Objective To investigate the clinical efficacy of Wumei Pills in the treatment of gastroesophageal reflux dis-ease(GERD)of cold and heat miscellaneous type.Methods One hundred and forty-four GERD patients with cold and heat miscellaneous type were randomly assigned into the control group(n =72)and the treatment group(n =72).All patients were given Western medicine,and patients in the treatment group were additionally given Wumei Pills,the treatment was performed for 8 weeks.The key observation was the gastroesophageal reflux disease questionnaire(GerdQ)score,traditional Chinese medi-cine(TCM)syndrome score,endoscopic mucosal grading,and Pittsburgh sleep quality index(PSQI)score.The esophageal ki-netic index including esophageal contraction amplitude,peristaltic wave amplitude,as well as serum gastrointestinal hormones melatonin(MLT),gastrin(GAS),vasoactive peptide(VIP),serum calcitonin gene-related peptide(CGRP),substance P(SP),and 5-hydroxytryptamine(5-HT)]were assessed in the two groups before and after treatment.Results The total ef-fective rate in the treatment group was better than that of the control group(97.2%[70/72]vs 87.5%[63/72],P<0.05).After treatment,the scores of GerdQ,TCM syndrome and PSQI score in the two groups were significantly lower(P<0.05),and the decrease in the treatment group was more significant(P<0.05).After treatment,the mucosal grading in the two groups was significantly improved(P<0.05),and the improvement in the treatment group was more obvious(P<0.05).The esophageal contraction amplitude and peristaltic wave amplitude in the two groups were significantly higher(P<0.05),and the increase in the treatment group was more obvious(P<0.05).Significantly increased GAS,MLT(P<0.05)and significantly decreased VIP(P<0.05)were detected in the two groups after treatment.The treatment group was superior to the control group in GAS,MLT,VIP(all P<0.05).CGRP,SP,5-HT in the two groups were significantly lower(P<0.05),and the decrease in the treatment group was more obvious(P<0.05).Conclusion For GERD patients with cold and heat miscellaneous type,Wumei Pills can relieve symptoms,improve sleep quality,reduce visceral sensitivity,and improve gastrointestinal hormone levels.