| ObjectiveIn the clinical trial part of this study,in order to observe the therapeutic effect of acupuncture on symptoms such as heartburn and quality of life in patients with gastroesophageal reflux disease(GERD),and analyze the correlation between heartburn and GERD health-related quality of life,acupuncturing the acupoints and non-acupoints below the spinous processes from T3～T12 on the dorsal segment of Du Meridian with filiform needles were compared with taking Omeprazole Enteric-coated Capsules according to the prescribed dosage.The part of clinical investigation was expanded to 130cases based on the 60 patients in the clinical trial,130 questionnaires were distributed to find out the characteristics of the GERD heartburn episodes and the patients’ awareness of it.And to differentiate the cold and heat syndrome of "heartburn" combined with the secondary symptoms before treatment.Thereby deepening the understanding of gastroesophageal reflux disease,providing the scientific basis for early diagnosis,treatment and health education of GERD.MethodsIn the clinical trial part,60 patients with GERD whose chief complaint is heartburn at the Beijing Guangji Hospital of Traditional Chinese Medicine from January 2017 to May 2018 were randomly selected and divided into acupuncture and medicine group according to the random number table method,30 cases in each group.For acupuncture group,to acupuncture the points below the spinous processes from T3～T12 on the dorsal segment of Du Meridian,including acupoints[Shenzhu(GV12),Shendao(GV11),Lingtai(GV10),Zhiyang(GV9),Jinsuo(GV8),Zhongshu(GV7),Jizhong(GV6)]and non-acupoints(T4,Ts,T,2).Treated 3 times a week.Patients of medicine group take Omeprazole Enteric-coated Capsules,twice a day,20mg/granule each time,take it before breakfast for the first time and before going to bed for the second time.Both groups were treated for 8 weeks.To differentiate the cold and heat syndrome before treatment,the therapeutic effect was accessed by the Reflux Disease Diagnostic Questionnaire(RDQ)and the Health-Related Quality of Life Scale for Gastroesophageal Reflux Disease(GERD-HRQL),and the correlation between the main symptoms of GERD and the health-related quality of life was analyzed.In the part of clinical investigation,130 patients(including the 60 cases in clinical trials)who met the inclusion criteria at the same hospital and same time period were selected as objects to release the questionnaires,in order to summarize the symptom characteristics of "heartburn",and find out the patients’ awareness of it,the main contents of the questionnaire include the general condition of the patient,the performance of "heartburn" symptoms,the understanding of"heartburn" of GERD patients,related signs and other symptoms,etc.Results1.Comparison of RDQ scores before and after treatment between the two groups:The difference of the RDQ scores between the two groups before treatment was not statistically significant(P>0.05),which was comparable.The RDQ scores of both groups were significantly lower after treatment(P<0.01).To compare the difference value of before and after treatment between the two groups,the RDQ score of the acupuncture group was significantly lower than that of the medicine group(P<0.05).2.Comparison of the therapeutic effect of RDQ scores before and after treatment between the two groups:7 cases were cured in the acupuncture group,12 cases were markedly effective;4 cases were cured in the western medicine group,and 4 cases were markedly effective.One patient was aggravated in the medicine group,and the acupuncture group had no worsening.The markedly effective rate was calculated by the number of cured and markedly effective patients,the markedly effective rate of RDQ scores of the acupuncture group and the medicine group were 63.33%and 26.67%,respectively.The curative effect of acupuncture group was significantly better than the medicine group(P<0.01).3.Comparison of symptom scores in RDQ before and after treatment:There was no significant difference in the scores of heartburn,acid and food regurgitation between the two groups before treatment(P>0.05),which was comparable.And there were significant differences in the scores of chest pain between the two groups before treatment(P<0.05),not comparable,had no inter-group comparison.After treatment,the scores of the four major symptoms for both the two groups were significantly lower(P<0.01).To compare the difference value of before and after treatment between the two groups,only the score of"heartburn" was significantly lower(P<0.01),compared with the medicine group.4.Comparison of GERD-HRQL scores before and after treatment between the two groups:There was no significant difference in the scores of GERD-HRQL between the two groups before treatment(P>0.05),which was comparable.After treatment,the GERD-HRQL scores of both groups were significantly lower(P<0.01).To compare the difference value of before and after treatment between the two groups,the score of GERD-HRQL was significantly lower after treatment in the acupuncture group(P<0.01),compared with the medicine group.5.Comparison of