Chinese medicine treatment of breast cancer - evidence-based
medicine analysis of domestic literature
【Abstract】 Objective To study the Chinese medicine treatment of breast cancer status and problems of clinical literature. Method according to EBM standards,
Chongqing PubMed Result NCBI full text database from 1995 to 2003 nine years, Chinese medicine treatment of breast cancer literature survey and evaluation. The results of inspection on the 118, including therapeutic papers 71, fish out RCTs / CCT
papers 27, and of questionable quality. Conclusion China's breast cancer medicine treatment RCTs / CCT quantity and quality can not meet the needs of clinical practice.
Key words Chinese medicine; breast cancer; Evidence-Based Medicine
Traditional Chinese medical treatment of breast cancer: an evidence-based
medicine analysis of domestic literature
【Abstract】 Objective To evaluate articles about traditional Chinese medical treatment of breast cancer. Methods Articles about traditional Chinese medical
treatment of breast cancer since from 1995 to 2003 in Chongqin VIP database were retrieved and evaluated according to the principle of EBM. Results There are some quality defects in 118 articles containing 71 therapeutic articles and 27 RCTs / CCT.
Conclusion The quantity and quality of RCTs / CCT of breast cancer's traditional Chinese medical treatment did not meet the need of clinical practice.
【Key words】 TCM; breast cancer; evidence-based medicine
With the medical model from a purely biomedical model to the community - the
psychological - changes in bio-medical model, clinical behavior from the past in order to increase the theoretical knowledge with personal experience as a guide to evidence-
based medicine based on a paradigm shift .
Evidence-based medicine require doctors to collect the latest and greatest scientific basis, according to the quality of these studies can be divided into five grades: 1,
according to a specific disease-specific therapies to collect all kinds of good quality randomized controlled trials of the system made after the assessment or Meta -
Analysis (systematic reviews and Meta-analyses); 2 level, a single sample is large
enough randomized controlled trials (randomized controlled trials); 3 level, with the control group but the study group with the random method (case-controlled studies) ;
4, no control group, a series of cases observed (case-series); 5 level, expert opinion
(expert opinion) . In order to understand Chinese medicine treatment of breast cancer research papers written by the status quo, is of Chongqing PubMed Result NCBI database contains full text of the relevant Chinese medicine treatment of breast
tumors analyzed and reported the following papers.
1 Materials and methods
1.1 The sources of information from 1995 to 2003, Chongqing PubMed Result NCBI full text database.
1.2 Retrieval of "breast cancer", "breast cancer", "breast cancer", "breast cancer"
and "Chinese medicine", "Chinese Medicine Therapy", "TCM Law," "Chinese Medicine" as a keyword search. Search strategy is as follows:
((((K = breast cancer) + (K = breast cancer) + (K = breast cancer) + (K = breast
tumor) × ((((K = Chinese medicine treatment) + (K = Chinese medicine) + (K = TCM France) + (K = Chinese medicine therapy).
1.3 inclusion criteria (1) to determine standards for therapeutic research papers: The five cases of patients over the study object; use of one or more of treatment; to
observe the effect of the main purposes. Where, A: case-series: meet the clinical
research standards; to observe the effect of the main purposes; no control group or only one type of intervention. B: RCTs: in line with clinical research standards; over
the same period of two or more interventions; the subjects when divided into different treatment groups were randomly assigned to describe the adoption of specific laws, or only marked with "randomized" but did not describe the those specific methods. C:
CCT: meet the clinical research standards; compared two kinds, a variety of interventions, the subjects were divided into different treatment groups when the semi-
random distribution method (for example, under a hospital order, hospital number,
date of birth, day of the week and so on alternately assigned to treatment group or control group) or can not determine the distribution method. (2) non-therapeutic
research papers to determine criteria: A: case-report: 1 ~ 4 patients were studied; use
of one or more of treatment; to observe the effect of the main purposes. B: expert opinion: Experts for their treatment of our experience and review.
1.4 Analysis of the first papers on the query to be determined according to inclusion
criteria, grouped into five categories: Expert Opinion; Case-report; Case-series; CCT;
RCTs. Then for all RCTs / CCT papers relating to sample size, random distribution, and blind adoption of control measures, case inclusion criteria and exclusion criteria,
comparability of baseline data in each group tested to determine standards of efficacy, adverse reaction reports, follow-up time and lost to follow-case reports for analysis.
