| Part Ⅰ Meta-analysisObjective: This article aims to systematically evaluate randomized controlled trials of traditional Chinese medicine in the treatment of functional dyspepsia using Meta-analysis method,including the analysis of its clinical efficacy,safety and other outcome indicators,so as to provide some guidance for the clinical treatment of functional dyspepsia.Methods: In order to deeply explore the curative effect and mechanism of traditional Chinese medicine in the treatment of functional dyspepsia,we searched Wanfang,China National Knowledge Network Database,China Biomedical Literature Service System,China Clinical Trial Registration Center,Chongqing VIP Chinese Science and Technology Journal Database,Pub Med by computer,Cochrane,Embase,Web of science and other nine major databases,the retrieval time is from the establishment time of each database to December 01,2022.Our goal is to select randomized controlled trial literature,conduct rigorous screening and data extraction on these literature,and evaluate their quality.In the process of screening literature,we had two reviewers independently operate according to the inclusion and exclusion criteria to ensure the accuracy and reliability of the screening results.We plan to use Rev Man 5.4 software and STATA15.0 software to conduct Meta-analysis on these literatures,and compare the differences in clinical efficacy rate,motilin level(MTL),cure rate and other aspects of different treatment methods.Results: A total of 12628 relevant literatures were retrieved,and 18 randomized controlled clinical studies were finally included,with a total of 1562 patients,including 782 cases in the traditional Chinese medicine treatment group and 780 cases in the western medicine control group;the included literatures were all high-quality studies.The results of Meta-analysis showed:(1)Total clinical effective rate:(1)Chinese medicine group VS Western medicine group: RR =1.21,95%CI(1.16,1.26),P=0.000<0.05;(2)Pure Chinese medicine group VS Western medicine group: RR = 1.22,95%CI(1.13,1.30),P=0.000<0.05;(3)Chinese and Western medicine group VS Western medicine group: RR =1.20,95%CI(1.14,1.27),P=0.000<0.05;(2)Clinical cure rate : Chinese medicine group VS Western medicine group: RR =1.77,95%CI(1.49,2.11),P=0.000<0.05;(3)Motilin level(MTL): Chinese medicine group VS Western medicine group: SMD=2.20,95%CI(0.97,3.42),P=0.000<0.05;(4)Somatostatin level(SS): Chinese medicine group VS Western medicine group:SMD=-1.90,95%CI(-2.23,-1.58),P=0.000<0.05;(5)Gastrin level(GAS):Chinese medicine group VS Western medicine group: SMD =-0.80,95%CI(-1.08,-0.52),P=0.000<0.05;(6)Total score of TCM symptoms:Chinese medicine group VS Western medicine group: SMD =-1.57,95%CI(-2.24,-0.90),P=0.000<0.05;(7)Epigastric pain score: Chinese medicine group VS Western medicine group: SMD =-2.07,95%CI(-2.32,-1.83),P=0.000<0.05;(8)Epigastric fullness score: Chinese medicine group VS Western medicine group: SMD =-0.79,95%CI(-0.98,-0.6),P=0.000<0.05;(9)Score for belching and acid reflux: Chinese medicine group VS Western medicine group: SMD =-1.05,95%CI(-1.24,-0.86),P=0.000<0.05;(10)Anorexia score: Chinese medicine group VS Western medicine group: SMD =-1.57,95%CI(-2.47,-0.67),P=0.000<0.05;(11)Nausea and vomiting score: Chinese medicine group VS Western medicine group: SMD =-0.29,95%CI(-0.59,0.00),P=0.053>0.05;(12)Adverse reaction: Chinese medicine group VS Western medicine group: RR =0.47,95%CI(0.22,0.99),P=0.048<0.05;(13)Relapse rate: Chinese medicine group VS Western medicine group: RR =0.28,95%CI(0.11,0.72),P=0.008<0.05.Conclusions:(1)Compared with the western medicine group,the traditional Chinese medicine group has higher clinical efficacy in terms of total effective rate,clinical cure rate,and decrease somatostatin level(SS),gastrin level(GAS),total syndrome score of traditional Chinese medicine,epigastric pain score,epigastric pain score,and epigastric pain score,Fullness score,belching acid reflux score,anorexia score,adverse reactions,and recurrence rate;(2)Compared with the western medicine group,the Chinese medicine group has no advantage in motilin