Study On The Regularity Of Diagnosis And Treatment Of Helicobacter Pylori Infection-related Diseases Treated By Traditional Chinese Medicine Based On The Theory Of Supporting Healthy Qi And Eliminating Pathogenic Evils

Background: So far,helicobacter pylori is recognized as the only microbial species that can survive in human stomach,infecting more than 50% of the global population.It is an important factor causing gastritis,peptic ulcer,gastric cancer and other gastrointestinal diseases,and is related to unexplained iron deficiency anemia,idiopathic thrombocytopenic purpura,diabetes,chronic urticaria and other gastrointestinal diseases,so anti-Hp treatment has long been a consensus.In China,as a developing country,there is a high incidence of Hp infection and gastric cancer,two of which are closely related and harmful to each other,and their treatment is the most concerned problem for gastroenterologists.At present,the quadruple therapy of proton pump inhibitor and secret agent combined with two kinds of antibiotics is often used in clinic,but with the non-standard use and abuse of antibiotics,the bacterial resistance rate increases,the Hp eradication rate decreases,the recurrence rate increases,and the adverse reactions are obvious.Effective treatment faces challenges.As a new way to treat Hp,Traditional Chinese medicine(abbreviated as TCM)has the characteristics of small adverse reactions,low drug resistance rate,not easy to cause intestinal flora imbalance and so on.Combined use of traditional Chinese medicine and western medicine can improve the eradication rate,reduce side effects and the use of antibiotics,protect gastric mucosa,the role traditional Chinese medicine played in the treatment of Hp has been gradually recognize.However,no comprehensive evidence has been found based on either TCM theory or laboratory experiment.Objective:1.To systematically reviewed the literature of traditional Chinese medicine on the treatment of Hp infection-related diseases,comprehensively synthesized the currently available evidence,and extracted the treatment ideas of supporting healthy qi and eliminating pathogenic factors.2.Combined with medical records and retrospective cohort study to integrate the application of supporting healthy qi and eliminating pathogenic evils,with corresponding formulas listed and clinical efficacy evaluated,then optimized the prevention and treatment of Hp infection with TCM.3.With the support of the existing evidence,the mechanism and the regularity of diagnosis and treatment of traditional Chinese medicine in the prevention and treatment of Hp were further revealed,so as to provide evidence support for the advantages and precision treatment of TCM in the intervention of Hp infection.Methods:1.Literature review and evaluationFor the first part,we systematically searched the Chinese and English databases,and at the same time supplemented the literature on the intervention of traditional Chinese medicine on Hp infection-related diseases through included references,grey literature,medical maitong and so on.Seven researchers conducted literature screening and information extraction individually,strictly sticking to the criteria,and then solved the problems encountered during the study together through discussing or resorting to a third party.The methodology quality of the included system evaluation/Meta analysis was evaluated using AMSTAR2 tool,and the reliability of outcome indicators and quality of evidence were further graded according the GRADE system.2.Clinical verification.In the second part,we verified the literature research results through effective medical records and clinical retrospective study,and systematically analyzed the the regularity of diagnosis and treatment of Hp infection-related disease treated by TCM with the help of Ancient and Modern Consilia cloud platform.Based on the existing medical data in the real clinical environment,a retrospective cohort study of TCM combined with quadruple therapy in the treatment of Hp infection-related diseases was conducted to evaluate the practical efficacy and safety of TCM,and to provide realistic,applicable and timely evidence support for the intervention of Hp infection-related diseases by traditional Chinese medicine.Results:1.In the part of evidence map and theoretical discussion,a total of 26661 articles were initially obtained from 8 Chinese and English databases,16461 articles were obtained after automatic check,and finally 3563 articles were included in the analysis,of which 3460 were about clinical studies,82 were about systematic reviews / Meta analysis,and 21 were about guidelines and path studies.(1)Clinical studies were mainly randomized controlled trials(80.72%),and the scale of studies was mostly between 60 and 100 cases.Observational studies(7.63%)mainly focus on the correlation between Hp infection and TCM syndrome types,and the distribution characteristics of TCM syndrome types of Hp infection related diseases,but there are relatively few studies on correlation between Hp infection and physique types(0.55%).(2)Consistent with the view of modern medicine on the treatment of certain people infected with Hp,there are relatively few studies on traditional Chinese medicine aiming at children(< 14 years old)and the elderly(> 70 years old).(3)Its necessary to note that Traditional Chinese medicine is often used in combination with western medicine,and are used alone in relatively few cases.Classic formulas such as Banxia Xiexin decoction,Huanglian Wendan decoction,Huangqi Jianzhong decoction and Liujunzi decoction are widely used in diseases related to Hp infection.