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. (September 2018)

• Record Type: Journal Article
• Authors: Fleischer, Tom; Chang, Tung-Ti; Chiang, Jen-Huai; Yen, Hung-Rong
• Is Part Of: Integrative cancer therapies. Volume 17:Number 3(2018:Sep.)
• Page Start: 665
• Page End: 673
• Publication Date: 2018-09
• Subjects: HSCT -- acute leukemia -- immune reconstitution -- Chinese herbal medicine; Cancer -- Alternative treatment -- Periodicals; 616.99406
• DOI: 10.1177/1534735418756736
• Languages: English
• ISSNs: 1534-7354

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.