System Evaluation Of Traditional Chinese Medicine Therapy For Menopause Insomnia

【Research Purpose】As one frequent disease in gynecology, symptoms of menopause insomnia is one series of physiological and pathological changes arising from the attenuation of nephric qi (energy). As the symptoms will be presented in light and grave level, it is essential for those ones who will be affected by those symptoms to receive treatment actively. In curing insomnia, modern medicine practices the use of sleep induction agents or sedative-hypnotic drug for the therapy. Despite the rapid and strong effectiveness for the two, it gives rise to certain side effects that lurks addiction and rebound. In the therapy to cure menopause insomnia, endocrine is one drug used frequently. Despite its certain effects, a long-term intake will make patients vulnerable easily to high incidence rate of uterine cancer, ovarian cancer, and breast cancer. In curing menopause insomnia, a treatment through Chinese medicine therapy, however, poses no such worry that consequently makes it to be accepted widely. Volumes of literatures and references about Chinese medicine therapies have recorded the satisfactory curative effects to menopause insomnia through Chinese medicines.This research conducts the quality analysis of scientific research design on the clinical literatures about the treatments to menopause insomnia by Chinese medicines. In light with the principles and methods of clinical epidemiology/DME, a "Review Form on System of Literature About the Treatments to Menopause Insomnia through Chinese Medicines" is enacted, and the areas cover the general symptoms of such disease, standards of incorporation and elimination, conditions of control, sample size, inter-group balance and conditions for the use of control drug, randomized status, condition of the application of blind method, application of statistical method, standardization of testing factors, and standards to judge curative effect, etc. The literatures are ones of randomized control clinical research about the treatments to menopause insomnia by Chinese medicine therapy published in domestic medicine journals from 1994 to 2007. As these literatures are further conducted the evaluation, researches conformed to the conditions are then conducted the quantitative Meta analysis prior to giving an objective evaluation and summarizing the existing problems posed for scientific research tasks and clinical trials of Chinese medicine and the insufficiency, thus being served as the basis and ground for methods of research design for the same prospect researches in the future as well as for instructing the clinical policy decision to find the effective therapeutic methods by Chinese medicines. Under Professor Hsiao-Yun Wang' s instructions, we conduct this research.【Research Methodology】Data and Methodology1. The clinical researches into the treatments to menopause insomnia by Chinese medicine therapy published in domestic medicine journals literatures are the research subjects. The research purpose of standard of incorporation (1) is to compare the clinical researches into the treatments to menopause insomnia by Chinese medicine therapy, sleeping pills, non-specific Western medicine, placebo or control group; (2) the research is randomized control trial (RCT) or semi-RCT or self-assumed RCT (whatever if the method is practiced); (3) the standard of curative effect takes recovery and effective rate as the indicators of curative effect as they reveal the consistent standards of curative effect, or the evaluation index of curative effect takes sleep scale index.2. Search strategy: Searches of literatures are conducted by means of electronic and manual methods. Data from e-search include China BioMedical Bibliographic Database (CBM disc) (1994-2007) and TCMLRS (1994-2007). CBA adopts topic and free-form-text searches, while the former one takes "menopause insomnia" as the title and "Chinese Medicine Therapy," "Therapy of Chinese Medicine & Pharmacy," and "Acupuncture Therapy" as the sub-titles; for free-form-text search, #1 represents "Menopause Insomnia" and "Insomnia," # 2 represents "Chinese Medicine" or "Chinese Pharmacy" or "Chinese Medicine & Pharmacy," and # 3 represents # 1 and # 2, i. e. the findings; TCM adopts the document type of "Randomized Control Trials" (RCT) to search the term "Menopause Insomnia" and checks the references from the searched ones (in particular summarized references) to find any deficiency or omission. Manual search conducts the search for randomized control literatures about the treatments to menopause insomnia by Chinese medicine therapy published from Jan to April 2007.3. Data extraction and quality assessment: Two researchers conducted the selection of literatures and data extraction independently prior to carrying out the cross checking. The researchers then reviewed any incompatible literatures and then had a discussion to bring feasible solutions. The researchers would consult experts over the solutions, if necessary. Articles published under the same clinical trial are incorporated into one. The quality of method incorporated into the research adopts Jadad scale as the scores for RCTs range from 1 to 5 (1-2 as low quality research, 3-5 is the high quality one). The failure to make a report about cases of withdrawal and failed control and the withdrawal reasons by non-blind alternate allocation semi-randomized trial will get a score of "0." The randomized allocation scheme hiding adopts the scoring methods specified in Cochrane manual, and the statistical software uses Revman4.1 offered by Cochrane Collaboration. 