Bridging Traditional Chinese and Western Medicine: Efficacy, Safety, and Diagnostic Advances in a Pilot Cohort-Based Observational Study for Moderate to Severe Anemia
Overview
- Phase
- Not Applicable
- Intervention
- TCM Herbal Therapy
- Conditions
- Moderate to Severe Anemia
- Sponsor
- Chia-Ying Chuang
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Monthly Change in Hemoglobin Levels (g/dL) to Assess Treatment Efficacy
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This observational study evaluates the efficacy and safety of integrated Traditional Chinese Medicine (TCM) and Western medicine in managing moderate to severe anemia. The study examines hemoglobin (Hb) level improvements and correlations with TCM pulse diagnosis parameters at six diagnostic positions (Right and Left Chung, Guan, and Chi). Conducted at Taichung Tzu Chi Hospital, it aims to explore TCM's role as a complementary approach to anemia care while maintaining a focus on patient safety and integrated diagnostic techniques.
Detailed Description
The study included 28 patients with moderate to severe anemia (Hb \< 10 g/dL) treated between February 26, 2021, and December 31, 2022. Participants were divided into two groups: those receiving TCM-based interventions (herbal formulations tailored to address systemic imbalances) and those following standard Western medicine protocols. Data collection involved monthly monitoring of Hb levels and pulse diagnosis parameters using the Huang-T1 Sphygmograph, which provided detailed insights into frequency-domain and waveform-derived characteristics. Primary outcomes included Hb level improvements and safety assessments, while secondary outcomes focused on the correlations between pulse parameters and hematological changes. Results indicated consistent Hb improvements in the TCM group, with notable trends observed in pulse diagnosis correlations. These findings highlight TCM's potential as a diagnostic and therapeutic adjunct in anemia care, emphasizing its role in bridging traditional and modern medical practices. The study adheres to ethical guidelines, with approval from the Taichung Tzu Chi Hospital Research Ethics Committee (Approval Number: REC109-61). All participants provided written informed consent prior to study inclusion. Future directions include larger-scale studies and randomized controlled trials to further validate findings and expand their clinical applicability.
Investigators
Chia-Ying Chuang
Doctor of Chinese medicine department, Principal Investigator, Resident physician
Taichung Tzu Chi Hospital
Eligibility Criteria
Inclusion Criteria
- •Confirmed diagnosis of moderate to severe anemia (Hb \< 10 g/dL).
- •Age between 18 and 90 years.
- •Willingness to provide informed consent and comply with study procedures.
- •Ability to attend monthly follow-up visits and provide clinical data for analysis.
Exclusion Criteria
- •Presence of psychiatric disorders affecting compliance.
- •Significant organ diseases, such as chronic obstructive pulmonary disease, advanced liver disease, or heart failure.
- •Pregnancy or lactation.
- •Concurrent participation in other clinical trials or use of investigational drugs within the past 30 days.
- •Non-compliance with follow-up schedules or study protocols.
Arms & Interventions
Traditional Chinese Medicine (TCM) Group
Participants in this group received individualized TCM herbal formulations tailored to address systemic imbalances observed in moderate to severe anemia. Commonly used formulations include Yougui Wan, Zuogui Wan, and Xiong Gui Jiao Ai Tang. Treatment was monitored monthly with adjustments made based on clinical symptoms and pulse diagnosis parameters.
Intervention: TCM Herbal Therapy
Western Medicine Group
Participants in this group were treated using standard Western medical protocols for moderate to severe anemia. Treatments included blood transfusions and erythropoiesis-stimulating agents when necessary, based on clinical evaluations.
Intervention: Standard Western Medicine Treatment
Outcomes
Primary Outcomes
Monthly Change in Hemoglobin Levels (g/dL) to Assess Treatment Efficacy
Time Frame: Baseline to 5 months
Monthly measurement of hemoglobin levels (g/dL) to evaluate improvements in anemia severity from baseline over a 5-month study period.
Secondary Outcomes
- Correlation Between Pulse Diagnosis Parameters and Monthly Hemoglobin Levels (g/dL)(Baseline to 5 months)
- Incidence of Treatment-Related Adverse Events (Safety)(Baseline to 5 months)