OBJECTIVETo observe the clinical efficacy of Xiaoshui Decoction (XSD) in treating ascites in patients suffered from primary liver cancer of Pi-deficiency with damp harassment syndrome (PDDHS) as well as to study the effect through the experiment in mice.

METHODSSixty-one patients confirmed to be primary liver cancer of PDDHS and accompanied with ascites were randomly divided into the treated group (n=33) and the control group (n=28). The treated group was treated by XSD combined with chemotherapy by locally applying of DDP via abdominal infusion, while the control group treated by DDP infusion alone. The treatment lasted for two months. The conditions of ascites, quality of life (QOL), survival period, and TCM syndrome after treatment were observed. In the experimental study, the mice models of ascites were grouped and treated to observe the conditions of ascites and their survival period.

RESULTSThe short-term total effective rate of the treated group and the control group was 42.4% and 21.4%, the interval of aspirating ascites after treatment was 17.95 +/- 9.63 days and 10.87 +/- 7.76 days, and the 1-year survival rate 33.3% and 14.3%, respectively, significant difference was shown between the two groups in the three parameters (all P < 0.05 ). QOL was improved in both groups with insignificant difference (P > 0.05). Besides, the main symptoms were improved in patients of both groups, especially in the ameliorating of fatigue, abdominal distension, nausea and vomiting. Evaluation on safety of treatment showed that XSD had no obvious toxic and adverse reaction, and so it was safe in use. Experimental study showed that on the two mice models of ascites induced by inoculating two kinds of tumor cell, the effect of XSD was superior to that of the control group in aspects of reducing ascites and prolonging survival period, showing significant difference (P < 0.05).

CONCLUSIONSatisfactory short-term efficacy in treating primary liver cancer with ascites of the Pi-deficiency with damp harassment syndrome could be obtained by XSD. Its effect in prolonging survival period was confirmed by experimental study. XSD can also improve the symptoms and QOL of patients, therefore, it is an effective and reliable remedy for treatment of primary liver cancer with ascites.