Traditional Chinese Medicine Intervention for Managing Type 2 Diabetes in Elderly Urban Populations: A Randomized Controlled Trial

Summary

This protocol assesses the efficacy of Traditional Chinese Medicine (TCM) in increasing glycemic control, quality of life, and complications in elderly type 2 diabetes patients by a randomized controlled trial and 3-month follow-up.

Abstract

To assess the effectiveness of Western medicine and TCM treatment for the improvement of glycaemia control, quality of life, and reducing complications among type 2 diabetes elderly patients in an urban community, a total of 132 elderly patients with type 2 diabetes (aged ≥ 60 years) were randomly allocated to either treatment or placebo control. The intervention group received a comprehensive TCM treatment regimen, including herbal medicine, acupuncture, massage, and dietary therapy, along with lifestyle changes. The control received the standard Western medical treatment. Blood glucose levels were measured upon arrival and again 2 h later. Glycated haemoglobin (HbA1c) was monitored over the duration of the study. In addition, lipid profiles were assessed. Quality of life was evaluated using the Diabetes-Specific Quality of Life Scale (DSQL). Other complications were also recorded. The secondary outcomes measured other kinds of social support (Social Support Rate Scale, SSRS) and health risk (WONCA scale). Compared to the control group, those in the TCM intervention group had better glycemic management, with significant improvements in fasting blood glucose (FBG) (6.82 ± 0.94 vs. 9.34 ± 1.43 mmol/L, P < 0.05) and HbA1c (6.51 ± 0.65% vs. 7.82 ± 0.88%, P < 0.05). Furthermore, the TCM intervention group had better lipid profiles and a higher DSQL score (21.25 ± 3.65 vs. 28.32 ± 4.89, P < 0.05). Finally, they did not suffer from TCM complications (1.52% vs. 10.61%, P < 0.05). Those in the intervention group also had significantly higher social support scores (SSRS; P < 0.05). Therefore, using TCM together with other treatments has a greater effect on the blood glucose, life quality, and diabetic complications of older diabetic patients in a community.

Introduction

The global ageing process is accelerating, and the incidence of diabetes in the elderly is rising year by year. According to the International Diabetes Federation (IDF), approximately 463 million people worldwide have diabetes, with the elderly accounting for over 30% of the total cases¹. Elderly diabetic patients often suffer from multiple complications, which seriously affect their quality of life and life expectancy². Currently, although conventional Western medicine management has achieved specific results in the treatment of elderly diabetes, problems such as significant drug side effects and low patient compliance ....

Protocol

This is a low-risk, exploratory pilot and feasibility study designed to refine a comprehensive Traditional Chinese Medicine (TCM) protocol for elderly patients with type 2 diabetes in the community in advance of a definitive multi-centre trial. In accordance with the institutional policy of Zhuhai Hospital, China, formal prospective review by an independent ethics committee is not required for non-interventional, low-risk pilot studies that use only standard-of-care medications and established Traditional Chinese Medicine practices. Before participating in the study, the patients provided written consent. All applicable processes were conducted in accordance with the ....

Results

Participant flow and baseline characteristics

Between October 2023 and September 2024, 250 community-dwelling elderly patients with type 2 diabetes were screened; 132 were randomized (n=66 per group). Participants were from Zhuhai Hospital. All participants completed the 8-month follow-up (100% retention). Baseline demographic and clinical characteristics were comparable between groups (p>0.10).

Figure 1 shows the Co.......

Discussion

This study proposed that using TCM would lead to better blood glucose control, improved lipid profiles, and improved quality of life in elderly diabetic patients. The study hypothesised that using TCM would improve the clinical signs of diabetes (blood sugar, lipid levels) and also make life better and reduce diabetes-related complications for the elderly²⁴. These results support the hypothesis by showing that TCM can benefit patients with diabetes, with lower blood sugar, better HbA1c, improved l.......

Materials

List of materials used in this article

Name	Company	Catalog Number	Comments
A cupuncture needles	YGQQOY	BODK X77MH3	Standard disposable stenle needles used by trained TCM physicians
Acupoints (e.g-, Zusanli - ST36, Sanyinjiao - SP6, and others)	lygchi	BOCP6XF 1FK	Selected based on syndrome differentiation
Blood collection tubes/consumables for glucose and lipid testng	Local hospital laboratory	BODWXF7QM5	Standard clinical lab reagents
Chinese herbal medicines (decoctions/formulas)	Plant Extracts	10.5772/intechopen.85733	Personalized according to TCM syndrome diflerentiation; specific formulas determined via Delphi expert consultation
Conventional Westem medicine (oral hypoglycemic agents and or insulin etc.)	Local hospital pharmacy BOOSIUBJYA		Standard diabetes management drugs per Chinese guidelines
Diabetes-Specific Quality of Life Scale (DSQL)	Chinese diabetes-specific instrument		Covers physiological, psychological, social and treatment dimensions
Low-sugar, high-fiber diet guidance For Dummies		470538708	Lifestyle intervention
Social Support Rate Scale (SSRS)	Shui Yuan Xiao (Chinese standardized scale)	APA PsycNet Direct	10 items, 3 dimensions
SPSS software (version 22.0)	IBM Corporation		Statistical analysis package
TCM dietary therapy recipes	Customized by TCM team		Recipes for tonifying kidney, strengthening spleen, stomach, clearing heat and  detoxification
TCM Tuina/massage	Performed by trained TCM physicians		Applied twice per week
WONCA/COOP health risk indicator charts	WHO/COOP-WONCA		7 items