Objective To investigate the therapeutic efficacy of Shenling Weixiao Capsules combined with Omeprazole Enteric-Coated Capsules in treating patients with reflux laryngitis of spleen deficiency and qi stagnation type,and to observe their effects on clinical presentation of reflux and gastric hormones.Methods A total of 160 patients with reflux laryngitis of spleen deficiency and qi stagnation type treated at Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine from September 2021 to June 2024 were randomly divided into a control group and an observation group using a random number table,with 80 cases in each group.The control group received oral use of Omeprazole Enteric-Coated Capsules alone,while the observation group was given additional Shenling Weixiao Capsules orally.Both groups were treated for 8 weeks.Changes in traditional Chinese medicine(TCM)syndrome scores,reflux parameters of reflux symptom index(RSI)and reflux finding score(RFS),gastric hormone levels of gastrin(GAS),motilin(MTL)and pepsin,and lower esophageal sphincter pressure(LESP)in the two groups were observed before and after treatment.After treatment,the clinical efficacy and adverse reaction rates were compared between groups.Results(1)After 8 weeks of treatment,the total effective rate was 90.00%(72/80)in the observation group versus 76.25%(61/80)in the control group.The intergroup comparison(tested by chi-square test)showed that the efficacy of the observation group was significantly superior to that of the control group(P＜0.05).(2)Both groups showed significant reductions in the scores of TCM symptoms of sore throat,belching,poor appetite or anorexia,and retrosternal or epigastric burning sensation compared to the baseline scores(P＜0.05).And the observation group exhibited markedly greater reductions than the control group(P＜0.01).(3)Both groups demonstrated decreased RSI and RFS after treatment(P＜0.05),and the decrease of RSI and RFS in the observation group was more obvious than the control group(P＜0.01).(4)After treatment,gastrin(GAS)and motilin(MTL)levels were increased(P＜0.05)while pepsin level was decreased(P＜0.05)in both groups compared to those before treatment,and the observation group had higher GAS and MTL levels and lower pepsin level than the control group(P＜0.01).(5)For lower esophageal sphincter pressure(LESP),both groups exhibited progressive increases at 4 and 8 weeks of treatment compared to the baseline level(P＜0.05),and LESP was elevated at 8 weeks of treatment versus at 4 weeks of treatment(P＜0.05).Intergroup comparisons revealed consistently high LESP in the observation group at both timepoints compared to that in the control group(P＜0.01).(6)The incidence was 7.50%(6/80)in the observation group versus 13.75%(11/80)in the control group,showing no statistically significant difference(P＞0.05).Conclusion Shenling Weixiao Capsules combined with Omeprazole Enteric-Coated Capsules are effective on improving TCM syndromes,enhancing gastrointestinal function,and alleviating reflux symptoms,demonstrating significant efficacy and good safety profile in the treatment of patients with reflux laryngitis of spleen deficiency and qi stagnation type.