| Objectives1.To systematic cevaluate the contemporary acupuncture literature on HDB,in order to explore evidence based medicine on clinical curative effect research of HDB used method bleeding stasis collateral combined with cupping.2.To conduct randomized controlled trial,evaluate the bleeding stasis collaterals combined with cupping method' clinical effect to the people who has a HDB and the eeffect on serum estradiol(E2),progestone(p),prolact in(pRI),in order to support new idea and scheme for clinical research on HDB.Methods1.The study of ancient literatureTo research on the views of modern bibliography experts,select key words and bibliography of ancient books,set a standard to ensure a literature taken in or not,form the Information Collection of Ancient Books of HDB,input and set up the database by Epidata3.1,administrate and analysis the information by SpSS13.0.The Content analysis is applied as the main study method.2.Modern literature system evaluationTo research randomized controlled trials with TCM external therapy of HDB,which published in formal academic journals since thevarious internal and external database setted,in order to conduct quality assessment and Meta-analysis.To evaluate objectively the clinical effective of TCM external therapy of HDB,and the existed problems and deficiency at present study,and what need to improve.Confirm the Chinese key words,which are "????or????or???or????or??"and"??or??or??or??" and"??or????or?????or????",combined and retrieved.The selected database consist of Medline or pubmed(1984-2015),Database(1984-2016);Chinese Biology Medical disc(CBMdisc)(1984-2016);Chinese periodical full text database(CNKI Web:www.cnki.net)(1994-2016);Wan Fang resource database(1984-2016).The English key words consist of "Hyperplasia of mammary glands" or"Mammary gland nodules" or "Lacteal painful diseaseorBreast cyst"or"rupi"and"Stab winding or bleeding or pricking blood orcupping" and "randomized controlled trials" or" clinical trials or prospective studies".and so on.Conduct system statistics and Meta analysis or separate descriptive analysis by Rev Man 5.3.3.Clinical researchThe patients who suffered from HDB visit at cl inic of Breast Diseases and traditional therapy center in Guangdong province hospital of TCM.According to the clinical trial treatment related statistical requirements,combined with clinical practice and the cases of withdrawing,loss follow-up,eliminating,according the list by date of right cases randomly divided into one treatment group(group A:28 cases)and two control groups(group B:26 cases;group C:24 cases)by the information of cards in the same number of envelopes.TreatmentSingle-blind Randomized Controlled TrialGroup A:Blood-letting puncturing and cupping group:effect on the point of QimenGroup B:Chinese medicines group:Take "Xiaopi" oral liquids,take one or two every time,three times a day,stop at menses,taking drugs last two menstrual cycle.(Group C:Acupuncture group,select acupoints which belonged to Liver,Stomach,Spleen Meridians on Acupuncture and Moxibustionpublished inpublic Health publishing House.Theses acupoints include Wuyi,Rugen,Danzhong,Tianzhong,Jianjing,Qimen.CourseGroup A:Blood-letting puncturing and cupping group:twice a week,two months for a course of treatment.Group B:Chinese medicines group:Take "Xiao-pi" oral liquids,take one or two every time,three times a day,two months for a course of treatment.All groups stop treatments on the female menstrual periods.ResultsClinical researchThree groups of patients with HDB were treated 8 weeks after treatment,9 shedding cases,3 shedding cases in A group,4 shedding cases in B group,2 shedding cases in C group.The factual cases included 28 cases of A group,26 cases of B group,24 cases of C group.(1)Baseline analysisBefore treatment,in order to determine the comparability of the results of the three groups,compare the age,course of disease,symptom scores of the three groups,a non-significant statistically difference between all of groups was indicated(p>0.05).(2)Treatment total score ComparisonCompare the total score of the three groups with rank Sum Test and mono factor analysis of variance before treatment,including the comparison oflump in breast(p=0.224>0.05),the comparison of breast pain(p=0.322>0.05),the comparison of symptoms(p=0.760>0.05).A non-significant statistically difference between all of groups was indicated.Compare the total score of the three groups with rank Sum Test and mono factor analysis of variance after 8 weeks treatment,the comparison of breast pain(p=0.000),the comparison of symptoms(p=0.001),A significant statistically difference between all of groups was indicated.the comparison of lump in breast(p=0.143),a non-significant statistically difference between all of groups was indicated.Compare of total score with rank Sum Test and mono factor analysis of variance after one month follow-up,the comparison of breast pain(p=0.000),the comparison of symptoms(p=0.000),A significant statistically difference between all of groups was indicated.the comparison