Effectiveness of Chinese Herbal Medicine as a Complementary Treatment for Neutropenia Prevention and Immunity Modulation During Chemotherapy in Patients With Breast Cancer: Protocol for a Real-World Pragmatic Clinical Trial.

BACKGROUND: In recent years, advancements in cancer treatment have enabled cancer cell inhibition, leading to improved patient outcomes. However, the side effects of chemotherapy, especially leukopenia, impact patients' ability to tolerate their treatments and affect their quality of life. Traditional Chinese medicine is thought to provide complementary cancer treatment to improve the quality of life and prolong survival time among patients with cancer. OBJECTIVE: This study aims to evaluate the effectiveness of Chinese herbal medicine (CHM) as a complementary treatment for neutropenia prevention and immunity modulation during chemotherapy in patients with breast cancer. METHODS: We will conduct a real-world pragmatic clinical trial to evaluate the effectiveness of CHM as a supplementary therapy to prevent neutropenia in patients with breast cancer undergoing chemotherapy. Patients will be classified into CHM or non-CHM groups based on whether they received CHM during chemotherapy. Using generalized estimating equations or repeated measures ANOVA, we will assess differences in white blood cell counts, absolute neutrophil counts, immune cells, and programmed cell death protein 1 (PD-1) expression levels between the 2 groups. RESULTS: This study was approved by the research ethics committee of Hualien Tzu Chi Hospital (IRB 110-168-A). The enrollment process began in September 2021 and will stop in December 2024. A total of 140 patients will be recruited. Data cleaning and analysis are expected to finish in the middle of 2025. CONCLUSIONS: Traditional Chinese medicine is the most commonly used complementary medicine, and it has been reported to significantly alleviate chemotherapy-related side effects. This study's findings may contribute to developing effective interventions targeting chemotherapy-related neutropenia among patients with breast cancer in clinical practice. TRIAL REGISTRATION: International Traditional Medicine Clinical Trial Registry ITMCTR2023000054; https://tinyurl.com/yc353hes. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/55662.

Effects and core patterns of Chinese herbal medicines on hematologic manifestations in systemic lupus erythematosus: A systematic review and meta-analysis.

OBJECTIVE: This systematic review and meta-analysis of randomized controlled trials (RCTs) aimed to evaluate the effects of Chinese herbal medicines (CHMs) on hematologic manifestations in patients with systemic lupus erythematosus (SLE). DATA SOURCES: PubMed, Embase, Cochrane Central Register of Controlled Trials, China National Knowledge Infrastructure, and Airiti Library were searched for the period January 2000 to February 2022. STUDY SELECTION: RCTs involving CHMs in patients with SLE with available hematologic data. DATA EXTRACTION: The primary outcomes included white blood cell (WBC) count, hemoglobin level, and platelet count. The Cochrane risk of bias tool was used to assess the quality of the included RCTs. Sensitivity analysis of RCTs with abnormal hematologic data before intervention was performed to verify the robustness of the results. Subgroup analysis was also applied for results with high heterogenicity. Core patterns of used herbal drug pairs had also been analyzed and visualized. DATA SYNTHESIS: Fifteen RCTs involving 1183 participants were included. The effects of elevating WBC count (weighted mean difference [WMD]: 0.69; 95% confidence interval [CI]: 0.33-1.06; p <0.001), hemoglobin levels (WMD: 0.64; 95% CI: 0.31-0.97; p <0.001), and platelet count (WMD: 0.61; 95% CI: 0.48-0.74; p <0.001) in the CHM group were significantly greater than those in the control group. In total, 23 single herbs and 152 herbal drug pairs were identified for core patterns network analysis. CONCLUSIONS: We demonstrated significantly superior therapeutic effects achieved with CHMs and conventional therapy regarding leukopenia, anemia, and thrombocytopenia compared to that of conventional therapy alone in patients with SLE.

