Clinical Study on the Use of Pei’s Soft Liver and Relieve Distention Pills Combined with Western Medicine in Treating Primary Liver Cancer

Clinical Study on the Use of Pei’s Soft Liver and Relieve Distention Pills Combined with Western Medicine in Treating Primary Liver Cancer

Dong Qinqin

Abstract

Objective: Through clinical trials, observe the clinical efficacy of Pei’s Soft Liver and Relieve Distention Pills in treating primary liver cancer by evaluating tumor remission rate, liver and kidney function, complete blood count, AFP level, and Karnofsky Performance Status score. Explore the unique characteristics and advantages of applying Pei’s academic thought of integrating traditional Chinese and Western medicine in treating this disease, providing a theoretical basis for combined TCM-Western medicine treatment of primary liver cancer.

Methods: From December 2011 to December 2012, 70 hospitalized cases of primary liver cancer meeting inclusion criteria were recruited from the Integrated Traditional Chinese and Western Medicine Department of Gansu Provincial Cancer Hospital. Patients were randomly assigned to treatment and control groups based on admission order, with 35 cases in each group. Both groups received standard Western medical treatment. The treatment group, in addition to standard Western treatment, was given Pei’s Soft Liver and Relieve Distention Pills, taken orally after meals, one packet twice daily, with one month constituting a treatment course. The tumor remission rate, AFP level, liver function, and Karnofsky Performance Status score before and after medication were observed to evaluate the clinical efficacy of Pei’s Soft Liver and Relieve Distention Pills in treating primary liver cancer. Additionally, complete blood count and kidney function tests were conducted before and after treatment to assess drug safety.

Results:

1. The treatment group showed a significant improvement in tumor remission rate compared with the control group (P<0.05), with statistical significance.
2. The treatment group demonstrated significantly better improvement in clinical symptoms and Karnofsky Performance Status score than the control group (P<0.05), with statistically significant differences.
3. The treatment group had a significantly greater reduction in AFP levels than the control group (P<0.05), with statistical significance.
4. In terms of improving liver function, the treatment group outperformed the control group (P<0.05), with statistical significance.
5. There were no significant differences between the treatment and control groups in terms of renal impairment or abnormal blood counts (P>0.05).

Conclusion: Pei’s Soft Liver and Relieve Distention Pills, when used in combination with Western medicine to treat primary liver cancer, can inhibit tumor growth, significantly improve patients’ quality of life, and provide a synergistic effect that reduces toxicity while enhancing efficacy. The treatment is safe and reliable, demonstrating the unique characteristics and advantages of combining traditional Chinese and Western medicine in treating this disease compared with Western medicine alone.

Keywords: Pei’s Soft Liver and Relieve Distention Pills; Primary Liver Cancer; Integrated Traditional Chinese and Western Medicine; Clinical Study

Research on Pei Zhengxue’s Series of Formulas and Medications

ABSTRACT

Objectives: Through clinical trials, observed Pei Shi Ruangan Xiaopi Pills' clinical effect of primary liver cancer by the index of primary liver cancer patients' remission rate, the function of liver and renal, blood tests, value of Kamofsky grade. Discuss Pei Shi's academic thought of the combination of traditional Chinese and Western medicine' characteristics and advantages in treating this disease. Provided theoretical basis for treatment of primary liver cancer with traditional Chinese and Western medicine. Methods: A total of 70 inpatients with primary liver cancer who met the inclusion criteria were enrolled from December 2011 to December 2012 at the Department of Integrated Traditional Chinese and Western Medicine of Gansu Provincial Tumor Hospital. According to the order of admission, the 70 cases were randomly divided into a treatment group and a control group using a completely randomized digital table, with 35 cases in each group. During the treatment, both groups received basic treatment, which consisted of conventional Western medical therapy. The treatment group, in addition to the basic treatment, was administered Pei Shi Ruangan Xiaopi Pills for one month. Patients took one bag twice daily with water after dinner. Changes in patients' remission rate, liver and renal function, blood tests, and Karnofsky performance status scores before and after medication were observed to evaluate the clinical efficacy of Pei Shi Ruangan Xiaopi Pills in treating primary liver cancer. Blood tests and renal function were also assessed before and after medication to evaluate the safety of Pei Shi Ruangan Xiaopi Pills.

Results:

1. The treatment group showed a significantly higher remission rate than the control group (p<0.05), with statistically significant differences.

