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 remain³.

Traditional Chinese Medicine (TCM) has the advantages of holistic regulation and individualized treatment⁴. In recent years, it has gradually attracted attention in diabetes management. In the context of urban communities, where elderly patients have diverse lifestyles, dietary habits, cultural backgrounds, and health awareness levels, TCM has a broader space for application⁵. For example, sulfonylureas commonly added to metformin in elderly patients are associated with an evident higher risk of severe hypoglycemia (up to 2-4 times greater in those ≥ 75 years) and contribute to treatment discontinuation rates of 10-20% due to intolerance or fear of events^6,7 Comprehensive TCM approaches, when used adjunctively with conventional therapies, have demonstrated modest additional reductions in HbA1c (-0.3 to -0.5%) and trends toward fewer hypoglycemic episodes and milder adverse effects in recent network meta-analyses, though evidence quality varies and superiority over conventional care alone is not consistently proven^8,9.

The adjunctive function is appropriate for community-dwelling older patients with mild- and moderate-type 2 diabetes (e.g., HbA1c 7.5-9.5%), intact cognitive function, and the capacity for a multimodal regimen. In contrast, caution is advised in individuals with advanced renal impairment (eGFR <30 mL/min/1.73 m²) due to the risks of herb-related accumulation or acute kidney injury, as well as those with severe comorbidities that may limit adherence^10,11. Using the TCM-primary care network and national guidelines to promote integration has helped the community-based implementation. However, there are challenges, including a lack of standardized herbal preparation and quality control, and a shortage of high-quality RCTs confirming long-term safety and efficacy^12,13.

This study aims to investigate the impact of TCM interventions on blood glucose control, quality of life, and complications in elderly diabetic patients through a randomized controlled trial, providing new strategies and evidence for community-based diabetes management.

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 Declaration of Helsinki.

Participants recruitment

Type 2 diabetes elderly patients aged 60 years and older in an urban community were selected for regular checkups at community health facilities. Participants were recruited in three stages using electronic health record data. An initial identification with a diagnosis of diffuse type 2 diabetes based on the record history (prior diagnosis of diabetes) was performed and confirmed by the physician. The physician reviewed the medical record and performed another fasting plasma glucose test before conducting an in-person assessment of eligibility through a standardized interview and physical examination.

Inclusion criteria

The diagnosis of type 2 diabetes was established in elderly patients in accordance with the Clinical Guidelines for Prevention and Treatment of Elderly Type 2 Diabetes in China and Guiding Principles for Clinical Research of New Traditional Chinese Medicines^13,14. Participants presented with polydipsia, polyuria, and any other additional symptoms were enrolled if they had 11.1 mmol/L random blood glucose (at any time of the day) or fasting blood glucose ≥ 7.0 mmol/L or 2 h post-glucose-load blood glucose ≥ 11.1 mmol/L (laboratory assays by blood glucose using a glucometer calibrated every day).

Exclusion Criteria

Patients were excluded if they had mental disorders as determined by a Mini-Mental State Examination score < 24, cognitive impairment indicated by a Montreal Cognitive Assessment score < 22, severe complications (e.g., estimated glomerular filtration rate < 30 mL/min/1.73 m² or recent myocardial infarction), or if they had lived in the community for less than one year, as verified by address. 132 eligible participants provided written informed consent following strict screening of 250 approached. We recorded all baseline demographics (age, sex, duration of diabetes, comorbidities) to document balance.

Randomization

The 132 selected patients were randomly divided into two groups (n=66) using a random number table: the intervention group (TCM comprehensive intervention group) and the control group (conventional management group).

Intervention administration

sup>Both groups received standard lifestyle education per China's 2024 Diabetes Prevention and Control Guidelines: low-sugar high-fibre diet (< 50 g added sugars/day, > 25 g fiber via vegetables/whole grains) and ≥ 150 min/week moderate aerobic exercise (brisk walking or Taijiquan at 50-70% max heart rate, monitored via pedometers)¹⁵.

