To assess the effectiveness of Tongjiang Granule (TJG

通降颗粒) on the patients with nonerosive reflux disease (NERD) of Gan (肝)-Wei (胃) incoordination syndrome

its impact on their quality of life

and its safety. A randomized

controlled

double-blinded

and double-dummy method was adopted in the trial. There were 120 NERD patients enrolled in the study and randomly divided into the experiment and control groups

each with 60 patients; drugs were distributed according to the drug number by patients’ inclusion sequences. In the experiment group

patients were given TJG 10 g and mosapride citrate dummy 5 mg three times a day

and in the control group

patients were given mosapride citrate 5 mg and TJG dummy 10 g three times a day. The treatment courses of both groups were 4 weeks. Among 120 included patients

112 were screened for full analysis set (FAS)

and 105 were screened per-protocol set (PPS). The results were as follows: (1) the improvement of total scores of symptom in the experiment group (0–4 week) were 15.93±7.88 scores by FAS and 16.22 ±7.75 scores by PPS

and they were 10.43±10.16 scores and 10.79±10.27 scores in the control group

respectively. The 95% CI of net scores improvement between the two groups were 2.10–8.90 scores and 1.92–8.94 scores in FAS and PPS; it was significantly better in the experiment group than that in the control group (P<0.05). (2) The improvement of scores of major symptom in the experiment group (0–4 week) were 10.68±5.35 by FAS and 10.89±5.29 by PPS and 7.40±7.41 and 7.60±7.46 in the control group

respectively. The 95% CI of net scores improvement in the two groups were 0.85–5.71 and 0.71–5.69 in FAS and PPS separately

and the improvement in the experiment group was significantly better than that in the control group (P<0.05). (3) The total effective rates were 86.0% and 61.8% in the experiment and the control group separately

and the Ridit analysis results showed that it was better in the experiment group (P<0.05). (4) The improvement quality of life in the domain of physical functioning and general health in the experiment group was better than that in the control group (P<0.05). (5) One case of experiment group caught a cold and recovered in six days without drug suspension. No adverse event was found in the other cases. There was no meaningful safety examination indices change in pretreatment and posttreatment periods in both groups. TJG showed a definite effect on the treatment of NERD with Gan-Wei incoordination syndrome

and it could improve the quality of life of NERD patient without obvious toxic and side effects.