A Cohort Study to Examine the Use of Chinese Herbal Medicine in
Combination With Conventional Therapies for Patients With Hepatocellular
Carcinoma in China

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Abstract

Background. Hepatocellular carcinoma (HCC) is one of the major malignancies associated with high mortality rates. Chinese herbal medicine (CHM) alone, or in combination with conventional therapies (CT), has been widely used for patients with HCC in China. This study aims to explore how integrative therapy (IT) through the combination of CHM and CT affects the survival of patients with intermediate-advanced HCC. Methods. A retrospective cohort study was performed at the First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China. Data of consecutive patients diagnosed with intermediate-advanced HCC and a specific traditional Chinese medicine diagnostic pattern between January 2006 and December 2013 were retrieved from the electronic medical record system at the hospital. Patients were divided into 3 groups based on the therapies used, that is, IT, CHM alone, and CT alone, and the survival times of these patients was compared. Results. A total of 328 patients were included in this study. Median follow-up period was 26.4 months (95% confidence interval [CI] = 22.7-38.9). Median overall survival was 11.0 months for IT, 8.6 months for CHM, and 9.4 months for CT groups ( P < .001). The adjusted hazard ratio (HR) of death for the IT group was 0.55 (95% CI = 0.38-0.79, P = .001) relative to the CT group and 0.68 (95% CI = 0.52-0.90, P = .007) relative to the CHM group, after adjusting for the factors that impact prognosis. Stratified analysis shows that IT can significantly lower the risk of death, especially for patients with good performance status (PS) and Child-Pugh class A. Conclusions. It was indicated that the integrative approach with combination of CHM and CT might improve survival for patients with intermediate-advanced HCC, especially for patients with good PS and Child-Pugh class A. However, a randomized controlled trial is warranted for a conclusive statement.

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Power and sample size calculations for studies involving linear regression.

W. D. Dupont, W. D. Plummer (1998)

This article presents methods for sample size and power calculations for studies involving linear regression. These approaches are applicable to clinical trials designed to detect a regression slope of a given magnitude or to studies that test whether the slopes or intercepts of two independent regression lines differ by a given amount. The investigator may either specify the values of the independent (x) variable(s) of the regression line(s) or determine them observationally when the study is performed. In the latter case, the investigator must estimate the standard deviation(s) of the independent variable(s). This study gives examples using this method for both experimental and observational study designs. Cohen's method of power calculations for multiple linear regression models is also discussed and contrasted with the methods of this study. We have posted a computer program to perform these and other sample size calculations on the Internet (see http://www.mc.vanderbilt.edu/prevmed/psintro+ ++.htm). This program can determine the sample size needed to detect a specified alternative hypothesis with the required power, the power with which a specific alternative hypothesis can be detected with a given sample size, or the specific alternative hypotheses that can be detected with a given power and sample size. Context-specific help messages available on request make the use of this software largely self-explanatory.