level(MTL)and nausea and vomiting scores.Part Ⅱ Data MiningObjective: To use data mining methods to explore the prescription and medication rules of traditional Chinese medicine in the treatment of functional dyspepsia,to explore new drug combinations and prescriptions,and to provide useful options for the clinical treatment of functional dyspepsia.Methods:(1)Data Mining: Data Collection: Search by computer from the establishment of the database to December 1,2022 in Chinese databases(China Biomedical Literature Service System(CBM),China Journal Full-text Database(CNKI),Wanfang Database(Wanfang),Chongqing VIP Chinese Science and Technology Journal Database(VIP))included randomized controlled clinical literature on the treatment of functional dyspepsia(Functional Dyspepsia,FD)with traditional Chinese medicine.(2)Data preprocessing: According to the inclusion and exclusion criteria,literatures were screened,duplicate literatures were deleted,and 61 literatures were finally included.Excel software was used to conduct descriptive statistics on the composition of drugs and syndrome differentiation,and the methods of association rule analysis,complex system entropy clustering and entropy hierarchical clustering of traditional Chinese medicine inheritance computing platform(V3.0)were used for analysis.result:(1)A total of 64 prescriptions that meet the standards were screened out,and 119 traditional Chinese medicines for treating functional dyspepsia were systematically extracted.Through frequency statistical analysis,the cumulative frequency of drugs was 664,and the frequencies were sorted from high to low.It was found that the frequency of use was ≥ 10 There are 21 traditional Chinese medicines,among which the top five are tangerine peel,Codonopsis pilosula,roasted licorice,white peony root,and Bupleurum,which are the core drugs for the treatment of FD.(2)Among the efficacy of medicines,tonifying drugs were used the most,with a total of 168times;followed by Qi-regulating drugs,126 times,exterior-relieving drugs,51 times,damp-removing drugs,44 times,and heat-clearing drugs,36 times.32 times of diuresis and dampness-removing drugs,30 times of blood-activating and stasis-removing drugs,26 times of phlegm-relieving,cough-relieving and asthma-relieving drugs,14 times of digestion-related drugs,8 times of internal-warming drugs,4 times of tranquilizing drugs,and4 times of astringent drugs,3 times of anthelmintic drugs,3 times of resuscitating drugs,2 times of hemostatic drugs,and 1 time of purgative drugs.(3)Syndrome classification is divided into 6 types,of which there are28 occurrences of liver-stomach disharmony syndrome,accounting for43.75%,13 occurrences of spleen deficiency and qi stagnation syndrome,accounting for 20.31%,and 8 occurrences of mixed cold and heat syndrome,accounting for 12.50%.There were 6 cases of spleen-stomach deficiency and cold syndrome,accounting for 9.38%,6 cases of spleen-stomach weakness syndrome,accounting for 9.38%,and 3 cases of spleen-stomach damp-heat syndrome,accounting for 4.69%.(4)According to the four types of drugs,warm drugs were used 234 times,accounting for 42.39%;mild drugs were used 154 times,accounting for 27.90%;cold drugs were used 150 times,accounting for 27.17%;hot drugs were used 9 times,1.63% %;cool drugs 5times,accounting for 0.91%.According to the classification of five flavors of medicines,bitter medicines were used 293 times,accounting for 33.49%,pungent medicines were used 293 times,accounting for 33.49%,sweet medicines were used 219 times,accounting for 25.03%,sour medicines were used 68 times,accounting for 7.77%,and salty medicines were used 293 times,accounting for 33.49%.times,accounting for 0.23%.The main meridian is the spleen meridian,with a total of 459 times,accounting for27.26%;followed by the lung meridian,with a total of 308 times,accounting for 18.29%;stomach meridian 270 times,16.03%,heart meridian 162 times,9.62%,liver meridian 157 times,9.32%,gallbladder meridian 96 times,5.70%,large intestine meridian 74 times,4.39%,kidney meridian 70 times,4.16%,triple burner meridian 44 times,2.61%,small intestine meridian 24 times,1.43%,bladder meridian 19 times Time,1.13%,pericardial meridian 1time,0.06%.