(4)The clinical research of the above decoction focused on the aspects ofnegative conversion of Hp,improvement of clinical symptoms,pathological efficacy and safety of gastroscopy,etc,but there are relatively few TCM syndrome efficacy indexes related to the level of TCM syndrome differentiation and treatment.The results from systematic review and Meta analysis re-evaluation of 76 articles about TCM intervention of Hp-related diseases show that although most of the conclusions believed that TCM has potential curative effect,affected by the quality of the original research methodology,the evidence quality is uneven and the high-quality evidence is less,so it is difficult to draw a definite conclusion.China has successively promulgated five consensus opinions or guidelines on the diagnosis and treatment of Hp,which provides a direction for the treatment of Hp.In 2012,the fourth national consensus on the diagnosis and treatment of Hp infection suggested that traditional Chinese medicine can be used in the treatment of Hp infection.TCM has become a new path of Hp treatment because of its unique advantages.In 2018,the release of the “National Consensus for the Treatment of Disease-Syndrome Related to Helicobacter Pylori Based on Integrative Traditional Chinese Medicine and Western Medicine”provides a Chinese idea for refractory Hp infection.By systematically combing the relevant evidence currently available,in general,Hp is the pathogenic factor of dampness heat,and its infection is closely related to spleen and stomach weakness and internal invasion of evil toxin leading to deficient healthy qi but excessive pathogenic evils,which is the basic pathogenesis of Hp-related diseases.Therefore the treatment principle lies in supporting healthy qi and eliminating pathogenic evils,the Hp-related diseases should be treated by invigorating the spleen and replenishing qi to support healthy qi,clearing heat and dispelling dampness to dispel evil,and eradicating Hp.2.In the part of Overviews,A total of 256 articles on systematic review / Meta analysis of the TCM treatment of Hp-related diseases were retrieved from 8 Chinese and English databases,and finally 40 articles were included to evaluate the evidence quality of the outcome indexes according to different intervention methods of supporting healthy qi,eliminating pathogenic evils,and strengthening qi and clearing damp.Among these 40 articles,7 of which focused on supporting healthy qi with such commonly used formulas as Huangqi Jianzhong decoction,Xiangsha Liujunzi decoction and Xiangsha Yangwei pills.17 of which focused on eliminating pathogenic evils by methods of opening and descending with pungent and bitter herbal medicines,clearing heat and damp to eradicate Hp.Formulas referred in these articles include Banxia Xiexin decoction,Zuojin Pill and Huanglian Wendan decoction are commonly used.16 of which focused on both supporting healthy qi and eliminating pathogenic evils with such formulas as Weifuchun,Jinghua Weikang,Chaihu Shugan Powder.Since 2012,the systematic evaluation of TCM anti-Hp has increased year by year.The rate of Hp eradication(negative,clearance),total effective rate,gastroscopic pathological effect and the incidence of adverse reactions are the main observation indicators,but affected by the whole process of systematic review,the methodological quality is "very low",the evidence quality is medium,low or very low,short of highquality evidence.3.The part of consilia analysis: A total of 158 medical records were detected on the Ancient and Modern Consilia cloud platform,including 72 medical records and 177 diagnoses,involving 45 formulas and 241 herbal medicines.Among all the herbal medicines,heat-clearing herbal medicines are the first commonly used,such as liquorice root,golden thread,largehead atractylodes rhizome,indian bread,dried tangerine peel,tangshen,and dandalion.While qi-regulating and deficiency-tonifying herbal medicines come second.Based on treatment principles of opening and descending,warming and cooling,and tonifying and purging,modifying along with the variation of disease and syndromes,applied herbal medicines with nature of warm,plain and cold,taste of bitter,sweet and pungent,and meridian tropism of liver,spleen,lung,to produce the efficacy of tonifying spleen qi to support healthy qi,clearing heat and removing toxin to eliminate pathogenic evils,activating qi,eliminating dampness and food retention to restore the functions of spleen.Complex network analysis shows that the core formulas of TCM anti-Hp are Shaoyao Gancao decoction and modified Liujunzi decoction.4.The part of clinical retrospective study:(1)A total of 283 patients with Hp infection were included,among which 114 were treated with traditional Chinese medicine combined with quadruple therapy(exposure group)and 169 were treated with quadruple therapy alone.The negative conversion rate of Hp in exposure group was80.7%(92/114),and that in non-exposure group was 69.8%(118/169).The difference was statistically significant(P < 0.05).According to the course of treatment of eradication drugs,they were divided into 5 groups: 7,10,14,14-42 days and more than42 days.The analysis showed that there was no statistical difference between groups of different courses and Hp eradication(P=0.84).Of the 283 patients,10 were reexamined after Hp eradication in between 3 months and 2 years,including 2 in the exposure group and 8 in the non-exposure group.Except for 1 case in the exposure group who was positive for breath test after 2 years,others were all tested negative.And 3 cases who were repeatedly eradicated for 3 times,the efficacy of repeated eradication therapy may be related to antibiotic resistance.(2)The analysis of the data of herbal medicines application in 111 cases of 96 patients showed that 268 kinds of herbal medicines were used among 1437 times of herbal medicines application.The commonly used herbal medicines were liquorice root,pinellia tuber,tangshen,indian bread,and largehead atractylodes rhiziomes.252 kinds of herbal medicines can be classified into three types according to actions,which are heat-clearing medicines occupying first place,then phlegm-resolving and deficiency-tonifying medicines coming second.Most of herbal medicines were warm,plain and mild cold in nature,sweet,pungent and bitter in taste,with meridian tropisms of spleen,stomach and lung.The core formula was modified Liujunzi and huangqin decoctions.Conclusion: Hp belongs to damp-heat evil qi in traditional Chinese medicine,and its infection is closely related to weakness of spleen and stomach of the host and the pathogenicity of Hp.Based on basic treatment principles of supporting healthy qi and eliminating pathogenic evils,TCM plays a therapeutic role in the initial treatment,remedial treatment and post-eradication of Hp infection.Combined with the specific situation of the patient,treated Hp-related diseases through invigorating spleen and harmonizing stomach,tonifying qi and blood to support healthy qi,or clearing heat and removing toxin and dampness to eliminate pathogenic evils,or sometimes supporting healthy qi and eliminating pathogenic evils simultaneously.The ideas of supporting healthy qi combined with eliminating pathogenic evils has become a new path and strategy for the eradication of Hp.Treatment of TCM alone or combined with western medicine can improve the negative conversion rate,relieve clinical symptoms to benefit patients.