role: Role: Role:

Hongyan Xie: URI : https://loop.frontiersin.org/people/1623990/overviewRole: Role: Role:

Hong Gao: Role: Role: Role: Role:

Chunguang Xie: URI : https://loop.frontiersin.org/people/1710819/overviewRole: Role: Role: Role: Role: Role:

Journal

Journal ID (nlm-ta): Front Cardiovasc Med

Journal ID (iso-abbrev): Front Cardiovasc Med

Journal ID (publisher-id): Front. Cardiovasc. Med.

Title: Frontiers in Cardiovascular Medicine

Publisher: Frontiers Media S.A.

ISSN (Electronic): 2297-055X

Publication date (Electronic): 08 January 2024

Publication date Collection: 2023

Volume: 10

Electronic Location Identifier: 1290240

Affiliations

[ ¹ ]Hospital of Chengdu University of Traditional Chinese Medicine , Chengdu, Sichuan, China

[ ² ]Traditional Chinese Medicine Regulating Metabolic Diseases Key Laboratory of Sichuan Province , Chengdu, Sichuan, China

Author notes

Edited by: Juncheng Wei, Temple University, United States

Reviewed by: Kaijian Hou, Shantou University, China

Anthony Jaworowski, RMIT University, Australia

[* ] Correspondence: Hong Gao cdgh76@ 123456163.com Chunguang Xie xiecg@ 123456cdutcm.edu.cn

Abbreviations AEs, adverse events; ASCVD, atherosclerotic cardiovascular disease; BMI, body mass index; CIMT, carotid intima-media thickness; CVD, cardiovascular disease; eGFR, estimated glomerular filtration rate; FPG, fasting plasma glucose; FINS, fasting insulin; HDL-C, high-density lipoprotein cholesterol; LDL-C, low-density lipoprotein cholesterol; SQC, Shenqi compound; T2DM, type 2 diabetes mellitus; TC, total cholesterol; TCM, traditional Chinese medicine; TGs, triglycerides.

Article

DOI: 10.3389/fcvm.2023.1290240

PMC ID: 10800938

PubMed ID: 38259322

SO-VID: 176f8b7b-7193-43da-9e83-ce1b12736981

License:

This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

History

Date received : 07 September 2023

Date accepted : 13 December 2023

Page count

Figures: 0, Tables: 1, Equations: 0, References: 48, Pages: 0, Words: 0

Funding

Funded by: innovation team and talents cultivation program of the National Administration of Traditional Chinese Medicine

Award ID: ZYYCXTD-C-202209

Funded by: major research and development project from the Sichuan Science and Technology Program

Award ID: 2022ZDZX0022

The author(s) declare financial support was received for the research, authorship, and/or publication of this article.

This study is supported by the innovation team and talents cultivation program of the National Administration of Traditional Chinese Medicine (No. ZYYCXTD-C-202209) and a major research and development project from the Sichuan Science and Technology Program (No. 2022ZDZX0022).

Custom metadata

section-at-acceptance Cardiovascular Pharmacology and Drug Discovery

Keywords: type 2 diabetes mellitus,cardiovascular risk,randomized controlled trial,traditional chinese medicine,shenqi compound

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Keywords: type 2 diabetes mellitus, cardiovascular risk, randomized controlled trial, traditional chinese medicine, shenqi compound

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Chinese herbal medicine Shenqi compound for early intervention in patients at high cardiovascular risk of type 2 diabetes mellitus: the protocol of a multicenter, randomized, double-blind, placebo-controlled trial

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Abstract

Introduction

Methods and analysis

Discussion

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Clinical Social Work and Health Intervention

Most cited references 48

Executive Summary of the Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III)

Effects of intensive blood-pressure control in type 2 diabetes mellitus.

Effect of a multifactorial intervention on mortality in type 2 diabetes.

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Most referenced authors 1,324