Research On Clinical Literature Of Hardness-softening And Masses-resolving Therapy

1 Objective:This article systematicly collected all ancient and modern literature on the clinical application of the soft-hardening method.Then we analyze internal laws and external features of the literature,which can guide the clinical and scientific research.Sanjie Zhentong Capsule is a kind of Chinese patent medicine with the effect of"hardness-softing,phlegm-resolving and analgesic".To evaluate the effect of Sanjie Zhentong capsule on endometriosis compared with gestrinone capsule,we conduct the evidence-based medicine meta-analysis.2 Research Methods:The study was divided into three major parts.The first two major parats were ancient and modern literature on the clinical application of the hardness-softing method.In the third part,based on the modern application we choosed endometriosis as feasible disease.Besides we used meta analysis method to evaluate the efficacy and safety of Sanjie Zhentong capsule in the treatment of endometriosis.The first part of this article mainly used computer to retrieve the fifth edition of the "Chinese Medical Clssics".In order to ensure the authenticity of the source documents,we choosed related library books to proofread the source documents.Then,the included documents were extracted into Excel forms according to the seven categories of dynasty,disease,prescription,Chinese medicine,writings,and the original text.Further more,the items were standardized and marked according to standards and textbooks.We established the ancient database,and performed descriptive statistical analysis.As a result,the study discussed the analysis results by using TCM theory.The second part of the study choosed the Chinese Journal Full-text Database(CNKI),Wanfang Database(WF),the VIP Chinese Science and Technology Periodical Database(VIP),the Chinese Biomedical Literature Database(CBM),and Pubmed as the search scope.The target literature was the clinical study which selects the hardness-softing method as main interventions.According to the data extraction table,the data of the year of inclusion,type of document,sample size,suitable disease,compound treatment,treatment measures,type of formula,absence of control,and adverse reaction report were extracted into the Epidata software.Then,we imported the data into an excel table and standardize the entries.We established modern database,and used Spss21.0 software for descriptive statistical analysis.In the third part,according to the established search strategy,we searched documents in the Chinese Journal Full-text Database(CNKI),Wanfang Database(WF),VIP Chinese Science and Technology Journal Database(VIP),China Biomedical Literature Database(CBM),Pubmed,and Cochrane Library.A randomized,controlled trial of Sanjie Zhentong Capsules versus gestrinone capsules in the treatment of endometriosis was conducted.Besides we performed data extraction and quality evaluation on the included literature.In order to compare the efficacy and safety of Sanjie Zhentong Capsules in the treatment of endometriosis with gestrinone capsules,we used Revman 5.3 software for statistical analysis.3 Research results:1.The external features of the ancient clinical application of Ruanjian Sanjie:The method of hardness-softing originated from the Yellow Emperor's Internal Classic Su Wen,and was explicitly proposed in the Han Dynasty.It involved 248 ancient works of Ruanjian Sanjie and 9 of them were more than 20 times in frequency,all of which were herbal works.The included ancient documents cover 1176 clauses.2.The rule of syndromes and cures in ancient clinical application of soft-firm dispersal method:There were 109 kinds of diseases in the disease spectrum of hardness-softing and masses-resolving method.Which included internal,external,gynecological,fetal,and ent diseases.The corresponding proportion of disease in each subject were:44%,37%,8%,2%,and 9%.The dominant diseases were:phlegm,goiter,mass,scrofula and carbuncle.There were 158 kinds of traditional Chinese medicine related to hardness-softing and masses-resolving method,and high-frequency representative drugs such as Glauber's salt,Pinellia,Fritillaria,Prunella vulgaris,seaweed,forsythia,honokiol,oysters,radix ampelopsis,and rhizoma belamcandae.131 prescriptions were related to the soft-hardening method,while the distribution of prescriptions was relatively scattered.The formulas used more than 5 times were Daxianxiong decoction,Xiaoxianxiong decoction,Dachengqi decoction,Fangfeng Sanjie decoction,and Xianfang Huomian decoction respectively.All of which were eliminating evil prescriptions.3.The external features of the literature on modern clinical application of the soft-hardening method:Since the first clinical study of the soft-hardening method was published in 1976,there have been 578 studies in the period of about 40 years till March 2017.The study included 62,385 subjects and the average sample size was 108.These clinical studies included randomized controlled trials,clinical