of lump in breast(p=0.126),a non-significant statistically difference between all of groups was indicated.Comparison of total score difference before and after treatment with rank Sum Test,the comparison of breast pain(p=0.000),the comparison of symptoms(p=0.000),A significant statistically difference between all of groups was indicated.the comparison of lump in breast(p=0.100),a non-significant statistically difference between all of groups was indicated.Comparison of the total score of the three groups before and After one month of follow-up with rank Sum Test,the comparison of breast pain(p=0.000),the comparison of symptoms(p=0.000),A significant statistically difference between all of groups was indicated.the comparison of lump in breast(p=0.067),a non-significant statistically difference between all of groups was indicated.(3)The comparison before and after treatmentIn the treatment group,the symptoms were tested by paired T-test,the comparison of symptoms(p<0.05),except the symptoms with lump in breast(p=0.0083),irritability(p=0.663),soreness and weakness of waist and knees(p=0.264),menstrualcyeledisorder(p=0.183),hypomenorrhea(p=0.713),which indicated the improvement of symptoms after the treatment.Compared post-treatment and 3 months follow-up,except the symptom with lump in breast(p=0.326),other symptoms included breast pain,increased before menses and relieeved after menses,fullness in chest and hypochondrium,irritability,soreness and weakness of waist and knees,intolerance of cold and coldlimbs,lassitude,irregular menstruation,hypomenorrhea,whose index p value is less than 0.05,which indicated the improvement of symptoms after cessation of treatment.In thel group B,the symptoms were tested by paired T-test,the comparison of symptoms(p<0.05),except the symptoms withbreast pain(),increased before menses and relieved after menses(p=0.327),irritability(p=0.161),intolerance of cold and cold limbs(p=0.327),lassitude(p=0.083),irregular menstruation(p=0.327),which indicated the improvement of symptoms after the treatment.There is no obvious difference from the symptoms with lump in breast,soreness and weakness of waist and knees,hypomenorrhea.Compared post-treatment and follow-up,except the symptom withincreased before menses and relieved after menses(p=0.083),stuffiness and oppression in the chest and rib-side(p=0.327),intolerance of cold and cold limbs(p=0.083),lassitude(p=0.083),hypomenorrhea(p=0.083),there are improvement of symptom with breast pain(p=0.043)after cessation of treatment.There is no obvious difference from the symptoms with lump in breast,irritability,soreness and weakness of waist and knees,hypomenorrhea.In thel group C,the symptoms were tested by paired T-test,except the symptom with irregular menstruation(p=0.328),other symptoms of p value less than 0.05,which indicated the improvement of symptoms after the treatment.There is no obvious difference from the symptom with lump in breast.Compared post-treatment and follow-up,except the symptom with increased before menses and relieved after menses(p=0.083),stuffiness and oppression in the chest and rib-side(p=0.185),irritability,intolerance of cold and cold limbs(p=0.083),lassitude(p=0.083),irregular menstruation(p=0.328),other symptoms with breast pain,soreness and weakness of waist and knees,hypomenorrheaof p value less than 0.05,which indicated the improvement of the three symptoms after the treatment.There is no obvious difference from the symptom with lump in breast.(4)Comparison of serum hormone.After 8 weeks of treatment,compare serum hormone levels between the three groups.Compare blood estradiol contents by single factor equation analysis,which conducted before and after therapy.The statistics(p<0.05)in group A and group C,the differencewas statistically significant;the statistics(p>0.05)in group B,the difference wasnot statistically significant.Compare the serum progesteronebefore and after therapy,the statistics(p<0.05)in group A and group B,the difference was statistically significant,the statistics(p>0.05)in group C,the difference was not statistically significant.Compare blood levels of prolactinbefore and after therapy,the statistics(p>0.05)in group A,group B and group C,the difference was not statistically significant.Conclusion1.Through the evaluation on modern literature system of blood-letting puncture and cupping,it is known that is effective to conduct blood-letting puncture and cupping on Qimen to treat HDB,and no adverse effect was observed.However,because of the low level of evidence,the conclusion argument should be strengthen2.Clinical studies of HDB treatment by blood-letting puncture and cupping on Qimen show that the symptoms with breast pain,hypomenorrhea,soreness and weakness of waist and knees,which indicated the improvement of symptoms after cessation of treatment.Therefore,blood-letting puncture and cupping on Qimenpossesses a good perspective in clinical use and is valuable for popularizationon account of fewer side effects. |
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