| Objective:On the condition that actual state of treatment based on syndrome differentiation (the "Treatment") by herb doctor is not disturbed, a forward-looking blinded randomized controlled trial (RCT) was designed to explore design methodology of efficacy evaluation of the Treatment and primary insomnia was taken as a paradigm to observe the feasibility of the research approach.Methods:In the research, the Treatment and blinded RCT were combined. At the first stage, theoretical research was conducted on how to apply internationally accepted blinded RCT design in efficacy evaluation of the Treatment. Later, key principles associated with randomization, placebo control and blinding were designed, and details of implementation and overall design flowchart of the research were given. At the second stage, primary insomnia was taken as a paradigm.3herb doctors were selected as research object respectively from each of the two research centers in Guang’anmen Hospital and Xiyuan Hospital affiliated to China Academy of Chinese Medicine Sciences. The herb doctors treated a total of116qualified subjects based on syndrome differentiation. The clinical research was in strict accordance with the design methods and schemes at the first stage, and rigorous randomization, placebo control and blinding design were adopted.Results:1.Clinical randomized controlled blind trial project: subjects need to accept various prescriptions of three physicians. Each subject took only one kind of Chinese Traditional Medicine or placebo prescribed by one physician. Key points of the program design including:(1) In order to maximally decreasing the bias might be present, we randomly grouped the order of the diagnosis treat by physicians and the treatment subjects respectively this research.(2) We set up the placebo control to achieve more accurate conclusion.(3) In order to prevent the influence of sedative-hypnotic drugs on efficacy which subjects might administer before they were included in the group, the washout period of a week was set in the research. At the end of the washout period, subjects were evaluated again according to inclusion criteria and exclusion criteria, and qualified subjects were formally enrolled in the group.(4) During the whole diagnosis and treatment, herb doctors were free from human disturbance and treated subjects based on syndrome differentiation and their conditions. They could choose or change the prescription on their own to cope with dynamic and complex features of the Treatment.(5) Case report form (CRF) was used to collect recorded data, which was then input and stored through online ClinResearch-a management system of clinical research data. The data concerning doctors’ syndrome differentiation and prescription in information observation form (IOF) was stored in structured clinical information collection system of TCM.(6) Project management team, clinical research team, diagnosis evaluation team and QC statistics team were set to ensure data quality and reliability of results in this research.2.Therapeutic effects by comparison of TCM group and placebo group:(1) Therapeutic effect of total sleep time:efficiency of TCM group was57.10%,53.50%of whose total sleep time had reached more than one hour, however, efficiency of placebo group was only15.00%.(2) Efficiency of the Pittsburgh Sleep Quality Index score:total effective rate of the criterion of therapeutic effect in the TCM group:37.50%, control group:10.00%.(3) Efficiency of integration of TCM symptoms:total effective rate in the TCM group:50.00%, control group:20.00%.3. Curative features of six TCM experts:Though the effect of doctors is different, all were superior to placebo. The effect of physician B and C were better than the others on the extension of total sleep time, shortening the sleep latency, raising the sleep efficiency, and improving the PSQI scores.4. Different doctors followed different diagnosis and treatment rules and medication features. The syndromes of insomnia that the doctors needed to treat were varied, but in general, most of them were liver depression, blood stasis, blood deficiency and kidney deficiency. Doctor A diagnosed and treated based on syndromes of blood and liver, among which blood deficiency, liver-yang hyperactivity, liver heat and liver depression were common TCM syndromes. Doctor B targeted at disharmony between heart and kidney, blood deficiency and internal heat due to yin deficiency. Doctor C targeted at uneasy soul and spirits, liver depression, spleen deficiency and blood stasis. Doctor D, doctor E and doctor F took blood stasis, liver depression, blood deficiency, kidney deficiency and qi (vital energy) deficiency as major TCM syndromes. Even if the results of syndrome differentiation were same, doctors would act differently in prescription selection and medication. All doctors were good at using Semen Ziziphi Spinosae, Chinese thorowax root, radix paeoniae alba, angelica sinensis and poria cocos to treat insomnia.Conclusions:1.This research established a randomized double blind controlled clinical study method base on the data of practical clinical Chinese traditional medical treatment that its therapeutic effect is fully guaranteed. This shows that it is feasible to evaluate the measurement of treatment effect on the fundamental rules of strictly implementing the randomized double blind controlled clinical study method and maintaining the dynamical dialectic together with complexity of Chinese medicine. The strict design of this randomized double blind controlled clinical study method and the Settings of the prognosis and therapeutic effect evaluation during washout period also could be used as the paradigm of Chinese traditional treatment in primary insomnia.2.The efficacy of herb doctors’treatment based on syndrome differentiation of primary insomnia was confirmed effective. Compared with placebo control group, the total sleep time of patients was greatly extended after4weeks’ treatment, proving that the Treatment can improve sleep quality, daytime dysfunction and symptoms and signs of TCM.3.Different doctors of traditional Chinese medicine, due to their different train of thought and experience of prescription medication, make different clinical prescriptions according to the variation of patients, time and illness. There may be a descrepency of the smell or dote of the medicine every time, but common rules underline the treatment for disease. |
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