A Controlled Trial of Sheng-Yu-Tang for Post–Hematopoietic Stem Cell Transplantation Leukemia Patients: A Proposed Protocol and Insights From a Preliminary Pilot Study

Abstract

Introduction: Hematopoietic stem cell transplantation has become a well-established treatment for hematologic disorders including acute leukemia. However, long-term survival rates following this procedure are still extremely low, due to posttransplantation relapse, infections, and graft-versus-host disease. We propose that adjunctive Chinese herbal medicine may benefit posttransplantation patients. In preparation for a randomized clinical trial, we conducted a pilot trial. Methods and Analysis: Between September 2015 and June 2017, 18 patients were consecutively enrolled at China Medical University Hospital and followed for up to 1 year. Fresh blood samples were obtained on a monthly basis, and immune reconstitution was analyzed. In addition to the standard-care treatment administered by their oncologist, a number of patients also received a Chinese herbal formula (Sheng-Yu-Tang) for up to 6 months. Results were used to improve on study protocol and estimate required sample size for a future randomized trial. Ethics and Dissemination: Study protocol was approved by the institutional review board of China Medical University Hospital (DMR-105-005), and all participants provided informed consent.

Effect of Chinese Herbal Medicine Therapy on Risks of Overall, Diabetes-Related, and Cardiovascular Diseases-Related Mortalities in Taiwanese Patients With Hereditary Hemolytic Anemias

“…The effectiveness, safety, less toxicity, and few side effects of Chinese herbal medicine (CHM) in treating anemia and blood-related diseases are reported ( Liu et al, 2006 ; Wu et al, 2006 ; Wang et al, 2008 ; Gao and Chong, 2012 ; Chu et al, 2014 ; Fleischer et al, 2016a ; Fleischer et al, 2016b ; Fleischer et al, 2017 ; Chen et al, 2018 ; Fleischer et al, 2018 ; Sun et al, 2018 ; Zhu et al, 2018 ). However, the long-term effect of CHM on patients with hereditary hemolytic anemias (HHAs) remain unclear.…”

“…Chinese herbal medicine (CHM) exhibits effective, safe, less toxic, and have few side effects and has been used to treat anemia and blood-related diseases ( Liu et al, 2006 ; Wu et al, 2006 ; Wang et al, 2008 ; Gao and Chong, 2012 ; Chu et al, 2014 ; Fleischer et al, 2016a ; Fleischer et al, 2016b ; Fleischer et al, 2017 ; Chen et al, 2018 ; Fleischer et al, 2018 ; Sun et al, 2018 ; Zhu et al, 2018 ). Furthermore, due to many complications occurred from the primary treatments for HHAs patients, HHAs patients in Taiwan may also seek for adjunctive therapies to alleviate their anemia symptoms and reduce these side effects.…”

“…Furthermore, due to many complications occurred from the primary treatments for HHAs patients, HHAs patients in Taiwan may also seek for adjunctive therapies to alleviate their anemia symptoms and reduce these side effects. In Taiwan, Chinese herbal medicine (CHM) has been one of the important health care system and has also been widely used in patients with anemia, chronic myeloid leukemia, chronic lymphocytic leukemia, acute myeloid leukemia, and patients with the HSCT treatment ( Fleischer et al, 2016a ; Fleischer et al, 2016b ; Fleischer et al, 2017 ; Chen et al, 2018 ; Fleischer et al, 2018 ). However, there are still limited studies in the CHM effect on patients with HHAs.…”

Adjunctive Chinese Herbal Medicine Treatment is Associated With an Improved Survival Rate in Patients With Cervical Cancer in Taiwan: A Matched Cohort Study

“…It has also been widely applied for adjuvant cancer treatment in Asian countries due to its anticancer effects proven by clinical response and evidence. 13,14 Recently, more and more literature indicated that CHM could enhance immunomodulatory activities, 15,16 inhibit carcinogenic properties, 17 prolong survival time, 18-22 alleviate side effects of chemotherapy and radiotherapy, 13 and improve the quality of life 12 in cancer patients.…”

Chinese Herbal Medicine Is Helpful for Survival Improvement in Patients With Multiple Myeloma in Taiwan: A Nationwide Retrospective Matched-Cohort Study

“…In recent years, more and more Taiwanese patients have tried CHM for complementary interventions following a cancer diagnosis, including hematologic malignant diseases. 6 , 7 …”