Objective To evaluate the methodological quality of clinical randomized control trials (RC T) on Traditional Chinese Medicine (TCM) for acute pancreatitis. Methods Papers published from 1995 to 2004 of clinical RCTs about the treatmen t of acute pancreatitis by TCM therapies were obtained by computer retrieval and assessed according to the evaluation criteria on design quality of RCTs and the principle of evidence-based medicine. Results There were 94 p apers of clinical RCTs on TCM for acute pancreatitis published on 61 journals, o f which 8 papers had inclusion criteria; 12 had exclusion criteria; 33 had a sam ple size over 50 cases; 4 had description of side effects; and 2 referred to fol low-up. Conclusions The methodological quality of clinical RCT s of TCM for acute pancreatitis is not good enough to provide reliable evidence for clinical practice.