(5)The core combination of commonly used medicine pairs(support set to 16,confidence level to 0.8)has a total of 13 pairs,among which Radix Paeoniae Alba and Bupleurum are the most,23 times,followed by Chenpi,Radix Paeoniae Alba,20 times;Zhigancao,20 times;Codonopsis,Poria,19 times;Chenpi,Bupleurum,19 times,in descending order.(6)Through cluster analysis(the number of clusters is set to 6),6 core combinations of prescriptions for the treatment of functional dyspepsia were obtained,among which core combination 1: roasted licorice,jujube,ginger,cassia twig,Bupleurum,Radix Paeoniae Alba,Angelica,Cyperus Cyperi;Core Combination 2: Yinchen,Malt,Tangerine Peel,Skullcap,Pinellia,Radix Paeoniae Alba,Licorice,Bupleurum;Core Combination 3: Atractylodes Rhizome,Poria,Corydalis Corydalis,Citrus Citrus,Codonopsis,Amomum,white peony root,licorice;core combination 4: Codonopsis,tangerine peel,Poria cocos,ginger pinellia,fried Atractylodes macrocephala,amomum,roasted licorice,woody fragrance;core combination 5: codonopsis,dried ginger,berberine,skullcap,roasted licorice,jujube,firewood Hu,Zhifu;core combination 6: tangerine peel,white peony,Bupleurum,aurantium,Codonopsis,roasted licorice,woody,Cyperus.Conclusions:(1)The lesion location of FD is mainly in spleen and stomach,involving liver and spleen much more.(2)The disease is dominated by deficiency,and the syndrome of deficiency and accumulation is common.(3)The pathogenesis is "spleen deficiency Qi stagnation,stomach disharmony."(4)FD syndrome differentiation was more common in syndrome of disharmony between liver and stomach,followed by syndrome of spleen deficiency and qi stagnation,followed by syndrome of mixed cold and heat,syndrome of spleen and stomach deficiency and cold,syndrome of spleen and stomach weakness,and syndrome of dampness-heat of spleen and stomach.(5)The main treatment of FD is to relax the liver and strengthen the spleen and stomach,and to strengthen the spleen and qi.(6)The selection of drugs to warm and sweet products into the spleen meridian,warm and tonifying the spleen and stomach to strengthen the acquired nature;Spicy,scented medicine can be dispersed,line gasification lag.Stomach disharmony can use Xin,sweet,bitter and warm drugs,xin open bitter,sweet and warm tonifying,in order to reduce turbid qi,spleen and stomach.(7)In the prediction of new prescription,bupleurus Shugan powder could be considered as the basic prescription for addition and reduction of the syndrome of liver and stomach discompatibility.Common drugs could be used as new prescription 5(Tangerine peel,Fructus aurantii,paeoniae alba,bupleurus bupleurus,Radix odoratum,Radix xylosa,Ligusticum Chuanxiong and Radix liquorice).For the syndrome of spleen deficiency and qi stagnation,Xiangsha Liu Junzi Decoction could be considered as the basic prescription,and new prescription 1(Codonopsis codonopsis,fried white art,prepared licorice,poria,tangerine peel,ginger pinellia,sand kernel,bupleurum)could be used as the common medication.(8)General conclusions: Combined with the results of meta-analysis and data mining of TCM inheritance computing platform,general conclusions are as follows: Compared with Western medicine,TCM treatment of FD has advantages in total clinical effective rate,cure rate,somatostatin(SS),gastrin(GAS),total TCM symptom score,epigastric pain,epigastric distension,belching and regurgitation,poor feeding,adverse reactions and recurrence rate.FD syndrome differentiation is mostly seen in the syndrome of disharmony between liver and stomach.The drug selection is mainly to take sweet and warm products into the spleen meridian,and warm up the spleen and stomach to strengthen the acquired nature.In the prediction of the new formula,the addition and reduction of Chaihu Shugan powder can be considered for the syndrome of disharmony between liver and stomach,and the addition and reduction of Xiangsha Liujunzi decoction can be considered for the syndrome of spleen deficiency and qi stagnation. |
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