| ObjectivesThe purpose of this study was to learn the status of herbal periodic treatment for hyperplasia of mammary glands, benefit the clinical and the research workers. By analyze the quality of the randomized control trials, learn the problems of the research methods about the researches, and try to provide a standardized reference for clinical study of the future. Finally, probe the effectiveness of the treatment with the method of systematic review, for providing codes for clinical application and research of herbal periodic treatment for hyperplasia of mammary glands of the future.MethodsFirstly, search the literatures about the herbal periodic treatment for hyperplasia of mammary glands, which published in domestic journals, with the data base of CNKI(1979-2010year) and VIP(1989-2010year), and then analyze the research situation, stating, medication and therapeutic method of the herbal periodic treatment with the bibliometrics analysis. Secondly, by making the "Literature Evaluation and Information Collection Table about herbal periodic treatment for hyperplasia of mammary glands", analysis the randomized control trials.The evaluation of content includes the research methodology and the professional research details. Thirdly, According to the systematic review methods of Cochrane, evaluate the randomized control trials of herbal periodic treatment for hyperplasia of mammary glands, the statistical software uses RevMan5.0.18 offered by Cochrane Collaboration.Result一,On Bibliometric analysis(一) general situation Altogether picks out the quantity of literatures is 77, published in 45 journals, of which 26 literatures (33.8%) were published in 18 core journals. 77 literatures include 59 literatures of clinical trials,11 literatures of experience, and 7 literatures of summary and theory. And the earliest literature is Harmonize the Flush and Conception Vessel Meridians for Treating Hyperplasia of Mammary Glands, which published on Shanghai Journal of Traditional Chinese Medicine on 1987.(二)on staging, medication and therapeutic methodExclude the 7 literatures of summary and theory, analyze the 70 literatures of clinical trials and experience.56 (80%) literatures resolution periodic treatment mainly, combing syndrome differentiation treatment.And 14 (20%) literatures treat with syndrome differentiation mainly, and combing periodic treatment.The literatures of treating by pre menstruation and pos menstruation 2 periods are the most, up to 38(54.29%). And literatures of treating by pre menstruation, pos menstruation, menstruation and intermenstrual 4 periods are 14(20%), literatures of treating by pre menstruation, pos menstruation, and intermenstrual 3 periods are 8(11.43%). The partition of each period is not uniform. According to the statistical analysis of the frequency of Chinese medicine, in pre menstruation, the kinds of Chinese medicine commonly used are "soothe the liver and regulate qi", "dissipate phlegm promote" and "activate the blood and remove the stagnation", and the main therapeutic methods are "soothe the liver and regulate qi, disperse accumulation and alleviate pain", "activate the blood and remove the stagnation, dissolve phlegm and disperse accumulation" and "soothe the liver and replenish the kidney, harmonize the flush and conception vessel Meridians". In pos menstruation, the kinds of Chinese medicine commonly used are "replenish the kidney and strengthen yang" and "nourish the blood and replenish yin", and the main therapeutic methods is "replenish the kidney, harmonize the Hlush and conception Vessel Meridians, accompanied by soothe the liver and nourish the blood". In menstruation, the main kinds of Chinese medicine are "activate the blood", "dissolve phlegm" and "regulate menstruation", and the therapeutic method is "activate the blood and remove the stagnation, dredge the meridians", which is uniform. In intermenstrual, the main kinds of Chinese medicine are "nourish the blood", "regulate qi" and "replenish the kidney", and the main therapeutic method is "replenish the kidney, harmonize the Hlush and conception Vessel Meridians"二. the quality of randomized controlled trials evaluatingExclude the literatures which are not randomized controlled trials, there are 33 literatures which are randomized controlled trials to be evaluated the quality.(一) on study designFirstly,23 literatures mention the word "randomization", but none of the literatures does not describe the detailed methods, and none of them describes the concealed random assignment. Secondly, none of essays has the description of blind method. Thirdly, none of the literatures has mentioned or carried on the estimation of sample size. Most of them can use the authority diagnostic criteria to determine the research target,2(6.06%) literatures use the diagnostic criteria made themselves while 3 (9.09%) literatures even haven't standards criteria at all. Almost all the literatures are not rigorous with the sample selection,32(96.97%) literatures haven't the standards on adoption on whilel 25(75.76%) literatures haven't the standards on adoption. Finally, most of the literatures can use the authority effect criteria On baseline characteristics,25(75.76%) literatures have carried on baseline characteristics, and 8 (24.24%) literatures.(二) on research designFirstly, in the specific treatment methods, the most studied is Chinese medicine decoction, about 21 literatures (63.65%). The literatures of Chinese patent drug, Chinese medicine and TAM, Chinese medicine decoction and external treatment each have 3, total of 9(27.27%). In the description of staging,24 literatures (72.73%)have detailed description of each stage of time, while 9 literatures don't described in detail nor described in the literature. Meanwhile,24 literatures(72.73%) treat by pre menstruation and pos menstruation 2 periods,8 literatures(24.24%) treat by pre menstruation, pos menstruation, menstruation and intermenstrual 4 periods. Secondly, little at-tention paid on the description of adverse reaction 26(78.79%) literatures do not mention it. Fifthly, only 7 (21.21%) literatures mention the follow-up visiting simply.(三) on statistical methods 17 (51.52%) literatures don't mention the statistical methods at all.13 (39.40%)literatures have test statistics and P value, but are lack of the specific value.3 literatures only have test statistic without P value, and 17(51.51%) literatures just have P value c without test statistic.三,the results of meta analysisMeta analysis shows that Chinese medicine periodic treatment is more effective than aperiodic treatment.ConclusionThe evaluating results of the literatures show the quality of the randomized controlled trials is low, many problems remain on both the research methods and professional techniques. Meta analysis shows that Chinese medicine periodic treatment is more effective than aperiodic treatment, but with the low quality of literature that may cause unreliable conclusion. Except that there will be high quality literatures which include completely randomized double-blind controlled clinical trial. The literatures about herbal periodic treatment for hyperplasia of mammary glands are few, showing that the therapy has not yet developed and widely used in clinical. Since this study included the limited literatures, how to stage, what's the specific of staging, what's the therapeutic method and how many periods is more effective, a lot of randomized controlled clinical trials need to answer. |
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