Objective To evaluate the clinical efficacy of Changweishu Capsule for diarrhea of the spleen-stomach dampness-heat pattern in patients with cancer.Methods One hundred and four patients with tumor-related diarrhea of the spleen-stomach dampness-heat pattern were randomly assigned to the test group(n=63)and the control group(n=30).The test group was treated with Changweishu Capsule (4 capsules per time

3 times a day).The control group was treated with Xianglian tablets (5 tablets per time

3 times a day).Both groups were administered continuously for 2 weeks.The TCM syndrome scores

TCM syndrome efficacy and single symptom efficacy were compared before and after treatment

and safety indicators were observed.Adverse reactions were recorded.Results Among the 63 cases in the test group

3 cases were cured

15 cases were markedly effective

39 cases were effective

6 cases were ineffective

the total number of effective cases were 57

and the total effective rate was 90.5%.Among the 30 cases in the control group

none was cured

5 cases were markedly effective

18 cases were effective

7 cases were ineffective

the total number of effective cases was 23

and the total effective rate was 76.7%.Rank sum test showed that Z=-1.913

P=0.056(P>0.05)

indicating that the symptoms curative effects of the two groups were not significantly different.Both drugs reduced the total score of TCM syndromes of tumor-related diarrhea(P<0.05).The test group decreased significantly as compared with the control group (P<0.05).After treatment

the scores of diarrhea

abdominal fullness

food intake

hiccup and nausea

dry mouth and bitter taste in the two groups all decreased.The scores of diarrhea and abdominal fullness in the test group were greatly lowered

as compared with the control group (P<0.05).During the observation

no adverse reactions were found during the observation process.Conclusions Both Changweishu Capsule and Xianglian Tablets can improve the clinical symptoms in tumor-related diarrhea and abdominal fullness.Changweishu Capsule has better efficacy in improving the two single symptoms of diarrhea. Abstract