RESUMEN
BACKGROUND: Conventional methods of treating cirrhotic ascites are inadequate. We sought to identify a novel, effective approach to relieve the suffering of patients with cirrhotic ascites. AIM OF THE STUDY: To investigate the efficacy of Xiaozhang Tie, a traditional Chinese herbal cataplasm composed of dahuang (Rheum palmatum L.), laifuzi (Raphanus sativus L.), concocted gansui (Euphorbia kansui T.N. Liou ex T.P. Wang), chenxiang [Aquilaria sinensis (Lour.) Gilg], dingxiang (Eugenia caryophyllata Thunb.), bingpian (Borneolum syntheticum) and shexiang (artificial Moschus), as an adjuvant in treating cirrhotic ascites. MATERIALS AND METHODS: A multicenter, randomized, placebo-controlled trial was conducted. One hundred patients with cirrhotic ascites were divided into two groups of equal size. The test group took an umbilical compress with Xiaozhang Tie for 30 days while the control group was administered an umbilical compress with placebo, in addition to primary therapy. Efficacy was evaluated according to the criteria including ascites volume, urine 24-h volume, abdominal circumference, body weight, abdominal distention, appetite, flatus and defecation. RESULTS: Ninety-two patients completed the study, 7 were withdrawn and 1 was excluded. The effective rate of grades I and II was 63.3% for the test group (n=49) and 38.0% for the control one (n=50). Both groups showed decreased body weight and abdominal circumference, increased urine volume and improved symptoms after treatment. However, the differences between pre-treatment and post-treatment in body weight, abdominal circumference and urine volume were 8.7±5.8 kg, 12.4±8.3 cm and 683±644 ml respectively in the test group, noticeably higher than those in the control group, which were 5.3±4.6 kg, 8.0±6.5 cm and 372±697 ml, respectively. The ranking orders of the symptoms of the test group were significantly lower than those of the control group after treatment. No severe adverse reactions were seen. CONCLUSION: Xiaozhang Tie as an adjuvant to primary therapy of cirrhotic ascites is safe and shows a remarkable efficacy on relieving abdominal distention.