Chinese medicine treatment of breast hyperplasia of the quality evaluation of literature
Authors: Lai Xi-wen, Liu Xiaoyan, Song Xinghua
【Abstract】 1997 ~ 2008 published in Chinese medicine treatment of breast hyperplasia in the clinical research literature to retrieve the collection, according to clinical epidemiology / DME approach and the principles of evidence-based medicine to develop evaluation form, right in line with randomized controlled trials (RCT ) and non-randomized
controlled trials (CCT) of the literature on quality evaluation. The results showed that met the inclusion criteria of the literature has 130; right into the qualitative analysis of the literature suggests that such literature, research design programs are not standardized. Prompt medical treatment of hyperplasia of mammary glands of the literature quality to be improved.
Key words breast hyperplasia / TCM therapy; literature quality assessment
The incidence of hyperplasia of mammary glands in women of childbearing
age is about 40%, accounting for 75% of breast disease . Research data show that, with work and lifestyle changes, the incidence of the disease there is a rising trend in recent years , its occurrence the risk of breast cancer than in healthy women with a high 1 4 ~ 1 5 times
 . Therefore, hyperplasia of the breast-depth and extensive research to
find effective prevention and treatment programs, has some practical significance. In this study the collection, collation and analysis from
1997 to 2008 of Chinese Medicine Treatment of hyperplasia of mammary glands of the literature, traditional Chinese medicine treatment of hyperplasia of mammary glands of clinical research and the validity of a preliminary quality evaluation.
1 Data and methods
1 1 Source
Collection of Chinese Biomedical Literature CD-ROM (CBMdisc)
Chongqing PubMed Result NCBI databases and full text database, VIP Chinese Science and Technology journals published between 1997-2008 on Chinese
medicine treatment of hyperplasia of mammary glands of the literature. CBMdisc database search strategy: to take words with subheadings [expand all the tree] of the retrieval method. Database Filter Search Type: fibrocystic breast hyperplasia [expand all tree] / Chinese medicine,
Chinese medicine therapy or traditional Chinese medicine therapy; or: milk addiction [expand all tree] / Chinese medicine, Chinese medicine therapy or TCM. Detection literature 1260 titles. Chongqing PubMed Result NCBI VIP Chinese Science and Technology Journals Full-text database search
strategy: to take the title, keywords and authors combining retrieval method. Documents were found in 1160.
1 2 literature inclusion and exclusion criteria
1 2 1 ? literature study inclusion criteria for the diagnosis
of breast hyperplasia patients, treatment measures for Chinese medicine treatment; ? study design as follows: randomized controlled trial (RCT) and non-randomized controlled trials (CCT); ? contains a single-blind or
a word, double-blind clinical trial.
1 2 2 ? supplement literature exclusion criteria, data
compilation of literature; ? case reports, lessons learned, theoretical
study, review, summaries and other documents; ? acupuncture, massage,
diet types of literature; ? Experimental Study of Literature and other
1 3 evaluation methods and content of
Controlled clinical trial evaluation of content: reference to our hospital developed by the Chinese medicine treatment of systemic evaluation of the quality and information literature evaluation form (Note: This table is based on clinical epidemiology / DME methodological principles and methods, from evidence-based medicine Methods Research
Group of the Organization of several clinical epidemiology experts and
received DME training clinicians to engage in collective discussion, after several trial and improvement of unified and standardized compiled), developed mammary hyperplasia of traditional Chinese medicine literature quality Evaluation of information collection form. Include an examination of the object selection, the study diagnostic criteria and the determination of inclusion and exclusion criteria between the two groups balanced comparison, sample size, randomization method, blind, controlled,
statistical methods, efficacy evaluation criteria, adverse drug reactions
so many aspects.
2 1 general
Chinese science and technology periodicals CBMdisc PubMed Result NCBI database with the two libraries combined, after excluding repeat the part of the bibliography were found in 1154. Having read the title and summary, to reject a synthesis of lessons learned to study the theories, experimental research, case reports, clinical research literature to be included in a total of 137. The actual number of 130 to obtain documents and information share of 94 9% (130/137); and 130 meet the above
inclusion criteria for quality assessment of literature. 130 clinical literature of 76 species found in the journal. No clinical multi-center
collaborative research report. 130 clinical research literature, 104 is a RCT, accounting for 80%; CCT 26 articles, accounting for 20%.
2 2130 Pian controlled clinical trial quality of program design
2 2 1 diagnostic criteria 35 (accounting for 26 9%) adopt
the "efficacy of TCM Syndrome Diagnostic criteria," 20 (accounting for 15
4%) used in 1987 China established the National Institute of Traditional Chinese Medicine Surgery diagnostic criteria, 7 (accounting for 5 4%) in line with the "Chinese Medicine Clinical Research Drug guiding principles" of the diagnostic criteria, 3 adopt the "Chinese
traditional surgery," the diagnostic criteria; using a self-prepared
standards were 20 (accounting for 15 4%), the remaining 26 has no clear
2 2 2 inclusion and exclusion criteria 26 (20%), literature has a clear inclusion criteria, 21 (accounting for 16 2%) have a clear
exclusion criteria, 44 (accounting for 33 8%) not listed in literature
out the inclusion criteria, 88 (accounting for 67 7%) not listed in the
2 2 3 effects determine the criterion-referenced Class ?
standard (international conferences, national academic institutions, the various professional committees, the Ministry of Health, the State Pharmaceutical Administration and other government departments to develop
standards) to the highest of 89 ( accounted for 68 5%), followed by a
30 (accounting for 23 1%) using a self-prepared standards, one
(accounting for 0 7%) use of internationally recognized standards, one (accounting for 0 7%) with type ? (textbooks, scholarly books,
developed by other authoritative standard), 9 (accounting for 6 9%) no
clear criteria to determine the efficacy. Reposted elsewhere in the paper
for free download http://
2 2 4 randomized quality of 27 (accounting for 20 8%) based
on randomized, of which there are 17 simple random, stratified random there are two, district randomly have two. 8 documents describe the randomization method of the error. There are nine semi-random, completely
random there are seven, there are five pseudo-random. Some studies
difference between the two groups the number of sample cases is too large (such as the number of two groups of cases were 168/60, 500/180, 130/66, 500/100). All the literature made no reference to random hidden.
2 2 5 In contrast, used in the utilization of contrast, 95 (accounting for 73 1%) in control basically rational, and the rest describe or unable to judge the reasonableness of the control.
2 2 6 sample size conditions unless there are two sample size