| Research purpose Insomnia is a common disease, but it is often difficult to treat, and gradually develop chronic insomnia, affect people’s work, life, learning and health, modern medical treatment of insomnia using sedative-hypnotics or sleep-inducing agent, although rapid onset the role of the strong, but there are some side effects, addiction and rebound. The Chinese medicine does not have this concern, widely accepted by people in ancient and modern medical literature, documented and reported in Chinese medicine for chronic insomnia is indeed effective.To fully understand the quality of medical treatment of chronic insomnia clinical literature, provide for future prospective studies of similar design methodology based on scientific research to guide clinical decision-making, which found a truly effective medical treatment methods. Under the guidance of Professor Ding Yanbing, we carried out the study.Research Methods With " chronic insomnia " as keywords / keyword retrieval can retrieve documents based on keywords earliest years- at home and abroad in 2014 published research on Chinese treatment of chronic insomnia clinical trial literature, selected on the basis ofquality assessment into the system clinical randomized controlled experimental study( 1) the article content for chronic insomnia : the inclusion criteria.( 2) the experimental group was pure Chinese medicine( dosage forms include soups, medicine preparations, etc.) treatment; control group therapy. According to the clinical epidemiology / DME principles and methods, development of " Western medicine treatment of insomnia Information System evaluation form " From the basic situation of the literature, the diagnostic criteria for the disease and the inclusion / exclusion criteria, experimental design(control cases, randomization methods, application blinded between groups at baseline conditions and control drug use, the sample size), interventions and medication situation, determine the efficacy of the use of standard statistical methods, quit and lost several aspects of case analysis, recording and analysis of side effects or adverse reactions, such as the reasonableness of the conclusions derived and systematically analyze,Calculate the percentage to evaluate its quality. On this basis, the use of comparative clinical efficacy of traditional Chinese medicine Rev Man for the treatment of chronic insomnia Meta- analysis; analysis published by funnel plot of the offset.The results( 1) systematic review In the retrieval of literature and reading the article, on the basis of 12 randomized controlled trials paper included in the standard. Literature generally: retrieve the 12 references is given priority to with Chinese medicine treatment of clinical randomizedcontrolled studies in the literature, there are funds supporters have 2 article, 16.7% of the total; On the source of the cases, there is no 2 description from outpatient or inpatient department, 16.7% of the total. 12 articles are in clinical research. On the category research units, with provincial above hospitals and research institutes, including various medical institutions and affiliated hospitals) is given priority to, a total of 12, other basic unit have 0. 12 articles are references. Diagnostic criteria: the disease is conforms to the diagnostic criteria of traditional Chinese medicine and western medicine diagnosis standard of 8, 66.7% of the total; Use only the article 8 of TCM diagnostic criteria, accounting for 66.7% of the total; Use only the diagnostic criteria of western medicine have 12 articles. In TCM diagnostic criteria adopted in country or industry standards, as promulgated by the state administration of traditional Chinese medicine "standard of disease diagnosis curative effect of traditional Chinese medicine" or "Chinese medicine new medicine clinical research guiding principles for the treatment of insomnia, or" adult insomnia diagnosis and treatment guidelines in China "or" insomnia in TCM clinical practice guidelines "seven articles, using the internal medicine of traditional Chinese medicine material standard of article 2;In western medicine diagnostic criteria adopted in country or industry standards, such as CCMD- 2- R, CCMD- 3, ICSD, China insomnia definition, diagnosis and drug treatment expert consensus with 12 articles. Inclusion criteria and exclusion criteria: 10 in the 12 articles were made clear and appropriate research purposes relatedinclusion criteria, 83.3% of the total, the rest is just 2 in description or the description is not detailed. For confounding factors may influence the formulation of standards out of 11, 8.3% of the total, the remaining 1 piece only scattered in the description. Outcome indicators and standard: definite curative effect for determining standard 9, 75% of the total, completely didn’t explain the curative effect of standard 2, 16.7% of the total. In 12 articles are outcome indicators, among them with PSQI, SDRS reduction rate, Mo CA scores for evaluation index has 9, 75% of the total, with symptoms as evaluation index of article 9, 75% of the total,At the same time using internationally recognized outcome indicators and 6 set at the national institutes of health indicators, 50% of the total. 