SUMMARY: 62 cancer patients with leukopenia and gastrointestinal (GI) adverse reactions after chemotherapy were randomly divided into the control group (30 subjects) and the treatment group (32 subjects). Inclusion criteria of this study were: age between 37-73 years old; no contraindication to chemotherapy; WBC > 4.0×109/L before chemotherapy; expected survival time more than 3 months; the ECOG Scale of Performance Status (designed by Eastern Cooperative Oncology Group) were between 0-2; consent to the treatment plan of this study. Exclusion criteria for this study were: patients with severe heart, liver, kidney dysfunction and other contraindications to chemotherapy; patients with other diseases that can affect the level of WBC; WBC < 1.0×109/L or granulocytes < 0.5×109/L. There was no significant difference in terms of gender, age, type of cancer and peripheral blood leukocyte count between the control and treatment group, thus, the two groups were statistically comparable (P>0.05).
In the treatment group, subjects were treated with Shengbai Tongbu Decoction (升白通補湯), which is consists of the following herbs: Huang Qi 30g (生黃耆 Radix Astragali seu Hedysari), Dang Shen 10g (黨參 Radix Condonopsis Pilosulae), Fu Ling 12g (茯苓 Poria), Bai Zhu 10g (白朮 Rhizoma Atractylodis Macrocephalae),Dang Gui 10g (當歸 Radix Angelicae Sinensis), Shu Di Huang 30g (熟地黃 Radix Rehmanniae Praeparata), Ji Xue Teng 15g (雞血藤 Caulis Spatholobi), Nu Zhen Zi 15g (女貞子 Fructus Ligustri Lucidi), Xian He Cao 30g (仙鶴草 Herba Agrimoniae), Tu Si Zi 15g (菟蕬子 Semen Cuscutae), Zhi Ke 10g (枳殼 Fructus Aurantii), Ban Xia 9g (半夏 Rhizoma Pinelliae), Mu Xiang 10g (木香 Radix Aucklandiae), Sha Ren 10g (砂仁 Fructus Amomi), and Cao Guo 10g (草果 Fructus Tsaoko). The formula was decocted twice into a 200ml solution, and subjects were instructed to consume 100ml one hour after meal in the morning and evening.
In the control group, subjects were treated with Shiyiwei Shenqi Pian (十一味参芪片) 4 tables three times a day. In both groups, treatment started 1 week before chemotherapy, with a course of treatment being 21 days. The routine blood parameters were rechecked once a week during follow-up.
The efficacy criteria of leukocyte enhancing medication described in “Practical Oncology” was applied; leukocyte count and GI adverse reactions were also monitored in both groups. In this study, the results were classified as the following:
- Markedly Effective: WBC increased within 7 days after treatment started; the level increased to > 4×109/L in 7-14d and remained stable for 14d.
- Effective: WBC increased within 7 days after treatment started; the level increased to > 4×109/L in 7-14d and remained stable for 7-13d.
- Improved: WBC increased 7 days after treatment started; the level increased to 4×109/L in 7-14d but remained stable for less than 7d.
- Ineffective: WBC level did not increased to 4×109/L after more than 15 days of treatment.
Table 1. Comparison of Clinical Efficacy between Treatment and Control Group
|Group||n||Markedly Effective (n)||Effective (n)||Improved||Ineffective (n)||Total Effective Rate|
According to the results, the treatment group showed a more significant improvement in the severity of leukopenia and GI adverse reaction in comparison to the control group (P<0.05), and the total effective rate was also significantly higher in treatment group (93.75 % vs. 80.00%). Shengbai Tongbu Decoction contains herbs that enhance the function of Spleen and Stomach, nourish Kidney essence and resolve stagnation; as a result, Shengbai Tongbu Decoction may have positive effects in the immune and digestive systems, and can therefore improve leukopenia and GI adverse reaction associated with chemotherapy.
Chunpeng Duan, Juan He, WenKui Jia, and Lingping Zhu. Journal of Shanxi University of Chinese Medicine. 2020. 21 (1): 53-57