individualized treatment with traditional chinese medicine for the patients with insomnia disorder: a cohort study

Conditions: Sleep Initiation and Maintenance Disorders

Summary: the primary purpose of this study is to discover, establish and refine the individual treatment protocol of each tcm expert for insomnia, and to explore what characteristics of the patients are considered with the corresponding treatment in clinical practices. the secondary purpose is to determine the effectiveness of tcm pattern differentiation treatment for the patients with insomnia.

traditional chinese medicine (tcm) has been effectively and instantly used for keeping chinese people's health over 2000 years. recently the tcm is becoming popular and well known home and abroad due to its effectiveness and individualized treatment. it has been known that tcm practitioners diagnosed, give the treatment and evaluated patients' health condition with symptoms and signs, what are called tcm patterns. this is why tcm practitioners always consider and emphasize the importance of tcm patterns in the tcm education and clinic practices. at the same time, tcm pattern differentiation is considered complicated and difficult to understand, due to the difference of tcm practitioners'clincal experience and knowledge. the one ,who has more experience and knowledge, treat patients more effective than the other. unlike modernized medicine, drugs are not always recommended for the diseases, conversely, the tcm practitioners and their knowledge are always recommended. in addition, young tcm practitioners have to follow and imitate the experts who are full of knowledge, if they want to be good ones. from these views, the experience and knowledge of experts are important and crucial to the clinical outcomes, meanwhile they are hard to discover and establish. therefore, we package the experts and their treatment as the one target to discover, establish and refine the individual treatment protocol (experience and knowledge) of each tcm expert, and to explore what characteristics of the patients are considered with the corresponding treatment in clinical practices. the prerequisite of the study is that experts chosen for the study are the ones who are the specialists on the insomnia treatment. so, the secondary purpose is to determine the effectiveness of tcm patter differentiation treatment for the patients with insomnia.

Eligibility criteria:
inclusion criteria: 1. patients with the diagnosis of insomnia; 2. patients' age between 18 and 65 years (18 and 65 years included); 3. patients with the oral or written informed consent. exclusion criteria: 1. patients with any uncontrolled and severe diseases which cause insomnia will be excluded. the diseases may include heart disease (like angina, cardiac arrhythmias, heart failure, myocardial infarction), pulmonary disease (copd, asthma), gastrointestinal disorders (stomach or duodenal ulcers, reflux disease), neurologic disorders (seizures, spastic torticollis, blepharospasm, dystonias, parkinson's disease, alzheimer's disease, dementia, sleep-disruptive headaches), head trauma (blow to the head with loss of consciousness, concussion), pain disorders (fibrositis/fibromyalgia, arthritis, muscle cramps, chronic low back pain, headaches), endocrine and metabolic disorders (thyroid disease, diabetes), kidney disease (kidney failure with dialysis, kidney stones) autoimmune disorders, cancer, and hiv/aids. 2. psychopath with suicidal tendency; 3. patients with pregnancy and lactation.

Keywords: insomnia traditional chinese medicine herbal medicine cohort study individualized treatment tcm pattern differentiation