12 articles were described mainly ending indicators and secondary indicators.Comparison: 12 references is given priority to with traditional Chinese medicine treatment of all research adopted control design. Sample(treatment group) : the content of sample determined not rigorous, only 1 piece of literature before the start of the experiment for the estimation of sample size and specify the calculation method. There is a clear case out standard with two references, 16.7% of the total. The treatment group sample size 8, 25 to 50 cases accounted for 66.7% of the total; 51-80 cases of article 4, 33.3% of the total. Equilibrium between groups are: 12 clinical randomized controlled trials on the baseline situation(age, gender, duration, take sleeping pills, etc.) on the basis of the comparison, it is pointed out in literature "comparable" or "P" > 0.05 there were12 articles, specify "balance" and other words have 2, 16.7% of the total. Randomization: the quality of the 12 study literature, to mention the word "random". Has 7 completely random method, accounts for 58.3% of the total, including six papers using random number table method, one piece of absence of specific use which completely random method, there are 3 article used false random method(according to the doctor order etc.), there are 2 article USES the "random" serial number, but no mention of specific methods, unable to judge whether it is right. No 1 article mentioned hidden allocation. Blind method of use: apply blind method of literature research rarely, only 1 piece by blind method, and the single blind, there is no article adopts double blind. Therapy: study by 12 articles are in Chinese medicine medicinal broth or proprietary Chinese medicine for treatment group, in terms of the standardization of experimental drugs, from the drug composition, dosage form, dosage, usage, period of treatment, party card is evaluated, which includes such aspects as preliminary think standardized good article 12. Using traditional Chinese medicine(TCM) or proprietary Chinese medicine as control group with 4, 33.3% of the total, adopting western medicine as control group of eight, 66.7% of the total. Exit, lost to follow-up and record and analysis of the case fall off: there are 2 article to eliminate standard are described, 16.7% of the total. To fall off, excluding 2 cases, accounting for 16.7% of the total, 10 other article for exit or lost to follow-up cases have no words to describe. Only three articles with appropriatefollow-up, 25% of the total. Only 2 article mentioned to take concrete steps to ensure compliance test subjects, 16.7% of the total. Statistical methods: the method is used in the chi-square test, t test, Ridit analysis, 12 articles to the statistical data processing, and illustrate statistical processing has 5, 41.7% of the total. Most failed to judge from article statistical method is correct or not, according to the judgment, most of the statistical methods using basic right, there are 12 in each P values are given, 11 article has carried on the statistical tests, accounting for 91.7% of the total, no specific P values are given. Ways to check all statistical analysis, and statistical analysis of prior to plan). The records of adverse reactions: in 12 articles, the adverse events were observed with 5, 41.7% of the total, including 2 study was not observed in the reaction of adverse events, 3 article gives some specific report(record each symptoms and the number of cases of adverse events, but not statistical inspection), the rest of the report. Other: neither during treatment for other medical treatment; 10 the score before and after the treatment compared; No 1 exit and lost to follow-up cases using an intention-to-treat analysis.(2) Meta analysis Screened using standard clinical criteria to take the same medicine of six clinical trials comparing Western literature, meta-analysis and literature do merge, acquire data. Determine the efficacy of the use of six " Chinese medicine treatment of insomnia clinical research guidelines," the efficacyof standard analytical studies : OR = 2.29 [1.47,3.56], a statistically significant test Z = 3.66, P = 0.0003. P <0.05 was statistically significant, indicating that the efficiency of the treatment group was significantly better than the control group, which displays traditional Chinese medicine treatment of insomnia have a good effect.In conclusion 1. Literature research quality analysis results show that: currently, more and more clinical researchers use epidemiological methods to design and research to the scientific research project, also found a lot of deficiencies, main performance in the application of epidemiological methodology is not enough attention, the standardization of clinical trials is poorer, clinical research conclusion is difficult to fully recognized. 2. Included in the articles of the Meta analysis results show that the traditional Chinese medicine treatment group effective than western medicine control group in the treatment of chronic insomnia, have very good prospects for treatment. In short,if they can have more good quality Chinese and Western medicine treatment of insomnia research articles appear, make higher future causal relationship between research demonstrated strength, expect the number of high-quality literature to completely randomized controlled clinical results of this study can be more of a confirmed progress, so as to better serve as a clinical decision. |
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