| IntroductionInsomnia is one of the most common sleeping disorders. It refers to a kind of subjective dissatisfied experience of patients to their sleeping time or sleeping quality, which even affects their daily social function. One of every10-12people around the world suffers from insomnia, it has became the first problem that hurt our health, lower our quality of life and reduce our efficiency of work. Currently, insomnia is assessed mainly according to the complaint of a patient and the inquiry of a doctor.In western medicine (WM), the management of insomnia includes non-drug therapy and drug therapy. Non-drug therapy like cognitive behavior therapy has shown reliable effect, it avoids the side effects of sleeping pills, but needs time to see the desired result. Drug therapy has short onset time, but causes dependence and a variety of side effects under long-term medication.Traditional Chinese medicine (TCM) has its advantage of stable clinical effect to regain normal sleep without adverse reaction in the treatment of insomnia. TCM performs individual therapy, emphasizes that man is an integral part of nature, searches for the primary cause of insomnia. TCM doctors treat insomnia through syndrome differentiation to dispel pathogenic factors that influence sleep, and recover the balance between yin and yang, qi and blood.Standard randomized controlled trial (RCT) evidences are not identical in mazy actual clinical practice. And the target of a special treatment in western medicine is a disease, but in TCM is a syndrome of a disease. To judge the effect of a TCM formula with western medicine criterion of therapeutic effect does not conform the theory of TCM, in which correspondence of a formula with its syndrome of a disease is advocated.TCM follows the same principle with qualitative research of natural property, inductive method, open character and holism concept. The author tried to combine both qualitative and quantitative methods in the investigation of clinical effect and superiority of modified Tianwang Buxindan for insomnia of heart-yin deficiency.Object1To explore the thinking model and academic properties of Professor Zhou Shaohua in his clinical application of modified Tianwang Buxindan.2To clarify the TCM "disease-syndrome" indications and contraindications of modified Tianwang Buxindan for insomnia of heart-yin deficiency.3To study the clinical effect of modified Tianwang Buxindan for insomnia of heart-yin deficiency.4To probe factors influence the clinical result of modified Tianwang Buxindan for insomnia of heart-yin deficiency.5To investigate the advantage of modified Tianwang Buxindan for insomnia of heart-yin deficiency, compared with western medicine.Method1Semi-structured interview was applied to Professor Zhou Shaohua, his3apprentice doctors and16insomnia patients treated with modified Tianwang Buxindan in the study. Cross case analysis and induction was proceeded with association comparison.2A prospective non-randomized controlled clinical trial of60cases was carried out among out-patients of insomnia of heart-yin deficiency. All subjects were orderly enrolled to herbal medicine group or western medicine group according to their personal intention. Patients to the TCM group were prescribed with modified Tianwang Buxindan, and patients to the WM group were prescribed with1-2mg of Estazolam.3Triangulation was used to prove mutually the above resultsResults1Understanding of Professor Zhou Shaohua to the etiology and pathology of insomnia in TCM:In modern society, young generations suffer more stress from their work and life. They overstrain their nerves, which injure the heart and consume blood, lead to insomnia. The key pathogenic location of insomnia is "heart". Liver, spleen and kidney are also affected. The critical pathogenic mechanism of heart-yin deficiency insomnia is "yin-deficiency". Professor Zhou Shaohua modified the ancient formula-Tianwang Buxindan to make it matched to the changed etiology and pathology of insomnia presently.2Understanding of Professor Zhou to the diagnosis and syndrome differentiation: Syndrome differentiation is more important than disease diagnosis for insomnia. Anxious emotion is more common than depressive emotion in heart-yin deficiency insomnia, and both impact sleep into a vicious circle. So it manifested in clinic with a syndrome of heart-yin deficiency. Professor emphasizes more of differentiation of symptoms and tongue picture for the recognition of heart-yin deficiency insomnia.3Characteristics of modified Tianwang Buxindan:(1) Herbs of cool property are selected to nourish yin.(2) Herbs with function to clear heart fire and relieve restlessness are added to the formula, which has action of anti-anxiety.(3) flowers to alleviate depression are added.(4) Sedative mineral medicine are needed to fortify action of tranquilization.4A retrospective survey of146cases shown the most common symptom of insomnia of heart-yin deficiency was difficulty to fall asleep, take up82.19%; then was shallow sleep,55.48%; early awakening and dreaminess were not so common among heart-yin deficiency insomnia patients.Difficulty to fall asleep, shallow sleep, fussiness and restlessness, anxiety, red tongue with thin yellow coating and thready pulse were found to be the key manifestations of the insomnia "disease-syndrome" for modified Tianwang Buxindan according to the analysis with optimization method, if the percentage of38.2%was taken as a cut point.5The result of prospective non-randomized controlled clinical trial shown the average subtraction score of PSQI in TCM group was8.97, and in WM group6.50; the average subtraction score of ISI in TCM group was4.86, and in WM group5.26.Although the values of PSQI, ISI, SAS and SDS in both groups before treatment were well balanced and comparable, the average TCM symptom scale score in TCM group was47.33±11.37, which was much higher than that in the control group, which was39.67±12.44. After treatment, the average TCM symptom scale score in TCM group went down to20.77±9.64, while in the control group to30.40±10.03.6Insomnia is a complicate neuropsychiatric disorder. Besides of the critical factor of appropriate differentiation and medication, there were some important factors also influence the clinical effect, such as the complication of somatic problems, past experience of western medicine, preparation and administration of herbal medicine, even the language, behavior could weigh in some degree.Conclusion1Modified Tianwang Buxindan was effective for insomnia, with superiority to western medicine Estazolam especially for heart-yin deficiency insomnia.2The effect of modified Tianwang Buxindan for insomnia was based on the right understanding of the etiology and pathology of insomnia of heart-yin deficiency. It is essential for better clinical result to make a correct syndrome differentiation and a proper modification of the formula.3The key manifestations of insomnia "disease-syndrome" for modified Tianwang Buxindan were as follows:Difficulty to fall asleep, shallow sleep, fussiness and restlessness, anxiety, red tongue with thin yellow coating and thready pulse.4From the view of TCM, a TCM doctor need not only to judge the effect of a formula for a special disease in WM, but also for a special TCM "syndrome". To value the effect of a TCM formula for a WM disease according to the WM criteria is not complete, nor proper. Modified Tianwang Buxindan has shown its superiority only for heart-yin deficiency insomnia, but not for insomnia generally, compared with western medicine.5Those insomnia patients would choose TCM decoction treatment in a TCM hospital might have more complicate situation. Modified Tianwang Buxindan might have an advantage for insomnia cases accompanied with somatic disorders or chronic multi-systematic illnesses. |
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