| Objectives:1.To evaluate the clinical efficacy and safety of traditional Chinese medicine combined with acupoint catgut embedding therapy in interfering life quality of patients with refractory gastroesophageal reflux disease(rGERD).2.The life quality of rGERD patients was assessed and analyzed by the Medical Outcomes Study 36-Item Short-Form Health Survey(SF-36).Methods:A randomized controlled clinical study was conducted,which selected 60 rGERD patients diagnosed in the outpatient and ward of the Department of Spleen and Stomach Disease,Wangjing Hospital,Chinese Academy of Traditional Chinese Medicine from Oct.2016 to Jun.2018.All 60 subjects were followed without any quitting.The experimental group was given(1)health education,(2)Chinese medicine formula granules,one dose a day;dividing into equal two after resolving it in 300 ml boiling water;150 ml each time for the morning and evening before meals,(3)Catgut embedding at acupoints:after routine disinfection,No.3/0 Catgut were embedded by injecting with No.7 sterile needle.After operation,iodophor was used to disinfect puncture points once a week.(4)40mg bid po Pantoprazole Sodium Enteric-coated Capsule for the morning and evening before meals.The control group was given(1)health education.(2)40mg bid po Pantoprazole Sodium Enteric-coated Capsule for the morning and evening before meals.Setting seven days as a course of treatment,the observation period was a total of four courses of treatment,or say 28 days.The scores of TCM syndromes,western medicine symptoms,reflux diagnostic questionnaire(RDQ),SF-36 scale and safety indexes were collected and evaluated before,during(the 2nd week)and after treatment(the 4th week).Statistical analysis was carried out by SPSS20.0 software.The statistical significance of this study was based on bilateral tests and P<0.05 was the criterion to judge the significant difference.Result:1.Among 60 rGERD patients,the youngest was 25 years old while the oldest was 70 years old.Patients aged 60-70 years old accounted for 35%of the total,followed by 50-59 years,which indicated that rGERD is more common in middle-aged and elderly people,and the rGERD incidence tended to increase along with age.2.In view of the symptom scores,there was no significant difference in the frequency of post-sternal pain and fecal dilution P>0.05 before and after treatment in the treatment group.The degree of post-sternal pain,acid reflux,reflux frequency,reflux degree,heartburn frequency and degree,acid reflux frequency,chest and epigastric discomfort,acid reflux with vomit,vague epigastralgea with warmth preference,fasting stomach pain,anorexia,fatigue,cold hand foot were significantly improved compared with those before treatment There was no significant difference in the degree of heartburn,sternal pain frequency and degree,acid regurgitation frequency,food regurgitation frequency,vague epigastralgea with warmth preference,fasting stomach pain,fecal dilution and cold hand foot before and after treatment in the control group P>0.05.However,Significant improvements had been showed in heartburn frequency,acid reflux degree,food reflux degree,sternum and epigastric discomfort,acid reflux with vomit,appetite loss and fatigue after treatment in the control group.Compared with the control group,there was no significant difference in the improvement of the frequency of post-sternal pain,sternal pain degree,acid reflux degree,food reflux frequency and degree in the treatment group P>0.05.Heartburn frequency and degree,acid reflux frequency,sternum and epigastric discomfort,acid reflux with vomit,vague epigastralgea with warmth preference,fasting stomach pain,appetite loss,fatigue,cold hand foot were all significantly improved in the treatment group,which suggested that in terms of improving the clinical symptoms of refractory gastroesophageal reflux disease,the heartburn frequency and degree,acid regurgitation frequency,sternum and stomach discomfort,acid regurgitation with vomit,vague epigastralgea with warmth preference,fasting stomach pain,appetite loss,fatigue,and cold hand foot improved improved better in the treatment group compared with the control group.The symptoms scores of both groups decreased after treatment.There were significant differences between the two groups before and after treatment,indicating that both treatment schemes were effective,and the efficacy in treatment group was better than that in the control group.3.In terms of SF-36 score,both treatment methods are effective in improving the life quality of patients,and the score of treatment group is slightly better than that of control group,however,without statistical significance.In view of 8 dimensions of SF-36:Physiological function(PF),role of physiology(RP),body pain(BP),role of emotion(RE),mental health(MH),general health(GH),vitality(VT),social function(SF),statistical analysis showed that PF,RP,BP,GH,VT,SF,RE,MH had been significantly improved in the experimental group after treatment.The differences were statistically significant.There were significant differences in PF,RP and GH in the control group,but no significant difference in other dimensions,suggesting that the control group improved significantly in physiological function,role of physiology,and overall health after treatment.7.Safety evaluation:Before and after treatment,no abnormal changes in safety examination indexes of 60 patients,including blood pressure,pulse,breathing,body temperature,blood,urine,stool and occult indexes,liver function(AST,ALT),renal function(BUN,CRE)and electrocardiogram occurred and treatment did not put any negative effects on basic diseases,which demonstrated the treatment is safe and effective.Conclusion:In this study,60 rGERD patients were observed in clinic.It was demonstrated that Xinkaikujiang therapy combined with acupoint catgut embedding could significantly improve all the clinical symptoms of rGERD patients,especially the main symptoms such as acid reflux,heartburn,cold hand foot and vague epigastralgea with warmth preference etc with less side effects,which was acceptable for the patients.Its treatment principle is to relieve bitterness and acidness,calm cold and heat,combining with long-lasting and benign stimulation of acupoints,make the spleen ascend and stomach descend,calm cold and heat,and relieve liver-qi,which laied a clinical foundation for the theory of "regulating pivot and deredging stomach".With further observation and analysis,both the clinical schemes have certain effects in improving their mental state and life quality of rGERD patients.The results objectively evaluated the clinical efficacy of traditional Chinese medicine combined with acupoint catgut embedding therapy under the guidance of Xinkai Kujiang therapy in the treatment of refractory gastroesophageal reflux disease,which showed good safety and no adverse events as well as side effects,derserving clinical promotion and further research. |
PDF Full Text Request