the therapeutic effect of GERD-HRQL scores before and after treatment between the two groups:The number of the cured,markedly effective,effective patients in the acupuncture group was 4,19 and 6 respectively.The number of the cured,markedly effective,effective patients in the western medicine group was 3,1 and 12 respectively.The effective rate was calculated by the number of cured,markedly effective and effective patients,the effective rate of the GERD-HRQL scores of the acupuncture group and the medicine group was 100%and 53.33%,respectively.The effective rate of the acupuncture group was significantly higher than that of the medicine group(P<0.01).6.Comparison of satisfaction rate of the health-related quality of life between the two groups:After treatment,there were 23 patients satisfied with health-related quality of life in the acupuncture group and 4 patients in the medicine group;The satisfaction rates of GERD-HRQL in the acupuncture group and the medicine group were 76.67%and 13.33%,respectively.The satisfaction rate of the acupuncture group was significantly higher than that of the western medicine group(P<0.01).7.Correlation between the main symptoms such as heartburn and health-related quality of life in two groups:RDQ scores and GERD-HRQL scores of 60 patients showed a linear trend,and the correlation coefficient between them was r=0.491,P<0.001,the difference was statistically significant.It shows that the RDQ scores has a linear correlation with the GERD-HRQL scores and the correlation is positively correlated.The correlation coefficients of chest pain,acid regurgitation,heartburn,food regurgitation scores and RDQ scores in 60 patients with GERD were 0.570,0.688,0.274,and 0.630,respectively.And all of it were positively correlated(P<0.05).The correlation coefficients of chest pain,acid regurgitation,heartburn scores and GERD-HRQL scores were 0.321,0.333,and 0.505,respectively,which were positively correlated(P<0.05).However,there is no correlation between the food regurgitation and GERD-HRQL scores(P>0.05).Among the four major symptoms,the correlation coefficient between heartburn and GERD-HRQL scores was largest,and there was a significant positive correlation of them(P<0.001).8.The patient’s cognition of the specific feeling of "heartburn":When the GERD patients with heartburn as the main complaint describing the specific feeling of "heartburn",the words"burning","feverish","heat","pungency","hot","Spicy","burning like fire","burning pain","irritation","smarts","scald","hot water flowing","boiling water flowing",chili irritating","needle sticking","liquor stimulation","alkaline water stimulation","salt stimulation","vinegar stimulation","scratch",etc.To categorize the words with the same or similar meaning,"burning/feverish","heat" and "pungency/hot/spicy"were accounted for the highest proportion,55.83%,22.67%and 18.33%,respectively.9.The patient’s cognition of where the "heartburn" should occur:120 GERD patients with the "heartburn" as the chief complaint think that the "heartburn"should appear at:below the xiphoid appendix,stomach,retrosternal area,esophagus,throat,precordial area and back.Among them,the occurrence frequency of below the xiphoid appendix,was ranked top,accounting for 57.50%.There were 17 patients who believed that "heartburn" should appear at throat,accounting for only 14.17%.10.120 patient’s cognition of the definition of "heartburn":Among 120 patients with GERD,there were 75 cases who thought their specific performance of "heartburn" was consistent with the medical definition of "heartburn",partly,accounting for 62.50%;38 cases were fully consistent with the medical definition of "heartburn",accounting for 31.67%;5 cases were completely inconsistent with the medical definition of "heartburn",accounting for 4.17%.Another 2 patients(1.67%)were uncertain.The cognitive correct rate was calculated by the number of patients who were fully consistent with the medical definition of"heartburn",38 patients were able to recognize the concept of "heartburn" correctly,accounting for 31.67%.11.Comparison of the locations where the "heartburn" occurred actually with the locations that the patients considered should occur in 120 GERD patients:The locations where the 120 patients actually feel burning are:below the xiphoid appendix,stomach,retrosternal area,esophagus,throat,precordial area,back,hypogastrium,head and face,oral cavity,nasal cavity,ears,the palms and soles,lumbosacral portion,hypochondrium,and whole body.The burning sensation at the esophagus ranked top,with 89 cases,accounting for 74.17%.Except the locations where the patients thought "heartburn" should occur,the locations where the "heartburn"occurred actually added hypogastrium,head and face,oral cavity,nasal cavity,ears,the palms and soles,lumbosacral portion,hypochondrium,and whole body.At the esophagus,retrosternal area,throat,oral cavity,back,nasal cavity,whole body,the palms and soles and hypogastrium,the frequency ratios of the locations where the patients considered "heartburn" should occur and the locations where the patients feel burning actually are significant