Lower risk of ischemic stroke among patients with chronic kidney disease using chinese herbal medicine as add-on therapy: A real-world nationwide cohort study.

Background: The incidence of ischemic stroke (IS) is much higher among patients with chronic kidney disease (CKD) compared to the general population. Few studies have evaluated the association between the risk of IS and the use of Chinese herbal medicine (CHM) in patients with CKD. We aimed to investigate the risk of IS among patients with CKD using CHM as add-on therapy. Methods: We conducted a retrospective cohort study based on Taiwan's National Health Insurance Research Database to assess 21,641 patients with newly diagnosed CKD between 2003 and 2012. Patients were classified as either the CHM (n = 3,149) or the non-CHM group (n = 3,149) based on whether they used CHM after first diagnosis of CKD. We used the proportional subdistribution hazards model of Fine and Gray to examine the hazard ratio (HR) of IS in propensity-score matched samples at a ratio of 1:1 for two groups. Results: The risk of IS was significantly reduced in the CHM group (adjusted HR [aHR]: 0.58, 95% confidence interval [CI]: 0.48-0.70) compared with the non-CHM group. Those who used CHM for >180 days had an even lower risk of IS than those in the non-CHM group (aHR: 0.51, 95% CI: 0.41-0.63). Additionally, frequently prescribed formulae, such as Ji-Sheng-Shen-Qi-Wan, Liu-Wei-Di-Huang-Wan, and Zhen-Wu-Tang were associated with a 30%-50% reduced risk of IS. Conclusion: Our results suggest that patients with CKD who used CHM as add-on therapy had a lower hazard of IS than those in the non-CHM group, especially for patients taking CHM for >180 days. Further experimental studies are required to clarify the causal relationship.

Chinese Herbal Medicines Have Potentially Beneficial Effects on the Perinatal Outcomes of Pregnant Women.

Introduction: Tocolytic treatment is beneficial to pregnant women with a risk of premature labor or miscarriage. However, previous reports have shown that progestogen might not be effective and ritodrine may increase the risk of maternal vascular-related diseases. Chinese herbal products (CHP) are used as alternative therapies for pregnant women. The goal was to evaluate the efficacy of combined tocolytic therapy and CHP therapy in pregnancy outcomes for pregnant women in Taiwan. Materials and Methods: We conducted a retrospective cohort study based on the National Health Insurance Research Database. A total of 47,153 pregnant women treated with tocolytics aged 18-50 years from 2001 to 2015 were selected from two million random samples. According to the medical use of tocolytics and CHP, we divided the users into two groups: western medicine (WM) only (n = 40,961) and WM/CHP (n = 6,192) groups. A propensity score (PS)-matched cohort (6,192 pairs) was established based on baseline confounders. All participants were followed up to perinatal outcomes. Conditional logistic regression analysis was used to examine the effects of CHP use on the odds of miscarriage and preterm birth. Results: The adjusted odds ratio (OR) for premature birth in the WM/CHP group (n = 411, 6.64%) was significantly lower than in the WM group (n = 471, 7,61%) (0,86, 95% confidence interval [CI], 0.74-0.99). Further subgroup analysis based on the usage of formulae that activate blood and remove stasis or purgative formulae, the adjusted OR of preterm birth of those using these formulae was significantly lower in the WM/CHP group (n = 215, 6.32%) than that in the WM group (n = 265, 7.77%) (OR: 0.79, 95% CI: 0.65-0.96). Conclusion: We found that the combination of CHP and tocolytics can be beneficial to pregnant women in the prevention of premature birth. Further research is required to investigate causal relationships.

Reduced System Complexity of Heart Rate Dynamics in Patients with Hyperthyroidism: A Multiscale Entropy Analysis.

