Prospective Study Evaluating Use of Traditional Chinese Medicine to Treat Refractory Cytopenia(s) In Chronic Hematological Disorders - Safety, Efficacy and Impact on Quality of Life

The use of Traditional Chinese Herbs (TCM) to treat disease or improve outlook is common among patients in Singapore particularly in situations where they have failed to respond favorably to Western medicines. As TCM and Western medicine practices are not integrated, patients seek such services separately. Being herbal in origin, TCM is generally considered safe and no monitoring of biochemical or hematological parameters is mandated. Current data suggest no significant drug-herb interactions except possibly for drugs which are highly protein bound or have narrow therapeutic range but studies in this area are lacking. We undertook a study to investigate the safety, efficacy and impact on quality of life (QoL) of TCM in patients with refractory cytopenia(s) due to primary hematological disorders.

All patients had chronic acquired hematological diseases and stable but significant cytopenia(s) that had failed standard therapies or where no effective therapies were available. The duration of study was 6 months and during this period they were supplied prebrewed sealed packs of 160ml liquid of TCM herbal concoctions twice daily, prepared at central facilities. Patients were categorized into 1 of 4 fixed TCM syndromes as assessed by TCM specialist on basis of TCM principles and published criteria. The herbal concoction comprised of a varying mixture of 12–18 herbs depending on the patient's syndrome and response. One week after starting TCM and subsequently monthly evaluation of blood counts, liver and renal function studies were performed. For MDS and myelofibrosis patients, QoL was assessed with EORTC QLQ-C30 at beginning and end of study. Response criteria were based on - International Working Group Criteria for MDS, European Myelofibrosis Network and as recommended by Camitta for severe aplastic anemia (SAA).

The only significant adverse effect noted was development of hyperkalemia in 2 patients. Of 7 patients on study who were on ACE inhibitors or Angiotensin II receptor blockers (ARB), 2 developed hyperkalemia in absence of deteriorating renal function. Both patients had diabetic nephropathy. Hyperkalemia resolved upon stopping TCM.

To date, hyperkalemia has not been reported with TCM use either alone or as herb-drug interaction. Further studies with larger patient numbers would be useful to confirm and possibly to define the herb component giving rise to this effect which we postulate could be due to herb-drug interaction. We recommend serum potassium monitoring in patients with diabetic nephropathy on ACE inhibitors or ARB who are taking TCM. Based on pre and post study EORTC QLQ-C30 QoL assessments of 15 MDS and myelofibrosis patients who completed study, significant improvements (moderate and very much) were noted in functional scale in 66%, symptom scale in 40% and global health status in 46%. This was despite the fact that only 4/15 (26%) of patients experienced hematological responses. Our study suggests a potential role of TCM in patient care to enhance quality of life and also therapeutically.

No relevant conflicts of interest to declare.