Clinical Observation Of Qiqinwubei Decoction Combined With Rabeprazole In Treating Gastroesophageal Reflux Disease With Spleen Deficiency And Damp-heat

Objective:The aim is to compare and analyze the curative effect of Qiqinwubei Decoction,which self-made by Professor Shan Zhaowei,combined with rabeprazole on Gastroesophageal Reflux Disease(GERD)with Spleen Deficiency and Dampness-heat Syndrome,in order to explore the optimal treatment plan which improves the clinical cure rate and reduces the recurrence rate.Methods:Ninety subjects who met the inclusion criteria were randomly included in the western medicine group,traditional Chinese medicine(TCM)group,and combination group,with 30 patients in each.The three groups were treated with rabeprazole sodium enteric-coated tablets,Qiqinwubei Decoction addition and subtraction,and rabeprazole sodium enteric-coated tablets plus Qiqinwubei Decoction addition and subtraction,respectively,for a total of 8 weeks.The efficacy was evaluated based on the changes in the total scores of the reflux diagnostic questionnaire(RDQ)and the symptom total scores before and after treatment.The patients were also followed up for 4 weeks after withdrawal and the total RDQ scores were calculated to evaluate the recurrence of the three groups.It can be regarded as relapse if the total RDQ score at 4 weeks after withdrawal is higher than that at the end of treatment and is larger than 12.Result:1.The total score of RDQ:After 2 weeks of treatment,the score of the TCM group dropped the least(P<0.01).At the end of treatment,the combination group had the lowest score while the western medicine group had the highest score(P<0.05).After 4 weeks of withdrawal,the score of the western medicine group was higher than that at the end of treatment(P<0.05).The scores of the other two groups were unchanged(P>0.05).The score of the combination group was lower than that of the TCM group(P<0.05).2.TCM symptom scores:① In terms of total scores for major symptoms,for secondary symptoms,and for TCM symptoms:After 2 weeks of treatment,the combination group improved most significantly(P<0.01),followed by the western medicine group.When the treatment process completed,the combination group got the most reduction while the western medicine group got the least(P<0.05).After 4 weeks of drug withdrawal,the total scores in the western medicine group all increased compared with those at the end of treatment(P<0.05)and were higher than those in other two groups(P<0.01).The total scores of the main symptoms and of TCM symptoms in the combination group were lower than those of the TCM group(P<0.01).②In terms of individual symptoms:The improvement of symptoms such as acid reflux,epigastric burning,chest tightness,and anorexia symptom in the western medicine group was better than that in the TCM group(P<0.01).At the end of the course,the improvement of various symptoms in the TCM group is no less than that in the western medicine group,where tiredness and stagnation of stool did not improve(P>0.05).Withdrawal for 4 weeks compared to end of treatment,the symptoms of acid reflux and epigastric burning in the western medicine group were significantly worsened(P<0.01),and the other symptoms were heavier than those in the other two groups(P<0.01).3.Efficacy evaluation of TCM syndromes:At the end of treatment,the total effective rates were the western medicine group 73.33%,TCM group 93.33%and the combination group 96.67%.The efficacy of the western medicine group was not as good as that of TCM group and the combination group(P<0.05).There was no difference in the total effective rates of the TCM group and the combination group(P>0.05).4.Evaluation of long-term efficacy:The recurrence rates of the three groups after 4 weeks of withdrawal showed significant differences,with 36.67%in the western medicine group,10.00%in TCM group,and 3.33%in the combination group.The recurrence rate of the western medicine group was significantly higher than that of TCM group and the combination group(P<0.05).There was no significant difference in the recurrence rate of TCM group and the combination group(P>0.05).Conclusion:Qiqinwubei Decoction combined with rabeprazole is effective in the treatment of GERD with Spleen Deficiency and Dampness-heat Syndrome.It is better than single TCM or western medicine alone in reducing total RDQ scores and improving TCM symptoms.The combined medicine is safe and stable with good long-term effects.TCM group is equivalent to the combination group in terms of total effective rate and long-term efficacy.The western medicine group could not relieve patients with GERD for sickness and fatigue and stagnation of stool,however,it is faster than TCM group in improving post-prandial acid reflux,epigastric burning pain,chest tightness,anorexia and other symptoms in the short-term.However,at the end of the course of treatment,the western medicine group is worse than TCM group in improving the individual symptoms of TCM and reducing the total RDQ score.For the western medicine group,the total effective rate of treatment is lower than that of TCM group,and the recurrence rate after stopping the medicine is higher.