2.1 The general situation in Table 1. Table 1 from 1995 to 2003 Chinese medicine
treatment of breast cancer research papers classified status (omitted)
Find this study a total of 118 traditional Chinese medicine treatment for breast
cancer research articles, treatment, research papers 71, non-therapeutic research
papers 47. Therapeutic research papers, 15 randomized controlled trials [3 ~ 17], accounting for 21.13%, clinical controlled trials of 12 [18 ~ 29], accounting for 16.90%, the series of cases observed 44, accounting for 61.97%; non-therapeutic research paper,
reported 10 cases, accounting for 21.28%, the expert experience of 37, accounting for 78.72%.
2.2 access to the 27 RCTs / CCT quality articles, in Table 2. Table 2 read 27 RCTs / CCT research papers article quality analysis (omitted)
The incidence of breast cancer increased year by year, in the treatment, Chinese medicine for benign breast tumor, breast cancer have a unique post-operative recovery,
especially in recent years, chemotherapy combined with traditional Chinese medicine
methods in clinical application is very broad, in the relevant journal published articles on clinical treatment. However, able to provide the correct guidance of clinical randomized controlled trials of the article are not many, and the quality of the article,
there are some problems, are as follows.
3.1 The random method described in the description of random methods of RCTs findings will help readers to judge the authenticity and credibility, effectively eliminate
the Study of confounding factors, in order to infer causal relationships to provide the most powerful evidence, and it allows researchers the process of standardization . The distribution of patients should be truly random, rather than writing random.
Among the 15 RCTs access to the article, only a random indication method (pumping letter law), the rest are only "random" words, there is no record of a specific random method, resulting in the findings of the authenticity, practicality as well as papers
quality be affected.
3.2 random imbalances between the two groups after the imbalance to some extent reflect the quality of random, if the data is not balanced between the two groups, we can not rule out the impact of certain non-test factors and interference. Of the
accessible 27 RCTs / CCT articles, only five (18.52%) reported the information imbalance between the two groups are given specific data, and made the relevant statistical analysis, while other articles described only in terms of between the two
groups comparable, did not give the probability of inspection, it can not determine whether the baseline comparability of tests.
3.3 The object of study inclusion and exclusion criteria of the diagnostic criteria, as well as a description of inclusion and exclusion criteria, will help readers better understand the representativeness of the study and practical. The inspection of the 27 RCTs / CCT articles with reference to the relevant meetings of the designated clear diagnostic criteria, but no clear inclusion / exclusion criteria were 25 (92.6%), the result difficult to be repeated and the use of others. Reposted elsewhere in the paper for free download http://
3.4 statistical analysis, statistics analysis is indispensable to the medical research
report, an important part of the statistical description of the data just is not enough to do, but also the need for parameter estimation and hypothesis testing, so that inferences can be enough information on the general characteristics of the sample. The inspection
of the 27 RCTs / CCT articles, there are 24 (88.89%) carried out a statistical analysis, P
values are listed, but only 14 (51.86%) A description of the statistical methods, numerical data multi-purpose t test, grade, multi-purpose data χ2 inspection, a few
with Ridit (2 Pian) analysis or statistical software analysis (3), but did not explain the basis for selection of statistical methods.
3.5 Most of the other study only focused on short-term effect, while for long-term
efficacy due to inadequate attention to follow-up of only six (22.22%), no research has
lost to a report, another report adverse reactions were 9 (33.33 %). Pairs of Chinese medicine treatment of breast tumors using a placebo and blinding is almost impossible,
unless it can be done formulations reform.
The basis of the principles of evidence-based medicine literature reviews have shown
that Chinese medicine for benign breast tumor, breast cancer have a unique post-
operative recovery, especially in recent years, the treatment of chemotherapy combined with traditional Chinese medicine widely used in clinical and achieved a certain effect, but the quality and level of study is not high, in terms of quantity and quality can not meet the needs of clinical practice, need to further strengthen the clinical epidemiology and evidence-based medicine and universal education.
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