SUMMARY: 60 patients diagnosed with high-risk cervical human papillomavirus (HPV) infection were randomly divided into treatment group and control group, with 30 subjects in each group. Inclusion criteria for the subjects were: 1) Meet the diagnostic criteria for cervical HPV infection; 2) Meet the diagnostic criteria for damp-heat stasis toxin according to Traditional Chinese Medicine diagnosis; 3) between 25-50 years old; 4) High-risk HPV positive; 5) No abnormality in cervical liquid-based cytology; 6) History of sexual activity. There was no significant difference in age, course of disease and general data between the two groups; thus, the two groups were statistically comparable (P>0.05).
In the control group, subjects received recombinant human interferon α2b vaginal effervescent tablets (500,000 IU/tablet). Subjects were instructed to use the tablet once every other day, one tablet at a time starting from 3 days after the last day of menstrual period. The total course of treatment was three, with 3 weeks as one course of treatment.
In the treatment group, subjects received oral Guben Qindu Decoction (固本清毒汤), which included the following herbs: Huang Qi 20g (黃耆 Radix Astragali seu Hedysari), Bai Hua She She Cao 20g (白花蛇舌草 Herba Hedyotis Diffusae), Dang Shen 20g (黨參 Radix Condonopsis Pilosulae), Dang Gui 20g (當歸 Radix Angelicae Sinensis), Ban Lan Gen 10g (板藍根 Radix Isatidis), Da Qing Ye 10g (大青葉 Folium Isatidis), Huang Bo 10g (黃柏 Cortex Phellodendri), Ban Zhi Lian 10g (半枝蓮 Scutellaria barbata), Zi Cao 10g (紫草 Radix Arnebiae seu Lithospermi), Guan Zhong 10g (貫眾 Cyrtomium fortunei), Huai Niu Xi 10g (牛膝Radix Achyranthis Bidentatae), and Chi Shao 15g (赤芍 Radix Paeoniae Rubra). Subjects were instructed to take the decoction twice a day, 250ml in the morning and evening, starting from 3 days after the last day of menstrual period. Total course of treatment was three menstrual period cycles.
To evaluate the efficacy of the treatment, HPV testing, serum interleukin-6 (IL-6), IL-8 levels, peripheral CD3+ and CD4+ T lymphocytes subsets and CD3+/CD4+ ratio were tested, and the Traditional Chinese Medicine Syndrome Score Scale (TCMSSS) for damp-heat stasis from “Guideline for Clinical Research of Traditional Chinese Medicine New Drugs (2002)” was also monitored. The result was considered as: 1). Cured: if TCMSSS reduction rate was ≥ 95%; 2). Markedly Effective: 70% ≤ TCM TCMSSS reduction rate <95%; 3). Effective: 30%≤ TCM TCMSSS reduction rate＜70%; 4). No Response: if TCM TCMSSS reduction rate was < 30%. Efficacy index = (TCMSSS before treatment – TCMSSS after treatment)/ TCMSSS before treatment × 100%.
Table 1. Comparison of Treatment Efficacy between Treatment and Control Group
| Group | n | Cured | Markedly Effective | Effective | No Response | Average Rank | Z-value | P-value |
| Control | 30 | 2 | 12 | 7 | 9 | 36.47 | -2.853 | 0.004 |
| Treatment | 30 | 6 | 18 | 4 | 2 | 24.53 |
According to the result of this study, the treatment efficacy was significantly higher in the treatment group, and the TCMSSS, IL-6 and IL-8 reduction rate was also more significant in the treatment group (P<0.05). After treatment, the control group showed an increase in CD3+ T lymphocytes, while the ratio of CD3+ and CD4+ T lymphocytes and CD4+/CD8+ ratio showed a more significant increase in the treatment group (P<0.05). There was also a significant difference in HPV clearance rate between treatment group and control group (83.3 % and 60%, P<0.05). The result indicates that combining Guben Qindu Decoction with routine treatment may effectively improve signs and symptoms for patients with high-risk cervical HPV infection, potentially by clearing the damp-heat stasis and toxin and regulating the immune system in the body.
Xuan Yang, et al. J Anhui Univ Chinese Med. 2021. 40 (4): 32-35.