| Purpose This research will include:use of TCM theory combined with modern research methods,a systematic review of all related literature and basic clinical experiences, an investigation into the clinical efficacy and mechanisms of XiaoYaoSan JiaWei in treating "liver depression with blood vacuity and stasis" type of insomnia,and a verification of the correctness and feasibility of these theories.Data 90 cases of"liver depression with blood vacuity and stasis"type of insomnia were collected from the Taipei NanTong Allied Traditional Chinese Medical Clinic,during a period from September 2006 thru September 2007(including 30 male patients in Group A, and 60 female patients in Group B).In group A there are 15 patients aged 41-60(Group A1),15 patients aged 30-40(Group A2);in group B there are 30 patients aged 41-60 (Group B1),and 30 patients aged 30-40(Group B2).The overall average age is 42.19±8.92. The average age of Group A1 is 48.80±5.11,Group A2 is 34.73±3.02,Group B1 is 50.50±5.37,and Group B2 is 34.30±3.38.Research Methods Use of self comparison before and after treatment,and a separate observation of the effectiveness of XiaoYaoSan JiaWei on 90 insomnia patients from groups A1,A2,B1,and B2.Selection criteria were based on classical insomnia symptoms, standard TCM diagnosis,the standard of TCM pattern identification,and a PSQI score higher than 7.To verify accompanying depression and anxiety both SDS and HAMA scores were established.Additionally scores from the Graded TCM pattern classification system, the Pittsburgh sleep Quality Index,the Self-Rating Depression Scale,and the Hamilton Anxiety Scale were coded and entered into the computer to set up a database.Statistics After completion of data coding and entry into the computer datatabase, statistics software was used to perform data analysis,data measurement used the((?)±S) indicator and t-test.Treatment efficacy was based on the Decreased score rate= [(Pre-treatment score - Post-treatment score)÷Pre-treatment score]×100%.Results一,TCM Symptom Classification(一)TCM Symptom Classification Pre-treatment and Post-treatment scores: 1.Total Cases:Pre-treatment score was 28.33±5.13,Post-treatment score wasl 4.80±7.45,a difference of 13.53±3.28。2.Group A1:Pre-treatment score was 25.20±3.49,Post-treatment score was 12.874±5.30,a difference of 12.60±2.89。3.Group A2:Pre-treatment score was 29.33±5.17,Post-treatment score was 16.20±7.71,a difference of 13.13±3.45。4.Group B1:Pre-treatment score was 25.63±3.89,Post-treatment score was 12.93±5.42,a difference of 12.70±2.72。5.Group B2:Pre-treatment score was 27.24±4.85,Post-treatment score was 14.30±6.77,a difference of 12.97±3.12。(二)TCM Symptom Classification Effectiveness:1.Total Cases:Marked Recovery Rate 49.17%(44 cases),Total Efficacy Rate 91.67% (82 cases)2.A1 Group:Marked Recovery Rate 40.00%(6 cases),Total Efficacy Rate 93.33%(14 cases)3.A2 Group:Marked Recovery Rate 60.00%(9 cases),Total Efficacy Rate 93.33%(14 cases)4.B1 Group:Marked Recovery Rate 40.00%(12 cases),Total Efficacy Rate 86.67% (26 cases)5.B2 Group:Marked Recovery Rate 56.67%(17 cases),Total Efficacy Rate 93.33% (28 cases)After performing the t-test,the marked recovery rate of Groups A2 and B2 TCM symptom classification effectiveness surpassed that of Groups A1 and B1.But the overall efficacy rate(p＞0.05),was without notable difference.二,PSQI(一)PSQI Pre-treatment and Post-treatment scores:1.Total Cases:Pre-treatment score was 15.78±1.67,Post-treatment score was 9.46±3.36,a difference of 6.32±2.34。2.Group A1:Pre-treatment score was 16.10±1.67,Post-treatment score was 10.40±3.36,a difference of 5.81±2.19。3.Group A2:Pre-treatment score was 15.50±1.71,Post-treatment score was 9.00±3.93, a difference of 6.19±2.83。4.Group B1:Pre-treatment score was 16.03±1.66,Post-treatment score was 9.90±2.77, a difference of 6.17±1.81。5.Group B2:Pre-treatment score was 15.55±1.59,Post-treatment score was 8.77±3.41, a difference of 6.70±2.58。After performing the t-test,all groups showed a marked difference in pre-treatment and post-treatment scores(P＜0.05) (二)PSQI Overall Efficacy Rate Post-treatment1.Total Cases:Marked Recovery Rate 33.33%(30 cases),Total Efficacy Rate 82.22% (74 cases)2.Group A1:Marked Recovery Rate 13.33%(2 cases),Total Efficacy Rate 80.00%(12 cases)3.Group A2:Marked Recovery Rate 46.67%(7 cases),Total Efficacy Rate 86.67%(13 cases)4.Group B1:Marked Recovery Rate 20.00%(6 cases),Total Efficacy Rate 76.67%(23 cases)5.Group B2:Marked Recovery Rate 50.00%(15 cases),Total Efficacy Rate 86.67% (26 cases)Because total score 1,total score 2 showed no notable difference in pre-treatment and post-treatment(P＞0.05),therefore the total score one of the PSQI overall efficiency rate post-treatment was used in calculations.After performing the t-test,Groups A2 and B2 overall efficacy rate surpassed that of Groups A1 and B1(P＜0.05).三,SDS Score(一)Total Cases:Pre-Treatment score 65.70±8.38,Post-Treatment Score 52.03±7.67, a difference of 13.74±5.86.(二)Group A1:Pre-Treatment score 66.60±5.65,Post-Treatment Score 52.67±8.84,a difference of 14.60±6.60.(三)Group A2:Pre-Treatment score 66.60±6.50,Post-Treatment Score 51.47±7.12,a difference of 15.13±3.77.(四)Group B1:Pre-Treatment score 66.47±8.79,Post-Treatment Score 52.57±7.58,a difference of 13.90±6.56.(五)Group B2:Pre-Treatment score 63.93±9.58,Post-Treatment Score 51.47±7.62,a difference of 12.47±5.31.After statistical analysis,the pre-treatment and post-treatment SDS scores show a very remarkable difference(P＜0.05)四,HAMA Score(一)Total Cases:Pre-Treatment score 16.12±4.64,Post-Treatment Score 10.38±3.83,a difference of 5.88±2.74.