Achieving consensus on syndrome differentiation and chinese herbal medicine for early breast cancer
Creators: name: Guo, Qianqian
Publisher: name: RMIT University
Year: 2024
Subjects: classificationCode: 420803
subject: Traditional Chinese medicine and treatments

description: Background

Breast cancer is the most frequently diagnosed cancer worldwide and is the leading cause of cancer-related deaths among women. With the development of adjuvant therapy, many new medications can improve the overall survival (OS) of these patients. However, patients still suffer from symptoms such as nausea and vomiting when receiving chemotherapy or menopausal symptoms with endocrine treatment. Such unwanted adverse events may affect patient adherence to critical cancer therapeutics. Hence, complementary medicine, such as Chinese herbal medicine (CHM), has been widely used in China and elsewhere in managing such conditions and improving patients’ quality of life.

Chinese medicine uses individualised treatments based on syndrome differentiation. Syndrome differentiation is the comprehensive analysis of clinical information gained by the four traditional diagnostic approaches: inspection; auscultation and olfaction; enquiry; and body palpation. In the case of early breast cancer (without metastases), the syndrome differentiation may vary due to a range of factors, such as signs and symptoms associated with various conventional interventions (e.g., chemotherapy and radiotherapy) during the long period of cancer treatment. Further, Chinese medicine practitioners exercise their clinical judgement in syndrome differentiation based on personal clinical experience and hence may select different CHM formulas/combinations for patients. In the context of evidence-based medicine development and healthcare, the current lack of consensus on Chinese medicine clinical decision-making for breast cancer challenges clinical research, translation and evidence-based practice. Therefore, there is a need to establish a consensus to support the development of Chinese medicine practice.

Research questions, aims and objectives

The research questions for this project are:
• What syndromes, signs and symptoms, and corresponding CHM formulas are described in contemporary Chinese medicine published literature for early breast cancer?
• What syndromes, signs and symptoms, and CHM formulas in early breast cancer are described in clinical care documents in major Chinese medicine public hospitals?
• What syndromes, signs and symptoms, and CHM formulas do women with early breast cancer experience in clinical practice?
• What syndromes, signs and symptoms, and CHM formulas do Chinese medicine experts consider are present during different treatment stages of early breast cancer?
The research aims of this project are to:
• achieve a consensus on syndrome differentiation for the five treatment stages (preoperative, postoperative, chemotherapy, radiation therapy and endocrine therapy) of early breast cancer treatment
• determine the CHM formulas for each syndrome in the five treatment stages of early breast cancer.
The specific objectives of this project are to:
• complete a systematic review of published literature (research articles and textbooks) and clinical care documents to identify the Chinese medicine syndromes, signs and symptoms, and CHM formulas used for early breast cancer
• conduct a multicentre prospective observational clinical study to investigate the Chinese medicine syndromes, signs and symptoms, and CHM formulas for early breast cancer in current clinical practice
• undertake a Delphi study to reach consensus among clinical experts on Chinese medicine clinical decision-making for early breast cancer patients with respect to syndrome differentiation and CHM selection.

Methods and results

Systematic review
Study 1 was a systematic review that identified the syndromes reported in the available contemporary literature. Descriptive statistics were calculated and hierarchical cluster analysis was conducted. Dual deficiency of qi and Blood was one of the most common syndromes reported among the various treatment stages. Cluster analysis identified three or four syndromes in each stage. Lassitude and lack of strength were the most common symptoms throughout all stages except the preoperative stage. The CHM formulas used for each syndrome varied, but the most commonly used formulas for specific syndromes were similar across the treatment stages.

Multicentre prospective observational clinical study
Study 2 was a multicentre prospective observational clinical study that collected data about the Chinese medicine syndromes, signs and symptoms, and CHM formulas used for early breast cancer patients. Eight hospital centres located in different regions of China were enrolled. Descriptive statistics and cluster analysis methods were employed. The participants were informed that they would be interviewed up to a maximum of five times. Finally, 964 interviews with 620 participants were included and analysed. The syndromes dual deficiency of qi and Blood, and dual deficiency of qi and yin were common to several treatment stages. The cluster analysis identified some of the same syndromes that were frequently recorded by clinicians in the health records. The most common signs and symptoms in each stage were associated with the syndromes in that stage and reflected the characteristics of different treatment approaches. The most frequently prescribed CHM formulas were similar to those identified in the systematic review.

Delphi study
Guided by findings from studies 1 and 2, study 3 was a Delphi study to gain clinical expert consensus on the most common Chinese medicine syndromes, signs and symptoms, and CHM formulas used for the different treatment stages of early breast cancer. Three survey rounds were conducted involving 30 experts and the response rate was high. The first-round survey collected the experts’ demographic information and opinions on the most common syndromes and CHM formulas currently used for the different treatment stages of early breast cancer. The syndromes selected by ≥ 50% of experts were considered to reach consensus and three syndromes were identified at each treatment stage. The second-round and third-round surveys assessed the importance of the signs and symptoms of the most common syndromes selected from the first round. Upon completion of the third round, consensus about the most common syndromes, the key signs and symptoms, and the CHM formula prescriptions for each treatment stage was established.

Conclusions
This project has used an evidence-based approach to seek consensus on Chinese medicine syndromes and CHM formulas for the different treatment stages of early breast cancer. Similarities and differences were identified in the results from the systematic review, the clinical study and the Delphi study. The findings of this project provide evidence to inform clinical practice that may lead to improved Chinese medicine care for early breast cancer patients.