difference(P<0.05).12.Changes in the location of "heartburn" in 120 patients during the course of the disease:Among the 120 patients,75 patients whose locations where the "heartburn"occurred actually did not change,accounting for 62.50%of the total number;44 patients occasionally changed,accounting for 36.67%;1 patient changed frequently,accounting for 0.83%of the all patients.13.The frequency statistics of "heartburn" in 120 patients:Among the 120 GERD patients with "heartburn" as the chief complaint,the number of people who have "heartburn"every day is the most,71 cases in total,accounting for 59.17%;Most patients who have"heartburn" 1 or 2 times a day,52 cases in total,accounting for 43.33%.14.The duration time of "heartburn" in 120 GERD patients:Among the 120 GERD patients with heartburn,the number of patient whose duration of heartburn less than 1 hour was the most,43 cases in total,accounting for 35.83%;The duration of heartburn between 6-12 hours was the least,only 2 cases,accounting for 1.67%;5 patients were uncertain about their duration of heartburn,accounting for 4.17%.15.The body positions cause the "heartburn" to appear or exacerbate:In the 120 GERD patients,body positions that cause "heartburn" to appear or worsen are supine position,right lateral position,sitting position,standing position,stoop,left lateral position and prone position.Among them,62 patients in the supine position appeared heartburn or the heartburn aggravated,accounting for 51.67%of the total;Another 11.67%of patients considered that their own "heartburn" was not related to body position,and 4.17%of patients were unclear about the influence of "body position" on "heartburn".16.The relationship between the occurrence of "heartburn" and eating:a total of 88 patients’ "heartburn" occurred or aggravated after eating,accounting for 73.33%,6 patients considered that the attack or exacerbation of their "heartburn" had nothing to do with eating.17.The period of occurrence and exacerbation of "heartburn":The proportion of"heartburn",occurring or exacerbating in the evening and at night is the highest.39 patients’"heartburn" occurred or aggravated in the evening,accounting for 32.50%;Likewise,39 patients’ "heartburn" appeared or the symptom aggravated at night,and even awakened because of the "heartburn",accounting for 32.50%.18.Factors inducing the occurrence or exacerbation of "heartburn":The clinical investigation found that the factors that cause the "heartburn" to appear or exacerbate are:negative emotions,eating some kind of food,catch a chill,be heated,smoking/drinking/tea drinking,hunger,had overeatened,tired,taking exercise and lack of sleep.Among these factors,the occurrence frequency of the eating some kind of food ranked top,106 cases in total,accounting for 88.33%.19.The "acid reflux" of 120 GERD patients with "heartburn" as the main symptom:Among the 120 GERD patients with "heartburn",99 patients thought they had "acid reflux"symptom,accounting for 82.50%;11 patients thought they did not have "acid reflux",accounting for 9.17%;another 10 patients did not understand the meaning of "acid reflux",8 cases thought they had "acid reflux" symptom after explanation,and 2 cases thought they did not have "acid reflux" after explanation,accounting for 6.67%,1.67%,respectively.That is,a total of 107 patients had both "heartburn" and "acid reflux",accounting for 89.17%of the total number.20.The statistics of cold and heat syndrome in 120 GERD patients with heartburn as the main complaint:Among the 120 heartburn-based GERD patients,60 cases are cold-heat complicated syndrome,accounting for 50%;49 cases are cold syndrome,accounting for 40.83%;Only 11cases are simple heat syndrome,accounting for 9.17%.Conclusion1.The curative effect of acupuncture group(acupuncturing the points and non-points below the spinous processes from T3～T12on the dorsal segment of Du Meridian)on GERD patients with heartburn as the mainly symptom is better than the medicine group,and the improvement to the "heartburn" is the greatest;Thus it can significantly improve the health-related quality of life of GERD patients.Acupuncture has a two-way regulation effect of reducing excess and tonifying deficiency,its curative effect is long-lasting,safe and has no side effects.It is one of the best choices for the treatment of gastroesophageal reflux disease with "heartburn" as the main symptom.2.GERD patients with heartburn have obvious deficiencies in cognition of the specific meaning and the occurrence location of "heartburn",it is necessary to further strengthen the popularization of health and health education;The "heartburn" symptom of gastroesophageal reflux disease are unique,the GERD with heartburn as the chief complaint is mainly composed of cold-heat complicated and cold syndrome,breaking the traditional thinking of treating the "heartburn" with "heat".It should be further studied in depth,and treated it based on syndrome differentiation combined with its characteristics and cold-heat essence,providing the scientific basis for diagnosis and treatment of GERD. |
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