4. Statistical analysis: Measurement data uses OR, while continuous variables adopts weighted mean difference, both are presented by 95% confidence intervals CI. Then carry out the heterogeneous inspection toward each result of trail. If there is any heterogeneity existed, adopt the random effects model, and on the contrary, use fixed effects model. Conduct sensitivity analysis between random effects model and fixed effects model and between high quality literatures and poor quality literatures, while funnel plot analysis takes OR of curative effect between experimental group and control group in Meta analysis as the abscissa (x) and takes logOR as the ordinate (y) to draw funnel plot and analyze the distribution pattern of the collected clinical research data, judging that if it exists any publication bias.ResultsGeneral situation and quality: Among those 2865 pieces of literatures acquired through electronic and manual searches, 11 of them with the term "Randomized" or "Control" or "Grouped" or "Contrast" about treatments to menopause insomnia by Chinese medicine therapy upon passing the reading title and abstract are selected. Following the circumspect reading of those 11 articles, there are three to be not in conformity to the incorporated standards that are eliminated, eventually leaving 8 pieces of articles. Evaluation standards for the curative effects on most of those 8 articles are diverse, thus leading to different judgment grading. When conducting cumulative meta analysis, sieve 5 literatures with the unanimous recovery rate and the controlled drug to be diazepam and conduct the data-consolidation analysis, 2 literatures with the unanimous recovery rate and nonspecific therapy by Chinese patent medicines are conducted the consolidation analysis, and there has no any literature about the analysis and controlled therapy by placebo. This research also conducts the evaluation of randomized control quality on the 8 literatures, while the 8 trials are low-quality ones, no any literature adopts blind method, all have not involved in concrete randomized schemes, all have not made the report about the hiding of randomized schemes, and all incorporated literatures have not delineated the cases of failed control and withdrawal. The consolidated findings on the control trails of the 8 literatures about Chinese medicine and Western medicine therapy reveal that the recovery rate for the Chinese medicine therapy to treat menopause insomnia is significant than that of the group treated by Western medicines, and the difference shows the statistical meaning. The number of recovered patients in experimental and control group are 289/319 (90.59%) and 198/266 (74.43%), the heterogeneous inspection p=0.66 that can be deemed as the 8 researches with different qualities, thus selecting random effects model (it is not necessary to illustrate for the following application, and just follow such principle), 0R3.55, 95%CI [2.20-5.73], and P＜0.00001. In the improvement of the insomnia, the findings for 5 literatures on the controlled triais by Chinese medicines and Estazolam tablets therapy show that the recovery rate on the treatments to menopause insomnia by Chinese medicine therapy is higher than that by Western medicines, and the difference has the statistical meaning as the number of recovered patients in experimental and control group are 195/218 (89.44%) and 124/167(74.25%), the heterogeneous inspection p=0.52, that can be deemed as the 5 researches with different qualities; thus selecting random effects model. In the comparison between the therapy by Chinese medicines and the therapy by Estazolam tablets, the difference shows statistical signification (3.18, 1.08-5.65, P=0.52); the findings for 2 literatures on the controlled trials by Chinese medicines and Chinese patent medicines therapy show that the recovery rate on the treatments to menopause insomnia by Chinese medicine therapy is higher than that by Western medicines, and the difference reveals no statistical meaning (4.44, 1.49-13.25, P=0.20). In the course of therapy, the two literatures reveal explicitly that it shows no poor reaction to the group treated by Chinese patent medicines, and there has no any description to poor reactions for the remaining literatures. Funnel Plot and Analysis of FindingsDraw the funnel plot (Figure 1) according to the data of the selected articles, taking OR as the abscissa (x) and standard error logOR as the ordinate (y). Findings shows the incorporated research is in skewed distribution by taking truth as the center, while it can be recognized that the certain published bias may be existed.ConclusionAccording to Meta analysis in the treatments to menopause insomnia by Chinese medicine therapy, the curative effect of experimental group is more effective than that of the control group. Despite that the Meta analysis illustrates the findings are reliable, it is still not enough. Conclusions from the convincing Meta analysis with high strength of evidence will be decided by the point that if it has high quality RCT. Quality for the incorporated 8 pieces of clinical research literatures used for the Meta analysis in this research is still far from satisfactory.In view of the preceding points, I recognize that the quality for methods of clinical research into the treatments to menopause insomnia by Chinese medicine therapy shall be valued. In point of the current situation for the published literatures about the treatments to menopause insomnia by Chinese medicine therapy, despite that quality of method of the clinical research is not valued, it will be valued with the advancement of time and the rise of evidence-based medicine, and, furthermore, it may give rise to the emergence of more such literatures. It is expected that there are adequate volume of quality RCT literatures to help verify the findings by this research.