A Randomized Controlled Clinical Study Of Qingre Huashi Decoction Combined With Triple Therapy To Eradicate Helicobacter Pylori Infection

Helicobacter pylori(HP)is the main pathogen of upper digestive tract diseases.Western medicine is currently facing many difficulties in treating HP infections.On the one hand,the increase in HP resistance leads to a decrease in the eradication rate.On the other hand,the adverse effects of HP treatment drugs affect patient compliance.Chinese medicine treatment of HP is an individualized treatment based on the symptoms of patients.It can change the living environment of HP,affect its adhesion and colonization,and can also adjust the internal environment of the human body to improve its own resistance.The advantage of group can reduce the adverse reaction and HP recurrence rate.In recent years,many scholars have explored the relationship between HP infection and spleen-stomach damp-heat syndrome from the perspective of experimental research and clinical application,and found that there is a close relationship between the two,and Chinese medicine and integrated traditional Chinese and western medicine have better therapeutic effects.Early experimental research by our team found that Qingre Huashi Recipe can significantly improve gastric mucosal inflammation in HP-infected mice,and has antibacterial effects on HP standard strains and drug-resistant strains in vitro.ObjectiveTaking bismuth quadruple therapy as a control,observe the HP eradication rate,clinical symptom improvement and adverse reactions of patients with HP infection(spleen and stomach damp heat syndrome)treated by Qingre Huashi Recipe combined with triple therapy,and evaluate the treatment of HP infection by Qingre Huashi Recipe combined with triple therapy effectiveness and safety.MethodsPatients of HP infection with Spleen-Stomach Damp-Heat Syndrome in the Department of Gastroenterology and Integrated Traditional Chinese and Western Medicine of Peking University First Hospital from January 2019 to February 2020 were selected,and a parallel randomized control design was adopted.The patients were randomized into the observation group(esmeprazole+amoxicillin+clarithromycin+Qingre Huashi Recipe),control group(esmeprazole+amoxicillin+clarithromycin+bismuth),The course of treatment was 14 days,and the efficacy and safety of Qingre Huashi Recipe combined with triple therapy were evaluated by taking the eradication rate of HP and the improvement of gastrointestinal symptoms as efficacy indicators and the incidence of adverse reactions as safety indicators.ResultsHP eradication rate:The HP eradication rates in the observation group and the control group were 83.64%(46/55)and 83.64%(46/55)in on-treatment analysis,respectively,and per-protocol analysis was 86.54%(45/52),87.23%(41/47),P>0.05.In terms of symptom scores,there was a statistically significant difference in the total score of symptoms between the observation group and the control group before and after treatment(P<0.001).Comparing between the groups,the difference of the total score of symptoms before and after treatment was statistically significant(P<0.05),and the overall effect of the observation group was better than that of the control group.In terms of single symptoms,the observation group had dry mouth,poor stools,dry stools,fatigue,shortness of breath,and yellow urine.In terms of symptom improvement rate,the overall symptom improvement rate in the observation group(75.09%)was higher than the control group(64.90%).Symptoms in the observation group such as vomiting,poor stools,dry stools,shortness of breath,and yellow urine were higher than those in the control group.In terms of safety:the incidences of adverse reactions in the observation group and the control group were(5.45%,3/55)and(17.36%,10/55),P<0.05.ConclusionFor patients with spleen and stomach damp heat syndrome,the HP eradication rate of Qingre Huashi Recipe combined triple therapy and bismuth quadruple therapy is equivalent.In terms of the improvement of overall symptoms and some symptoms,Qingre Huashi Recipe combined triple therapy is more advantageous and adverse reactions also less than bismuth quadruple.Qingre Huashi Recipe combined with triple therapy is effective for the treatment of HP,and the medication is safer,especially for those who are intolerant to bismuth or have contraindications to bismuth.