Control group

The control group continued conventional Western management: oral hypoglycemics (e.g., metformin 500-1,000 mg BID, titrated to HbA1c < 8.0% in the elderly; ±SGLT2 inhibitors/GLP-1 agonists if tolerated), with monthly physician reviews for safety¹⁵.

TCM intervention group

The intervention group received, in addition, a 3-month comprehensive TCM program (adjunctive to Western care) delivered by licensed practitioners, focusing on qi-yin/spleen-kidney deficiency syndromes common in elderly T2DM^16,9.

Herbal decoction: 200 mL twice daily without any problems. It can be done by decocting in 1 L of water for 30 min, then straining it.

Formulas individualized via baseline syndrome differentiation

Qi-yin deficiency (n=38): Liuwei, Dihuang Tang modifications with 15 g Shu Di Huang, 10 g Shan Zhu Yu.

Spleen-kidney deficiency (n=22): Shenling Baizhu San with 10 g Ren Shen, 10 g Bai Zhu^16,17.

Other patterns: n=6

Acupuncture (3 Times, 30 min)

Core points: Zusanli (ST36, qi tonification), Sanyinjiao (SP6, yin nourishment), Taixi (KI3), plus 2-4 syndrome-specific (e.g., Hegu/LI4)^18,19.

Needles: Sterile 0.25 × 40 mm needles inserted 1-2 cm to de qi; even reinforcing-reducing manipulation (180° rotation every 5 min) for 20-25 min.

TCM dietary therapy (weekly 30 min)

This involved group sessions with printed recipes for spleen-kidney support (e.g., black bean-millet congee: 50 g black beans, 100 g millet simmered 40 min; mung bean soup for heat-clearing: 30 g mung beans, 10 g chrysanthemum boiled 20 min; 1,800-2,200 kcal/day, warm-cooked)^20,21.

Tuina massage (20 min sessions, twice weekly)

This involved targeting the abdomen/lower limbs for meridian dredging and spleen-kidney Tonification^22,23. First, the coach performs a warm-up with effleurage on the patient's legs, then uses kneading strokes, applying pressure to the patient's leg muscles. The coach applies concentrated pressure to the patient's calves, finishing with vibration to relieve tiredness.

Outcome assessment

Before the study and 8 months later, data on blood glucose control indicators (fasting blood glucose (FBG), 2 h postprandial blood glucose (2hPBG) compliance rates, glycated haemoglobin (HbA1c) at 12 weeks, blood lipid indicators (total cholesterol, triglyceride, low-density lipoprotein cholesterol), social support, health risk indicators, quality of life scores, and complication incidence were collected.

Questionnaires

The Social Support Rate Scale (SSRS) was used to evaluate social support, which included three dimensions: objective support (3 items, scored 1-4 points per item, with a total score of 3-12 points), subjective support (4 items, scored 1-4 points per item, with a total score of 4-16 points), and social support (3 items, scored 1-4 points per item, with a total score of 3 - 12 points). Higher scores indicated a higher level of social support. The WONCA health risk indicator scale contained 7 items, scored 1-5 points per item, with a total score of 7-35 points. Higher scores indicated a poorer health status. The quality of life was evaluated using the authoritative Diabetes-Specific Quality of Life Scale (DSQL), which systematically collected data on the psychological, social, physiological, and treatment dimensions.

Safety

The occurrence of complications, including ketoacidosis, gastrointestinal discomfort, hypoglycemia, and nutritional disorders, was also recorded during the 3-month follow-up period.

Statistical methods

Data were analysed using SPSS version 22.0. Continuous Variables were expressed as mean ± standard deviation. Independent-samples t-tests were used for between-group comparisons were checked through the use of ANCOVA. Paired t-tests were conducted to evaluate within-group changes. The use of multiple imputation (five datasets) was the primary approach for this analysis. Treatment effect sizes are reported as mean difference with 95% confidence intervals (95% CI) and Cohen's d (standardised mean difference). Categorical outcomes were compared using Fisher's exact test. Two-sided p-values < 0.05 were considered statistically significant. No adjustment for multiplicity was performed because this was an exploratory pilot trial. Sample size was based on feasibility (n = 66 per arm) rather than formal power calculation.

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