Abstract
BackgroundLiver cancer is a common malignancy with a high mortality rate. Given the poor prognosis associated with this cancer, many patients seek additional therapies that may improve quality of life or survival. Several Traditional Chinese Medicines (TCM) have been evaluated in clinical trials, but little is known about them outside of China.MethodsWe searched independently and in duplicate 8 electronic databases, including 2 Chinese language databases, until February 2009. We included any randomized clinical trials (RCT) evaluating a TCM oral preparation for the treatment of hepatocellular cancers. We abstracted data on survival, tumor response, and performance scores. We conducted a random-effects meta-analysis and applied a meta-regression analysis.ResultsWe included 45 RCTs (n = 3,236). All studies employed an active control group. In general, the reporting of methodological issues was poor. We analyzed data from 37 trials reporting on complete response effects score (Relative Risk [RR] of 1.26 (95 CI, 1.04–1.52, P = 0.01, I2 = 0%, P = 0.99). Products containing ginseng, astragalus and mylabris had a larger treatment effect (OR 1.34, 95% CI, 1.04–1.71, P = 0.01) than the pooled broad estimate, also the case for astragalus-based treatments (OR 1.35, 95% CI, 1.001–1.80. P = 0.048). We examined survival rates and pooled 15 studies reporting on 6 month outcomes (RR 1.10, 95% CI, 1.04–1.15, P = < 0.0001, I2 = 0%, P = 0.60). This effect was consistent at other prospective dates, including 12 months (22 trials, RR 1.26, 95% CI, 1.17–1.36, P = < 0.0001, I2 = 7%, P = 0.36), 24 months (15 trials, 1.72, 95% CI, 1.40–2.03, P = < 0.0001, I2 = 0%, P = 0.75); and, at 36 months (8 trials, RR 2.40, 95% CI, 1.65–3.49, P = < 0.0001, I2 = 0%, P = 0.62).LimitationsAll included trials were conducted in China where emerging evidence suggests many RCTs are not, in fact, randomized. Publication bias may exist, favouring positive reports.ConclusionOur meta-analysis displays compelling evidence of effectiveness for hepatocellular cancers that should be evaluated in high-quality and transparent clinical trials.
Highlights
Worldwide, liver cancer is the fifth most common malignancy in men and the eighth in women[1]
Applying meta-regression, we found that products containing ginseng, astragalus and mylabris had a larger treatment effect than the pooled broad estimate and that any product containing astragalus had this effect
When we examined if differential effects existed across specific formulations, we found that studies using bufotoxin demonstrated increased effects, as did studies using ginseng, astragalus and mylabris and any product using astragalus
Summary
Liver cancer is the fifth most common malignancy in men and the eighth in women[1]. According to the World Health Organization (WHO), liver cancer is a major health problem and its incidence is increasing[2]. In the United States alone, it is estimated that there will be 22,620 new cases and 18,160 deaths related to liver cancer in 2009[3]. The major risk factor for liver cancer is the presence of cirrhosis of the liver, largely due to chronic hepatitis C virus (HCV) and hepatitis B virus (HBV) infection[4]. It is believed that the combined effects of these infections account for well over 80% of liver cancer cases worldwide[1]. Liver cancer is a common malignancy with a high mortality rate. Several Traditional Chinese Medicines (TCM) have been evaluated in clinical trials, but little is known about them outside of China
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