Herb Selection And Safety Issues For Breast Cancer Patients Using Traditional Chinese Medicine Plus Conventional Therapies

Objectives:This study aimed to quantitatively describe clinical practice in an integrative biomedical and Traditional Chinese Medicine(TCM)hospital,exploring the correlations between TCM herb selection and biomedical approaches to breast cancer,while collecting safety data on herbs given alongside conventional therapies.The study also aimed to implement and assess a pilot methodology to explore whether analyzing herb selection by TCM treatment principles may be a useful alternative to analyzing by Zheng diagnoses or single herbs.Methods:This study retrospectively examined the prescriptions of 100 post-surgical breast cancer patients receiving herbs at the Jiangsu Provincial Hospital of Traditional Chinese Medicine.(1)To examine herb selection,a pilot methodology was used to parse prescriptions by TCM treatment principles,then apply ordered regression analysis to determine associations between the treatment principles and biomedical factors(i.e.breast cancer patients' stages,subtypes,and concurrent conventional therapies);(2)To analyze herb safety,data was collected on common herb-drug combinations,dosage,timing,and adverse event incidence.Results:Herb selection results showed that the pilot methodology was able to detect numerous significant associations between patients'biomedical factors and herbal treatment principles,and furthermore was able to separate effects of diagnoses from concurrent therapies.For example,Luminal A and B subtypes were more likely to be treated for Phlegm-Stasis-Binding patterns and not for Kidney deficiency(which had been predicted for patients taking endocrine therapy).Earlier clinical stages were associated with relatively more Blood-Cooling and Qi-Regulating herbs,versus more Tonifying and Detoxifying herbs for Stage IV.In terms of concurrent treatment phases,the post-surgical recovery phase was associated with more Cool Blood herbs,and fewer Calm Shen Settle Heart or Nourish Tonify Liver Kidney herbs.Patients who had undergone radiation were prescribed relatively fewer Cool Blood herbs,and relatively more Tonify Qi and Regulate Qi herbs.Patients in palliative chemotherapy had higher odds of being prescribed Invigorate Blood,Detoxifying,Reduce Swelling,and Attack Toxin herbs.Patients who were currently using TCM alone had higher odds of being prescribed more Detoxifying and Attack Toxin herbs.The use of anti-toxin herbs in later stages and treatment phases was more common than predicted from the literature review.Results showed no significant trends associated with targeted therapy,endocrine therapy,or adjuvant chemotherapy,nor between the biomedical predictors and the odds of using Yin-nourishing and Yang-tonifying herbs.Most common treatment principles overall were:Tonify Qi,Transform Phlegm,Invigorate Blood,Regulate Qi,Reduce Swellings,Calm Shen,and Detoxify,reinforcing the "Cancer Toxin" theory.In terms of herb safety results,common herbs,dosages,timing and combinations were recorded.Among those in active chemotherapy therapy,slightly over half of herbal prescriptions were administered on the same day as chemotherapy.Most post-surgical formulas were given during the first 1-2 days following surgery.The most common chemotherapy-herb combinations were:Epirubicin/Cyclophosphamide(EC)+Huang Qi,EC+Bai Zhu,EC+Jiang Huang,Docetaxel+Huang Qi,Docetaxel+Bai Zhu,EC+Gan Cao,EC+Fu Ling,EC+Chen Pi,EC+Hong Jing Tian,EC+Da Huang,Docetaxel+Fu Ling.Herbs most commonly co-prescribed with trastuzumab were Bai Zhu,Tai Zi Shen and Fu Ling.Si Wu Tang was not used for any patients along with endocrine or targeted therapy.With endocrine therapy,most herbs with suspected estrogen-receptor-simulating effects were not used,although Dang Gui was prescribed to 4 patients.No significant difference was found between the average dose of Dang Gui in ER+versus ER-patients.No herbs with potential serious toxicities were used,aside from Ma Huang,prescribed to 2 patients.The vast majority of adverse events recorded after herbs were prescribed occurred following surgery or adjuvant chemotherapy,and none were recorded when herbs were used alone.Fewer adverse events were seen among patients who were older,post-menopausal,or in active palliative chemotherapy.Conclusions:The herb selection pilot methodology,analyzing by TCM treatment principles,had certain strengths and was able to identify statistically significant relationships between TCM treatment principles and biomedical diagnosis/treatment of breast cancer.Results reinforced many of the treatment guidelines recommended by TCM experts,while differing with others,including some clinical guidelines.For example,the Calm Shen Settle Heart treatment principle is commonly seen and can be considered for addition to clinical guidelines.This suggests that despite a certain degree of expert consensus,current guidelines do not complete reflect clinical practice in all integrative hospitals,and that individualized treatment in TCM still plays a key role.The study produced data on common herb-drug combinations,dosage,timing,and adverse event incidence.A minimal use of potentially toxic or interacting herbs,coupled with adverse events data,suggested herb use may be relatively safe when used alone;however further research with improved adverse event tracking is needed to analyze incidence during combined herb-drug use,including with Dang Gui.