(二)Group A1:Pre-Treatment score 17.33±5.00,Post-Treatment Score 10.53±4.29,a difference of 6.80±2.74.(三)Group A2:Pre-Treatment score 14.40±3.30,Post-Treatment Score(四)10.20±3.39, a difference of 4.20±2.20.(四)Group B1:Pre-Treatment score 18.07±4.98,Post-Treatment Score 10.97±4.14,a difference of 7.43±2.63. (五)Group B2:Pre-Treatment score 14.43±3.58,Post-Treatment Score 9.80±3.35,a difference of 4.70±1.93.After statistical analysis,the pre-treatment and post-treatment HAMA scores show a very remarkable difference(P＜0.05)。All of the groups showed;(一)In TCM symptom classification effectiveness:1.There is a marked difference in the TCM symptoms and classification(insomnia,depression, irritability,heart palpitations,dizziness,vertigo,lusterless facial complexion,fullness or swelling in the chest,loss of appetite,bound stool)between pre-treatment and post-treatment scores.2.In TCM symptom classification effectiveness every group showed marked difference between pre-treatment and post-treatment;Groups A2 and B2 marked recovery rate surpassed that of Groups A1 and B1(P＜0.05),but the overall efficacy rate (P＞0.05)is without notable difference.As far as the marked recovery rate,this clearly shows that the young groups(A2 and B2)have faster results when using this formula than the older group(A1 and B1),but the overall efficacy rate is more similar.(二)As far as the PSQI Post-treatment effectiveness:All the groups showed a marked difference between pre-treatment and post-treatment scores.But after performing a t-test,Groups A2 and B2 marked recovery rate surpassed that of Groups A1 and B1(P＜0.05).From(一)and(二) the results showed:Groups A1 and B1 are older with a weaker constitution,blood vacuity, vacuous and limp spleen qi,and a slower intestinal absorption than the younger groups, therefore the marked recovery rate of Groups A2 and B2 was not as outstanding.But after using the "nourishing blood and fortifying spleen" formula,the pre-treatment and post-treatment efficacy rate showed a remarkable difference.Discussion Because current clinical research methods are lacking sufficient objective indicators to reflect healing efficacy of insomnia,therefore the use of a simple and easy to use,highly reliable and valid,and more relevant than the frequently used sleep EEG test results can better understand the patient's sleep quality,sleep latency,sleep duration,sleep efficiency,sleep disorders,use of medication and day time functioning.The Pittsburgh Sleep Quality Index(PSQI)and the TCM symptom classification scale bring together the healing efficacy indicators of the main symptoms of insomnia.Because insomnia is often paired with symptoms of anxiety and depression,which often have mutual influence,this study will also use a depression scale(SDS),an anxiety scale(HAMA)bringing in efficacy indicators.There is a positive correlation between PSQI,SDS,and HAMA scores,the more severe the insomnia,the more severe the depression and anxiety.Therefore this study uses more rational and scientific indicators in evaluating insomnia patient's quality of sleep, depression,and anxiety.Currently sleeping pills are the common form of clinical treatment,normally taken after the evening meal,but leading to daytime sleepiness,fatigue,and other side effects.In treating insomnia,the best choice is to correct evening sleeping patterns,and at the same time maintain alert daytime functioning and also maintain the natural circadian rhythm. Western medicine's sedative-hypnotic medication may cause some side effects;such as dry mouth,dizziness,loss of appetite,daytime "hangover" response,dependence on medication, memory impairment,rebound insomnia,an so on.As compared with the toxic side effects of western medicine and the harmful reactions,Chinese medicine's safety and effectiveness has been confirmed by long-term clinical experience.This study uses XiaoYaoSanJiaWei, which can soothe the liver and relieve depression,nourish the blood and fortify the spleen, quicken the blood and quiet the spirit,directed at the physiological characteristics of the liver,effectively resolving liver depression with blood vacuity and stasis,and therefore its use can achieve more ideal results in clinical treatment of insomnia.Conclusions In accordance with the increasing rate of insomnia,domestic and international research of insomnia is also increasing.Western medicine believes that the incidence of insomnia is related to malfunctioning of the control mechanism of the sleep-wake cycle.In recent years the research and development of new drugs has proven effective,but there are still more side effects,especially the problem of drug dependence which is still yet to be resolved.Traditional Chinese Medical treatment emphasized the importance of the pattern classification system and regulation of the whole body through adjustments in the bowels and viscera,the qi and blood,balance of the yin and yang helping the patient to obtain normal regular sleep.Through the study and analysis of related classical and modern literature and an understanding of the process of onset of insomnia, liver depression with blood vacuity and stasis should be regarded as the main pathogenic factor.The clinical use of XiaoYaoSanJiaWei Decoction with it's soothing the liver and relieving depression,fortifying the spleen and nourishing the blood,and quickening the blood and quieting the spirit treatment principles on 90 patients showed outstanding results. This shows that XiaoYaoSanJiaWei can improve clinical symptoms,promote sleep quality, and at the same time improve accompanying depression and anxiety of insomnia patients.
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