non-randomized controlled studies,case series studies,and case reports.Randomized controlled studies accounted for approximately 48.4%.Throughout the literature,it could be seen that Chinese medicine alone accounted for 61.9%,and Chinese and Western medicine combined therapy accounted for 38.1%.However,in the clinical randomized controlled study,Chinese medicine alone used 44.3%,and Chinese and Western medicine combined treatment accounted for 55.7%.There were seventy clinical studies(14.2%)showed no adverse reactions and 320 clinical studies(64.8%)did not report adverse events.4.The rule of syndromes and governance of the modern clinical application of soft-hardening method was as follows:The soft-hardening method involves 16 system diseases,and the top three were urogenital diseases,tumors,and endocrine diseases.The dominant diseases were breast hyperplasia,endometriosis,uterine leiomyoma,lung cancer,thyroid nodules,vocal nodules,adenomyosis,cirrhosis,ovarian cysts,and gastric cancer.In addition to the use of soft-hardening method alone in the treatment,it could also combined with pathogenesis combined with blood activating,Liqi,sputum resolving and other methods to form a composite treatment.The prescriptions used by modern clinical research institutes were modern prescriptions,self-prescriptions,experience prescriptions,in-hospital preparations,ancient prescriptions,and unreported prescriptions.About 32.2%studies had not report the origin of prescriptions.There were 469 clinical studies(94.9%)with exact results.5.Sanjie Zhentong capsules versus gestrinone capsules for endometriosis:a systematic review of randomised controlled trials.A total of 15 RCTS involving 1739 patients with endometriosis were identified.Six trials were Sanjie Zhentong capsules versus gestrinone capsules,while nine studies were based on laparoscopic conservative surgery Sanjie Zhentong capsules versus gestrinone capsules.The results of the study were as follows:The Sanjiezhentong capsule group was superior to the gestrinone group in clinical efficiency.There were no significant difference in pregnancy rate,adverse reactions,recurrence rate,and dysmenorrhea relief.Laparoscopic surgery combined with Sanjietongtong Capsules were superior to laparoscopic surgery combined with gestrinone capsules in terms of pregnancy rate.There were no significant differences in clinical efficacy,adverse reactions,relapse rates,and relief of dysmenorrhea.The methodological quality of the included literature was low.Most of the studies did not clearly explain the blinding method and the allocation of hidden solutions.All of them were domestic studies.The sample size was low.The sample size of the individual experimental group and the control group varied greatly,and the grouping may had a certain degree.Arbitrary,there may be selection bias,so the analysis of the results of this study should be cautious,we still need high quality clinical randomized controlled trials to further verify the conclusions of this study.4 ConclusionIn ancient times,the method are used in the application of a wide range of hardness-softing and masses-resolving methods.Common dominant diseases are phlegm and fluid retention,goiter,mass,scrofula,carbuncle.Besides,dysfunction of the organs which account for qi stagnation,blood stasis,phlegm,toxic accumulation,may also be treated with hardness-softing.Such as blemishes,acne,dermatitis,rickets,cough,edema,etc.The commonly used drugs are Glauber's salt,Pinellia,Fritillaria,Prunella vulgaris,seaweed,forsythia,honokiol,oysters,radix ampelopsis,and rhizoma belamcandae.Prescription are scattered distributed.Modern clinical studies have shown that clinicians are increasingly aware of the importance of evidence-based medicine.Clinical randomized controlled studies with higher levels of evidence have gradually increased.But due to multiple reasons,the report is still not regulated.The hardness-softing method has certain advantages in the treatment of mammary gland hyperplasia,endometriosis,uterine leiomyoma,lung cancer,thyroid nodule and other diseases.When it comes to disease with local pathological product formation or accumulation,if the general treatment is not effective,you can try to use the hardness-softing method.In clinical practice,it is feasible to applied separatly or combined with blood activating,Liqi,sputum resolving and other methods to form a composite treatment.Compared with gestrinone capsules,Sanjie Zhentong Capsules may have certain advantages in clinical efficiency in the treatment of endometriosis.Laparoscopic combined with Sanjie Zhentong Capsule is superior to laparoscopy combined with gestrinone capsules in pregnancy rate.However,due to the small sample size,there is a large difference between the sample size of individual experimental group and control group.There may be some randomness in grouping,and there may be selection bias.Therefore,the analysis of this research result should be cautious,and high quality clinical randomized control is still needed.