Distribution of Traditional Chinese Medicine Pattern Elements in Patients with Gastric Cancer: A Cross-Sectional Study

Summary

This study establishes a reproducible protocol for identifying and quantifying Traditional Chinese Medicine (TCM) syndrome elements in patients with gastric cancer, enabling systematic analysis through cluster, correlation, and principal component analysis methods.

Abstract

Gastric cancer remains a major cause of morbidity and mortality worldwide, with a particularly high burden in China. Traditional Chinese Medicine (TCM) emphasizes holistic regulation and syndrome differentiation, yet reproducible methods for quantifying syndrome elements in gastric cancer are limited. We conducted a cross-sectional study of 60 patients at Wuxi Second Traditional Chinese Medicine Hospital (December 2022-March 2024) and present a standardized, reproducible protocol for syndrome-element evaluation. Demographics, medical history, and TCM diagnostic information were captured with a standardized case-report form; syndrome elements were identified using a weighted scoring system with dual-expert adjudication. Analysis followed a prespecified multivariate pipeline-two-stage H-K clustering (hierarchical Ward.D2 to suggest k followed by k-means refinement), correlation-network mapping, and principal component analysis. The most frequent elements were qi stagnation, qi deficiency, blood stasis, spleen deficiency, and dampness; strong associations were observed between qi stagnation and blood stasis and between qi deficiency and blood stasis, with additional links involving dampness/phlegm. Principal component analysis indicated that a small set of elements accounted for the largest share of between-patient variation, supporting clinically meaningful stratification. This protocol operationalizes TCM syndrome-element assessment into measurable steps with shareable forms and code, enhancing objectivity and reproducibility and providing a methodological basis for clinical decision-making and multicenter validation. The framework is adaptable to other malignancies, facilitating broader integration of TCM within evidence-based oncology.

Introduction

Gastric cancer remains one of the most prevalent and lethal malignancies worldwide, with China bearing a disproportionately high incidence and mortality burden^1,2. Despite advances in surgical resection, chemotherapy, and targeted therapies, the overall prognosis remains unsatisfactory, underscoring the need for complementary approaches that address both disease biology and patient quality of life³. Traditional Chinese Medicine (TCM), emphasizing holistic regulation and syndrome differentiation, is widely used in oncology; however, the lack of standardized, replicable methods for syndro....

Protocol

Ethics and Oversight

This study was approved by the Ethics Committee of Wuxi Second Traditional Chinese Medicine Hospital (20220904). All participants provided written informed consent in accordance with the Declaration of Helsinki; procedures were consistent with ICH-GCP principles. Any identifiable media used for demonstration was separately consented. To reduce assessment bias, physicians who evaluated TCM syndrome elements were blinded to the American Joint Committee on Cancer (AJCC) stage and treatment status throughout scoring and adjudication; blinding was maintained by a data steward who removed those fields from as....

Results

Participant characteristics

Sixty patients with gastric cancer were enrolled between December 2022 and March 2024. Age distribution was: 41-50 years, 9/60 (15.0%); 51-60 years, 18/60 (30.0%); 61-70 years, 15/60 (25.0%); 71-80 years, 13/60 (21.7%); and 81-90 years, 5/60 (8.3%). Overall sex distribution was male 37/60 (61.7%) and female 23/60 (38.3%). Counts by sex within each age band are reported in Tabl.......

Discussion

This study developed and applied a standardized, protocol-centric workflow to identify and quantify TCM syndrome elements in gastric cancer. By combining a weighted scoring system, dual-expert adjudication, and a prespecified multivariate pipeline-two-stage H-K clustering, correlation network analysis, and principal component analysis-the method consistently highlighted qi stagnation, qi deficiency, blood stasis, and dampness as the most frequent and clinically relevant elements in this cohort, in line with prior observa.......

Materials

List of materials used in this article

Name	Company	Catalog Number	Comments
Case Report Form (CRF)	Wuxi Second TCM Hospital	CRF-001	Standardized form for collecting patient data
cluster R Package	CRAN	R-cluster-008	R package for clustering and silhouette analysis
Examination Light (5,000–6,500 K)	Philips	EX-LIGHT-003	Light used for TCM examination
igraph R Package	CRAN	R-igraph-007	R package for network visualization
Pulse Measuring Device	Omron	PMD-005	Device for measuring pulse during TCM evaluation
R Software	The R Project	R-001	Open-source software for statistical analysis
stats R Package	CRAN	R-Stats-006	R package for statistical analysis (prcomp, hclust, kmeans)
Syndrome Element Scale	Wuxi Second TCM Hospital	SE-Scale-002	Scoring tool for evaluating syndrome elements
Tongue Imaging Device	Canon	TI-IMG-004	Device used to capture tongue images