Studying heart rate dynamics would help understand the effects caused by a hyperkinetic heart in patients with hyperthyroidism. By using a multiscale entropy (MSE) analysis of heart rate dynamics derived from one-channel electrocardiogram recording, we aimed to compare the system complexity of heart rate dynamics between hyperthyroid patients and control subjects. A decreased MSE complexity index (CI) computed from MSE analysis reflects reduced system complexity. Compared with the control subjects (n = 37), the hyperthyroid patients (n = 37) revealed a significant decrease (p < 0.001) in MSE CI (hyperthyroid patients 10.21 ± 0.37 versus control subjects 14.08 ± 0.21), sample entropy for each scale factor (from 1 to 9), and high frequency power (HF) as well as a significant increase (p < 0.001) in low frequency power (LF) in normalized units (LF%) and ratio of LF to HF (LF/HF). In conclusion, besides cardiac autonomic dysfunction, the system complexity of heart rate dynamics is reduced in hyperthyroidism. This finding implies that the adaptability of the heart rate regulating system is impaired in hyperthyroid patients. Additionally, it might explain the exercise intolerance experienced by hyperthyroid patients. In addition, hyperthyroid patients and control subjects could be distinguished by the MSE CI computed from MSE analysis of heart rate dynamics.

Prescription patterns and factors influencing the use of Chinese herbal medicine among pregnant women in Taiwan: a population-based retrospective study.

BACKGROUND: The use of Chinese herbal medicine (CHM) has been widely promoted as a natural and safe way to treat illness during pregnancy. However, prescription patterns and factors influencing its use are largely unknown. Therefore, we conducted a population-based study to address these questions. METHODS: Pregnant women aged 18-50 years were selected from Taiwan's National Health Insurance Research Database between 2001 to 2011. CHM prescriptions and diagnostic records were collected. Demographic data and pre-existing diseases were compared between CHM users and non-users. A multivariate logistic regression analysis was performed to identify possible factors influencing the use of CHM during pregnancy. RESULTS: A total of 81,873 eligible prescription records were identified, and 16,553 pregnant women were prescribed CHM during pregnancy, yielding a CHM prescription rate of 20.2%. The three most frequently used herbs were Scutellariae Radix (Huang Qin) (4.4%), Eucommiae cortex (Du Zhong) (2.5%), and Atractylodes Rhizome (Bai Zhu) (2.4%). The most frequently used herbal formulae were Dang-Guei-Shao-Yao-San (4.1%), Jia-Wei-Xiao-Yao-San (3.5%), and Xiang-Sha-Liu-Jun-Zi-Tang (2.6%). Multivariate logistic regression revealed that subjects with an older age, a university education, a pre-pregnancy history of CHM use, asthma, chronic renal disease, and cardiac valvular disease and living in a residential area other than northern Taiwan had an increase in adjusted odds ratio for CHM use during pregnancy. CONCLUSIONS: In this population-based study, we found that demographic factors and pre-existing diseases were associated with the use of CHM among pregnant women. It is worth noting that Leonuri Herba (Yi Mu Cao) and Shao-Fu-Zhu-Yu-Tang should be used with caution in the first trimester. Further research is needed to explore the safety and effectiveness of the use of CHM in pregnant women.

The risk of coronary artery disease in patients with rheumatoid arthritis using Chinese herbal products and conventional medicine in parallel: a population-based cohort study.

BACKGROUND: Few studies have evaluated the association between the risk of coronary artery disease (CAD) and the use of Chinese herbal products (CHP) in patients with rheumatoid arthritis (RA). This study investigated the risk of CAD among patients with RA using CHP in combination with conventional medicine. METHODS: A retrospective cohort study was conducted using the Taiwan National Insurance Research Database to assess 22,353 patients who had been newly diagnosed with RA between 1997 and 2010. Patients were assigned to the CHP group or non-CHP group according to their use or nonuse of CHP after being diagnosed with RA. The Cox proportional hazards model was used to estimate the hazard ratio (HR) of CAD for a 1:1 matched sample. RESULTS: Both the CHP and non-CHP groups comprised 4889 patients after 1:1 matching. The risk of CAD was significantly reduced in the CHP group [adjusted HR (aHR): 0.59, 95% confidence interval (CI): 0.50-0.71] compard with the non-CHP group. Those who used CHP for > 180 days had an even lower risk of CAD than users with CHP usage less than 30 days (aHR: 0.64, 95% CI: 0.43-0.95). Additionally, frequently prescribed formulae, such as Kuei-Chih-Shao-Yao-Chih-Mu-Tang, Tang-Kuei-Nien-Tung-Tang, and Shu-Ching-Huo-Hsieh-Tang, were associated with a reduced risk of CAD. CONCLUSION: The use of CHP was associated with a lower risk of CAD in patients with RA. Additional randomized controlled trials are required to assess any causal relationship between the effect of CHP usage and the risk of CAD.