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Of the estimated 50 million new cases of hepatitis B virus (HBV) infection diagnosed annually, 5-10% of adults and up to 90% of infants will become chronically infected, 75% of these in Asia where hepatitis B is the leading cause of chronic hepatitis, cirrhosis and hepatocellular carcinoma (HCC). In Indonesia, 4.6% of the population was positive for HBsAg in 1994 and of these, 21% were positive for HBeAg and 73% for anti-HBe; 44% and 45% of Indonesian patients with cirrhosis and HCC, respectively, were HBsAg positive. In the Philippines, there appear to be two types of age-specific HBsAg prevalence, suggesting different modes of transmission. In Thailand, 8-10% of males and 6-8% of females are HBsAg positive, with HBsAg also found in 30% of patients with cirrhosis and 50-75% of those with HCC. In Taiwan, 75-80% of patients with chronic liver disease are HBsAg positive, and HBsAg is found in 34% and 72% of patients with cirrhosis and HCC, respectively. In China, 73% of patients with chronic hepatitis and 78% and 71% of those with cirrhosis and HCC, respectively, are HBsAg positive. In Singapore, the prevalence of HBsAg has dropped since the introduction of HBV vaccination and the HBsAg seroprevalence of unvaccinated individuals over 5 years of age is 4.5%. In Malaysia, 5.24% of healthy volunteers, with a mean age of 34 years, were positive for HBsAg in 1997. In the highly endemic countries in Asia, the majority of infections are contracted postnatally or perinatally. Three phases of chronic HBV infection are recognized: phase 1 patients are HBeAg positive with high levels of virus in the serum and minimal hepatic inflammation; phase 2 patients have intermittent or continuous hepatitis of varying degrees of severity; phase 3 is the inactive phase during which viral concentrations are low and there is minimal inflammatory activity in the liver. In general, patients who clear HBeAg have a better prognosis than patients who remain HBeAg-positive for prolonged periods of time. The outcome after anti-HBe seroconversion depends on the degree of pre-existing liver damage and any subsequent HBV reactivation. Without pre-existing cirrhosis, there may be only slight fibrosis or mild chronic hepatitis, but with pre-existing cirrhosis, further complications may ensue. HBsAg-negative chronic hepatitis B is a phase of chronic HBV infection during which a mutation arises resulting in the inability of the virus to produce HBeAg. Such patients tend to have more severe liver disease and run a more rapidly progressive course. The annual probability of developing cirrhosis varies from 0.1 to 1.0% depending on the duration of HBV replication, the severity of disease and the presence of concomitant infections or drugs. The annual incidence of hepatic decompensation in HBV-related cirrhosis varies from 2 to 10% and in these patients the 5-year survival rate drops dramatically to 14-35%. The annual risk of developing HCC in patients with cirrhosis varies between 1 and 6%; the overall reported annual detection rate of HCC in surveillance studies, which included individuals with chronic hepatitis B and cirrhosis, is 0.8-4.1%. Chronic hepatitis B is not a static disease and the natural history of the disease is affected by both viral and host factors. The prognosis is poor with decompensated cirrhosis and effective treatment options are limited. Prevention of HBV infection thorough vaccination is still, therefore, the best strategy for decreasing the incidence of hepatitis B-associated cirrhosis and HCC.

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Xiaofeng Liang, SHENGLI BI, Weizhong Yang … (2013)

To determine the prevalence of hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (anti-HBs), and hepatitis B core anti-body (anti-HBc) in a representative population in China 14 years after introduction of hepatitis B vaccination of infants.

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Author and article information

Journal

Journal ID (nlm-ta): Integr Cancer Ther

Journal ID (iso-abbrev): Integr Cancer Ther

Journal ID (publisher-id): ICT

Journal ID (hwp): spict

Title: Integrative Cancer Therapies

Publisher: SAGE Publications (Sage CA: Los Angeles, CA )

ISSN (Print): 1534-7354

ISSN (Electronic): 1552-695X

Publication date (Electronic): 18 May 2018

Publication date Collection: September 2018

Volume: 17

Issue: 3

Pages: 902-911

Affiliations

[1 ]Guangzhou University of Chinese Medicine First Affiliated Hospital, Guangzhou, Guangdong, China

[2 ]Western Sydney University, Campbelltown, New South Wales, Australia

[3 ]South West Sydney Local Health District, Liverpool, New South Wales, Australia

Author notes

[*]Lizhu Lin, Integrative Cancer Centre, Guangzhou University of Chinese Medicine First Affiliated Hospital, Airport Road 14, Guangzhou, Guangdong 510405, China. Email: lizhulin26@ 123456yahoo.com

Author information

Lingling Sun https://orcid.org/0000-0001-7033-1698

Paul Fahey https://orcid.org/0000-0002-6351-9876

Article

Publisher ID: 10.1177_1534735418775819

DOI: 10.1177/1534735418775819

PMC ID: 6142107

PubMed ID: 29775121

SO-VID: 2609783d-d34d-43ad-a659-561eb926e9a0

License:

This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License ( http://www.creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages ( https://us.sagepub.com/en-us/nam/open-access-at-sage).

History

Date received : 5 January 2018

Date revision received : 21 March 2018

Date accepted : 6 April 2018

Funding

Funded by: National Natural Science Foundation of China, FundRef https://doi.org/10.13039/501100001809;

A Cohort Study to Examine the Use of Chinese Herbal Medicine in Combination With Conventional Therapies for Patients With Hepatocellular Carcinoma in China

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Karger: Oncology

Most cited references 26

Power and sample size calculations for studies involving linear regression.

Chronic hepatitis B virus infection in Asian countries.

Reprint of: Epidemiological serosurvey of Hepatitis B in China--declining HBV prevalence due to Hepatitis B vaccination.

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