OBJECTIVETo assess the short- and long-term efficacy and safety of treating functional dyspepsia (FD) by Chinese medical syndrome typing (CMST).

METHODSA randomized, positive-drug parallel controlled study was conducted. Recruited were 170 FD patients who were randomly assigned to the test group (13 cases, treated by Chinese herbs) and the control group (34 cases, treated by Western medicine) in the ratio of 4:1. Different recipes were administered to patients in the test group according to CMST at the 1st, 2nd, and 4th week, respectively, while those in the control group took Domperidone or Esomeprazole Magnesium Enteric-coated Tablet according to Roma III Criteria. The therapeutic efficacy was observed at the 1st, 2nd, and 4th week of the treatment, including (1) clinical symptom score; (2) the score of SF-36 quality of life scale; (3) safety (4) compliance; (5) satisfaction; (6) the relapse rate; (7) cost-effectiveness ratio (C/E). The follow-up were performed at the 1st, 3rd, and 6th month.

RESULTSSixteen patients fell off in the test group and 4 fell off i the control group, and the expulsion rate being 11.76% in the two groups, showing no statistical difference ( P > 0.05). The clinical symptom scores in the test group decreased from 5.62 +/- 2.30 before treatment to 1.41 +/- 1.22 after 4-week treatment, showing statistical difference (P < 0.01), but with no statistical difference when compared with the control group at the same time point (P>0.05). The healing rate and the total effective rate at week 4 were 38.24% and 86.76% respectively in the test group, and they were 60.00% and 65.00% at 6-month withdrawal. They were 41.18%, 79.41%, 46.67%, and 50.00%, respectively, in the control group. There was no statistical difference between the two groups (P>0.05). The scores of physical component-summary (PCS) and mental component-summary (MCS) both increased after 4-week treatment in the two groups, showing no statistical difference when compared with before treatment (P>0.05). There was statistical difference in the scores of PCS and MCS between at 6-month withdrawal and before treatment (P<0.05), but there was no statistical difference between the two groups (P>0.05). No obvious adverse reaction occurred in the two groups. The compliance and satisfaction after 4-week treatment were 95.59% and 91.91% in the test group, and 94.12% and 91.18% in the control group, showing no statistical difference between the two groups (P>0.05). The relapse rate in the test group was 10.29%, 19.12%, and 29.41%, respectively, after 1, 3, 6-month withdrawal, lower than that of the control group (17.65%, 23.53%, and 35.29%, respectively) at the same time point, but with no statistical difference. The C/E ratio of the test group/the control group was 15.59: 16. 53 at 4-week treatment and 22.27:28.28 after 6-month withdrawal respectively. The further analysis of incremental cost/incremental effectiveness showed that the ratio in the long-term decreased from 5.44 to 2.35 in the test group.

CONCLUSIONSThe 4-week treatment of CMST had definite short- and long-term efficacy on FD patients, and improved their quality of life. It had better safety, compliance, and satisfaction. It was dominant in lower relapse rate and the cost/effectiveness. Therefore, it was worth spreading.