Adjunctive Chinese Herbal Products Therapy Reduces the Risk of Ischemic Stroke Among Patients With Rheumatoid Arthritis.

We performed a retrospective cohort study to investigate the association between the risk of ischemic stroke (IS) and the use of Chinese herbal products (CHP) in combination with western medicine (WM) among patients with rheumatoid arthritis (RA). The data were sourced from the registry for beneficiaries, inpatient and ambulatory care claims, and Registry for Catastrophic Illness from the National Health Insurance Research Database (NHIRD) in Taiwan between 1997 and 2011. Patients, who were newly diagnosed with RA between 1997 and 2010, were classified as the CHP group or non-CHP group depending on the presence of absence the adjunctive use of CHP following a diagnosis of RA. A total of 4,148 RA patients were in both the CHP and non-CHP groups after 1:1 matching. Patients in the CHP group had a significantly lower risk of IS compared to patients in the non-CHP group (adjusted hazard ratio [aHR], 0.67; 95% confidence interval [CI], 0.52-0.86). In the CHP group, patients who used CHP for more than 30 days had a lower risk of IS than their counterparts (aHR: 0.61, 95% CI: 0.40-0.91). Gui-Zhi-Shao-Yao-Zhi-Mu-Tang, Shu-Jin-Huo-Xie-Tang, and Du-Huo-Ji-Sheng-Tang might be associated with a lower risk of IS. Finally, the use of CHP in combination with WM was associated with a decreased risk of IS in patients with RA, especially among those who had used CHP for more than 30 days. A further randomized control trial is required to clarify the casual relationship between these results.

Effect of early use of Chinese herbal products on mortality rate in patients with lung cancer.

ETHNOPHARMACOLOGICAL RELEVANCE: Patients with lung cancer are frequently treated with Western medical treatments. Recently, patients have begun to use Chinese medicine to strengthen the immune system and alleviate side effects. AIM OF THE STUDY: We aimed to evaluate the association between mortality rate and early use of Chinese herbal products (CHPs) among patients with lung cancer. MATERIALS AND METHODS: We conducted a retrospective cohort study based on the National Health Insurance Research Database, Taiwan Cancer Registry, and Cause of Death Data. Patients with newly diagnosed lung cancer between 2002 and 2010 were classified as either the CHP (n = 422) or the non-CHP group (n = 2828) based on whether they used CHP within 3 months after first diagnosis of lung cancer. A robust Cox regression model was used to examine the hazard ratio (HR) of death for propensity score (PS) matching samples. RESULTS: After PS matching, average survival time of the CHP group was significantly longer than that of the non-CHP group. The adjusted HR (0.82; 95% CI: 0.73-0.92) in the CHP group was lower than the non-CHP group. Stratified by clinical cancer stages, CHP group had longer survival time in stage 3 subgroup. When the exposure period of CHP use was changed from 3 to 6 months, results remained similar (HR = 0.85; 95% CI: 0.76-0.95). CONCLUSION: Results indicated that patients with lung cancer who used CHP within 3 months after first diagnosis had a lower hazard of death than non-CHP users, especially for stage 3 lung cancer. Further experimental studies are needed to examine the causal relationship.