Efficacy and safety of Buzhong Yiqi Decoction in improving cancer-related fatigue and immunity of cervical carcinoma patients

Abstract

Background: Cancer-related fatigue (CRF) is essentially universal in cervical carcinoma patients. It develops rapidly, with physical and mental manifestations including generalized weakness, diminished concentration or attention, and it has a negative impact in overall quality of life. Buzhong Yiqi Decoction (BYD), a classical Chinese medical prescription, could be used for allergic rhinitis, gut microbiota disorders, and chronic obstructive pulmonary disease. We preliminarily found that BYD could relieve CRF in cervical carcinoma patients. However, there are few trials on whether BYD could relieve CRF and improve immunity in cervical carcinoma patients. Methods: This is a double-blinded, randomized, controlled clinical trial. From December 1, 2021 to May 31, 2022, cervical carcinoma patients with CRF will be assessed for randomization into treatment group (BYD) and control group (BYD simulation) in a 1:1 ratio. The outcomes are cancer fatigue scale, self-rating anxiety scales, self-rating depression scales, Pittsburgh sleep quality index, and immunity index (CD3 + , CD4 + , and CD8 + ) before and after the treatment. Statistical analysis will be performed using SPSS v22.0 software. Results and conclusions: The study will clarify the efficacy and safety of BYD in improving CRF and immunity in cervical carcinoma patients. Trial registration: OSF Registration number: DOI 10.17605/OSF.IO/QFNMD.

Analysis of Outcome Indicators of Cancer-Related Fatigue Treated with Chinese Herbal Compounding

“…The interventions in the 70 RCT treatment groups included in this research were limited to herbal compounding alone, and the interventions in the control group included studies with symptomatic treatment at most as the control group 6 , 8 , 12 , 14–16 , 18–20 , 22 , 27 , 29 , 30 , 32–36 , 38 , 40 , 42 , 47 , 50 , 52 , 53 , 55 , 59 , 60 , 64 , 67–69 , 71 , 74 in 35 studies, chemotherapy alone as a control group 9 , 10 , 21 , 26 , 37 , 39 , 41 , 48 , 51 , 54 , 56 , 57 , 65 , 66 , 70 , 72 , 73 in 17 studies, placebo as a control group 23 , 24 , 44 , 62 in 4 studies, and the rest adopting symptomatic treatment + buzhongyiqi compound, 63 symptomatic treatment + compound zebrano capsules, 46 symptomatic treatment + guipiwan, 6 chemotherapy + detox tang, 11 chemotherapy + buzhongyiqi compound, 49 addy injection, 31 buzhongyiqi wan, 7 anti-tumor and potent formula, 45 modafinil capsule, 13 zhenqifuzheng capsule, 25 bozhi glycopeptide, 61 huangqi, 61 ...…”

“…From the 70 included studies, six fatigue scales were used in the herbal preparation for cancer fatigue of which 25 studies 6 , 14 , 16 , 18 , 20 , 26 , 29 , 32–34 , 37–40 , 44 , 46 , 50 , 51 , 54 , 55 , 57 , 64 , 65 , 71 , 72 used the piper fatigue scale (PFS) and 18 studies 6 , 14 , 16 , 18 , 20 , 26 , 29 , 32–34 , 37–40 , 44 , 46 , 50 , 51 , 54 , 55 , 57 , 64 , 65 , 71 , 72 took advantage of the PFS revised (PFS-R), 11 studies 4 , 9 , 13 , 17 , 23 , 31 , 42 , 45 , 49 , 61 , 73 using the cancer fatigue scale, and 8 studies 5 , 10 , 24 , 25 , 45 , 60 , 62 , 68 using the brief fatigue inventory, 3 studies 47 , 48 , 66 using the fatigue symptom inventory, and 2 studies ...…”

“…Insomniaseverityindex 62 Scored patient-generated subjective global assessment 62 Functional assessment of breast cancer treatment scale 35 Pittsburgh sleep quality index 35 Numerical rating scale 71 Sleep quality point scale 71 Weight score 71 Lung cancer specificity scale 60 Adult dispositional hope scale 60 Montreal cognitive assessment 62 Appetite loss score 5 MD Anderson symptom inventory 43 Biochemical indicators T lymphocyte subpopulation 4,11,12,[16][17][18]23,25,26,30,[33][34][35]37,45,46,49,51,53,54,56,57,60,61,63,71 Natural killer cell 12,16,26,34,56,63 Albumin 6,27,39 Hemoglobin 6,11,16,26,…”

“…Neutrophil 32,48,53,71,73 C-reactive protein 13,27,34,50,54,64 Tumor necrosis factor-α 16,34,63 Interleukin-1β, 63 interleukin-2, 26,64,67 interleukin-4, 64,67 interleukin-5, 67 interleukin-6, 13,16,34,54,64 interleukin-8, 54 interferon-γ, 63,64,67 interleukin-10, 64 interleukin-17a 64 Immunoglobulin G, immunoglobulin A, immunoglobulin M 21,51,56,57 CD56+, CD19+ 45 Cortisol level 45 Adrenocorticotrop(h)ic hormone 13 CEA, 13 Cyfra21-1, 20 CA125, 20 CA199, 25,37 CA724 25 Thyroid stimulating hormone, free triiodothyronine 25 The proportion of quality-of-life scales is low and there is no consistent standard. The assessment of the quality-oflife is an essential step for cancer patients and is also crucial for the determination of clinical efficacy, while the current quality of life scale accounts for about 57%, and its proportion should be further escalated.…”

Integrating network pharmacology and experimental verification to investigate the pharmacological mechanisms of Buzhong Yiqi decoction in the treatment of non‐small cell lung cancer

“…Clinically, BZYQD could be used for allergic rhinitis, gut microbiota disorders, and chronic obstructive pulmonary disease (Fan et al., 2020; Feng et al., 2021; Ni et al., 2021). In addition, clinical studies have shown that BZYQD had a certain effect on patients with bladder and cervical cancer, and can reduce the side effects of chemotherapy and radiotherapy (Hu et al., 2021; Wang, Zhang, Liu, Li, & Jin, 2021b). However, the potential mechanism of action of BZYQD against NSCLC remains ambiguous due to the complex composition of traditional Chinese medicine formulations and their interactions.…”