2. The treatment group demonstrated significantly better improvement in clinical symptoms and Karnofsky performance status scores compared with the control group (p<0.05), with statistically significant differences.

3. The treatment group had a significantly greater reduction in AFP levels than the control group (p<0.05), with statistically significant differences.

4. In terms of improving liver function, the treatment group's therapeutic effect was superior to that of the control group, with statistically significant differences.

5. However, there were no statistically significant differences between the treatment group and the control group in areas such as renal function and blood test results (p>0.05).

Conclusion: Pei Shi Ruangan Xiaopi Pills combined with Western medicine in the treatment of primary liver cancer can inhibit tumor growth, significantly improve the quality of life of inpatients, reduce toxicity, and are safe and reliable. This reflects the characteristics and advantages of combining traditional Chinese and Western medicine in treating this disease.

Research on Pei Zhengxue’s Series of Formulas and Medicines

Keywords: Pei’s Soft Liver and Anti-Bloating Pills; Primary Liver Cancer; Integrated Traditional Chinese and Western Medicine; Clinical Trial Study

Introduction

Pei’s Soft Liver and Anti-Bloating Pills are an effective formula developed by Professor Pei Zhengxue based on 50 years of clinical experience for the treatment of primary liver cancer and gastric cancer. These pills can enhance patients’ immune function, reduce surgical complications and the side effects of radiotherapy and chemotherapy, markedly improve clinical symptoms, enhance quality of life, prevent and treat tumor metastasis and recurrence, and thus have certain clinical value.

Primary liver carcinoma (PLC) is one of the most common malignant tumors worldwide. In China, approximately 34.7 per 100,000 people die from PLC each year, accounting for about 53% of global liver cancer deaths [1-2]. This disease is characterized by rapid progression, poor prognosis, and extremely high mortality rates [3-4]. By the time of clinical diagnosis, most patients are already in the middle or late stages, having lost the opportunity for surgery or interventional embolization therapy [5-6], seriously endangering human life and health.

The etiology of PLC remains unclear, but it may be related to the following factors: viral infection, aflatoxin, contaminated drinking water, cirrhosis, nitrosamines, and others. There are three pathological types of PLC: ① hepatocellular carcinoma (HCC), which accounts for about 90% of cases; ② intrahepatic bile duct carcinoma (ICC); ③ mixed-type liver cancer. Early-stage small liver cancers are still primarily treated by surgical resection; other options include interventional therapy, radiotherapy, chemotherapy, radiofrequency ablation, biological therapy, and traditional Chinese medicine. However, by the time PLC is detected, most cases are already in the middle or late stages, with intrahepatic metastasis, extrahepatic metastasis, cirrhosis, or other complications, missing the chance for surgery or intervention. Moreover, PLC is often insensitive to chemotherapy drugs, and the cytotoxic effects of chemotherapy make it difficult for patients to tolerate. Recently, some researchers have proposed that inflammation is a “friend” of cancer, as the inflammatory microenvironment can promote cancer cell growth and is considered one of the seven hallmarks of cancer [7]. Anti-infective treatment can inhibit cancer development, further progression, and metastasis, while enhancing the body’s immunity and responsiveness to drugs. Numerous studies have shown that traditional Chinese medicine and herbal remedies are effective in adjuvant treatment of various malignant tumors [8-10].

The five-year survival rate for liver cancer has reached a bottleneck, mainly due to cancer metastasis and recurrence. Over-treatment and stimulation can promote liver cancer metastasis [11]. Furthermore, even small liver cancers have a high potential for metastasis, not just advanced-stage cancers [12]. Traditional Chinese medicine is a treasure trove of Chinese culture, with a long history and profound depth. Modern physicians have used advanced scientific research methods to verify its great advantages in enhancing the overall immune system, preventing precancerous lesions, inhibiting cancer cell growth, slowing down metastasis and recurrence.

This clinical trial study employs a randomized controlled method, using Pei’s Soft Liver and Anti-Bloating Pills in combination with Western medicine to treat PLC patients, observing tumor regression rates, improvements in liver function, quality of life, renal impairment, and abnormalities in blood counts. The study aims to verify the clinical efficacy of Pei’s Soft Liver and Anti-Bloating Pills in treating PLC, explore the unique features and advantages of Pei’s integrated traditional Chinese and Western medicine approach compared with Western medicine alone, and provide clinical evidence for the use of Pei’s Soft Liver and Anti-Bloating Pills in treating PLC.

Rationale for the Study