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Chinese Herbal Medicine and Chemotherapy in the Treatment of Hepatocellular Carcinoma: A Meta-analysis of Randomized Controlled Trials

Pine Street Foundation, San Anselmo, California.; School of Public Health, Nanjing Medical University, Nanjing, P.R. China.

Michael McCulloch, LAc, MPH

Institute of Biophysics, Chinese Academy of Sciences, Beijing P.R. China.; Pine Street Foundation, 124 Pine Street, San Anselmo, CA 94960.; mcculloch{at}pinestreetfoundation.org

Hang Xiao, MPH, PhD

School of Public Health, Nanjing Medical University, Nanjing, P.R. China.

Michael Broffman, LAc

Pine Street Foundation, San Anselmo, California.

Jin Gao, MD,PhD

Institute of Biophysics, Chinese Academy of Sciences, Beijing P.R. China.

Background: Hepatocellular carcinoma (HCC), one of the most common malignancies worldwide, is highly resistant to standard therapy. It is unclear whether chemotherapy, arterial embolization, or arterial chemoembolization improve survival advantage enough to justify their high toxicity. Treatment with Chinese herbal medicine has been explored, combining herbs that stimulate host immune response with those that have cytotoxic activity against HCC cells. The authors sought to evaluate the effectiveness of Chinese herbal medicine combined with chemotherapy. The hypothesis was that Chinese herbal medicine added to chemotherapy for the treatment of HCC would improve survival and tumor response, when compared to treatment with chemotherapy alone.Methods:The authors searched the databases TCMLARS, PubMed, and EMBASE as well as the bibliographies of studies identified in the systematic search for potentially relevant titles or abstracts of studies in any language. They retained those that (1) treated only HCC patients, (2) were described as randomized or reported that there was no statistical difference between treatment groups, (3) gave patients either Chinese herbal medicine therapy combined with chemotherapy in the treatment group or chemotherapy alone in the control group, and (4) provided data on the number of enrolled subjects and responders and nonresponders for tumor response and survival. The authors used random effects meta-analysis to combine data.Results:Twenty-six studies representing 2079 patients met the inclusion criteria. Chinese herbal medicine combined with chemotherapy, compared to chemotherapy alone, improved survival at 12 months (relative risk [RR], 1.55; 95% confidence interval [CI], 1.39-1.72;P< .000), 24 months (RR, 2.15; 95% CI, 1.75-2.64;P< .000), and 36 months (RR, 2.76; 95% CI, 1.95-3.91;P< .000). Tumor response increased (RR, 1.39; 95% CI, 1.24-1.56;P< .000). Conclusions:These findings provide promising evidence that combining Chinese herbal medicine with chemotherapy may benefit patients with HCC. Because of the low quality of these studies, these findings should be confirmed through conducting high-quality, rigorously controlled trials.

Key Words: hepatocellular carcinoma (HCC) • chemotherapy • Chinese herbal medicine • randomized, controlled trials (RCTs) • quasi-randomized, controlled trials (quasi-RCTs) • survival • tumor response (TR)

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